or = 55 years of age who were recently hospitalized with New York Heart Association class II or III CHF and with an ejection fraction of TM or health education ( HE ) group . MAIN OUTCOME MEASURES Primary outcome measure was six-minute walk test ; secondary outcomes were generic and disease-specific health-related quality of life , quality of well being , perceived stress , Center for Epidemiologic Studies Depression Scale ( CES-D ) , rehospitalizations , brain natriuretic peptide , and cortisol . Changes in outcomes from baseline to three and six months after treatment were analyzed by using repeated measures analysis of variance , covarying for baseline score . RESULTS For the primary outcome of functional capacity , the TM group significantly improved on the six-minute walk test from baseline to six months after treatment compared to the HE group ( P = .034 ) . On the secondary outcome measures , the TM group showed improvements in SF-36 subscales and total score on the Minnesota Living with Heart Failure scale . On the CES-D , the TM group showed significant decrease from baseline to six months compared to the HE group ( P = .03 ) . Also , the TM group had fewer rehospitalizations during the six months of followup . CONCLUSIONS Results indicate that TM can be effective in improving the quality of life and functional capacity of African American CHF patients . Further validation of outcomes is planned via a large , multicenter trial with long-term follow-up\",\n \"INTRODUCTION AND OBJECTIVES The objective of this study was to determine whether a home-based intervention can reduce mortality and hospital readmissions and improve quality of life in patients with heart failure . METHODS A r and omized clinical trial was carried out between January 2004 and October 2006 . In total , 283 patients admitted to hospital with a diagnosis of heart failure were r and omly allocated to a home-based intervention ( intervention group ) or usual care ( control group ) . The primary end-point was the combination of all-cause mortality and hospital readmission for worsening heart failure at 1-year follow-up . RESULTS The primary end-point was observed in 41.7 % of patients in the intervention group and in 54.3 % in the control group . The hazard ratio was 0.70 ( 95 % confidence interval [ CI ] 0.55 - 0.99 ) . Taking significant clinical variables into account slightly reduced the hazard ratio to 0.62 ( 95 % CI 0.50 - 0.87 ) . At the end of the study , the quality of life of patients in the intervention group was better than in the control group ( 18.57 vs. 31.11 ; P intervention for patients with heart failure reduced the aggregate of mortality and hospital readmissions and improved quality of life\",\n \"INTRODUCTION AND OBJECTIVES To determine the effectiveness of a primarily educational intervention in heart failure ( HF ) patients implemented in a home care unit . METHODS This r and omized controlled clinical trial involved 279 HF patients who were discharged from a tertiary-care hospital between February 2001 and June 2002 . Patients with dementia , terminal non-cardiac disease , or chronic obstructive pulmonary disease were excluded . Data collected included the cause of cardiac decompensation . A primarily educational intervention was implemented in the patient 's home for up to 15 days after hospital discharge . Treatment was adjusted during the first week if necessary . The primary outcome measure was the 1-year cumulative incidence of readmission or death . Secondary measures were the incidence of readmission , mortality , and emergency department admission . Telephone interviews were carried out 3 , 6 and 12 months after discharge , and clinical records were up date d when necessary . Emergency department admission in the first 6 months was monitored . RESULTS At 1-year follow-up , 62 of the 137 patients ( 45.3 % ) in the intervention group had been readmitted or died , compared with 75 of the 142 ( 52.8 % ) in the control group , ( relative risk=0.86 , P=.232 ) . Among patients who suffered decompensation because failure to adhere to treatment , 16 of the 45 ( 35.6 % ) in the intervention group were readmitted or died , compared with 34 of the 56 ( 60.7 % ) control group patients ( relative risk=0.59 , P=.016 ) . CONCLUSIONS This intervention is feasible but , when applied indiscriminately to every discharged heart failure patient , the best that can be expected is only a modest reduction in readmission and death rates , which , in this study in particular , did not achieve statistical significance\",\n \"BACKGROUND Despite the availability of proven therapies , outcomes in patients with heart failure ( HF ) remain poor . In this 2-stage , multicenter trial , we evaluated the effect of a disease management program on clinical and economic outcomes in patients with HF . METHODS AND RESULTS In Stage 1 , a pharmacist or nurse assessed each patient and made recommendations to the physician to add or adjust angiotensin-converting enzyme ( ACE ) inhibitors and other HF medications . Before discharge ( Stage 2 ) , patients were r and omized to a patient support program ( PSP ) ( education about HF , self-monitoring , adherence aids , newsletters , telephone hotline , and follow-up at 2 weeks , then monthly for 6 months after discharge ) or usual care . In Stage 1 ( 766 patients ) ACE inhibitor use increased from 58 % on admission to 83 % at discharge ( P dose ( in enalapril equivalents ) increased from 11.3 + /- 8.8 mg to 14.5 + /- 8.8 mg ( P Stage 2 ( 276 patients ) there was no difference in ACE inhibitor adherence , but a reduction in cardiovascular-related emergency room visits ( 49 versus 20 , P = .030 ) , hospitalization days ( 812 versus 341 , P = .003 ) , and cost of care ( 2,531 Canadian dollars less per patient ) in favor of the PSP . CONCLUSION Simple interventions can improve ACE inhibitor use and patient outcomes\",\n \"BACKGROUND Hospital admissions among patients with congestive heart failure ( CHF ) are a major contributor to health-care costs . Previous investigations suggest that the therapeutic efficacy of pharmacotherapy in CHF may be improved by strategies incorporating home visits to identify and address factors precipitating deterioration and result ant readmission . METHODS Chronic CHF patients discharged home after acute hospital admission were r and omly assigned usual care ( n=100 ) or a multidisciplinary , home-based intervention ( n=100 ) , consisting of a home visit by a cardiac nurse 7 - 14 days after discharge . The primary endpoint of the study was frequency of unplanned readmission plus out-of-hospital death within 6 months . FINDINGS During 6 months ' follow-up there were 129 primary endpoint events in the usual-care group and 77 in the intervention group ( p=0.02 ) . More intervention-group than usual-care patients remained event-free ( 38 vs 51 ; p=0.04 ) . Overall , there were fewer unplanned readmissions ( 68 vs 118 ; p=0.03 ) and associated days in hospital ( 460 vs 1173 ; p=0.02 ) among intervention-group patients . Hospital-based costs were Australian $ 490,300 for the intervention group and A$ 922,600 for the usual-care group ( p=0.16 ) ; the mean cost of the intervention was A$ 350 per patient , and other community-based costs were similar for both groups . INTERPRETATION A home-based intervention has the potential to decrease the rate of unplanned readmissions and associated health-care costs , prolong event-free and total survival , and improve quality of life among patients with chronic CHF\",\n \"HF is a leading health care concern , often under-recognized and under-treated in older women . Management of this complex condition frequently requires a multidisciplinary approach and a clinical pathway can be used to deliver coordinated care . This report is based on the intervention/treatment arm ( n = 45 ) of a r and omized controlled trial in older women who participated in a multidisciplinary clinic . We describe the development of a clinical pathway for HF and the variance reporting including factors affecting adherence with the pathway . Variances are patient or staff actions that did not meet the expected outcomes . Of the 45 intervention arm female patients , 5 were able to fully complete the program , meaning that all of the intended 12 visits were completed successfully . Thirteen women missed more than three clinic visits , and the rest attended most visits . Variance tracking identified that visits were interrupted most often by patient-related health issues , such as fatigue and pain , which may not be surprising given the expected multiple co-morbidities in this population . Transportation problems were identified as a barrier to attendance . Our study demonstrates that a clinical pathway can be implemented in an older , female population with HF . This report identifies some of the challenges and provides future recommendations for prospect i ve pathway development\",\n \"AIMS This paper is a report on the effectiveness of a self-management programme based on the self-efficacy construct , in older people with heart failure . BACKGROUND Heart failure is a major health problem worldwide , with high mortality and morbidity , making it a leading cause of hospitalization . Heart failure is associated with a complex set of symptoms that arise from problems in fluid and sodium retention . Hence , managing salt and fluid intake is important and can be enhanced by improving patients ' self-efficacy in changing their behaviour . DESIGN R and omized controlled trial . METHODS Heart failure patients attending cardiac clinics in northern Taiwan from October 2006-May 2007 were r and omly assigned to two groups : control ( n = 46 ) and intervention ( n = 47 ) . The intervention group received a 12-week self-management programme that emphasized self-monitoring of salt/fluid intake and heart failure-related symptoms . Data were collected at baseline as well as 4 and 12 weeks later . Data analysis to test the hypotheses used repeated- measures anova models . RESULTS Participants who received the intervention programme had significantly better self-efficacy for salt and fluid control , self-management behaviour and their heart failure-related symptoms were significantly lower than participants in the control group . However , the two groups did not differ significantly in health service use . CONCLUSION The self-management programme improved self-efficacy for salt and fluid control , self-management behaviours , and decreased heart failure-related symptoms in older Taiwanese out patients with heart failure . Nursing interventions to improve health-related outcomes for patients with heart failure should emphasize self-efficacy in the self-management of their disease\",\n \"BACKGROUND The aim of this study was to determine the effects of a home-based exercise program on clinical outcomes . Exercise training improves exercise capacity in patients with heart failure ( HF ) but the long-term effects on clinical outcomes remain unknown . METHODS We r and omized 173 patients with systolic HF to control ( n = 87 ) or home-based exercise ( n = 86 ) . The primary end point was a composite of all-cause hospitalizations , emergency department admissions , urgent transplantation , and death at 12 months . Functional performance ( as assessed by cardiopulmonary exercise testing and the 6-minute walk test ) , quality of life , and psychological states were measured at baseline , 3 months , and 6 months . RESULTS There was no significant difference between experimental and control groups in the combined clinical end point at 12 months and in functional status , quality of life , or psychological states over 6 months . Patients in the exercise group had a lower incidence of multiple ( 2 or more ) hospitalizations compared with the control group : 12.8 % versus 26.6 % , respectively ( P = .018 ) . CONCLUSIONS A home-based walking program that incorporated aerobic and resistance exercise did not result in improved clinical outcomes at 1-year follow-up in this cohort of patients with systolic HF . However , the exercise program result ed in reduced rehospitalization rates\",\n \"Exercise is an important behavior for long-term weight control in overweight and obese patients . However , little evidence exists confirming such findings in patients with advanced heart failure ( HF ) . Using a prospect i ve , experimental design , the effects of 24 weeks of a low-level , home-based walking program on weight loss were studied in overweight and obese ( body mass index > or = 27 kg/m(2 ) ) patients with advanced HF who were r and omized to exercise ( n = 48 ) and control ( n = 51 ) groups . Weight changes between the 2 groups at baseline and 6 months were compared using repeated- measures analysis of variance . Patients were on average aged 53.3 + /- 10.1 years and predominantly male ( 75 % ) , Caucasian ( 57 % ) , and married ( 55 % ) . Most patients were in New York Heart Association class III or IV ( 67 % ) , with a mean ejection fraction of 25 % . Patients in the exercise group showed significant weight reduction from baseline to 6 months compared with those in the control group ( -6.37 + /- 11.7 vs -0.33 + /- 9.3 kg , p = 0.002 ) . No significant differences were noted between the 2 groups in 6-minute walk distance or depression , although the changes were in the anticipated direction . Modest weight losses of > 5 % were associated with cardiopulmonary exercise test-documented workload levels at 6 months ( r = 0.331 , p = 0.006 ) , as well as decreased depression ( r = -0.315 , p = 0.01 ) and hostility ( r = -0.355 , p = 0.005 ) . The number of hospital admissions was significantly smaller for patients in the exercise group compared with those in the control group ( 0.63 + /- 0.94 vs 1.07 + /- 0.95 , p low-level , home-based walking program on weight loss in overweight and obese patients with advanced HF\",\n \"OBJECTIVE The purpose of this study was to determine the effect of a tailored message intervention on heart failure readmission rates , quality of life , and health beliefs in persons with heart failure ( HF ) . DESIGN This r and omized control trial provided a tailored message intervention during hospitalization and 1 week and 1 month after discharge . Theoretic framework The organizing framework was the Health Belief Model . SUBJECTS Seventy persons with a primary diagnosis of chronic HF were included in the study . RESULTS HF readmission rates and quality of life did not significantly differ between the treatment and control groups . Health beliefs , except for benefits of medications , significantly changed from baseline in the treatment group in directions posited by the Health Belief Model . CONCLUSIONS A tailored message intervention changed the beliefs of the person with HF in regard to the benefits and barriers of taking medications , following a sodium-restricted diet , and self-monitoring for signs of fluid overload . Future research is needed to explore the effect of health belief changes on actual self-care behaviors\",\n \"BACKGROUND A growing body of evidence suggests that the fluid accumulation plays a key role in the pathophysiology of heart failure ( HF ) and that the inflammatory and neurohormonal activation contribute strongly to the progression of this disorder . METHODS AND RESULTS The study evaluated the long-term effects of 2 different sodium diets on cytokines neurohormones , body hydration and clinical outcome in compensated HF out patients ( New York Heart Association Class II ) . A total of 173 patients ( 105 males , mean age 72.5+/-7 ) recently hospitalized for worsening advanced HF and discharged in normal hydration and in clinical compensation were r and omized in 2 groups ( double blind ) . In Group 1 , 86 patients received a moderate restriction in sodium ( 120mmol to 2.8g/day ) plus oral furosemide ( 125 to 250 mg bid ) ; in Group 2 , 87 patients : received a low-sodium diet ( 80mmol to 1.8g/day ) plus oral furosemide ( 125 to 250 mg bid ) . Both groups were followed for 12 months and the treatment was associated with a drink intake of 1000mL daily . Neurohormonal ( brain natriuretic peptide , aldosterone , plasma rennin activity ) and cytokines values ( tumor necrosis factor-alpha , interleukin-6 ) were significantly reduced with a significant increase of the anti-inflammatory cytokine interleukin-10 at 12 months in normal , P activation of neurohormones and cytokines and worsening the body hydration , whereas moderate sodium restriction maintained dry weigh and improved outcome in the long term . CONCLUSIONS Our results appear to suggest a surprising efficacy of a new strategy to improve the chronic diuretic response by increasing Na intake and limiting fluid intake . This counterintuitive approach underlines the need for a better underst and ing of factors that regulate sodium and water h and ling in chronic congestive HF . A larger sample of patients and further studies are required to evaluate whether this is due to the high dose of diuretic used or the low-sodium diet\",\n \"We evaluated a structured pharmaceutical care program for elderly patients ( > 65 yrs ) with congestive heart failure ( CHF ) based on objective measures of disease control , quality of life , and use of health care facilities in a r and omized , controlled , longitudinal , prospect i ve clinical trial . The 42 patients in group A received education from a pharmacist on the disease and its treatment , and lifestyle changes that could help control symptoms . Patients also were encouraged to monitor their symptoms and comply with prescribed drug therapy . If necessary , dosage regimens were simplified in liaison with hospital physicians . The 41 control patients ( group B ) received st and ard care . The following outcome measures were assessed in all patients at baseline ( before the start of the trial ) and at 3 , 6 , 9 , and 12 months : 2-minute walk test , blood pressure , body weight , pulse , forced vital capacity , quality of life [ disease-specific ( Minnesota Living with Heart Failure question naire ) and generic ( SF-36 ) ] , knowledge of symptoms and drugs , compliance with therapy , and use of health care facilities ( hospital admissions , visits to emergency room , emergency calls ) . Patients in group A showed improved compliance with drug therapy , which in turn improved their exercise capacity compared with those in group B ; education on management of symptoms , lifestyle changes , and dietary recommendations were also of benefit . Group A patients significantly improved knowledge of their drug therapy over the 12-month study and had fewer hospital admissions compared with group B patients . They also had improved outcomes compared with group B , despite the small sample s. An extension of this trial to other sites with pooling of results would provide additional evidence of the value of this structured program in elderly patients with CHF\",\n \"BACKGROUND The multidisciplinary approach to managing heart failure has been shown to improve outcomes . The role of a clinical pharmacist in treating heart failure has not been evaluated . METHODS One hundred eighty-one patients with heart failure and left ventricular dysfunction ( ejection fraction were r and omized to an intervention or a control group . Patients in the intervention group received clinical pharmacist evaluation , which included medication evaluation , therapeutic recommendations to the attending physician , patient education , and follow-up telemonitoring . The control group received usual care . The primary end point was combined all-cause mortality and heart failure clinical events . All clinical events were adjudicated by a blinded end point committee . RESULTS Baseline characteristics were similar except for slightly higher age in the intervention group . Median follow-up was 6 months . All-cause mortality and heart failure events were significantly lower in the intervention group compared with the control group ( 4 vs 16 ; P= .005 ) . In addition , patients in the intervention group received higher angiotensin-converting enzyme inhibitor doses as reflected by the median fraction of target reached ( 25th and 75th percentiles ) , 1.0 ( 0.5 and 1 ) and 0.5 ( 0.1875 and 1 ) in the intervention and control groups , respectively ( P use of other vasodilators in angiotensin-converting enzyme inhibitor-intolerant patients was higher in the intervention group ( 75 % vs 26 % ; P= .02 ) . CONCLUSIONS Outcomes in heart failure can be improved with a clinical pharmacist as a member of the multidisciplinary heart failure team . This observation may be due to higher doses of angiotensin-converting enzyme inhibitors and /or closer follow-up\",\n \"Objective To study the effects of a management programme on hospitalisation and health care costs one year after admission for heart failure . Design Prospect i ve , r and omised trial . Setting University hospital with a primary catchment area of 250 000 inhabitants . Patients 190 patients ( aged 65–84 years , 52.3 % men ) hospitalised because of heart failure . Intervention Two types of patient management were compared . The intervention group received education on heart failure and self management , with follow up at an easy access , nurse directed outpatient clinic for one year after discharge . The control group was managed according to routine clinical practice . Main outcome measures Time to readmission , days in hospital , and health care costs during one year . Results The one year survival rate was 71.8 % ( n = 79 ) in the control group and 70.0 % ( n = 56 ) in the intervention group ( NS ) . The mean time to readmission was longer in the intervention group than in the control group ( 141 ( 87 ) v106 ( 101 ) ; p number of days in hospital tended to be fewer ( 4.2 ( 7.8 ) v 8.2 ( 14.3 ) ; p = 0.07 ) . There was a trend towards a mean annual reduction in health care costs per patient of US$ 1300 ( US$ 1 = SEK 7.76 ) in the intervention group compared with costs in the controls ( US$ 3594 v 2294 ; p = 0.07 ) . Conclusions A management programme for patients with heart failure discharged after hospitalisation reduces health care costs and the need for readmission \",\n \"BACKGROUND Patients with chronic heart failure characteristically have multiple hospital admissions for symptom control , deleteriously affecting their quality of life and imposing a burden on national healthcare costs . We assessed the effect of a novel transtelephonic monitoring and follow-up program on the admission rate and length of hospital stay as well as changes in their subjectively rated quality of life of patients with chronic heart failure . METHODS This prospect i ve 1-year study was conducted on compliant subscribers to ' SHL ' , a telecardiological service with > 60,000 subscribers , who were admitted > or = 2 times during the previous year for recurrent pulmonary edema or deterioration in heart failure . Their heart rate , blood pressure and body weight measurements were now automatically transmitted daily to ' SHL\\\"s data bank and added to stored and up date d medical records . A question naire survey acquired information on their quality of life . RESULTS The study cohort included 118 patients , mean age 75 years ( range 49 - 89 years ) , 65 % males , a II-IV class functional capacity and a 25 % ( range 10 - 39 % ) mean ejection fraction . There was a 66 % reduction in the total hospitalization days ( from 1623 in the year preceding study entry to 558 during the study period , p quality of life . CONCLUSIONS Data are provided to demonstrate that a transtelephonic system allowing primary care at the patient 's home can significantly reduce hospitalization rate and length of stay and significantly enhance the quality of life of patients with chronic heart failure\",\n \"Studies have shown that patients with compensated heart failure ( HF ) receiving high diuretic doses associated with normal sodium diet and fluid intake restrictions demonstrated significant reductions in readmissions and mortality compared with those who received low-sodium diets , and over a 6-month observation period , a reduction in neurohormonal activation was also observed . The aim of this study was to evaluate the effects of different sodium diets associated with different diuretic doses and different levels of fluid intake on hospital readmissions and neurohormonal changes after 6-month follow-up in patients with compensated HF . Four hundred ten consecutive patients with compensated HF ( New York Heart Association class II to IV ) aged 53 to 86 years , with ejection fractions , were r and omized into 8 groups : group A ( n = 52 ) : 1,000 ml/day of fluid intake , 120 mmol/day , and 250 mg furosemide twice daily ; group B ( n = 51 ) : 1,000 ml/day of fluid intake , 120 mmol/day , and 125 mg furosemide twice daily ; group C ( n = 51 ) : 1,000 ml/day fluid intake , 80 mmol/day , and 250 mg furosemide twice daily ; group D ( n = 51 ) : 1,000 ml/day fluid intake , 80 mmol/day , and 125 mg furosemide twice daily ; group E ( n = 52 ) : 2,000 ml/day fluid intake , 120 mmol/day , and 250 mg furosemide twice daily ; group F ( n = 50 ) : 2,000 ml/day fluid intake , 120 mmol/day , and 125 mg furosemide twice daily ; group G ( n = 52 ) : 2,000 ml/day fluid intake , 80 mmol/day , and 250 mg furosemide twice daily ; and group H ( n = 51 ) : 2,000 ml/day fluid intake , 80 mmol/day , and 125 mg furosemide twice daily . All patients received the treatments > or=30 days after discharge and for 180 days afterward . Signs of HF , body weight , blood pressure , heart rate , laboratory parameters , electrocardiograms , echocardiograms , brain natriuretic peptide , aldosterone , and plasma renin activity were examined at baseline and 180 days later . Group A showed the best results , with a significant reduction ( p readmissions , brain natriuretic peptide , aldosterone , and plasma renin activity compared with the other groups during follow-up ( p normal-sodium diet with high diuretic doses and fluid intake restriction , compared with different combinations of sodium diets with more modest fluid intake restrictions and conventional diuretic doses , leads to reductions in readmissions , neurohormonal activation , and renal dysfunction\",\n \"BACKGROUND Patients with heart failure must monitor for and recognize escalating symptoms to take action to relieve symptoms and decrease hospitalizations . However , symptom monitoring is not commonly performed . One way to promote patients ' engagement in symptom monitoring is by providing a symptom diary . PURPOSE The aim of this study was to test the effect of a comprehensive daily symptom diary intervention on event-free survival and health-related quality of life ( HRQOL ) . METHODS Patients were r and omized into either intervention ( n = 23 ) or usual-care groups ( n = 21 ) . The intervention group received a symptom diary with self-care education and counseling at baseline with 5 follow-up calls for 3 months . All patients were interviewed to obtain survival data at 1 month and 3 months . HRQOL was measured at baseline , 1 month , and 3 months . Kaplan-Meier curves with the log-rank test were used to compare group differences in time to first event . Linear mixed models were conducted to examine the relationship between groups and changes in HRQOL over 3 months . RESULTS The intervention group had longer event-free survival than the usual-care group ( P = .03 ) . There were no differences in changes in HRQOL scores between the groups over 3 months . CONCLUSIONS Positive effects of the intervention on survival were found . However , there was no significant difference in changes in HRQOL\",\n \"BACKGROUND Currently , fluid restriction recommendations in heart failure ( HF ) are based on expert opinion . After implementing a 1,000-mL/d fluid restriction for 60 days after discharge , outcomes were examined . METHODS AND RESULTS In a r and omized controlled design , hyponatremic patients ( serum sodium ≤137 mg/dL ) received usual care ( UC ; n = 26 ) or 1,000 mL/d fluid restriction ( n = 20 ) at discharge . Quality of life ( QoL ) , thirst , difficulty following fluid recommendations , adherence to fluid restriction , HF emergency care , HF rehospitalization , and all-cause death were examined . Mean age was 62.8 ± 12.8 years ; 46 % were white . There were no differences by group in baseline demographics , comorbidities , and QoL , except that more UC patients had New York Heart Association ( NYHA ) functional class III/IV status ( P = .019 ) . Median [ interquartile range ] QoL scores were better in the 1,000 mL/d group for symptom burden ( 83.3 [ 68.8 - 91.7 ] vs 50 [ 29.2 - 79.2 ] ; P = .018 ) , total symptoms ( 77.1 [ 58.1 - 91.7 ] vs 54.2 [ 30.2 - 73.9 ] ; P = .022 ) , overall QoL summary ( 72.6 [ 52.2 - 86.3 ] vs 51.0 [ 37.7 - 68.5 ] ; P = .038 ) , and clinical QoL summary ( 75.5 [ 57.8 - 92.9 ] vs 59.1 [ 35.7 - 77.3 ] ; P = .039 ) . There were no group differences in thirst , difficulty adhering to fluid recommendations , adherence to fluid restriction , or health care consumption . CONCLUSIONS The 1,000 mL/d fluid restriction led to improved QoL at 60 days after discharge . Future research in a larger more heterogeneous sample is needed\",\n \"Background : Heart failure ( HF ) has clinical ly significant psychological and physical consequences for older persons , and hospitalization for HF is frequent and costly to the Medicare program . As HF is the most common primary Medicare home care diagnosis , there is a critical need to develop home care services that improve heath-related outcomes for this population . The primary aim of this pilot study was to develop , implement , and test the initial feasibility and potential efficacy of the Home-Care Education , Assessment , Remote-Monitoring , and Therapeutic Activities ( HEART ) trial , a nurse-directed multicomponent home care intervention . Observed outcomes were quality of life ( QOL ) , depressive symptoms , and 90-day hospitalization . Methods : Twenty-four patients with a primary diagnosis of HF were assigned to the intervention ( n = 12 ) or control group ( n = 12 ) according to geographical location in a large multibranch Medicare-certified home health agency . Intervention group patients received 8 structured nurse education visits using evidence -based protocol s design ed in previous trials to teach HF self-management and to prevent/reduce depression , as well as a telemonitoring system . Control group patients received usual care and telemonitoring . Quality of life was assessed using the Minnesota Living With Heart Failure question naire . Depressive symptoms were assed using the Patient Health Question naire 9 at baseline and 90-day study end point . Results : Study protocol s and instrumentation were found to be feasible and effective . Examination of enrollment data led to a reevaluation of eligibility criteria . Patients participating in the HEART intervention demonstrated significantly improved QOL ( F = 8.99 , P = .007 ) and significantly reduced depressive symptoms ( F = 35.10 , P = .001 ) in comparison to control group patients at the study end point . There was a trend toward lower hospital readmission rates in the intervention group ( 16 % vs 25 % ) , but this was not statistically significant . Conclusion : This pilot study suggests that a full-scale trial of the HEART intervention is feasible\",\n \"OBJECTIVE To assess the efficacy of a multifactorial educational intervention carried out by a pharmacist in patients with heart failure ( HF ) . METHOD A r and omized , prospect i ve , open clinical trial in patients admitted for HF . The patients assigned to the intervention group received information about the disease , drug therapy , diet education , and active telephone follow-up . Visits were completed at 2 , 6 , and 12 months . Hospital re-admissions , days of hospital stay , treatment compliance , satisfaction with the care received , and quality of life ( EuroQol ) were evaluated ; a financial study was conducted in order to assess the possible impact of the program . The intervention was performed by the pharmacy department in coordination with the cardiology unit . RESULTS 134 patients were included , with a mean age of 75 years and a low educational level . The patients of the intervention group had a higher level of treatment compliance than the patients in the control group . At 12 months of follow-up , 32.9 % fewer patients in the intervention group were admitted again vs. the control group . The mean days of hospital stay per patient in the control group were 9.6 ( SD=18.5 ) vs. 5.9 ( SD=14.1 ) in the intervention group . No differences were recorded in quality of life , but the intervention group had a higher score in the satisfaction scale at two months [ 9.0 ( SD=1.3 ) versus 8.2 ( SD=1.8 ) p=0.026 ] . Upon adjusting a Cox survival model with the ejection fraction , the patients in the intervention group had a lower risk of re-admission ( Hazard ratio 0.56 ; 95 % CI : 0.32 - 0.97 ) . The financial analysis evidence d savings in hospital costs of euro 578 per patient that were favorable to the intervention group . CONCLUSIONS Postdischarge pharmaceutical care allows for reducing the number of new admissions in patients with heart failure , the total days of hospital stay , and improves treatment compliance without increasing the costs of care\",\n \"Objective : To determine the feasibility and potential impact of a non-pharmacologic multidisciplinary intervention for reducing hospital readmissions in elderly patients with congestive heart failure . Design : Prospect i ve , r and omized clinical trial , with 2:1 assignment to the study intervention or usual care . Setting : 550-bed secondary and tertiary care university teaching hospital . Patients and participants : 98 patients ≥70 years of age ( mean 79±6 years ) admitted with documented congestive heart failure . Interventions : Comprehensive multidisciplinary treatment strategy consisting of intensive teaching by a geriatric cardiac nurse , a detailed review of medications by a geriatric cardiologist with specific recommendations design ed to improve medication compliance and reduce side effects , early consultation with social services to facilitate discharge planning , dietary teaching by a hospital dietician , and close follow-up after discharge by home care and the study team . Measurements and main results : All patients were followed for 90 days after initial hospital discharge . The primary study endpoints were rehospitalization within the 90-day interval and the cumulative number of days hospitalized during follow-up . The 90-day readmission rate was 33.3 % ( 21.7%–44.9 % ) for the patients receiving the study intervention ( n=63 ) compared with 45.7 % ( 29.2–62.2 % ) for the control patients ( n=35 ) . The mean number of days hospitalized was 4.3±1.1 ( 2.1–6.5 ) for the treated patients vs. 5.7±2.0 ( 1.8–9.6 ) for the usual-care patients . In a prospect ively defined subgroup of patients at intermediate risk for readmission ( n=61 ) , readmissions were reduced by 42.2 % ( from 47.6 % to 27.5 % ; p=0.10 ) , and the average number of hospital days during follow-up decreased from 6.7±32 days to 3.2±1.2 days ( p = NS ) . Conclusions : These pilot data suggest that a comprehensive , multidisciplinary approach to reducing repetitive hospitalizations in elderly patients with congestive heart failure may lead to a reduction in readmissions and hospital days , particularly in patients at moderate risk for early rehospitalization . Further evaluation of this treatment strategy , including an assessment of the cost-effectiveness , is warranted\",\n \"Background : The Self-management and Care of Heart Failure through Group Clinics Trial evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high-risk heart failure ( HF ) patients . Objective : The purpose of this article is to ( 1 ) describe key Self-management and Care of Heart Failure through Group Clinics Trial group clinic interactive learning strategies , ( 2 ) describe re sources and material s used in the group clinic appointment , and ( 3 ) present results supporting this patient-centered group intervention . Methods : This clinical trial included 198 HF patients ( r and omized to either group clinical appointments or to st and ard care ) . Data were collected from 72 group clinic appointments via patients ’ ( 1 ) group clinic session evaluations , ( 2 ) HF self-care behaviors skills , ( 3 ) HF-related discouragement and quality of life scores , and ( 4 ) HF-related reshopitalizations during the 12-month follow-up . Also , the costs of delivery of the group clinical appointments were tabulated . Results : Overall , patients rated group appointments as 4.8 of 5 on the “ helpfulness ” in managing HF score . The statistical model showed a 33 % decrease in the rate of rehospitalizations ( incidence rate ratio , 0.67 ) associated with the intervention over the 12-month follow-up period when compared with control patients ( & khgr;21 = 3.9 , P = .04 ) . The total cost for implementing 5 group appointments was $ 243.58 per patient . Conclusion : The intervention was associated with improvements in HF self-care knowledge and home care behavior skills and managing their for HF care . In turn , better self-care was associated with reductions in HF-related hospitalizations\",\n \"Purpose : Many health systems have implemented interventions to reduce the rate of heart failure readmissions . Pharmacists have the training and expertise to provide effective medication-related education . However , few studies have examined the impact of discharge education provided by pharmacy students and residents on patients hospitalized with heart failure exacerbations . Methods : This was a nonr and omized intervention study evaluating the impact of a pharmacy student and resident-led discharge counseling program on heart failure readmissions . The primary end point was the 30-day heart failure readmission rate . Secondary end points included self-reported patient underst and ing of medications , number of medication errors documented , and estimated associated cost avoidance . Results : A total of 86 and 94 patients were enrolled into the intervention and control groups , respectively . No statistically significant difference in readmission rates was detected between the intervention and the control groups . Thirty-four medication errors and discrepancies were documented , or 1 for every 2.5 patients counseled , result ing in an estimated cost avoidance of $ 4241 for the institution . Eighty-nine percent of patients who received discharge counseling agreed they had a better underst and ing of their medications after speaking with a pharmacy resident or student . Conclusions : There was no statistically significant difference in readmission rates ; however , several medication errors were prevented , and a large percentage of patients expressed an improved underst and ing of their medications\",\n \"AIMS Mild cognitive impairment ( MCI ) is prevalent in heart failure , and can contribute to poor self-care and higher hospital readmissions . Strategies to improve self-care in patients with MCI have not been studied . This r and omized controlled trial aim ed to test the effect of a targeted intervention on self-care , heart failure knowledge , and 30-day readmissions . METHODS AND RESULTS The study included 125 patients hospitalized for exacerbation of heart failure who screened positive for MCI . The treatment group received a targeted self-care teaching intervention using principles of cognitive training . Self-care , heart failure knowledge , depression , and social support were assessed at baseline and 30 days post-discharge . Mean heart failure knowledge scores improved significantly in the intervention group , but decreased in the control group ( P in heart failure knowledge than patients in the control group ( P = 0.027 ) . Black race was significantly associated with lower heart failure knowledge scores ( P = 0.030 ) . Mean change scores for self-care showed greater improvement in the intervention group when compared with the control group ; however , this was not statistically significant . There was no difference in readmission rates between the groups . CONCLUSION It is feasible to conduct a r and omized controlled trial in patients with MCI . Patients in the treatment group had greater heart failure knowledge at 30 days post-discharge ; however , this did not impact readmission rates . Further research is needed to describe how MCI affects self-care and knowledge , and how race and other factors may influence outcomes in this population\",\n \"OBJECTIVE To explore the effects on the st and ardized management of patients with coronary atherosclerotic heart disease complicated with chronic heart failure . METHODS A total of 823 patients discharged from our department were r and omly enrolled . Among 734 patients with follow-up consents , they were divided into management and control groups ( n = 440 , 294 ) . The management group received st and ardized out-of-hospital management , regular health education and follow-ups of telephone and outpatient visits . RESULTS Compared with the control group , the management group had lower rates of all-cause mortality , cardiac death and readmission due to cardiovascular events ( CVE ) declining by 26.5 % , 32.2 % and 57.0 % respectively . Over a 4-year period , the annular survival rate of management group was 92 % , 85 % , 83 % and 82 % while that of control group 95 % , 89 % , 82 % and 75 % respectively . Patient compliance of digoxin and diuretics in the control group was inferior to that in the management group . CONCLUSION Through st and ardized out-of-hospital management , the patients with coronary atherosclerotic heart disease plus chronic heart failure may achieve significant benefits through reducing the rates of all-cause mortality , cardiac death and readmission due to CVE and improving survival rate\",\n \"Abstract Objectives . To evaluate whether a new home intervention system ( HIS , OPTILOGG ® ) consisting of a specialised software , a tablet computer ( tablet ) wirelessly connected to a weight scale may improve self-care behaviour , health-related quality of life ( HRQoL ) , knowledge about heart failure ( HF ) and reduce hospital days due to HF . Design . 82 patients ( 32 % females ) with mean age : 75 ± 8 years hospitalised with HF were r and omised at discharge to an intervention group ( IG ) equipped with the HIS or to a control group ( CG ) receiving st and ard HF information only . The tablet contained information about HF and lifestyle advice according to current guidelines . It also showed present dose of diuretic , changes in patient-measured weight and HRQoL over time . Results . After 3 months the IG displayed a dramatic improvement in self-care with p : 17 , 25 ] ) . The disease-specific HRQoL was measured by Kansas City Cardiomyopathy Question naire . The IG had significantly higher score ( median IG : 65.1 [ IQR : 38.5 , 83.3 ] vs. CG : 52.1 [ IQR : 41.1 , 64.1 ] p 0.05 ) and an improved physical limitation ( median IG : 54.2 [ IQR : 37.7 , 83.3 ] vs. CG : 45.8 [ IQR : 25.0 , 54.2 ] p ) There was no difference in knowledge . IG showed fewer HF-related days in the hospital , with 1.3 HF-related hospital days/patient versus 3.5 in CG ( risk ratio : 0.38 ; 95 % confidence interval : 0.31–0.46 ; p . HF patients with a HIS tablet computer and scale improved in self-care and HRQoL. Days in hospital due to HF were reduced . A medical device that is easy to use can be a valuable tool for improving self-care and outcome in patients with HF \",\n \"Peer support has been used effectively in a variety of patient population s , but its effectiveness in improving outcomes in persons with chronic heart failure has not been explored . We trained 9 persons with heart failure to mentor other heart failure patients and tested the effectiveness of this approach in a r and omized controlled clinical trial . A low proportion ( 37 % ) of the eligible population of hospitalized patients agreed to participate . At the end of the 3-month trial , there was significantly higher heart failure self-care in the intervention group ( P perceived support reciprocity in the intervention group ( F = 5.94 , P = .004 ) . No significant group differences in heart failure readmissions , length of stay , or cost were evident at 90-days , although the heart failure readmission rate was 96 % higher in the intervention group when compared to that in the control group . The reasons for low overall enrollment and high readmission rates in the intervention group require further study . Including additional self-care education by a professional , rather than leaving all the education to the mentor , could strengthen the peer support intervention trialed in this study . Small group meetings may be less intrusive and more desirable for this patient population\",\n \"Community care for heart failure patients is difficult due to multiple comorbidities , polypharmacy , and advanced age of patients . Studies show that hospital admissions and emergency room visits decrease with increased nursing interventions in home and community setting s. The purpose of this study 1 was to assess the effectiveness of regular telephone interventions by nursing students on outcomes of heart failure patients in the home . Senior students were paired with community nursing staff and assigned 2 heart failure patients to follow up by telephone calls for 12 to 14 weeks . Patients who received telephone interventions had fewer hospital readmissions ( 13 % ) than the comparison group ( 35 % ) . Patients in the telephone intervention group also had fewer overt heart failure symptoms as measured by the Minnesota Living With Heart Failure Question naire\",\n \"OBJECTIVES To examine the effectiveness of a transitional care intervention delivered by advanced practice nurses ( APNs ) to elders hospitalized with heart failure . DESIGN R and omized , controlled trial with follow-up through 52 weeks postindex hospital discharge . SETTING Six Philadelphia academic and community hospitals . PARTICIPANTS Two hundred thirty-nine eligible patients were aged 65 and older and hospitalized with heart failure . INTERVENTION A 3-month APN-directed discharge planning and home follow-up protocol . MEASUREMENTS Time to first rehospitalization or death , number of rehospitalizations , quality of life , functional status , costs , and satisfaction with care . RESULTS Mean age of patients ( control n=121 ; intervention n=118 ) enrolled was 76 ; 43 % were male , and 36 % were African American . Time to first readmission or death was longer in intervention patients ( log rank chi(2)=5.0 , P=.026 ; Cox regression incidence density ratio=1.65 , 95 % confidence interval=1.13 - 2.40 ) . At 52 weeks , intervention group patients had fewer readmissions ( 104 vs 162 , P=.047 ) and lower mean total costs ( $ 7,636 vs $ 12,481 , P=.002 ) . For intervention patients , only short-term improvements were demonstrated in overall quality of life ( 12 weeks , P physical dimension of quality of life ( 2 weeks , P patient satisfaction ( assessed at 2 and 6 weeks , P comprehensive transitional care intervention for elders hospitalized with heart failure increased the length of time between hospital discharge and readmission or death , reduced total number of rehospitalizations , and decreased healthcare costs , thus demonstrating great promise for improving clinical and economic outcomes\",\n \"BACKGROUND Congestive heart failure is the most common indication for admission to the hospital among older adults . Behavioral factors , such as poor compliance with treatment , frequently contribute to exacerbations of heart failure , a fact suggesting that many admissions could be prevented . METHODS We conducted a prospect i ve , r and omized trial of the effect of a nurse-directed , multidisciplinary intervention on rates of readmission within 90 days of hospital discharge , quality of life , and costs of care for high-risk patients 70 years of age or older who were hospitalized with congestive heart failure . The intervention consisted of comprehensive education of the patient and family , a prescribed diet , social-service consultation and planning for an early discharge , a review of medications , and intensive follow-up . RESULTS Survival for 90 days without readmission , the primary outcome measure , was achieved in 91 of the 142 patients in the treatment group , as compared with 75 of the 140 patients in the control group , who received conventional care ( P = 0.09 ) . There were 94 readmissions in the control group and 53 in the treatment group ( risk ratio , 0.56 ; P = 0.02 ) . The number of readmissions for heart failure was reduced by 56.2 percent in the treatment group ( 54 vs. 24 , P = 0.04 ) , whereas the number of readmissions for other causes was reduced by 28.5 percent ( 40 vs. 29 , P not significant ) . In the control group , 23 patients ( 16.4 percent ) had more than one readmission , as compared with 9 patients ( 6.3 percent ) in the treatment group ( risk ratio , 0.39 ; P = 0.01 ) . In a subgroup of 126 patients , quality -of-life scores at 90 days improved more from base line for patients in the treatment group ( P = 0.001 ) . Because of the reduction in hospital admissions , the overall cost of care was $ 460 less per patient in the treatment group . CONCLUSIONS A nurse-directed , multidisciplinary intervention can improve quality of life and reduce hospital use and medical costs for elderly patients with congestive heart failure\",\n \"BACKGROUND Heart failure ( HF ) disease management programs are widely implemented , but data about their effect on outcome have been inconsistent . METHODS The Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure ( COACH ) was a multicenter , r and omized , controlled trial in which 1023 patients were enrolled after hospitalization because of HF . Patients were assigned to 1 of 3 groups : a control group ( follow-up by a cardiologist ) and 2 intervention groups with additional basic or intensive support by a nurse specializing in management of patients with HF . Patients were studied for 18 months . Primary end points were time to death or rehospitalization because of HF and the number of days lost to death or hospitalization . RESULTS Mean patient age was 71 years ; 38 % were women ; and 50 % of patients had mild HF and 50 % had moderate to severe HF . During the study , 411 patients ( 40 % ) were readmitted because of HF or died from any cause : 42 % in the control group , and 41 % and 38 % in the basic and intensive support groups , respectively ( hazard ratio , 0.96 and 0.93 , respectively ; P = .73 and P = .52 , respectively ) . The number of days lost to death or hospitalization was 39 960 in the control group , 33 731 days for the basic intervention group ( P = .81 ) , and 34 268 for the intensive support group ( P = .49 ) . All-cause mortality occurred in 29 % of patients in the control group , and there was a trend toward lower mortality in the intervention groups combined ( hazard ratio , 0.85 ; 95 % confidence interval , 0.66 - 1.08 ; P = .18 ) . There were slightly more hospitalizations in the 2 intervention groups ( basic intervention group , P = .89 ; and intensive support group , P = .60 ) . CONCLUSIONS Neither moderate nor intensive disease management by a nurse specializing in management of patients with HF reduced the combined end points of death and hospitalization because of HF compared with st and ard follow-up . There was a nonsignificant , potentially relevant reduction in mortality , accompanied by a slight increase in the number of short hospitalizations in both intervention groups . Clinical Trial Registry http://trialregister.nl Identifier : NCT 98675639\",\n \"Eighty-two patients aged > or = 70 years with heart failure were r and omized to a gentle , seated exercise program or to usual care . Six-minute walk distance and quality of life did not change between groups , but daily activity as measured by accelerometry increased in the exercise group relative to the control group\",\n \"In this r and omized controlled trial we tested the efficacy of an intervention program ( CARE : Creating Avenues for Relative Empowerment ) for improving outcomes of hospitalized older adults and their family caregivers ( FCGs ) . FCG-patient dyads ( n = 407 ) were r and omized into two groups . The CARE group received a two-session empowerment-educational program 1 - 2 days post-admission and 1 - 3 days pre-discharge . The attention control group received a generic information program during the same timeframe . Follow-up was at 2 weeks and 2 months post-discharge . There were no statistically significant differences in patient or FCG outcomes . However , inconsistent evidence of role outcome differences suggests that CARE may benefit certain FCG subgroups instead of being a one-size-fits-all intervention strategy . Closer examination of CARE 's mechanisms and effects is needed\",\n \"OBJECTIVE To investigate the business case of postdischarge care transition ( PDCT ) among Medicare beneficiaries by conducting a cost-benefit analysis . DESIGN R and omized controlled trial . SETTING A general hospital in upstate New York State . PARTICIPANTS Elderly Medicare beneficiaries being treated from October 2008 through December 2009 were r and omly selected to receive services as part of a comprehensive PDCT program ( intervention--173 patients ) or regular discharge process ( control--160 patients ) and followed for 12 months . INTERVENTION The intervention comprised five activities : development of a patient-centered health record , a structured discharge preparation checklist of critical activities , delivery of patient self-activation and management sessions , follow-up appointments , and coordination of data flow . MEASUREMENTS Cost-benefit ratio of the PDCT program ; self-management skills and abilities . RESULTS The 1-year readmission analysis revealed that control participants were more likely to be readmitted than intervention participants ( 58.2 % vs 48.2 % ; P = .08 ) ; with most of that difference observed in the 91 to 365 days after discharge . Findings from the cost-benefit analysis revealed a cost-benefit ratio of 1.09 , which indicates that , for every $ 1 spent on the program , a saving of $ 1.09 was realized . In addition , participating in a care transition program significantly enhanced self-management skills and abilities . CONCLUSION Postdischarge care transition programs have a dual benefit of enhancing elderly adults ' self-management skills and abilities and producing cost savings . This study builds a case for the inclusion of PDCT programs as a reimbursable service in benefit packages\",\n \"BACKGROUND It is still a matter of debate whether exercise training ( ET ) is a beneficial treatment in chronic heart failure ( CHF ) . METHODS AND RESULTS To determine whether long-term moderate ET improves functional capacity and quality of life in patients with CHF and whether these effects translate into a favorable outcome , 110 patients with stable CHF were initially recruited , and 99 ( 59+/-14 years of age ; 88 men and 11 women ) were r and omized into 2 groups . One group ( group T , n=50 ) underwent ET at 60 % of peak & f1;O2 , initially 3 times a week for 8 weeks , then twice a week for 1 year . Another group ( group NT , n=49 ) did not exercise . At baseline and at months 2 and 14 , all patients underwent a cardiopulmonary exercise test , while 74 patients ( 37 in group T and 37 in group NT ) with ischemic heart disease underwent myocardial scintigraphy . Quality of life was assessed by question naire . Ninety-four patients completed the protocol ( 48 in group T and 46 in group NT ) . Changes were observed only in patients in group T. Both peak & f1;O2 and thallium activity score improved at 2 months ( 18 % and 24 % , respectively ; P Quality of life also improved and paralleled peak VO2 . Exercise training was associated both with lower mortality ( n=9 versus n=20 for those with training versus those without ; relative risk (RR)=0.37 ; 95 % CI , 0.17 to 0.84 ; P=0.01 ) and hospital readmission for heart failure ( 5 versus 14 ; RR=0.29 ; 95 % CI , 0.11 to 0.88 ; P=0.02 ) . Independent predictors of events were ventilatory threshold at baseline ( beta-coefficient=0.378 ) and posttraining thallium activity score ( beta-coefficient -0.165 ) . CONCLUSIONS Long-term moderate ET determines a sustained improvement in functional capacity and quality of life in patients with CHF . This benefit seems to translate into a favorable outcome\",\n \"BACKGROUND Multidisciplinary heart failure programs including patient education and self-management strategies such as daily recording of body weight and use of a patient diary decrease hospital readmissions and improve quality of life . However , the degree of uptake of individual components of these programs and their contribution to patient benefit are uncertain . METHODS Patients with heart failure admitted to Auckl and Hospital were r and omised into the management or usual care groups of the Auckl and heart failure management study ( AHFMS ) . Patients in the management group were given a heart failure diary for the recording of daily weights , attended a heart failure clinic and were encouraged to attend three education sessions . Patients in the usual care group received routine clinical care , mainly from general practitioners . Patients were followed to 12 months . This study investigated the uptake of self-management by assessing diary use and self-weighing behaviour in the group receiving the heart failure intervention , and compared the level of knowledge of heart failure self-management of the management group to the control group after 12 months . RESULTS Of the 197 patients in the AHFMS , 100 patients were included in the management group and received a diary and education about heart failure self-management including monitoring weight daily . Of these patients , 76 patients used the diary . These patients were on more medication ; were more likely to attend the education sessions , heart failure clinic , and primary care , and had a lower mortality rate over the course of the study . Variables independently associated with use of the diary included less severe symptoms ( OR 15 , 95 % confidence intervals 1.7 , 144 ) , frequent attendance at the heart failure clinic ( OR 15 , 95 % CI 3 , 78 ) and attendance at an education session ( OR 8 , 95 % CI 1.5 , 42 ) . Of the 76 patients who used the diary , 51 weighed themselves regularly . More of these patients owned scales at home ; they were also more likely to attend the education sessions , and experienced fewer hospital admissions than those patients who did not weigh themselves regularly . Variables independently associated with regular self-weighing included the presence of scales at home ( OR 6.3 , 95 % CI 1.7 , 14.1 ) , left ventricular ejection fraction > 30 % ( OR 4.3 , 95 % CI 1.1 , 17.5 ) , and attendance at the education session(s ) ( OR 6.3 , 95 % CI 1.7 , 14.1 ) . Patients in the management group exhibited higher levels of knowledge at 12 months of follow-up and were more likely to monitor their condition using daily weighing , compared to the control group . CONCLUSIONS At 12 months of follow-up , implementation of self-management strategies including daily weight monitoring and level of education on self-management was significantly higher in the management group than the control group . For the patients in the management group , not using the diary or inability to perform daily weighing were associated with less frequent attendance at the heart failure clinic and education sessions and poorer health outcomes . In this study , attendance at the education sessions was associated with the adoption of self-management , underlining the importance of education in multidisciplinary heart failure programmes . Self-weighing could be increased by provision of scales to all patients . The subset of patients who did not adopt self-management strategies in this study were at high risk of death or readmission\",\n \"This study sought to determine the effect of an advanced- practice -nurse (APN)-led telephone intervention on hospital readmissions , quality of life , and self-care behaviors ( SCBs ) of patients with heart failure ( HF ) . Twenty participants were r and omly assigned to either an experimental group that received the APN-led telephone intervention ( ALTI ) or a control group that received usual care in this pretest-posttest experimental study . The results of this study support the idea that an ALTI positively impacts outcomes of patient with HF , particularly by improving SCBs and decreasing hospital readmissions . An ALTI warrants consideration to improve outcomes of patients with HF\",\n \"AIMS Disease management programs can reduce hospitalizations in high-risk heart failure ( HF ) patients , but generalizability to the population hospitalized for HF remains to be proven . We aim ed to assess the effectiveness of a discharge and outpatient management program in a non-selected cohort of patients hospitalized for HF . METHODS AND RESULTS Patients admitted with decompensated HF were r and omized to receive usual care ( n=174 ) or an intervention ( n=164 ) consisting of a comprehensive hospital discharge planning and close follow-up at a HF clinic . After a median of 509 days , there were fewer events ( readmission or death ) in the intervention as compared with the control group ( 156 vs. 250 ) , which represents 47 % ( 95%CI : 29 - 65 ; P time to first event , time to first all-cause and HF readmission , and time to death were increased in the intervention group ( P All-cause and HF readmission rates per observation year were significantly lower , quality of life improved and overall cost of care was reduced in the intervention group . CONCLUSIONS This comprehensive hospital discharge and outpatient management program prolonged time to first event , reduced hospital readmissions , improved survival and quality of life of patients hospitalized for HF , while reducing cost of management\",\n \"Background Heart failure is a common and costly condition , particularly in the elderly . A range of models of interventions have shown the capacity to decrease hospitalizations and improve health-related outcomes . Potentially , cardiac rehabilitation models can also improve outcomes . Aim To assess the impact of a nurse-coordinated multidisciplinary , cardiac rehabilitation program to decrease hospitalizations , increase functional capacity , and meet the needs of patients with heart failure . Method In a r and omized control trial , a total of 105 patients were recruited to the study . Patients in the intervention group received an individualized , multidisciplinary 12-week cardiac rehabilitation program , including an individualized exercise component tailored to functional ability and social circumstances . The control group received an information session provided by the cardiac rehabilitation coordinator and then follow-up care by either their cardiologist or general practitioner . This trial was stopped prematurely after the release of state-based guidelines and funding for heart failure programs . Results During the study period , patients in the intervention group were less likely to have been admitted to hospital for any cause ( 44 vs. 69 % , P = 0.01 ) or after a major acute coronary event ( 24 vs. 55 % , P = 0.001 ) . Participants in the intervention group were more likely to be alive at 12 months , ( 93 vs. 79 % ; P = 0.03 ) ( odds ratio = 3.85 ; 95 % confidence interval = 1.0314.42 ; P = 0.0042 ) . Quality of life scores improved at 3 months compared with baseline ( intervention t = 4.37 , P [ 0.0001 ; control t= 3.52 , P [ 0.01 ) . Improvement was also seen in 6-min walk times at 3 months compared with baseline in the intervention group ( t = 3.40 ; P = 0.01 ) . Conclusion This study shows that a multidisciplinary heart failure cardiac rehabilitation program , including an individualized exercise component , coordinated by a specialist heart failure nurse can substantially reduce both all-cause and cardiovascular readmission rates , improve functional status at 3 months and exercise tolerance\",\n \"BACKGROUND Chronic heart failure ( CHF ) remains a common cause of disability , death and hospital admission . Several investigations support the usefulness of programs of disease management for improving clinical outcomes . However , the effect of home-based telemanagement programs on the rate of hospital readmission is still unclear and the cost-effectiveness ratio of such programs is unknown . The aim of the study was to determine whether a home-based telemanagement ( HBT ) programme in CHF patients decreased hospital readmissions and hospital costs in comparison with the usual care ( UC ) follow-up programme over a one-year period . METHODS AND RESULTS Four hundred-sixty CHF patients ( pts ) , aged 57+/-10 years were r and omised to two management strategies : 230 pts to HBT programme and 230 pts to UC programme . The HBT pts received a portable device , transferring , by telephone , a one-lead trace to a receiving station where a nurse was available for interactive teleconsultation . The UC pts were referred to their primary care physicians and cardiologists . The primary objective of the study was one-year hospital readmission for cardiovascular reasons . During one-year follow-up 55 pts ( 24 % ) in HBT group and 83 pts ( 36 % ) in UC group had at least one readmission ( RR=0.56 ; 95 % CI : 0.38 - 0.82 ; p=0.01 ) . After adjusting for clinical and demographic characteristics , the HBT group had a significantly lower risk of readmission compared with the UC group ( HR=0.50 , 95 % CI : 0.34 - 0.73 ; p=0.01 ) . The intervention was associated with a 36 % decrease in the total number of hospital readmissions ( HBT group : 91 readmissions ; UC group : 142 readmissions ) and a 31 % decrease in the total number of episodes of hemodynamic instability ( 101 in HBT group vs 147 in UC group ) . The rate of hearth failure-related readmission was 19 % ( 43 pts ) in HBT group and 32 % ( 73 pts ) in UC group ( RR=0.49 , 95 % [ CI ] : 0.31 - 0.76 ; p=0.0001 ) . No significant difference was found on cardiovascular mortality between groups . Mean cost for hospital readmission was significantly lower in HBT group ( euro 843+/-1733 ) than in UC group ( euro 1298+/-2322 ) , ( -35 % , p hospital readmissions and costs in CHF patients\",\n \"OBJECTIVES We compared the longer-term impact of the two most commonly applied forms of post-discharge management design ed to minimize recurrent hospitalization and prolong survival in typically older patients with chronic heart failure ( CHF ) . METHODS We followed a multi-center r and omized controlled trial cohort of Australian patients hospitalized with CHF and initially allocated to home-based or specialized CHF clinic-based intervention for 1368 ± 216 days . Blinded endpoints included event-free survival from all-cause emergency hospitalization or death , all-cause mortality and rate of all-cause hospitalization and stay . RESULTS 280 patients ( 73 % male , aged 71 ± 14 years and 73 % left ventricular systolic dysfunction ) were initially r and omized to home-based ( n=143 ) or clinic-based ( n=137 ) intervention . During extended follow-up ( complete for 274 patients ) , 1139 all-cause hospitalizations ( 7477 days of hospital stay ) and 121 ( 43.2 % ) deaths occurred . There was no difference in the primary endpoint ; 20 ( 14.0 % ) home-based versus 13 ( 7.4 % ) clinic-based patients remained event-free ( adjusted HR 0.89 , 95 % CI 0.70 to 1.15 ; p=0.378 ) . Significantly fewer home-based ( 51/143 , 35.7 % ) than clinic-based intervention ( 71/137 , 51.8 % ) patients died ( adjusted HR 0.62 , 95 % CI 0.42 to 0.90 : p=0.012 ) . Home-based versus clinic-based intervention patients accumulated 592 and 547 all-cause hospitalizations ( p=0.087 ) associated with 3067 ( median 4.0 , IQR 2.0 to 6.8 ) versus 4410 ( 6.0 , IQR 3.0 to 12.0 ) days of hospital stay ( p clinic-based intervention , home-based intervention was not associated with prolonged event-free survival . Home-based intervention was , however , associated with significantly fewer all-cause deaths and significantly fewer days of hospital stay in the longer-term . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry number 12607000069459 ( http://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=81803 )\",\n \"BACKGROUND The Support , Education , and Research in Chronic Heart Failure ( SEARCH ) study was design ed to assess the impact of a mindfulness-based psychoeducational intervention on clinical outcomes , depression , and quality of life in patients with chronic heart failure ( CHF ) . Although research has shown that psychosocial factors including depression are important risk factors for adverse events in patients with CHF , no large clinical trials have investigated the efficacy of psychosocial interventions to reduce these factors in this population . METHODS This was a prospect i ve cohort study of 208 adults with left ventricular ejection fraction geographically assigned to treatment or control groups with follow-up at 3 , 6 , and 12 months . Treatment groups met weekly for 8 consecutive weeks for training in mindfulness meditation , coping skills , and support group discussion . RESULTS Subjects had a mean age of 61 years , left ventricular ejection fraction 26 % , and median New York Heart Association class II . The majority were treated with angiotensin-converting enzyme inhibitors ( 80 % ) and beta-blockers ( 86 % ) . At baseline , patients in the treatment group had more severe CHF with higher New York Heart Association class ( P = .0209 ) and more severe psychological distress ( Center of Epidemiology - Depression , Profile of Mood States ; P anxiety ( Profile of Mood States , P = .003 ) , depression ( Center of Epidemiology - Depression , P = .05 ) , improved symptoms ( Kansas City Cardiomyopathy Question naire symptom scale , P = .033 ) and clinical scores ( Kansas City Cardiomyopathy Question naire clinical score , P = .024 ) over time . There were no treatment effects on death/rehospitalization at 1 year . CONCLUSIONS An 8-week mindfulness-based psychoeducational intervention reduced anxiety and depression ; this effect was attenuated at 1 year . Importantly , the intervention led to significantly better symptoms of CHF at 12 months compared to control subjects . Our results suggest that interventions of this type might have a role in optimal therapy for CHF\",\n \"Background — Patients with heart failure ( HF ) who live in rural areas have less access to cardiac services than patients in urban areas . We conducted a r and omized , clinical trial to determine the impact of an educational intervention on the composite end point of HF rehospitalization and cardiac death in this population . Methods and Results — Patients ( n=602 ; age , 66±13 years ; 41 % female ; 51 % with systolic HF ) were r and omized to 1 of 3 groups : control ( usual care ) , Fluid Watchers LITE , or Fluid Watchers PLUS . Both intervention groups included a face-to-face education session delivered by a nurse focusing on self-care . The LITE group received 2 follow-up phone calls , whereas the PLUS group received biweekly calls ( mean , 5.3±3.6 ; range , 1–19 ) until the nurse judged the patient to be adequately trained . Over 2 years of follow-up , 35 % of patients ( n=211 ) experienced cardiac death or hospitalization for HF , with no difference among the 3 groups in the proportion who experienced the combined clinical outcome ( P=0.06 ) . Although patients in the LITE group had reduced cardiac mortality compared with patients in the control group over the 2 years of follow-up ( 7.5 % and 17.7 % , respectively ; P=0.003 ) , there was no significant difference in cardiac mortality between patients in the PLUS group and the control group . Conclusions — A face-to-face education intervention did not significantly decrease the combined end point of cardiac death or hospitalization for HF . Increasing the number of contacts between the patient and nurse did not significantly improve outcome . Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT00415545\"\n]"},"id":{"kind":"string","value":"41171f7c-06ff-11f0-808a-c43d1ab1c353"}}},{"rowIdx":1199,"cells":{"target":{"kind":"string","value":"Abstract Sarcopenia is a potentially modifiable risk factor for falls and fractures in older adults , but the strength of the association between sarcopenia , falls , and fractures is unclear . This study aims to systematic ally assess the literature and perform a meta‐ analysis of the association between sarcopenia with falls and fractures among older adults . A literature search was performed using MEDLINE , EMBASE , Cochrane , and CINAHL from inception to May 2018 . Inclusion criteria were the following : published in English , mean/median age ≥ 65 years , sarcopenia diagnosis ( based on definitions used by the original studies ' authors ) , falls and /or fractures outcomes , and any study population . Pooled analyses were conducted of the associations of sarcopenia with falls and fractures , expressed in odds ratios ( OR ) and 95 % confidence intervals ( CIs ) . Subgroup analyses were performed by study design , population , sex , sarcopenia definition , continent , and study quality . Heterogeneity was assessed using the I 2 statistics . The search identified 2771 studies . Thirty‐six studies ( 52 838 individuals , 48.8 % females , and mean age of the study population s ranging from 65.0 to 86.7 years ) were included in the systematic review . Four studies reported on both falls and fractures . Ten out of 22 studies reported a significantly higher risk of falls in sarcopenic compared with non‐sarcopenic individuals ; 11 out of 19 studies showed a significant positive association with fractures . Thirty‐three studies ( 45 926 individuals ) were included in the meta‐ analysis . Sarcopenic individuals had a significant higher risk of falls ( cross‐sectional studies : OR 1.60 ; 95 % CI 1.37–1.86 , P 37 % ) and fractures ( cross‐sectional studies : OR 1.84 ; 95 % CI 1.30–2.62 , P = 0.001 , I 2 = 91 % ; prospect i ve studies : OR 1.71 ; 95 % CI 1.44–2.03 , P = 0.011 , I 2 = 0 % ) compared with non‐sarcopenic individuals . This was independent of study design , population , sex , sarcopenia definition , continent , and study quality . The positive association between sarcopenia with falls and fractures in older adults strengthens the need to invest in sarcopenia prevention and interventions to evaluate its effect on falls and fractures"},"src_docs":{"kind":"list like","value":["Muscle mass decreases with age , leading to \" sarcopenia , \" or low relative muscle mass , in elderly people . Sarcopenia is believed to be associated with metabolic , physiologic , and functional impairments and disability . Methods of estimating the prevalence of sarcopenia and its associated risks in elderly population s are lacking . Data from a population -based survey of 883 elderly Hispanic and non-Hispanic white men and women living in New Mexico ( the New Mexico Elder Health Survey , 1993 - 1995 ) were analyzed to develop a method for estimating the prevalence of sarcopenia . An anthropometric equation for predicting appendicular skeletal muscle mass was developed from a r and om sub sample ( n = 199 ) of participants and was extended to the total sample . Sarcopenia was defined as appendicular skeletal muscle mass (kg)/height2 ( m2 ) being less than two st and ard deviations below the mean of a young reference group . Prevalences increased from 13 - 24 % in persons under 70 years of age to > 50 % in persons over 80 years of age , and were slightly greater in Hispanics than in non-Hispanic whites . Sarcopenia was significantly associated with self-reported physical disability in both men and women , independent of ethnicity , age , morbidity , obesity , income , and health behaviors . This study provides some of the first estimates of the extent of the public health problem posed by sarcopenia","Background Patients with hip fracture frequently have sarcopenia and are at great risk of loss of mobility . We have investigated if sarcopenia predicts change in mobility after hip fracture . Methods This is a prospect i ve , multicenter observational study with one-year follow-up . Patients with hip fracture who were community-living and capable of walking before the fracture were included at three hospitals in Norway ( 2011–2013 ) . The primary outcome of the study was change in mobility , measured by the New Mobility Score ( NMS ) . Sarcopenia was determined postoperatively by anthropometry , grip strength , and NMS . Results We included 282 participants and sarcopenia status was determined in 201 , of whom 38 % ( 77/201 ) had sarcopenia , 66 % ( 128/194 ) had low muscle mass , 52 % ( 116/222 ) had low grip strength and 8 % ( 20/244 ) had low pre-fracture mobility ( NMS change in mobility ( effect 0.2 points ; 95 % CI –0.5 to 0.9 , P = 0.6 ) , but it was associated with having lower mobility at one-year ( NMS 5.8 ( SD 2.3 ) vs. 6.8 ( SD 2.2 ) , P = 0.003 ) , becoming a resident of a nursing home ( odds ratio 3.2 , 95 % CI 0.9 to 12.4 , P = 0.048 ) , and the combined endpoint of becoming a resident of a skilled nursing home or death ( odds ratio 3.6 , 95 % CI 1.2 to 12.2 , P = 0.02 ) . Conclusions Sarcopenia did not predict change in mobility in the year after hip fracture","Sarcopenia , a complex multifactorial condition , is characterized by loss of muscle mass and function , which increases progressively with age . The existence of different definitions has contributed to the large variation in the prevalence estimates of sarcopenia . We aim ed to estimate the prevalence of sarcopenia in the general population using the European Working Group on Sarcopenia in Older People ( EWGSOP ) proposed definition and compared baseline demographic and clinical characteristics between the nonsarcopenia , presarcopenia , and sarcopenia individuals , with particular emphasis on the overlap with osteoporosis and fracture risk . We studied 5911 subjects at a mean age of 69.2 years ( 55.8 % female ) with data on sarcopenia participating in the Rotterdam Study , a prospect i ve population -based cohort study in Rotterdam , the Netherl and s. Presarcopenia was defined as having only low muscle mass , whereas sarcopenia was defined based on the presence of low muscle mass , plus either low muscle strength or low physical performance . The prevalence of presarcopenia and sarcopenia was 5.9 % and 4.4 % , respectively . Individuals with sarcopenia were older , more often males , smokers , with less optimal dietary intake , and more often disabled with lower physical activity . Although the prevalence of fractures was higher in individuals with low lean mass ( presarcopenic [ 16.6 % ] and sarcopenic [ 23.5 % ] ) compared with the no sarcopenic group ( 15.5 % ) , the differences were not present after correcting for age and sex . There were no statistical differences in the prevalence of chronic diseases , with the exception of a higher prevalence of COPD in presarcopenic ( 29.1 % ) and sarcopenic ( 26.9 % ) individuals compared with nonsarcopenic ( 13.4 % ) individuals . Osteoporotic individuals with ( odds ratio [ OR ] = 2.59 , 95 % confidence interval [ CI ] 1.41 - 4.45 ) and without sarcopenia ( OR = 2.75 , 95 % CI 2.01 - 3.75 ) had similar elevated risk of nonvertebral fractures . The presence of sarcopenia appears to be independent of chronic diseases with the exception of COPD and more related to lifestyle factors and disabilities . Sarcopenic individuals in the general population are at no greater risk of fracture than what is determined by their low bone mineral density . © 2018 American Society for Bone and Mineral Research","AIM The purpose of the present study was to investigate whether sarcopenia was associated with future falls in the general Japanese older population . METHODS This study was a 2-year prospect i ve observational study . Participants were recruited from individuals who had an annual town-sponsored medical check-up and had not received nursing care . The inclusion criteria for participants in our study were : ( i ) agreement to participate ; ( ii ) living independently ; and ( iii ) the ability to walk to where the survey was carried out and to provide self-reported data . A total of 223 residents ( 82 men , 141 women ) participated in the baseline assessment in the study . Demographic information , previous fall history , locomotive syndrome , body function and structural measurements and pain at the knee and /or lumber spine were assessed . The Asian Working Group for Sarcopenia algorithm was used to classify the presence of sarcopenia , and assess the history of falling when the participant received their annual medical check-up . RESULTS A total of 162 participants had an annual follow-up assessment , 50 of whom ( 30.8 % ) fell at least once during the 2-year observational period after baseline assessment . Previous falling history , prevalence of locomotive syndrome , sarcopenia and pain were significantly higher in participants who had fallen compared with participants who had not . Multiple logistic regression analysis showed the prevalence of sarcopenia was a significant predictor of falling . CONCLUSION The key finding of the present study suggests that sarcopenia is a risk factor for falling in older adults who are living independently even after adjustment for previous falls and confounding factors . Geriatr Gerontol Int 2017 ; 17 : 2124 - 2130","Summary There is no clear consensus on definition , cut-points or st and ardised assessment s of sarcopenia . We found a lower limb strength assessment was at least as effective in predicting balance , mobility and falls in 419 older people as muscle mass-based measures of sarcopenia . Introduction There is currently no consensus on the definition , cut-points or st and ardised assessment s of sarcopenia . This study aim ed to investigate whether several published definitions of sarcopenia differentiate between older people with respect to important functional and health outcomes . Methods Four hundred nineteen community-living older adults ( mean age 81.2 ± 4.5 , 49 % female ) completed assessment s of body composition ( dual-energy X-ray absorptiometry ) , strength , balance , mobility and disability . Falls were recorded prospect ively for a year using monthly calendars . Sarcopenia was defined according to four skeletal mass-based definitions , two strength-based definitions ( h and grip or knee extensor force ) and a consensus algorithm ( low mass and low strength or slow gait speed ) . Obesity was defined according to percentage fat mass or waist circumference . Results The four skeletal mass-based definitions varied considerably with respect to the percentage of participants classified as sarcopenic and their predictive accuracy for functional and health outcomes . The knee extension strength-based definition was equivalent to or better than the mass-based and consensus algorithm definitions ; i.e. weaker participants performed poorly in tests of leaning balance , stepping reaction time , gait speed and mobility . They also had higher physiological fall risk scores and were 43 % more likely to fall at home than their stronger counterparts . Adding obesity to sarcopenia definitions identified participants with greater self-reported disability . Conclusions A simple lower limb strength assessment was at least as effective in predicting balance , functional mobility and falls in older people as more expensive and time-consuming muscle mass-based measures . These findings imply that functional terms such as muscle weakness or motor impairment are preferable to sarcopenia","Objective Sarcopenia might be associated with bone fragility in elderly individuals . This study aim ed to investigate the prevalence of sarcopenia and its association with fragility fracture sites in elderly Chinese patients . Methods Patients ( 322 men and 435 women ) aged 65–94 years and with a history of fragility fractures in the ankle , wrist , vertebrae or hip , and healthy men ( n = 1263 ) and women ( n = 1057 ) aged 65–92 years without a history of fractures were enrolled . Whole-body dual energy X-ray absorptiometry was used to analyze skeletal muscle mass index ( SMI ) , fat mass and bone mineral density . Sarcopenia was defined as SMI less than two st and ard deviations below the mean of a young reference group . Results Sarcopenia occurrence varied with fracture location . Sarcopenia was more common in females with vertebral and hip fractures and in men with hip and ankle fractures than in the non-fracture group ) . Sarcopenia was significantly more prevalent in men with wrist , hip and ankle fractures than in women . SMI was correlated with BMD in different fracture groups . Logistic regression analyses revealed that lower SMI was associated with an increased risk of hip fracture both in men and women and ankle fracture in men . Discussion Sarcopenia may be an independent risk factor for hip and ankle fractures in men , and for hip fractures in women","Background : The decline in skeletal muscle in old age is a factor in the development of functional limitations . Objective : The objective of this study was to assess if there is a correlation between muscle mass based on bioelectrical impedance analysis ( BIA ) detection and the fall incidence in nursing home residents and to examine the risk factors for falling in nursing home residents . Methods : This prospect i ve cohort study was part of a longitudinal study on nutritional issues in 52 nursing homes in Antwerp ( Belgium ) from October 2007 to April 2008 . Two hundred and seventy-six people aged 65 years and older were included . Each subject was assessed with BIA , the timed get-up- and -go test , the Katz score , the Mini Nutritional Assessment – Short Form and the 36-Item Short Form Health Survey . The primary outcome parameter was fall incidence during the study . Results : The prevalence of sarcopenia varied from 24.3 to 81.5 % depending on which definition was used . No association was found between BIA-derived muscle mass and fall incidence . Logistic regression analysis showed that gait speed ( odds ratio 1.029 ; p = 0.003 ) and mental health ( odds ratio 0.981 ; p = 0.015 ) are significantly associated with fall incidence in nursing homes . A receiver operating characteristic curve showed that none of the BIA-derived muscle parameters are good predictors of the risk of falling . Conclusions : This study shows that there is no association between sarcopenia based on BIA and fall incidence and that BIA-derived muscle mass has no additional value in predicting fall incidents compared to the timed get-up- and -go test","Background Lack of appropriate reporting of method ological details has previously been shown to distort risk of bias assessment s in r and omized controlled trials . The same might be true for observational studies . The goal of this study was to compare the Newcastle-Ottawa Scale ( NOS ) assessment for risk of bias between review ers and authors of cohort studies included in a published systematic review on risk factors for severe outcomes in patients infected with influenza . Methods Cohort studies included in the systematic review and published between 2008–2011 were included . The corresponding or first authors completed a survey covering all NOS items . Results were compared with the NOS assessment applied by review ers of the systematic review . Inter-rater reliability was calculated using kappa ( K ) statistics . Results Authors of 65/182 ( 36 % ) studies completed the survey . The overall NOS score was significantly higher ( p . Inter-rater reliability by item ranged from slight ( K = 0.15 , 95 % confidence interval [ CI ] = −0.19 , 0.48 ) to poor ( K = −0.06 , 95 % CI = −0.22 , 0.10 ) . Reliability for the overall score was poor ( K = −0.004 , 95 % CI = −0.11 , 0.11 ) . Conclusions Differences in assessment and low agreement between review ers and authors suggest the need to contact authors for information not published in studies when applying the NOS in systematic review","OBJECTIVES To examine whether the inclusion of sarcopenia in prediction models adds any incremental value to fracture risk assessment tool ( FRAX ) . DESIGN , SETTING , AND PARTICIPANTS Data from a prospect i ve cohort of 4000 community-dwelling Chinese men and women aged 65 years and older with adjudicated fracture outcomes were analyzed . MEASUREMENTS At baseline , femoral neck bone mineral density ( BMD ) was assessed , as were the clinical risk factors included in FRAX , along with additional appendicular skeletal muscle mass , grip strength , and gait speed . Sarcopenia was defined according to the Asian Working Group for Sarcopenia algorithm . Incident fractures were documented during the follow-up period from 2001 to 2013 . RESULTS Of 4000 participants , 565 experienced at least 1 type of incident fracture and 132 experienced a hip fracture during a follow-up of 10.2 years . Hazard ratios ( HRs ) for 1-unit increase in FRAX score without BMD in men were 1.12 [ 95 % confidence interval ( CI ) 1.08 - 1.16 ] for all fractures combined and 1.19 ( 95 % CI 1.13 - 1.27 ) for hip fracture , and in women were 1.04 ( 95 % CI 1.03 - 1.06 ) for all fractures combined and 1.08 ( 95 % CI 1.06 - 1.11 ) for hip fracture . Similar to results of the FRAX score without BMD , HRs for 1-unit increase in FRAX score with BMD in men were 1.04 ( 95 % CI 1.03 - 1.06 ) for all fractures combined and 1.19 ( 95 % CI 1.13 - 1.25 ) for hip fracture , and in women were 1.04 ( 95 % CI 1.03 - 1.05 ) for all fractures combined and 1.06 ( 95 % CI 1.05 - 1.08 ) for hip fracture . Sarcopenia was significantly associated with all fractures combined ( Adjusted HR 1.87 ; 95 % CI 1.30 - 2.68 ) and hip fracture ( Adjusted HR 2.67 ; 95 % CI 1.46 - 4.90 ) in men but not in women . The discriminative values for fracture , as measured by the area under the receiver operating characteristic curve , were 0.60 - 0.73 and 0.62 - 0.76 for FRAX without and with BMD , respectively . Adding sarcopenia did not significantly improve the discriminatory capacity over FRAX ( P > .05 ) . Using reclassification techniques , sarcopenia significantly enhanced the integrated discrimination improvement by 0.6 % to 1.2 % and the net reclassification improvement by 7.2 % to 20.8 % in men , but it did not contribute to predictive accuracy in women . CONCLUSIONS Sarcopenia added incremental value to FRAX in predicting incident fracture in older Chinese men","OBJECTIVES To determine whether obesity concurrent with sarcopenia ( low muscle mass ) or dynapenia ( low muscle strength ) is associated with increased falls risk in middle-aged and older adults . METHODS 5-year prospect i ve cohort study including 674 community-dwelling volunteers ( mean ± SD age 61.4 ± 7.0 years ; 48 % female ) . Sarcopenia and dynapenia were defined as lowest sex-specific tertiles for dual-energy X-ray (DXA)-assessed appendicular lean mass ( adjusted for height and fat mass ) or lower-limb strength , respectively . Obesity was defined as the highest tertiles of DXA-assessed total or trunk fat mass . Change in falls risk was calculated using the Physiological Profile Assessment ( z-scores : 0 - 1 = mild increased risk ; 1 - 2 = moderate increased risk ; > 2 = marked increased risk ) . RESULTS Multivariable linear regression analyses revealed mild but significantly increased falls risk scores for dynapenic obesity ( change in mean z-score compared to non-dynapenic , non-obese group : 0.33 , 95 % CI 0.06 - 0.59 [ men ] and 0.46 , 95 % CI 0.21 - 0.72 [ women ] ) and dynapenia ( 0.25 , 95 % CI 0.05 - 0.46 [ women only ] ) . CONCLUSIONS Dynapenic obesity , but not sarcopenic obesity , is predictive of increased falls risk score in middle-aged and older adults . In clinical setting s , muscle function assessment s may be useful for predicting falls risk in obese patients","Objectives : Purpose To compare the performance of low muscle mass and function with falls risk , incident fracture and mortality over 10 years . Methods 1041 participants ( 50 % women ; mean age 63±7.5 years ) were prospect ively followed for 10 years . Falls risk was measured using the Physiological Profile Assessment , fractures were self-reported and mortality was ascertained from the death registry . Appendicular lean mass ( ALM ) was assessed using dual energy X-ray absorptiometry . Four anthropometric : ( ALM/height2 , ALM/body mass index , ALM/weight × 100 , a residuals method of ALM on height and total body fat ) and four performance-based measures : ( h and grip strength , lower-limb muscle strength , upper and lower-limb muscle quality ) were examined . Participants in the lowest 20 % of the sex-specific distribution for each anthropometric and performance-based measure were classified has having low muscle mass or function . Regression analyses were used to estimate associations between each anthropometric and performance-based measure at baseline and 10-year falls risk , incident fractures and mortality . Results Mean falls risk z-score at 10 years was 0.64 ( SD 1.12 ) , incident fractures and mortality over 10 years were 16 % and 14 % respectively . All baseline performancebased measures were significantly associated with higher falls risk score at 10 years . Low h and grip ( RR 1.55 , 95 % CI : 1.09 , 2.20 ) and ALM/body mass index ( RR 1.54 , 95 % CI : 1.14 , 2.08 ) were the only significant predictors of fracture and mortality respectively . Conclusions Low h and grip strength , a simple and inexpensive test could be considered in clinical setting s for identifying future falls and fractures . ALM/ body mass index could be most suitable in estimating 10-year mortality risk , but requires specialised equipment","Summary In this study , we compare the extent to which seven available definitions of sarcopenia and two related definitions predict the rate of falling . Our results suggest that the definitions of Baumgartner and Cruz-Jentoft best predict the rate of falls among sarcopenic versus non-sarcopenic community-dwelling seniors . Introduction The purpose of the study is to compare the extent to which seven available definitions of sarcopenia and two related definitions predict the prospect i ve rate of falling . Methods We studied a cohort of 445 seniors ( mean age 71 years , 45 % men ) living in the community who were followed with a detailed fall assessment for 3 years . For comparing the rate of falls in sarcopenic versus non-sarcopenic individuals , we used multivariate Poisson regression analyses adjusting for gender and treatment ( original intervention tested vitamin D plus calcium against placebo ) . Of the seven available definitions , three were based on low lean mass alone ( Baumgartner , Delmonico 1 and 2 ) and four required both low muscle mass and decreased performance in a functional test ( Fielding , Cruz-Jentoft , Morley , Muscaritoli ) . The two related definitions were based on low lean mass alone ( Studenski 1 ) and low lean mass contributing to weakness ( Studenski 2 ) . Results Among 445 participants , 231 fell , sustaining 514 falls over the 3-year follow-up . The prospect i ve rate of falls in sarcopenic versus non-sarcopenic individuals was best predicted by the Baumgartner definition based on low lean mass alone ( RR = 1.54 ; 95 % CI 1.09–2.18 ) with 11 % prevalence of sarcopenia and the Cruz-Jentoft definition based on low lean mass plus decreased functional performance ( RR = 1.82 ; 95 % CI 1.24–2.69 ) with 7.1 % prevalence of sarcopenia . Consistently , fall rate was non-significantly higher in sarcopenic versus non-sarcopenic individuals based on the definitions of Delmonico 1 , Fielding , and Morley . Conclusion Among the definitions investigated , the Baumgartner definition and the Cruz-Jentoft definition had the highest validity for predicting the rate of falls","OBJECTIVES To test the hypothesis that men and women with low bone mineral density ( BMD ) and sarcopenia have a higher risk of fracture than those with only one or neither conditions . DESIGN The Osteoporotic Fractures in Men Study and the Study of Osteoporotic Fractures in women are prospect i ve observational studies with a mean follow up of 9 ( 2000 - 2012 ) and 8 years ( 1997 - 2009 ) , respectively . SETTING U.S. clinical centers . PARTICIPANTS Men ( n = 5,544 ; mean age 73.7 ) and women ( n = 1,114 ; mean age 77.6 ) aged 65 and older , able to walk without assistance , and without bilateral hip replacement . MEASUREMENTS Sarcopenia was defined as low appendicular lean mass plus slowness or weakness and low BMD according to the World Health Organization definition of a T-score less than -1.0 . Participants were classified as having normal BMD and no sarcopenia ( 3,367 men , 308 women ) , sarcopenia only ( 79 men , 48 women ) , low BMD only ( 1,986 men , 626 women ) , and low BMD and sarcopenia ( 112 men , 132 women ) . RESULTS Men with low BMD and sarcopenia ( hazard ratio (HR)=3.79 , 95 % confidence interval (CI)=2.65 - 5.41 ) and men with low BMD only ( HR=1.67 , 95 % CI=1.45 - 1.93 ) but not men with sarcopenia only ( HR=1.14 , 95 % CI=0.62 - 2.09 ) had greater risk of fracture than men with normal BMD and no sarcopenia . Women with low BMD and sarcopenia ( HR=2.27 , 95 % CI=1.37 - 3.76 ) and women with low BMD alone ( HR=2.62 , 95 % CI=1.74 - 3.95 ) , but not women with only sarcopenia , had greater risk of fracture than women with normal BMD and no sarcopenia . CONCLUSION Men with low BMD and sarcopenia are at especially high risk of fracture . Sarcopenia alone did not increase fracture risk in either group"],"string":"[\n \"Muscle mass decreases with age , leading to \\\" sarcopenia , \\\" or low relative muscle mass , in elderly people . Sarcopenia is believed to be associated with metabolic , physiologic , and functional impairments and disability . Methods of estimating the prevalence of sarcopenia and its associated risks in elderly population s are lacking . Data from a population -based survey of 883 elderly Hispanic and non-Hispanic white men and women living in New Mexico ( the New Mexico Elder Health Survey , 1993 - 1995 ) were analyzed to develop a method for estimating the prevalence of sarcopenia . An anthropometric equation for predicting appendicular skeletal muscle mass was developed from a r and om sub sample ( n = 199 ) of participants and was extended to the total sample . Sarcopenia was defined as appendicular skeletal muscle mass (kg)/height2 ( m2 ) being less than two st and ard deviations below the mean of a young reference group . Prevalences increased from 13 - 24 % in persons under 70 years of age to > 50 % in persons over 80 years of age , and were slightly greater in Hispanics than in non-Hispanic whites . Sarcopenia was significantly associated with self-reported physical disability in both men and women , independent of ethnicity , age , morbidity , obesity , income , and health behaviors . This study provides some of the first estimates of the extent of the public health problem posed by sarcopenia\",\n \"Background Patients with hip fracture frequently have sarcopenia and are at great risk of loss of mobility . We have investigated if sarcopenia predicts change in mobility after hip fracture . Methods This is a prospect i ve , multicenter observational study with one-year follow-up . Patients with hip fracture who were community-living and capable of walking before the fracture were included at three hospitals in Norway ( 2011–2013 ) . The primary outcome of the study was change in mobility , measured by the New Mobility Score ( NMS ) . Sarcopenia was determined postoperatively by anthropometry , grip strength , and NMS . Results We included 282 participants and sarcopenia status was determined in 201 , of whom 38 % ( 77/201 ) had sarcopenia , 66 % ( 128/194 ) had low muscle mass , 52 % ( 116/222 ) had low grip strength and 8 % ( 20/244 ) had low pre-fracture mobility ( NMS change in mobility ( effect 0.2 points ; 95 % CI –0.5 to 0.9 , P = 0.6 ) , but it was associated with having lower mobility at one-year ( NMS 5.8 ( SD 2.3 ) vs. 6.8 ( SD 2.2 ) , P = 0.003 ) , becoming a resident of a nursing home ( odds ratio 3.2 , 95 % CI 0.9 to 12.4 , P = 0.048 ) , and the combined endpoint of becoming a resident of a skilled nursing home or death ( odds ratio 3.6 , 95 % CI 1.2 to 12.2 , P = 0.02 ) . Conclusions Sarcopenia did not predict change in mobility in the year after hip fracture\",\n \"Sarcopenia , a complex multifactorial condition , is characterized by loss of muscle mass and function , which increases progressively with age . The existence of different definitions has contributed to the large variation in the prevalence estimates of sarcopenia . We aim ed to estimate the prevalence of sarcopenia in the general population using the European Working Group on Sarcopenia in Older People ( EWGSOP ) proposed definition and compared baseline demographic and clinical characteristics between the nonsarcopenia , presarcopenia , and sarcopenia individuals , with particular emphasis on the overlap with osteoporosis and fracture risk . We studied 5911 subjects at a mean age of 69.2 years ( 55.8 % female ) with data on sarcopenia participating in the Rotterdam Study , a prospect i ve population -based cohort study in Rotterdam , the Netherl and s. Presarcopenia was defined as having only low muscle mass , whereas sarcopenia was defined based on the presence of low muscle mass , plus either low muscle strength or low physical performance . The prevalence of presarcopenia and sarcopenia was 5.9 % and 4.4 % , respectively . Individuals with sarcopenia were older , more often males , smokers , with less optimal dietary intake , and more often disabled with lower physical activity . Although the prevalence of fractures was higher in individuals with low lean mass ( presarcopenic [ 16.6 % ] and sarcopenic [ 23.5 % ] ) compared with the no sarcopenic group ( 15.5 % ) , the differences were not present after correcting for age and sex . There were no statistical differences in the prevalence of chronic diseases , with the exception of a higher prevalence of COPD in presarcopenic ( 29.1 % ) and sarcopenic ( 26.9 % ) individuals compared with nonsarcopenic ( 13.4 % ) individuals . Osteoporotic individuals with ( odds ratio [ OR ] = 2.59 , 95 % confidence interval [ CI ] 1.41 - 4.45 ) and without sarcopenia ( OR = 2.75 , 95 % CI 2.01 - 3.75 ) had similar elevated risk of nonvertebral fractures . The presence of sarcopenia appears to be independent of chronic diseases with the exception of COPD and more related to lifestyle factors and disabilities . Sarcopenic individuals in the general population are at no greater risk of fracture than what is determined by their low bone mineral density . © 2018 American Society for Bone and Mineral Research\",\n \"AIM The purpose of the present study was to investigate whether sarcopenia was associated with future falls in the general Japanese older population . METHODS This study was a 2-year prospect i ve observational study . Participants were recruited from individuals who had an annual town-sponsored medical check-up and had not received nursing care . The inclusion criteria for participants in our study were : ( i ) agreement to participate ; ( ii ) living independently ; and ( iii ) the ability to walk to where the survey was carried out and to provide self-reported data . A total of 223 residents ( 82 men , 141 women ) participated in the baseline assessment in the study . Demographic information , previous fall history , locomotive syndrome , body function and structural measurements and pain at the knee and /or lumber spine were assessed . The Asian Working Group for Sarcopenia algorithm was used to classify the presence of sarcopenia , and assess the history of falling when the participant received their annual medical check-up . RESULTS A total of 162 participants had an annual follow-up assessment , 50 of whom ( 30.8 % ) fell at least once during the 2-year observational period after baseline assessment . Previous falling history , prevalence of locomotive syndrome , sarcopenia and pain were significantly higher in participants who had fallen compared with participants who had not . Multiple logistic regression analysis showed the prevalence of sarcopenia was a significant predictor of falling . CONCLUSION The key finding of the present study suggests that sarcopenia is a risk factor for falling in older adults who are living independently even after adjustment for previous falls and confounding factors . Geriatr Gerontol Int 2017 ; 17 : 2124 - 2130\",\n \"Summary There is no clear consensus on definition , cut-points or st and ardised assessment s of sarcopenia . We found a lower limb strength assessment was at least as effective in predicting balance , mobility and falls in 419 older people as muscle mass-based measures of sarcopenia . Introduction There is currently no consensus on the definition , cut-points or st and ardised assessment s of sarcopenia . This study aim ed to investigate whether several published definitions of sarcopenia differentiate between older people with respect to important functional and health outcomes . Methods Four hundred nineteen community-living older adults ( mean age 81.2 ± 4.5 , 49 % female ) completed assessment s of body composition ( dual-energy X-ray absorptiometry ) , strength , balance , mobility and disability . Falls were recorded prospect ively for a year using monthly calendars . Sarcopenia was defined according to four skeletal mass-based definitions , two strength-based definitions ( h and grip or knee extensor force ) and a consensus algorithm ( low mass and low strength or slow gait speed ) . Obesity was defined according to percentage fat mass or waist circumference . Results The four skeletal mass-based definitions varied considerably with respect to the percentage of participants classified as sarcopenic and their predictive accuracy for functional and health outcomes . The knee extension strength-based definition was equivalent to or better than the mass-based and consensus algorithm definitions ; i.e. weaker participants performed poorly in tests of leaning balance , stepping reaction time , gait speed and mobility . They also had higher physiological fall risk scores and were 43 % more likely to fall at home than their stronger counterparts . Adding obesity to sarcopenia definitions identified participants with greater self-reported disability . Conclusions A simple lower limb strength assessment was at least as effective in predicting balance , functional mobility and falls in older people as more expensive and time-consuming muscle mass-based measures . These findings imply that functional terms such as muscle weakness or motor impairment are preferable to sarcopenia\",\n \"Objective Sarcopenia might be associated with bone fragility in elderly individuals . This study aim ed to investigate the prevalence of sarcopenia and its association with fragility fracture sites in elderly Chinese patients . Methods Patients ( 322 men and 435 women ) aged 65–94 years and with a history of fragility fractures in the ankle , wrist , vertebrae or hip , and healthy men ( n = 1263 ) and women ( n = 1057 ) aged 65–92 years without a history of fractures were enrolled . Whole-body dual energy X-ray absorptiometry was used to analyze skeletal muscle mass index ( SMI ) , fat mass and bone mineral density . Sarcopenia was defined as SMI less than two st and ard deviations below the mean of a young reference group . Results Sarcopenia occurrence varied with fracture location . Sarcopenia was more common in females with vertebral and hip fractures and in men with hip and ankle fractures than in the non-fracture group ) . Sarcopenia was significantly more prevalent in men with wrist , hip and ankle fractures than in women . SMI was correlated with BMD in different fracture groups . Logistic regression analyses revealed that lower SMI was associated with an increased risk of hip fracture both in men and women and ankle fracture in men . Discussion Sarcopenia may be an independent risk factor for hip and ankle fractures in men , and for hip fractures in women\",\n \"Background : The decline in skeletal muscle in old age is a factor in the development of functional limitations . Objective : The objective of this study was to assess if there is a correlation between muscle mass based on bioelectrical impedance analysis ( BIA ) detection and the fall incidence in nursing home residents and to examine the risk factors for falling in nursing home residents . Methods : This prospect i ve cohort study was part of a longitudinal study on nutritional issues in 52 nursing homes in Antwerp ( Belgium ) from October 2007 to April 2008 . Two hundred and seventy-six people aged 65 years and older were included . Each subject was assessed with BIA , the timed get-up- and -go test , the Katz score , the Mini Nutritional Assessment – Short Form and the 36-Item Short Form Health Survey . The primary outcome parameter was fall incidence during the study . Results : The prevalence of sarcopenia varied from 24.3 to 81.5 % depending on which definition was used . No association was found between BIA-derived muscle mass and fall incidence . Logistic regression analysis showed that gait speed ( odds ratio 1.029 ; p = 0.003 ) and mental health ( odds ratio 0.981 ; p = 0.015 ) are significantly associated with fall incidence in nursing homes . A receiver operating characteristic curve showed that none of the BIA-derived muscle parameters are good predictors of the risk of falling . Conclusions : This study shows that there is no association between sarcopenia based on BIA and fall incidence and that BIA-derived muscle mass has no additional value in predicting fall incidents compared to the timed get-up- and -go test\",\n \"Background Lack of appropriate reporting of method ological details has previously been shown to distort risk of bias assessment s in r and omized controlled trials . The same might be true for observational studies . The goal of this study was to compare the Newcastle-Ottawa Scale ( NOS ) assessment for risk of bias between review ers and authors of cohort studies included in a published systematic review on risk factors for severe outcomes in patients infected with influenza . Methods Cohort studies included in the systematic review and published between 2008–2011 were included . The corresponding or first authors completed a survey covering all NOS items . Results were compared with the NOS assessment applied by review ers of the systematic review . Inter-rater reliability was calculated using kappa ( K ) statistics . Results Authors of 65/182 ( 36 % ) studies completed the survey . The overall NOS score was significantly higher ( p . Inter-rater reliability by item ranged from slight ( K = 0.15 , 95 % confidence interval [ CI ] = −0.19 , 0.48 ) to poor ( K = −0.06 , 95 % CI = −0.22 , 0.10 ) . Reliability for the overall score was poor ( K = −0.004 , 95 % CI = −0.11 , 0.11 ) . Conclusions Differences in assessment and low agreement between review ers and authors suggest the need to contact authors for information not published in studies when applying the NOS in systematic review\",\n \"OBJECTIVES To examine whether the inclusion of sarcopenia in prediction models adds any incremental value to fracture risk assessment tool ( FRAX ) . DESIGN , SETTING , AND PARTICIPANTS Data from a prospect i ve cohort of 4000 community-dwelling Chinese men and women aged 65 years and older with adjudicated fracture outcomes were analyzed . MEASUREMENTS At baseline , femoral neck bone mineral density ( BMD ) was assessed , as were the clinical risk factors included in FRAX , along with additional appendicular skeletal muscle mass , grip strength , and gait speed . Sarcopenia was defined according to the Asian Working Group for Sarcopenia algorithm . Incident fractures were documented during the follow-up period from 2001 to 2013 . RESULTS Of 4000 participants , 565 experienced at least 1 type of incident fracture and 132 experienced a hip fracture during a follow-up of 10.2 years . Hazard ratios ( HRs ) for 1-unit increase in FRAX score without BMD in men were 1.12 [ 95 % confidence interval ( CI ) 1.08 - 1.16 ] for all fractures combined and 1.19 ( 95 % CI 1.13 - 1.27 ) for hip fracture , and in women were 1.04 ( 95 % CI 1.03 - 1.06 ) for all fractures combined and 1.08 ( 95 % CI 1.06 - 1.11 ) for hip fracture . Similar to results of the FRAX score without BMD , HRs for 1-unit increase in FRAX score with BMD in men were 1.04 ( 95 % CI 1.03 - 1.06 ) for all fractures combined and 1.19 ( 95 % CI 1.13 - 1.25 ) for hip fracture , and in women were 1.04 ( 95 % CI 1.03 - 1.05 ) for all fractures combined and 1.06 ( 95 % CI 1.05 - 1.08 ) for hip fracture . Sarcopenia was significantly associated with all fractures combined ( Adjusted HR 1.87 ; 95 % CI 1.30 - 2.68 ) and hip fracture ( Adjusted HR 2.67 ; 95 % CI 1.46 - 4.90 ) in men but not in women . The discriminative values for fracture , as measured by the area under the receiver operating characteristic curve , were 0.60 - 0.73 and 0.62 - 0.76 for FRAX without and with BMD , respectively . Adding sarcopenia did not significantly improve the discriminatory capacity over FRAX ( P > .05 ) . Using reclassification techniques , sarcopenia significantly enhanced the integrated discrimination improvement by 0.6 % to 1.2 % and the net reclassification improvement by 7.2 % to 20.8 % in men , but it did not contribute to predictive accuracy in women . CONCLUSIONS Sarcopenia added incremental value to FRAX in predicting incident fracture in older Chinese men\",\n \"OBJECTIVES To determine whether obesity concurrent with sarcopenia ( low muscle mass ) or dynapenia ( low muscle strength ) is associated with increased falls risk in middle-aged and older adults . METHODS 5-year prospect i ve cohort study including 674 community-dwelling volunteers ( mean ± SD age 61.4 ± 7.0 years ; 48 % female ) . Sarcopenia and dynapenia were defined as lowest sex-specific tertiles for dual-energy X-ray (DXA)-assessed appendicular lean mass ( adjusted for height and fat mass ) or lower-limb strength , respectively . Obesity was defined as the highest tertiles of DXA-assessed total or trunk fat mass . Change in falls risk was calculated using the Physiological Profile Assessment ( z-scores : 0 - 1 = mild increased risk ; 1 - 2 = moderate increased risk ; > 2 = marked increased risk ) . RESULTS Multivariable linear regression analyses revealed mild but significantly increased falls risk scores for dynapenic obesity ( change in mean z-score compared to non-dynapenic , non-obese group : 0.33 , 95 % CI 0.06 - 0.59 [ men ] and 0.46 , 95 % CI 0.21 - 0.72 [ women ] ) and dynapenia ( 0.25 , 95 % CI 0.05 - 0.46 [ women only ] ) . CONCLUSIONS Dynapenic obesity , but not sarcopenic obesity , is predictive of increased falls risk score in middle-aged and older adults . In clinical setting s , muscle function assessment s may be useful for predicting falls risk in obese patients\",\n \"Objectives : Purpose To compare the performance of low muscle mass and function with falls risk , incident fracture and mortality over 10 years . Methods 1041 participants ( 50 % women ; mean age 63±7.5 years ) were prospect ively followed for 10 years . Falls risk was measured using the Physiological Profile Assessment , fractures were self-reported and mortality was ascertained from the death registry . Appendicular lean mass ( ALM ) was assessed using dual energy X-ray absorptiometry . Four anthropometric : ( ALM/height2 , ALM/body mass index , ALM/weight × 100 , a residuals method of ALM on height and total body fat ) and four performance-based measures : ( h and grip strength , lower-limb muscle strength , upper and lower-limb muscle quality ) were examined . Participants in the lowest 20 % of the sex-specific distribution for each anthropometric and performance-based measure were classified has having low muscle mass or function . Regression analyses were used to estimate associations between each anthropometric and performance-based measure at baseline and 10-year falls risk , incident fractures and mortality . Results Mean falls risk z-score at 10 years was 0.64 ( SD 1.12 ) , incident fractures and mortality over 10 years were 16 % and 14 % respectively . All baseline performancebased measures were significantly associated with higher falls risk score at 10 years . Low h and grip ( RR 1.55 , 95 % CI : 1.09 , 2.20 ) and ALM/body mass index ( RR 1.54 , 95 % CI : 1.14 , 2.08 ) were the only significant predictors of fracture and mortality respectively . Conclusions Low h and grip strength , a simple and inexpensive test could be considered in clinical setting s for identifying future falls and fractures . ALM/ body mass index could be most suitable in estimating 10-year mortality risk , but requires specialised equipment\",\n \"Summary In this study , we compare the extent to which seven available definitions of sarcopenia and two related definitions predict the rate of falling . Our results suggest that the definitions of Baumgartner and Cruz-Jentoft best predict the rate of falls among sarcopenic versus non-sarcopenic community-dwelling seniors . Introduction The purpose of the study is to compare the extent to which seven available definitions of sarcopenia and two related definitions predict the prospect i ve rate of falling . Methods We studied a cohort of 445 seniors ( mean age 71 years , 45 % men ) living in the community who were followed with a detailed fall assessment for 3 years . For comparing the rate of falls in sarcopenic versus non-sarcopenic individuals , we used multivariate Poisson regression analyses adjusting for gender and treatment ( original intervention tested vitamin D plus calcium against placebo ) . Of the seven available definitions , three were based on low lean mass alone ( Baumgartner , Delmonico 1 and 2 ) and four required both low muscle mass and decreased performance in a functional test ( Fielding , Cruz-Jentoft , Morley , Muscaritoli ) . The two related definitions were based on low lean mass alone ( Studenski 1 ) and low lean mass contributing to weakness ( Studenski 2 ) . Results Among 445 participants , 231 fell , sustaining 514 falls over the 3-year follow-up . The prospect i ve rate of falls in sarcopenic versus non-sarcopenic individuals was best predicted by the Baumgartner definition based on low lean mass alone ( RR = 1.54 ; 95 % CI 1.09–2.18 ) with 11 % prevalence of sarcopenia and the Cruz-Jentoft definition based on low lean mass plus decreased functional performance ( RR = 1.82 ; 95 % CI 1.24–2.69 ) with 7.1 % prevalence of sarcopenia . Consistently , fall rate was non-significantly higher in sarcopenic versus non-sarcopenic individuals based on the definitions of Delmonico 1 , Fielding , and Morley . Conclusion Among the definitions investigated , the Baumgartner definition and the Cruz-Jentoft definition had the highest validity for predicting the rate of falls\",\n \"OBJECTIVES To test the hypothesis that men and women with low bone mineral density ( BMD ) and sarcopenia have a higher risk of fracture than those with only one or neither conditions . DESIGN The Osteoporotic Fractures in Men Study and the Study of Osteoporotic Fractures in women are prospect i ve observational studies with a mean follow up of 9 ( 2000 - 2012 ) and 8 years ( 1997 - 2009 ) , respectively . SETTING U.S. clinical centers . PARTICIPANTS Men ( n = 5,544 ; mean age 73.7 ) and women ( n = 1,114 ; mean age 77.6 ) aged 65 and older , able to walk without assistance , and without bilateral hip replacement . MEASUREMENTS Sarcopenia was defined as low appendicular lean mass plus slowness or weakness and low BMD according to the World Health Organization definition of a T-score less than -1.0 . Participants were classified as having normal BMD and no sarcopenia ( 3,367 men , 308 women ) , sarcopenia only ( 79 men , 48 women ) , low BMD only ( 1,986 men , 626 women ) , and low BMD and sarcopenia ( 112 men , 132 women ) . RESULTS Men with low BMD and sarcopenia ( hazard ratio (HR)=3.79 , 95 % confidence interval (CI)=2.65 - 5.41 ) and men with low BMD only ( HR=1.67 , 95 % CI=1.45 - 1.93 ) but not men with sarcopenia only ( HR=1.14 , 95 % CI=0.62 - 2.09 ) had greater risk of fracture than men with normal BMD and no sarcopenia . Women with low BMD and sarcopenia ( HR=2.27 , 95 % CI=1.37 - 3.76 ) and women with low BMD alone ( HR=2.62 , 95 % CI=1.74 - 3.95 ) , but not women with only sarcopenia , had greater risk of fracture than women with normal BMD and no sarcopenia . CONCLUSION Men with low BMD and sarcopenia are at especially high risk of fracture . 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BACKGROUND Sustained elevated blood pressure , unresponsive to lifestyle measures , leads to a critically important clinical question : What class of drug to use first-line ? This review answers that question . OBJECTIVES PRIMARY OBJECTIVE To quantify the benefits and harms of the major first-line anti-hypertensive drug classes : thiazides , beta-blockers , calcium channel blockers , angiotensin converting enzyme ( ACE ) inhibitors , alpha-blockers , and angiotensin II receptor blockers ( ARB ) . SEARCH STRATEGY Electronic search of MEDLINE ( Jan. 1966-June 2008 ) , EMBASE , CINAHL , the Cochrane clinical trial register , using st and ard search strategy of the hypertension review group with additional terms . SELECTION CRITERIA R and omized trials of at least one year duration comparing one of 6 major drug classes with a placebo or no treatment . More than 70 % of people must have BP > 140/90 mmHg at baseline . DATA COLLECTION AND ANALYSIS The outcomes assessed were mortality , stroke , coronary heart disease ( CHD ) , cardiovascular events ( CVS ) , decrease in systolic and diastolic blood pressure , and withdrawals due to adverse drug effects . Risk ratio ( RR ) and a fixed effects model were used to combine outcomes across trials . MAIN RESULTS Of 57 trials identified , 24 trials with 28 arms , including 58,040 patients met the inclusion criteria . Thiazides ( 19 RCTs ) reduced mortality ( RR 0.89 , 95 % CI 0.83 , 0.96 ) , stroke ( RR 0.63 , 95 % CI 0.57 , 0.71 ) , CHD ( RR 0.84 , 95 % CI 0.75 , 0.95 ) and CVS ( RR 0.70 , 95 % CI 0.66 , 0.76 ) . Low-dose thiazides ( 8 RCTs ) reduced CHD ( RR 0.72 , 95 % CI 0.61 , 0.84 ) , but high-dose thiazides ( 11 RCTs ) did not ( RR 1.01 , 95 % CI 0.85 , 1.20 ) . Beta-blockers ( 5 RCTs ) reduced stroke ( RR 0.83 , 95 % CI 0.72 , 0.97 ) and CVS ( RR 0.89 , 95 % CI 0.81 , 0.98 ) but not CHD ( RR 0.90 , 95 % CI 0.78 , 1.03 ) or mortality ( RR 0.96 , 95 % CI 0.86 , 1.07 ) . ACE inhibitors ( 3 RCTs ) reduced mortality ( RR 0.83 , 95 % CI 0.72 - 0.95 ) , stroke ( RR 0.65 , 95 % CI 0.52 - 0.82 ) , CHD ( RR 0.81 , 95 % CI 0.70 - 0.94 ) and CVS ( RR 0.76 , 95 % CI 0.67 - 0.85 ) . Calcium-channel blocker ( 1 RCT ) reduced stroke ( RR 0.58 , 95 % CI 0.41 , 0.84 ) and CVS ( RR 0.71 , 95 % CI 0.57 , 0.87 ) but not CHD ( RR 0.77 95 % CI 0.55 , 1.09 ) or mortality ( RR 0.86 95 % CI 0.68 , 1.09 ) . No RCTs were found for ARBs or alpha-blockers . AUTHORS ' CONCLUSIONS First-line low-dose thiazides reduce all morbidity and mortality outcomes . First-line ACE inhibitors and calcium channel blockers may be similarly effective but the evidence is less robust . First-line high-dose thiazides and first-line beta-blockers are inferior to first-line low-dose thiazides
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"The mechanism of risk reduction obtained by blood pressure-lowering pharmacological treatment remains unclear . We explored the amount of risk reduction attributable to the apparent effect of antihypertensive medicines on blood pressure by using the capture approach . Five r and omized , placebo or nil controlled trials with a total of 28,997 subjects and 1,935 cardiovascular fatal or non-fatal events from the INDANA data base met the eligibility criteria . Computations were performed on the original individual records using multiple Cox 's proportional hazard regression models design ed for meeting the assumed treatment mode of action and comparing relevant assumptions . For coronary event , the results are inconclusive essentially because the risk reduction is mild . However , for stroke the risk reduction adjusted for baseline risk factors is 34 % ( P systolic blood pressure is 49 % of this reduction , with 95 % confidence interval not including 100 % . This result suggests that the apparent effect on blood pressure is not the only cause of stroke risk reduction in hypertensive subjects su bmi tted to an antihypertensive medicine",
"CONTEXT The Systolic Hypertension in the Elderly Program ( SHEP ) demonstrated that treating isolated systolic hypertension in older patients decreased incidence of total stroke , but whether all types of stroke were reduced was not evaluated . OBJECTIVE To investigate antihypertensive drug treatment effects on incidence of stroke by type and subtype , timing of strokes , case-fatality rates , stroke residual effects , and relationship of attained systolic blood pressure to stroke incidence . DESIGN The SHEP study , a r and omized , double-blind , placebo-controlled trial began March 1 , 1985 , and had an average follow-up of 4.5 years . SETTING AND PARTICIPANTS A total of 4736 men and women aged 60 years or older with isolated systolic hypertension at 16 clinical centers in the United States . INTERVENTIONS Patients were r and omly assigned to receive treatment with 12.5 mg/d of chlorthalidone ( step 1 ) ; either 25 mg/d of atenolol or 0.05 mg/d of reserpine ( step 2 ) could be added ( n = 2365 ) ; or placebo ( n = 2371 ) . MAIN OUTCOME MEASURES Occurrence , type and subtype , and timing of first strokes and stroke fatalities ; and change in stroke incidence for participants ( whether in active treatment or placebo groups ) reaching study -specific systolic blood pressure goal ( decrease of at least 20 mm Hg from baseline to below 160 mm Hg ) compared with participants not reaching goal . RESULTS A total of 85 and 132 participants in the active treatment and placebo groups , respectively , had ischemic strokes ( adjusted relative risk [ RR ] , 0.63 ; 95 % confidence interval [ CI ] , 0.48 - 0.82 ) ; 9 and 19 had hemorrhagic strokes ( adjusted RR , 0.46 ; 95 % CI , 0.21 - 1.02 ) ; and 9 and 8 had strokes of unknown type ( adjusted RR , 1.05 ; 95 % CI , 0.40 - 2 . 73 ) , respectively . Four subtypes of ischemic stroke were observed in active treatment and placebo group participants , respectively , as follows : for lacunar , n = 23 and n = 43 ( adjusted RR , 0.53 ; 95 % CI , 0.32 - 0.88 ) ; for embolic , n = 9 and n = 16 ( adjusted RR , 0.56 ; 95 % CI , 0.25 - 1.27 ) ; for atherosclerotic , n = 13 and n = 13 ( adjusted RR , 0 . 99 ; 95 % CI , 0.46 - 2.15 ) ; and for unknown subtype , n = 40 and n = 60 ( adjusted RR , 0.64 ; 95 % CI , 0.43 - 0.96 ) . Treatment effect was observed within 1 year for hemorrhagic strokes but was not seen until the second year for ischemic strokes . Stroke incidence significantly decreased in participants attaining study -specific systolic blood pressure goals . CONCLUSIONS In this study , antihypertensive drug treatment reduced the incidence of both hemorrhagic and ischemic ( including lacunar ) strokes . Reduction in stroke incidence occurred when specific systolic blood pressure goals were attained . JAMA . 2000;284:465 -",
"Background — Early after coronary artery bypass surgery ( CABG ) , activation of numerous neurohumoral and endogenous vasodilator systems occurs that could be influenced favorably by angiotensin-converting enzyme inhibitors . Methods and Results — The Ischemia Management with Accupril post – bypass Graft via Inhibition of the coNverting Enzyme ( IMAGINE ) trial tested whether early initiation ( ≤7 days ) of an angiotensin-converting enzyme inhibitor after CABG reduced cardiovascular events in stable patients with left ventricular ejection fraction ≥40 % . The trial was a double-blind , placebo-controlled study of 2553 patients r and omly assigned to quinapril , target dose 40 mg/d , or placebo , who were followed up to a maximum of 43 months . The mean ( SD ) age was 61 ( 10 ) years . The incidence of the primary composite end point ( cardiovascular death , resuscitated cardiac arrest , nonfatal myocardial infa rct ion , coronary revascularization , unstable angina or heart failure requiring hospitalization , documented angina , and stroke ) was 13.7 % in the quinapril group and 12.2 % in the placebo group ( hazard ratio 1.15 , 95 % confidence interval 0.92 to 1.42 , P=0.212 ) over a median follow-up of 2.95 years . The incidence of the primary composite end point increased significantly in the first 3 months after CABG in the quinapril group ( hazard ratio 1.52 , 95 % confidence interval 1.03 to 2.26 , P=0.0356 ) . Adverse events also increased in the quinapril group , particularly during the first 3 months after CABG . Conclusions — In patients at low risk of cardiovascular events after CABG , routine early initiation of angiotensin-converting enzyme inhibitor therapy does not appear to improve clinical outcome up to 3 years after CABG ; however , it increases the incidence of adverse events , particularly early after CABG . Thus , early after CABG , initiation of angiotensin-converting enzyme inhibitor therapy should be individualized and continually reassessed over time according to risk",
"Although the benefits of antihypertensive treatment in \" young \" elderly ( under 70 years ) hypertensive patients are well established , the value of treatment in older patients ( 70 - 84 years ) is less clear . The Swedish Trial in Old Patients with Hypertension ( STOP-Hypertension ) was a prospect i ve , r and omised , double-blind , intervention study set up to compare the effects of active antihypertensive therapy ( three beta-blockers and one diuretic ) and placebo on the frequency of fatal and non-fatal stroke and myocardial infa rct ion and other cardiovascular death in hypertensive Swedish men and women aged 70 - 84 years . We recruited 1627 patients at 116 health centres throughout Sweden , who were willing to participate , and who met the entry criteria of three separate recordings during a 1-month placebo run-in period of systolic blood pressure between 180 and 230 mm Hg with a diastolic pressure of at least 90 mm Hg , or a diastolic pressure between 105 and 120 mm Hg irrespective of the systolic pressure . The total duration of the study was 65 months and the average time in the study was 25 months . 812 patients were r and omly allocated active treatment and 815 placebo . The mean difference in supine blood pressure between the active treatment and placebo groups at the last follow-up before an endpoint , death , or study termination was 19.5/8.1 mm Hg . Compared with placebo , active treatment significantly reduced the number of primary endpoints ( 94 vs 58 ; p = 0.0031 ) and stroke morbidity and mortality ( 53 vs 29 ; p = 0.0081 ) . Although we did not set out to study an effect on total mortality , we also noted a significantly reduced number of deaths in the active treatment group ( 63 vs 36 ; p = 0.0079 ) . The benefits of treatment were discernible up to age 84 years . We conclude that antihypertensive treatment in hypertensive men and women aged 70 - 84 confers highly significant and clinical ly relevant reductions in cardiovascular morbidity and mortality as well as in total mortality",
"BACKGROUND Questions regarding the efficacy of nonpharmacologic approaches for the treatment of stage 1 hypertension were addressed as part of the Treatment of Mild Hypertension Study ( TOMHS ) , a 4-year , r and omized clinical trial ( N = 902 ) . This report describes the lifestyle intervention program used in TOMHS , presents data on the lifestyle changes observed , and focuses on the effect of weight loss on blood pressure and blood lipid levels . METHODS Participants were r and omly assigned to receive either placebo or one of five different antihypertensive medications . All took part in a lifestyle intervention program to reduce weight and sodium and alcohol intake and to increase physical activity . RESULTS Substantial changes from baseline levels were achieved for all lifestyle intervention variables . Mean weight change was -10.5 lb ( -5.6 % ) at 1 year , -8.5 lb ( -4.5 % ) at 2 years , -7.4 lb ( -4.0 % ) at 3 years , and -5.7 lb ( -3.0 % ) at 4 years . At 4 years , 70 % of participants remained below baseline weight and 34 % maintained a weight loss of 10 lb or greater . Mean change in urinary sodium excretion was -12.5 mmol/8 hr ( -23 % ) at 1 year , -10.7 mmol/8 hr ( -20 % ) at 2 years , -8.4 mmol/8 hr ( -16 % ) at 3 years , and -4.6 mmol/8 hr ( -9 % ) at 4 years . Alcohol intake declined by 1.6 drinks/week among drinkers at 4 years . Reported leisure physical activity increased by 86 % at 1 year and remained 50 % above baseline at 4 years . Beneficial changes in blood pressure and serum lipids were associated with these changes . CONCLUSIONS These results support a role for lifestyle interventions as the initial treatment for stage 1 hypertension and demonstrate that such interventions can be successfully implemented in the clinical setting",
"OBJECTIVE --To investigate the relation between mortality and treated systolic and diastolic blood pressures . DESIGN --R and omised double blind placebo controlled trial . Mortality in the two treatment groups was examined in thirds of treated systolic and diastolic blood pressures . PATIENTS --339 And 352 patients allocated to placebo and active treatment , respectively . The groups were similar at r and omisation in sex ratio ( 70 % women ) , mean age ( 71.5 years ) , blood pressure ( 182/101 mm Hg ) , and proportion of patients with cardiovascular complications ( 35 % ) . MEASUREMENTS AND MAIN RESULTS --In the placebo group total mortality rose with increasing systolic pressure whereas it had a U shaped relation with diastolic pressure , the total lowest mortality being in patients in the middle third of the distribution of diastolic pressure . In the group given active treatment total mortality showed a U shaped relation with systolic pressure and an inverse association with treated diastolic pressure . In both groups cardiovascular and non-cardiovascular mortality followed the same trends as total mortality . The increased mortality in the lowest thirds of pressure was not associated with an increased proportion of patients with cardiovascular complications at r and omisation or with a fall in diastolic pressure exceeding the median fall in pressure in each group . In contrast , patients in the lowest thirds of pressure showed greater decreases in body weight and haemoglobin concentration than those in the middle and upper thirds of pressure . CONCLUSIONS --In patients taking active treatment total mortality was increased in the lowest thirds of treated systolic and diastolic blood pressures . This increased mortality is not necessarily explained by an exaggerated reduction in pressure induced by drugs as for diastolic pressure a U shaped relation also existed during treatment with placebo . In addition , patients in the lowest thirds of systolic and diastolic pressures were characterised by decreases in body weight and haemoglobin concentration , and the patients in the lowest thirds of diastolic pressure taking active treatment also by an increased non-cardiovascular mortality , suggesting some deterioration of general health",
"Background — Diuretics are recommended as first-line agents for the treatment of hypertension . This r and omized , double-blind , multicenter study assessed the long-term efficacy and safety of the direct renin inhibitor aliskiren in comparison with the diuretic hydrochlorothiazide in patients with essential hypertension . Methods and Results — After a 2- to 4-week placebo run-in , 1124 patients ( mean sitting diastolic blood pressure [ BP ] 95 to 109 mm Hg ) were r and omized to aliskiren 150 mg ( n=459 ) , hydrochlorothiazide 12.5 mg ( n=444 ) , or placebo ( n=221 ) once daily . Forced titration ( to aliskiren 300 mg or hydrochlorothiazide 25 mg ) occurred at week 3 ; at week 6 , patients receiving placebo were reassigned ( 1:1 ratio ) to aliskiren 300 mg or hydrochlorothiazide 25 mg . From week 12 , amlodipine 5 mg was added and titrated to 10 mg from week 18 for patients whose BP remained uncontrolled . Efficacy variables were analyzed for the intent-to-treat population with the use of the last observation carried forward method . BP reductions ( mean sitting systolic BP/mean sitting diastolic BP ) were significantly greater with aliskiren- versus hydrochlorothiazide-based treatment at week 26 ( −20.3/−14.2 versus −18.6/−13.0 mm Hg ; P for mean sitting diastolic BP ) . At the end of the monotherapy period ( week 12 ) , aliskiren 300 mg was superior to hydrochlorothiazide 25 mg in reducing BP ( −17.4/−12.2 versus −14.7/−10.3 mm H ; P rates were similar with aliskiren- ( 65.2 % ) and hydrochlorothiazide-based therapy ( 61.5 % ) . Hypokalemia was more frequent with hydrochlorothiazide-based therapy than aliskiren-based therapy ( 17.9 % versus 0.9 % ; P Aliskiren treatment , both as monotherapy and with optional addition of amlodipine , provided significantly greater BP reductions than the respective hydrochlorothiazide regimens . Aliskiren-based therapy was well tolerated . Direct renin inhibition with aliskiren therefore represents an effective option for the long-term treatment of essential hypertension",
"The Systolic Hypertension in the Elderly Program ( SHEP ) , a r and omized , double-masked , placebo-controlled trial of 4736 persons , was design ed to assess the efficacy of antihypertensive drug treatment to reduce the risk of fatal and nonfatal strokes among people age 60 and over with isolated systolic hypertension . The statistical method used in interim monitoring of results was conditional power ( or stochastic curtailment ) . The findings did not become conclusive until near the completion of the trial , and therefore SHEP was continued to its scheduled closing date . The trial demonstrated a 36 % reduction in the incidence of stroke in the active treatment group ( P = .0003 ) . In addition to evaluating overall efficacy of treatment , the monitoring process considered such other issues as nonstroke outcomes , lag time between first report of stroke and final confirmation of stroke diagnosis , consistency of results across subgroups , and completeness of follow-up . The purpose of this article is to review these factors with primary emphasis on the statistical aspects",
"Hypertensive patients over the age of 60 years were admitted to a double-blind placebo-controlled trial . Patients in the actively treated group received a combined potassium-losing and -sparing diuretic ( triamterene 50 mg plus hydrochlorothiazide 25 mg ; n = 416 ) ; this dose could be doubled and methyldopa ( up to 2 g , daily ) was added in 35 % of patients when blood pressure remained high . The placebo group ( n = 424 ) received matching capsules and tablets . Adverse effects were assessed in the double-blind period of the trial by calculating the incidence of abnormal biochemical results , investigator reports of diseases and prescriptions of concomitant therapy and a self-administered symptom question naire completed by patients . In 1000 hypertensive subjects over 60 years of age , 1 year of active treatment would prevent 11 fatal cardiac events , 6 fatal and 11 non-fatal strokes and 8 cases of severe congestive heart failure . No unexpected adverse treatment effects were observed . A significant excess incidence rate ( per 1000 person years ) was found in the active group compared with placebo for : ( 1 ) impaired renal function , a serum creatinine greater than 180 mumol/l ( 2.0 mg/dl ) ; ( 2 ) mild hypokalaemia , a serum potassium less than 3.5 mmol/l ; ( 3 ) reports of gout ; and ( 4 ) an elevated serum uric acid greater than 0.52 mmol/l in men or greater than 0.46 in women . Elevated blood sugar and prescriptions for hypoglycaemic drugs tended to be more frequent in the actively treated group , but this difference was not statistically significant . In both groups , there was a low incidence ( less than 7 per 1000 person years ) of anaemia and depression and diseases of the liver , gall bladder or pancreas . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND There are scant data on the effect of body mass index ( BMI ) ( calculated as weight in kilograms divided by the square of height in meters ) on cardiovascular events and death in older patients with hypertension . OBJECTIVE To determine if low body mass in older patients with hypertension confers an increased risk of death or stroke . PATIENTS Participants were 3975 men and women ( mean age , 71 years ) enrolled in 17 US centers in the Systolic Hypertension in the Elderly Program trial , a r and omized , double-blind , placebo-controlled clinical trial of lowdose antihypertensive therapy , with follow-up for 5 years . MAIN OUTCOME MEASURES Five-year adjusted mortality and stroke rates from Cox proportional hazards analyses . RESULTS There was no statistically significant relation of death or stroke with BMI in the placebo group ( P = .47 ) , and there was a U- or J-shaped relation in the treatment group . The J-shaped relation of death with BMI in the treated group ( P = .03 ) showed that the lowest probability of death for men was associated with a BMI of 26.0 and for women with a BMI of 29.6 ; the curve was quite flat for women across a wide range of BMI s. For stroke , men and women did not differ , and the BMI nadir for both sexes combined was 29 , with risk increasing steeply at BMI s below 24 . Those in active treatment , however , had lower death and stroke rates compared with those taking placebo . CONCLUSIONS Among older patients with hypertension , a wide range of BMI s was associated with a similar risk of death and stroke ; a low BMI was associated with increased risk . Lean , older patients with hypertension in treatment should be monitored carefully for additional risk factors",
"Background The risks and benefits of treating hypertension in individuals older than 80 years are uncertain . A meta- analysis has suggested that a reduction in stroke events of 36 % may have to be balanced against a 14 % increase in total mortality . Objectives To report the results of the pilot study of the Hypertension in the Very Elderly Trial ( HYVET ) , which is in progress to address these issues . Methods The HYVET-Pilot was a multicentre international open pilot trial . In 10 European countries , 1283 patients older than 80 years and with a sustained blood pressure of 160–219/90–109 mmHg were allocated r and omly to one of three treatments : a diuretic-based regimen ( usually bendroflumethiazide ; n = 426 ) , an angiotensin-converting enzyme inhibitor regimen ( usually lisinopril ; n = 431 ) or no treatment ( n = 426 ) . The procedure permitted doses of the drug to be titrated and diltiazem slow-release to be added to active treatment . Target blood pressure was the reduction in stroke events relative hazard rate ( RHR ) was 0.47 [ 95 % confidence interval ( CI ) 0.24 to 0.93 ] and the reduction in stroke mortality RHR was 0.57 ( 95 % CI 0.25 to 1.32 ) . However , the estimate of total mortality supported the possibility of excess deaths with active treatment ( RHR 1.23 , 95 % CI 0.75 to 2.01 ) . Conclusions The preliminary results support the need for the continuing main HYVET trial . It is possible that treatment of 1000 patients for 1 year may reduce stroke events by 19 ( nine non-fatal ) , but may be associated with 20 extra non-stroke deaths ",
"Patients with mild to moderate essential hypertension were treated mainly with an ACE inhibitor ( delapril , n = 980 ) or a Ca antagonist ( n = 956 ) for 12 months , and the incidence of cerebrovascular and cardiovascular events as well as drug-related side effects were compared between the two groups . There were no significant differences between the clinical background s of the two groups . In both groups , the blood pressure was decreased significantly from 1 month of treatment onwards , with the degree of reduction being greater in the Ca antagonist group throughout the study period ( p Cerebrovascular or cardiovascular events occurred in 11 out of 980 patients in the delapril group and 18 out of 956 patients in the Ca antagonist group ( p = NS ) . Cerebrovascular disease developed in 5 delapril-treated patients and 11 Ca antagonist-treated patients , and heart disease developed in 5 and 7 patients , respectively ( both p = NS ) . Discontinuation of treatment due to side effects was significantly more common in the delapril group than in the Ca antagonist group ( p incidence of cerebrovascular and cardiovascular events between the two groups , and the results suggested that blood pressure reduction per se did not necessarily lead to a parallel decrease in cerebrovascular and cardiovascular complications",
"Syst-Eur is a multicenter placebo-controlled outcome trial design ed by the European Working Party on High Blood Pressure in the Elderly to investigate the effect of antihypertensive treatment on the incidence of stroke in elderly patients with isolated systolic hypertension ( ISH ) . Eligible patients must be at least 60 years old and have a systolic blood pressure averaging 160 - 219 mm Hg with a diastolic blood pressure less than 95 mm Hg . The present paper is an interim report on the first 316 patients r and omized into this trial . The placebo ( n = 170 ) and active treatment ( n = 146 ) groups were similar at r and omization with respect to age ( 73 + /- 8 years ; mean + /- SD ) , sitting blood pressure ( 178 + /- 12 mm Hg systolic ; 85 + /- 7 mm Hg diastolic ) , percentage of men ( 34 % ) , and percentage of patients with cardiovascular complications ( 29 % ) . After r and omization blood pressure fell more ( p less than 0.001 ) in patients on active treatment than in those in the placebo group ( 19 + /- 20 mm Hg systolic ; 6 + /- 10 mm Hg diastolic vs. 7 + /- 19 and 1 + /- 10 mm Hg for sitting blood pressure ) . This first interim report on the Syst-Eur trial demonstrates that a multinational trial in elderly patients with ISH is feasible and that a significant blood pressure difference between the two treatment groups can be achieved and maintained . New centers are being recruited in order to r and omize a total of 3,000 patients",
"OBJECTIVE To assess variability in the use of coronary artery bypass grafting ( CABG ) and percutaneous transluminal angioplasty ( PTCA ) in the Systolic Hypertension in the Elderly Program ( SHEP ) cohort with incident coronary heart disease ( CHD ) by age , sex , and race . DESIGN Retrospective analysis of a multicenter prospect i ve cohort study . SETTING Community-based ambulatory population in academic centers . PATIENTS Among 4736 subjects initially enrolled in SHEP , there were 432 incident cases of CHD , excluding those patients who experienced rapid or sudden cardiac death . MAIN OUTCOME MEASURE Incident cases of CHD who underwent CABG or PTCA . RESULTS Of those participants > or = 60 and age , 7.3 % underwent PTCA , compared with 3.9 % of those > or = 75 years ( P = 0.14 ) . 15.4 % of those CABG surgery , compared with 7.8 % of those 75 and older ( P = 0.018 ) . When both of these endpoints , CABG and PTCA , were combined , 22.4 % of those CABG or PTCA ( P use of procedures in participants Race , activity limitations , number of comorbid conditions , education level , marital status , employment status , and social support were not significantly associated with CABG or PTCA use . When the variables studied were entered into a logistic regression model , increased age and female sex remained independently associated with decreased CABG and PTCA use . CONCLUSION In the SHEP trial older patients and women , regardless of comorbid conditions , socioeconomic status , and social support , underwent less intensive cardiovascular interventions than did younger patients and men when they developed CHD",
"BACKGROUND Calcium antagonists are a first-line treatment for hypertension . The effectiveness of diltiazem , a non-dihydropyridine calcium antagonist , in reducing cardiovascular morbidity or mortality is unclear . We compared the effects of diltiazem with that of diuretics , beta-blockers , or both on cardiovascular morbidity and mortality in hypertensive patients . METHODS In a prospect i ve , r and omised , open , blinded endpoint study , we enrolled 10,881 patients , aged 50 - 74 years , at health centres in Norway and Sweden , who had diastolic blood pressure of 100 mm Hg or more . We r and omly assigned patients diltiazem , or diuretics , beta-blockers , or both . The combined primary endpoint was fatal and non-fatal stroke , myocardial infa rct ion , and other cardiovascular death . Analysis was done by intention to treat . FINDINGS Systolic and diastolic blood pressure were lowered effectively in the diltiazem and diuretic and beta-blocker groups ( reduction 20.3/18.7 vs 23.3/18.7 mm Hg ; difference in systolic reduction p Fatal and non-fatal stroke occurred in 159 patients in the diltiazem group and in 196 in the diuretic and beta-blocker group ( 6.4 vs 7.9 events per 1000 patient-years ; 0.80 [ 0.65 - 0.99 ] , p=0.04 ) and fatal and non-fatal myocardial infa rct ion in 183 and 157 patients ( 7.4 vs 6.3 events per 1000 patient-years ; 1.16 [ 0.94 - 1.44 ] , p=0.17 ) . INTERPRETATION Diltiazem was as effective as treatment based on diuretics , beta-blockers , or both in preventing the combined primary endpoint of all stroke , myocardial infa rct ion , and other cardiovascular death",
"BACKGROUND It is unknown whether either the angiotensin-II-receptor blocker irbesartan or the calcium-channel blocker amlodipine slows the progression of nephropathy in patients with type 2 diabetes independently of its capacity to lower the systemic blood pressure . METHODS We r and omly assigned 1715 hypertensive patients with nephropathy due to type 2 diabetes to treatment with irbesartan ( 300 mg daily ) , amlodipine ( 10 mg daily ) , or placebo . The target blood pressure was 135/85 mm Hg or less in all groups . We compared the groups with regard to the time to the primary composite end point of a doubling of the base-line serum creatinine concentration , the development of end-stage renal disease , or death from any cause . We also compared them with regard to the time to a secondary , cardiovascular composite end point . RESULTS The mean duration of follow-up was 2.6 years . Treatment with irbesartan was associated with a risk of the primary composite end point that was 20 percent lower than that in the placebo group ( P=0.02 ) and 23 percent lower than that in the amlodipine group ( P=0.006 ) . The risk of a doubling of the serum creatinine concentration was 33 percent lower in the irbesartan group than in the placebo group ( P=0.003 ) and 37 percent lower in the irbesartan group than in the amlodipine group ( P irbesartan was associated with a relative risk of end-stage renal disease that was 23 percent lower than that in both other groups ( P=0.07 for both comparisons ) . These differences were not explained by differences in the blood pressures that were achieved . The serum creatinine concentration increased 24 percent more slowly in the irbesartan group than in the placebo group ( P=0.008 ) and 21 percent more slowly than in the amlodipine group ( P=0.02 ) . There were no significant differences in the rates of death from any cause or in the cardiovascular composite end point . CONCLUSIONS The angiotensin-II-receptor blocker irbesartan is effective in protecting against the progression of nephropathy due to type 2 diabetes . This protection is independent of the reduction in blood pressure it causes",
"Summary The Syst-Eur Trial is a concerted action of the European Community ’s Medical and Health Research Programme . The trial is carried out in consultation with the World Health Organization , the International Society of Hypertension , the European Society of Hypertension and the World Hypertension League . This article describes the objectives and the protocol of Syst-Eur , a multicentre trial design ed by the European Working Party on High Blood . Pressure in the Elderly ( EWPHE ) , to test the hypothesis that antihypertensive treatment of elderly patients with isolated systolic hypertension results in a significant change in stroke morbidity and mortality . Secondary endpoints include cardiovascular events , such as myocardial infa rct ion and congestive heart failure . To be eligible patients must be at least 60 years old and have a systolic blood pressure averaging 160–219 mmHg with a diastolic pressure less than 95 mmHg . Patients must give their informed consent and be free of major cardiovascular and non-cardiovascular diseases at entry . The patients are r and omized to active treatment or placebo . Active treatment consists of nitrendipine ( 10–40 mg/day ) , combined with enalapril ( 5–20 mg/day ) and hydrochlorothiazide ( 12.5–25 mg/day ) , as necessary . The patients of the control group receive matching placebos . The drugs ( or matching placebos ) are stepwise titrated and combined in order to reduce systolic blood pressure by 20 mmHg at least to a level below 150 mmHg . Morbidity and mortality are monitored to enable an intention-to-treat and per protocol comparison of the outcome in the 2 treatment groups . A one-year pilot trial ( 1989 ) showed that the protocol is practicable . The Ethics Committee therefore decided to start the definite study ( 1990 ) , in which r and omized patients will be followed for 5 years . Recruitment of new centres and of the required 3,000 patients will last 3 years ( until 1993 )",
"BACKGROUND Previous studies have suggested that blockade of the renin-angiotensin system may prevent diabetes in people with cardiovascular disease or hypertension . METHODS In a double-blind , r and omized clinical trial with a 2-by-2 factorial design , we r and omly assigned 5269 participants without cardiovascular disease but with impaired fasting glucose levels ( after an 8-hour fast ) or impaired glucose tolerance to receive ramipril ( up to 15 mg per day ) or placebo ( and rosiglitazone or placebo ) and followed them for a median of 3 years . We studied the effects of ramipril on the development of diabetes or death , whichever came first ( the primary outcome ) , and on secondary outcomes , including regression to normoglycemia . RESULTS The incidence of the primary outcome did not differ significantly between the ramipril group ( 18.1 % ) and the placebo group ( 19.5 % ; hazard ratio for the ramipril group , 0.91 ; 95 % confidence interval [ CI ] , 0.81 to 1.03 ; P=0.15 ) . Participants receiving ramipril were more likely to have regression to normoglycemia than those receiving placebo ( hazard ratio , 1.16 ; 95 % CI , 1.07 to 1.27 ; P=0.001 ) . At the end of the study , the median fasting plasma glucose level was not significantly lower in the ramipril group ( 102.7 mg per deciliter [ 5.70 mmol per liter ] ) than in the placebo group ( 103.4 mg per deciliter [ 5.74 mmol per liter ] , P=0.07 ) , though plasma glucose levels 2 hours after an oral glucose load were significantly lower in the ramipril group ( 135.1 mg per deciliter [ 7.50 mmol per liter ] vs. 140.5 mg per deciliter [ 7.80 mmol per liter ] , P=0.01 ) . CONCLUSIONS Among persons with impaired fasting glucose levels or impaired glucose tolerance , the use of ramipril for 3 years does not significantly reduce the incidence of diabetes or death but does significantly increase regression to normoglycemia . ( Clinical Trials.gov number , NCT00095654 [ Clinical Trials.gov ] . )",
"BACKGROUND The multicenter double-blind , r and omized Bergamo Nephrologic Diabetes Complications Trial ( BENEDICT ) was design ed to assess whether angiotensin-converting-enzyme inhibitors and non-dihydropyridine calcium-channel blockers , alone or in combination , prevent microalbuminuria in subjects with hypertension , type 2 diabetes mellitus , and normal urinary albumin excretion . METHODS We studied 1204 subjects , who were r and omly assigned to receive at least three years of treatment with tr and olapril ( at a dose of 2 mg per day ) plus verapamil ( sustained-release formulation , 180 mg per day ) , tr and olapril alone ( 2 mg per day ) , verapamil alone ( sustained-release formulation , 240 mg per day ) , or placebo . The target blood pressure was 120/80 mm Hg . The primary end point was the development of persistent microalbuminuria ( overnight albumin excretion , > or = 20 microg per minute at two consecutive visits ) . RESULTS The primary outcome was reached in 5.7 percent of the subjects receiving tr and olapril plus verapamil , 6.0 percent of the subjects receiving tr and olapril , 11.9 percent of the subjects receiving verapamil , and 10.0 percent of control subjects receiving placebo . The estimated acceleration factor ( which quantifies the effect of one treatment relative to another in accelerating or slowing disease progression ) adjusted for predefined baseline characteristics was 0.39 for the comparison between verapamil plus tr and olapril and placebo ( P=0.01 ) , 0.47 for the comparison between tr and olapril and placebo ( P=0.01 ) , and 0.83 for the comparison between verapamil and placebo ( P=0.54 ) . Tr and olapril plus verapamil and tr and olapril alone delayed the onset of microalbuminuria by factors of 2.6 and 2.1 , respectively . Serious adverse events were similar in all treatment groups . CONCLUSIONS In subjects with type 2 diabetes and hypertension but with normoalbuminuria , the use of tr and olapril plus verapamil and tr and olapril alone decreased the incidence of microalbuminuria to a similar extent . The effect of verapamil alone was similar to that of placebo",
"Abstract A prospect i ve r and omised controlled trial of hypotensive therapy in 97 hypertensive patients surviving an ischaemic-type stroke was started in 1964 and terminated 4 years later . The patients were under 80 years of age , consecutively admitted to one hospital and the control and treated groups compared well for age , sex , and severity of hypertension . The drugs used were methyldopa , bethanidine or debrisoquine combined with restriction of salt intake , weight reduction , and thiazide diuretics , and the results were analysed with regard to survival and recurrence rates . Hypertension was defined as diastolic if this pressure was 110 mm . Hg or above , and as systolic if this pressure was over 160 mm . Hg with the diastolic below 110 mm . Hg . The mortality-rate at the end of a 2 to 5 year followup was 26 % in the treated group and 46 % in the untreated , and the non-fatal recurrence-rate 14 % in the treated and 23 % in the controls . Good smooth control was essential to success , untreated patients doing better than those whose control was unsatisfactory . In patients aged over 65 treatment of systolic hypertension was of no benefit , although the diastolic hypertensives improved marginally with treatment . As age increased this effect was progressively less apparent but the figures are probably too small to mean anything . In this series significant improvement occurred in treated hypertensive patients who had survived a stroke if they were aged 65 or below , but not if they were older",
" A total of 123 out of 549 elderly residents of local authority welfare homes in Nottinghamshire were found at screening to have a st and ing or lying diastolic blood pressure of 100 mm Hg or more . These 123 subjects were r and omly allocated to simple observation or to treatment with methyldopa . The cumulative mortality was similar in the observed and treated groups and in the normotensive group from which the subjects had been separated . Thus moderate hypertension , whether treated or not , was not a major risk predictor in the elderly population studied",
"CONTEXT Hypertension is associated with a significantly increased risk of morbidity and mortality . Only diuretics and beta-blockers have been shown to reduce this risk in long-term clinical trials . Whether newer antihypertensive agents reduce the incidence of cardiovascular disease ( CVD ) is unknown . OBJECTIVE To compare the effect of doxazosin , an alpha-blocker , with chlorthalidone , a diuretic , on incidence of CVD in patients with hypertension as part of a study of 4 types of antihypertensive drugs : chlorthalidone , doxazosin , amlodipine , and lisinopril . DESIGN R and omized , double-blind , active-controlled clinical trial , the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial , initiated in February 1994 . In January 2000 , after an interim analysis , an independent data review committee recommended discontinuing the doxazosin treatment arm based on comparisons with chlorthalidone . Therefore , outcomes data presented herein reflect follow-up through December 1999 . SETTING A total of 625 centers in the United States and Canada . PARTICIPANTS A total of 24,335 patients ( aged > or = 55 years ) with hypertension and at least 1 other coronary heart disease ( CHD ) risk factor who received either doxazosin or chlorthalidone . INTERVENTIONS Participants were r and omly assigned to receive chlorthalidone , 12.5 to 25 mg/d ( n=15,268 ) , or doxazosin , 2 to 8 mg/d ( n=9067 ) , for a planned follow-up of 4 to 8 years . MAIN OUTCOME MEASURES The primary outcome measure was fatal CHD or nonfatal myocardial infa rct ion ( MI ) , analyzed by intent to treat ; secondary outcome measures included all-cause mortality , stroke , and combined CVD ( CHD death , nonfatal MI , stroke , angina , coronary revascularization , congestive heart failure [ CHF ] , and peripheral arterial disease ) ; compared by the chlorthalidone group vs the doxazosin group . RESULTS Median follow-up was 3.3 years . A total of 365 patients in the doxazosin group and 608 in the chlorthalidone group had fatal CHD or nonfatal MI , with no difference in risk between the groups ( relative risk [ RR ] , 1.03 ; 95 % confidence interval [ CI ] , 0.90 - 1.17 ; P=.71 ) . Total mortality did not differ between the doxazosin and chlorthalidone arms ( 4-year rates , 9.62 % and 9.08 % , respectively ; RR , 1.03 ; 95 % CI , 0.90 - 1.15 ; P=.56 . ) The doxazosin arm , compared with the chlorthalidone arm , had a higher risk of stroke ( RR , 1.19 ; 95 % CI , 1.01 - 1.40 ; P=.04 ) and combined CVD ( 4-year rates , 25.45 % vs 21.76 % ; RR , 1.25 ; 95 % CI , 1.17 - 1.33 ; P CHF risk was doubled ( 4-year rates , 8.13 % vs 4.45 % ; RR , 2.04 ; 95 % CI , 1.79 - 2.32 ; P RRs for angina , coronary revascularization , and peripheral arterial disease were 1.16 ( P doxazosin , chlorthalidone yields essentially equal risk of CHD death/nonfatal MI but significantly reduces the risk of combined CVD events , particularly CHF , in high-risk hypertensive patients",
"Abstract Objective : To determine whether tight control of blood pressure with either a β blocker or an angiotensin converting enzyme inhibitor has a specific advantage or disadvantage in preventing the macrovascular and microvascular complications of type 2 diabetes . Design : R and omised controlled trial comparing an angiotensin converting enzyme inhibitor ( captopril ) with a β blocker ( atenolol ) in patients with type 2 diabetes aim ing at a blood pressure of Setting : 20 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Subjects : 1148 hypertensive patients with type 2 diabetes ( mean age 56 years , mean blood pressure 160/94 mm Hg ) . Of the 758 patients allocated to tight control of blood pressure , 400 were allocated to captopril and 358 to atenolol . 390 patients were allocated to less tight control of blood pressure . Main outcome measures : Predefined clinical end points , fatal and non-fatal , related to diabetes , death related to diabetes , and all cause mortality . Surrogate measures of microvascular and macrovascular disease included urinary albumin excretion and retinopathy assessed by retinal photography . Results : Captopril and atenolol were equally effective in reducing blood pressure to a mean of 144/83 mm Hg and 143/81 mm Hg respectively , with a similar proportion of patients ( 27 % and 31 % ) requiring three or more antihypertensive treatments . More patients in the captopril group than the atenolol group took the allocated treatment : at their last clinic visit , 78 % of those allocated captopril and 65 % of those allocated atenolol were taking the drug ( P Captopril and atenolol were equally effective in reducing the risk of macrovascular end points . Similar proportions of patients in the two groups showed deterioration in retinopathy by two grade s after nine years ( 31 % in the captopril group and 37 % in the atenolol group ) and developed clinical grade albuminuria ≥300 mg/l ( 5 % and 9 % ) . The proportion of patients with hypoglycaemic attacks was not different between groups , but mean weight gain in the atenolol group was greater ( 3.4 kg v 1.6 kg ) . Conclusion : Blood pressure lowering with captopril or atenolol was similarly effective in reducing the incidence of diabetic complications . This study provided no evidence that either drug has any specific beneficial or deleterious effect , suggesting that blood pressure reduction in itself may be more important than the treatment used",
"Abstract Objective To investigate whether a low dose of the angiotensin converting enzyme ( ACE ) inhibitor ramipril lowers cardiovascular and renal events in patients with type 2 diabetes who have microalbuminuria or proteinuria . Design R and omised , double blind , parallel group trial comparing ramipril ( 1.25 mg/day ) with placebo ( on top of usual treatment ) for cardiovascular and renal outcomes for at least three years . Setting Multicentre , primary care study conducted mostly by general practitioners in 16 European and north African countries . Participants 4912 patients with type 2 diabetes aged > 50 years who use oral antidiabetic drugs and have persistent microalbuminuria or proteinuria ( urinary albumin excretion 20 mg/l in two consecutive sample s ) , and serum creatinine ≤ 150 μmol/l . Main outcome measures The primary outcome measure was the combined incidence of cardiovascular death , non-fatal myocardial infa rct ion , stroke , heart failure leading to hospital admission , and end stage renal failure . Results Participants were followed for 3 to 6 ( median 4 ) years . There were 362 primary events among the 2443 participants taking ramipril ( 37.8 per 1000 patient years ) and 377 events among the 2469 participants taking placebo ( 38.8 per 1000 patient years ; hazard ratio 1.03 ( 95 % confidence interval 0.89 to 1.20 , P = 0.65 ) ) . None of the components of the primary outcome was reduced . Ramipril lowered systolic and diastolic blood pressures ( by 2.43 and 1.06 mm Hg respectively after two years ) and favoured regression from microalbuminuria ( 20 - 200 mg/l ) or proteinuria ( > 200mg/l ) to normal level ( ) in 1868 participants who completed the study . Conclusions Low dose ( 1.25 mg ) ramipril once daily has no effect on cardiovascular and renal outcomes of patients with type 2 diabetes and albuminuria , despite a slight decrease in blood pressure and urinary albumin . The cardiovascular benefits of a daily higher dose ( 10 mg ) ramipril observed elsewhere are not found with an eightfold lower daily dose",
"BACKGROUND Whether the treatment of patients with hypertension who are 80 years of age or older is beneficial is unclear . It has been suggested that antihypertensive therapy may reduce the risk of stroke , despite possibly increasing the risk of death . METHODS We r and omly assigned 3845 patients from Europe , China , Australasia , and Tunisia who were 80 years of age or older and had a sustained systolic blood pressure of 160 mm Hg or more to receive either the diuretic indapamide ( sustained release , 1.5 mg ) or matching placebo . The angiotensin-converting-enzyme inhibitor perindopril ( 2 or 4 mg ) , or matching placebo , was added if necessary to achieve the target blood pressure of 150/80 mm Hg . The primary end point was fatal or nonfatal stroke . RESULTS The active-treatment group ( 1933 patients ) and the placebo group ( 1912 patients ) were well matched ( mean age , 83.6 years ; mean blood pressure while sitting , 173.0/90.8 mm Hg ) ; 11.8 % had a history of cardiovascular disease . Median follow-up was 1.8 years . At 2 years , the mean blood pressure while sitting was 15.0/6.1 mm Hg lower in the active-treatment group than in the placebo group . In an intention-to-treat analysis , active treatment was associated with a 30 % reduction in the rate of fatal or nonfatal stroke ( 95 % confidence interval [ CI ] , -1 to 51 ; P=0.06 ) , a 39 % reduction in the rate of death from stroke ( 95 % CI , 1 to 62 ; P=0.05 ) , a 21 % reduction in the rate of death from any cause ( 95 % CI , 4 to 35 ; P=0.02 ) , a 23 % reduction in the rate of death from cardiovascular causes ( 95 % CI , -1 to 40 ; P=0.06 ) , and a 64 % reduction in the rate of heart failure ( 95 % CI , 42 to 78 ; P serious adverse events were reported in the active-treatment group ( 358 , vs. 448 in the placebo group ; P=0.001 ) . CONCLUSIONS The results provide evidence that antihypertensive treatment with indapamide ( sustained release ) , with or without perindopril , in persons 80 years of age or older is beneficial . ( Clinical Trials.gov number , NCT00122811 [ Clinical Trials.gov ] . )",
"The pilot study of the Systolic Hypertension in the Elderly Program was a r and omized , double-blind , placebo-controlled trial of drug therapy for isolated systolic hypertension . It followed 551 elderly participants with untreated blood pressures of greater than 160/less than 90 mm Hg for an average of 34 months . Mean age of the participants was 72 years ; 63 % were women , and 82 % were white . Pretreatment blood pressures averaged 172/75 mm Hg . Participants were r and omly assigned to treatment with chlorthalidone or placebo as Step I medication . Blood pressures at annual visits averaged 141/68 and 157/73 mm Hg for the drug-treated and placebo-treated groups , respectively , with 60 % and 33 % of the survivors on blinded medication having systolic blood pressures of less than 160 mm Hg at their last annual visit . All-cause mortality rates for the drug-treated and placebo-treated groups were 25.4 and 22.7 deaths per 1,000 participant-years of risk , and rates for definite \" first stroke \" were 8.3 and 12.8 per 1,000 years of risk . Differences between groups were significant for systolic and diastolic blood pressure but not for death or stroke rates . A full-scale study has begun to determine the effects of drug therapy for isolated systolic hypertension on stroke and mortality rates",
"BACKGROUND Observational epidemiological studies have shown a positive association between hypertension and risk of incident dementia ; however , the effects of antihypertensive therapy on cognitive function in controlled trials have been conflicting , and meta-analyses of the trials have not provided clear evidence of whether antihypertensive treatment reduces dementia incidence . The Hypertension in the Very Elderly trial ( HYVET ) was design ed to assess the risks and benefits of treatment of hypertension in elderly patients and included an assessment of cognitive function . METHODS Patients with hypertension ( systolic pressure 160 - 200 mm Hg ; diastolic pressure in this double-blind , placebo-controlled trial . Participants were r and omly assigned to receive 1.5 mg slow release indapamide , with the option of 2 - 4 mg perindopril , or placebo . The target systolic blood pressure was 150 mm Hg ; the target diastolic blood pressure was 80 mm Hg . Participants had no clinical diagnosis of dementia at baseline , and cognitive function was assessed at baseline and annually with the mini-mental state examination ( MMSE ) . Possible cases of incident dementia ( a fall in the MMSE score to stroke and total mortality . Analysis was by intention to treat . The trial is registered with Clinical Trials.gov , number NCT00122811 . FINDINGS 3336 HYVET participants had at least one follow-up assessment ( mean 2.2 years ) and were included : 1687 participants were r and omly assigned to the treatment group and 1649 to the placebo group . Only five reports of adverse effects were attributed to the medication : three in the placebo group and two in the treatment group . The mean decrease in systolic blood pressure between the treatment and placebo groups at 2 years was systolic -15 mm Hg , p dementia . The rates of incident dementia were 38 per 1000 patient-years in the placebo group and 33 per 1000 patient-years in the treatment group . There was no significant difference between treatment and placebo groups ( hazard ratio [ HR ] 0.86 , 95 % CI 0.67 - 1.09 ) ; however , when these data were combined in a meta- analysis with other placebo-controlled trials of antihypertensive treatment , the combined risk ratio favoured treatment ( HR 0.87 , 0.76 - 1.00 , p=0.045 ) . INTERPRETATION Antihypertensive treatment in elderly patients does not statistically reduce incidence of dementia . This negative finding might have been due to the short follow-up , owing to the early termination of the trial , or the modest effect of treatment . Nevertheless , the HYVET findings , when included in a meta- analysis , might support antihypertensive treatment to reduce incident dementia",
"BACKGROUND It is not known whether drugs that block the renin-angiotensin system reduce the risk of diabetes and cardiovascular events in patients with impaired glucose tolerance . METHODS In this double-blind , r and omized clinical trial with a 2-by-2 factorial design , we assigned 9306 patients with impaired glucose tolerance and established cardiovascular disease or cardiovascular risk factors to receive valsartan ( up to 160 mg daily ) or placebo ( and nateglinide or placebo ) in addition to lifestyle modification . We then followed the patients for a median of 5.0 years for the development of diabetes ( 6.5 years for vital status ) . We studied the effects of valsartan on the occurrence of three co primary outcomes : the development of diabetes ; an extended composite outcome of death from cardiovascular causes , nonfatal myocardial infa rct ion , nonfatal stroke , hospitalization for heart failure , arterial revascularization , or hospitalization for unstable angina ; and a core composite outcome that excluded unstable angina and revascularization . RESULTS The cumulative incidence of diabetes was 33.1 % in the valsartan group , as compared with 36.8 % in the placebo group ( hazard ratio in the valsartan group , 0.86 ; 95 % confidence interval [ CI ] , 0.80 to 0.92 ; P Valsartan , as compared with placebo , did not significantly reduce the incidence of either the extended cardiovascular outcome ( 14.5 % vs. 14.8 % ; hazard ratio , 0.96 ; 95 % CI , 0.86 to 1.07 ; P=0.43 ) or the core cardiovascular outcome ( 8.1 % vs. 8.1 % ; hazard ratio , 0.99 ; 95 % CI , 0.86 to 1.14 ; P=0.85 ) . CONCLUSIONS Among patients with impaired glucose tolerance and cardiovascular disease or risk factors , the use of valsartan for 5 years , along with lifestyle modification , led to a relative reduction of 14 % in the incidence of diabetes but did not reduce the rate of cardiovascular events . ( Clinical Trials.gov number , NCT00097786 .",
"Assessing the compliance of people over 60 years of age and older with an antihypertensive treatment regimen was a major objective of the Systolic Hypertension in the Elderly Program ( SHEP ) pilot study . The study r and omized 551 men and women over the age of 60 ( mean age = 72 years ) to a stepped care treatment that included chlorthalidone or placebo in a double-blind trial . Three measures of compliance to treatment protocol --pill count , self-report , and a urine chlorthalidone assay -- all indicated high levels of compliance in 80 to 90 % of participants at 3 months and 1 year after r and omization . Pill-taking compliance was similar in the active and placebo groups , although the rate of discontinuance from study medications at 1 year was higher in the placebo than in the active group . Compliance was high in all age categories , including those over age 80 . These data suggest that elderly patients can achieve high levels of compliance with antihypertensive medications",
"The Oslo Hypertension Study began in 1972 ; patients were followed for an average of 66 months ( range : 60 to 78 ) . A total of 785 healthy men , aged 40 to 49 , with mild hypertension was r and omly assigned to either a drug-treated group or to an untreated control group . Hydrochlorothiazide was used alone in 36 percent of patients , in combination with propranolol in 26 percent , and with methyldopa in 20 percent . Other drugs , including combinations with hydrochlorothiazide , were used in 18 percent . A total of 95 percent of patients in the drug-treated group received hydrochlorothiazide . Complications of hypertension such as stroke and aneurysm occurred only in the control group . Coronary events were more numerous in the drug-treated group ; thus , the total incidence of cardiovascular complications did not significantly differ between the treated and untreated groups . After five and 10 years , total mortality was the same in both groups . However , the coronary heart disease mortality rate at 10 years was significantly greater in the drug-treated group than in the untreated control group ( 14 versus three , p less than 0.01 ) . This article presents possible reasons for the failure of antihypertensive drug therapy to prevent coronary heart disease . The adverse effect of diuretics and beta-adrenergic blockers , both on lipid and carbohydrate metabolism , is contrasted with the effect of the alpha-adrenergic blocker prazosin , which has been shown to have no adverse effect on the blood lipid profile . In a short-term trial that was part of the Oslo Study , prazosin was found to reduce total serum cholesterol by 9 percent , low-density lipoprotein and very-low-density lipoprotein cholesterol by 10 percent , and total triglycerides by 16 percent . All these changes are statistically significant",
"The Systolic Hypertension in the Elderly Program ( SHEP ) is a r and omized double-blind placebo-controlled trial to determine if antihypertensive treatment of isolated systolic hypertension ( ISH ) [ systolic blood pressure ( SBP ) greater than or equal to 160 mmHg , diastolic blood pressure ( DBP ) less than 90 mmHg ] reduces the 5 year incidence of fatal and nonfatal stroke . Between March 1 , 1985 and January 15 , 1988 , 4736 persons ( target 4800 ) with ISH , age 60 years and over , were enrolled . Potential participants met blood pressure ( BP ) and age criteria . Those on antihypertensive medication prior to enrollment without documented diastolic hypertension had their medication tapered and discontinued , and then met BP criteria ( 33 % of cohort ) . Stepped-care therapy with chlorthalidone and atenolol ( alternative , reserpine ) or matching placebos was initiated as first and second steps . At baseline the trial population was 43.1 % male , 56.9 % female ; 13.9 % black , 86.1 % non-black . Also , the mean age was 71.6 years ; the mean SBP was 170.3 mmHg and the mean DBP was 76.6 mmHg ; 59.8 % had codeable resting electrocardiographic abnormalities . The trial is now in follow-up phase with scheduled termination in 1991",
"OBJECTIVES The primary objective of this study was to investigate the effects of the angiotensin-converting enzyme ( ACE ) inhibitor , ramipril , on carotid atherosclerosis in patients with coronary , cerebrovascular or peripheral vascular disease . BACKGROUND Angiotensin-converting enzyme inhibitors have been shown to reduce the risk of coronary events in various patient groups and to prevent the development of atherosclerosis in animal models . It has been hypothesized that the clinical benefits of ACE inhibitors may , therefore , be mediated by effects on atherosclerosis . METHODS Six hundred seventeen patients were r and omized in equal proportions to ramipril ( 5 - 10 mg daily ) or placebo . At baseline , two years and four years , carotid atherosclerosis was assessed by B-mode ultrasound , and left ventricular mass was assessed by M-mode echocardiography . RESULTS Blood pressure ( BP ) was reduced by a mean of 6 mm Hg systolic and 4 mm Hg diastolic in the ramipril group compared with the placebo group ( p common carotid artery wall thickness ( p = 0.58 ) or in carotid plaque ( p = 0.93 ) . Left ventricular mass index decreased by 3.8 g/m2 ( 4 % ) in the ramipril group compared with the placebo group ( 2p = 0.04 ) . CONCLUSIONS The results provide no support for the hypothesis that reduced atherosclerosis is responsible for the beneficial effects of ACE inhibitors on major coronary events . It is more likely that the benefits are due to lower BP , reduced left ventricular mass or other factors such as reversal of endothelial dysfunction",
"OBJECTIVE To describe the design of the HOPE ( Heart Outcomes Prevention Evaluation ) study . DESIGN Description of the key design features of HOPE , a large , simple r and omized trial of two widely applicable treatments -- ramipril , an angiotensin-converting enzyme inhibitor ; and vitamin E , a naturally occurring antioxidant vitamin -- in the prevention of myocardial infa rct ion , stroke or cardiovascular death . SETTING Two-hundred and sixty-seven hospitals , physician offices and clinics in Canada , the United States , Mexico , Europe and South America . PATIENTS Over 9000 women and men aged 55 years and above at high risk for cardiovascular events such as myocardial infa rct ion and stroke were recruited over 18 months . INTERVENTIONS A 2X2 factorial design with ramipril and vitamin E with follow-up for up to four years . CONCLUSIONS HOPE will be one of the largest trials of two new interventions to prevent myocardial infa rct ion , stroke or cardiovascular death in high risk patients . The results of HOPE will have direct public health impact and are likely to be readily incorporated into clinical practice . Key design features of HOPE are inclusion of individuals at high risk of cardiovascular disease , inclusion of a substantial proportion of patients with diabetes ( 36 % ) and women ( 27 % ) , and detailed sub studies to provide data on mechanisms of benefit",
"Direct evidence about the effects of antihypertensive treatment on vascular disease in older patients is available from five r and omized trials conducted exclusively in patients over the age of 60 years . These trials involved a total of 12,483 individuals with systolic or diastolic hypertension ( mean age = 72 years , mean entry blood pressure = 181/88 mmHg ) . Over an average follow-up period of 4.7 years , a 15/6 mmHg difference in blood pressure between study and control groups was achieved . Among those patients assigned active treatment , stroke incidence was reduced by 34 % SD6 and coronary heart disease incidence was reduced by 19 % SD7 . These proportional reductions were of similar size to those observed in trials in predominantly younger patients . However , the absolute benefits observed in older patients were more than twice as great as those observed in younger patients . The results suggest that over 10 years , treatment would prevent at least one major vascular event among every 10 elderly patients at similar risk to those enrolled in the trials",
"As sub studies of the Medical Research Council 's trials of treatment of mild hypertension and of hypertension in the elderly , two studies were carried out comparing the effects of different doses of two diuretics on blood pressure , concentrations of some biochemical variables , and the incidence of subjective adverse reactions . In one study , in which 484 patients with mild hypertension participated , daily doses of bendrofluazide 5 mg and 10 mg , with and without oral potassium supplements , were compared . In the second , involving 701 elderly patients with hypertension , daily doses of hydrochlorothiazide 25 mg together with amiloride 2.5 mg were compared with hydrochlorothiazide 50 mg together with amiloride 5 mg . The mean ( + /- SD ) duration s of treatment were 35 + /- 17 months in the first study and 10 + /- 7 months in the second . Neither study showed any significant difference in blood pressure response to the two doses of diuretic , whereas biochemical changes and the reported incidence of subjective adverse reactions were dose-related . In the first study , potassium supplementation with potassium chloride 16.8 or 33.6 mmol did not have a significant effect on the fall in serum potassium level , which was only slightly reduced , and did not have any significant effect on the antihypertensive effect of either dose of bendrofluazide",
"BACKGROUND There is a pressing clinical requirement for an early simple test of severity in acute pancreatitis . We investigated the use of an assay of trypsinogen activation peptide ( TAP ) . METHODS We undertook a multicentre study in 246 patients ( 172 with acute pancreatitis [ 35 with severe disease ] , 74 controls ) . We assessed the predictive value of urinary TAP concentrations measured by a vali date d competitive immunoassay . We compared the results with those for plasma C-reactive protein and three clinicobiochemical scoring systems . TAP and C-reactive protein concentrations were analysed at set times after symptom onset and compared with the clinicobiochemical systems scores at key times during hospital stay . FINDINGS At 24 h after symptom onset , the median urinary TAP concentration was 37 nmol/L ( IQR 17 - 110 ) for severe and 15 nmol/L ( 5 - 35 ) for mild disease ( p plasma C-reactive protein were 24 mg/L ( 3 - 34 ) and 25 mg/L ( 6 - 75 ; p=0.208 ) . The sensitivity , specificity , positive predictive , and negative predictive values of the test to show severe acute pancreatitis compared with mild acute pancreatitis at 24 h were : for TAP ( > 35 nmol/L ) , 58 % , 73 % , 39 % , and 86 % , respectively , and for C-reactive protein ( > 150 mg/L ) , 0 % , 90 % , 0 % , and 75 % . 48 h after admission the values for the clinicobiochemical scoring systems were : APACHE II ( > or = 8) , 56 % , 64 % , 30 % , and 85 % ; Ranson score ( > or = 3 ) , 89 % , 64 % , 38 % , and 96 % ; and Glasgow score ( > or = 3 ) , 77 % , 75 % , 44 % , and 93 % . At 48 h , the values for C-reactive protein were 86 % , 61 % , 37 % , and 94 % and for TAP were 83 % , 72 % , 44 % , and 94 % . Combined testing of C-reactive protein and TAP was not superior to TAP alone for accuracy . INTERPRETATION Urinary TAP provided accurate severity prediction 24 h after onset of symptoms . This single marker of severity in acute pancreatitis deserves routine clinical application",
"OBJECTIVE The objective of this study was to examine the prevalence and correlates of postural hypotension ( defined as a drop in systolic blood pressure of greater than or equal to 20 mm Hg ) in a cohort of elderly persons with isolated systolic hypertension ( ISH ) . DESIGN Baseline cross-sectional analysis of the 4,736 persons r and omized in the Systolic Hypertension in the Elderly Program ( SHEP ) . SETTING A r and omized multi-center double-blind outpatient clinical trial of the impact of treating ISH . PARTICIPANTS Men and women age greater than or equal to 60 years with the systolic blood pressure ( SBP ) greater than or equal to 160 mm Hg and diastolic blood pressure ( DBP ) less than 90 mm Hg . MEASURES Medical histories were obtained using interviewer-administered , st and ardized clinical history forms . At entry into the study , seated and st and ing BP was measured by certified BP technicians using a r and om zero sphygmomanometer . Postural hypotension ( PH ) was assessed at 1 and 3 minutes after the participant arose from a seated position . MAIN RESULTS PH was found in 10.4 % of participants at 1 minute and in 12.0 % of participants at 3 minutes . 5.3 % of participants demonstrated PH at both time intervals while 17.3 % demonstrated PH at either or both of the time intervals . Factors significantly ( P less than 0.05 ) associated with the presence of PH were higher mean SBP and a lower mean body mass index . CONCLUSIONS Somewhat different persons were defined as having PH based upon the 1 minute and 3 minute st and ing measures of BP , and prevalence estimates of PH can vary depending on whether one or more intervals of measurement are used . Cross-sectional data analysis indicated that PH , in healthy community-dwelling older persons with ISH , may not be associated with a history of disorders or problems usually thought to be related to PH . However , prospect i ve data are needed to determine the prognostic significance of PH , and whether one or multiple measurements carry more significance",
"BACKGROUND Blood pressure is an important determinant of the risks of macrovascular and microvascular complications of type 2 diabetes , and guidelines recommend intensive lowering of blood pressure for diabetic patients with hypertension . We assessed the effects of the routine administration of an angiotensin converting enzyme ( ACE ) inhibitor-diuretic combination on serious vascular events in patients with diabetes , irrespective of initial blood pressure levels or the use of other blood pressure lowering drugs . METHODS The trial was done by 215 collaborating centres in 20 countries . After a 6-week active run-in period , 11 140 patients with type 2 diabetes were r and omised to treatment with a fixed combination of perindopril and indapamide or matching placebo , in addition to current therapy . The primary endpoints were composites of major macrovascular and microvascular events , defined as death from cardiovascular disease , non-fatal stroke or non-fatal myocardial infa rct ion , and new or worsening renal or diabetic eye disease , and analysis was by intention-to-treat . The macrovascular and microvascular composites were analysed jointly and separately . This trial is registered with Clinical Trials.gov , number NCT00145925 . FINDINGS After a mean of 4.3 years of follow-up , 73 % of those assigned active treatment and 74 % of those assigned control remained on r and omised treatment . Compared with patients assigned placebo , those assigned active therapy had a mean reduction in systolic blood pressure of 5.6 mm Hg and diastolic blood pressure of 2.2 mm Hg . The relative risk of a major macrovascular or microvascular event was reduced by 9 % ( 861 [ 15.5 % ] active vs 938 [ 16.8 % ] placebo ; hazard ratio 0.91 , 95 % CI 0.83 - 1.00 , p=0.04 ) . The separate reductions in macrovascular and microvascular events were similar but were not independently significant ( macrovascular 0.92 ; 0.81 - 1.04 , p=0.16 ; microvascular 0.91 ; 0.80 - 1.04 , p=0.16 ) . The relative risk of death from cardiovascular disease was reduced by 18 % ( 211 [ 3.8 % ] active vs 257 [ 4.6 % ] placebo ; 0.82 , 0.68 - 0.98 , p=0.03 ) and death from any cause was reduced by 14 % ( 408 [ 7.3 % ] active vs 471 [ 8.5 % ] placebo ; 0.86 , 0.75 - 0.98 , p=0.03 ) . There was no evidence that the effects of the study treatment differed by initial blood pressure level or concomitant use of other treatments at baseline . INTERPRETATION Routine administration of a fixed combination of perindopril and indapamide to patients with type 2 diabetes was well tolerated and reduced the risks of major vascular events , including death . Although the confidence limits were wide , the results suggest that over 5 years , one death due to any cause would be averted among every 79 patients assigned active therapy",
"The Renoprotection of Optimal Antiproteinuric Doses ( ROAD ) study was performed to determine whether titration of benazepril or losartan to optimal antiproteinuric doses would safely improve the renal outcome in chronic renal insufficiency . A total of 360 patients who did not have diabetes and had proteinuria and chronic renal insufficiency were r and omly assigned to four groups . Patients received open-label treatment with a conventional dosage of benazepril ( 10 mg/d ) , individual uptitration of benazepril ( median 20 mg/d ; range 10 to 40 ) , a conventional dosage of losartan ( 50 mg/d ) , or individual uptitration of losartan ( median 100 mg/d ; range 50 to 200 ) . Uptitration was performed to optimal antiproteinuric and tolerated dosages , and then these dosages were maintained . Median follow-up was 3.7 yr . The primary end point was time to the composite of a doubling of the serum creatinine , ESRD , or death . Secondary end points included changes in the level of proteinuria and the rate of progression of renal disease . Compared with the conventional dosages , optimal antiproteinuric dosages of benazepril and losartan that were achieved through uptitration were associated with a 51 and 53 % reduction in the risk for the primary end point ( P = 0.028 and 0.022 , respectively ) . Optimal antiproteinuric dosages of benazepril and losartan , at comparable BP control , achieved a greater reduction in both proteinuria and the rate of decline in renal function compared with their conventional dosages . There was no significant difference for the overall incidence of major adverse events between groups that were given conventional and optimal dosages in both arms . It is concluded that uptitration of benazepril or losartan against proteinuria conferred further benefit on renal outcome in patients who did not have diabetes and had proteinuria and renal insufficiency",
"Abstract Objective : To determine whether tight control of blood pressure prevents macrovascular and microvascular complications in patients with type 2 diabetes . Design : R and omised controlled trial comparing tight control of blood pressure aim ing at a blood pressure of angiotensin converting enzyme inhibitor captopril or a β blocker atenolol as main treatment ) with less tight control aim ing at a blood pressure of 20 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Subjects : 1148 hypertensive patients with type 2 diabetes ( mean age 56 , mean blood pressure at entry 160/94 mm Hg ) ; 758 patients were allocated to tight control of blood pressure and 390 patients to less tight control with a median follow up of 8.4 years . Main outcome measures : Predefined clinical end points , fatal and non-fatal , related to diabetes , deaths related to diabetes , and all cause mortality . Surrogate measures of microvascular disease included urinary albumin excretion and retinal photography . Results : Mean blood pressure during follow up was significantly reduced in the group assigned tight blood pressure control ( 144/82 mm Hg ) compared with the group assigned to less tight control ( 154/87 mm Hg ) ( P Reductions in risk in the group assigned to tight control compared with that assigned to less tight control were 24 % in diabetes related end points ( 95 % confidence interval 8 % to 38 % ) ( P=0.0046 ) , 32 % in deaths related to diabetes ( 6 % to 51 % ) ( P=0.019 ) , 44 % in strokes ( 11 % to 65 % ) ( P=0.013 ) , and 37 % in microvascular end points ( 11 % to 56 % ) ( P=0.0092 ) , predominantly owing to a reduced risk of retinal photocoagulation . There was a non-significant reduction in all cause mortality . After nine years of follow up the group assigned to tight blood pressure control also had a 34 % reduction in risk in the proportion of patients with deterioration of retinopathy by two steps ( 99 % confidence interval 11 % to 50 % ) ( P=0.0004 ) and a 47 % reduced risk ( 7 % to 70 % ) ( P=0.004 ) of deterioration in visual acuity by three lines of the early treatment of diabetic retinopathy study ( ETDRS ) chart . After nine years of follow up 29 % of patients in the group assigned to tight control required three or more treatments to lower blood pressure to achieve target blood pressures . Conclusion : Tight blood pressure control in patients with hypertension and type 2 diabetes achieves a clinical ly important reduction in the risk of deaths related to diabetes , complications related to diabetes , progression of diabetic retinopathy , and deterioration in visual acuity",
"It is well established that hypertensive patients benefit from drug treatment of their disorder . In recent years three major out-come studies of antihypertensive treatment in elderly hypertensives have shown substantial benefits , i.e. a reduction in the risk of stroke and other cardiovascular mortality and morbidity . In all these studies beta-blockers and /or diuretics were used in comparison with placebo . Newer therapeutic alternatives have , however , at least theoretically , many advantages which could result in further improvements in prognosis . The initial Swedish Trial in Old Patients with Hypertension ( STOP-Hypertension 1 ) was conducted in men and women aged 70 - 84 years . STOP-Hypertension 2 will evaluate the therapy used in STOP-Hypertension 1 against therapy based on either ACE-inhibitors ( enalapril and lisinopril ) or on calcium antagonists ( isradipine and felodipine ) , using the PROBE design ( Prospect i ve , R and omised , Open , Blinded Endpoint evaluation ) . The primary aim will be to assess the effect on cardiovascular mortality . Statistical calculations indicate that 6,600 patients , followed for four years will be needed ( 2p or = 180/105 mmHg ( and /or ) . Recruitment of patients started in September 1992 and so far more than 100 patients /week have been included",
"BACKGROUND Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke . In addition , inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events , including stroke . However , the effect of lowering of blood pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established . We evaluated the effects of therapy with an angiotensin-receptor blocker , telmisartan , initiated early after a stroke . METHODS In a multicenter trial involving 20,332 patients who recently had an ischemic stroke , we r and omly assigned 10,146 to receive telmisartan ( 80 mg daily ) and 10,186 to receive placebo . The primary outcome was recurrent stroke . Secondary outcomes were major cardiovascular events ( death from cardiovascular causes , recurrent stroke , myocardial infa rct ion , or new or worsening heart failure ) and new-onset diabetes . RESULTS The median interval from stroke to r and omization was 15 days . During a mean follow-up of 2.5 years , the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group . A total of 880 patients ( 8.7 % ) in the telmisartan group and 934 patients ( 9.2 % ) in the placebo group had a subsequent stroke ( hazard ratio in the telmisartan group , 0.95 ; 95 % confidence interval [ CI ] , 0.86 to 1.04 ; P=0.23 ) . Major cardiovascular events occurred in 1367 patients ( 13.5 % ) in the telmisartan group and 1463 patients ( 14.4 % ) in the placebo group ( hazard ratio , 0.94 ; 95 % CI , 0.87 to 1.01 ; P=0.11 ) . New-onset diabetes occurred in 1.7 % of the telmisartan group and 2.1 % of the placebo group ( hazard ratio , 0.82 ; 95 % CI , 0.65 to 1.04 ; P=0.10 ) . CONCLUSIONS Therapy with telmisartan initiated soon after an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke , major cardiovascular events , or diabetes . ( Clinical Trials.gov number , NCT00153062 .",
"The never-treated control group in the Oslo Study hypertension trial of middle-aged men 40 - 49 years old at entry ( n = 379 ) was studied with respect to five-year change in blood pressure and its correlates . The study began in 1972 and ended in 1979 , and each patient was followed for five years . Both baseline and rate of change of correlates were analyzed as independent variables versus rate of change in blood pressure as the dependent variable . Rate of change in serum triglycerides were found to be the strongest correlate of rate of change in blood pressure in this population of healthy mild hypertensives . In addition , rate of change in serum cholesterol and body weight made significant contributions in some analyses , but to a lower degree than did rate of change in triglycerides . The model predicts a substantial decrease in blood pressure if lipids and body weight are reduced . Rate of change in sodium , uric acid , and chloride concentrations were also associated with blood pressure change , but total degree of explanation of all explaining variables only accounted for 11 - 15 % of total variation in annual blood pressure change",
"Background The prognostic benefits of blood pressure lowering treatment in elderly hypertensive patients were established more than a decade ago , but are less clear in those with mildly to moderately elevated blood pressure . Objective To assess whether c and esartan-based antihypertensive treatment in elderly patients with mildly to moderately elevated blood pressure confers a reduction in cardiovascular events , cognitive decline and dementia . Design Prospect i ve , double-blind , r and omized , parallel-group study conducted in 1997–2002 . Setting and participants The study was of 4964 patients aged 70–89 years , with systolic blood pressure 160–179 mmHg , and /or diastolic blood pressure 90–99 mmHg , and a Mini Mental State Examination ( MMSE ) test score ⩾ 24 . A total of 527 centres in 15 countries participated in the study . Intervention Patients were assigned r and omly to receive the angiotensin receptor blocker c and esartan or placebo , with open-label active antihypertensive therapy added as needed . As a consequence , active antihypertensive therapy was extensively used in the control group ( 84 % of patients ) . Mean follow-up was 3.7 years . Main outcome measures The primary outcome measure was major cardiovascular events , a composite of cardiovascular death , non-fatal stroke and non-fatal myocardial infa rct ion . Secondary outcome measures included cardiovascular death , non-fatal and fatal stroke and myocardial infa rct ion , cognitive function measured by the MMSE and dementia . Results Blood pressure fell by 21.7/10.8 mmHg in the c and esartan group and by 18.5/9.2 mmHg in the control group . A first major cardiovascular event occurred in 242 c and esartan patients and in 268 control patients ; risk reduction with c and esartan was 10.9 % [ 95 % confidence interval ( CI ) , −6.0 to 25.1 , P = 0.19 ] . C and esartan-based treatment reduced non-fatal stroke by 27.8 % ( 95 % CI , 1.3 to 47.2 , P = 0.04 ) , and all stroke by 23.6 % ( 95 % CI , −0.7 to 42.1 , P = 0.056 ) . There were no significant differences in myocardial infa rct ion and cardiovascular mortality . Mean MMSE score fell from 28.5 to 28.0 in the c and esartan group and from 28.5 to 27.9 in the control group ( P = 0.20 ) . The proportions of patients who had a significant cognitive decline or developed dementia were not different in the two treatment groups . Conclusions In elderly hypertensive patients , a slightly more effective blood pressure reduction during c and esartan-based therapy , compared with control therapy , was associated with a modest , statistically non-significant , reduction in major cardiovascular events and with a marked reduction in non-fatal stroke . Cognitive function was well maintained in both treatment groups in the presence of substantial blood pressure reductions . Both treatment regimens were generally well tolerated",
"BACKGROUND Angiotensin-converting-enzyme inhibitors improve the outcome among patients with left ventricular dysfunction , whether or not they have heart failure . We assessed the role of an angiotensin-converting-enzyme inhibitor , ramipril , in patients who were at high risk for cardiovascular events but who did not have left ventricular dysfunction or heart failure . METHODS A total of 9297 high-risk patients ( 55 years of age or older ) who had evidence of vascular disease or diabetes plus one other cardiovascular risk factor and who were not known to have a low ejection fraction or heart failure were r and omly assigned to receive ramipril ( 10 mg once per day orally ) or matching placebo for a mean of five years . The primary outcome was a composite of myocardial infa rct ion , stroke , or death from cardiovascular causes . The trial was a two-by-two factorial study evaluating both ramipril and vitamin E. The effects of vitamin E are reported in a companion paper . RESULTS A total of 651 patients who were assigned to receive ramipril ( 14.0 percent ) reached the primary end point , as compared with 826 patients who were assigned to receive placebo ( 17.8 percent ) ( relative risk , 0.78 ; 95 percent confidence interval , 0.70 to 0.86 ; P rates of death from cardiovascular causes ( 6.1 percent , as compared with 8.1 percent in the placebo group ; relative risk , 0.74 ; P myocardial infa rct ion ( 9.9 percent vs. 12.3 percent ; relative risk , 0.80 ; P stroke ( 3.4 percent vs. 4.9 percent ; relative risk , 0.68 ; P death from any cause ( 10.4 percent vs. 12.2 percent ; relative risk , 0.84 ; P=0.005 ) , revascularization procedures ( 16.3 percent vs. 18.8 percent ; relative risk , 0.85 ; P cardiac arrest ( 0.8 percent vs. 1.3 percent ; relative risk , 0.62 ; P=0.02 ) , [ corrected ] heart failure ( 9.1 percent vs. 11.6 percent ; relative risk , 0.77 ; P complications related to diabetes ( 6.4 percent vs. 7.6 percent ; relative risk , 0.84 ; P=0.03 ) . CONCLUSIONS Ramipril significantly reduces the rates of death , myocardial infa rct ion , and stroke in a broad range of high-risk patients who are not known to have a low ejection fraction or heart failure",
"Adverse treatment effects were assessed in 840 elderly hypertensive patients r and omly assigned to active treatment ( a combination of triamterene and hydrochlorothiazide ) or placebo ; methyldopa was added to the regimen in one third of the treated patients . Symptoms of dry mouth , nasal stuffiness , and diarrhea were reported by significantly more treated patients than placebo control subjects . More patients receiving diuretics plus methyldopa than diuretics alone reported dry mouth and diarrhea . Significantly more treated patients than control subjects showed evidence of a high serum creatinine level , mild hypokalemia , and gout . More treated patients tended to have diabetes . The benefits of treatment outweighed these adverse treatment effects",
"Long-term effects of antihypertensive treatment on various electrocardiogram ( ECG ) voltages and the association between ECG findings at r and omization and subsequent mortality were evaluated in the double-blind , placebo-controlled trial of elderly hypertensive patients , conducted by the European Working Party on High Blood Pressure in the Elderly ( EWPHE ) . Patients were treated with a combination of hydrochlorothiazide and triamterene or matching placebo ; methyldopa or placebo was added if blood pressures remained high . RaVL and SV1 + RV5 at r and omization were related to systolic blood pressure ( SBP ) and RaVL was also related to diastolic blood pressure ( DBP ) , after adjustment for age , gender , and body mass index ( BMI ) . When adjusted for age and body mass index , the decreases in RaVL and SV1 + RV5 were not correlated with the changes in SBP after 1 year of active treatment but the decreases in SV1 + RV5 were positively related to the fall in DBP . After 4 years of active treatment , the fall in SBP was associated with decreases in RaVL and in SV1 + RV5 , after adjustment for age and changes in BMI",
"OBJECTIVE To investigate the long-term effects of multifactorial primary prevention of cardiovascular diseases ( CVD ) . DESIGN The 5-year r and omized , controlled trial was performed between 1974 and 1980 . The subjects and their risk factors were reevaluated in 1985 . Posttrial mortality follow-up was continued up to December 31 , 1989 . SETTING Institute of Occupational Health , Helsinki , Finl and , and Second Department of Medicine , University of Helsinki . PARTICIPANTS In all , 3490 business executives born during 1919 through 1934 participated in health checkups in the late 1960s . In 1974 , 1222 of these men who were clinical ly healthy , but with CVD risk factors , were entered into the primary prevention trial ; 612 were r and omized to an intervention and 610 to a control group . INTERVENTIONS During the 5-year trial , the subjects of the intervention group visited the investigators every fourth month . They were treated with intensive dietetic-hygienic measures and frequently with hypolipidemic ( mainly clofibrate and /or probucol ) and antihypertensive ( mainly beta-blockers and /or diuretics ) drugs . The control group was not treated by the investigators . MAIN OUTCOME MEASURES Total mortality , cardiac mortality , mortality due to other causes . RESULTS Total coronary heart disease risk was reduced by 46 % in the intervention group as compared with the control group at end-trial . During 5 posttrial years , the risk factor and medication differences were largely leveled off between the groups . Between 1974 and 1989 the total number of deaths was 67 in the intervention group and 46 in the control group ( relative risk [ RR ] , 1.45 ; 95 % confidence interval [ CI ] , 1.01 to 2.08 ; P = .048 ) ; there were 34 and 14 cardiac deaths ( RR , 2.42 ; 95 % CI , 1.31 to 4.46 ; P = .001 ) , two and four deaths due to other CVD ( not significant ) , 13 and 21 deaths due to cancer ( RR , 0.62 ; 95 % CI , 0.31 to 1.22 ; P = .15 ) , and 13 and one deaths due to violence ( RR , 13.0 ; 95 % CI , 1.70 to 98.7 ; P = .002 ) , respectively . Multiple logistic regression analysis of treatments in the intervention group did not explain the 15-year excess cardiac mortality . CONCLUSION These unexpected results may not question multifactorial prevention as such but do support the need for research on the selection and interaction(s ) of methods used in the primary prevention of cardiovascular diseases",
"Context Previously published results of this r and omized , double-blind trial showed that high-risk patients with type 2 diabetic nephropathy had better renal protection if they were treated with irbesartan rather than amlodipine in addition to conventional antihypertensive therapy . Contribution These detailed analyses showed no differences in overall cardiovascular outcomes between patients given irbesartan or amlodipine . Fewer patients given irbesartan had heart failure and fewer patients given amlodipine had heart attacks . Caution s The trial had limited power to detect important differences between groups in mortality or strokes , and most patients received several antihypertensive agents . The Editors Patients with diabetes have an increased risk for cardiovascular complications and death ( 1 ) . Studies that analyzed the effects of inhibition of the reninangiotensin system on the risk for cardiovascular complications included a substantial number of patients with diabetes ( 2 - 5 ) or were done exclusively in patients with diabetes ( 6 - 8 ) . The meta- analysis of these studies ( 9 ) , the analysis of the diabetic cohorts in the Heart Outcomes Prevention Evaluation ( HOPE ) study ( 2 ) , and the Losartan Intervention for Endpoint Reduction in Hypertension ( LIFE ) trial ( 5 ) demonstrated that angiotensin-converting enzyme ( ACE ) inhibitors ( 2 , 9 ) and angiotensin-receptor blockers ( 5 ) had a statistically significant advantage over placebo or alternative agents in decreasing the risk for several cardiovascular events . These studies r and omly assigned few patients with renal involvement and overt proteinuria . Overt proteinuria occurred in fewer than 20 % of the 470 patients in the Appropriate Blood Pressure Control in Diabetes ( ABCD ) trial ( 6 ) , and only 11 % of the 1195 patients in the LIFE trial ( 5 ) . The Captopril Prevention Project ( CAPP ) ( 3 ) and the Swedish Trial in Old Patients with Hypertension-2 ( STOP Hypertension-2 ) ( 4 ) did not state the number of patients with diabetes and overt proteinuria . There were no such patients in the Fosinopril versus Amlodipine Cardiovascular Events Trial ( FACET ) ( 7 ) , and patients with dipstick-positive albuminuria were excluded from the HOPE trial ( 2 ) . Since proteinuria is an independent risk factor for cardiovascular disease ( 10 , 11 ) , the data obtained in the aforementioned trials can not be extrapolated to patients with type 2 diabetes and overt nephropathy . Trials performed in such patients have reported a blood pressureindependent effect of two different angiotensin-receptor blocker agents to protect against nephropathy ( 12 , 13 ) without a change in all-cause mortality . Apart from studies in heart failure , few cardiovascular data exist for receptor blockers compared with either placebo or calcium-channel blockers . We report on the analysis of the cardiovascular end points that were monitored as secondary end points in the Irbesartan Diabetic Nephropathy Trial ( IDNT ) ( 12 ) and assess whether an angiotensin II receptor blocker or a calcium-channel blocker alters the risk for cardiovascular events beyond those observed by blood pressure reduction alone without such agents . Methods Patients The IDNT was a r and omized , double-blind study on the effect of treatment with irbesartan or amlodipine compared with placebo in patients with type 2 diabetic nephropathy . The protocol of this study has been published ( 12 , 14 ) . Entry criteria required that patients be between 30 and 70 years of age and have type 2 diabetes mellitus and overt nephropathy , as evidence d by current treatment for hypertension or by a protein excretion rate of 900 mg/d or greater , serum creatinine level of 89 mol/L ( 1.0 mg/dL ) to 266 mol/L ( 3.0 mg/dL ) in women or of 106 mol/L ( 1.2 mg/dL ) to 266 mol/L ( 3.0 mg/dL ) in men , and baseline seated blood pressure greater than 135/85 mm Hg . The institutional review boards of each center approved the protocol . All patients gave written informed consent . Treatment and R and omization Patients were r and omly assigned central ly by computer to receive treatment with irbesartan , 300 mg/d ( Avapro , Bristol-Myers Squibb , Princeton , New Jersey ) ; amlodipine , 10 mg/d ( Norvasc , Pfizer , New York ) ; or matched placebo . To minimize any center effect , r and omization was blocked by center . All patients had blood pressure controlled to the same blood pressure goal of less than 135/85 mm Hg by using antihypertensive agents other than ACE inhibitors , angiotensin II receptor blocking agents , or calcium-channel blockers . For the analysis of cardiovascular end points , patients were followed to initiation of treatment for end-stage renal failure ( dialysis or renal transplantation ) , reaching a serum creatinine level of 530.4 mol/L ( 6.0 mg/dL ) or higher , death , or administrative censoring in December 2000 . Outcomes We prospect ively established cardiovascular outcomes , defined in the Appendix Table . Appendix Table . Classification for Fatal and Nonfatal Cardiovascular Events Ascertainment of Cardiovascular Events Information about hospitalizations and adverse events were screened at Bristol-Myers Squibb , Princeton , New Jersey , by trained , blinded clinical research associates to identify potential cardiovascular events . Investigators used study forms to report and characterize all cardiovascular outcomes . For all potential events , records , including laboratory values , electrocardiograms , and radiographic reports were obtained for clarification . Since myocardial infa rct ions may go unrecognized , a central electrocardiogram reading center was established at Brigham and Women 's Hospital , Boston , Massachusetts , where two cardiologists review ed every electrocardiogram . Electrocardiography was performed at baseline , 6 months , 12 months , and annually thereafter . A total of 5698 electrocardiograms were review ed at the center . When a new Q-wave infa rct ion was found , the cardiologists asked whether a clinical myocardial infa rct ion was reported . Even when myocardial infa rct ions were not clinical ly reported , these Q-wave infa rct ions were adjudicated as myocardial infa rct ions . Adjudication of Cardiovascular Events Investigators at each center reported cardiovascular events , defined in the Appendix Table . The information on all potential events was referred to one member of the Outcomes Confirmation and Classification Committee ( Appendix ) . If the committee member agreed with the judgment of the center investigator , their combined judgment was accepted . If the center investigator and the committee member differed , the case material was review ed by the membership of the committee , whose decision was accepted . Deaths were adjudicated by a Mortality Committee ( Appendix ) . Each death was review ed by two members of the committee and presented to the membership , whose decision was accepted as final . Statistical Analysis For graphical presentation ( Figure ) and overall testing for statistically significant differences among the three treatment groups , time to the first occurrence of either a specific cardiovascular outcome or one of the composite outcomes was analyzed by product-limit survival curves and the log-rank test ( 15 ) . We used proportional hazards modeling to determine hazard ratios . For the cardiovascular death outcome , which could occur only once , we used the st and ard proportional hazards model ( 16 ) , with treatment assignment as the only independent covariate . For other cardiovascular outcomes , which could occur more than once , we used the And ersonGill formulation of the proportional hazards model ( 17 ) , in which patients are considered at risk for the first event from r and omization to the first event , at risk for the second event from the day following the first event to the second event , and so forth , permitting use of all the data . In accordance with the method of Lee and colleagues ( 18 ) , we used a robust variance estimate that accounts for the possibility of correlation of risk for several events within a patient . We believed that occurrence of a first event of a given type increases the likelihood of a subsequent similar event . Therefore , both treatment assignment and a time-dependent covariate indicating whether the event was the first of its type or a subsequent event were included in these analyses . The time-dependent covariate was statistically significant in each case , confirming the above assumption . There was no statistically significant interaction between treatment and the time-dependent covariatethe effects of treatment assignment were similar for first and subsequent events and inclusion of the time-dependent covariate did not change either the estimates of the treatment effect or their statistical significance s. Figure . Time to first cardiovascular composite event as a function of treatment assignment . P Data management and computations were done by using SAS software for Windows , version 8 ( SAS Institute , Inc. , Cary , North Carolina ) , or S-Plus for Windows , version 6.0 ( Insightful Corp. , Seattle , Washington ) . Statistical tests were two sided . A P value of 0.05 or less , unadjusted for the multiple comparisons , was considered statistically significant . Role of the Funding Sources The funding sources were involved in the data collection but not in the analysis or interpretation or the decision to su bmi t the manuscript for publication . Results The baseline characteristics of the three groups are shown in Table 1 . A flow diagram of the study is shown in the Appendix Figure . Table 1 . Baseline Characteristics Appendix Figure . Flow diagram for the Irbesartan Diabetic Nephropathy Trial . Clinical Management During the study , the blood pressure decreased from the baseline values to 140/77 mm Hg in the irbesartan group , 141/77 mm Hg in the amlodipine group , and 144/80 mm Hg in the placebo group . Blood pressure in the two active treatment groups did not differ ; values in both groups were statistically significantly lower than in the placebo group ( P = 0.001 ) . The distribution of non study drugs used to achieve the target blood pressure was similar",
"Because many r and omized clinical trials study more than one important outcome variable , evaluation of efficacy is often difficult and not completely satisfactory . This paper considers the use of a procedure for endpoint determination described by Follmann et al. , that allows raters to integrate subjectively all relevant information about an individual 's clinical course into a single univariate assessment . To explore the method 's feasibility , we tested the procedure with data from a completed clinical trial , the Systolic Hypertension in the Elderly Program ( SHEP ) . We provided raters blinded to treatment assignment with cards that schematically represent the clinical trajectories of SHEP study participants . The raters independently ranked these trajectories . The method combined ranks across raters to determine a single rank for each study participant ; we used a rank procedure to test treatment effect . The major findings were : ( i ) the raters showed a high level of concordance of rankings ; ( ii ) tests of treatment effect were highly statistically significant ; ( iii ) three statistical methods were effective for implementing the ranking in the large study size case . These methods were use of : ( a ) scoring rules ; ( b ) incomplete block design s , and ( c ) categorical ranking",
"The 4 year prospect i ve trial on the effectiveness of the antihypertensive treatment was performed in 100 mild hypertensive patients of the aged , the average age being 76.1 years . Dropouts during the drug-off control period were 9 cases . The matched pair group was selected by the age , sex , and blood pressure . Forty-four drug treated cases and 47 placebo treated cases were comparable in blood pressure as well as in laboratory data . Cerebrovascular and cardiac complications were observed in 4 cases or 10.5 % in the drug group , and in 9 cases or 22.0 % in the placebo group . When 8 cases of blood pressure elevation over 200/110 mmHg in the placebo group were added to the cardiovascular complications , dropouts in placebo group reached 41.5 % , and this showed the significant difference . Other complications were observed in 12 cases or 31.6 % in the drug group and in 17 cases or 41.5 % in the placebo group . Major complications were cancers , infections , and bone or joint diseases . Blood pressure was decreased from 171/87 to 151/80 in the drug group , and the average decrease was 20/7 mmHg in 4 year period . No significant changes in hematocrit , serum protein , urea nitrogen , uric acid , sodium , and potassium were observed during the trial period . The present study suggested that antihypertensive treatment was effective in the aged with mild hypertension , and that careful follow up was needed not only for cardiovascular complications but also for general health condition",
"Summary The Hypertension in the Very Elderly Trial ( HYVET ) is a multicentre , open , r and omised , controlled trial . The aim of this trial is to investigate the effect of active treatment on stroke incidence in hypertensive patients over the age of 80 years . Secondary end-points include total cardiovascular mortality and morbidity . Entry criteria include a sustained sitting systolic blood pressure of 160 to 219 mm Hg plus a sustained sitting diastolic pressure of 95 to 109 mm Hg . Also required is a st and ing systolic blood pressure of at least 140 mm Hg . Patients must give their informed consent , and be free of congestive heart failure requiring treatment , gout , renal failure or a recent cerebral haemorrhage . Patients are to be r and omised to 3 groups — ( i ) no treatment ; ( ii ) treatment with a diuretic [ bendroflumethiazide ( bendrofluazide ) ] ; or ( iii ) treatment with an angiotensin converting enzyme ( ACE ) inhibitor (lisinopril).Starting dosage for bendroflumethiazide and lisinopril is 2.5 mg/day . In order to achieve goal sitting systolic and diastolic blood pressures ( diltiazem ( 120 mg/day increasing to 240 mg/day if required ) may be added to the medication of the actively treated groups . These drugs have been chosen as inexpensive and appropriate representatives of their therapeutic classes.700 patients in each group ( a total of 2100 ) will be sufficient to detect a 40 % difference in cerebrovascular events between no treatment and active treatment ( α = 0.01 , 1−β = 0.90 ) . These numbers will also detect a difference in total mortality of 25 % and in cardiovascular mortality of 35%.The pilot phase of the trial has been started with support from the British Heart Foundation . Centres which are interested in taking part should contact C. J. Bulpitt or any of the other authors",
"Background : Earlier angiographic studies have suggested that calcium antagonists may prevent the formation of new coronary lesions and the progression of minimal lesions . Conversely , a meta- analysis suggested that these drugs may increase cardiovascular mortality and morbidity in patients with coronary heart disease . Objective : To investigate whether nisoldipine retards the progression of coronary atherosclerosis or reduces the occurrence of clinical events . Design and setting : The NICOLE study ( NIsoldipine in COronary artery disease in LEuven ) is a single centre , r and omised , double blind , placebo controlled trial with coronary angiography at baseline , six months , and three years of follow up . Patients : 826 patients who had undergone successful coronary angioplasty were r and omised to nisoldipine 40 mg once daily or placebo . The intention to treat and per protocol population consisted of 819 and 578 patients , respectively . Results : In the per protocol population , 625 of the nisoldipine treated and 655 of the placebo treated patients ( NS ) showed angiographic progression in at least one coronary arterial segment , defined as an increase in diameter stenosis of ≥ 13 % . The average minimum luminal diameter of the non-dilated lesions decreased by 0.163 mm and 0.167 mm in the nisoldipine and placebo groups , respectively ( NS ) . The respective numbers of new lesions detected were 7 and 13 ( NS ) . In the intention to treat population , the rates of death , stroke , and acute myocardial infa rct ion were similar in both treatment groups . However , nisoldipine use was associated with fewer revascularisation procedures and thus the percentage of patients with any clinical event was lower ( 44.6 % v 52.6 % , p = 0.02 ) . Conclusions : Nisoldipine has no demonstrable effect on the angiographic progression of coronary atherosclerosis or the risk of major cardiovascular events but its use is associated with fewer revascularisation procedures ",
"Results of the European Working Party on High Blood Pressure in the Elderly ( EWPHE ) trial have been analysed in relation to age , sex , blood pressure , and previous cardiovascular disease . Cardiovascular mortality and the cardiovascular study -terminating events were significantly and independently related to treatment , age , cardiovascular complications at r and omisation , and systolic but not diastolic blood pressure . The benefits of treatment observed in the trial seemed to be independent of entry blood pressure and the presence or absence of cardiovascular complications at entry . There was some evidence that treatment effect decreases with advancing age . Little or no benefit from treatment could be demonstrated in patients over the age of 80 years , the great majority of whom were women",
"This report from the double-blind placebo-controlled SYST-EUR trial investigated whether modern antihypertensive drugs are suitable for maintaining long-term BP control in older ( > or = 60 years of age ) subjects with isolated systolic hypertension ( SBP 160 - 219 mmHg and DBP Active treatment consisted of nitredipine ( 10 - 40 mg/day ) with the possible addition of enalapril ( 5 - 20 mg/day ) and hydrochlorothiazide ( 12.5 - 25 mg/day ) , if necessary to reduce SBP to or = 20 mmHg . Matching placebos were used in the control group . This analysis was restricted to 18 months of follow-up . The placebo ( n = 456 ) and active treatment ( n = 485 ) groups had similar characteristics at r and omisation ( sitting pressure 176/85 mmHg ; age 73 years ) . SBP fell ( P placebo and DBP 4 mmHg more . Fewer patients remained on monotherapy in the placebo than in the active treatment group ( P placebo the second and third line medications were started earlier ( P Nitrendipine tablets were discontinued in nine patients on placebo and in 29 patients assigned to active treatment ( P significant BP reduction can be achieved and maintained in older patients with isolated systolic hypertension treated with a calcium antagonist ( associated with a converting-enzyme inhibitor and a thiazide , where necessary ) . Whether this BP reduction results in a clinical ly meaningful decrease of cardiovascular complications is under investigation",
"The relation between serum cholesterol and mortality was investigated in 822 elderly hypertensive patients r and omly assigned to treatment with diuretics , with or without methyldopa , or placebo . Cox 's proportional hazards model showed that pretreatment serum total cholesterol levels were independently and inversely correlated with total mortality ( p = 0.03 ) , noncardiovascular mortality ( p = 0.02 ) , and cancer mortality ( p = 0.04 ) during treatment . Total and noncardiovascular mortality were also negatively correlated with pretreatment hemoglobin levels and body weight . All factors being equal , an increase in total serum cholesterol of 2.3 mmol/L was associated with a one-year prolongation of survival . After adjustment for gender , age , pretreatment cardiovascular complications , and systolic pressure , the correlations between serum cholesterol and cardiovascular and cardiac mortality were not significant",
"Blood pressure ( BP ) and metabolic variables were determined initially and after 1 , 2 , 4 , 6 and 10 years ' treatment in two groups of hypertensive men ( n = 53 each ) r and omized to bendroflumethiazide 2.5 - 5 mg/day or propranolol 160 - 320 mg daily . There was no significant differences in BP or metabolic variables between the two groups at entry . BP was reduced to the same degree by both treatments . Five men in the propranolol group and one man in the thiazide group developed clinical ly overt diabetes during follow-up . Fasting blood sugar increased slightly but significantly though equally in both groups . Oral glucose tolerance was initially impaired to the same degree in both groups but improved significantly during treatment with both drugs . Fasting insulin increased slightly but to the same degree . While serum potassium decreased significantly in the thiazide group , the total body potassium was unchanged in this group . In the propranolol group , serum potassium rose , while total body potassium decreased significantly . Serum urate increased in both groups , though slightly more during thiazide treatment . One case of gout was found in each group . There was no difference in serum lipids between the two groups . The finding in this long-term trial indicate that in middle-aged men with mild to moderate hypertension a low-dose thiazide diuretic like bendroflumethiazide is as effective and safe an antihypertensive agent as the beta-blocker propranolol is and that it does not induce diabetes . The total clinical picture favors the retention of thiazide diuretics as a first choice drug in hypertension",
"Angiotensin-converting enzyme inhibitors improve endothelial function , inhibit experimental atherogenesis , and decrease ischemic events . The Quinapril Ischemic Event Trial was design ed to test the hypothesis that quinapril 20 mg/day would reduce ischemic events ( the occurrence of cardiac death , resuscitated cardiac arrest , nonfatal myocardial infa rct ion , coronary artery bypass grafting , coronary angioplasty , or hospitalization for angina pectoris ) and the angiographic progression of coronary artery disease in patients without systolic left ventricular dysfunction . A total of 1,750 patients were r and omized to quinapril 20 mg/day or placebo and followed a mean of 27 + /- 0.3 months . The 38 % incidence of ischemic events was similar for both groups ( RR 1.04 ; 95 % confidence interval 0.89 to 1.22 ; p = 0.6 ) . There was also no significant difference in the incidence of patients having angiographic progression of coronary disease ( p = 0.71 ) . The rate of development of new coronary lesions was also similar in both groups ( p = 0.35 ) . However , there was a difference in the incidence of angioplasty for new ( previously unintervened ) vessels ( p = 0.018 ) . Quinapril was well tolerated in patients after angioplasty with normal left ventricular function . Quinapril 20 mg did not significantly affect the overall frequency of clinical outcomes or the progression of coronary atherosclerosis . However , the absence of the demonstrable effect of quinapril may be due to several limitations in study design",
"BACKGROUND The association of serum lipids with coronary heart disease has been studied extensively in middle-aged men and , to a lesser extent , in similar women . Less well defined are lipid variables predictive of CHD in individuals of age > or = 60 years . METHODS AND RESULTS The Systolic Hypertension in the Elderly Program recruited 4736 persons ( mean age , 72 years ; 14 % were black ; and 43 % were men ) . Mean systolic and diastolic blood pressures were 170 and 77 mm Hg , respectively . Baseline mean total cholesterol was 6.11 mmol/L ( 236 mg/dL ) ; HDL cholesterol , 1.39 mmol/L ( 54 mg/dL ) ; and non-HDL cholesterol , 4.72 mmol/L ( 182 mg/dL ) . Triglyceride levels were 1.62 mmol/L ( 144 mg/dL ) for fasting participants and 1.78 mmol/L for the total group . LDL cholesterol , estimated in fasting sample s with triglycerides of baseline total , non-HDL , and LDL cholesterol levels and the ratios of total , non-HDL , and LDL to HDL cholesterol were significantly related to CHD incidence . HDL cholesterol and triglycerides were not significant in these analyses . In fasting participants with triglyceride levels of total , non-HDL , or LDL cholesterol was associated with a 30 % to 35 % higher CHD event rate . CONCLUSIONS The results of this study support the concept that serum lipids are CHD risk factors in older Americans",
"BACKGROUND Treatment with angiotensin-converting-enzyme ( ACE ) inhibitors reduces the rate of cardiovascular events among patients with left-ventricular dysfunction and those at high risk of such events . We assessed whether the ACE inhibitor perindopril reduced cardiovascular risk in a low-risk population with stable coronary heart disease and no apparent heart failure . METHODS We recruited patients from October , 1997 , to June , 2000 . 13655 patients were registered with previous myocardial infa rct ion ( 64 % ) , angiographic evidence of coronary artery disease ( 61 % ) , coronary revascularisation ( 55 % ) , or a positive stress test only ( 5 % ) . After a run-in period of 4 weeks , in which all patients received perindopril , 12218 patients were r and omly assigned perindopril 8 mg once daily ( n=6110 ) , or matching placebo ( n=6108 ) . The mean follow-up was 4.2 years , and the primary endpoint was cardiovascular death , myocardial infa rct ion , or cardiac arrest . Analysis was by intention to treat . FINDINGS Mean age of patients was 60 years ( SD 9 ) , 85 % were male , 92 % were taking platelet inhibitors , 62 % beta blockers , and 58 % lipid-lowering therapy . 603 ( 10 % ) placebo and 488 ( 8 % ) perindopril patients experienced the primary endpoint , which yields a 20 % relative risk reduction ( 95 % CI 9 - 29 , p=0.0003 ) with perindopril . These benefits were consistent in all predefined subgroups and secondary endpoints . Perindopril was well tolerated . INTERPRETATION Among patients with stable coronary heart disease without apparent heart failure , perindopril can significantly improve outcome . About 50 patients need to be treated for a period of 4 years to prevent one major cardiovascular event . Treatment with perindopril , on top of other preventive medications , should be considered in all patients with coronary heart disease",
"Ventricular ectopic activity was recorded at baseline in 5.6 % of the 12-lead electrocardiograms and 8.2 % of the 2-minute rhythm strips of 4674 subjects with isolated systolic hypertension ( systolic blood pressure 160 to 219 mm Hg , diastolic blood pressure In this study 1.3 % had 6 to 10 ventricular premature beats ( VPB ) , and 0.7 % had > 10 VPB on the 2-minute rhythm strip . Correlates of VPB presence on the 12-lead ECG were older-age male sex , presence of Q/QS pattern and higher heart rate . Participants with serum potassium prevalence of VPB . Similarly , the number of VPB on the 2-minute rhythm strip was associated with male sex , increasing age , with lower serum potassium , history of palpitations , and presence of Q/QS patterns",
"The Systolic Hypertension in the Elderly Program ( SHEP ) Pilot Study was conducted to determine the feasibility of conducting a long-term placebo-controlled r and omized clinical trial in elderly subjects . Enrolled in the study were 551 men and women between the ages of 60 and 90 years with isolated systolic hypertension ( SBP greater than or equal to 160 mmHg and DBP less than 90 mmHg ) . The study showed that it is possible to recruit old and very old subjects into a clinical trial ; the elderly are good compliers ( drugs and follow-up visits ) , with some decline after the age of 80 ; control of blood pressure was accomplished in the large majority of patients ; evaluation of side effects represents a potential problem as varied complaints increase with age thus creating difficulties in distinguishing those attributed to the study drug ; and finally , cause-specific mortality is probably preferable to all-cause mortality as an end-point in prevention trials of antihypertensive regimens",
"BACKGROUND The efficacy of antihypertensive drugs newer than diuretics and beta-blockers has not been established . We compared the effects of the calcium-channel blocker nifedipine once daily with the diuretic combination co-amilozide on cardiovascular mortality and morbidity in high-risk patients with hypertension . METHODS We did a prospect i ve , r and omised , double-blind trial in Europe and Israel in 6321 patients aged 55 - 80 years with hypertension ( blood pressure > or = 150/95 mm Hg , or > or = 160 mm Hg systolic ) . Patients had at least one additional cardiovascular risk factor . We r and omly assigned patients nifedipine 30 mg in a long-acting gastrointestinal-transport-system ( GITS ) formulation ( n=3157 ) , or co-amilozide ( hydrochlorothiazide 25 mg [ corrected ] plus amiloride 2.5 mg ; n=3164 ) . Dose titration was by dose doubling , and addition of atenolol 25 - 50 mg or enalapril 5 - 10 mg . The primary outcome was cardiovascular death , myocardial infa rct ion , heart failure , or stroke . Analysis was done by intention to treat . FINDINGS Primary outcomes occurred in 200 ( 6.3 % ) patients in the nifedipine group and in 182 ( 5.8 % ) in the co-amilozide group ( 18.2 vs 16.5 events per 1000 patient-years ; relative risk 1.10 [ 95 % CI 0.91 - 1.34 ] , p=0.35 ) . Overall mean blood pressure fell from 173/99 mm Hg ( SD 14/8 ) to 138/82 mm Hg ( 12/7 ) . There was an 8 % excess of withdrawals from the nifedipine group because of peripheral oedema ( 725 vs 518 , p serious adverse events were more frequent in the co-amilozide group ( 880 vs 796 , p=0.02 ) . Deaths were mainly non-vascular ( nifedipine 176 vs co-amilozide 172 ; p=0.81 ) . 80 % of the primary events occurred in patients receiving r and omised treatment ( 157 nifedipine , 147 co-amilozide , difference 0.33 % [ -0.7 to 1.4 ] ) . INTERPRETATION Nifedipine once daily and co-amilozide were equally effective in preventing overall cardiovascular or cerebrovascular complications . The choice of drug can be decided by tolerability and blood-pressure response rather than long-term safety or efficacy",
"BACKGROUND Microalbuminuria and hypertension are risk factors for diabetic nephropathy . Blockade of the renin-angiotensin system slows the progression to diabetic nephropathy in patients with type 1 diabetes , but similar data are lacking for hypertensive patients with type 2 diabetes . We evaluated the renoprotective effect of the angiotensin-II-receptor antagonist irbesartan in hypertensive patients with type 2 diabetes and microalbuminuria . METHODS A total of 590 hypertensive patients with type 2 diabetes and microalbuminuria were enrolled in this multinational , r and omized , double-blind , placebo-controlled study of irbesartan , at a dose of either 150 mg daily or 300 mg daily , and were followed for two years . The primary outcome was the time to the onset of diabetic nephropathy , defined by persistent albuminuria in overnight specimens , with a urinary albumin excretion rate that was greater than 200 microg per minute and at least 30 percent higher than the base-line level . RESULTS The base-line characteristics in the three groups were similar . Ten of the 194 patients in the 300-mg group ( 5.2 percent ) and 19 of the 195 patients in the 150-mg group ( 9.7 percent ) reached the primary end point , as compared with 30 of the 201 patients in the placebo group ( 14.9 percent ) ( hazard ratios , 0.30 [ 95 percent confidence interval , 0.14 to 0.61 ; P average blood pressure during the course of the study was 144/83 mm Hg in the placebo group , 143/83 mm Hg in the 150-mg group , and 141/83 mm Hg in the 300-mg group ( P=0.004 for the comparison of systolic blood pressure between the placebo group and the combined irbesartan groups ) . Serious adverse events were less frequent among the patients treated with irbesartan ( P=0.02 ) . CONCLUSIONS Irbesartan is renoprotective independently of its blood-pressure-lowering effect in patients with type 2 diabetes and microalbuminuria",
"The purpose of this study was to evaluate the long-term safety and efficacy of moexipril , a non-sulphydryl angiotensin converting enzyme inhibitor , alone or in combination with hydrochlorothiazide in older patients with hypertension . One hundred and seventy two hypertensive men and women , 65 - 80 years old , with seated DBP between 95 and 114 mm Hg were studied . The study was a 2 year , multicentre ( 12 centres ) , open-label protocol of moexipril monotherapy or combination therapy ( with hydrochlorothiazide ) . Blood pressure , pulse rate , weight , adverse effects and laboratory studies were assessed following moexipril at 7.5 or 15 mg once daily or 7.5 or 15 mg daily in combination with 25 mg of hydrochlorothiazide if the seated DBP remained > or = 90 mm Hg on moexipril monotherapy . The primary measure of efficacy was a change from baseline in seated DBP . Secondary outcome measures included changes in seated DBP , pulse rate , laboratory parameters and adverse side-effects . Following 1 year of therapy in 135 patients , the BP fell 16/14 mm Hg among patients receiving moexipril monotherapy and 27/17 mm Hg for those receiving combined therapy compared with baseline ( P experiences . There were no significant changes in pulse rate or postural reductions in BP on either moexipril monotherapy or combination treatment . Three adverse side-effects occurred at a frequency exceeding 2 % that were possibly or probably attributable to moexipril or combination therapy : hypotension ( 2 % ) , dizziness ( 6 % ) and increased cough ( 12 % ) . There were no clinical ly relevant mean group changes from baseline laboratory values in the treatment groups . In conclusion , these long-term data demonstrate that moexipril , either alone or in combination with hydrochlorothiazide , has long-term anti-hypertensive efficacy and is generally well tolerated in elderly patients with hypertension",
"BACKGROUND Angiotensin-converting-enzyme ( ACE ) inhibitors are effective in reducing the risk of heart failure , myocardial infa rct ion , and death from cardiovascular causes in patients with left ventricular systolic dysfunction or heart failure . ACE inhibitors have also been shown to reduce atherosclerotic complications in patients who have vascular disease without heart failure . METHODS In the Prevention of Events with Angiotensin Converting Enzyme Inhibition ( PEACE ) Trial , we tested the hypothesis that patients with stable coronary artery disease and normal or slightly reduced left ventricular function derive therapeutic benefit from the addition of ACE inhibitors to modern conventional therapy . The trial was a double-blind , placebo-controlled study in which 8290 patients were r and omly assigned to receive either tr and olapril at a target dose of 4 mg per day ( 4158 patients ) or matching placebo ( 4132 patients ) . RESULTS The mean ( + /-SD ) age of the patients was 64+/-8 years , the mean blood pressure 133+/-17/78+/-10 mm Hg , and the mean left ventricular ejection fraction 58+/-9 percent . The patients received intensive treatment , with 72 percent having previously undergone coronary revascularization and 70 percent receiving lipid-lowering drugs . The incidence of the primary end point -- death from cardiovascular causes , myocardial infa rct ion , or coronary revascularization -- was 21.9 percent in the tr and olapril group , as compared with 22.5 percent in the placebo group ( hazard ratio in the tr and olapril group , 0.96 ; 95 percent confidence interval , 0.88 to 1.06 ; P=0.43 ) over a median follow-up period of 4.8 years . CONCLUSIONS In patients with stable coronary heart disease and preserved left ventricular function who are receiving \" current st and ard \" therapy and in whom the rate of cardiovascular events is lower than in previous trials of ACE inhibitors in patients with vascular disease , there is no evidence that the addition of an ACE inhibitor provides further benefit in terms of death from cardiovascular causes , myocardial infa rct ion , or coronary revascularization",
"Syst-Eur is a multicentre placebo-controlled outcome trial , design ed by the European Working Party on High Blood Pressure in the Elderly ( EWPHE ) , to investigate the effect of antihypertensive treatment on the incidence of stroke in elderly patients with isolated systolic hypertension ( ISH ) . Eligible patients must be at least 60 years old and have a systolic blood pressure averaging 160 - 219 mmHg with a diastolic blood pressure less than 95 mmHg . The present paper in an interim report on the first 316 patients r and omized into this trial . The placebo ( N = 170 ) and active treatment ( N = 146 ) groups were similar at r and omization with respect to age ( 73 + /- 8 years ; mean + /- st and ard deviation ) , sitting blood pressure ( 178 + /- 12/85 + /- 7 mmHg ) , percentage men ( 34 % ) and percentage of patients with cardiovascular complications ( 29 % ) . After r and omization blood pressure fell more ( p sitting blood pressure ) . This first interim report on the Syst-Eur trial demonstrates that a multinational trial in elderly patients with ISH is feasible and that a significant blood pressure difference between the 2 treatment groups can be achieved and maintained . New centres are being recruited in order to r and omize a total of 3,000 patients",
" Elderly hypertensive patients were r and omly assigned to treatment with diuretics and methyldopa ( n = 352 ) or placebo ( n = 339 ) , and divided into three groups , each according to their blood pressures , after nine months of treatment . Subsequently , 65 placebo patients and 56 treated patients died . A U-shaped relation was seen in treated patients between mortality and systolic blood pressure , and in placebo patients between mortality and diastolic blood pressure . Whereas in treated patients , the highest mortality was seen in patients with the lowest diastolic pressure , the lowest mortality was seen in the group with the highest diastolic pressure . The increased mortality in treated patients with the lowest blood pressure may not be drug-induced , but an expression of deterioration in general health , as indicated by the decreases in body weight and hemoglobin levels found in patients with the lowest blood pressures in previous analyses of these data",
"Although limited numbers of elderly subjects have occasionally been included in population -based studies , only a few studies have been conducted specifically on elderly hypertensives , and practically none at a population level . We studied 655 hypertensive subjects from a cohort of 2,254 elderly subjects . The intervention consisted of the creation of a Hypertension Out patients ' Clinic under our auspices but with complete co-operation from general practitioners , r and omizing the identified hypertensive patients into pre-established therapeutic drug regimens , and early follow-up recording of mortality for 7 years . The drugs used were clonidine ( n = 61 ) , nifedipine ( n = 146 ) and the fixed combination of atenolol+chlorthalidone ( n = 144 ) ; 304 subjects underwent \" free therapy \" by their personal physicians without any special intervention . There were 1,404 normotensive subjects . Overall 7-year follow-up mortality was 34.9 % in the hypertensive subjects receiving \" free therapy \" , 22.5 % in those receiving \" special care \" , and 24.2 % in the normotensives . Cardiovascular mortality was respectively 23.7 % , 12.2 % , and 12.0 % . Overall and cardiovascular annual cumulative mortality were significantly lower in the > than in the > group . The fixed combination of atenolol and chlorthalidone reduced mortality below that of the normotensives , independent of other cardiovascular risk factors",
" Orthostatic fall in blood pressure in the very elderly hypertensive : results from the Hypertension in the Very Elderly Trial ( HYVET ) —",
"A r and omised trial of the treatment of hypertension in 884 patients aged 60 to 79 years at the onset showed a reduction of 18/11 mm Hg in blood pressure over a mean follow up period of 4.4 years . The principal antihypertensive agents were atenolol and bendrofluazide . There was a reduction in the rate of fatal stroke in the treatment group to 30 % of that in the control group ( 95 % confidence interval 11 - 84 % , p less than 0.025 ) . The rate of all strokes ( fatal and non-fatal ) in the treatment group was 58 % of that in the control group ( 95 % confidence interval 35 - 96 % , p less than 0.03 ) . The incidence of myocardial infa rct ion and total mortality was unaffected by treatment . Question naires completed by the patients and their relatives failed to identify any differences in symptoms that were likely to be due to treatment",
"BACKGROUND Characteristics such as age and race are often cited as determinants of the response of blood pressure to specific antihypertensive agents , but this clinical ly important issue has not been examined in sufficiently large trials , involving all st and ard treatments , to determine the effect of such factors . METHODS In a r and omized , double-blind study at 15 clinics , we assigned 1292 men with diastolic blood pressures of 95 to 109 mm Hg , after a placebo washout period , to receive placebo or one of six drugs : hydrochlorothiazide ( 12.5 to 50 mg per day ) , atenolol ( 25 to 100 mg per day ) , captopril ( 25 to 100 mg per day ) , clonidine ( 0.2 to 0.6 mg per day ) , a sustained-release preparation of diltiazem ( 120 to 360 mg per day ) , or prazosin ( 4 to 20 mg per day ) . The drug doses were titrated to a goal of less than 90 mm Hg for maximal diastolic pressure , and the patients continued to receive therapy for at least one year . RESULTS The mean ( + /- SD ) age of the r and omized patients was 59 + /- 10 years , and 48 percent were black . The average blood pressure at base line was 152 + /- 14/99 + /- 3 mm Hg . Diltiazem therapy had the highest rate of success : 59 percent of the treated patients had reached the blood-pressure goal at the end of the titration phase and had a diastolic blood pressure of less than 95 mm Hg at one year . Atenolol was successful by this definition in 51 percent of the patients , clonidine in 50 percent , hydrochlorothiazide in 46 percent , captopril in 42 percent , and prazosin in 42 percent ; all these agents were superior to placebo ( success rate , 25 percent ) . Diltiazem ranked first for younger blacks ( ) and older blacks ( > or = 60 years ) , among whom the success rate was 64 percent , captopril for younger whites ( success rate , 55 percent ) , and atenolol for older whites ( 68 percent ) . Drug intolerance was more frequent with clonidine ( 14 percent ) and prazosin ( 12 percent ) than with the other drugs . CONCLUSIONS Among men , race and age have an important effect on the response to single-drug therapy for hypertension . In addition to cost and quality of life , these factors should be considered in the initial choice of a drug",
"BACKGROUND In 1989 , the European Working Party on High Blood Pressure in the Elderly started the double-blind , placebo-controlled , Systolic Hypertension in Europe Trial to test the hypothesis that antihypertensive drug treatment would reduce the incidence of fatal and nonfatal stroke in older patients with isolated systolic hypertension . This report addresses whether the benefit of antihypertensive treatment varied according to sex , previous cardiovascular complications , age , initial blood pressure ( BP ) , and smoking or drinking habits in an intention-to-treat analysis and explores whether the morbidity and mortality results were consistent in a per- protocol analysis . METHODS After stratification for center , sex , and cardiovascular complications , 4695 patients 60 years of age or older with a systolic BP of 160 to 219 mm Hg and diastolic BP less than 95 mm Hg were r and omized . Active treatment consisted of nitrendipine ( 10 - 40 mg/d ) , with the possible addition of enalapril maleate ( 5 - 20 mg/d ) and /or hydrochlorothiazide ( 12.5 - 25 mg/d ) , titrated or combined to reduce the sitting systolic BP by at least 20 mm Hg , to below 150 mm Hg . In the control group , matching placebo tablets were employed similarly . RESULTS In the intention-to-treat analysis , male sex , previous cardiovascular complications , older age , higher systolic BP , and smoking at r and omization were positively and independently correlated with cardiovascular risk . Furthermore , for total ( P = .009 ) and cardiovascular ( P = .09 ) mortality , the benefit of antihypertensive drug treatment weakened with advancing age ; for total mortality ( P = .05 ) , the benefit increased with higher systolic BP at entry , while for fatal and nonfatal stroke ( P = .01 ) , it was most evident in nonsmokers ( 92.5 % of all patients ) . In the per protocol analysis , active treatment reduced total mortality by 24 % ( P = .05 ) , reduced all fatal and nonfatal cardiovascular end points by 32 % ( P all strokes by 44 % ( P = .004 ) , reduced nonfatal strokes by 48 % ( P = .005 ) , and reduced all cardiac end points , including sudden death , by 26 % ( P = .05 ) . CONCLUSIONS In elderly patients with isolated systolic hypertension , stepwise antihypertensive drug treatment , starting with the dihydropyridine calcium channel blocker nitrendipine , improves prognosis . The per- protocol analysis suggested that treating 1000 patients for 5 years would prevent 24 deaths , 54 major cardiovascular end points , 29 strokes , or 25 cardiac end points . The effects of antihypertensive drug treatment on total and cardiovascular mortality may be attenuated in very old patients",
"In 1972 - -1973 , 785 symptom-free men , aged 40 to 49 years , without target organ damage , with systolic blood pressures between 150 and 179 mm Hg and diastolic blood pressure below 110 mm Hg , were assigned at r and om to one of two groups : ( 406 to a drug treatment group and 379 to a control group ) for a five-year controlled drug treatment trial to evaluate the effect of therapy on cardiovascular complications . Drug treatment started with hydrochlorothiazide . If systolic blood pressure remained above 140 mm Hg and /or diastolic blood pressure above 90 mm Hg , alphamethyldopa was added . If there were side effects , methyldopa was replaced with propranolol . The control group was not given a placebo . The mean observation time was 66 months ( range 60 to 78 months ) . A difference in blood pressure between groups of about 17 mm Hg systolic and 10 mm Hg diastolic was maintained throughout the study . The study protocol had a rather low \" ethical \" blood pressure roof , 180 mm Hg systolic and /or 110 mm Hg diastolic . Seventeen percent of the control group had an increase in blood pressure above this level during the trial , and drug treatment was started . There was no effect on major cardiovascular morbidity comparing groups as established by r and omization , with 18 events in the treatment group and 20 events in the control group . There was no difference between the groups in total mortality and mortality from cardiovascular events . However , in the subgroups with diastolic blood pressure greater than or equal to 100 mm Hg before r and omization , there was a probable reduction in total morbidity from cardiovascular events in favor or the group receiving drug therapy , 7.6 and 16.4 percent events in the treated and control groups , respectively . Cerebrovascular events occurred only in the control group , 7 versus 0 . Two cases of fatal aortic aneurysms also occurred in the control group . Other \" pressure \" complications , such as marked left ventricular hypertrophy in the electrocardiogram and left ventricular failure , occurred only in the control group . However , regarding coronary heart disease , including sudden death , the incidence tended to be higher in the treated group , although it was not statistically significant . Only 13 men ( 1.7 percent ) failed to meet for regular examinations . At the end of the study these men were also followed up with regard to possible cardiovascular events",
"Five hundred and seven elderly hypertensive patients were followed for 1 year , 371 for 2 years and 270 for 3 years in a double-blind , r and omized , controlled trial in which they received either placebo or 25 - 50 mg hydrochlorothiazide and 50 - 100 mg of triamterene daily . One third of the active treatment group also received 250 mg to 2 g methyldopa daily . After 1 year the active treatment group had an average increase in fasting blood sugar of 2.5 mg/dl compared with an average fall of 1.4 mg/dl in the placebo group ( P = 0.01 ) . The increase in blood sugar 1 hour and 2 hours after 50 g oral glucose tended to be greater in the actively treated group but these increases did not achieve statistical significance . The effects of diuretic treatment were established after one year and did not increase further over the next 2 years . Overall there was an increase in fasting blood sugar of 5 mg/dl in the active treatment group which occurred mainly in the first year . The hyperglycaemic effect of diuretics appeared to be partly or wholly related to potassium loss since , in both groups , impairment of glucose tolerance was most marked in those in whom serum potassium decreased . The measures of blood sugar were also positively related to systolic pressure before and after treatment",
"OBJECTIVES To assess the risk of total and cardiovascular mortality in older adults with systolic hypertension and with a low ankle-arm index ( AAI ) as a marker of sub clinical peripheral arterial disease ( PAD ) . DESIGN Prospect i ve observational study PARTICIPANTS A subgroup of 1537 participants in the Systolic Hypertension in the Elderly Program ( SHEP ) were screened for lower extremity arterial disease using the AAI . Participants were evaluated at 4 years to determine vital status and cause of death . Total and cardiovascular disease ( CVD ) mortality rates were assessed in relationship to clinical CVD at baseline , cardiovascular risk factors and the presence of a low AAI ( sub clinical PAD ) . RESULTS Total mortality rates increased as the AAI decreased in those with and without clinical CVD at baseline . In those without clinical CVD at baseline , the presence of an AAI total mortality in men and 2.67 in women . Results were similar for CVD mortality and persisted after adjustment for cardiovascular risk factors including the presence of an abnormal electrocardiogram . CONCLUSIONS A low ankle arm-index predicted a two to three-fold increase in total and cardiovascular mortality in older adults with systolic hypertension of risk for incident cardiovascular disease . In this study of older adults with systolic hypertension , 19.7 % of the participants had sub clinical PAD . Risk factor modification could be targeted to older adults based on markers of asymptomatic atherosclerosis",
"The Australian Therapeutic Trial in Mild Hypertension was a controlled trial in which mildly hypertensive patients , aged between 35 and 65 years ( diastolic blood pressure 95 - 109 ) were r and omly assigned to take antihypertensive drugs or matched placebos for periods of up to 6 years . The overall data showed that the treated group had a lower incidence of both death and of nonfatal cardiovascular events . The differences in the incidence of noncardiovascular deaths did not differ significantly between the two groups . Univariate analysis of possible prognostic factors at the time of entry into the study showed a higher incidence of trial endpoints -- mostly events due to ischemic heart disease and cerebrovascular disease -- in older subjects , men , cigarette smokers and those with higher systolic blood pressures , and in thinner subjects than in others . There was a lower incidence of these events in actively treated persons than in control subjects at each level of incidence of each covariate measured . Treatment benefit was greatest in persons with lower systolic blood pressures and lower serum cholesterol levels . Multivariate regression analyses confirmed that the incidence of trial endpoints increased with age and with systolic blood pressures . There was a higher incidence in smokers than in nonsmokers , especially in those with low body weights . Treatment benefited thin smokers most , and the effects of treatment seemed to be reduced in those with higher serum cholesterol levels . There was a substantial fall in blood pressure in many of the placebo group",
"BACKGROUND Renal function declines progressively in patients who have diabetic nephropathy , and the decline may be slowed by antihypertensive drugs . The purpose of this study was to determine whether captopril has kidney-protecting properties independent of its effect on blood pressure in diabetic nephropathy . METHODS We performed a r and omized , controlled trial comparing captopril with placebo in patients with insulin-dependent diabetes mellitus in whom urinary protein excretion was > or = 500 mg per day and the serum creatinine concentration was Blood-pressure goals were defined to achieve control during a median follow-up of three years . The primary end point was a doubling of the base-line serum creatinine concentration . RESULTS Two hundred seven patients received captopril , and 202 placebo . Serum creatinine concentrations doubled in 25 patients in the captopril group , as compared with 43 patients in the placebo group ( P = 0.007 ) . The associated reductions in risk of a doubling of the serum creatinine concentration were 48 percent in the captopril group as a whole , 76 percent in the subgroup with a baseline serum creatinine concentration of 2.0 mg per deciliter ( 177 mumol per liter ) , 55 percent in the subgroup with a concentration of 1.5 mg per deciliter ( 133 mumol per liter ) , and 17 percent in the subgroup with a concentration of 1.0 mg per deciliter ( 88.4 mumol per liter ) . The mean ( + /- SD ) rate of decline in creatinine clearance was 11 + /- 21 percent per year in the captopril group and 17 + /- 20 percent per year in the placebo group ( P = 0.03 ) . Among the patients whose base-line serum creatinine concentration was > or = 1.5 mg per deciliter , creatinine clearance declined at a rate of 23 + /- 25 percent per year in the captopril group and at a rate of 37 + /- 25 percent per year in the placebo group ( P = 0.01 ) . Captopril treatment was associated with a 50 percent reduction in the risk of the combined end points of death , dialysis , and transplantation that was independent of the small disparity in blood pressure between the groups . CONCLUSIONS Captopril protects against deterioration in renal function in insulin-dependent diabetic nephropathy and is significantly more effective than blood-pressure control alone",
"Abstract Morbidity , mortality , and target organ function have been followed in a double-blind study of a predominantly Negro clinic population with mild to moderately severe hypertension over a 2-year period . Patients were placed r and omly on either hypotensive drug therapy ( reserpine , thiazide , guanethedine ) or matched placebos . There were 6 treatment failures among 45 patients in the treatment group and 19 failures among 42 patients in the placebo group . All but one of the failures in the placebo group improved or cleared upon early institution of appropriate hypertensive and supportive therapy . Abnormalities in carbohydrate metabolism and serum uric acid levels were found in patients receiving long-term thiazide therapy . Hypertensive disease in the Negro population of Baltimore is a serious , life-threatening condition . Our study provides evidence of the need for continuous close supervision , and the provision of organized teams devoted to the care , of such a population",
"OBJECTIVES The purpose of this study was to investigate the effects of angiotensin II receptor blockers on the prevention of cardiovascular events in patients with coronary artery disease ( CAD ) . BACKGROUND Angiotensin II may contribute to the pathogenesis of CAD . Long-term clinical trials have shown that blockade of the renin-angiotensin system can reduce cardiovascular events in patients with acute myocardial infa rct ion complicated by heart failure . METHODS Patients with a history of coronary intervention and no significant coronary stenosis on follow-up angiography 6 months after intervention were r and omly assigned into a c and esartan group ( n = 203 ; baseline treatment plus c and esartan 4 mg/d ) or a control group ( n = 203 ; baseline treatment alone ) . The primary end point was a composite of revascularization , nonfatal myocardial infa rct ion , or cardiovascular death . The secondary end point was hospitalization for cardiovascular causes . RESULTS There were no changes in blood pressure and in other coronary risk factors in either group during a mean follow-up of 24 months . Primary end point risk was significantly lower in the c and esartan group ( n = 12 ) than in control group patients ( n = 25 ) ( P = .03 ) . C and esartan treatment reduced primary end point risk ( 5.9 % vs 12.3 % for control subjects ; relative risk , 0.47 ; 95 % CI , 0.24 to 0.93 ) . The incidence of all events including secondary end points and noncardiovascular death was significantly lower in the c and esartan group than in control group patients ( 23 vs 40 cases ) ( P = .02 ) . CONCLUSIONS Relatively low-dose c and esartan , which did not alter blood pressure levels , reduces cardiovascular risk in high-risk patients with CAD",
"The main aim of the trial was to determine whether drug treatment of mild hypertension ( phase V diastolic pressure 90 - 109 mm Hg ) reduced the rates of stroke , of death due to hypertension , and of coronary events , in men and women aged 35 - 64 years . A total of 17,354 patients was recruited , and 85,572 patient-years of observation accrued . Patients were r and omly allocated at entry to take bendrofluazide or placebo , or propranolol or placebo . The stroke rate was reduced with treatment ( 60 strokes , vs 109 in the placebo groups ) , being 1.4 and 2.6 per 1,000 patient-years of observation , respectively ( p less than 0.01 ) , but overall rates of coronary events were not different ( 222 with treatment and 234 with placebos ) . The incidence of all cardiovascular events was reduced with treatment ( 286 events , vs 352 with placebos ; p less than 0.05 ) . For rates of mortality from all causes , treatment made no difference . Several post hoc analyses of subgroup results were performed . The all-cause mortality was reduced in men on treatment ( 157 deaths , vs 181 in placebo groups ) but increased in women on treatment ( 91 deaths , vs 72 with placebos ) ; this difference between the sexes was significant ( p = 0.05 ) . The reduction in stroke rate was greater with bendrofluazide than with propranolol ( p = 0.002 ) . The rate of strokes was reduced in both smokers and non-smokers taking bendrofluazide , but only in non-smokers taking propranolol ; this difference between the drugs was significant ( p = 0.03 ) . The coronary-event rate was not reduced by bendrofluazide , whatever the smoking habit , nor in smokers taking propranolol , but it was reduced in non-smokers taking propranolol . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Abstract Objective : To compare the effectiveness and tolerability of hydrochlorothiazide , atenolol , nitrendipine , and enalapril in patients with mild to moderate hypertension . Design : R and omised multicentre trial over 48 weeks with double blind comparison of treatments . Setting : 48 centres in four countries . Patients : 868 patients with essential hypertension ( diastolic blood pressure 95 - 120 mm Hg ) Interventions : Initial treatment ( step 1 ) consisted of 12.5 mg hydrochlorothiazide ( n=215 ) , 25 mg atenolol ( n=215 ) , 10 mg nitrendipine ( n=218 ) , or 5 mg enalapril ( n=220 ) once daily . If diastolic blood pressure was not reduced to : Blood pressure by means of an automatic device with repeated measurements . Results : After eight weeks the response rate for atenolol ( 63.7 % ) was significantly higher than for enalapril ( 50.0 % ) , hydrochlorothiazide ( 44.7 % ) , or nitrendipine ( 44.5 % ) . After one year atenolol was still more effective ( 48.0 % ) than hydrochlorothiazide ( 35.4 % ) and nitrendipine ( 32.9 % ) , but not significantly better than enalapril ( 42.7 % ) . The treatment related dropout rate was higher ( P nitrendipine group ( n=28 ) . Conclusions : There is no evidence of superiority for antihypertensive effectiveness or tolerability of the “ new ” classes of antihypertensives ( calcium channel blockers and angiotensin converting enzyme inhibitors ) . As these drugs are now widely used as treatment of first choice , our results further emphasise the need for studies confirming that they also reduce morbidity and mortality , as has been shown for diuretics and ß blockers . Key messages Calcium channel blockers and angiotensin converting enzyme inhibitors as initial monotherapy in the treatment of hypertension Reduction in mortality has been shown only with established ß blockers and diuretics Comparison of treatment with hydrochlorothiazide , atenolol , nitrendipine , and enalapril showed no superiority of the new drug classes Atenolol was the most effective drug , while nitrendipine showed the highest drop out rat Elderly patients respond better to hydrochlorothiazide and nitrendipine , and women better to enalapril , although in both subgroups the highest rate of response was with",
"BACKGROUND One third of patients treated for hypertension attain adequate blood pressure ( BP ) control , and multidrug regimens are often required . Given the lifelong nature of hypertension , there is a need to evaluate the long-term efficacy and tolerability of higher doses of combination anti-hypertensive therapies . OBJECTIVE This study investigated the efficacy and tolerability of valsartan ( VAL ) or hydrochlorothiazide (HCTZ)-monotherapy and higher-dose combinations in patients with essential hypertension . METHODS The first part of this study was an 8-week , multicenter , r and omized , double-blind , placebo controlled , parallel-group trial . Patients with essential hypertension ( mean sitting diastolic BP [ MSDBP ] , > or = 95 mm Hg and were r and omized to 1 of 8 treatment groups : VAL 160 or 320 mg ; HCTZ 12.5 or 25 mg ; VAL/HCTZ 160/12.5 , 320/12.5 , or 320/25 mg ; or placebo . Mean changes in MSDBP and mean sitting systolic BP ( MSSBP ) were analyzed at the 8-week core study end point . VAL/HCTZ 320/12.5 and 320/25 mg were further investigated in a 54-week , open-label extension . Response was defined as MSDBP or = 10 mm Hg decrease compared to baseline . Control was defined as MSDBP Tolerability was assessed by monitoring adverse events at r and omization and all subsequent study visits and regular evaluation of hematology and blood chemistry . RESULTS A total of 1346 patients were r and omized into the 8-week core study ( 734 men , 612 women ; 924 white , 291 black , 23 Asian , 108 other ; mean age , 52.7 years ; mean weight , 92.6 kg ) . All active treatments were associated with significantly reduced MSSBP and MSDBP during the core 8-week study , with each monotherapy significantly contributing to the overall effect of combination therapy ( VAL and HCTZ , P reductions in MSSBP and MSDBP compared with the monotherapies and placebo ( all , P mean reduction in MSSBP/MSDBP with VAL/HCTZ 320/25 mg was 24.7/16.6 mm Hg , compared with 5.9/7.0 mm Hg with placebo . The reduction in MSSBP was significantly greater with VAL/HCTZ 320/25 mg compared with VAL/HCTZ 160/12.5 mg ( P Rates of response and BP control were significantly higher in the groups that received combination treatment compared with those that received monotherapy . The incidence of hypokalemia was lower with VAL/HCTZ combinations ( 1.8%-6.1 % ) than with HCTZ monotherapies ( 7.1%-13.3 % ) . The majority of adverse events in the core study were of mild to moderate severity . The efficacy and tolerability of VAL/HCTZ combinations were maintained during the extension ( 797 patients ) . CONCLUSIONS In this study population , combination therapies with VAL/HCTZ were associated with significantly greater BP reductions compared with either monotherapy , were well tolerated , and were associated with less hypokalemia than HCTZ alone",
"Summary 1 . A total of 450 hypertensive patients above the age of 60 years have entered the double-blind multicentre trial of the European Working Party on High blood pressure in Elderly ( EWPHE ) . After stratification and r and omization half were treated with one capsule daily containing 25 mg of hydrochlorothiazide and 50 mg of triamterene and half were given placebo . In those receiving active treatment , if blood pressure control was not adequate they were given a second capsule and if necessary up to 2 g of methyldopalday . 2 . No significant differences between the groups were present before r and omization . A significant blood pressure difference of 25/10 mmHg was obtained between the groups and maintained during 4 years of follow-up . No major disturbances in serum potassium or serum sodium were noted with the present drug combination . 3 . During the initial phase an increase in serum creatinine and serum uric acid was noted in the actively treated group , which was maintained during the later years . This increase in serum creatinine in the actively treated group was related ( P = 0.003 and r = -0.247 ) to the decrease in sitting systolic blood pressure . Changes in serum uric acid were ( r = 0.3 and P = 0 - 003 ) correlated with the changes in serum creatinine both in the placebo and in the actively treated group , but Correspondence : Professor Dr A. Amery , Hypertension and Cardiovascular Rehabilitation Unit , Academic Hospital , St Raphael , Kapucijnenvoer 35 , B-3000 Leuven , Belgium . independent of the change in creatinine ; the serum uric acid was on average 1 mg higher in the actively treated than in the placebo group . 4 . Fasting blood glucose did not change significantly in the placebo-treated group but in the active treatment group the rise was statistically signficant . 5 . A favourable influence on prognosis by active treatment can be expected on the basis of the blood pressure reduction and in the absence of major electrolytes disturbances . However , the balance between this decreased risk and the increased risk produced by the rise in blood glucose and the other treatment effects remains to be determined . Therefore the trial continues and more patients are being admitted",
"In the Hypertension Detection and Follow-up Program , 7825 ( 71.5 per cent ) of the 10,940 participants had diastolic blood pressures averaging between 90 and 104 mm Hg on entry into the study and were design ated Stratum 1 . Half were referred to their usual source of care in the community ( the referred-care group ) , and half were treated intensively in special clinics ( the stepped-care group ) . Five-year mortality in the Stratum 1 patients given stepped care was 20.3 per cent lower than in those given referred care ( P less than 0.01 ) . Particularly noteworthy was the beneficial effect of stepped-care treatment on persons with diastolic pressures of 90 to 104 mm Hg who had no evidence of end-organ damage and were not receiving antihypertensive medication when they entered the study . This subgroup had 28.6 per cent fewer deaths at five years among those treated with stepped care than among those treated with referred care ( P less than 0.01 ) . These findings support a recommendation that in patients with mild hypertension , treatment should be considered early , before damage to end organs occurs",
"Background and Purpose : & bgr;‐Blockers prevent vascular events in patients after myocardial infa rct ion and lower blood pressure , the main risk factor for stroke . Hence , we assessed the effects of atenolol on the occurrence of death from vascular causes , stroke , or myocardial infa rct ion and on blood pressure in patients after a transient ischemic attack or nondisabling ischemic stroke . Methods : In a double‐blind , placebo‐controlled r and omized clinical trial we studied the occurrence of the outcome event death from vascular causes , nonfatal stroke , or nonfatal myocardial infa rct ion and the outcome event fatal or nonfatal stroke as well as blood pressure on follow‐up . A total of 1,473 aspirin‐treated patients with transient ischemic attack or nondisabling ischemic stroke were r and omized to 50 mg atenolol daily or placebo . The mean follow‐up was 2.6 years . Results : Patients on atenolol had a risk of 97/732 ( 13.3 % ) for the combined outcome event versus a risk of 95/741 ( 12.8 % ) for those on placebo ( adjusted hazard ratio , 1.00 ; 95 % confidence interval , 0.76‐1.33 ) . The adjusted hazard ratio for fatal or nonfatal stroke was 0.82 ( 95 % confidence interval , 0.57‐1.19 ) . More patients on & bgr;‐blocker ( 153 ) reported adverse effects than on placebo ( 103 ) . At the first follow‐up visit after r and omization ( median at 4 months ) systolic blood pressure in the atenolol group had dropped by 8.0 mm Hg compared with 2.2 mm Hg in the placebo group ( difference , 5.8 mm Hg ; 95 % confidence interval , 2.9‐8.6 mm Hg ) . For diastolic blood pressure this difference was 2.9 mm Hg ( 95 % confidence interval , 1.5‐4.4 mm Hg ) . Conclusions : Our data neither confirm nor rule out that atenolol prevents important vascular events in patients after transient ischemic attack or nondisabling ischemic stroke , given the modest effect on blood pressure , the restrictions in patient selection , and the limited number of patient‐years . ( Stroke 1993;24:543‐548",
"OBJECTIVE To determine the relationship between increasing depressive symptoms and cardiovascular events or mortality . DESIGN Cohort analytic study of data from r and omized placebo-controlled double-blind clinical trial of antihypertensive therapy . Depressive symptoms were assessed semi-annually with the Center for Epidemiological Studies -Depression ( CES-D ) scale during an average follow-up of 4.5 years . SETTING Ambulatory patients in 16 clinical centers of the Systolic Hypertension in the Elderly Program . PATIENTS Generally healthy men and women aged 60 years or older r and omized to active antihypertensive drug therapy or placebo who were 70 % white and 53 % women and had follow-up CES-D scores and no outcome events during the first 6 months ( N=4367 ) . MAIN OUTCOME MEASURES All-cause mortality , fatal or nonfatal stroke , or myocardial infa rct ion . RESULTS Baseline depressive symptoms were not related to subsequent events ; however , an increase in depression was prognostic . Cox proportional hazards regression analyses with the CES-D scale as a time-dependent variable , controlling for multiple covariates , indicated a 25 % increased risk of death per 5-unit increase in the CES-D score ( relative risk [ RR ] , 1.25;95 % confidence interval [ CI ] , 1.15 to 1.36 ) . The RR for stroke or myocardial infa rct ion was 1.18(95%CI,1.08 to 1.30 ) . Increase in CES-D score was an independent predictor in both placebo and active drug groups , and it was strongest as a risk factor for stroke among women ( RR,1.29;95%CI,1.07 to 1.34 ) . CONCLUSIONS Among elderly persons , a significant and substantial excess risk of death and stroke or myocardial infa rct ion was associated with an increase in depressive symptoms over time , which may be a marker for subsequent major disease events and warrants the attention of physicians to such mood changes . However , further studies of casual pathways are needed before wide-spread screening for depression in clinical practice is to be recommended",
"The Systolic Hypertension in the Elderly ( SHEP ) pilot trial was a five-center study in which 551 persons aged 60 years or older with isolated systolic hypertension were given antihypertensive drugs or placebos in order to determine the effects on blood pressure control and possible side effects of therapy . A life events inventory was administered to the cohort one year into the study . Results of this inventory were then compared to blood pressure and changes in blood pressure in the placebo and active therapy groups . One or more of the life events assessed were present in about 65 % of the population . Although the sample was too small to detect very subtle effects , there was no evidence in this study that either individual or groups of life events play a major role in blood pressure regulation of persons with isolated systolic hypertension",
"Background This long-term , multicenter , r and omized , double-blind , placebo-controlled , 2 × 2 factorial , angiographic trial evaluated the effects of cholesterol lowering and angiotensin-converting enzyme inhibition on coronary atherosclerosis in normocholesterolemic patients . Methods and Results There were a total of 460 patients : 230 received simvastatin and 230 , a simvastatin placebo , and 229 received enalapril and 231 , an enalapril placebo ( some subjects received both drugs and some received a double placebo ) . Mean baseline measurements were as follows : cholesterol level , 5.20 mmol/L ; triglyceride level , 1.82 mmol/L ; HDL , 0.99 mmol/L ; and LDL , 3.36 mmol/L. Average follow-up was 47.8 months . Changes in quantitative coronary angiographic measures between simvastatin and placebo , respectively , were as follows : mean diameters , −0.07 versus −0.14 mm ( P = 0.004 ) ; minimum diameters , −0.09 versus −0.16 mm ( P = 0.0001 ) ; and percent diameter stenosis , 1.67 % versus 3.83 % ( P = 0.0003 ) . These benefits were not observed in patients on enalapril when compared with placebo . No additional benefits were seen in the group receiving both drugs . Simvastatin patients had less need for percutaneous transluminal coronary angioplasty ( 8 versus 21 events;P = 0.020 ) , and fewer enalapril patients experienced the combined end point of death/myocardial infa rct ion/stroke ( 16 versus 30;P = 0.043 ) than their respective placebo patients . Conclusions This trial extends the observation of the beneficial angiographic effects of lipid-lowering therapy to normocholesterolemic patients . The implication s of the neutral angiographic effects of angiotensin-converting enzyme inhibition are uncertain , but they deserve further investigation in light of the positive clinical benefits suggested here and seen elsewhere",
"The present study of primary prevention in white men aged 40 to 64 years attempts to investigate whether a beta-blocker given as initial antihypertensive treatment would lower total mortality to a greater extent than thiazide diuretics . Patients were r and omized to metoprolol ( n = 1609 , 8110 patient-years ) or a thiazide diuretic ( n = 1625 , 8070 patient-years ) . The median follow-up time was 4.2 years . The mean dose of metoprolol was 174 mg/d , and of thiazide diuretics , 46 mg/d of hydrochlorothiazide or 4.4 mg/d of bendroflumethiazide . Identical control of blood pressure was achieved using a fixed therapeutic schedule . Total mortality was significantly lower for metoprolol than for thiazide diuretics because of fewer deaths from coronary heart disease and stroke . Total mortality was also significantly lower in smokers r and omized to metoprolol . The benefit demonstrated in patients treated with metoprolol seems to have important implication s for clinical practice",
"The Hypertension Optimal Treatment ( HOT ) Study is an ongoing prospect i ve , r and omized , multicenter trial conducted in 26 countries . Its two main aims are to evaluate the relationship between three levels of target diastolic blood pressure ( incidence of cardiovascular morbidity and mortality in hypertensive patients and the effects on morbidity and mortality of a low dose , 75 mg daily , of acetylsalicylic acid ( ASA , aspirin ) compared with placebo . Altogether 19,193 patients have been recruited and r and omized and one-year data are now available for all patients . This is a report on the blood pressures achieved , the tolerability and other available data after 12 months of follow-up of all patients . Special reference will be given to the subgroup of elderly patients ( > or = 65 years , n = 6,113 ) as compared to younger patients ( On average , the target group diastolic blood pressure has reached 86 mmHg , the target group target blood pressures is 84 % in the target group elderly subgroup ( > or = 65 years of age ) the percentage of patients at target is higher for all target groups , being 86 , 76 and 61 % , respectively , at 12 months . Antihypertensive treatment is initiated with a calcium antagonist , felodipine , at a dose of 5 mg once daily . If target blood pressure is not reached , additional antihypertensive therapy , with either an angiotensin converting enzyme ( ACE ) inhibitor or a beta-adrenoceptor blocking agent , is given . Further dose adjustments are made in accordance with a set protocol . As a fifth and final step a diuretic may be added . Side effects have been relatively few in this large multinational series of intensively treated hypertensive patients . Only ankle edema , 2.6 % and 3.0 % , and coughing , 1.3 % and 0.8 % , in young and elderly patients , respectively , exceed a frequency of 1 % , and 88 % of all patients are still taking their baseline therapy felodipine after one year . The one-year data presented here indicate that it should be possible to fulfill the primary aims of the HOT Study",
"Objective To assess longitudinally the association of serum uric acid and its change due to diuretic treatment with cardiovascular events in hypertensive patients . Design Cohort study in a r and omized trial . Setting Cohort of hypertensive patients . Participants A total of 4327 men and women , aged ≥ 60 years , with isolated systolic hypertension , r and omized to placebo or chlorthalidone , with the addition of atenolol or reserpine if needed , were observed for 5 years . Main outcome measures Major cardiovascular events , coronary events , stroke and all-cause mortality . Results Cardiovascular event rates for quartiles of baseline serum uric acid were : I , 32.7 per 1000 person-years ; II , 34.5 per 1000 person-years ; III , 38.1 per 1000 person-years ; and IV , 41.4 per 1000 person-years ( P for trend = 0.02 ) . The adjusted hazard ratio ( HR ) , of cardiovascular events for the highest quartile of serum uric acid versus the lowest quartile was 1.32 ( 95 % CI , 1.03–1.69 ) . The benefit of active treatment was not affected by baseline serum uric acid . After r and omization , an increase of serum uric acid with a HR of 0.58 ( 0.37–0.92 ) for coronary events compared with those with a serum uric acid increase ≥ 0.06 mmol/l . This difference was not explained by blood pressure effects . Those with a serum uric acid increase ≥ 0.06 mmol/l in the active treatment group had a similar risk of coronary events as the placebo group . Conclusions Serum uric acid independently predicts cardiovascular events in older persons with isolated systolic hypertension . Monitoring serum uric acid change during diuretic treatment may help to identify patients who will most benefit from treatment",
"Despite the clear-cut result of the Australian Therapeutic Trial in Mild Hypertension , which demonstrated prospect ively the benefit of treatment of diastolic blood pressure in the range of 95 to 109 mm Hg , a retrospective analysis that classified subjects by the average diastolic pressure level attained during the trial purported to show an absence of treatment benefit at lower average diastolic pressures and a negative treatment effect at higher levels . However , the method of classification by average attained diastolic pressure introduced substantial selection bias , invalidating the retrospective analysis and rendering as spurious both the deleterious treatment effect and its lack of efficacy at lower diastolic levels",
"Serum glucose levels , triglyceride levels , and body weight are reported from a controlled drug trial in men , aged 40 to 49 , with uncomplicated mild hypertension . The drug treatment started with hydrochlorothiazide alone , and methyldopa was added when necessary . If side effects occurred , methyldopa was replaced by propranolol . No detailed advice about diet , smoking , or weight reduction was given to any group . The untreated control subjects had a small increase in serum glucose levels during five years , from 6.08 to 6.21 mmol/liter . Those treated with hydrochlorothiazide alone and those treated with hydrochlorothiazide plus methyldopa had a small increase in serum glucose levels of the same order as that in the control subjects . However , those receiving the thiazide/propranolol combination experienced a sizeable increase in glucose levels , from 5.96 to 6.53 mmol/liter ( p less than 0.001 ) . This increase was significantly greater than the increase in the other groups ( p less than 0.001 ) . The thiazide/propranolol group also showed a significant increase in serum triglyceride levels ( p less than 0.05 ) . There was no difference in serum potassium levels in the different drug groups . The results indicate that moderate thiazide doses do not have significant effects on serum glucose levels in this age group . Propranolol in combination with thiazide seems to increase the level of serum glucose",
"A feasibility trial to investigate the practicality of determining the advantages and disadvantages of prompt pharmacologic treatment for mild hypertension was jointly funded by the Veterans Administration and the National Heart , Lung and Blood Institute . Its clinical phase has been completed , and it demonstrated 1 . that the required relatively young asymptomatic population could be enrolled in the study and 2 . that it could be persuaded to adhere to the protocol for 2 years ; however , it was evident that intensive efforts would be required in both areas . The feasibility trial screened almost 120,000 potential subjects over a period of 16 months to r and omize about 1,000 subjects at four clinical centers . These men and women were 21 to 50 years old , had diastolic pressures from 85 to 105 mm Hg as out patients , and had no evidence of cardiovascular renal abnormalities . They were r and omized in double-blind fashion into active drug therapy and placebo groups . Stepped care therapy involved 50 mg chlorthalidone ( Step 1 ) , 100 mg chlorthalidone ( Step 2 ) and 100 chlorthalidone plus 0.25 mg reserpine ( Step 3 ) . Death , myocardial infa rct ion , stroke , angina pectoris , and congestive heart failure were the \" major \" morbid events that were looked for ; also recorded were \" minor \" morbid events consisting primarily of electrocardiographic arrhythmias . The development of significant hypertension was considered a treatment failure . Side effects were carefully tabulated in both active drug and placebo groups . The study revealed an average drop in diastolic pressure of almost 12 mm Hg for active drug group and less than half of that for the placebo group ; once established 6 months after r and omization , the new pressure levels persisted almost without change throughout the study . Although the feasibility trial was not design ed to answer the primary question regarding the benefits of treatment , the events were tabulated for each group . A total of 12 placebo-treated subjects developed significant hypertension and were put on active drug . There was not a significant difference between the two groups in the incidence of \" major \" morbid events ; a total of eight active and five placebo patients developed myocardial infa rct ion or died suddenly . There , however , was an excess of arrhythmias among the active drug subjects ( 17 in the active group versus 8 in the placebo group on the basis of preliminary data ) . Finally , there were twice as many side effects and 20 times as many chemical abnormalities among the active as among the placebo subjects . A protocol for a full scale study of the benefits of pharmacologic therapy in mild hypertensives has been prepared and is ready for implementation as needed ; it involves relatively minor modifications of the protocol tested in the feasibility trial",
"OBJECTIVE To compare the rate of progression of mean maximum intimal-medial thickness ( IMT ) in carotid arteries , using quantitative B-mode ultrasound imaging , during antihypertensive therapy with isradipine vs hydrochlorothiazide . DESIGN R and omized , double-blind , positive-controlled trial . SETTING Nine medical center clinics . POPULATION A total of 883 patients with baseline mean + /- SD systolic and diastolic blood pressure ( SBP and DBP , respectively ) of 149.7 + /- 16.6 and 96.5 + /- 5.1 mm Hg , age of 58.5 + /- 8.5 years , and maximum IMT of 1.17 + /- 0.20 mm . INTERVENTIONS Twice daily doses of isradipine ( 2.5 - 5.0 mg ) or hydrochlorothiazide ( 12.5 - 25 mg ) . MAIN OUTCOME MEASURE ( PRIMARY END POINT ) : Rate of progression of mean maximum IMT in 12 carotid focal points over 3 years . RESULTS There was no difference in the rate of progression of mean maximum IMT between isradipine and hydrochlorothiazide over 3 years ( P=.68 ) . There was a higher incidence of major vascular events ( eg , myocardial infa rct ion , stroke , congestive heart failure , angina , and sudden death ) in isradipine ( n=25 ; 5.65 % ) vs hydrochlorothiazide ( n=14 ; 3.17 % ) ( P=.07 ) , and a significant increase in nonmajor vascular events and procedures ( eg , transient ischemic attack , dysrhythmia , aortic valve replacement , and femoral popliteal bypass graft ) in isradipine ( n=40 ; 9.05 % ) vs hydrochlorothiazide ( n=23 ; 5.22 % ) ( P=.02 ) . At 6 months , mean DBP decreased by 13.0 mm Hg in both groups , and mean SBP decreased by 19.5 mm Hg in hydrochlorothiazide and 16.0 mm Hg in isradipine ( P=.002 ) ; the difference in SBP between the 2 groups persisted throughout the study but did not explain the increased incidence of vascular events in patients treated with isradipine . CONCLUSION The rate of progression of mean maximum IMT in carotid arteries , the surrogate end point in this study , did not differ between the 2 treatment groups . The increased incidence of vascular events in patients receiving isradipine compared with hydrochlorothiazide is of concern and should be studied further",
"OBJECTIVES To ascertain the baseline characteristics of the high-risk hypertensive patients entering the International Nifedipine GITS Study : Intervention as a Goal in Hypertension Treatment ( INSIGHT ) . To determine the success of single and combination therapy in achieving target blood pressures in such a population . DESIGN INSIGHT is a double-blind , prospect i ve outcome trial comparing the efficacy of the calcium channel blocker , nifedipine GITS , and the thiazide , co-amilozide , in preventing myocardial infa rct ion and stroke . We recruited 2996 men and 3454 women , aged 55 - 80 years , with blood pressure during placebo run-in > 150/95 mmHg or isolated systolic blood pressure > 160 mmHg from nine countries . Treatment allocation to nifedipine GITS 30 mg daily or co-amilozide ( hydrochlorothiazide 25 mg/amiloride 5 mg ) once daily was performed by minimization rather than r and omization to balance additional risk factors . This was followed by four optional increases in treatment : dose-doubling of the primary drug , addition of atenolol 25/50 mg or enalapril 5/10 mg , and then any other hypotensive drug excluding calcium blockers or diuretics . Target blood pressure was 140/90 mmHg or a fall > or = 20/10 mmHg . RESULTS Blood pressure at r and omization was 172+/-15 / 99+/-9 mmHg . Thirteen per cent of the patients were previously untreated . The proportions of each additional risk factors were : smoking > 10/day , 29 % ; cholesterol > 6.43 mmol/l , 52 % ; family history of premature myocardial infa rct ion or stroke , 21 % ; diabetes mellitus 20 % ; left ventricular hypertrophy , 10 % ; previous myocardial infa rct ion , other presentations of coronary heart disease , and peripheral vascular disease , each 6 % ; proteinuria , 3 % . Fifty-five per cent of patients had one additional risk factor , whereas 33 % , 9 % and 3 % had two , three or more additional risk factors , respectively . The blood pressure ( and falls in blood pressure ) at the end of titration and at 1 year after minimization was 139+/-12 / 82+/-7 mmHg ( 33+/-15 / 17+/-9 ) in the 5226 patients still on r and omized treatment The numbers requiring the four treatment increments were , respectively , 1591 , 780 , 597 and 294 , meaning that almost 70 % of patients on r and omized treatment in INSIGHT are receiving only the primary drug . At one year , 69 % of patients had a blood pressure blood pressure control in most patients without the addition of multiple additional treatments that may dilute any differences between the primary agents",
"In an ancillary study of the Systolic Hypertension in the Elderly Program ( SHEP ) , the effects of diuretics on ventricular ectopic activity were investigated in 186 patients with isolated systolic hypertension . Ventricular premature complexes ( VPCs ) were examined as the number of VPCs/24 hours , presence of > or = 1 VPC , presence of > or = 10 VPCs/24 hours , and presence of VPC pairs or ventricular tachycardia . Significant changes in VPCs were not observed either in the 92 patients r and omized to chlorthalidone stepped-care ( 12.5 and 25 mg/day ) or in the 94 placebo-treated patients ( p > 0.1 for all VPC definitions and both groups ) . Serum potassium decreased from 4.4 + /- 0.5 to 4.1 + /- 0.5 mEq/liter ( p = 0.002 ) in the chlorthalidone group and did not change ( 4.4 + /- 0.5 to 4.5 + /- 0.4 mEq/liter ) in the placebo group . Potassium was prescribed routinely for confirmed hypokalemia serum potassium and VPC or change in serum potassium and change in VPC was not observed in the chlorthalidone group . In summary , in patients with isolated systolic hypertension , chlorthalidone in doses that are effective in decreasing stroke and cardiovascular event rates ( 12.5 or 25 mg/day ) , did not increase VPCs",
"Men aged 40 - 64 years with mild to moderate hypertension [ diastolic blood pressure ( DBP ) 100 - 130 mmHg ] were r and omized to treatment with a diuretic ( n = 3272 ) or a beta-blocker ( n = 3297 ) , with additional drugs if necessary , to determine whether a beta-blocker based treatment differs from thiazide diuretic based treatment with regard to the prevention of coronary heart disease ( CHD ) events and death . Patients with previous CHD , stroke or other serious diseases , or with contraindications to diuretics or beta-blockers were excluded . If normotension ( DBP less than 95 mmHg ) was not achieved by monotherapy , other antihypertensive drugs were added , but the two basic drugs were not crossed over . Patients were assessed at 6-monthly intervals . The mean follow-up for end-points was 45.1 months . Blood pressure ( BP ) side effects and end-points were recorded in a st and ardized manner . Entry characteristics and the BP reduction achieved were very similar in both treatment groups . All analyses were made on an intention-to-treat basis . The incidence of CHD did not differ between the two treatment groups . The incidence of fatal stroke tended to be lower in the beta-blocker treated group than in the diuretic treated group . Total mortality and the total number of end-points were similar in both groups . The percentage of patients withdrawn due to side effects was similar , whereas the number of reported symptoms , according to a question naire , was higher for patients on beta-blockers . The incidence of diabetes did not differ between the two groups . Subgroup analyses did not detect a difference in the effect of beta-blockers compared with diuretics in smokers as opposed to non-smokers , and beta-blockers also had the same effects as diuretics in the quartile with the highest predicted risk for CHD . Beta-blockers and thiazide diuretics were approximately equally well tolerated . The two drugs had a similar BP reducing effect although additional drugs had to be given more often in the diuretic group . Antihypertensive treatment based on a beta-blocker or on a thiazide diuretic could not be shown to affect the prevention of hypertensive complications , including CHD , to a different extent",
"Obesity and hypertension are often found in the same patients , particularly in elderly women . However , few data on the joint impact of these two conditions in women and the elderly are available . In the current study of 800 elderly hypertensive patients r and omly assigned to active treatment or placebo , the initial mean body mass index ( BMI ) was 26.7 kg/m2 in 560 women and 25.7 kg/m2 in 240 men . During the trial , total mortality and cardiovascular and noncardiovascular terminating events were highest in the patients at the leanest BMI quintile . The association between BMI and cardiovascular end points was U-shaped , whereas noncardiovascular mortality decreased with increasing BMI . The results in the women were similar to those in the total group . The U-shaped relation was confirmed with Cox 's proportional hazards model , controlling for age , gender , systolic blood pressure , hemoglobin , serum cholesterol , blood glucose , and cardiovascular complications at entry . The BMI level with the lowest risk was 28 to 29 kg/m2 for total mortality and cardiovascular terminating events , 26 to 27 kg/m2 for cardiovascular mortality , and 31 to 32 kg/m2 for noncardiovascular mortality . BMI did not modify the favorable effects of drug treatment . There was no evidence that obesity would protect elderly hypertensive men or women from cardiovascular complications",
"The Systolic Hypertension in the Elderly Program ( SHEP ) is a r and omized , blinded test of the efficacy of antihypertensive drug treatment . In a large feasibility trial , 551 men and women who had isolated systolic hypertension and were at least 60 years old received chlorthalidone ( 25 to 50 mg/day ) or matching placebo as the step I drug . After 1 year , 83 % of the chlorthalidone group and 80 % of the placebo group were still taking SHEP medications . Of those still taking chlorthalidone , 88 % had reached goal blood pressure ( BP ) without requiring a step II drug , and most had responded to the lower dose ( 25 mg/day ) . The BP response was similar in all age , sex and race subgroups , with an overall mean difference between r and omized groups of 17 mm Hg for systolic BP ( p less than 0.001 ) and 6 mm Hg for diastolic BP ( p less than 0.001 ) . The only common adverse effects were asymptomatic changes in the serum levels of potassium ( 0.5 mEq/liter lower in the chlorthalidone group , p less than 0.001 ) , uric acid ( 0.9 mg/dl higher , p less than 0.001 ) and creatinine ( 0.08 mg/dl higher , p = 0.02 ) . This study indicates that chlorthalidone is effective for lowering BP in elderly patients with systolic hypertension and sets the stage for a larger trial of the effects of such treatment on the incidence of cardiovascular disease",
"BACKGROUND Diabetic nephropathy is the leading cause of end-stage renal disease . Interruption of the renin-angiotensin system slows the progression of renal disease in patients with type 1 diabetes , but similar data are not available for patients with type 2 , the most common form of diabetes . We assessed the role of the angiotensin-II-receptor antagonist losartan in patients with type 2 diabetes and nephropathy . METHODS A total of 1513 patients were enrolled in this r and omized , double-blind study comparing losartan ( 50 to 100 mg once daily ) with placebo , both taken in addition to conventional antihypertensive treatment ( calcium-channel antagonists , diuretics , alpha-blockers , beta-blockers , and central ly acting agents ) , for a mean of 3.4 years . The primary outcome was the composite of a doubling of the base-line serum creatinine concentration , end-stage renal disease , or death . Secondary end points included a composite of morbidity and mortality from cardiovascular causes , proteinuria , and the rate of progression of renal disease . RESULTS A total of 327 patients in the losartan group reached the primary end point , as compared with 359 in the placebo group ( risk reduction , 16 percent ; P=0.02 ) . Losartan reduced the incidence of a doubling of the serum creatinine concentration ( risk reduction , 25 percent ; P=0.006 ) and end-stage renal disease ( risk reduction , 28 percent ; P=0.002 ) but had no effect on the rate of death . The benefit exceeded that attributable to changes in blood pressure . The composite of morbidity and mortality from cardiovascular causes was similar in the two groups , although the rate of first hospitalization for heart failure was significantly lower with losartan ( risk reduction , 32 percent ; P=0.005 ) . The level of proteinuria declined by 35 percent with losartan ( P patients with type 2 diabetes and nephropathy , and it was generally well tolerated",
"A study protocol for a double-blind r and omised control trial of hypotensive treatment in elderly hypertensive patients has been tested in a number of pilot centres throughout Europe . It was shown that this study is possible from the logistic point of view . In these elderly patients , hydrochlorothiazide + triamterene treatment with or without methyldopa , maintained a significant hypotensive effect in the absence of major electrolyte disturbances . The initiation of hypotensive therapy did not provoke an excess of cardiovascular complications . The influence of hypotensive therapy on the general well-being and on the morbidity and the mortality of elderly patients with high blood pressure , is thereby being assessed . The study will continue for 5 years and other centres are invited to join",
"BACKGROUND Angiotensin-converting enzyme ( ACE ) inhibitors reduce major cardiovascular events , but are not tolerated by about 20 % of patients . We therefore assessed whether the angiotensin-receptor blocker telmisartan would be effective in patients intolerant to ACE inhibitors with cardiovascular disease or diabetes with end-organ damage . METHODS After a 3-week run-in period , 5926 patients , many of whom were receiving concomitant proven therapies , were r and omised to receive telmisartan 80 mg/day ( n=2954 ) or placebo ( n=2972 ) by use of a central automated r and omisation system . R and omisation was stratified by hospital . The primary outcome was the composite of cardiovascular death , myocardial infa rct ion , stroke , or hospitalisation for heart failure . Analyses were done by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00153101 . FINDINGS The median duration of follow-up was 56 ( IQR 51 - 64 ) months . All r and omised patients were included in the efficacy analyses . Mean blood pressure was lower in the telmisartan group than in the placebo group throughout the study ( weighted mean difference between groups 4.0/2.2 [ SD 19.6/12.0 ] mm Hg ) . 465 ( 15.7 % ) patients experienced the primary outcome in the telmisartan group compared with 504 ( 17.0 % ) in the placebo group ( hazard ratio 0.92 , 95 % CI 0.81 - 1.05 , p=0.216 ) . One of the secondary outcomes -a composite of cardiovascular death , myocardial infa rct ion , or stroke-occurred in 384 ( 13.0 % ) patients on telmisartan compared with 440 ( 14.8 % ) on placebo ( 0.87 , 0.76 - 1.00 , p=0.048 unadjusted ; p=0.068 after adjustment for multiplicity of comparisons and overlap with primary outcome ) . 894 ( 30.3 % ) patients receiving telmisartan were hospitalised for a cardiovascular reason , compared with 980 ( 33.0 % ) on placebo ( relative risk 0.92 , 95 % CI 0.85 - 0.99 ; p=0.025 ) . Fewer patients permanently discontinued study medication in the telmisartan group than in the placebo group ( 639 [ 21.6 % ] vs 705 [ 23.8 % ] ; p=0.055 ) ; the most common reason for permanent discontinuation was hypotensive symptoms ( 29 [ 0.98 % ] in the telmisartan group vs 16 [ 0.54 % ] in the placebo group ) . INTERPRETATION Telmisartan was well tolerated in patients unable to tolerate ACE inhibitors . Although the drug had no significant effect on the primary outcome of this study , which included hospitalisations for heart failure , it modestly reduced the risk of the composite outcome of cardiovascular death , myocardial infa rct ion , or stroke . FUNDING Boehringer Ingelheim"
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411707b2-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To quantify the association between atrial fibrillation and cardiovascular disease , renal disease , and death . DESIGN Systematic review and meta- analysis . DATA SOURCES Medline and Embase . ELIGIBILITY CRITERIA Cohort studies examining the association between atrial fibrillation and cardiovascular disease , renal disease , and death . Two review ers independently extracted study characteristics and the relative risk of outcomes associated with atrial fibrillation : specifically , all cause mortality , cardiovascular mortality , major cardiovascular events , any stroke , ischaemic stroke , haemorrhagic stroke , ischaemic heart disease , sudden cardiac death , congestive heart failure , chronic kidney disease , and peripheral arterial disease . Estimates were pooled with inverse variance weighted r and om effects meta- analysis . RESULTS 104 eligible cohort studies involving 9 686 513 participants ( 587 867 with atrial fibrillation ) were identified . Atrial fibrillation was associated with an increased risk of all cause mortality ( relative risk 1.46 , 95 % confidence interval 1.39 to 1.54 ) , cardiovascular mortality ( 2.03 , 1.79 to 2.30 ) , major cardiovascular events ( 1.96 , 1.53 to 2.51 ) , stroke ( 2.42 , 2.17 to 2.71 ) , ischaemic stroke ( 2.33 , 1.84 to 2.94 ) , ischaemic heart disease ( 1.61 , 1.38 to 1.87 ) , sudden cardiac death ( 1.88 , 1.36 to 2.60 ) , heart failure ( 4.99 , 3.04 to 8.22 ) , chronic kidney disease ( 1.64 , 1.41 to 1.91 ) , and peripheral arterial disease ( 1.31 , 1.19 to 1.45 ) but not haemorrhagic stroke ( 2.00 , 0.67 to 5.96 ) . Among the outcomes examined , the highest absolute risk increase was for heart failure . Associations between atrial fibrillation and included outcomes were broadly consistent across subgroups and in sensitivity analyses . CONCLUSIONS Atrial fibrillation is associated with an increased risk of death and an increased risk of cardiovascular and renal disease . Interventions aim ed at reducing outcomes beyond stroke are warranted in patients with atrial fibrillation
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"Aims Multiple trials have shown that implantable cardioverter defibrillators ( ICDs ) prolong survival in secondary and primary prevention population s. However , in spite of the efficacy of these devices in terminating life-threatening arrhythmias , total mortality remains high . Methods and results We evaluated 1703 patients ( mean age : 67 ± 12 years , 82 % male ) with conventional ICD indications , who were enrolled and followed between 2001 and 2004 at 128 US centres . Patients were followed for up to a year , and vital status was obtained for 1655 patients ( 97 % , median follow-up : 377 days ) . There were 183 deaths within 1 year of ICD implantation ( 1-year mortality rate : 16 % ) . Predictors of mortality included a history of atrial fibrillation ( AF , P diabetes ( P = 0.0001 ) , failure to use cholesterol-lowering medications ( P of digitalis and derivatives ( P of diuretics ( P low body mass index ( BMI , P low left ventricular ejection fraction ( P low activity hours ( P elevated resting heart rate ( P = 0.014 ) , low mean arterial pressure ( MAP , P = 0.007 ) , and poor functional status ( New York Heart Association class , P , poor functional status , low MAP , diabetes , low BMI , and AF were strongly associated with death within a year",
"Objective To develop and vali date a risk algorithm ( QStroke ) to estimate risk of stroke or transient ischaemic attack in patients without prior stroke or transient ischaemic attack at baseline ; to compare ( a ) QStroke with CHADS2 and CHA2DS2VASc scores in patients with atrial fibrillation and ( b ) the performance of QStroke with the Framingham stroke score in the full population free of stroke or transient ischaemic attack . Design Prospect i ve open cohort study using routinely collected data from general practice during the study period 1 January 1998 to 1 August 2012 . Setting 451 general practice s in Engl and and Wales contributing to the national Q Research data base to develop the algorithm and 225 different Q Research practice s to vali date the algorithm . Participants 3.5 million patients aged 25 - 84 years with 24.8 million person years in the derivation cohort who experienced 77 578 stroke events . For the validation cohort , we identified 1.9 million patients aged 25 - 84 years with 12.7 million person years who experienced 38 404 stroke events . We excluded patients with a prior diagnosis of stroke or transient ischaemic attack and those prescribed oral anticoagulants at study entry . Main outcome measures Incident diagnosis of stroke or transient ischaemic attack recorded in general practice records or linked death certificates during follow-up . Risk factors Self assigned ethnicity , age , sex , smoking status , systolic blood pressure , ratio of total serum cholesterol to high density lipoprotein cholesterol concentrations , body mass index , family history of coronary heart disease in first degree relative under 60 years , Townsend deprivation score , treated hypertension , type 1 diabetes , type 2 diabetes , renal disease , rheumatoid arthritis , coronary heart disease , congestive cardiac failure , valvular heart disease , and atrial fibrillation Results The QStroke algorithm explained 57 % of the variation in women and 55 % in men without a prior stroke . The D statistic for QStroke was 2.4 in women and 2.3 in men . QStroke had improved performance on all measures of discrimination and calibration compared with the Framingham score in patients without a prior stroke . Among patients with atrial fibrillation , levels of discrimination were lower , but QStroke had some improved performance on all measures of discrimination compared with CHADS2 and CHA2DS2VASc . Conclusion QStroke provides a valid measure of absolute stroke risk in the general population of patients free of stroke or transient ischaemic attack as shown by its performance in a separate validation cohort . QStroke also shows some improvement on current risk scoring methods , CHADS2 and CHA2DS2VASc , for the subset of patients with atrial fibrillation for whom anticoagulation may be required . Further research is needed to evaluate the cost effectiveness of using these algorithms in primary care",
"Atrial fibrillation ( AF ) has been established as an independent predictor of long-term mortality after acute myocardial infa rct ion . However , this is less well defined across the whole spectrum of acute coronary syndromes ( ACSs ) . The Acute Coronary Syndrome Prospect i ve Audit is a prospect i ve multicenter registry with 12-month outcome data for 3,393 patients ( 755 with ST-segment elevation myocardial infa rct ion , 1942 with high-risk non-ST-segment elevation ACS [ NSTE-ACS ] , and 696 with intermediate-risk NSTE-ACS ) . A total of 149 patients ( 4.4 % ) had new-onset AF and 387 ( 11.4 % ) had previous AF . New-onset AF was more , and previous AF was less frequent in those with ST-segment elevation myocardial infa rct ion than in those with high-risk NSTE-ACS or intermediate-risk NSTE-ACS ( p high-risk features at presentation ( p AF more often had left main coronary artery disease , result ing in a greater rate of surgical revascularization ( p new-onset AF result ed in adverse in-hospital outcomes ( p greater long-term mortality ( hazard ratio 1.42 , p New-onset AF was only associated with a worse long-term composite outcome ( hazard ratio 1.66 , p = 0.004 ) . However , the odds ratio for the composite outcome was greatest for patients with new-onset AF with intermediate-risk NSTE-ACS ( odds ratio 3.9 , p = 0.02 ) than for those with high-risk NSTE-ACS ( odds ratio 2.0 , p = 0.01 ) or ST-segment elevation myocardial infa rct ion ( odds ratio 1.4 , p = 0.4 ) . In conclusion , new-onset AF was associated with worse short-term outcomes and previous AF was associated with greater mortality even at long-term follow-up . The prognostic burden of new-onset AF differed with the type of ACS presentation",
"BACKGROUND Atrial fibrillation ( AF ) is a common arrhythmia in patients with heart failure ( HF ) , but its prognostic importance is controversial . The effect of AF on long-term outcomes , including mortality and rehospitalization , among unselected HF patients hospitalized with HF in routine clinical practice in Japan was assessed in the present study . METHODS AND RESULTS The Japanese Cardiac Registry of Heart Failure in Cardiology ( JCARE-CARD ) prospect ively studied the characteristics and treatment strategies of a broad sample of patients hospitalized with worsening HF and the outcomes were followed with an average of 2.4 years of follow-up . The study cohort ( n=2,659 ) was grouped according to the presence ( n=937 ; 35.2 % ) or absence ( n=1,722 ; 64.8 % ) of AF at baseline . After multivariable adjustment , patients with and without AF had a comparable risk for all-cause death ( adjusted hazard ratio ( HR ) 0.931 , 95 % confidence interval ( CI ) 0.690 - 1.258 , P=0.643 ) , cardiac death ( adjusted HR 0.949 , 95%CI 0.655 - 1.377 , P=0.784 ) , rehospitalization because of the worsening HF ( adjusted HR 1.028 , 95%CI 0.816 - 1.295 , P=0.816 ) , and all-cause death or rehospitalization ( adjusted HR 1.039 , 95%CI 0.842 - 1.281 , P=0.722 ) . CONCLUSIONS Among patients hospitalized for HF in Japan , AF was common , but was not an independent risk for long-term adverse outcomes , including death or rehospitalization , in routine clinical practice",
"BACKGROUND Atrial fibrillation is the most common supraventricular arrhythmia in patients with acute myocardial infa rct ion . Recent advances in pharmacological treatment of myocardial infa rct ion may have changed the impact of this arrhythmia . OBJECTIVE To assess the incidence and prognosis of atrial fibrillation complicating myocardial infa rct ion in a large population of patients receiving optimal treatment , including angiotensin converting enzyme ( ACE ) inhibitors . METHODS Data were derived from the GISSI-3 trial , which included 17 944 patients within the first 24 hours after acute myocardial infa rct ion . Atrial fibrillation was recorded during the hospital stay , and follow up visits were planned at six weeks and six months . Survival of the patients at four years was assessed through census offices . RESULTS The incidence of in-hospital atrial fibrillation or flutter was 7.8 % . Atrial fibrillation was associated with indicators of a worse prognosis ( age > 70 years , female sex , higher Killip class , previous myocardial infa rct ion , treated hypertension , high systolic blood pressure at entry , insulin dependent diabetes , signs or symptoms of heart failure ) and with some adverse clinical events ( reinfa rct ion , sustained ventricular tachycardia , ventricular fibrillation ) . After adjustment for other prognostic factors , atrial fibrillation remained an independent predictor of increased in-hospital mortality : 12.6%v 5 % , adjusted relative risk ( RR ) 1.98 , 95 % confidence interval ( CI ) 1.67 to 2.34 . Data on long term mortality ( four years after acute myocardial infa rct ion ) confirmed the persistent negative influence of atrial fibrillation ( RR 1.78 , 95 % CI 1.60 to 1.99 ) . CONCLUSIONS Atrial fibrillation is an indicator of worse prognosis after acute myocardial infa rct ion , both in the short term and in the long term , even in an unselected population",
"OBJECTIVES Preoperative atrial fibrillation ( PAF ) has been associated with poorer early and mid-term outcomes after isolated valvular or coronary artery bypass graft surgery . Few studies , however , have evaluated the impact of PAF on early and mid-term outcomes after concomitant aortic valve replacement and coronary aortic bypass graft ( AVR-CABG ) surgery . METHODS Data obtained prospect ively between June 2001 and December 2009 by the Australian and New Zeal and Society of Cardiac and Thoracic Surgeons National Cardiac Surgery Data base Program was retrospectively analysed . Patients who underwent concomitant atrial arrhythmia surgery/ablation were excluded . Demographic and operative data were compared between patients undergoing concomitant AVR-CABG who presented with PAF and those who did not using chi-square and t-tests . The independent impact of PAF on 12 short-term complications and mid-term mortality was determined using binary logistic and Cox regression , respectively . RESULTS Concomitant AVR-CABG surgery was performed in 2563 patients ; 322 ( 12.6 % ) presented with PAF . PAF patients were generally older ( mean age 76 vs 74 years ; P congestive heart failure , chronic pulmonary disease and cerebrovascular disease ( all P 30-day mortality on univariate analysis ( P = 0.019 ) but not multivariate analysis ( P = 0.53 ) . The incidence of early complications was not significantly higher in the PAF group . PAF was independently associated with reduced mid-term survival ( HR , 1.58 ; 95 % CI , 1.14 - 2.19 ; P = 0.006 ) . CONCLUSIONS PAF is associated with reduced mid-term survival after concomitant AVR-CABG surgery . Patients with PAF undergoing AVR-CABG should be considered for a concomitant surgical ablation procedure",
"Failure to expeditiously diagnose atrial fibrillation ( AF ) as the cause of ischemic stroke has unclear consequences . We studied the association between detection of AF after discharge and the risk of recurrent stroke . We followed a prospect ively assembled cohort of patients hospitalized for stroke for 1 year for new diagnoses of AF and recurrent stroke . We compared rates of recurrent stroke in patients with a new diagnosis of AF and those without a new diagnosis of AF after discharge using Kaplan-Meier survival statistics . We conducted Cox proportional hazards analysis of the diagnosis and timing of AF and recurrent stroke after adjustment for age , sex , race , preexisting AF , hypertension , dyslipidemia , diabetes , previous stroke , and use of antithrombotic and statin medications . Among 5575 patients with stroke , 113 ( 2.0 % ) received a new diagnosis of AF after discharge , and 221 ( 4.0 % ) had recurrent stroke . At 1 year , the Kaplan‒Meier rate of recurrent stroke was 18.9 % in those with a new diagnosis of AF and 4.5 % in others , including those with AF diagnosed before or during the index hospitalization ( P = .001 ) . The association between a new diagnosis of AF and stroke recurrence persisted after adjustment for potential confounders ( hazard ratio , 5.6 ; 95 % confidence interval , 3.4 - 9.1 ) . A new diagnosis of AF after discharge for stroke is associated with an increased risk of recurrent stroke , even compared with patients with known AF . These findings identify a subset of patients at high risk for recurrent stroke and highlight the importance of timely detection of AF in patients with stroke",
"Background — Atrial fibrillation is associated with increased mortality , but the specific causes of death and their predictors have not been described among patients on effective anticoagulant therapy . Methods and Results — The R and omized Evaluation of Long-Term Anticoagulant Therapy ( RE-LY ) trial r and omized 18 113 patients ( age , 71.5±9 years ; male , 64 % ; CHADS2 score , 2.1±1 ) to receive dabigatran or warfarin . Median follow-up was 2 years , and complete follow-up was achieved in 99.9 % of patients . All deaths were categorized by the investigators using prespecified definitions followed by central adjudication . Overall , 1371 deaths occurred ( annual mortality rate , 3.84 % ; 95 % confidence interval [ CI ] , 3.64–4.05 ) . Cardiac deaths ( sudden cardiac death and progressive heart failure ) accounted for 37.4 % of all deaths , whereas stroke- and hemorrhage-related deaths represented 9.8 % of the total mortality . An examination of the causes of death according to dabigatran or warfarin showed that dabigatran significantly reduced vascular ( embolism and hemorrhage-related ) mortality ( relative risk , 0.63 ; 95 % CI , 0.45–0.88 ; P=0.007 ) , whereas other causes of death were similar between treatments , including cardiac mortality ( relative risk , 0.96 ; 95 % CI , 0.80–1.15 ; P=0.638 ) . The two strongest independent predictors of cardiac death in this population were heart failure ( hazard ratio , 3.02 ; 95 % CI , 2.45–3.73 ; P and prior myocardial infa rct ion ( hazard ratio , 2.05 ; 95 % CI , 1.61–2.62 ; P of deaths are not related to stroke in a contemporary anticoagulated atrial fibrillation population . These results emphasize the need to identify interventions beyond effective anticoagulation to further reduce mortality in atrial fibrillation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00262600",
"Background : Atrial fibrillation ( AF ) is strongly associated with age , and epidemiologic studies are needed to evaluate the impact of both aging of the population and the use of anticoagulant therapy in patients with AF on the incidence of cardioembolic stroke with AF ( CE/AF stroke ) . Methods : We evaluated trends in incidence rates , risk factors , prestroke therapy , and survival in CE/AF stroke from a prospect i ve population -based registry , from 1985 to 2006 . Results : A total of 3,064 ischemic strokes , including 572 ( 18.7 % ) CE/AF strokes , were recorded . Over the 22 years , a decrease in the incidence of overall CE/AF stroke was noted ( incidence rate ratio 0.9858 , 95 % confidence interval [ CI ] 0.9731–0.9986 ; p = 0.03 ) . We observed a higher prevalence of previous AF , previous myocardial infa rct ion , and patients aged > 70 years in CE/AF stroke ( p hypercholesterolemia was more prevalent in other ischemic strokes ( p = 0.003 ) . A significant increase in the use of anticoagulants and antiplatelet agents was noted , and was particularly pronounced for CE/AF stroke with previous AF . For CE/AF stroke , survival rates were 72 % at 1 month ( 95 % CI 0.68–0.76 ) , 52 % at 1 year ( 95 % CI 0.48–0.56 ) , and 43 % at 2 years ( 95 % CI 0.39–0.48 ) , and remained lower than those of other ischemic stroke . Conclusions : The decrease in the incidence of cardioembolic/atrial fibrillation stroke in our study was probably due to a slight increase in the utilization of antithrombotic therapy in patients with atrial fibrillation , but the use of such therapies will have to increase further because of the expected aging of the population in coming years . AF = atrial fibrillation ; CE = cardioembolic ; CI = confidence interval ; IRR = incidence rate ratios",
"AIMS Atrial fibrillation ( AF ) is a common complication in patients with acute myocardial infa rct ion and is associated with an increase in the risk of death . The excess mortality associated with AF complicating acute myocardial infa rct ion has not been studied in detail . Observations indicate that AF facilitates induction of ventricular arrhythmias , which may increase the risk of sudden cardiovascular death ( SCD ) . A close examination of the mode of death could potentially provide useful knowledge to guide further investigations and treatments . METHODS AND RESULTS We analysed the relation between AF/atrial flutter ( AFL ) and modes of death in 5983 consecutive patients discharged alive after an acute myocardial infa rct ion screened in the TR And olapril Cardiac Evaluation registry . This cohort of patients with an enzyme-verified acute myocardial infa rct ion was admitted to 27 centres in 1990 - 92 . Survival status was obtained 2 years after screening of the last patient . An independent endpoint committee assessed the modes of death . Left ventricular ejection fraction was determined in all the screened patients and information about presence or absence of AF/AFL was prospect ively collected . Sustained or paroxysmal AF/AFL was observed in 1149 patients ( 19 % ) during hospitalization . During follow-up , 1659 patients ( 34 % ) died : 482 ( 50 % ) patients with AF/AFL and 1177 ( 30 % ) patients without AF/AFL , P SCD occurred in 536 , non-SCD occurred in 725 , and 398 died of non-cardiovascular causes ( includes 142 unclassifiable cases ) . The adjusted risk ratio of AF/AFL for total mortality was 1.33 ( 95 % CI : 1.19 - 1.49 ; P SCD was 1.31 ( 95 % CI : 1.07 - 1.60 ; P adjusted risk ratio of AF/AFL for non-SCD was 1.43 ( 95 % CI : 1.21 - 1.70 ; P mortality observed in patients with AF/AFL following acute myocardial infa rct ion is due to a significant increase in both SCD and non-SCD",
"Background —Atrial fibrillation ( AF ) is an important risk factor for stroke and is common among elderly patients undergoing transcatheter aortic valve implantation . The aim of this study was to assess the impact of AF on clinical outcomes among patients undergoing transcatheter aortic valve implantation . Methods and Results —Between August 2007 and October 2011 , a total of 389 high-risk patients undergoing transcatheter aortic valve implantation were included into a prospect i ve registry . AF was recorded in 131 patients ( 33.7 % ) with a mean CHA2DS2–VASC score of 4.5±1.2 and was paroxysmal in 26 ( 25.0 % ) , persistent in 8 ( 7.7 % ) , and permanent in 70 patients ( 67.3 % ) . Patients with and without AF had similar baseline characteristics except for fewer revascularization procedures ( coronary artery bypass grafting : 12 % versus 22 % ; P=0.03 ) among AF patients . At 1 year , all-cause mortality was higher among patients with AF ( 30.9 % ) compared with those without AF ( 13.9 % ; hazard ratio [ HR ] , 2.36 ; 95 % confidence interval [ CI ] , 1.43–3.90 ; P=0.0008 ) . This was observed irrespective of the type of AF ( permanent , HR , 2.47 ; 95 % CI , 1.40–4.38 ; persistent , HR , 3.60 ; 95 % CI , 1.10–11.78 ; paroxysmal , HR , 2.88 ; 95 % CI , 1.37–6.05 ) . Mortality gradually increased with higher CHA2DS2–VASC scores ( score 1–3 : HR , 2.20 ; 95 % CI , 0.92–5.27 ; score 6–8 : HR , 4.12 ; 95 % CI , 2.07–8.20 ) . The risks of stroke ( 3.9 % versus 5.1 % ; HR , 0.76 ; 95 % CI , 0.23–1.96 ; P=0.47 ) and life-threatening bleeding ( 19.8 % versus 14.7 % ; HR , 1.37 ; 95 % CI , 0.86–2.19 ; P=0.19 ) were similar among patients with and without AF . Conclusions —AF is common among high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation and is associated with a > 2-fold increased risk of all-cause and cardiovascular mortality , irrespective of the type of AF . The gradient of risk directly correlates with the CHA2DS2–VASC score",
"BACKGROUND Stroke is a devastating complication in patients with prosthetic valves , but characterization of its late occurrence from a large cohort is lacking . METHODS Three thous and one hundred eighty-nine adult patients who underwent a total of 3,576 operations for left-heart valve replacement were managed with contemporary anticoagulation guidelines and prospect ively followed in a dedicated clinic . Total follow-up was 20,096 patient years . Bootstrapped survival analysis was used to determine the impact of patient and valve related factors on the incidence of stroke . RESULTS Most strokes were embolic . Linearized embolic stroke rates were 1.3 % + /- 0.2 % per year for aortic bioprostheses , 1.4 % + /- 0.2 % per year for aortic mechanical valves , 1.3 % + /- 0.3 % per year for mitral bioprostheses , and 2.3 % + /- 0.4 % per year for mitral mechanical valves ( p = 0.002 , vs other implant types ) . Age more than 75 years , female gender , and smoking were independent risk factors after aortic and mitral valve replacement . Atrial fibrillation , coronary disease , and tilting-disc mechanical prostheses were independent predictors of embolic stroke after aortic valve replacement . Preoperative left ventricular ( LV ) dysfunction was an independent risk factor in patients with mitral prostheses . Primary operative indication , diabetes , redo status , or the presence of two prosthetic valves were not associated with an increased hazard . The addition of acetyl salicylic or dipyridamole to warfarin anticoagulation did not significantly lower embolic stroke risk in patients with mechanical prostheses . CONCLUSIONS Approximately 20 % of patients with valve prostheses have an embolic stroke by 15 years after valve replacement . Some risk factors such as the avoidance of smoking , mitral mechanical prostheses , aortic tilting-disc valves , and proceeding to mitral surgery before LV dysfunction occurs are potentially modifiable",
"In a prospect i ve study of 2,384 persons , mean age 81 years , at 44-month follow-up , new thromboembolic stroke developed in 510 of 2,384 persons ( 21 % ) . The Cox regression model showed that significant independent risk factors for new thromboembolic stroke were atrial fibrillation ( risk ratio 3.2 ) , left ventricular hypertrophy ( risk ratio 2.8 ) , prior stroke ( risk ratio 2.2 ) , and male gender ( risk ratio 1.2 )",
"Background —Prevalent atrial fibrillation ( AF ) is associated with a higher sudden cardiac death ( SCD ) rate in some population s , and incident AF predicts increased mortality risk in the general population and after myocardial infa rct ion . However , the relationship of SCD to new-onset AF is unclear . Methods and Results —The relationship of SCD to new-onset AF was evaluated in 8831 hypertensive patients with electrocardiographic left ventricular hypertrophy with no history of AF , in sinus rhythm on their baseline electrocardiogram , r and omly assigned to losartan- or atenolol-based treatment . During 4.7±1.1 years mean follow-up , new-onset AF occurred in 701 patients ( 7.9 % ) and SCD in 151 patients ( 1.7 % ) . In univariate Cox analyses , new-onset AF was associated with a > 4-fold higher risk of SCD ( hazard ratio , 4.69 ; 95 % CI interval , 2.96–7.45 ; P myocardial infa rct ion , in-treatment use of digoxin , systolic and diastolic pressure , heart rate , QRS duration , Cornell voltage- duration product , and Sokolow-Lyon voltage left ventricular hypertrophy treated as time-varying covariates , new-onset AF remained associated with a > 3-fold increased risk of SCD ( hazard ratio , 3.13 ; 95 % confidence interval , 1.87–5.24 ; P hypertensive patients at increased risk of SCD . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00338260",
"Background and Purpose — This article examines stroke recurrence and whether the subtype of the initial stroke influences the risk and subtypes of further strokes . The proportion of recurrences attributable to conventional risk factors is quantified . Methods — From January 1995 to August 2000 , all first-in-a-lifetime strokes ( n=1626 ) were identified and prospect ively followed up in a defined multiethnic inner city population of 234 533 . Twelve overlapping referral sources and face-to-face follow-up at 3 months and 1 and 3 years were used to attain complete registration of stroke recurrence . Index and recurrent stroke were classified according to the Oxford Community Stroke Project classification . Results — In 2744 person-years of follow-up , 153 recurrences were observed . At 5 years , the cumulative risk of first stroke recurrence was 16.6 % ( 95 % CI , 13.5 to 20.4 ) , and the combined risk of death or stroke recurrence was 65.3 % ( 95 % CI , 61.9 to 68.6 ) . Ethnicity and subtype of index stroke were not associated with stroke recurrence . A change in subtype between index and recurrent stroke occurred in 45.5 % ( 95 % CI , 35.8 to 55.2 ) of cases and was most frequent among index lacunar strokes and primary intracerebral hemorrhages . In multivariable analyses , diabetes mellitus and atrial fibrillation were associated with both stroke recurrence and recurrence-free survival . In the stroke population , 9.1 % ( 95 % CI , −2.0 to 20.2 ) of recurrences were attributable to diabetes and 4.9 % ( 95 % CI , −7.3 to 17.2 ) to atrial fibrillation during the first year after the index stroke . Conclusions — The cause of stroke recurrence is multifactorial , and the subtypes of index and recurrent strokes are often not identical . Most recurrences remain unexplained by conventional risk factors",
"Objective To develop , vali date , and evaluate a new QRISK model to estimate lifetime risk of cardiovascular disease . Design Prospect i ve cohort study with routinely collected data from general practice . Cox proportional hazards models in the derivation cohort to derive risk equations accounting for competing risks . Measures of calibration and discrimination in the validation cohort . Setting 563 general practice s in Engl and and Wales contributing to the Q Research data base . Subjects Patients aged 30–84 years who were free of cardiovascular disease and not taking statins between 1 January 1994 and 30 April 2010 : 2 343 759 in the derivation data set , and 1 267 159 in the validation data set . Main outcomes measures Individualised estimate of lifetime risk of cardiovascular disease accounting for smoking status , ethnic group , systolic blood pressure , ratio of total cholesterol : high density lipoprotein cholesterol , body mass index , family history of coronary heart disease in first degree relative aged . Age-sex centile values for lifetime cardiovascular risk compared with 10 year risk estimated using QRISK2 ( 2010 ) . Results Across all the 1 267 159 patients in the validation data set , the 50th , 75th , 90th , and 95th centile values for lifetime risk were 31 % , 39 % , 50 % , and 57 % respectively . Of the 10 % of patients in the validation cohort classified at highest risk with either the lifetime risk model or the 10 year risk model , only 18 385(14.5 % ) were at high risk on both measures . Patients identified as high risk with the lifetime risk approach were more likely to be younger , male , from ethnic minority groups , and have a positive family history of premature coronary heart disease than those identified with the 10 year QRISK2 score . The lifetime risk calculator is available at www.qrisk.org/lifetime/. Conclusions Compared with using a 10 year QRISK2 score , a lifetime risk score will tend to identify patients for intervention at a younger age . Although lifestyle interventions at an earlier age could be advantageous , there would be small gains under the age of 65 , and medical interventions carry risks as soon as they are initiated . Research is needed to examine closely the cost effectiveness and acceptability of such an approach",
"AIMS To characterize the relationship between known and newly diagnosed atrial fibrillation ( AF ) and the risk of death and major cardiovascular ( CV ) events in patients with acute myocardial infa rct ion ( MI ) complicated by heart failure ( HF ) and /or left ventricular systolic dysfunction ( LVSD ) . METHODS The VALIANT trial enrolled 14,703 individuals with acute MI complicated by HF and /or LVSD . AF was assessed at presentation and at r and omization ( median 4.9 days after symptom onset ) . Primary outcomes were risk of death and major CV events 3 years following acute MI . RESULTS A total of 1812 with current AF ( AF between presentation and r and omization ) , 339 patients with prior AF ( history of AF without current AF ) , and 12,509 without AF were enrolled . Patients with AF were older ; had more prior HF , angina , and MI , and received beta-blockers and thrombolytics less often than those without AF . Three-year mortality estimates were 20 % in those without AF , 37 % with current AF , and 38 % with prior AF . Compared with patients without AF , the multivariable adjusted HR of death was 1.25 ( 1.03 - 1.52 ; p=0.03 ) for prior AF and 1.32 ( 1.20 - 1.45 ; p HR for major CV events was 1.15 ( 0.98 - 1.35 ; p=0.08 ) and 1.21 ( 1.12 - 1.31 ; p long-term mortality and adverse CV events with acute MI complicated by HF or LVSD",
"Background Only a few population -based cohort studies have investigated the impact of atrial fibrillation ( AF ) on stroke in Japan . Methods A total of 10 929 participants ( 4147 men and 6782 women ) were included in this population -based prospect i ve cohort study . Baseline data , including electrocardiograms ( ECGs ) to ascertain AF status , were obtained from April 1992 through July 1995 in 12 areas in Japan . Cox proportional hazards models were used to analyze the association of AF with stroke . Results A total of 54 participants had AF ( 0.49 % ) . The mean follow-up period was 10.7 years , during which 405 strokes were identified ; 12 of these occurred in participants with AF . The crude incidence of stroke in participants with and without AF was 14.9 and 4.5 per 1000 person-years in men , respectively , and 39.3 and 2.7 per 1000 person-years in women . After adjusting for geographical area , sex , age , smoking status , drinking status , obesity , hypertension , dyslipidemia , and diabetes mellitus , the hazard ratios ( 95 % confidence interval ) of AF in all participants and in male and female participants were 4.11 ( 2.28–7.41 ) , 2.12 ( 0.77–5.84 ) , and 10.6 ( 5.01–22.4 ) , respectively . The population attributable fraction ( PAF ) of stroke caused by AF was 2.2 % ; the PAFs were 1.0 % and 3.6 % in men and women , respectively . Conclusions The present Japanese population -based prospect i ve cohort study showed that AF is a major risk factor for stroke , especially in women",
"IMPORTANCE Myocardial infa rct ion ( MI ) is an established risk factor for atrial fibrillation ( AF ) . However , the extent to which AF is a risk factor for MI has not been investigated . OBJECTIVE To examine the risk of incident MI associated with AF . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve cohort of 23,928 participants residing in the continental United States and without coronary heart disease at baseline were enrolled from the Reasons for Geographic and Racial Differences in Stroke ( REGARDS ) cohort between 2003 and 2007 , with follow-up through December 2009 . MAIN OUTCOMES AND MEASURES Expert-adjudicated total MI events ( fatal and nonfatal ) . RESULTS Over 6.9 years of follow-up ( median 4.5 years ) , 648 incident MI events occurred . In a sociodemographic-adjusted model , AF was associated with about 2-fold increased risk of MI ( hazard ratio [ HR ] , 1.96 [ 95 % CI , 1.52 - 2.52 ] ) . This association remained significant ( HR , 1.70 [ 95 % CI , 1.26 - 2.30 ] ) after further adjustment for total cholesterol , high-density lipoprotein cholesterol , smoking status , systolic blood pressure , blood pressure-lowering drugs , body mass index , diabetes , warfarin use , aspirin use , statin use , history of stroke and vascular disease , estimated glomerular filtration rate , albumin to creatinine ratio , and C-reactive protein level . In subgroup analysis , the risk of MI associated with AF was significantly higher in women ( HR , 2.16 [ 95 % CI , 1.41 - 3.31 ] ) than in men ( HR , 1.39 [ 95 % CI , 0.91 - 2.10 ] ) and in blacks ( HR , 2.53 [ 95 % CI , 1.67 - 3.86 ] ) than in whites ( HR , 1.26 [ 95 % CI , 0.83 - 1.93 ] ) ; for interactions , P = .03 and P = .02 , respectively . On the other h and , there were no significant differences in the risk of MI associated with AF in older ( ≥75 years ) vs younger ( increased risk of incident MI , especially in women and blacks . These findings add to the growing concerns of the seriousness of AF as a public health burden : in addition to being a well-known risk factor for stroke , AF is also associated with increased risk of MI",
"BACKGROUND The extent to which atrial fibrillation ( AF ) contributes to mortality in the Japanese general population has not been clarified . METHODS AND RESULTS A r and omly sample d general population from all over Japan ( 4,154 men , 5,329 women ; age > or = 30 years ) was enrolled . Single electrocardiogram recordings were taken in the baseline survey . Stroke death , cardiovascular deaths and all-cause deaths during the subsequent 19 years were analyzed by the presence of AF at baseline . Cox 's regression analysis was carried out to estimate the hazard ratios ( HRs ) of each cause of death attributable to AF after adjusting for other risk factors . Prevalence of AF was 0.64 % in the study . The observed person-years were 162,980 among persons without AF and 699 among persons with AF . There were 1,919 deaths . Multivariate adjusted HRs for stroke death , cardiovascular death and all-cause death were 2.69 , 2.76 and 1.88 , respectively ( p stroke mortality , cardiovascular mortality and all-cause mortality in the Japanese general population . Careful attention should be paid to persons with AF in order to prevent future cardiovascular events",
"BACKGROUND Lipid-lowering drugs , particularly statins , have anti-inflammatory and antioxidant properties that may prevent atrial fibrillation ( AF ) . This effect has not been investigated on new-onset AF in asymptomatic patients with aortic stenosis ( AS ) . METHODS Asymptomatic patients with mild-to-moderate AS ( n = 1,421 ) were r and omized ( 1:1 ) to double-blind simvastatin 40 mg and ezetimibe 10 mg combination or placebo and followed up for a mean of 4.3 years . The primary end point was the time to new-onset AF adjudicated by 12-lead electrocardiogram at a core laboratory reading center . Secondary outcomes were the correlates of new-onset AF with nonfatal nonhemorrhagic stroke and a combined end point of AS-related events . RESULTS During the course of the study , new-onset AF was detected in 85 ( 6 % ) patients ( 14.2/1,000 person-years of follow-up ) . At baseline , patients who developed AF were , compared with those remaining in sinus rhythm , older and had a higher left ventricular mass index a smaller aortic valve area index . Treatment with simvastatin and ezetimibe was not associated with less new-onset AF ( odds ratio 0.89 [ 95 % CI 0.57 - 1.97 ] , P = .717 ) . In contrast , age ( hazard ratio [ HR ] 1.07 [ 95 % CI 1.05 - 1.10 ] , P new-onset AF . The occurrence of new-onset AF was independently associated with 2-fold higher risk of AS-related outcomes ( HR 1.65 [ 95 % CI 1.02 - 2.66 ] , P = .04 ) and 4-fold higher risk of nonfatal nonhemorrhagic stroke ( HR 4.04 [ 95 % CI 1.18 - 13.82 ] , P = .03 ) . CONCLUSIONS Simvastatin and ezetimibe were not associated with less new-onset AF . Older age and greater left ventricular mass index were independent predictors of AF development . New-onset AF was associated with a worsening of prognosis",
"BACKGROUND The impact of atrial fibrillation ( AF ) on mortality , stroke , and medical costs is unknown . METHODS We conducted a prospect i ve cohort study of hospitalized Medicare patients with AF and 1 other cardiovascular diagnosis ( CVD ) compared with a matched group without AF ( n = 26,753 ) , r and omly selected in 6 age-sex strata from 1989 MedPAR files of more than 1 million patients diagnosed as having AF . Stroke rates were also determined in another cohort free of CVD ( n = 14,267 ) . Total medical costs after hospitalization were available from a 1991 cohort . Cumulative mortality , stroke rates , and costs following index admission were adjusted by multivariate and proportional hazard regression analyses . RESULTS Mortality rates were high in individuals with CVD , ranging from 19.0 % to 52.1 % in 1 year . Adjusted relative mortality risk was approximately 20 % higher in patients with AF in all age-sex strata during each of the 3 years studied ( P Incidence of stroke was high in individuals with CVD , 6.2 % to 15.4 % in 1 year , with and without AF , and was at least 5-fold higher than in individuals without CVD . In those with CVD , stroke rates were approximately 25 % higher in women with AF ( P Adjusted total Medicare spending in 1 year was 8.6- to 22.6-fold greater in men , and 9.8- to 11.2-fold greater in women with AF ( P Second- and third-year costs were increased as well . CONCLUSION Prevention of AF and treatment of patients with AF and associated CVD may yield benefits in reduced mortality and stroke as well as reducing health care costs",
"BACKGROUND Patients with atrial fibrillation ( AF ) are at increased risk of thromboembolic events . The long-term prognostic implication s of AF in patients with atherothrombosis are unknown . METHODS We compared 4-year CV outcomes in patients with and without a history of AF recorded at their baseline visit in the REACH Registry , an international , prospect i ve cohort of patients with established atherosclerotic arterial disease ( CAD , CVD , PAD ) or at least 3 risk factors ( RFO ) . RESULTS AF status and 4 year follow-up data were available on 44,518 patients . The prevalence of AF at baseline was 10.3 % ( n=4582 ) . Overall , patients with AF had approximately a 2-fold increase in the composite of CV death , MI , or stroke compared with patients without AF after adjustment for age , gender , prior ischemic event , vascular disease , congestive heart failure , diabetes , smoking , body mass index , region , aspirin and statin use ( 18.9 % vs. 9.4 % , p risk was observed both in patients with established atherothrombosis ( CAD : 15.5 % vs. 8.0 % , p=0.0001 ; CVD : 23.6 % vs. 13.6 % , p Patients with a history of both AF and atherothrombosis have particularly high long-term CV risk . Despite this increased risk , almost half of all patients with AF do not receive guideline recommended anticoagulation , highlighting an important public health priority",
"OBJECTIVES The U.K. Transcatheter Aortic Valve Implantation Registry reported 30-day and 1-year mortality rates of 7.1 % and 21.4 % , respectively , for patients who underwent transcatheter aortic valve replacement ( TAVR ) in the United Kingdom between 2007 and 2009 . The study aim was to report long-term outcomes in this same cohort of patients . BACKGROUND There are few data on outcomes beyond 3 years after TAVR in any notable number of patients . METHODS Data from all TAVR procedures performed in the United Kingdom between January 2007 and December 2009 were prospect ively collected . All-cause mortality status was reported in March 2014 . Mortality tracking was achieved in 97.7 % patients . RESULTS The minimal time from replacement to census was 4.1 years , and the maximal time was 7.0 years . The 3- and 5-year survival rates were 61.2 % and 45.5 % , respectively . Independent predictors of 3-year mortality were renal dysfunction ( hazard ratio [ HR ] : 1.65 ) , atrial fibrillation ( HR : 1.36 ) , logistic European System for Cardiac Operative Risk Evaluation ( EuroSCORE ) ≥18.5 ( HR : 1.33 ) , respiratory dysfunction ( HR : 1.28 ) , and ventricular dysfunction ( left ventricular ejection fraction 30 days of TAVR was the only independent procedural predictor of mortality at 3 and 5 years ( HR : 2.17 at 3 years ) . Device type , access route , and paravalvular leak did not independently predict long-term outcome . CONCLUSIONS In the large U.K. Transcatheter Aortic Valve Implantation Registry , long-term outcomes after TAVR are favorable with 3- and 5-year survival rates of 61.2 % and 45.5 % , respectively . Long-term survival after TAVR is largely determined by intrinsic patient factors . Other than stroke , procedural variables , including paravalvular aortic leak , did not appear to be independent predictors of long-term survival",
"OBJECTIVE To correlate atrial fibrillation with the incidence of new thromboembolic ( TE ) stroke in older patients with and without prior TE stroke . DESIGN In a prospect i ve study of 2101 older patients , electrocardiograms showed that atrial fibrillation was present in 283 patients ( 13 % ) . At 42-month mean follow-up , atrial fibrillation was associated with the incidence of new TE stroke in patients with and without prior TE stroke . SETTING A large long-term health care facility where 2101 older patients were studied . PATIENTS The 2101 patients included 1451 women and 650 men , mean age 81 + /- 8 years ( range 60 to 103 ) . MEASUREMENTS AND MAIN RESULTS Atrial fibrillation was present in 283 of 2101 patients ( 13 % ) . The mean age was 84 + /- 7 years in patients with atrial fibrillation and 81 + /- 8 years in patients with sinus rhythm ( P = .0001 ) . The prevalence of atrial fibrillation was 5 % in patients aged 60 to 70 years , 14 % in patients aged 71 to 80 years , 13 % in patients aged 81 to 90 years , and 22 % in patients aged 91 to 103 years ( P Mean follow-up was 31 + /- 18 months in patients with atrial fibrillation and 44 + /- 27 months in patients with sinus rhythm ( P = .0001 ) . Previous TE stroke occurred in 123 of 283 patients ( 43 % ) with atrial fibrillation and in 431 of 1818 patients ( 24 % ) with sinus rhythm ( P New TE stroke occurred in 131 of 283 patients ( 46 % ) with atrial fibrillation and in 303 of 1818 patients ( 17 % ) with sinus rhythm ( P new TE stroke than those with sinus rhythm ( P new TE stroke were male sex ( relative risk = 1.3 ) , prior TE stroke ( relative risk = 3.1 ) , and atrial fibrillation ( relative risk = 3.3 ) . CONCLUSIONS Atrial fibrillation , prior TE stroke , and male sex are independent risk factors for the development of new TE stroke in older patients",
"BACKGROUND Atrial fibrillation ( AF ) and chronic kidney disease share risk factors and pathophysiologic mechanisms , suggesting that two conditions have close relationships . METHODS This is a prospect i ve community-based observational cohort study including 235,818 subjects based upon a voluntary annual health check-up program in Japan . We studied the association of kidney dysfunction at entry with subsequent new-onset AF and the association of AF at entry with the development of kidney disease . RESULTS During a follow-up of 5.9 + /- 2.4 years , AF developed in 2947 subjects ( 1.3 % ) . Baseline serum creatinine and estimated glomerular filtration rate ( GFR ) were associated with risk of subsequent AF . The HRs ( 95 % CI ) for AF were 1.32 ( 1.08 - 1.62 ) and 1.57 ( 0.89 - 2.77 ) for GFR 30 to 59 and effect of kidney disease on risk of new-onset AF remained significant in subjects without treated hypertension or diabetes . During the follow-up , 7791 subjects ( 3.3 % ) developed kidney dysfunction ( GFR proteinuria . Atrial fibrillation at entry was associated with development of kidney dysfunction ( HRs [ 95 % CI ] , 1.77 [ 1.50 - 2.10 ] ) and proteinuria ( HR [ 95 % CI ] , 2.20 [ 1.92 - 2.52 ] ) . The association persisted in subjects without treated hypertension or diabetes . CONCLUSIONS Kidney dysfunction increased the risk of new onset of AF , and AF increased the risk of development of kidney disease . This finding supports the concept that the two conditions share common abnormal molecular signaling pathways contributing to their pathogenesis",
"Risk stratification for heart failure ( HF ) in patients with atrial fibrillation ( AF ) has not been well established . The aim of this study was to identify the predictors of HF events in patients with AF , consequently developing a new risk-scoring system that stratifies the risk for HF events . In this prospect i ve , single hospital-based cohort , all patients who presented from July 2004 to March 2010 were registered ( Shinken Data base 2004 - 2009 ) . Follow-up was maintained by being linked to the medical records or by sending study documents of prognosis . Of the 13,228 patients in the Shinken Data base 2004 - 2009 , 1,942 patients with AF were identified . Of the patients with AF , HF events ( hospitalization or death from HF ) occurred in 147 patients ( 7.6 % ) during a mean follow-up period of 776 ± 623 days . After identifying the parameters that were independently associated with the incidence of HF events ( coexistence of organic heart diseases , anemia [ hemoglobin level renal dysfunction [ estimated glomerular filtration rate H(2)ARDD score ( heart diseases = 2 points , anemia = 1 point , renal dysfunction = 1 point , diabetes = 1 point , and diuretic use = 1 point ; range 0 to 6 points ) . This scoring system discriminated the low- and high-risk population s well ( incidence in patients scoring 0 and 6 points of 0.2 % and 40.8 % per patient-year , respectively ) and showed high predictive ability ( area under the curve 0.840 , 95 % confidence interval 0.803 to 0.876 ) . In conclusion , the new H(2)ARDD score may help identify the population of patients with AF at high risk for HF events",
"Prospect i ve data from Busselton , Western Australia , collected during triennial surveys from 1966 - 81 with follow-up of subjects to 1983 , showed that atrial fibrillation ( AF ) was frequent in elderly people and associated with increased mortality . Of 1770 people aged over 60 years , 40 were in atrial fibrillation when first seen and a further 47 developed it during follow-up . Atrial fibrillation was positively associated with angina , history of a myocardial infa rct ion and left bundle branch block . Relative mortality in those with atrial fibrillation compared with those without it , was 1.92 for all causes , 1.82 for death from cardiovascular causes ( excluding stroke ) and 3.78 for deaths from stroke , after adjustment by proportional hazards regression for confounding effects of age , sex , history of a myocardial infa rct ion , an abnormal electrocardiogram , angina , cholesterol level systolic blood pressure and Quetelet 's Index ( weight/height2 ) . The excess relative mortality declined with increasing age for both women and men . This raised relative mortality remained constant with time from the first detection of AF for all causes and cardiovascular causes but appeared to increase with time from detection for stroke death . The risk of death from stroke was greatest in the younger women . The observed risk of death from stroke in patients with AF suggests that anticoagulant use should be considered in selected patients",
"AIMS The European CRT Survey is a joint initiative of the Heart Failure Association ( HFA ) and the European Heart Rhythm Association ( EHRA ) of the European Society of Cardiology evaluating the contemporary implantation practice of cardiac resynchronization therapy ( CRT ) in Europe . METHODS AND RESULTS Patients who had a successful CRT implantation were enrolled from 141 centres in 13 countries between November 2008 and June 2009 . Baseline demographics , clinical and implantation data were collected , with a follow-up of ∼1 year ( 9 - 15 months ) . The current report describes clinical outcomes including symptom severity , cardiovascular ( CV ) hospitalization , and survival . A total of 2438 patients were enrolled , and follow-up data were acquired from 2111 patients ( 87 % ) . The population included important groups of patients poorly represented in r and omized controlled trials , including very elderly patients and those with prior device implantation , atrial fibrillation , and /or QRS duration Investigators reported substantial improvement in New York Heart Association ( NYHA ) functional class at follow-up . Patient self- assessment indicated that 81 % of the patients felt improved , 16 % reported no change , and 4 % reported deterioration . During follow-up , 207 ( 10 % ) patients died , 346 ( 16 % ) had a CV hospitalization , and 501 ( 24 % ) died or had CV hospitalization . Worse NYHA functional class , atrial fibrillation , ischaemic aetiology , and device type ( CRT-P , i.e. CRT alone ) were associated with poorer survival . Women had a better outcome , as did patients who had a CRT-D ( with an implantable cardioverter defibrillator function ) device . CONCLUSIONS Outcomes including death and hospitalization in this European CRT survey were consistent with results from clinical trials of CRT . At 1 year follow-up , most patients who received a CRT device considered their symptoms improved compared with their pre-implant assessment . Although prospect i ve , this is an observational study of successful CRT implantations , and outcomes in subgroup analyses must be interpreted with appropriate conservatism",
"OBJECTIVES We assessed the risk of adverse cardiovascular ( CV ) outcomes associated with atrial fibrillation ( AF ) in the C and esartan in Heart failure- Assessment of Reduction in Mortality and morbidity ( CHARM ) program , which enrolled patients with chronic heart failure ( CHF ) and a broad range of ejection fractions ( EFs ) . BACKGROUND Atrial fibrillation is associated with an increased risk of adverse CV outcomes in patients with CHF and reduced EF . The risk of AF in patients with CHF and preserved left ventricular ejection fraction ( PEF ) is unknown . METHODS A total of 7,599 patients with symptomatic CHF were r and omized to c and esartan or placebo . Patients were divided by baseline EF ( 40 % ) in low or preserved EF groups . Major outcomes were cardiovascular death or hospitalization for worsening heart failure , and all-cause mortality . Median follow-up was 37.7 months . RESULTS A total of 670 ( 17 % ) patients in the low EF group and 478 ( 19 % ) in the PEF group had AF at baseline . Atrial fibrillation predicted a high risk of cardiovascular morbidity and mortality regardless of baseline EF . Patients with AF and low EF had the highest absolute risk for adverse CV outcomes . However , AF was associated with greater relative increased risk of the major outcomes in patients with PEF than in patients with low EF : hazard ratio 1.72 ( 95 % confidence interval [ CI ] 1.45 to 2.06 ) versus 1.29 ( 95 % CI 1.14 to 1.46 ) , respectively . The same was true for the risk of all-cause mortality . C and esartan was associated with similar treatment effects regardless of baseline rhythm . CONCLUSIONS Atrial fibrillation is associated with an increased risk of CV outcomes in patients with CHF and either reduced EF or PEF . C and esartan improved outcomes similarly regardless of baseline rhythm",
"OBJECTIVE This study undertook to determine if the presence of atrial fibrillation in patients with asymptomatic and symptomatic left ventricular dysfunction was associated with increased mortality and , if so , whether the increase could be attributed to progressive heart failure or arrhythmic death . BACKGROUND Atrial fibrillation is a common condition in heart failure with the potential to impact hemodynamics and progression of left ventricular systolic dysfunction as well as the electrophysiologic substrate for arrhythmias . The available data do not conclusively define the effect of atrial fibrillation on prognosis in heart failure . METHODS A retrospective analysis of the Studies of Left Ventricular Dysfunction Prevention and Treatment Trials was conducted that compared patients with atrial fibrillation to those in sinus rhythm at baseline for the risk of all-cause mortality , progressive pump-failure death and arrhythmic death . RESULTS The patients with atrial fibrillation at baseline , compared to those in sinus rhythm , had greater all-cause mortality ( 34 % vs. 23 % , p death attributed to pump-failure ( 16.7 % vs. 9.4 % , p end point of death or hospitalization for heart failure ( 45 % vs. 33 % , p arrhythmic deaths . After multivariate analysis , atrial fibrillation remained significantly associated with all-cause mortality ( relative risk [ RR ] 1.34 , 95 % confidence interval [ CI ] 1.12 to 1.62 , p=0.002 ) , progressive pump-failure death ( RR 1.42 , 95 % CI 1.09 to 1.85 , p=0.01 ) , the composite end point of death or hospitalization for heart failure ( RR 1.26 , 95 % CI 1.03 to 1.42 , p=0.02 ) , but not arrhythmic death ( RR 1.13 ; 95 % CI 0.75 to 1.71 ; p=0.55 ) . CONCLUSIONS The presence of atrial fibrillation in patients with asymptomatic and symptomatic left ventricular systolic dysfunction is associated with an increased risk for all-cause mortality , largely explained by an increased risk for pump-failure death . These data suggest that atrial fibrillation is associated with progression of left ventricular systolic dysfunction",
"CONTEXT The risks associated with new-onset atrial fibrillation ( AF ) among middle-aged women and population s with a low comorbidity burden are poorly defined . OBJECTIVES To examine the association between incident AF and mortality in initially healthy women and to evaluate the influence of associated cardiovascular comorbidities on risk . DESIGN , SETTING , AND PARTICIPANTS Between 1993 and March 16 , 2010 , 34,722 women participating in the Women 's Health Study underwent prospect i ve follow-up . Participants were 95 % white , older than 45 years ( median , 53 [ interquartile range { IQR } , 49 - 59 ] years ) , and free of AF and cardiovascular disease at baseline . Cox proportional hazards models with time-varying covariates were used to determine the risk of events among women with incident AF . Secondary analyses were performed among women with paroxysmal AF . MAIN OUTCOME MEASURES Primary outcomes included all-cause , cardiovascular , and noncardiovascular mortality . Secondary outcomes included stroke , congestive heart failure , and myocardial infa rct ion . RESULTS During a median follow-up of 15.4 ( IQR , 14.7 - 15.8 ) years , 1011 women developed AF . Incidence rates per 1000 person-years among women with and without AF were 10.8 ( 95 % confidence interval [ CI ] , 8.1 - 13.5 ) and 3.1 ( 95 % CI , 2.9 - 3.2 ) for all-cause mortality , 4.3 ( 95 % CI , 2.6 - 6.0 ) and 0.57 ( 95 % CI , 0.5 - 0.6 ) for cardiovascular mortality , and 6.5 ( 95 % CI , 4.4 - 8.6 ) and 2.5 ( 95 % CI , 2.4 - 2.6 ) for noncardiovascular mortality , respectively . In multivariable models , hazard ratios ( HRs ) of new-onset AF for all-cause , cardiovascular , and noncardiovascular mortality were 2.14 ( 95 % CI , 1.64 - 2.77 ) , 4.18 ( 95 % CI , 2.69 - 6.51 ) , and 1.66 ( 95 % CI , 1.19 - 2.30 ) , respectively . Adjustment for nonfatal cardiovascular events potentially on the causal pathway to death attenuated these risks , but incident AF remained associated with all mortality components ( all-cause : HR , 1.70 [ 95 % CI , 1.30 - 2.22 ] ; cardiovascular : HR , 2.57 [ 95 % CI , 1.63 - 4.07 ] ; and noncardiovascular : HR , 1.42 [ 95 % CI , 1.02 - 1.98 ] ) . Among women with paroxysmal AF ( n = 656 ) , the increase in mortality risk was limited to cardiovascular causes ( HR , 2.94 ; 95 % CI , 1.55 - 5.59 ) . CONCLUSION Among a group of healthy women , new-onset AF was independently associated with all-cause , cardiovascular , and noncardiovascular mortality , with some of the risk potentially explained by nonfatal cardiovascular events ",
"BACKGROUND Atrial fibrillation ( AF ) or flutter occurring after myocardial infa rct ion may occur alone or in association with other complications . Whether the arrhythmia portends a poor prognosis independent of other complications with contemporary therapy is unknown . METHODS AND RESULTS As part of the Global Use of Strategies To Open occluded coronary arteries ( GUSTO-III ) trial , we evaluated whether postinfa rct ion complications were associated with the subsequent development of AF and whether AF independently predicted death over periods of 30 days and 1 year . Information including exact timing was collected on deaths and major in-hospital postinfa rct ion complications up to 30 days . Of the 13,858 patients with sinus rhythm at enrollment , 906 later had AF or flutter and 12 , 952 did not . We compared outcomes between these 2 groups , adjusting for differences in baseline characteristics and prefibrillation complications . Worsening heart failure , hypotension , third-degree heart block , and ventricular fibrillation were independent predictors of new-onset AF . The unadjusted odds ratio ( OR ) for death among patients with versus those without AF was 2.74 ( 95 % confidence interval [ 95 % CI ] , 2.56 - 3.34 ) . After adjusting for baseline differences , the OR was reduced to 1.63 ( 95 % CI , 1.31 - 2.02 ) . Adjustment for other in-hospital complications before the onset of AF further reduced the OR to 1.49 ( 95 % CI , 1.17 - 1.89 ) . CONCLUSIONS Atrial fibrillation or flutter occurs secondary to other postinfa rct ion complications but independently portends a worse prognosis . Prevention and management may improve outcome",
"In a prospect i ve study of 651 older persons with congestive heart failure after prior myocardial infa rct ion , persons with atrial fibrillation had a significantly higher mortality than those with sinus rhythm if they had an abnormal ( p = 0.005 ) or normal ( p = 0.0001 ) left ventricular ejection fraction . The Cox regression model showed that significant independent risk factors for total mortality were age ( risk ratio 1.03 for an increment of 1 year of age ) , hypertension ( risk ratio 1.2 ) , diabetes mellitus ( risk ratio 1.4 ) , abnormal left ventricular ejection fraction ( risk ratio 2.1 ) , and atrial fibrillation ( risk ratio 1.5 )",
"BACKGROUND Although implantable cardioverter-defibrillator ( ICD ) therapy has been evaluated in r and omized controlled trials , enrolling highly selected patients , mortality events in ICD patients have received little attention in routine medical care . We sought to assess the 24-month total and cause-specific mortality rates and their predictors in \" real life \" patients with an ICD . METHODS The Evaluation Médico-Economique du Défibrillateur Automatique Implantable study was a French multicenter , prospect i ve , observational cohort study of ICD patients with a 2-year follow-up . Cause-specific mortality rates and predictors at implantation of sudden cardiac death ( SCD ) or progressive heart failure ( HF ) death were assessed using competing risk methodology . RESULTS From June 2001 to June 2003 , 2,296 unselected patients were implanted and followed until June 2005 . During a mean follow-up of 20.5 + /- 6.7 months , 274 deaths occurred : 29 ( 10.6 % ) were SCD and 146 ( 53.3 % ) were HF deaths , corresponding to 24-month cause-specific mortality rates of 1.4 % ( 95 % confidence interval 0.9%-1.9 % ) and 6.9 % ( 95 % confidence interval 5.8%-8.0 % ) , respectively . Among the characteristics at implantation , ejection fraction ( EF ) SCD ; age , high New York Heart Association class , systemic hypertension , prior atrial fibrillation , QRS duration , EF HF death . CONCLUSIONS In this large cohort of \" daily \" patients , the 2-year incidence of SCD ( 1.4 % ) was comparable with the event rate observed in r and omized controlled trials ; HF remained the predominant mode of death . An EF < 30 % at implantation appears to be the most important predictor of ICD-unresponsive SCD",
"OBJECTIVE To evaluate prognosis of stroke and identify the risk factors for stroke recurrence . METHODS Based on the West China Hospital stroke register data base , we conducted a prospect i ve follow-up study of stroke patients to record the potential risk factors of stroke recurrence and investigate stroke recurrence at 1 year . Analysis of the risk factors was performed using a logistic regression model . RESULTS A total of 1913 stroke consecutive patients admitted to our department were prospect ively registered . Of these patients , 599 ( 31.3 % ) were identified to have intracerebral hemorrhage ( ICH ) , and 1314 ( 68.7 % ) had ischemic stroke . The total recurrence rate at 1 year was 11.2 % , and was 10.5 % in ischemic patients and 12.7 % in ICH patients . Multivariate analysis adjusted for age and gender identified atrial fibrillation , hypertension , hyperlipemia , family history of stroke , and smoking as the risk factors of stroke recurrence at 1 year . CONCLUSION The 1 year recurrent rate is about 11 % , and monitoring the factors of atrial fibrillation , hyperlipemia , hypertension , and smoking may help reduce the recurrence of stroke",
"Background : The aim of this study was to examine the 1-year cumulative mortality rate and cause of death , and to identify the predictive factors for death after hospital discharge following ischemic stroke and transient ischemic attack ( TIA ) using data from the Japan Multicenter Stroke Investigators ’ Collaboration study . Methods : We prospect ively registered 16,922 consecutive patients with acute ischemic stroke or TIA from May 1999 to April 2000 in 156 Japanese hospitals . We mailed a question naire to the 15,322 patients who were alive at hospital discharge . Results : 10,981 patients ( 6,945 men , 4,036 women , age 70 ± 11 years , median 71 , range 19–100 years ) were enrolled in the follow-up study . The mean follow-up period was 271 ± 110 days ( median 272 days ; range 1–487 days ) . The 1-year cumulative mortality was 6.8 % ( 7.0 % for 10,234 stroke patients and 3.5 % for 747 TIA patients ) . The causes of death were : cerebrovascular disease , 24.1 % ; pneumonia , 22.6 % ; heart disease , 18.1 % ; cancer , 11.0 % , and miscellaneous causes , 24.1 % . Multivariate analysis suggested that male gender , age , diabetes mellitus , atrial fibrillation , history of stroke , nonlacunar stroke , functional disability and transfer to another hospital or nursing home on discharge were significant independent predictors of death during the follow-up period . Conclusions : The major causes of death after hospital discharge were found to be cerebrovascular diseases , pneumonia and heart diseases . Thus , in order to improve survival after hospital discharge , in addition to appropriate management of vascular risk factors following stroke , it appears to be important to take measures to prevent pneumonia and to discharge patients to their own home , if possible",
"OBJECTIVES Low ankle-brachial index ( ABI ) , indicative of peripheral arterial disease ( PAD ) , is a risk factor for stroke . ABI has been shown to be associated with cerebral arterial disease and prognosis following stroke . We studied the associations of the degree of ABI lowering with extracranial carotid disease ( ECD ) , intracranial large artery disease ( ICLAD ) , and subsequent vascular events in a prospect i ve cohort of acute ischemic stroke patients . METHODS ABI , extracranial and intracranial cerebral arteries were assessed in a blinded manner . ABI was categorized into 0.9 - 1.3 ( normal ) , 0.8 - 0.89 ( mildly lowered ) and 1 year were obtained from st and ardized telephone interviews and verified with medical records . RESULTS Among the 1311 patients , 73 % had normal ABI , 13 % had ABI 0.8 - 0.89 and 13 % had ABI . Compared to patients with normal ABI , those with ABI severe ECD ( 15 % vs. 5 % , p = 0.006 ) and ICLAD ( 72 % vs. 48 % , p = 0.003 ) , even after adjustment for age , gender , hypertension , diabetes , hyperlipidemia , smoking , ischemic heart disease and atrial fibrillation ( severe ECD p ABI composite vascular events ( 19 % vs. 11 % , p = 0.02 ) , stroke ( 15 % vs. 10 % , p = 0.06 ) and myocardial infa rct ion ( 4 % vs. 2 % , p = 0.07 ) than patients with normal ABI . CONCLUSION Among ischemic stroke patients , large cerebral arterial disease and incidence of subsequent vascular events at 1 year were associated with severe ABI lowering , but not with mild ABI lowering ( 0.8 - 0.89 )"
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4117082a-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE Over the last 2 decades , sport-related concussion ( SRC ) has garnered significant attention . Even with increased awareness and athlete education , sideline recognition and real-time diagnosis remain crucial . The need for an objective and st and ardized assessment of concussion led to the eventual development of the Sport Concussion Assessment Tool ( SCAT ) during the Second International Conference on Concussion in Sport in 2004 , which is now in its third iteration ( SCAT3 ) . In an effort to up date our underst and ing of the most well-known sideline concussion assessment , the authors conducted a systematic review of the SCAT and the evidence supporting its use to date . METHODS English- language titles and abstract s published between 1995 and October 2015 were search ed systematic ally across 4 electronic data bases and a review was conducted in accordance with the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) guidelines adapted for the review of a heterogeneous collection of study design s. Peer- review ed journal articles were included if they reported quantitative data on any iteration of the SCAT , St and ardized Assessment of Concussion ( SAC ) , or modified Balance Error Scoring System ( mBESS ) data at baseline or following concussion in an exclusively athlete population with any portion older than 13 years of age . Studies that included nonathletes , only children less than 13 years old , exclusively BESS data , exclusively symptom scale data , or a non-SCAT-related assessment were excluded . RESULTS The data base search process yielded 549 abstract s , and 105 full-text articles were review ed with 36 meeting criteria for inclusion . Nineteen studies were associated with the SAC , 1 was associated with the mBESS exclusively , and 16 studies were associated with a full iteration of the SCAT . The majority of these studies ( 56 % ) were prospect i ve cohort studies . Male football players were the most common athletes studied . An analysis of the studies focused on baseline differences associated with age , sex , concussion history , and the ability to detect an SRC . CONCLUSIONS Looking toward the upcoming Concussion in Sport Group meeting in fall 2016 , one may expect further revision to the SCAT3 . However , based on this systematic review , the authors propose further , in-depth study of an already comprehensive concussion test , with acute , diagnostic , as well as long-term use
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"Background : Sports-related concussion commonly affects the visual pathways . Current sideline protocol s test cognition and balance but do not include assessment s of visual performance . We investigated how adding a vision-based test of rapid number naming could increase our ability to identify concussed athletes on the sideline at youth and collegiate levels . Methods : Participants in this prospect i ve study included members of a youth ice hockey and lacrosse league and collegiate athletes from New York University and Long Isl and University . Athletes underwent preseason baseline assessment s using : 1 ) the King – Devick ( K-D ) test , a , 2 ) the St and ardized Assessment of Concussion ( SAC ) , a test of cognition , and 3 ) a timed t and em gait test of balance . The SAC and timed t and em gait are components of the currently used Sport Concussion Assessment Tool , 3rd Edition ( SCAT3 and Child-SCAT3 ) . In the event of a concussion during the athletic season , injured athletes were retested on the sideline/rink-side . Nonconcussed athletes were also assessed as control participants under the same testing conditions . Results : Among 243 youth ( mean age 11 ± 3 years , range 5–17 ) and 89 collegiate athletes ( age 20 ± 1 years , range 18–23 ) , baseline time scores for the K-D test were lower ( better ) with increasing participant age ( P , K-D scores worsened from baseline by an average of 5.2 seconds ; improvement by 6.4 seconds was noted for the nonconcussed controls ( n = 14 ) . The vision-based K-D test showed the greatest capacity to distinguish concussed vs control athletes based on changes from preseason baseline to postinjury ( receiver operating characteristic [ ROC ] curve areas from logistic regression models , accounting for age = 0.92 for K-D , 0.87 for timed t and em gait , and 0.68 for SAC ; P = 0.0004 for comparison of ROC curve areas ) . Conclusions : Adding a vision-based performance measure to cognitive and balance testing enhances the detection capabilities of current sideline concussion assessment . This observation in patients with mild traumatic brain injury reflects the common involvement and widespread distribution of brain pathways dedicated to vision",
"AIM To use the King-Devick ( KD ) test and Sports Concussion Assessment Tool 2 ( SCAT2 ) in amateur rugby union players to identify witnessed and unrecognised episodes of concussion that occurred from match participation . METHODS A prospect i ve observational cohort study was conducted on a premier club level amateur rugby union team during the 2012 competition in New Zeal and . Every player completed a pre-competition question naire on concussion history , a baseline PCSS and two trials of the KD before they participated in any match activities . RESULTS For players reporting a concussion in the previous three years there was an average of 4.0±2.8 concussions per player . There were 22 concussive incidents recorded over the duration of the competition ( 46 per 1000 match hours ) . Five concussive incidents were witnessed ( 11 per 1000 match hours ) and 17 unrecognised concussive incidents were identified with the KD ( 37 per 1000 match hours ) . Witnessed concussions recorded , on average , a longer KD on the day of injury ( 5.5±2.4s ) than unrecognised concussions ( 4.4±0.9s ) when compared with their baseline KD . DISCUSSION The KD was able to identify players that had not shown , or reported , any signs or symptoms of a concussion but who had meaningful head injury . The current rate of concussion reported was a ten-fold increase in previously reported concussion injury rates . This makes the KD suitable for rapid assessment in a limited time frame on the sideline such as a five-minute window to assess and review suspected concussed players in rugby union",
"AIM To use the King-Devick ( K-D ) test in senior amateur rugby union and rugby league players over a domestic competition season to see if it could identify witnessed and unwitnessed episodes of concussion that occurred from participation in competition matches over three years . METHODS A prospect i ve observational cohort study was conducted on a club level senior amateur rugby union team ( n=36 players in 2012 and 35 players in 2013 ) and a rugby league team ( n=33 players in 2014 ) during competition seasons in New Zeal and . All 104 players completed two trials 10min apart of the K-D at the beginning of their competition season . Concussions ( witnessed or unwitnessed ) were only recorded if they were formally diagnosed by a health practitioner . RESULTS A total of 52 ( 8 witnessed ; 44 unwitnessed ) concussive events were identified over the duration of the study result ing in a concussion injury incidence of 44 ( 95 % CI : 32 to 56 ) per 1000 match participation hours . There was a six-fold difference between witnessed and unwitnessed concussions recorded . There were observable learning effects observed between the first and the second K-D test baseline testing ( 50 vs. 45s ; z=-8.81 ; p K-D test times post-match for changes in orientation ( 2.9s ) , immediate memory ( 1.8s ) concentration ( 2.8s ) , delayed recall ( 2.0s ) and SAC total score ( 1.7s ) . DISCUSSION The rate of undetected concussion was higher than detected concussions by using the K-D test routinely following matches . Worsening of the K-D test post-match was associated with reduction in components of the SAC . The appeal of the K-D test is in the rapid , easy manner of its administration and the reliable , objective results it provides to the administrator . The K-D test helped identify cognitive impairment in players without clinical ly observable symptoms",
"OBJECT The aim of this study was to evaluate the effectiveness of an educational intervention on concussion knowledge within a sample of junior fourth-tier ice hockey players . METHODS A prospect i ve cohort study , called the Hockey Concussion Education Project , was conducted during 1 junior ice hockey regular season ( 2009 - 2010 ) with 67 male fourth-tier ice hockey players ( mean age 18.2 ± 1.2 years , range 16 - 21 years ) from 2 teams . All participating players were r and omized into 3 concussion education intervention groups ( DVD group , interactive computer module [ ICM ] group , or control group ) before the beginning of the season . Each individual received a preintervention knowledge test prior to the intervention . The DVD and ICM groups received a posttest after the completion of their intervention . All participants were offered the same knowledge test at 15 games ( 50 days ) and 30 games ( 91 days ) later . RESULTS In the concussion education intervention component no significant group differences were observed at baseline between individuals in the control group and between individuals within the interventional group . At the 15-game follow-up , however , the difference between groups approached significance ( F [ 1 , 30 ] = 3.91 , p = 0.057 ) . This group difference remained consistent at the 30-game follow-up . CONCLUSIONS This study demonstrates a positive trend concerning concussion education intervention and knowledge acquisition with either the ICMs or the educational DVD . Both forms of intervention produced a positive and sustainable improvement that approached statistical significance when compared with the control group . The control group demonstrated a negative longitudinal trend concerning concussion knowledge",
"OBJECTIVE : To assess whether repeated administration of the St and ardized Assessment of Concussion ( SAC ) and Balance Error Scoring System ( BESS ) demonstrates a practice effect in high school athletes . DESIGN AND SETTING : Subjects were assigned to either a control or practice group . Subjects in the control group were assessed twice , 30 days apart . Subjects in the practice group were assessed on 5 occasions . Four assessment s were performed within a 7-day period and 1 more assessment 30 days after the initial test . SUBJECTS : Thirty-two uninjured high school athletes participated in this investigation . Sixteen were r and omly assigned to a control group and 16 to a practice group . MEASUREMENTS : We measured performance on the SAC and on 6 test conditions of the BESS . RESULTS : We found a significant time-by-group interaction on BESS performance on the day-30 test session . A significant practice effect of the BESS was found during the course of repeated administrations in the practice group . After repeated testing , the number of BESS errors decreased with each test session , and error scores on day 5 ( 10.94 + /- 2.17 ) and day 7 ( 9.44 + /- 3.32 ) were significantly lower than the baseline score ( 12.88 + /- 3.34 ) . We did not find group differences or a practice effect on the SAC ( baseline score = 26.16 ) . CONCLUSIONS : Our results revealed no practice effect with the SAC and a slight practice effect with repeated administrations of the BESS , especially with the single-leg stance on foam . Clinicians must acknowledge the potential for practice effects when readministering these concussion assessment s to track recovery of an athlete or as a guide in return-to-play decision making",
"Our purpose was to determine if an acute bout of heading soccer balls adversely affected postural control and self-reported symptoms of cerebral concussion . Thirty-one college-aged soccer players were r and omly placed into either a kicking group or a heading group . Subjects either kicked or headed 18 soccer balls over the course of 40 minutes . Subjects had their postural control assessed while st and ing on a force plate and completed a concussion symptoms checklist on three separate occasions : prior to , immediately following , and 24 hours after kicking or heading . There were no significant differences between the heading and kicking groups on the postural control measures prior to , immediately following , and 24 hours after kicking/heading . The heading group did , however , report significantly more concussion symptoms than the kicking group immediately after heading , but not 24 hours after heading . The number of previous concussions sustained by subjects did not influence the effects of heading . An acute bout of soccer heading appears to cause an increase in self-reported symptoms of cerebral concussion lasting less than 24 hours but no quantifiable deficits in postural control . Further research is needed to investigate the cumulative effects of soccer heading on postural control and other objective measures of brain function",
"Context : Monitoring of subjective symptoms is the foundation of all sport concussion management programmes . The purpose of this study is to examine method ological variables that impact symptom reporting during baseline testing . Objective : To investigate how the administration method of a concussion assessment tool ( self-report vs interview ) affects the report of symptoms . Design , setting and participants : This was a cross-sectional , semi-r and omized study of 117 athletes . Main outcome measurements : Subjects completed the Post-Concussion Scale during pre-season evaluations . Results : A two-factor ANOVA revealed a significant difference in total symptom scores ( p = 0.02 ) and number of endorsed symptoms ( p = 0.02 ) across administration modes . Athletes had a greater total symptom score and reported a greater number of symptoms in the self-administration condition than in the interview condition . Furthermore , there was a significant difference in symptom reporting across interviewer gender . Athletes endorsed more symptoms when the interviewer was a woman . Conclusions : Because the method of collecting symptoms , as well as interviewer gender , can impact test results , self-report measures may be a better way of obtaining consistent results . Clinicians and research ers should be aware that both the nature and extent of symptom reporting is greater when using question naires than when athletes are interviewed",
"BACKGROUND The benefit of preseason concussion education on athletes ’ knowledge , attitudes , and behaviors is unclear . The purpose of the study was to determine the influence of preseason concussion education on knowledge and self-reported attitudes and reporting behaviors . We hypothesized that preseason education would lead to better knowledge and self-reported attitudes and better reporting of concussion symptoms during the season . METHODS This study involved a prospect i ve cohort comparing the benefits of a preseason lectured-based concussion education session at one high school with a control school . Participants included males and females age 13 years to 18 years from two community high schools who were participating in higher concussion risk , fall or winter sports ( football , soccer , wrestling , and basketball ) . The education school and control school included 234 and 262 participants , respectively . Outcomes were a preseason and postseason survey assessing knowledge and self-reported attitudes about concussions and an end-of-season question naire assessing concussion reporting behaviors during the season . RESULTS Total scores on the combined ( p returning to play before symptoms resolved ( p = 0.81 ) . CONCLUSION These findings suggest that a didactic-based preseason concussion education likely has minimal benefits . Other factors besides knowledge are likely influencing student-athlete concussion reporting behavior . Future research focused on changing the culture of concussion reporting is needed . LEVEL OF EVIDENCE Therapeutic study , level III",
"Objective : To determine if serial administration of the St and ardized Assessment of Concussion ( SAC ) and Balance Error Scoring System ( BESS ) would elicit a learning effect in young athletes and to determine the intratester reliability of scoring the BESS . Design : A prospect i ve study of 50 healthy young athletes who were assigned to either the control or practice group . All subjects were administered the assessment s on 2 occasions , 60 days apart . In addition , subjects in the practice group received serial administration of the assessment s on 3 occasions in the week following the initial assessment . Setting : University Sports Medicine/Athletic Training Research Laboratory . Subjects : Fifty uninjured young athletes between 9 and 14 years of age . Main Outcome Measured : Scores on 2 clinical concussion assessment s , the SAC and the BESS . Results : We found a significant learning effect upon serial BESS testing in the practice group . BESS error scores were significantly lower than baseline ( 15.0 ± 4.6 ) on days 5 ( 11.3 ± 5.33 ) , 7 ( 12.4 ± 6.2 ) , and 60 ( 12.6 ± 6.2 ) . We also found a significant learning effect upon the day 60 BESS administration across all subjects . We did not find a practice or learning effect with serial SAC test administration . The intratester reliability of the investigator ’s ability to score repeated observations of the same BESS test ranged from 0.87 to 0.98 . Conclusions : Our results demonstrated that serial administration of the BESS elicited a learning effect , which was more prominent during the t and em conditions . Clinicians utilizing the BESS as a measure of postural stability should be aware of the potential for improvement with repeated testing . Clinicians should not expect improvement with the SAC , as scores remained relatively stable across all trials",
"Background Concussion is one of the most commonly occurring injuries in sport today . The Sport Concussion Assessment Tool ( SCAT ) is a commonly used paper neurocognitive tool . To date , little is known about SCAT baseline normative values in youth athletes . Objective The purpose of this study was to determine normative values on the SCAT for male and female youth hockey players . Methods This is a secondary data analysis of pooled data from three prospect i ve cohort studies examining the risk of injury in paediatric ice hockey players aged 9–17 years . A preseason baseline demographic and injury history question naire was completed by each player . Results A total of 4193 players completed SCATs at baseline and were included in the analysis . 781 players ( 18.6 % ) reported a previous history of concussion . Fatigue and low energy followed by headache were the most commonly reported symptoms in all players . The majority of youth players could recite all five words immediately but only three words when delayed . A smaller proportion of the males were able to report the months of the year in reverse order compared with females of a similar age . The median number of digits recited in reverse order was 4 . Conclusions Youth ratings varied between age groups , gender and from previously reported ratings of varsity athletes , possibly reflecting developmental and gender differences . An underst and ing of these differences in youth athletes is important to ensure appropriate performance expectations on the SCAT and when making clinical decisions following a concussion",
"OBJECTIVE To prospect ively measure the immediate neurocognitive effects and early course of recovery from concussion and to examine the effects of loss of consciousness ( LOC ) and posttraumatic amnesia ( PTA ) on the severity of neurocognitive impairment immediately after concussion . METHODS A sports-related concussion research model was used to allow prospect i ve immediate evaluation of concussion . A total of 2385 high school and college football players were studied . Ninety-one players ( 3.8 % ) sustained concussions during the study . A brief neurocognitive and neurological screening measure , the St and ardized Assessment of Concussion , was used to assess cognitive functioning before the football season , immediately after injury , and 15 minutes , 48 hours , and 90 days after injury . RESULTS St and ardized Assessment of Concussion scores immediately after concussion were significantly lower than the preseason baseline score and the noninjured population baseline mean , even for injured subjects without LOC or PTA . Subjects with LOC were most severely impaired immediately after injury , whereas those without LOC or PTA were least impaired . Significant impairment was also detected 15 minutes after injury , but all three groups returned to baseline levels of cognitive functioning within 48 hours . CONCLUSION These findings are the first to demonstrate not only that a gradient of increasing concussion severity is represented by PTA and LOC but also that measurable neurocognitive abnormalities are evident immediately after injury without PTA or LOC",
"CONTEXT Lack of empirical data on recovery time following sport-related concussion hampers clinical decision making about return to play after injury . OBJECTIVE To prospect ively measure immediate effects and natural recovery course relating to symptoms , cognitive functioning , and postural stability following sport-related concussion . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study of 1631 football players from 15 US colleges . All players underwent preseason baseline testing on concussion assessment measures in 1999 , 2000 , and 2001 . Ninety-four players with concussion ( based on American Academy of Neurology criteria ) and 56 noninjured controls underwent assessment of symptoms , cognitive functioning , and postural stability immediately , 3 hours , and 1 , 2 , 3 , 5 , 7 , and 90 days after injury . MAIN OUTCOME MEASURES Scores on the Grade d Symptom Checklist ( GSC ) , St and ardized Assessment of Concussion ( SAC ) , Balance Error Scoring System ( BESS ) , and a neuropsychological test battery . RESULTS No player with concussion was excluded from participation ; 79 players with concussion ( 84 % ) completed the protocol through day 90 . Players with concussion exhibited more severe symptoms ( mean GSC score 20.93 [ 95 % confidence interval [ CI ] , 15.65 - 26.21 ] points higher than that of controls ) , cognitive impairment ( mean SAC score 2.94 [ 95 % CI , 1.50 - 4.38 ] points lower than that of controls ) , and balance problems ( mean BESS score 5.81 [ 95 % CI , -0.67 to 12.30 ] points higher than that of controls ) immediately after concussion . On average , symptoms gradually resolved by day 7 ( GSC mean difference , 0.33 ; 95 % CI , -1.41 to 2.06 ) , cognitive functioning improved to baseline levels within 5 to 7 days ( day 7 SAC mean difference , -0.03 ; 95 % CI , -1.33 to 1.26 ) , and balance deficits dissipated within 3 to 5 days after injury ( day 5 BESS mean difference , -0.31 ; 95 % CI , -3.02 to 2.40 ) . Mild impairments in cognitive processing and verbal memory evident on neuropsychological testing 2 days after concussion resolved by day 7 . There were no significant differences in symptoms or functional impairments in the concussion and control groups 90 days after concussion . CONCLUSIONS Collegiate football players may require several days for recovery of symptoms , cognitive dysfunction , and postural instability after concussion . Further research is required to determine factors that predict variability in recovery time after concussion . St and ardized measurement of postconcussive symptoms , cognitive functioning , and postural stability may enhance clinical management of athletes recovering from concussion",
"OBJECT The objective of this study was to measure the incidence of concussion ( scaled relative to number of athlete exposures ) and recurrent concussion within 2 teams of fourth-tier junior ice hockey players ( 16 - 21 years old ) during 1 regular season . METHODS A prospect i ve cohort study called the Hockey Concussion Education Project was conducted during 1 junior ice hockey regular season ( 2009 - 2010 ) involving 67 male fourth-tier ice hockey players ( mean age 18.2 ± 1.2 years , range 16 - 21 years ) from 2 teams . Prior to the start of the season , every player underwent baseline assessment s using the Sideline Concussion Assessment Tool 2 ( SCAT2 ) and the Immediate Post-Concussion Assessment and Cognitive Test ( ImPACT ) . The study protocol also required players who entered the study during the season to complete baseline SCAT2 and ImPACT testing . If the protocol was not followed , the postinjury test results of a player without true baseline test results would be compared against previously established age and gender group normative levels . Each regular season game was observed by a qualified physician and at least 1 other neutral nonphysician observer . Players who suffered a suspected concussion were evaluated at the game . If a concussion diagnosis was made , the player was subsequently examined in the physician 's office for a full clinical evaluation and the SCAT2 and ImPACT were repeated . Based on these evaluations , players were counseled on the decision of when to return to play . Athlete exposure was defined as 1 game played by 1 athlete . RESULTS Twenty-one concussions occurred during the 52 physician-observed games ( incidence 21.5 concussions per 1000 athlete exposures ) . Five players experienced repeat concussions . No concussions were reported during practice sessions . A concussion was diagnosed by the physician in 19 ( 36.5 % ) of the 52 observed games . One of the 5 individuals who suffered a repeat concussion sustained his initial concussion in a regular season game that was not observed by a physician , and as a result this single case was not included in the total of 21 total concussions . This initial concussion of the player was identified during baseline testing 2 days after the injury and was subsequently medically diagnosed and treated . CONCLUSIONS The incidence of game-related concussions ( per 100 [ corrected ] athlete exposures ) in these fourth-tier junior [ corrected ] ice hockey players was 7 [ corrected ] times higher than [ corrected ] previously reported in the literature . This difference may be the result of the use of st and ardized direct physician observation , diagnosis , and subsequent treatment . The results of this study demonstrate the need for follow-up studies involving larger and more diverse sample groups to reflect generalizability of the findings . These follow-up studies should involve other contact sports ( for example football and rugby ) and also include the full spectrum of gender , age , and skill levels "
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41170884-06ff-11f0-808a-c43d1ab1c353
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Background : Previous clinical trials have reported that etoricoxib has been utilized to treat ankylosing spondylitis ( AS ) effectively . However , no study systematic ally investigated the efficacy and safety of etoricoxib for patients with AS . In this systematic review , we will assess the efficacy and safety of etoricoxib for AS . Methods : The following electronic data bases will be search ed from inception to the February 1 , 2019 : Cochrane Library , Embase , PubMed , Cumulative Index to Nursing and Allied Health Literature , China National Knowledge Infrastructure , Chinese Biomedical Literature Data base , and Chinese Scientific Journal Data base . This study will include r and omized controlled trials that explore the efficacy and safety of etoricoxib for AS . The primary outcome is pain intensity , as measured by any pain scales , such as Numerical Rating Scale . The secondary outcomes consist of AS function , as measured by Bath Ankylosing Spondylitis Functional Index , or other tools ; quality of life , as assessed by Ankylosing Spondylitis Quality of Life question naire or any other relevant instruments ; as well as adverse events . Two authors will independently carry out the study selection , data extraction , and risk of bias assessment . Statistical analysis will be performed by using RevMan 5.3 software . Results : This systematic review will provide a detailed summary of present evidence related to the efficacy and safety of etoricoxib for patients with AS . Conclusion : The results of this study may provide management guidance for AS treated by etoricoxib . Dissemination and ethics : This systematic review dose not needs ethical approval , because it will not analyze individual patient data . The findings of this study are expected to publish through a peer- review ed journal . Systematic review registration : CRD42019124768
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[
"Objective : The combined efficacy of selective and non-selective cyclo-oxygenase-2 ( COX-2 ) inhibition on the axial manifestations of ankylosing spondylitis ( AS ) in the presence or absence of chronic peripheral arthritis was evaluated . Methods : In a post hoc subgroup analysis of a 6 week , r and omised , double blind , placebo controlled trial , 387 patients with active axial AS were r and omised to receive etoricoxib 90 mg or 120 mg once a day , naproxen 500 mg twice daily , or placebo . R and omisation was stratified by the presence or absence of chronic peripheral arthritis . The primary outcome measure was the time weighted average change from baseline of spine pain intensity . Efficacy data from the three groups receiving active treatment ( the NSAID/COX-2 inhibitor group ) were combined to improve precision . An analysis of covariance model was used to evaluate the effect of peripheral disease on treatment response . Results : 93 patients were allocated to receive placebo and 294 to active treatment ( naproxen or etoricoxib ) . The combined NSAID/COX-2 inhibitor group had a significant treatment response compared with the placebo group for all efficacy measures , both in patients with and without peripheral arthritis . A significantly greater difference in mean patient assessment of spine pain was found between active and placebo treatments in patients without compared with those with peripheral arthritis ( p = 0.005 ; −32.5 mm v −17.0 mm , respectively ) . Similar differences , although not statistically significant , were seen for other end points . Conclusion : NSAIDs and COX-2 inhibitors have a clinical ly relevant symptomatic effect on axial AS irrespective of the presence of peripheral arthritis . In this exploratory analysis spinal improvement appeared to be greater in patients without peripheral disease",
"Objective : To describe and assess the response to short-term etoricoxib as shown by MRI and clinical variables in patients with ankylosing spondylitis ( AS ) selected for eligibility for anti-tumour necrosis factor therapy . Methods : In a 6-week open-label study , 22 patients with AS and eligible for biological therapy were treated with 90 mg of etoricoxib daily . Clinical and laboratory parameters were obtained and MRI of the sacroiliac joints and the lower thoracic and lumbar spine performed at baseline and at week 6 . The primary end point was the proportion of patients fulfilling the SpondyloArthritis international Society ( ASAS ) response criteria for biological therapies ( ASASBIO ) while secondary end points included the change in MRI-determined bone lesions . Results : Eight of 20 completers improved enough to meet the ASASBIO response criteria and most clinical variables improved significantly . Fifteen patients had a total of 63 MRI-detectable lesions ; overall , 13/60 lesions with paired scans either resolved completely or improved , while five lesions worsened or appeared during treatment . Conclusion : Etoricoxib is an effective symptomatic treatment for patients with AS ; however , its effect on MRI-detected lesions is small . Further studies are needed to determine the effect of etoricoxib on MRI-determined bone oedema",
"Background Clinical analgesic trials typically report response as group mean results . However , research has shown that few patients are average and most have responses at the extremes . Moreover , group mean results do not convey response levels and thus have limited value in representing the benefit-risk at an individual level . Responder analyses and numbers-needed-to-treat ( NNT ) are considered more relevant for evaluating treatment response . We evaluated levels of analgesic response and Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) score improvement and the associated NNTs . Methods This was a post-hoc analysis of a 6-week , r and omized , double-blind study ( N = 387 ) comparing etoricoxib 90 mg , etoricoxib 120 mg , naproxen 1000 mg , and placebo in AS . Spine pain and BASDAI were measured on a 100-mm visual analog scale . The number and percentage of patients achieving ≥30 % and ≥50 % improvement in both BASDAI and spine pain were calculated and used to determine the corresponding NNTs . Patients who discontinued from the study for any reason were assigned zero improvement beyond 7 days of the time of discontinuation . Results For etoricoxib 90 mg , etoricoxib 120 mg and naproxen 1000 mg , the NNTs at 6 weeks compared with placebo were 2.0 , 2.0 , and 2.7 respectively for BASDAI ≥30 % improvement , and 3.2 , 2.8 , and 4.1 for ≥50 % improvement . For spine pain , the NNTs were 1.9 , 2.0 , and 3.2 , respectively , for ≥30 % improvement , and 2.7 , 2.5 , and 3.7 for ≥50 % improvement . The differences between etoricoxib and naproxen exceeded the limit of ±0.5 units described as a clinical ly meaningful difference for pain . Response rates and NNTs were generally similar and stable over 2 , 4 , and 6 weeks . Conclusions For every 2 patients treated with etoricoxib , 1 achieved a clinical ly meaningful ( ≥30 % ) improvement in spine pain and BASDAI beyond that expected from placebo , whereas the corresponding values were approximately 1 in every 3 patients treated with naproxen . Use of NNTs and responder analyses provide additional , complementary information beyond population mean responses when assessing efficacy compared to placebo and amongst active therapies",
"AIM To study a trend in active sacroiliitis ( ASI ) in patients with axial spondyloarthritis ( axSpA ) during different short-term regimens using etoricoxib ( ET ) 90 mg . SUBJECTS AND METHODS Forty patients with axSpA , including 30 with ankylosing spondyloarthritis ) , and ASI ( sacroiliac joint ( SIJ ) osteitis as evidence d by magnetic resonance imaging ) were examined and then r and omized to 2 groups : 1 ) 20 patients who took ET 90 mg four days or more a week ; 2 ) 20 patients who received ET 90 mg 3 days or less a week . Osteitis was measured in 4 quadrants of each SIJ ( 0 - 3 scores ) . Its main criterion was considered to be a decrease in total osteitis activity ( TOA ) 12 week later . RESULTS In all the patients ( n = 40 ) , TOA decreased from 6.5 ( 4 ; 9 ) to 2 ( 0 ; 5 ) scores ( p TOA achieved no statistical significance ( p=0.056 ) . In these groups , there were 19 ( 95 % ) and 14 ( 70 % ) treatment-responsive patients , respectively . CONCLUSION The intake of ET 90 mg for 12-weeks is associated with a reduction in the degree of ASI in patients with axSpA. The use of ET 4 times or more a week is more effective in diminishing osteitis than that of ET 3 days or less",
"OBJECTIVES To evaluate the efficacy of etoricoxib in patients with axial ankylosing spondyloarthritis ( AS ) refractory to traditional NSAIDs . METHODS This was an open label , multicentric , r and omised , prospect i ve ( 4 weeks with and open extension to 6 months ) , non-controlled study . Consecutive patients with axial AS refractory to traditional NSAID eligible for anti-TNF-α therapy were selected . The primary outcomes were the rate of patients with good clinical response ( not eligible for anti-TNF-α therapy after etoricoxib ) and the Assessment of Spondyloarthritis International Society response criteria for biologic therapies ( ASASBIO ) response at 4 weeks . Secondary outcomes included : ASAS20 and 40 responses , ASDAS-CRP response , BASDAI , BASFI , back and night back pain , global patient and physician assessment of the disease , and biologic parameters like C-reactive protein ( CRP ) at 2 , 4 weeks and 6 months . RESULTS A total of 57 axial AS patients were recruited , 46 men , with mean age of 43 years . After 4 weeks of treatment , 26 patients ( 46 % ) achieved a good clinical response and 11 ( 20 % ) an ASASBIO response . These results at 24 weeks were 19 ( 33 % ) and 13 ( 23 % ) respectively . All individual clinical variables improved significantly after 4 weeks of treatment . CRP serum levels decreased after 4 weeks but reached no statistical significance , although 30 % of patients showed a normalisation of CRP . CONCLUSIONS Etoricoxib provided a clear clinical improvement in around a third of patients with axial AS refractory to traditional NSAIDs . Special care should be required when deciding to start anti-TNF-α therapy ; it seems reasonable to keep in mind these results of etoricoxib treatment"
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411708ca-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Sarcopenia is the loss of skeletal muscle mass and function that occurs with advancing age and certain diseases . It is thought to have a negative impact on survival in cancer patients . Routine computed tomography imaging is often used to quantify skeletal muscle in cancer patients . Sarcopenia is defined by a low skeletal muscle index ( SMI ) . Skeletal muscle radiation attenuation ( SMRA ) is used to define muscle quality . The primary aim of this meta- analysis was to study the association between sarcopenia or SMRA and overall survival ( OS ) or complications in patients with ovarian cancer . METHODS Medline , Embase , CINAHL , and PEDro data bases were search ed from inception to 15 February 2019 . Studies evaluating the prognostic effect of SMI and SMRA on ovarian cancer survival or surgical complications were included . Risk of bias and study quality were evaluated with the Quality in Prognosis Studies Instrument ( QUIPS ) according to the modified Grading of Recommendations Assessment , Development , and Evaluation ( GRADE ) framework . RESULTS The search strategy yielded 4262 hits in all four data bases combined . Ten and eight studies were included for qualitative and quantitative analysis , respectively . Meta- analysis revealed a significant association between the SMI and OS [ 0.007 ; hazard ratio ( HR ) : 1.11 , 95 % confidence interval ( CI ) : 1.03 - 1.20 ] . SMRA was also significantly associated with OS ( P between the SMI and surgical complications had borderline statistical significance ( 0.05 ; HR : 1.23 , 95 % CI : 1.00 - 1.52 ) . The risk of bias assessed with QUIPS was high in all studies . The quality of the evidence was very low . CONCLUSIONS Whereas our meta- analysis indicated that a low SMI and low SMRA are associated with survival in ovarian cancer patients , the low quality of the source data precludes drawing definitive conclusions
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"Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items",
"Objective Cancer cachexia is a paraneoplastic syndrome comprising involuntary weight loss and muscle depletion ( sarcopenia ) . Although weight loss has been associated with poor clinical outcome , there is only limited information on the prevalence and prognostic impact of sarcopenia in ovarian cancer so far . Methods Total skeletal muscle mass was determined by computed tomography image analysis of the third lumbar skeletal muscle cross-sectional area in 128 patients with advanced serous ovarian cancer . Longitudinal change of muscle mass was studied in 209 consecutive computed tomography scans from 43 patients . Association with survival was determined using Cox proportional hazards model . Results The prevalence of sarcopenia at first diagnosis was 11 % ( 12/105 ; 95 % confidence interval [ CI ] , 6%–20 % ) . Sarcopenic patients had a significantly reduced progression-free ( hazard ratio , 2.64 ; 95 % CI , 1.24–5.64 ; P = 0.012 ) and overall survival ( hazard ratio , 3.17 ; 95 % CI , 1.29–7.80 ; P = 0.012 ) . On multivariable analysis , these prognostic effects remained significant after adjustment for age , International Federation of Gynecology and Obstetrics stage , and postsurgical residual disease . Longitudinal analyses identified both patients with loss and gain of muscle mass . However , change in muscle mass over time was not associated with survival . Conclusions Baseline sarcopenia is a prognostic factor in advanced serous ovarian cancer . Identification of sarcopenic patients and early enrollment in physical or nutritional education programs might thus be a feasible way to improve outcome and should be further evaluated in prospect i ve clinical trials",
"BACKGROUND Treatment of newly diagnosed advanced‐stage ovarian cancer typically involves cytoreductive surgery and systemic chemotherapy . We conducted a trial to investigate whether the addition of hyperthermic intraperitoneal chemotherapy ( HIPEC ) to interval cytoreductive surgery would improve outcomes among patients who were receiving neoadjuvant chemotherapy for stage III epithelial ovarian cancer . METHODS In a multicenter , open‐label , phase 3 trial , we r and omly assigned 245 patients who had at least stable disease after three cycles of carboplatin ( area under the curve of 5 to 6 mg per milliliter per minute ) and paclitaxel ( 175 mg per square meter of body‐surface area ) to undergo interval cytoreductive surgery either with or without administration of HIPEC with cisplatin ( 100 mg per square meter ) . R and omization was performed at the time of surgery in cases in which surgery that would result in no visible disease ( complete cytoreduction ) or surgery after which one or more residual tumors measuring 10 mm or less in diameter remain ( optimal cytoreduction ) was deemed to be feasible . Three additional cycles of carboplatin and paclitaxel were administered postoperatively . The primary end point was recurrence‐free survival . Overall survival and the side‐effect profile were key secondary end points . RESULTS In the intention‐to‐treat analysis , events of disease recurrence or death occurred in 110 of the 123 patients ( 89 % ) who underwent cytoreductive surgery without HIPEC ( surgery group ) and in 99 of the 122 patients ( 81 % ) who underwent cytoreductive surgery with HIPEC ( surgery‐plus‐HIPEC group ) ( hazard ratio for disease recurrence or death , 0.66 ; 95 % confidence interval [ CI ] , 0.50 to 0.87 ; P=0.003 ) . The median recurrence‐free survival was 10.7 months in the surgery group and 14.2 months in the surgery‐plus‐HIPEC group . At a median follow‐up of 4.7 years , 76 patients ( 62 % ) in the surgery group and 61 patients ( 50 % ) in the surgery‐plus‐HIPEC group had died ( hazard ratio , 0.67 ; 95 % CI , 0.48 to 0.94 ; P=0.02 ) . The median overall survival was 33.9 months in the surgery group and 45.7 months in the surgery‐plus‐HIPEC group . The percentage of patients who had adverse events of grade 3 or 4 was similar in the two groups ( 25 % in the surgery group and 27 % in the surgery‐plus‐HIPEC group , P=0.76 ) . CONCLUSIONS Among patients with stage III epithelial ovarian cancer , the addition of HIPEC to interval cytoreductive surgery result ed in longer recurrence‐free survival and overall survival than surgery alone and did not result in higher rates of side effects . ( Funded by the Dutch Cancer Society ; Clinical Trials.gov number , NCT00426257 ; EudraCT number , 2006‐003466‐34 .",
"Abstract Background Malnutrition , weight loss , and muscle wasting ( sarcopenia ) are common among women with advanced ovarian cancer and have been associated with adverse clinical outcomes and survival . Our objective is to investigate overall survival ( OS ) related to changes in skeletal muscle ( SM ) for patients with advanced ovarian cancer treated with neoadjuvant chemotherapy and interval debulking . Methods Ovarian cancer patients ( n = 123 ) treated with neoadjuvant chemotherapy and interval debulking in the area of Maastricht ( the Netherl and s ) between 2000 and 2014 were included retrospectively . Surface areas of SM and adipose tissue were defined on computed tomography at the level of the third lumbar vertebra . Low SM at baseline and SM changes during chemotherapy were compared with Kaplan Meier curves , and Cox‐regression models were applied to test predictors of OS . Results Median OS for patients who lost SM ( n = 83 ) was 916 ± 99 days , which was significantly different from median OS for patients who maintained or gained SM ( n = 40 ) , which was 1431 ± 470 days ( P = 0.004 ) . Loss of SM was also a significant predictor of OS in multivariable Cox‐regression analysis ( hazard ratio 1.773 ( 95%CI : 1.018–3.088 ) , P = 0.043 ) . Low baseline SM did not influence survival . Conclusions Patients with ovarian cancer have a worse survival when they lose SM during neoadjuvant chemotherapy . Evaluation of low SM at a specific time point is not prognostic for OS . External and prospect i ve validation of these findings is imperative . Nutritional , pharmacological , and /or physical intervention studies are necessary to establish whether SM impairment can be prevented to prolong ovarian cancer survival",
"BACKGROUND Sarcopenia , severe skeletal muscle loss , has been identified as a prognostic factor in various malignancies . This study aims to investigate whether sarcopenia is associated with overall survival ( OS ) and surgical complications in patients with advanced ovarian cancer undergoing primary debulking surgery ( PDS ) . METHODS Ovarian cancer patients ( n = 216 ) treated with PDS were enrolled retrospectively . Total skeletal muscle surface area was measured on axial computed tomography at the level of the third lumbar vertebra . Optimum stratification was used to find the optimal skeletal muscle index cut-off to define sarcopenia ( ≤38.73 cm2/m2 ) . Cox-regression and Kaplan-Meier analysis were used to analyse the relationship between sarcopenia and OS . The effect of sarcopenia on the development of major surgical complications was studied with logistic regression . RESULTS Kaplan-Meier analysis showed a significant survival disadvantage for patients with sarcopenia compared to patients without sarcopenia ( p = 0.010 ) . Sarcopenia univariably predicted OS ( HR 1.536 ( 95 % CI 1.105 - 2.134 ) , p = 0.011 ) but was not significant in multivariable Cox-regression analysis ( HR 1.362 ( 95 % CI 0.968 - 1.916 ) , p = 0.076 ) . Significant predictors for OS in multivariable Cox-regression analysis were complete PDS , treatment in a specialised centre and the development of major complications . Sarcopenia was not predictive of major complications . CONCLUSION Sarcopenia was not predictive of OS or major complications in ovarian cancer patients undergoing primary debulking surgery . However a strong trend towards a survival disadvantage for patients with sarcopenia was seen . Future prospect i ve studies should focus on interventions to prevent or reverse sarcopenia and possibly increase ovarian cancer survival . Complete cytoreduction remains the strongest predictor of ovarian cancer survival ",
"Emerging research suggests that body composition can predict toxicity of certain chemotherapeutic agents . We used data from a clinical study to investigate associations between body composition and combined DOXIL ( pegylated liposomal doxorubicin ; PLD ) and trabectedin ( Yondelis ) treatment , an effective treatment for ovarian cancer that shows high interpatient variation in toxicity profile . Patients ( n = 74 ) participating in a phase III r and omized trial of relapsed advanced ovarian cancer receiving PLD ( 30 mg/m(2 ) ) and trabectedin ( 1.1 mg/m(2 ) ) were included . Muscle tissue was measured by analysis of computerized tomography images , and an extrapolation of muscle and adipose tissue to lean body mass ( LBM ) and fat mass ( FM ) were employed . Toxicity profile after cycle 1 was used and grade d according to the National Cancer Institute Common Toxicity Criteria ( version 3 ) . Patients presented with a wide range of body composition . In overweight and obese patients ( body mass index ( BMI ) ≥ 25 kg/m(2 ) , n = 48 ) toxicity was more prevalent in those with lower BMI ( p = 0.028 ) and a lower FM ( n = 43 , p = 0.034 ) . Although LBM alone was not predictive of toxicity , a lower FM/LBM ratio was the most powerful variable associated with toxicity ( p = 0.006 ) . A different pattern emerged among normal weight patients ( n = 26 ) where toxicity was rare among patients with smaller BMI ( FM and LBM ( primarily driven by FM ) in explaining PLD plus trabectedin toxicity emerged , but only in individuals with excess body weight , with a lower ratio predicting higher exposure and risk for toxicity",
"BACKGROUND & AIMS Low skeletal muscle mass and density have recently been discovered as prognostic and predictive parameters to guide interventions in various population s , including cancer patients . The gold st and ard for body composition analysis in cancer patients is computed tomography ( CT ) . To date , the effect of contrast-enhancement on muscle composition measurements has not been established . The aim of this study was to determine the effect of contrast-enhancement on skeletal muscle mass and density measurements on four-phase CT studies . DESIGN In this observational study , two observers measured cross-sectional skeletal muscle area corrected for patients ' height ( skeletal muscle index [ SMI ] ) and density ( SMD ) at the level of the third lumbar vertebra on 50 r and omly selected CT examinations with unenhanced , arterial , and portal-venous phases . The levels of agreement between enhancement phases for SMI and SMD were calculated using intra-class correlation coefficients ( ICCs ) . RESULTS Mean SMI was 42.5 ( ±9.9 ) cm2/m2 on the unenhanced phase , compared with 42.8 ( ±9.9 ) and 43.6 ( ±9.9 ) cm2/m2 for the arterial and portal-venous phase , respectively ( both p ) . Mean SMD was lower for the unenhanced phase ( 30.9 ± 8.0 Hounsfield units [ HU ] ) compared with the arterial ( 38.0 ± 9.9 HU ) and portal-venous ( 38.7 ± 9.2 HU ) phase ( both p No significant difference was found between SMD in the portal-venous and arterial phase ( p = 0.161 ) . The ICCs were excellent ( ≥0.992 ) for all SMIs and for SMD between the contrast-enhanced phases ( 0.949 ) . The ICCs for the unenhanced phase compared with the arterial ( 0.676 ) and portal-venous ( 0.665 ) phase were considered fair to good . CONCLUSIONS Statistically significant differences in SMI were observed between different enhancement phases . However , further work is needed to assess the clinical relevance of these small differences . Contrast-enhancement strongly influenced SMD values . Studies using this measure should therefore use the portal-venous phase of contrast-enhanced CT examinations",
"OBJECTIVE To investigate whether patients ' altered body composition ( measured with bioimpedentiometry ) , due to a poor nutritional status , predicts the incidence of no residual disease at primary debulking and the risk of complications in patients with newly-diagnosed advanced epithelial ovarian cancer ( EOC ) . METHODS Data regarding patients with newly-diagnosed stage IIIC-IV EOC undergoing elective nutritional assessment between December 2016 and March 2017 , were prospect ively collected . Bioelectrical impedance analysis ( BIA ) with measurement of BIA-derived phase angle [ PhA ] at 50KHz , was accomplished . Only patients with disease which was considered resectable at staging laparoscopy were su bmi tted to open primary cytoreduction . The rate of residual tumor (RT)=0 and the incidence of complications were assessed . RESULTS Seventy patients were included . Fifty-two of them were su bmi tted to primary cytoreduction ( 74.3 % ) and 48 ( 68.6 % of the entire cohort , 92.3 % of those who underwent primary debulking ) had RT=0 at the end of surgery . Median values of PhA were significantly lower in patients with RT > vs . = 0 ( 4.7 , range : 3.6 - 5.8 vs. 5.3 , range : 4.2 - 6.8 ; p=0.001 ) . Twenty-four ( out of the 52 operated ) patients ( 46.2 % ) developed at least one complication . PhA was significantly lower in patients with vs. without complications ( 5 , range : 3.6 - 6.4 , vs. 5.4 , range 4.5 - 6.8 ; p=0.03 ) . After multivariable analysis , Fagotti score and PhA were the only independent predictors of residual disease ( OR:13.56 ; 95%CI:1.33 - 137.6 ; p=0.027 and 9.24 ; 1.16 - 73.43 ; p=0.036 , respectively ) and of any complication ( OR:4.9;95%CI:1.17 - 20.6 ; p=0.03 and 7.27 ; 1.45 - 36.4 ; p=0.01 , respectively ) . CONCLUSIONS Derangement of body composition ( likely due to disease-related malnutrition ) expressed as a low phase angle , is an independent predictor of residual disease and peri-operative complications at the time of upfront cytoreduction for advanced EOC"
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41170910-06ff-11f0-808a-c43d1ab1c353
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Polymerization shrinkage of resin composite can compromise the longevity of restorations . To minimize this problem , the monomeric composition of composites have been modified . The objective of this study was to conduct a meta- analysis to assess the clinical behavior of restorations performed with low polymerization shrinkage resin composite in comparison with traditional methacrylates-based resin composite . This systematic review was registered at Prospero data system ( CRD42015023940 ) . Studies were search ed in the electronic data bases PubMed , Web of Science , Scopus , Lilacs and EMBASE according to a predefined search strategy . The inclusion criteria were as follow : ( 1 ) r and omized controlled clinical trials with at least six months of follow-up ; ( 2 ) studies investigating composites with monomers design ed to reduce polymerization shrinkage ; ( 3 ) studies conducted with class I or II restorations in the permanent dentition ; and ( 4 ) studies that assessed at least one of the following criteria : marginal integrity/adaptation , marginal discoloration , recurent caries , retention of composite restorations , and postoperative sensitivity . Two independent review ers analyzed the articles to determine inclusion and risk of bias . The search conducted in the data bases result ed in a total of 14,217 studies . After review ing the references and citations , 21 articles remained . The longest clinical follow-up time was 60 months . The meta- analysis of the data in the included studies demonstrated that only one variable ( marginal adaptation after 12 months ) showed statistically significant outcomes , in which methacrylates-based composites presented significantly better results than resin composites containing modified monomers . The good level of the scientific evidence as well as the overall low risk of bias of the included studies indicate that composites with silorane , ormocer or bulk-fill type modified monomers have a clinical performance similar to conventional resin composites
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[
"STATEMENT OF PROBLEM Composite resins are still outperformed by amalgams in the clinical practice with secondary caries and fractures being their most common failures . A material that suffers less polymerization shrinkage might improve the clinical performance of composite resins . PURPOSE To evaluate the clinical performance of a low-shrink silorane-based composite resin ( Filtek LS Low Shrink Posterior Restorative , 3 M ESPE , St. Paul , MN , USA ) in comparison with a methacrylate-based composite resin ( Tetric EvoCeram , Ivoclar Vivadent , Schaan , Principality of Liechtenstein ) over time . MATERIAL S AND METHODS C and i date s in need of Class II composite resin restorations participated in this r and omized controlled clinical trial . Those were 25 female and six male subjects with average age of 44.3 ± 12.7 years . Participants received 82 restorations , being 54 in premolars and 28 in molars . Procedures , which included the restoration of primary caries lesions or replacement of failing restorations , were done using modified preparations with no bevels or additional retention . Restorations were placed using Filtek LS ( and dedicated self-etch adhesive ) or Tetric EvoCeram ( with AdheSE , Ivoclar Vivadent ) , following manufacturers ' instructions . Incremental placement technique was applied and the restorations were immediately finished . Follow-up evaluations occurred at six , 12 , 24 , and 36 months and were done using the Fédération Dentaire Internationale criteria . Statistical analysis was performed using generalized estimating equations . RESULTS The recall rate at 36 months was 89 % . All interaction terms were not significant . CONCLUSIONS Filtek LS performs as well as Tetric EvoCeram performs in the clinical setting at 36 months . CLINICAL SIGNIFICANCE The silorane-based composite resin Filtek LS and the conventional methacrylate-based composite resin Tetric EvoCeram performed similarly well in posterior restorations over at least 36 months of clinical service",
"STUDY QUESTION Are there differences in the method ological quality of Cochrane systematic review s ( CRs ) and non-Cochrane systematic review s ( NCRs ) of assisted reproductive technologies ? SUMMARY ANSWER CRs on assisted reproduction are of higher method ological quality than similar review s published in other journals . WHAT IS KNOWN ALREADY The quality of systematic review s varies . STUDY DESIGN , SIZE AND DURATION This was a cross-sectional study of 30 CR and 30 NCR systematic review s that were r and omly selected from the eligible review s identified from a literature search for the years 2007 - 2011 . MATERIAL S , SETTING AND METHODS We extracted data on the reporting and method ological characteristics of the included systematic review s. We assessed the method ological quality of the review s using the 11-domain Measurement Tool to Assess the Method ological Quality of Systematic Review s ( AMSTAR ) tool and subsequently compared CR and NCR systematic review s. MAIN RESULTS AND THE ROLE OF CHANCE The AMSTAR quality assessment found that CRs were superior to NCRs . For 10 of 11 AMSTAR domains , the requirements were met in > 50 % of CRs , but only 4 of 11 domains showed requirements being met in > 50 % of NCRs . The strengths of CRs are the a priori study design , comprehensive literature search , explicit lists of included and excluded studies and assessment s of internal validity . Significant failings in the CRs were found in duplicate study selection and data extraction ( 67 % meeting requirements ) , assessment for publication bias ( 53 % meeting requirements ) and reporting of conflicts of interest ( 47 % meeting requirements ) . NCRs were more likely to contain method ological weaknesses as the majority of the domains showed assessment of study quality ( 27 % ) , study quality in the formulation of conclusions ( 23 % ) and reporting of conflict of interests ( 10 % ) . LIMITATIONS , REASONS FOR CAUTION The AMSTAR assessment can only judge what is reported by authors . Although two of the five authors are involved in the production of CRs , the risk of bias was reduced by not involving these authors in the assessment of the systematic review quality . WIDER IMPLICATION S OF THE FINDINGS Not all systematic review s are equal . The reader needs to consider the quality of the systematic review when they consider the results and the conclusions of a systematic review . STUDY FUNDING /COMPETING INTEREST(S ) There are no conflicts with any commercial organization . Funding was provided for the students by the summer studentship programme of the Faculty of Medical and Health Sciences of the University of Auckl and",
"OBJECTIVE The aim of this prospect i ve r and omized-controlled clinical trial is to assess the long-term performance of two direct composite resins in posterior teeth . This study provides a survey of the one-year results . MATERIAL S AND METHODS A total of 1805 restorations were placed by students in stress-bearing Class I/II cavities ( including cuspal-coverage ) in molars and premolars in 456 patients . Clinical evaluation was performed at baseline and after one year using modified USPHS criteria . The restorations in each patient were performed either with Ceram X/Prime&Bond NT or Tetric Ceram/Optibond Solo Plus . RESULTS After one year 528 fillings with Ceram X and 580 with Tetric Ceram were available for evaluation of substance loss , contact point , color match , marginal staining , marginal adaptation , secondary caries and radiographic examination ( if necessary ) . This represents a recall rate of 61.18 % ( 279 patients ) . The failure rate per material was 5.3 % in the Ceram X group and 6.1 % in the Tetric Ceram group . Most of the failures were associated with marginal adaptation/integrity of the filling . A significant influence on the occurrence of a failure was observed for the number of treated teeth per patient , the age of the patient , the mesio-distal extension of the restoration and the tooth position . Gender , material , a previous root canal treatment , the bucco-lingual extension of the filling or cuspal-coverage did not significantly influence the failure rate . Patients attending the first recall were significantly older and had more fillings than patients not attending . CONCLUSIONS In a group of Class I/II restorations ( including cuspal-coverage ) , there was no significant difference in failure rates between ormocer-based and bis-GMA-based restorative systems after one year . A previous root canal treatment had no negative influence on the failure rate . A longer observation period is indicated to get clear evidence of the long-term performance of these composite resin systems",
"PURPOSE To compare the 2-year clinical performance of a silorane-based resin composite with that of an established nanoceramic resin composite for class 1 posterior restorations . METHODS In this r and omized controlled study , 100 class 1 molar cavities were prepared in 50 subjects . Each subject received a restoration with Filtek Silorane and Ceram . X Duo in different quadrants . The restorations were evaluated using the modified USPHS criteria at baseline and 6 , 12 , and 24 months . Parametric changes over the 2-year period were assessed with the Friedman test . The baseline and recall scores were compared by using the Wilcoxon signed-rank test ( P secondary caries or postoperative sensitivity . Further , the resin composites showed no significant differences in all the evaluated parameters over 2 years ( P > 0.05 ) . At 2 years , four Filtek Silorane and seven Ceram . X Duo restorations had Bravo scores for anatomic form , marginal adaptation , and surface texture ( P < 0.05 ) ; however , these changes were mainly the effect of scoring shifts from Alfa to Bravo . Overall , both material s showed good clinical results with predominantly Alfa scores",
"OBJECTIVES To determine the marginal adaptation of bulk-fill composites in class II MO cavities . METHODS St and ardized class II MO cavities with bevelled enamel margins were prepared in 40 extracted human molars . The teeth were r and omly assigned to one of the five experimental groups ( n=8 ) . The teeth were restored with two horizontal increments of composite ( 4 mm and 2 mm thickness ) . The experimental groups were ( 1st/2nd increment ) : Gr . A - Venus Bulk-Fill/Venus Diamond ; Gr . B - Tetric EvoCeram BulkFill/Tetric EvoCeram ; Gr . C - Surefil SDR/Ceram-X ; Gr . D - SonicFill ; Gr . E - Ceram-X/Ceram-X ( control ) . After finishing procedures , impressions were made using a polyvinyl siloxane and epoxy resin replicas were obtained . Thermo-mechanical stressing was carried out 24h after the restorative procedure . All specimens were su bmi tted to 240,000 occlusal loading and simultaneous 600 thermal cycles in water at 5 ° C and 50 ° C . After loading , a new set of epoxy resin replicas was obtained . Scanning electron microscopy was carried out at 200 × magnification . Results for the marginal adaptation were expressed as percentages of continuity relative to the exposed interface and analyzed by ANOVA and Duncan post hoc test ( p no significant differences were detected before and after thermo-mechanical loading between groups . In dentine , the worst results were observed in Gr . A CONCLUSION By applying simple layering techniques , bulk-fill material s do not allow better marginal adaptation than a st and ard composite . CLINICAL SIGNIFICANCE A new class of resin-base composite ( bulk-fill ) was recently launched on the market . The bulk-fill composites exhibited adequate marginal adaptation and similar to the results of the st and ard composite ",
"OBJECTIVE The objective of this r and omized controlled prospect i ve clinical trial was to evaluate the efficacy of a flowable resin composite ( SDR ) bulk fill technique in posterior restorations and to compare it intraindividually with a conventional 2 mm resin composite curing technique in a 3-year follow up . MATERIAL S AND METHODS Thirty-eight pairs Class II and 15 pairs Class I restorations were placed in 38 patients with a mean age of 55.3 years ( range 32 - 87 ) . Each patient received at r and om at least two , as similar as possible , Class II or Class I restorations of two restorative techniques . In all cavities a single step self-etch adhesive ( Xeno V ) was applied . In one of the cavities of each pair , a flowable resin composite ( SDR ) was placed , in bulk increments up to 4 mm as needed to fill the cavity 2 mm short of the occlusal cavosurface . The occlusal part was completed with a nano-hybrid resin composite ( Ceram X mono ) layer . In the second cavity , the hybrid resin composite was placed in 2 mm increments . The restorations were evaluated using slightly modified USPHS criteria at baseline and then yearly during 3 years . Caries risk and parafunctional habits of the participants were estimated . RESULTS After three years , 76 Class II and 28 Class I restorations could be observed . One molar resin composite-only tooth showed post-operative sensitivity during 3 weeks for temperature changes and occlusal forces . Two failed Class II molar restorations in the resin composite-only group were observed during the first year , one cusp fracture and one resin composite fracture . An annual failure rate of 1.3 % was found for the resin composite only restorations and of 0 % in the bulk-filled restorations ( n.s . ) . Ten participants were estimated as having high caries risk and eleven showed active bruxing habits . SIGNIFICANCE The 4 mm bulk-fill technique with the flowable resin composite SDR showed highly clinical effectiveness , which was comparable during the 3-year follow-up with the 2 mm resin composite layering technique",
"OBJECTIVES The aim of this study was to quantify the polymerization volumetric shrinkage of one regular and two low shrinkage bulk fill composites in class I cavities with or without an adhesive layer , using three-dimensional ( 3D ) micro-computed tomography ( μCT ) . METHODS Class I cavity preparations ( 2.5 mm depth × 4 mm length × 4 mm wide ) were st and ardized in 36 extracted human third molars , which were r and omly divided in six groups ( n = 6 each ) as follows : Group VIT ( regular composite without bonding agent ) ; Group SDR ( low shrinkage flowable composite without bonding agent ) ; Group TET ( low shrinkage composite without bonding agent ) ; Group VIT/P ( regular composite with bonding agent ) ; Group SDR/X ( low shrinkage flowable composite with bonding agent ) ; TET/T ( low shrinkage composite with bonding agent ) . Each tooth was scanned via µCT at cavity preparation , immediately after cavity filling , and after light-curing . Acquired μCT data were imported into Amira software for analysis and volume values evaluated between steps from cavity preparation until light-curing . RESULTS Both low shrinkage composites showed a significantly less volumetric shrinkage than VIT . The use of dental adhesive significantly decreased the average volumetric contraction similarly for the three composites , by about 20 % . CONCLUSION Both low shrinkage composites showed less volumetric polymerization contraction than the regular composite . The use of dental adhesive decreased the total volumetric shrinkage for all evaluated composites",
"PURPOSE To compare the clinical performance of a silorane-based with a methacrylate-based restorative system in class 2 restorations after an 18-month follow-up . METHODS This r and omized , double-blind and controlled study included 33 subjects receiving 100 direct resin composite restorations that were completely r and omized to silorane-based group ( Filtek P90/Silorane System Adhesive - 3 M ESPE ) or methacrylate-based group ( Filtek P60/Adper SE Plus - 3 M ESPE ) . The restorative system was determined by chance using a coin toss until 50 units for each group were completed . Each subject contributed with one to seven restorations . A single operator performed all of the restorative procedures . Two calibrated examiners ( kw > or = 0.7 ) assessed the restorations at baseline and after 18 months according to modified United States Public Health System ( USPHS ) criteria . The data were analyzed with Mann-Whitney U-test , Wilcoxon signed rank and Kaplan-Meier survival curves ( alpha = 0.05 ) . RESULTS After 18 months , 88 restorations were evaluated , and five unacceptable restorations were observed . Proximal contact loss was the main reason for failure ( three ) followed by composite fracture ( two ) . The marginal integrity of the silorane-based group was significantly worse than that of the methacrylate-based group ( P= 0.035 ) . Comparing baseline to 18-month evaluations , the silorane-based group showed significant differences for marginal discoloration , marginal integrity and surface texture ( P methacrylate-based group differed significantly for marginal discoloration and surface texture ( P Combined survival rate for both groups together was 95 % . No statistically significant difference was found between methacrylate-based ( 98 % ) and silorane-based ( 92 % ) overall survival rate ( Log rank test ; P = 0.185 )",
"OBJECTIVES Ormocer composites , consisting of a silicon-based polymer , have been developed recently as a tooth-colored restorative material . The purpose of this prospect i ve r and omized clinical trial was to evaluate the performance of two small-particle hybrid ormocer-based restorative systems ( AD , Admira/Admira Bond , VOCO ; DE , Definite/Etch & Prime 3.0 , Dentsply ) and one small-particle hybrid bis-GMA-based composite restorative system ( TC , Tetric-Ceram/Syntac , Ivoclar-Vivadent ) in class II cavities . METHODS From 128 occlusal-proximal restorations ( 44 AD , 43 DE and 41 TC ) placed in 32 adult patients , eventually 77 ( 22 AD , 29 DE and 26 TC ) remained available for evaluation after 5 years . Their clinical performance was scored according to the USPHS criteria and evaluation of bite-wing radiographs . RESULTS After 5 years , eight AD , six DE and seven TC restorations had failed ( p=0.10 , log-rank test ) . The main reason was fracture or marginal gap formation , while secondary caries accounted for four failures . In all restorations the quality of surface , margins and contact point decreased significantly compared to baseline . DE had a significant poorer color match ( p<0.01 ) . Statistical evaluation using the KW test showed that failures were concentrated on specific patients . CONCLUSIONS In a group of class II restorations , there was no significant difference in failures after 5 years between ormocer-based and bis-GMA-based restorative systems",
"R and omised controlled trials , when appropriately design ed , conducted , and reported , represent the gold st and ard in evaluating healthcare interventions . However , r and omised trials can yield biased results if they lack method ological rigour [ 1 ] . To assess a trial accurately , readers of a published report need complete , clear , and transparent information on its methodology and findings . Unfortunately , attempted assessment s frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information [ 2,3,4 ] . That lack of adequate reporting fuelled the development of the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement in 1996 [ 5 ] and its revision five years later [ 6,7,8 ] . While those statements improved the reporting quality for some r and omised controlled trials [ 9,10 ] , many trial reports still remain inadequate [ 2 ] . Furthermore , new method ological evidence and additional experience has accumulated since the last revision in 2001 . Consequently , we organised a CONSORT Group meeting to up date the 2001 statement [ 6,7,8 ] . We introduce here the result of that process , CONSORT 2010 .",
"OBJECTIVES Ormocer composites , consisting of a silicon-based polymer , have been developed recently as a tooth-coloured restorative material . The purpose of this prospect i ve r and omised clinical trial was to evaluate the performance of two small-particle hybrid ormocer-based restorative systems ( AD , Admira/Admira Bond , VOCO ; DE , Definite/Etch & Prime 3.0 , Dentsply ) and one small-particle hybrid bis-GMA-based composite restorative system ( TC , Tetric-Ceram/Syntac , Ivoclar-Vivadent ) in occlusal stress-bearing restorations . METHODS One hundred and twenty-eight occlusal-proximal restorations ( 44 AD , 43 DE and 41 TC ) were placed according to the manufacturer 's instructions in thirty-two adult patients . Their clinical performance was scored according to the USPHS criteria and evaluation of bite-wing radiographs . RESULTS After 3 years , four AD , five DE and four TC restorations had failed due to fracture or marginal gap formation . Surface roughness improved significantly when compared to the baseline in AD and TC ( Friedman test , p discolouration ( p internal porosities . ANOVA showed that larger restorations ( > or = 3 surfaces ) showed significantly more degradation than smaller ones . CONCLUSIONS In a group of class II restorations , there was no significant difference in failures after 3 years between ormocer-based and bis-GMA-based restorative systems"
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4117094c-06ff-11f0-808a-c43d1ab1c353
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Background Cardiovascular disease ( CVD ) is the leading cause of death globally . However , many individuals are unaware of their CVD risk factors . The objective of this systematic review is to determine the effectiveness of existing intervention strategies to increase uptake of CVD risk factors screening . Methods A systematic search was conducted through Pubmed , CINAHL , EMBASE and Cochrane Central Register of Controlled Trials . Additional articles were located through cross-checking of the references list and bibliography citations of the included studies and previous review papers . We included intervention studies with controlled or baseline comparison groups that were conducted in primary care practice s or the community , targeted at adult population s ( r and omized controlled trials , non-r and omized trials with controlled groups and pre- and post-intervention studies ) . The interventions were targeted either at individuals , communities , health care professionals or the health-care system . The main outcome of interest was the relative risk ( RR ) of screening uptake rates due to the intervention . Results We included 21 studies in the meta- analysis . The risk of bias for r and omization was low to medium in the r and omized controlled trials , except for one , and high in the non-r and omized trials . Two analyses were performed ; optimistic ( using the highest effect sizes ) and pessimistic ( using the lowest effect sizes ) . Overall , interventions were shown to increase the uptake of screening for CVD risk factors ( RR 1.443 ; 95 % CI 1.264 to 1.648 for pessimistic analysis and RR 1.680 ; 95 % CI 1.420 to 1.988 for optimistic analysis ) . Effective interventions that increased screening participation included : use of physician reminders ( RR ranged between 1.392 ; 95 % CI 1.192 to 1.625 , and 1.471 ; 95 % CI 1.304 to 1.660 ) , use of dedicated personnel ( RR ranged between 1.510 ; 95 % CI 1.014 to 2.247 , and 2.536 ; 95 % CI 1.297 to 4.960 ) and provision of financial incentives for screening ( RR 1.462 ; 95 % CI 1.068 to 2.000 ) . Meta-regression analysis showed that the effect of CVD risk factors screening uptake was not associated with study design , types of population nor types of interventions . Conclusions Interventions using physician reminders , using dedicated personnel to deliver screening , and provision of financial incentives were found to be effective in increasing CVD risk factors screening uptake
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"Recent re-evaluation of preventive health care has result ed in more limited and directed guidelines ; nonetheless , physician compliance has remained poor . This study assessed whether an inexpensive reminder system of preventive care checklists would improve physician implementation of periodic health measures . Residents in internal medicine were r and omly placed into two groups : one received a copy of the appropriate checklist with each patient 's medical record ; the other did not . After one year , 200 r and omly selected records were audited to determine the proportion of recommendations implemented for each patient . Residents who received checklists performed appropriate preventive health measures at a significantly higher rate than those who did not ( 0.56 + /- 0.26 versus 0.39 + /- 0.22 , p less than 0.002 ) . The actual use of the checklist to record the results was associated with an even higher rate of compliance compared with instances in which the checklists were provided but not used and instances in which checklists were not received ( 0.70 + /- 0.21 versus 0.44 + /- 0.24 and 0.39 + /- 0.22 , respectively , p less than 0.002 ) . These data suggest that a physician 's use of simple checklists can provide an inexpensive and effective means of improving implementation of periodic health maintenance",
"OBJECTIVES To apply and evaluate the effects of a program for computer generated physician reminders , integrated with an electronic patient record ( EPR ) system , for opportunistic health screening in elderly patients . DESIGN A pilot study design ed as a 20-month clinical trial with a control group and a 20-month non-intervention follow-up using a computer reminder program that selects patients for screening in five intervention areas ( diabetes , hypertension , cobalamin deficiency , hypothyroidism and anaemia ) . SETTING Four primary health care ( PHC ) centres in suburban Stockholm . SUBJECTS The intervention was design ed for patients 70 years or older from one health care centre who visited a general practitioner ( GP ) during the first 20-month period . Patients from the three remaining centres served as controls . MAIN OUTCOME MEASURES The number of patients who underwent the tests , who had pathological test results , new diagnoses and new pharmacological treatments in both patient groups . RESULTS In total , 602 patients underwent screening and 1989 were controls . There was a statistically significant , moderate or marked increase ( 13 - 75 % ) in the number of patients who were tested in all five intervention areas . An increase in pathological test results ( 1 - 8 % ) was found in two areas : hypertension and cobalamin deficiency . There was an increase in the number of patients with the diagnosis of cobalamin deficiency during the study . At follow-up a decrease in new diagnoses for anaemia was found . CONCLUSION The system seems to be associated with a moderate to large increase in laboratory and manual screening tests for both established and new screening areas . The effect on clinical outcomes was found mainly in a not-yet-established screening area ( cobalamin deficiency ) , indicating that the system may be clinical ly useful when introducing new screening services",
"Background — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners",
"Background Primary care provides most of the evidence -based chronic disease prevention and screening services offered by the healthcare system . However , there remains a gap between recommended preventive services and actual practice . This trial ( the BETTER Trial ) aim ed to improve preventive care of heart disease , diabetes , colorectal , breast and cervical cancers , and relevant lifestyle factors through a practice facilitation intervention set in primary care . Methods Pragmatic two-way factorial cluster RCT with Primary Care Physicians ’ practice s as the unit of allocation and individual patients as the unit of analysis . The setting was urban Primary Care Team practice s in two Canadian provinces . Eight Primary Care Team practice s were r and omly assigned to receive the practice -level intervention or wait-list control ; 4 physicians in each team ( 32 physicians ) were r and omly assigned to receive the patient-level intervention or wait-list control . Patients r and omly selected from physicians ’ rosters were stratified into two groups : 1 ) general and 2 ) moderate mental illness . The interventions involved a multifaceted , evidence -based , tailored practice -level intervention with a Practice Facilitator , and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored ‘ prevention prescription ’ . The primary outcome was a composite Summary Quality Index of 28 evidence -based chronic disease prevention and screening actions with pre-defined targets , expressed as the ratio of eligible actions at baseline that were met at follow-up . A cost-effectiveness analysis was conducted . Results 789 of 1,260 ( 63 % ) eligible patients participated . On average , patients were eligible for 8.96 ( SD 3.2 ) actions at baseline . In the adjusted analysis , control patients met 23.1 % ( 95 % CI : 19.2 % to 27.1 % ) of target actions , compared to 28.5 % ( 95 % CI : 20.9 % to 36.0 % ) receiving the practice -level intervention , 55.6 % ( 95 % CI : 49.0 % to 62.1 % ) receiving the patient-level intervention , and 58.9 % ( 95 % CI : 54.7 % to 63.1 % ) receiving both practice - and patient-level interventions ( patient-level intervention versus control , P extra cost of the intervention was $ 26.43CAN ( 95 % CI : $ 16 to $ 44 ) per additional action met . Conclusions A Prevention Practitioner can improve the implementation of clinical ly important prevention and screening for chronic diseases in a cost-effective manner",
"Background Practice facilitation has been associated with meaningful improvements in disease prevention and quality of patient care . Using practice facilitation , the Improved Delivery of Cardiovascular Care ( IDOCC ) project aim ed to improve the delivery of evidence -based cardiovascular care in primary care practice s across a large health region . Our goal was to evaluate IDOCC ’s impact on adherence to processes of care delivery . Methods A pragmatic stepped wedge cluster r and omized trial recruiting primary care providers in practice s located in Eastern Ontario , Canada ( Clinical Trials.gov : NCT00574808 ) . Participants were r and omly assigned by region to one of three steps . Practice facilitators were intended to visit practice s every 3–4 ( year 1—intensive ) or 6–12 weeks ( year 2—sustainability ) to support changes in practice behavior . The primary outcome was mean adherence to indicators of evidence -based care measured at the patient level . Adherence was assessed by chart review of a r and omly selected cohort of 66 patients per practice in each pre-intervention year , as well as in year 1 and year 2 post-intervention . Results Eighty-four practice s ( 182 physicians ) participated . On average , facilitators had 6.6 ( min : 2 , max : 11 ) face-to-face visits with practice s in year 1 and 2.5 ( min : 0 max : 10 ) visits in year 2 . We collected chart data from 5292 patients . After adjustment for patient and provider characteristics , there was a 1.9 % ( 95 % confidence interval ( CI ) : −2.9 to −0.9 % ) and 4.2 % ( 95 % CI : −5.7 to −2.6 % ) absolute decrease in mean adherence from baseline to intensive and sustainability years , respectively . Conclusions IDOCC did not improve adherence to best- practice guidelines . Our results showed a small statistically significant decrease in mean adherence of question able clinical significance . Potential reasons for this result include implementation challenges , competing priorities in practice s , a broad focus on multiple chronic disease indicators , and use of an overall index of adherence . These results contrast with findings from previously reported facilitation trials and highlight the complexities and challenges of translating research findings into clinical practice .Trial registration Clinical Trials.gov",
"BACKGROUND Decision-support information technology is often adopted to improve clinical decision making , but it is rarely rigorously evaluated . Congress m and ated the evaluation of Problem-Knowledge Couplers ( PKC Corp , Burlington , Vt ) , a decision-support tool proposed for the Department of Defense 's new health information network . METHODS This was a patient-level r and omized trial conducted at 2 military practice s. A total of 936 patients were allocated to the intervention group and 966 to usual care . Couplers were applied before routine ambulatory clinic visits . The primary outcome was quality of care , which was assessed based on the total percentage of any of 24 health care quality process measures ( opportunities to provide evidence -based care ) that were fulfilled . Secondary outcomes included medical re sources consumed within 60 days of enrollment and patient and provider satisfaction . RESULTS There were 4639 health care opportunities ( 2374 in the Coupler group and 2265 in the usual-care group ) , with no difference in the proportion of opportunities fulfilled ( 33.9 % vs 30.7 % ; P = .12 ) . Although there was a modest improvement in performance on screening/preventive measures , it was offset by poorer performance on some measures of acute care . Coupler patients used more laboratory and pharmacy re sources than usual-care patients ( logarithmic mean difference , 71 dollars ) . No difference in patient satisfaction was observed between groups , and provider satisfaction was mixed . CONCLUSION This study provides no strong evidence to support the utility of this decision-support tool , but it demonstrates the value of rigorous evaluation of decision-support information technology",
"BACKGROUND there is inadequate evidence to support currently formulated NHS strategies to achieve health promotion and preventative care in older people through broad-based screening and assessment in primary care . The most extensively evaluated delivery instrument for this purpose is Health Risk Appraisal ( HRA ) . This article describes a trial using HRA to evaluate the effect on health behaviour and preventative-care uptake in older people in NHS primary care . METHODS a r and omised controlled trial was undertaken in three London primary care group practice s. Functionally independent community-dwelling patients older than 65 years ( n = 2,503 ) received a self-administered Health Risk Appraisal for Older Persons ( HRA-O ) question naire leading to computer-generated individualised written feedback to participants and general practitioners ( GPs ) , integrated into practice information-technology ( IT ) systems . All primary care staff received training in preventative health in older people . The main outcome measures were self-reported health behaviour and preventative care uptake at 1-year follow-up . RESULTS of 2,503 individuals r and omised , 2,006 respondents ( 80.1 % ) ( intervention , n = 940 , control n = 1,066 ) were available for analysis . Intervention group respondents reported slightly higher pneumococcal vaccination uptake and equivocal improvement in physical activity levels compared with controls . No significant differences were observed for any other categories of health behaviour or preventative care measures at 1-year follow-up . CONCLUSIONS HRA-O implemented in this way result ed in minimal improvement of health behaviour or uptake of preventative care measures in older people . Supplementary reinforcement involving contact by health professionals with patients over and above routine clinical encounters may be a prerequisite to the effectiveness of IT-based delivery systems for health promotion in older people",
"Objective To compare the effect of an invitation promoting informed choice for screening with a st and ard invitation on attendance and motivation to engage in preventive action . Design R and omised controlled trial . Setting Four English general practice s. Participants 1272 people aged 40 - 69 years , at risk for diabetes , identified from practice registers using a vali date d risk score and invited to attend for screening . Intervention Intervention was a previously vali date d invitation to inform the decision to attend screening , presenting diabetes as a serious potential problem , and providing details of possible costs and benefits of screening and treatment in text and pie charts . This was compared with a brief , st and ard invitation simply describing diabetes as a serious potential problem . Main outcome measures The primary end point was attendance for screening . The secondary outcome measures were intention to make changes to lifestyle and satisfaction with decisions made among attenders . Results The primary end point was analysed for all 1272 participants . 55.8 % ( 353/633 ) of those in the informed choice group attended for screening , compared with 57.6 % ( 368/639 ) in the st and ard invitation group ( mean difference −1.8 % , 95 % confidence interval −7.3 % to 3.6 % ; P=0.51 ) . Attendance was lower among the more deprived group ( most deprived third 47.5 % v least deprived third 64.3 % ; P ) . Interaction between deprivation and effect of invitation type on attendance was not significant . Among attenders , intention to change behaviour was strong and unaffected by invitation type . Conclusions Providing information to support choice did not adversely affect attendance for screening for diabetes . Those from more socially deprived groups were , however , less likely to attend , regardless of the type of invitation received . Further attention to invitation content alone is unlikely to achieve equity in uptake of preventive services . Trial registration Current Controlled Trials IS RCT N 73125647",
"Background Preventive health care is an important part of general practice however uptake of activities by patients is variable . Monetary incentives for doctors have been used in the UK and Australia to improve rates of screening and immunisation . Few studies have focussed on incentives for patients to attend preventive health care examinations . Our objective was to investigate the use of a monetary incentive to increase patient attendance with their general practitioner for a cardiovascular risk assessment ( CVRA ) . Methods A pragmatic RCT was conducted in two Australian general practice s. Participating GPs underwent academic detailing for cardiovascular risk assessment . 301 patients aged 40–74 , who did not have cardiovascular disease , were independently r and omised to receive a letter inviting them to a no cost cardiovascular risk assessment with their GP , or the same letter plus an offer of a $ 25 shopping voucher if they attended . An audit of patient medical records was also undertaken and a patient question naire administered to a sub sample of participants . Our main outcome measure was attendance for cardiovascular risk assessment . Results In the RCT , 56/301(18.6 % ) patients attended for cardiovascular risk assessment , 29/182 ( 15.9 % ) in the control group and 27/119 ( 22.7 % ) in the intervention group . The estimated difference of 6.8 % ( 95 % CI : -2.5 % to 16.0 % ) was not statistically significant , P = 0.15 . The audit showed that GPs may underestimate patients ’ absolute cardiovascular risk and the question naire that mailed invitations from GPs for a CVRA may encourage patients to attend . Conclusions A small monetary incentive does not improve attendance for cardiovascular risk assessment . Further research should be undertaken to determine if there are other incentives that may increase attendance for preventive activities in the general practice setting . Clinical trials registration",
"BACKGROUND Although there is much room for improvement in the performance of recommended preventive manoeuvres , many inappropriate preventive interventions are being done . We evaluated a multifaceted intervention , delivered by nurses trained in prevention facilitation , to improve prevention in primary care . METHODS Forty-six health service organizations ( HSOs ) were recruited from 100 sites in Ontario . After baseline data were collected , we r and omly assigned the practice s to either an 18-month ( July 1997 to December 1998 ) multifaceted intervention delivered by 1 of 3 nurse facilitators ( 23 practice s ) or no intervention ( 23 practice s ) . The unit of intervention and analysis was the medical practice . The outcome measure was an overall index of preventive performance , which was calculated as the proportion of eligible patients who received 8 recommended preventive manoeuvres less the proportion of eligible patients who received 5 inappropriate preventive manoeuvres . RESULTS One HSO , in the intervention group , was lost to follow-up . Before the intervention , the index of preventive performance was similar for the intervention and control groups ( 31.9 % [ 95 % confidence interval ( CI ) 27.3%-36.5 % ] and 32.1 % [ 95 % CI 27.2%-37.0 % ] respectively ) . At follow-up the corresponding values were 43.2 % ( 95 % CI 38.4%-48.0 % ) and 31.9 % ( 95 % CI 26.8%-37.0 % ) , for an absolute improvement in the intervention group of 11.5 % ( p mean proportion of eligible patients who received the recommended manoeuvres was 62.3 % ( 95 % CI 58.2%-66.4 % ) in the intervention group , as compared with 57.4 % ( 95 % CI 54.1%-60.7 % ) in the control group , for an absolute improvement of 7.2 % ( p = 0.008 ) . The corresponding values for the inappropriate manoeuvres were 19.1 % ( 95 % CI 15.6%-22.6 % ) and 25.5 % ( 95 % CI 20.0%-31.0 % ) , for an absolute improvement of 4.4 % ( p = 0.019 ) . INTERPRETATION The tailored multifaceted intervention delivered by nurse facilitators was effective in modifying physician practice patterns and significantly improved preventive care performance",
"OBJECTIVE To determine whether a cardiovascular disease ( CVD ) health screening program is associated with CVD-related health conditions , incidence of cardiovascular events , mortality , healthcare utilization , and costs . METHODS Cohort study of a 3 % r and om sample of all Korea National Health Insurance members 40years of age or older and free of CVD or CVD-related health conditions was conducted . A total 443,337 study participants were followed-up from January 1 , 2005 through December 31 , 2010 . RESULTS In primary analysis , the hazard ratios for CVD mortality , all-cause mortality , incident composite CVD events , myocardial infa rct ion , cerebral infa rct ion , and cerebral hemorrhage comparing participants who attended a screening exam during 2003 - 2004 compared to those who did not were 0.58 ( 95 % CI : 0.53 - 0.63 ) , 0.62 ( 95 % CI : 0.60 - 0.64 ) , 0.82 ( 95 % CI : 0.78 - 0.85 ) , 0.84 ( 95 % CI : 0.75 - 0.93 ) , 0.84 ( 95 % CI : 0.79 - 0.89 ) , and 0.73 ( 95 % CI : 0.67 - 0.80 ) , respectively . Screening attenders had higher rates of newly diagnosed hypertension , diabetes mellitus , and dyslipidemia , lower inpatient days of stay and cost , and lower outpatient cost compared to non-attenders . CONCLUSIONS Participation in CVD health screening was associated with lower rates of CVD , all-cause mortality , and CVD events , higher detection of CVD-related health conditions , and lower healthcare utilization and costs",
"OBJECTIVE --To assess whether an organised programme of prevention including the use of a health promotion nurse noticeably improved recording and follow up of cardiovascular risk factors and cervical smears in a general practice that had access to computerised cell and recall . DESIGN --R and omised controlled trial . SETTING --General practice in inner London . PATIENTS --All 3206 men and women aged 30 - 64 registered with the practice . INTERVENTION -- The intervention group had their risk factors ascertained and followed up by the health promotion nurse and the general practitioner , whereas those in the control group were managed by the general practitioner alone . END POINT -- Recording and follow up of blood pressure and cervical smears after three years . Recording of smoking , family history of ischaemic heart disease , and serum cholesterol concentrations were also examined . MEASUREMENTS and MAIN RESULTS --When the trial was stopped after two years the measurements of blood pressure in the preceding five years were 93 % ( 1511/1620 ) v 73 % ( 1160/1586 ) ( 95 % confidence interval for difference 17.5 to 22.7 % ) for intervention and control groups respectively . For patients with hypertension the figures were 97 % ( 104/107 ) v 69 % ( 80/116 ) ( 18.2 to 38.2 % ) . For women the proportion who had had a cervical smear in the preceding three years were 76 % ( 606/799 ) v 49 % ( 392/806 ) ( 22.5 to 31.9 % ) . Recording of smoking , family history of ischaemic heart disease , and serum cholesterol concentrations was also higher in the intervention group compared with the control group . CONCLUSION --An organised programme , which includes a nurse with specific responsibility for adult prevention , is likely to make an important contribution to recording of risk factors and follow up of those patients with known risks",
"BACKGROUND Primary care data bases contain cardiovascular disease risk factor data , but practical tools are required to improve identification of at-risk patients . AIM To test the effects of a system of electronic reminders ( the ' e-Nudge ' ) on cardiovascular events and the adequacy of data for cardiovascular risk estimation . DESIGN OF STUDY R and omised controlled trial . SETTING Nineteen general practice s in the West Midl and s , UK . METHOD The e-Nudge identifies four groups of patients aged over 50 years on the basis of estimated cardiovascular risk and adequacy of risk factor data in general practice computers . Screen messages highlight individuals at raised risk and prompt users to complete risk profiles where necessary . The proportion of the study population in the four groups was measured , as well as the rate of cardiovascular events in each arm after 2 years . RESULTS Over 38 000 patients ' electronic records were r and omised . The intervention led to an increase in the proportion of patients with sufficient data who were identifiably at risk , with a difference of 1.94 % compared to the control group ( 95 % confidence interval [ CI ] = 1.38 to 2.50 , P proportion potentially at risk but requiring further data for a risk estimation ( difference = -3.68 % , 95 % CI = -4.53 to -2.84 , P incidence of cardiovascular events ( rate ratio = 0.96 , 95 % CI = 0.85 to 1.10 , P = 0.59 ) . CONCLUSION Automated electronic reminders using routinely collected primary care data can improve the adequacy of cardiovascular risk factor information during everyday practice and increase the visibility of the at-risk population ",
"Abstract BACKGROUND : In New Zeal and , more than 5 % of people aged 50 years and older have undiagnosed diabetes ; most of them attend family practitioners ( FPs ) at least once a year . OBJECTIVES : To test the effectiveness of patients or computers as reminders to screen for diabetes in patients attending FPs . DESIGN : A r and omized-controlled trial compared screening rates in 4 intervention arms : patient reminders , computer reminders , both reminders , and usual care . The trial lasted 2 months . The patient reminder was a diabetes risk self- assessment sheet filled in by patients and given to the FP during the consultation . The computer reminder was an icon that flashed only for patients considered eligible for screening . PARTICIPANTS : One hundred and seven FPs . MEASUREMENTS : The primary outcome was whether each eligible patient , who attended during the trial , was or was not tested for blood glucose . Analysis was by intention to treat and allowed for clustering by FP . RESULTS : Patient reminders ( odds ratio [ OR ] 1.72 , 95 % confidence interval [ CI ] 1.21 , 2.43 ) , computer reminders ( OR 2.55 , 1.68 , 3.88 ) , and both reminders ( OR 1.69 , 1.11 , 2.59 ) were all effective compared with usual care . Computer reminders were more effective than patient reminders ( OR 1.49 , 1.07 , 2.07 ) . Patients were more likely to be screened if they visited the FP repeatedly , if patients were non-European , if they were “ regular ” patients of the practice , and if their FP had a higher screening rate prior to the study . CONCLUSIONS : Patient and computer reminders were effective methods to increase screening for diabetes . However , the effects were not additive",
"A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis",
"OBJECTIVES To determine the effectiveness of a telephone reminder to increase pneumococcal vaccination in a population that had received mailed reminders and to evaluate whether the intervention effect is similar for clinics serving primarily non-Hispanic black or non-Hispanic white patient population s. STUDY DESIGN R and omized trial within a managed care network . METHODS All unvaccinated patients 18 years and older with chronic medical conditions and 65 years and older without chronic medical conditions ( N = 6106 ) were r and omized to receive telephone intervention or st and ard care and followed up for 6-month vaccination status . The intervention was a telephone call initiated by a nurse to inform patients that pneumococcal vaccination was recommended and was a covered benefit of their insurance . RESULTS Intervention patients were 2.3 times as likely to be vaccinated during the study period than control patients ( P telephone intervention versus control was similar across clinics ( P = .16 ) and across the chronic disease and elderly groups ( P = .14 ) . In subanalyses of individuals reached by telephone intervention , unvaccinated black subjects were less likely to be vaccinated during the study than unvaccinated white subjects ( 34 % vs 25 % , P = .03 ) . Nurse staff time for telephone intervention cost $ 147.35 per additional patient vaccinated . CONCLUSIONS Telephone intervention was successful at increasing vaccination rates in a diverse managed care population that had already received mailed reminders . Tailored messaging for pneumococcal vaccination through telephone reminders increases patient dem and for vaccination and should be implemented by managed care organizations seeking to increase their vaccination rates ",
"BACKGROUND The Health Education and Research Trial ( HEART ) was a multicenter clinical trial design ed to test methods to improve primary care practice systems for heart disease prevention services . We present the trial methodology , the practice s ' use of medical record tools , and changes in documentation of cardiovascular risk factor screening and management . METHODS Primary care practice s were recruited from 4 Midwestern states . The factorial design result ed in 4 study groups : conference only , conference and quality improvement consultations , conference and prevention coordinator , and all interventions combined . Medical record audits and physician , staff , and patient surveys assessed practice change in cardiovascular disease risk factor documentation . RESULTS Practice s participated fully in this project , set goals to improve preventive services , and implemented recommended medical record tools . The number of goals set and the increase in the use of medical record tools were greatest in the combined intervention group , with improvements noted in all groups . The use of patient history question naires , problem lists , and flow sheets was significantly higher in the combined intervention group when compared with the conference-only group . Documentation of risk factor screening in a recommended-medical record location improved in all intervention groups , with significant sustained improvements in the practice s that received the combined intervention . Documented risk factor management significantly improved in all intervention groups compared with the conference-only control . CONCLUSION Primary care practice s are interested in improving prevention systems and can change these systems in response to supportive external interventions . Promoting organizational change to produce sustained improvement in preventive service clinical outcomes is a complex process that requires further research",
"Despite an emerging consensus on appropriate preventive services , a minority of patients receive them . A study was undertaken to assess the impact of computer-generated reminders to adult patients , their physicians , or both patients and physicians on adherence to five recommended preventive services : cholesterol measurements , fecal occult blood testing , mammography , Papanicolaou smears , and tetanus immunization . During the academic year 1988 - 1989 , all 7397 adult patients and their 49 physicians in a university family medicine clinical practice were r and omized by practice group into one of four study groups : control , physician reminders , patient reminders , and both physician and patient reminders . Adherence was defined in community-oriented terms : the percentage of patients within each group who had received the preventive service in the recommended interval . During the study period , adherence to four of the five preventive services increased significantly , with the largest increases in the physician and patient reminder group : cholesterol measurements increased from 19.5 % to 38.1 % , fecal occult blood testing 9.3 % to 27.0 % , mammography 11.4 % to 27.1 % , and tetanus immunization 23.4 % to 35.4 % ( for each increase , P less than .0001 , McNemar 's chi-square test ) . In general , increases were greater in blacks and in patients with any form of insurance coverage . Computer-based physician and patient reminder systems have great promise of improving adherence to preventive services in primary care setting",
"OBJECTIVE All Japanese aged ≥40 years are eligible for free annual health check-ups including blood pressure and cholesterol measurements . It is well known that health check-up screenees are more likely to have healthy lifestyles and better health conditions than non-screenees . Therefore , controlling these factors is required to investigate whether screenees have a lower mortality risk than non-screenees independent of their lifestyles or health conditions . METHODS We followed 48,775 Japanese National Health Insurance beneficiaries aged 40 - 79 years since 1994 for 11 years . We used Cox proportional hazard models adjusted for possible confounding factors . We also performed propensity for use of the health check-up matched cohort analyses . RESULTS Compared to non-screenees , multiple-adjusted hazard ratios ( 95 % confidence intervals ) for all-cause and cardiovascular disease mortality among screenees were 0.74 ( 0.62 - 0.88 ) and 0.65 ( 0.44 - 0.95 ) for men and 0.69 ( 0.52 - 0.91 ) and 0.61 ( 0.36 - 1.04 ) for women , respectively . These relations were also observed when we used propensity matched cohort analyses . CONCLUSION This is the first study to show that mortality rates are lower among screenees than non-screenees in Japanese health check-ups when propensity matched cohort analyses were used for adjusting confounding factors . Further prospect i ve studies , including r and omized controlled trials , are required to confirm whether screening lowers mortality ",
"BACKGROUND Preventive care is an important role for general practitioners , yet opportunities for prevention are often missed . METHOD We provided an automatic electronic record preventive care reminder system for 12 preventive care activities for one 10 doctor practice . All patients who attended were r and omised by the terminal digit of their record number . RESULTS The control uptake of opportunistic prevention was low ; ranging from 1.5 % ( tetanus immunisation ) to 27 % ( influenza immunisation ) . The reminders increased this by significant but small amounts for four out of 12 activities ( immunisation for tetanus and pneumococcus and recording of allergies and weight ) , insignificant increases for four ( mumps , measles and rubella immunisation , recording of smoking , and taking of cervical smears and of blood pressure ) , and insignificantly decreased influenza immunisation , and screening for diabetes and hyperlipidaemia . DISCUSSION Opportunistic electronic reminders have the potential to increase preventive care in general practice ",
"BACKGROUND The role of portable cholesterol analyzers in the identification and management of hypercholesterolemia is controversial . This study investigated the effect of free office cholesterol testing on screening behavior and on blood cholesterol reduction in a family practice center . METHODS After a baseline period of 5 months , an office cholesterol analyzer was made available for 1 year to two teams of patients and providers ( study group ) , but not to the other two teams ( control group ) . RESULTS The percentage of patients screened increased from 28 % to 52 % in the study group , and from 29 % to 42 % in the control group ( difference favoring study group , prevalence odds ratio = 1.47 , 95 % confidence interval [ CI ] = 1.33 to 1.62 ) . Compared with those whose cholesterol tests were sent to outside laboratories , patients screened with the office analyzer were younger ( mean age 36 years vs 42 years ) , and the barrier to those without insurance was reduced . There was no clinical ly or statistically significant effect on lowering cholesterol ( difference favoring study group = 0.01 mmol/L , 95 % CI = -0.15 to 0.17 ) . CONCLUSIONS The availability of free office cholesterol testing increased the prevalence of cholesterol testing , particularly for younger patients and those without insurance ; however , the testing had no discernible effect of motivating patients to lower their blood cholesterol levels",
"In a r and omized , controlled trial ( N = 8,298 ) the authors compared three ways of encouraging patients in a large family practice to obtain a blood pressure check . Working from computerized medical records at a teaching familymedicine center , the study included patients aged 18 years and over who had not had a blood pressure measurement during the previous year . In a normalcare control group , 21.1 % of those due for a blood pressure reading obtained one during the trial year . In one intervention group , a computer-generated message reminded the doctor to check the blood pressure of patients who happened to visit the center for an appointment ; 30.7 % of patients allocated to this group were checked . In the second group , the nurse contacted patients by telephone and encouraged 24.1 % of those who were due for a check to obtain one . Sending a letter to patients in the third group yielded a 35.7 % compliance rate . Considering the costs of the three interventions , the physician reminder was the most cost effective , followed by the letter reminder . Although statistically significant , the impact of the reminders was modest . A better approach might involve a combination of routine reminders to the physician , followed by letters to noncompliant patients"
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QUESTIONS Does home-based exercise improve exercise capacity and quality of life in people with chronic heart failure ? Is it safe ? DESIGN Systematic review with meta- analysis . PARTICIPANTS Adults with heart failure > 3 months duration . INTERVENTION Home-based aerobic exercise with or without resistance exercise . OUTCOME MEASURES Exercise capacity ( measured at the impairment level by peak VO2 and at the activity level by 6-min Walk Test ) , quality of life ( measured by disease-specific scales ) , and adverse events ( measured as death , hospitalisation ) . RESULTS 10 r and omised controlled trials with 648 participants of New York Heart Association Class II or III were included . Most participants were male > or = 50 years old with an ejection fraction The exercise programs ranged from 6 weeks to 9 months at low to moderate intensity ( 40 - 70 % of maximum heart rate or heart rate at 70 % peak VO2 . Home-based exercise increased 6-min walking distance by 41 m ( WMD , 95 % CI 19 to 63 ) and peak VO2 by 2.71 ml/kg/min ( WMD , 95 % CI 0.67 to 4.74 ) more than usual activity . It did not improve scores on the Minnesota Heart Failure Question naire ( WMD 0.5 points out of 105 , 95 % CI -4.4 to 5.4 ) or increase the odds of hospitalisation ( OR 0.75 , 95 % CI 0.19 to 2.92 ) more than usual activity . CONCLUSIONS Home-based exercise increased exercise capacity safely but did not improve quality of life in patients with chronic heart failure . It could therefore be used to improve the management of people with chronic heart failure who do not have access to hospital-based exercise
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"BACKGROUND Case management is believed to promote continuity of care and decrease hospitalization rates , although few controlled trials have tested this approach . OBJECTIVE To assess the effectiveness of a st and ardized telephonic case-management intervention in decreasing re source use in patients with chronic heart failure . METHODS A r and omized controlled clinical trial was used to assess the effect of telephonic case management on re source use . Patients were identified at hospitalization and assigned to receive 6 months of intervention ( n = 130 ) or usual care ( n = 228 ) based on the group to which their physician was r and omized . Hospitalization rates , readmission rates , hospital days , days to first rehospitalization , multiple readmissions , emergency department visits , inpatient costs , outpatient re source use , and patient satisfaction were measured at 3 and 6 months . RESULTS The heart failure hospitalization rate was 45.7 % lower in the intervention group at 3 months ( P = .03 ) and 47.8 % lower at 6 months ( P = .01 ) . Heart failure hospital days ( P = .03 ) and multiple readmissions ( P = .03 ) were significantly lower in the intervention group at 6 months . Inpatient heart failure costs were 45.5 % lower at 6 months ( P = .04 ) . A cost saving was realized even after intervention costs were deducted . There was no evidence of cost shifting to the outpatient setting . Patient satisfaction with care was higher in the intervention group . CONCLUSIONS The reduction in hospitalizations , costs , and other re source use achieved using st and ardized telephonic case management in the early months after a heart failure admission is greater than that usually achieved with pharmaceutical therapy and comparable with other disease management approaches",
"Background —Whether cardiac rehabilitation ( CR ) is effective in patients older than 75 years , who have been excluded from most trials , remains unclear . We enrolled patients 46 to 86 years old in a r and omized trial and assessed the effects of 2 months of post-myocardial infa rct ion ( MI ) CR on total work capacity ( TWC , in kilograms per meter ) and health-related quality of life ( HRQL ) . Methods and Results —Of 773 screened patients , 270 without cardiac failure , dementia , disability , or contraindications to exercise were r and omized to outpatient , hospital-based CR ( Hosp-CR ) , home-based CR ( Home-CR ) , or no CR within 3 predefined age groups ( middle-aged , 45 to 65 years ; old , 66 to 75 years ; and very old , > 75 years ) of 90 patients each . TWC and HRQL were determined with cycle ergometry and Sickness Impact Profile at baseline , after CR , and 6 and 12 months later . Within each age group , TWC improved with Hosp-CR and Home-CR and was unchanged with no CR . The improvement was similar in middle-aged and old persons but smaller , although still significant , in very old patients . TWC reverted toward baseline by 12 months with Hosp-CR but not with Home-CR . HRQL improved in middle-aged and old CR and control patients but only with CR in very old patients . Complications were similar across treatment and age groups . Costs were lower for Home-CR than for Hosp-CR . Conclusions —Post-MI Hosp-CR and Home-CR are similarly effective in the short term and improve TWC and HRQL in each age group . However , with lower costs and more prolonged positive effects , Home-CR may be the treatment of choice in low-risk older patients",
"AIMS Recent guidelines recommend regular exercise in the management of patients with chronic heart failure ( CHF ) . This study was design ed to compare the safety and efficacy of conventional bicycle exercise and functional electrical stimulation ( FES ) of the legs as forms of home-based exercise training for patients with stable CHF . METHODS AND RESULTS Forty-six patients ( 38 male ) with stable NYHA Class II/III heart failure underwent a 6-week training programme using either a bicycle ergometer or electrical stimulation of the quadriceps and gastrocnemius muscles . In the bike group , significant increases were seen in 6-min walk ( 44.6 m , 95 % confidence interval ( CI ) 29.3 - 60.9 m ) , treadmill exercise time ( 110 s , 95 % CI 72.2 - 148.0 s ) , maximum leg strength ( 5.32 kg , 95 % CI 3.18 - 7.45 kg ) , and quadriceps fatigue index ( 0.08 , 95 % CI 0.04 - 0.12 ) following training . In the stimulator group , similar significant increases were seen following training for 6-min walk ( 40.6 m , 95 % CI 28.2 - 53.0 m ) , treadmill exercise time ( 67 s , 95 % CI 11.8 - 121.8s ) , maximum leg strength ( 5.35 kg , 95 % CI 1.53 - 9.17 kg ) , and quadriceps fatigue index ( 0.10 , 95 % CI 0.04 - 0.17 ) . Peak VO(2)did not change in either group following training , indicating a low-intensity regime . Quality of life scores improved following training when the bicycle and stimulator groups were considered together , but not when considered separately ( -0.43 , 95 % CI -8.13 to -0.56 ) . CONCLUSIONS FES produces beneficial changes in muscle performance and exercise capacity in patients with CHF . Within this study , the benefits were similar to those observed following bicycle training . FES could be offered to patients with heart failure as an alternative to bicycle training as part of a home-based rehabilitation programme",
"Background — Exercise training reduces the symptoms of chronic heart failure . Which exercise intensity yields maximal beneficial adaptations is controversial . Furthermore , the incidence of chronic heart failure increases with advanced age ; it has been reported that 88 % and 49 % of patients with a first diagnosis of chronic heart failure are > 65 and > 80 years old , respectively . Despite this , most previous studies have excluded patients with an age > 70 years . Our objective was to compare training programs with moderate versus high exercise intensity with regard to variables associated with cardiovascular function and prognosis in patients with postinfa rct ion heart failure . Methods and Results — Twenty-seven patients with stable postinfa rct ion heart failure who were undergoing optimal medical treatment , including & bgr;-blockers and angiotensin-converting enzyme inhibitors ( aged 75.5±11.1 years ; left ventricular [ LV ] ejection fraction 29 % ; & OV0312;o2peak 13 mL · kg−1 · min−1 ) were r and omized to either moderate continuous training ( 70 % of highest measured heart rate , ie , peak heart rate ) or aerobic interval training ( 95 % of peak heart rate ) 3 times per week for 12 weeks or to a control group that received st and ard advice regarding physical activity . & OV0312;o2peak increased more with aerobic interval training than moderate continuous training ( 46 % versus 14 % , P with reverse LV remodeling . LV end-diastolic and end-systolic volumes declined with aerobic interval training only , by 18 % and 25 % , respectively ; LV ejection fraction increased 35 % , and pro-brain natriuretic peptide decreased 40 % . Improvement in brachial artery flow-mediated dilation ( endothelial function ) was greater with aerobic interval training , and mitochondrial function in lateral vastus muscle increased with aerobic interval training only . The MacNew global score for quality of life in cardiovascular disease increased in both exercise groups . No changes occurred in the control group . Conclusions — Exercise intensity was an important factor for reversing LV remodeling and improving aerobic capacity , endothelial function , and quality of life in patients with postinfa rct ion heart failure . These findings may have important implication s for exercise training in rehabilitation programs and future studies",
"Background : Self-efficacy is a person 's confidence in being able to successfully perform a specific activity or behavior . Self-efficacy has been shown to influence exercise capacity in patients post myocardial infa rct ion , but has not been fully explored in patients with heart failure ( HF ) . This study examined the impact of performance of a single treadmill exercise test and participation in a 3-month program of walking and resistance exercise on self-efficacy in HF patients . Methods : 24 patients were r and omized to either a home-based walking and resistance exercise program or usual care for 3 months . Prior to enrollment into the exercise program all participants performed a single treadmill exercise test with respiratory gas analysis . Self-efficacy question naires were completed at 3 time points , 1 ) prior to performance of an exercise treadmill test ; 2 ) immediately after completing an exercise test ; and 3 ) at the end of a 3-month exercise program . Results : Self-efficacy for walking ( p = 0.07 ) , climbing ( p = 0.17 ) , lifting ( p = 0.73 ) and general activity ( p = 0.15 ) did not improve after performance of a single treadmill exercise test and usual care . However , self-efficacy for walking increased after 3 months of a walking and resistance exercise program . ( p = 0.04 ) . Conclusions : The findings from this study suggest that in patients with stable mild to moderate heart failure , self-efficacy is improved with participation in a home-based walking and endurance exercise program . Self-efficacy is not enhanced by performance of a single treadmill exercise test and usual care",
"BACKGROUND The effect of home-based exercise training on neurovascular control in heart failure patients is unknown . AIMS To test the hypothesis that home-based training would maintain the reduction in muscle sympathetic nerve activity ( MSNA ) and forearm vascular resistance ( FVR ) acquired after supervised training . METHODS AND RESULTS Twenty-nine patients ( 54+/-1.9 years , EF into two groups : untrained control ( n=12 ) and exercise trained ( n=17 ) . Both groups underwent assessment of Quality of Life ( QoL ) , MSNA , and forearm blood flow . The exercise group underwent a 4-month supervised training program followed by 4 months of home-based training . After the initial 4 months of training , patients in the exercise group showed a significant increase in peak VO(2 ) and reduction in MSNA , compared to the untrained group , but this was not maintained during 4 months of home-based training . In contrast , the decrease in FVR ( 56+/-3 vs. 46+/-4 vs. 40+/-2 U , p=0.008 ) and the improvement in QOL that were achieved during supervised training were maintained during home-based training . CONCLUSIONS Home-based training following supervised training is a safe strategy to maintain improvements in QoL and reduction in FVR in chronic heart failure patients , but is an inadequate strategy to maintain fitness as estimated by peak VO(2 ) or reduction in neurohumoral activation",
"Background —The effects of exercise training ( ET ) on left ventricular ( LV ) remodeling in chronic heart failure are not definitively established , and the safety of ET in these patients is still debated . Methods and Results —This multicenter study investigated the long-term effect of moderate ET on LV remodeling , work capacity , and quality of life ( QoL ) in 90 patients with stable chronic heart failure caused by LV systolic dysfunction , r and omized to a 6-month ET program ( T , n=45 ) or a control group ( C , n=45 ) . All patients underwent resting echocardiography , a cardiopulmonary exercise test , 6-minute walking test , and QoL assessment at entry and after 6 months . At entry , end-diastolic ( EDV ) and end-systolic ( ESV ) volume , ejection fraction , work capacity , peak & OV0312;o2 , and walking distance were similar in the 2 groups . After 6 months , LV volumes diminished in T ( EDV , from 142±26 to 135±26 mL/m2 , P 118±34 mL/m2 , P improved in T ( P NS ) . Significant improvement in work capacity ( P & OV0312;o2 ( P ( P ( P ( P = 0.05 ) hospital readmissions for worsening dyspnea in the absence of other adverse cardiac events . Conclusions —In stable chronic heart failure , long-term moderate ET has no detrimental effect on LV volumes and function ; rather , it attenuates abnormal remodeling . Furthermore , ET is safe and effective in improving exercise tolerance and",
"Walking tests , frequently used to document effects of treatment on exercise capacity , have never been st and ardised . We studied the effects of encouragement on walking test performance in a r and omised study that controlled for the nature of the underlying disease , time of day , and order effects . We r and omised 43 patients with chronic airflow limitation or chronic heart failure or both to receive or not receive encouragement as they performed serial two and six minute walks every fortnight for 10 weeks . Simple encouragement improved performance ( p less than 0.02 for the six minute walk ) , and the magnitude of the effect was similar to that reported for patients in studies purporting to show beneficial effects of therapeutic manoeuvres . Age and test repetition also affected performance . These results demonstrate the need for careful st and ardisation of the performance of walking tests , and suggest caution in interpreting studies in which st and ardisation is not a major feature of the study design",
"AIMS Previous studies have shown an abnormal expression of cellular adhesion molecules and cytokines in chronic heart failure , which may be related to endothelial dysfunction characterizing this syndrome . Our study investigates the effects of physical training on serum activity of some peripheral inflammatory markers associated with endothelial dysfunction , such as granulocyte-macrophage colony-stimulating factor ( GM-CSF ) , macrophage chemoattractant protein-1 ( MCP-1 ) , soluble intercellular adhesion molecule-1 ( sICAM-1 ) and soluble vascular cell adhesion molecule-1 ( sVCAM-1 ) in patients with chronic heart failure . METHODS AND RESULTS Serum levels of GM-CSF , MCP-1 , sICAM-1 and sVCAM-1 were determined in 12 patients with stable chronic heart failure ( ischaemic heart failure : 6/12 , dilated cardiomyopathy : 6/12 , New York Heart Association : II-III , ejection fraction : 24+/-2 % ) before and after a 12-week programme of physical training in a r and omized crossover design . In addition , the functional status of chronic heart failure patients was evaluated by using a cardiorespiratory exercise stress test to measure peak oxygen consumption . Physical training produced a significant reduction in serum GM-CSF ( 28+/-2 vs 21+/-2 pg . ml(-1 ) , P MCP-1 ( 192+/-5 vs 174+/-6 pg . ml(-1 ) , P sICAM-1 ( 367+/-31 vs 314+/-29 ng . ml(-1 ) , P sVCAM-1 ( 1247+/-103 vs 1095+/-100 ng . ml(-1 ) , P peak oxygen consumption ( 14.6+/-0.5 vs 16.5+/-0.5 ml . kg(-1)min(-1 ) , P peak oxygen consumption and percentage reduction in soluble adhesion molecules sICAM-1 ( r=-0.72 , P sVCAM-1 ( r=-0.67 , P Physical training affects beneficially peripheral inflammatory markers reflecting monocyte/macrophage-endothelial cell interaction . Training-induced improvement in exercise tolerance is correlated with the attenuation of the inflammatory process , indicating that inflammation may contribute significantly to the impaired exercise capacity seen in chronic heart failure",
"Background —In chronic heart failure ( CHF ) , cross-talk between inflammatory activation and oxidative stress has been anticipated in skeletal muscle ( SM ) . The role of the radical scavenger enzymes superoxide dismutase ( SOD ) , catalase ( Cat ) , and glutathione peroxidase ( GPX ) , which remove oxygen radicals , has never been assessed in the SM in this context . Moreover , it remains unknown whether exercise training augments the activity of these enzymes in CHF . Methods and Results —Twenty-three patients with CHF were r and omized to either 6 months of exercise training ( T ) or a sedentary lifestyle ( C ) ; 12 age-matched healthy subjects ( HS ) were studied in parallel . Activity of Cat , SOD , and GPX was assessed in SM biopsies before and after 6 months ( 6 months ) . Oxidative stress was determined by measuring nitrotyrosine formation . SOD , Cat , and GPX activity was reduced by 31 % , 57 % , and 51 % , respectively , whereas nitrotyrosine formation was increased by 107 % in SM in CHF ( P , exercise training augmented GPX and Cat activity in SM by 41 % ( P decreased nitrotyrosine production by 35 % ( from 3.8±0.4 % tissue area before to 2.5±0.3 % after 6 months ; P major antioxidative enzymes in the SM of CHF patients is associated with increased local oxidative stress . Exercise training exerts antioxidative effects in the SM in CHF , in particular , due to an augmentation in activity of radical scavenger enzymes",
"In chronic heart failure , oxidative stress is thought to lead to endothelial dysfunction . In this study , we assessed the effect of home‐based exercise training on variables of the NO and purine pathways",
"BACKGROUND The improvement of exercise capacity in patients with chronic heart failure ( CHF ) by physical training has been connected with reversal of the abnormalities in muscle fiber distribution and with the reduced activity of the enzymes of oxidative metabolism in skeletal muscle . However , the change in fiber type distribution induced by training is controversial and in previous studies the activities of the rate-limiting enzymes of the metabolic pathways have not been measured . AIMS To examine the effect of dynamic training on percentage distribution of muscle fibers , on activities of the rate-limiting enzymes of the metabolic pathways and on electrophysiology in skeletal muscle . METHODS A total of 27 patients with stable CHF ( NYHA class II-III ) were r and omized to a training ( N=12 ) or a control ( N=15 ) group . The training group exercised on a bicycle ergometer for 30 min three times a week for 3 months using a load corresponding to 50 - 60 % of their peak oxygen consumption . This was followed by a 3-month training period at home according to personal instructions . The control group did not change its physical activities . We studied muscle histology and measured the activities of the rate-limiting enzymes of anaerobic glycolysis ( phosphofructokinase , PFK ) , glycogenolysis ( phosphorylase ) , citric acid cycle ( alpha-ketoglurate dehydrogenase , KGDH ) and fatty acid oxidation ( carnitinepalmitoyl transferase I and II , CPT I and II ) from biopsies of the vastus lateralis muscle at baseline and after 3 and 6 months . Muscle strength and strength endurance with surface EMG and macro EMG of the right knee extensors were also determined . RESULTS Exercise capacity , particularly submaximal , improved in the training group . The activity of PFK rose significantly but that of the other enzymes did not when compared with the change in the controls . Training had no effect on the percentage distribution of slow-twitch and fast-twitch muscle fibers or on capillary density around these fibers in skeletal muscle . Maximum voluntary force , strength endurance and the function of motor units remained unaffected . CONCLUSIONS Dynamic training results in improved exercise endurance in CHF . In skeletal muscle , the capacity of anaerobic glycolysis is increased but that of the citric acid cycle and fatty acid oxidation is not . Furthermore , the improvement in exercise endurance seems to be independent of changes in the percentage distribution of muscle fibers , capillarity or electrophysiological factors",
"BACKGROUND Diastolic heart failure ( DHF ) is common in older women . There have been no clinical trials that have identified therapies to improve symptoms in these patients . A total of 32 women with New York Heart Association class II and III DHF ( left ventricular ejection fraction > 45 % and symptoms of dyspnea or fatigue ) were r and omized into a 12-week home-based , low-to-moderate intensity ( 40 % and 60 % , respectively ) exercise and education program ( intervention ) or education only program ( control ) . Methods and results The intervention group improved in the 6-minute walk test from 840 + /- 366 ft to 1043 + /- 317 ft versus 824 + /- 367 ft to 732 + /- 408 ft in the control group ( P = .002 ) . Quality of life also improved in the intervention group compared with the control group as measured by the Living with Heart Failure Question naire ( 41 + /- 26 to 24 + /- 18 vs 27 + /- 18 to 28 + /- 22 at 12 weeks , P = .002 ; 24 + /- 18 to 19 + /- 18 vs 28 + /- 22 to 32 + /- 27 at the 3-month follow-up , P = .014 ) and the Geriatric Depression Scale ( 6 + /- 4 to 4 + /- 4 vs 5 + /- 3 to 7 + /- 5 at 12 weeks , P = .012 ; 4 + /- 4 to 4 + /- 4 vs 7 + /- 5 to 7 + /- 5 at the 3-month follow-up , P = .009 ) . CONCLUSIONS Women with DHF exhibit significant comorbidities and physical limitations . Home-based , low-to-moderate intensity exercise , in addition to education , is an effective strategy for improving the functional capacity and quality of life in women with DHF . Further study is needed to assess the long-term effect of exercise on clinical outcomes",
"Background Chronic heart failure ( CHF ) is accompanied by an inflammatory activation which occurs both systemically and in the skeletal muscle . Exercise training has been shown to reduce the local expression of cytokines and inducible nitric oxide synthase ( iNOS ) in muscle biopsies of CHF patients . INOS-derived NO can inhibit oxidative phosphorylation and contribute to skeletal muscle dysfunction in CHF . Design To investigate the correlation between changes in local iNOS expression associated with regular exercise and changes in aerobic enzyme activities in the skeletal muscle of patients with CHF . Twenty male CHF patients [ ejection fraction 25 % ( SE 2 ) , age 54 ( SE 2 ) years ] were r and omized to a training ( n = 10 ) or a control group ( C , n = 10 ) . Methods At baseline and after 6 months skeletal muscle iNOS expression was measured by real-time polymerase chain reaction . INOS protein and protein nitrosylation were assessed by immunohistochemistry . Cytochrome c oxidase ( COX ) activity was quantified electrochemically using the Clark oxygen electrode . Results Exercise training led to a 27 % increase in cytochrome c oxidase activity [ from 21.8 ( SE 3.2 ) to 27.7 ( SE 3.5 ) nmol O2/mg per min , P=0.02 versus baseline ] . Changes in iNOS expression and iNOS protein content were inversely correlated with changes in COX-activity ( r= −0.60 , P=0.01 ; r= −0.71 , P iNOS expression/iNOS protein content and COX-activity indicates that local anti-inflammatory effects may contribute to improved muscular oxidative metabolism",
"BACKGROUND Accurate data for prevalence rates for heart failure due to various causes , and for left-ventricular systolic dysfunction in all adults are unavailable . Our aim was to assess prevalence of left-ventricular systolic dysfunction and heart failure in a large representative adult population in Engl and . METHODS Of 6286 r and omly selected patients aged 45 years and older , 3960 ( 63 % ) participated in the study . They came from 16 r and omly selected general practice s. We assessed patients by history and examination , electrocardiography , and echocardiography . Prevalence of left-ventricular systolic dysfunction ( defined as ejection fraction heart failure was calculated for the overall population on the basis of strict criteria and , when necessary , adjudication by a panel . FINDINGS Left-ventricular systolic dysfunction was diagnosed in 72 ( 1.8 % [ 95 % CI 1.4 - 2.3 ] ) participants , half of whom had no symptoms . Borderline left-ventricular function ( ejection fraction 40 - 50 % ) was seen in 139 patients ( 3.5 % [ 3.0 - 4.1 ] ) . Definite heart failure was seen in 92 ( 2.3 % , [ 1.9 - 2.8 ] ) and was associated with an ejection fraction of less than 40 % in 38 ( 41 % ) patients , atrial fibrillation in 30 ( 33 % ) , and valve disease in 24 ( 26 % ) . Probable heart failure was seen in a further 32 ( 0.8 % [ 0.6 - 1.1 ] ) patients . In total , 124 ( 3.1 % [ 2.6 - 3.7 ] ) patients aged 45 years or older had definite or probable heart failure . INTERPRETATION Heart failure is often misdiagnosed or underdiagnosed in primary care . Our results suggest that assessment of left-ventricular function in patients with suspected heart failure could lead to more effective diagnosis and treatment of this disorder",
"Exercise is an important behavior for long-term weight control in overweight and obese patients . However , little evidence exists confirming such findings in patients with advanced heart failure ( HF ) . Using a prospect i ve , experimental design , the effects of 24 weeks of a low-level , home-based walking program on weight loss were studied in overweight and obese ( body mass index > or = 27 kg/m(2 ) ) patients with advanced HF who were r and omized to exercise ( n = 48 ) and control ( n = 51 ) groups . Weight changes between the 2 groups at baseline and 6 months were compared using repeated- measures analysis of variance . Patients were on average aged 53.3 + /- 10.1 years and predominantly male ( 75 % ) , Caucasian ( 57 % ) , and married ( 55 % ) . Most patients were in New York Heart Association class III or IV ( 67 % ) , with a mean ejection fraction of 25 % . Patients in the exercise group showed significant weight reduction from baseline to 6 months compared with those in the control group ( -6.37 + /- 11.7 vs -0.33 + /- 9.3 kg , p = 0.002 ) . No significant differences were noted between the 2 groups in 6-minute walk distance or depression , although the changes were in the anticipated direction . Modest weight losses of > 5 % were associated with cardiopulmonary exercise test-documented workload levels at 6 months ( r = 0.331 , p = 0.006 ) , as well as decreased depression ( r = -0.315 , p = 0.01 ) and hostility ( r = -0.355 , p = 0.005 ) . The number of hospital admissions was significantly smaller for patients in the exercise group compared with those in the control group ( 0.63 + /- 0.94 vs 1.07 + /- 0.95 , p low-level , home-based walking program on weight loss in overweight and obese patients with advanced HF",
"BACKGROUND Hospital-based exercise programs using a bicycle ergometer or a combination of exercise modalities have shown positive benefits in heart failure , but may not be readily accessible to many patients . Thus , we sought to evaluate the effects of a 12-week home walking exercise program on functional status and symptoms in patients with heart failure . METHODS A r and omized controlled trial comparing a 12-week progressive home walking exercise program ( n = 42 ) to a \" usual activity \" control group ( n = 37 ) was conducted in patients with heart failure ( 78 [ 99 % ] male ; mean age 62.6 + /- 10.6 years ; ejection fraction 27 % + /- 8.8 % ; 63 [ 80 % ] New York Heart Association class II ; 15[20 % ] New York Heart Association class III-IV ) from a Veterans Affairs medical center and a university-affiliated medical center . Functional status ( peak oxygen consumption via cardiopulmonary exercise testing , 6-minute walk test , the Heart Failure Functional Status Inventory ) , and symptoms ( Dyspnea-Fatigue Index score with a postglobal rating of symptoms ) were measured at baseline and 12 weeks . RESULTS No adverse events related to exercise training occurred . Overall mean compliance to training was 74 + /- 37 % . Peak oxygen consumption and the Heart Failure Functional Status Inventory were unchanged with training . Compared to the usual activity group , the training group had significantly longer walking distances measured by the 6-minute walk test ( 1264 + /- 255 vs 1337 + /- 272 feet , P = .001 ) , and improved postglobal rating of symptoms ( P = .03 ) . CONCLUSION In patients with heart failure , a progressive home walking exercise program is acceptable , increases walking distance , and decreases global rating of symptoms",
"CONTEXT Exercise training in patients with chronic heart failure improves work capacity by enhancing endothelial function and skeletal muscle aerobic metabolism , but effects on central hemodynamic function are not well established . OBJECTIVE To evaluate the effects of exercise training on left ventricular ( LV ) function and hemodynamic response to exercise in patients with stable chronic heart failure . DESIGN Prospect i ve r and omized trial conducted in 1994 - 1999 . SETTING University department of cardiology/outpatient clinic in Germany . PATIENTS Consecutive sample of 73 men aged 70 years or younger with chronic heart failure ( with LV ejection fraction of approximately 0.27 ) . INTERVENTION Patients were r and omly assigned to 2 weeks of in-hospital ergometer exercise for 10 minutes 4 to 6 times per day , followed by 6 months of home-based ergometer exercise training for 20 minutes per day at 70 % of peak oxygen uptake ( n=36 ) or to no intervention ( control group ; n=37 ) . MAIN OUTCOME MEASURES Ergospirometry with measurement of central hemodynamics by thermodilution at rest and during exercise ; echocardiographic determination of LV diameters and volumes , at baseline and 6-month follow-up , for the exercise training vs control groups . RESULTS After 6 months , patients in the exercise training group had statistically significant improvements compared with controls in New York Heart Association functional class , maximal ventilation , exercise time , and exercise capacity as well as decreased resting heart rate and increased stroke volume at rest . In the exercise training group , an increase from baseline to 6-month follow-up was observed in mean ( SD ) resting LV ejection fraction ( 0.30 [ 0.08 ] vs 0.35 [ 0.09 ] ; P=.003 ) . Mean ( SD ) total peripheral resistance ( TPR ) during peak exercise was reduced by 157 ( 306 ) dyne/s/cm(-5 ) in the exercise training group vs an increase of 43 ( 148 ) dyne/s/cm(-5 ) in the control group ( P=.003 ) , with a concomitant increase in mean ( SD ) stroke volume of 14 ( 22 ) mL vs 1 ( 19 ) mL in the control group ( P=.03 ) . There was a small but significant reduction in mean ( SD ) LV end diastolic diameter of 4 ( 6 ) mm vs an increase of 1 ( 4 ) mm in the control group ( P resting TPR for both groups were correlated with changes in stroke volume ( r=-0.76 ; P LV end diastolic diameter ( r=0.45 ; P patients with stable chronic heart failure , exercise training is associated with reduction of peripheral resistance and results in small but significant improvements in stroke volume and reduction in cardiomegaly . JAMA . 2000",
"BACKGROUND Chronic heart failure ( CHF ) is characterized by endothelial dysfunction . Vascular endothelium is important for control of haemostasis and vasoregulation . The aim of the present study was to investigate plasma levels of several endothelial markers and the exercise-induced changes on these plasma levels in CHF patients . Subsequently , the effect of a 6-month training programme on these markers is described . MATERIAL S AND METHODS Twenty-nine male CHF patients ( NYHA II/III , age 60 + /- 8 year , body mass index 26.7 + /- 2.3 kg m(-2 ) , left ventricular ejection fraction 26.3 - 7.2 % ; mean + /- SD ) participated . Patients were r and omly assigned to a training or control group . Training ( 26 weeks ; combined strength and endurance exercises ) was four sessions/week : two sessions supervised and two sessions at home . Before and after intervention , anthropometry , endothelial markers ( haemostasis and vasoregulation ) , maximal workload and peak oxygen uptake were assessed . RESULTS Physical training positively affected maximal workload . Plasma levels of endothelial markers were not affected by physical training and not related to exercise tolerance . After training , stimulated ( maximal exercise ) plasma von Willebr and Factor ( vWF ) release was present , whereas at baseline this release was absent . CONCLUSION Physical training led to normalization of the stimulated plasma vWF release . Plasma levels of other endothelial markers were not affected by physical training either at rest or under stimulated ( maximal exercise ) conditions",
"OBJECTIVES We sought to evaluate the effect of physical training on neurohormonal activation in patients with heart failure ( HF ) . BACKGROUND Patients with HF benefit from physical training . Chronic neurohormonal activation has detrimental effects on ventricular remodeling and prognosis of patients with HF . METHODS A total of 95 patients with HF were assigned r and omly into two groups : 47 patients ( group T ) underwent a nine-month training program at 60 % of the maximal oxygen uptake ( VO2 ) , whereas 48 patients did not ( group C ) . The exercise load was adjusted during follow-up to achieve a progressive training effect . Plasma assay of B-type natriuretic peptide ( BNP ) , amino-terminal pro-brain natriuretic peptide ( NT-proBNP ) , norepinephrine , plasma renin activity , and aldosterone ; quality -of-life question naire ; echocardiogram ; and cardiopulmonary stress test were performed upon enrollment and at the third and ninth month . RESULTS A total of 85 patients completed the protocol ( 44 in group T , left ventricular ejection fraction [ EF ] 35 + /- 2 % , mean + /- SEM ; and 41 in group C , EF 32 + /- 2 % , p = NS ) . At the ninth month , patients who underwent training showed an improvement in workload ( + 14 % , p peak VO2 ( + 13 % , p systolic function ( EF + 9 % , p quality of life . We noted that BNP , NT-proBNP , and norepinephrine values decreased after training ( -34 % , p peak VO2 with training correlated significantly with the decrease in both BNP/NT-proBNP level ( p training showed no changes . CONCLUSIONS Clinical benefits after physical training in patients with HF are associated with blunting of adrenergic overactivity and of natriuretic peptide overexpression",
"BACKGROUND Heart rate recovery ( HRR ) is a marker of vagal tone that is associated with survival , but little is known about the effects of exercise training on HRR in patients with heart failure ( HF ) . METHODS Twenty-four patients with HF were r and omized to a 2-month residential rehabilitation program or to usual care . Symptom-limited exercise testing was performed at baseline and at discharge from the program . Heart rate recovery was expressed as the decline in heart rate from peak exercise through 6 minutes into recovery . In addition , HRR recovery curves were normalized to a range of 1 at peak heart rate and 0 at 6 minutes and adjusted for differences in heart rate reserve , facilitating the comparison of recovery curve shapes between groups . RESULTS Mean peak oxygen uptake and oxygen uptake at the lactate threshold increased 26 % ( P Heart rate recovery was significantly more rapid in the exercise group after training ( main effect 12.6 vs 2.6 beat/min in the trained and control groups , respectively , P = .005 ) . The normalized curves showed that the largest improvement in recovery curve shape occurred in the exercise group , but most of the HRR improvement was accounted for by a widening of the difference between peak and resting heart rate . CONCLUSION Exercise training results in a faster HRR in patients with HF . Heart rate recovery , as a simple marker of autonomic function , is an easily acquired response that may be useful for evaluating patient outcomes in cardiac rehabilitation",
"BACKGROUND The purpose of this study was to examine the effects of exercise training on functional capacity in patients with heart failure . METHODS One hundred eighty-one patients in New York Heart Association class I to III , with ejection fraction were recruited into a r and omized , controlled , single-blind trial comparing 3 months of supervised training , then 9 months of home-based training with usual care . RESULTS There was a significant increase in 6-minute walk distance at 3 and 12 months but no between-group differences . Incremental peak oxygen uptake increased in the exercise group compared with the control group at 3 months ( 0.104 + /- 0.026 L/min vs 0.025 + /- 0.023 L/min ; P = .026 ) and 12 months ( 0.154 + /- 0.074 L/min vs 0.024 + /- 0.027 L/min ; P = .081 ) . Compared with the control group , significant increases were observed in the exercise group for arm and leg strength . No significant changes were observed in cardiac function or quality of life . Adherence to exercise was good during supervised training but reduced during home-based training . CONCLUSIONS Exercise training improves peak oxygen uptake and strength during supervised training . Over the final 9 months of the study , there was little further improvement , suggesting that some supervision is required for these patients . There were no adverse effects on cardiac function or clinical events",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"BACKGROUND Exercise training ( ExT ) improves exercise capacity in chronic heart failure , but the results of home-based training have been variable . We sought the predictors of favorable outcome using a telemonitoring approach . METHODS Exercise capacity and quality of life ( QOL ) were assessed in 30 patients ( 28 men , age 64 + /- 8 years ) with symptomatic chronic heart failure and left ventricular ejection fraction home ExT. Patients were provided with heart rate monitors and exercise diaries after undergoing 4 months of hospital-based ExT. Weekly telephone contact was established and heart rate data were downloaded bimonthly . Changes in peak oxygen consumption per unit time ( V*O2 ) and QOL were compared between the 15 most and 15 least adherent patients defined by the number of hours per week at > 60 % maximum heart rate , observed during heart-rate monitoring . RESULTS Peak V*O2 increased by 26 % ( P peak V*O2 at 12 months ( P = .02 ) . Improvement in peak V*O2 at 12 months was associated with baseline peak V*O2 ( r = -0.61 , P Quality of life improvements were sustained at 12 months for the Minnesota Living with Heart Failure Question naire and Hare-Davis Depression Question naire . Nevertheless , QOL improvements achieved during the outpatient program were lost or attenuated at 12 months in nonadherent patients but were maintained in adherent patients . CONCLUSIONS Telemonitoring is feasible for following adherence to home ExT. Ongoing adherence is critical in obtaining sustained benefit from ExT in heart failure",
"Community care for heart failure patients is difficult due to multiple comorbidities , polypharmacy , and advanced age of patients . Studies show that hospital admissions and emergency room visits decrease with increased nursing interventions in home and community setting s. The purpose of this study 1 was to assess the effectiveness of regular telephone interventions by nursing students on outcomes of heart failure patients in the home . Senior students were paired with community nursing staff and assigned 2 heart failure patients to follow up by telephone calls for 12 to 14 weeks . Patients who received telephone interventions had fewer hospital readmissions ( 13 % ) than the comparison group ( 35 % ) . Patients in the telephone intervention group also had fewer overt heart failure symptoms as measured by the Minnesota Living With Heart Failure Question naire",
"Background Physical training is a well-known complementary treatment for chronic heart failure ( CHF ) ; however , many aspects require further studies . One of them is the impact on remodeling of the left ventricle ( LV ) . The purpose of this study was to evaluate the effect of 6 months of training on LV , exercise capacity and safety issues in patients with ischemic CHF . Methods Fifty patients ( mean age 60.1 ± 9.2 years ) with ischemic CHF , New York Heart Association ( NYHA ) classification class II and III and left ventricular ejection fraction ( LVEF ) ≤ 35 % were r and omized into groups : undergoing 6-month training ( 25 patients ) and not trained ( 25 patients ) . In both groups at baseline and at 6 months a cardiopulmonary exercise test and magnetic resonance imaging ( MRI ) with evaluation of LV were performed . Training was limited by the achievement of 80 % of the predicted heart rate at VO2PEAK achieved at the baseline cardiopulmonary exercise test . Results All patients completed the 6-month observation . No serious adverse events were found in either group . Exercise capacity improved only in the trained group ( VO 2peak increased by 31 % ) . At 6 months in the trained group there was a tendency towards an improvement in some LV parameters : ejection fraction , end-diastolic volume and wall motion score index ( WMSI ) , whereas an opposite trend was seen in the controls ( P training in ischemic CHF patients is a safe modality . Training improves exercise capacity . There was no negative impact on LV morphology , and a trend towards improvement of functional parameters on MRI may suggest an anti-remodeling effect of training in patients with ischemic CHF . Eur J Cardiovasc Prev Rehabil 14 : 85 - 91 © 2007 The European Society of",
"Eighty-two patients aged > or = 70 years with heart failure were r and omized to a gentle , seated exercise program or to usual care . Six-minute walk distance and quality of life did not change between groups , but daily activity as measured by accelerometry increased in the exercise group relative to the control group",
"AIMS To determine the prevalence , incidence rate , lifetime risk and prognosis of heart failure . METHODS AND RESULTS The Rotterdam Study is a prospect i ve population -based cohort study in 7983 participants aged > or = 55 . Heart failure was defined according to criteria of the European Society of Cardiology . Prevalence was higher in men and increased with age from 0.9 % in subjects aged 55 - 64 to 17.4 % in those aged > or = 85 . Incidence rate of heart failure was 14.4/1000 person-years ( 95 % CI 13.4 - 15.5 ) and was higher in men ( 17.6/1000 man-years , 95 % CI 15.8 - 19.5 ) than in women ( 12.5/1000 woman-years , 95 % CI 11.3 - 13.8 ) . Incidence rate increased with age from 1.4/1000 person-years in those aged 55 - 59 to 47.4/1000 person-years in those aged > or = 90 . Lifetime risk was 33 % for men and 29 % for women at the age of 55 . Survival after incident heart failure was 86 % at 30 days , 63 % at 1 year , 51 % at 2 years and 35 % at 5 years of follow-up . CONCLUSION Prevalence and incidence rates of heart failure are high . In individuals aged 55 , almost 1 in 3 will develop heart failure during their remaining lifespan . Heart failure continues to be a fatal disease , with only 35 % surviving 5 years after the first diagnosis",
"Background Although numerous health-related quality -of-life instruments are available to measure patients ’ quality of life , few studies have compared these measures directly to determine how they function in the same group of patients . Objective The purpose of this study was to empirically compare psychometric properties of the Chronic Heart Failure Question naire ( CHQ ) , the Minnesota Living with Heart Failure Question naire ( LHFQ ) , and the General Health Survey Short-form-12 ( SF-12 ) . Sample A convenience sample of 211 patients with heart failure completed baseline question naires ; 165 patients completed the entire 26-week study . Methods Patients completed telephone interviews at baseline and at 4 , 8 , and 26 weeks after baseline . To compare mode of administration , a subset of patients ( n = 173 ) completed face-to-face and telephone interviews . Results Patients reported low-to-moderate health-related quality -of-life overall . Reliability of the three instruments was satisfactory . Responsiveness to changing condition , as evaluated by analysis of variance , receiver operating curve characteristics , and the minimal clinical ly important difference method , indicated that the CHQ and LHFQ were more responsive to changing conditions than the SF-12 . No major differences were noted between the scores of the face-to-face interviews and the baseline telephone interviews . The LHFQ and SF-12 were easier and took less time to administer than the CHQ . Conclusions While all three instruments were reliable and valid , the CHQ and LHFQ were more sensitive than the SF-12 in detecting clinical ly important changes over time"
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Context Human growth hormone ( GH ) is widely sold and used as an antiaging agent . Contributions The research ers review ed all clinical trials of GH to determine if it is safe and effective in the healthy elderly . They found that GH had no important effects on body composition but led to frequent adverse effects , most notably soft tissue edema and arthralgias . Caution s Clinical trials of GH have been small , and they may not have been able to detect important differences . Implication s Published data about GH use in the elderly is limited , but available evidence suggests that risks far outweigh benefits when it is used as an antiaging treatment in healthy older adults . The Editors Since the 1990 publication of an article by Rudman and colleagues ( 1 ) suggesting that a short course of recombinant human growth hormone ( GH ) therapy could reverse decades of age-related changes in body composition in otherwise healthy elderly men , the use of GH as an antiaging therapy has increased rapidly in the United States and worldwide ( 2 ) . Interest in Rudman and colleagues ' results has remained high ( 3 ) , spawning several popular books in the lay press ( 47 ) . Use of GH as an antiaging therapy ranks as 1 of the most popular health-related Internet search es ( 8) . Although the exact number of people who use GH as an antiaging therapy is unknown , Perls and colleagues ( 2 ) reported that 20000 to 30000 people used GH in the United States as an antiaging therapy in 2004 ( 9 ) , a more than 10-fold increase since the mid-1990s ( 10 , 11 ) . Annual sales of GH worldwide exceed $ 1.5 billion ( 2 ) , one third of which may be for off-label use ( 12 ) . Proponents of GH for its antiaging properties cl aim ed that more than 100000 people received GH without a prescription in 2002 ( 2 , 11 ) . The rationale for using GH as an antiaging therapy , referred to by some as the sweet syringe of youth ( 10 ) , lies in the age-related decline in activity of the hypothalamic growth hormoneinsulin-like growth factor axis , a phenomenon referred to as the somatopause ( 1319 ) . Some signs and symptoms of GH deficiency ( that is , GH deficiency due to hypothalamic or pituitary defects ) , such as increased adiposity and decreased lean body mass , are similar to changes that occur with aging , suggesting that GH replacement therapy may ameliorate age-related changes . Although GH therapy improves body composition ( 20 ) , bone density ( 20 , 21 ) , and cholesterol levels ( 22 ) and may decrease death ( 23 ) in people who are GH-deficient , its safety , efficacy , and role in the healthy elderly is highly controversial ( 24 ) . Whereas proponents of GH have recommended its use for treating the somatopause ( 18 , 19 , 25 , 26 ) , others , including the American Association of Clinical Endocrinologists ( 27 ) , have warned that such therapy is not warranted . High levels of insulin-like growth factor-1 ( IGF-1 ) , which are regulated by GH levels , may be associated with serious adverse events ( 12 ) , including prostate cancer ( 28 ) . Furthermore , the distribution of GH for use as an antiaging therapy in the United States is illegal ( 2 ) . We performed a systematic review and meta- analysis of r and omized , controlled trials to determine the safety and efficacy of GH therapy in the healthy elderly . We aim ed to evaluate the effects of GH on body composition , exercise capacity , bone density , serum lipid levels , and glucose metabolism . In addition , we sought to synthesize the evidence on adverse events associated with GH use in the healthy elderly . Methods Literature Search es An author and a professional librarian developed search strategies to identify potentially relevant studies . We search ed MEDLINE and EMBASE data bases for English- language studies published through 21 November 2005 using keywords including growth hormone ; aging ; and r and omized , controlled clinical trials ( Appendix Table 1 ) . We search ed bibliographies of retrieved articles for additional studies . Appendix Table 1 . Search Strategy Study Selection We sought 2 types of r and omized , controlled trials : those that compared injectable GH therapy with no GH therapy and those that compared injectable GH therapy plus lifestyle interventions ( that is , exercise with or without a dietary intervention ) with lifestyle interventions alone . We included studies that : 1 ) evaluated at least 10 participants ; 2 ) included participants who received GH therapy for 2 weeks or more ; 3 ) enrolled only community-dwelling participants ; 4 ) assessed participants with a mean body mass index of 35 kg/m2 or less and a mean age of 50 years or more ; and 5 ) provided data on at least 1 clinical outcome of interest . We excluded studies that : 1 ) focused solely on evaluating GH-releasing factor , other GH secretagogues , or IGF-1 ; 2 ) explicitly included patients with diabetes mellitus , cardiac disease , thyroid disease , osteoporosis , or cancer ; or 3 ) evaluated GH as a treatment for a specific illness ( for example , adult GH deficiency , the HIV wasting syndrome , renal failure , or critical illness ) . Data Abstract ion An author review ed the titles and abstract s of articles identified through our search and retrieved potentially relevant studies . Two physicians with postdoctoral training in health services research , endocrinology , or both review ed each retrieved study and abstract ed data independently onto pretested abstract ion forms . We resolved abstract ion differences by repeated review . If a study did not present data necessary for analysis , mentioned results but did not present data , or presented data graphically , we requested additional data from study authors . If several studies presented findings from the same cohort , we used these data only once in our analysis . Abstract ed Data We abstract ed 4 types of data from each study : 1 ) study quality ( for example , quality of r and omization , blinding , outcomes , and statistical analyses ) ( 29 , 30 ) ; 2 ) study sample characteristics ( for example , age , sex , weight , medical conditions , and baseline IGF-1 levels ) ; 3 ) study interventions ( for example , dosage , frequency , and length of GH therapy ) ; and 4 ) clinical outcomes . We included studies that provided data on at least 1 of the following 6 clinical outcomes of interest : 1 ) body composition ( for example , weight , lean body or fat-free mass , or fat mass ) ; 2 ) strength or functional capacity ( for example , h and grip strength or maximal rate of oxygen consumption ) ; 3 ) bone dynamics ( for example , femoral neck or lumbar spine bone mineral density or bone mineral content ) ; 4 ) cardiovascular risk factors ( for example , heart rate , total , low-density lipoprotein , and high-density lipoprotein cholesterol levels or triglyceride levels ) ; 5 ) insulin resistance markers ( for example , fasting glucose and insulin levels and 2-hour glucose post75-gram oral glucose tolerance test results ) ; 5 ) quality -of-life or depression scales ; or 6 ) adverse events . Because the terms lean body mass and fat-free mass are typically used interchangeably in scientific literature , we combined data on fat-free mass and lean body mass into the single category of lean body mass . Quantitative Data Synthesis To describe key study characteristics , we computed mean values weighted by the number of participants in each trial . To evaluate the effects of GH on the outcomes of interest , we computed a change score for each clinical outcome for participants in the treatment and control groups as the value of the outcome at the end of the trial minus the value of the outcome at the start of the trial . We then used these change scores to calculate 2 study effect sizes : the Hedges ' adjusted g , which is an estimate of the st and ardized mean difference ( 31 ) , and the weighted mean difference ( 32 ) . We calculated both study effect sizes because the Hedges ' adjusted g , although an unbiased estimate , lacks units ; whereas the results of the weighted mean difference are in the same units as the clinical outcome of interest , facilitating clinical interpretation . Our results from either method did not substantially differ , and we present effect sizes calculated by using only the weighted mean difference . If studies reported st and ard errors , we converted them to st and ard deviations . For studies that did not report the variance of an outcome at the end of the trial minus that at the start of the trial , we calculated the variance as the sum of the variances at the start and end of the trial minus twice the covariance . Calculation of the covariance between the end of the trial and the start of the trial requires the correlations from individual patient data . Because these correlations were unavailable , we computed the correlation of the reported means , which ranged from 0.61 to 0.99 , and used values over this interval to estimate the covariance for each outcome . We chose a correlation of 0.80 as our baseline value , although the pooled effect sizes did not substantially change when we varied the correlation over the range of 0.61 to 0.99 . We combined studies by using the DerSimonian and Laird inverse variance weighted method ( r and om-effects model ) and the MantelHaenszel method ( fixed-effects model ) ( 31 , 32 ) . We present the results from only the r and om-effects model because of statistical heterogeneity in some clinical outcomes . For body composition measures , we calculated separate summary effect sizes for the following : 1 ) studies of groups receiving GH versus studies of groups not receiving GH ; 2 ) studies of GH plus lifestyle interventions versus studies of lifestyle interventions alone ; 3 ) studies in which research ers administered GH for less than 26 weeks versus studies in which they administered GH for 26 weeks or more ; and 4 ) study population s in which research ers evaluated only men versus studies evaluating only women . Because few studies have reported outcomes other than body composition measures , we calculated a single effect size for other clinical outcomes . We evaluated the effects of study heterogeneity on our summary results . We sought sources of heterogeneity affecting body composition outcomes
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"Abdominal/visceral obesity is associated with blunted growth hormone ( GH ) secretion and an unfavourable lipoprotein pattern . In this study , the effect of GH treatment on LDL size and on serum lipoprotein concentrations was determined in abdominally obese men . Thirty men , aged 48 - 66 years , with a body mass index ( BMI ) of 25 - 35 kg/m(2 ) and a waist : hip ratio of > 0.95 , received treatment with GH ( 9 . 5 microg/kg/day ) or placebo for 9 months . Serum concentrations of total cholesterol ( TC ) , low density lipoprotein-cholesterol ( LDL-C ) and apolipoprotein B ( apoB ) were reduced ( P Serum lipoprotein(a ) [ Lp(a ) ] concentration increased ( P Mean low density lipoprotein ( LDL ) particle diameter was marginally increased by active treatment as compared with placebo ( P = 0.08 ) . No changes were observed in the serum concentrations of high density lipoprotein-cholesterol ( HDL-C ) , apolipoprotein A-I ( apoA-I ) and apolipoprotein E ( apoE ) . In conclusion , 9 months of GH treatment in abdominally obese men beneficially reduced serum concentrations of TC , LDL-C and apoB , and marginally increased mean LDL diameter , while serum Lp(a ) increased . The ultimate effect of GH therapy on the cardiovascular risk remains , however , to be determined",
"OBJECTIVE We studied the relationship between plasma level of insulin‐like growth hormone I ( IGF‐I ) , changes in lean body mass and in adipose mass , and adverse side‐effects during human growth hormone ( hGH ) treatment of elderly men who had low IGF‐I levels",
"The present study has examined the short- and long-term effects of growth hormone ( GH ) treatment on the leptin system and energy expenditure . Thirty male individuals with abdominal obesity were r and omised to GH or placebo treatment in a 9-month , double-blind study . The dose of GH was 9.5 microg/kg , administered subcutaneously every evening . Serum leptin concentrations were measured by a human leptin RIA . Total RNA was isolated from adipose tissue biopsies and leptin mRNA levels were determined by a semi-quantitative reverse transcriptase-PCR assay . Body composition was determined by potassium-40 and the basal metabolic rate ( BMR ) was measured by a computerised , ventilated , open-hood system . As compared with placebo , an overall decrease in serum leptin concentrations as assessed by the area under the curve ( AUC ) ( P BMR ( AUC , P serum leptin concentrations and BMR after 6 weeks of treatment . After 9 months of GH treatment there was a significant reduction in body fat ( BF ) while serum leptin concentrations and BMR did not differ from baseline values . Leptin mRNA levels did not change over the study period . We speculate that long-term GH treatment induces a new energy balance steady state with decreased BF stores . The effects of GH on the leptin system is suggested to be of importance for the maintenance of a lower BF mass",
"Normal aging is characterized by detrimental changes in body composition , muscle strength , and somatotropic function . Reduction in muscle strength contributes to frailty and risk for fracture in the elderly . Although older adults increase muscle strength as a result of resistance exercise training , the strength gains quickly level off , with only modest increases thereafter despite continued training . To investigate whether age-related deficits in the somatotropic axis limit the degree to which muscle strength can improve with resistance training in older individuals , we conducted a double blind , placebo-controlled exercise trial . Eighteen healthy elderly men ( 65 - 82 yr ) initially underwent progressive weight training for 14 weeks to invoke a trained state . Subjects were then r and omized to receive either 0.02 mg/kg BW.day recombinant human GH ( rhGH ) or placebo , given sc , while undertaking a further 10 weeks of strength training . Sequential measurements were made of muscle strength ( one repetition maximum ) , body composition ( dual energy x-ray absorptiometry ) , and circulating levels of insulin-like growth factor-I ( IGF-I ) and IGF-binding protein-3 . For each exercise , strength increased for both groups ( P = 0.0001 ) through 14 weeks of training , with little improvement thereafter . Increases in muscle strength ranged from 24 - 62 % depending on the muscle group . Baseline plasma IGF-I concentrations were similar in both groups ( mean + /- SEM , 106 + /- 9 micrograms/L ) , approximately half that observed in healthy young adults . In the rhGH group , IGF-I levels increased to 255 + /- 32 micrograms/L at week 15 and 218 + /- 21 micrograms/L at week 24 ( P placebo group , IGF-I increased slightly to 119 + /- 6 micrograms/L at 24 weeks . IGF-binding protein-3 also increased in the rhGH group ( P rhGH had no effect on muscle strength at any time , and no systematic difference in muscle strength was observed between groups throughout the study . Body weight did not change in either group , but lean body mass increased , and fat mass decreased ( P response to strength training in elderly men . These results suggest that deficits in GH secretion do not underlie the time-dependent leveling off of muscle strength seen with training in the elderly and provide no support for the popular view of GH as an ergogenic aid",
"Adults with hypopituitarism receive therapy that replaces cortisol , thyroid hormone , and gonadal steroids , but growth hormone replacement has typically been reserved for children with growth hormone deficiency . However , several observations suggest that growth hormone may have an important role in maintaining bone density and body composition in adults . Bone density is reduced in patients with growth hormone deficiency that develops during childhood or adulthood [ 1 - 3 ] . In vitro , growth hormone binds to growth hormone receptors on rat osteoblast-like cells and produces a mitogenic response mediated by local synthesis and action of insulin-like growth factor 1 ( IGF-1 ) [ 4 , 5 ] . Administration of growth hormone to adults with growth hormone deficiency increases serum and urine markers of bone turnover [ 6 - 10 ] . In adults with childhood-onset growth hormone deficiency ( in whom osteopenia probably results from a failure to reach peak bone mass ) , growth hormone therapy increases bone density [ 3 , 8 , 10 , 11 ] . However , the effects of growth hormone replacement on bone density in adult-onset growth hormone deficiency are largely unknown . In addition to having an increased risk for fracture , adults with growth hormone deficiency have an excess risk for cardiovascular-related death that may be attributed to increased central fat mass [ 12 - 17 ] . Growth hormone therapy reduces body fat and increases lean mass in adults with growth hormone deficiency , primarily those in whom the deficiency developed during childhood [ 6 - 9 , 18 - 20 ] . However , previous studies of growth hormone replacement in adults have several important limitations . First , most of these studies used pharmacologic rather than physiologic doses of growth hormone . Second , most have focused on childhood-onset growth hormone deficiency . Third , effects of growth hormone on bone density in patients with adult-onset growth hormone deficiency have not been examined in a controlled study . Because of these limitations , the critical question of whether long-term growth hormone therapy is beneficial in patients with adult-onset growth hormone deficiency has not been definitively answered . We sought to determine whether long-term growth hormone replacement therapy , given at a dose adjusted according to IGF-1 levels , improves bone density , bone turnover , body composition , and several variables associated with quality of life in patients with adult-onset growth hormone deficiency . Methods Patients Thirty-two men ( median age , 51 years ; range , 24 to 62 years ) with a history of pituitary disease were recruited from the Massachusetts General Hospital Neuroendocrine Clinical Center and from surrounding communities . Growth hormone secretion profiles in 23 of these patients have been reported elsewhere [ 21 ] . All patients met the following inclusion criteria : 1 ) normal growth and development , 2 ) benign sellar neoplasm , pituitary apoplexy , or idiopathic hypopituitarism diagnosed after age 18 years , and 3 ) peak serum growth hormone levels less than 5 mg/L after receipt of two pharmacologic stimuli on separate mornings . The 13 patients younger than 50 years of age received intravenous insulin , 0.1 U/kg of body weight , and oral clonidine , 0.15 mg . The 18 patients 50 years of age or older received oral clonidine , 0.15 mg , and intravenous arginine , 30 g ; these patients were given arginine rather than insulin to avoid potential cardiovascular complications of hypoglycemia . Patients were excluded if they had a history of acromegaly or diabetes mellitus ; were taking drugs ( such as phenytoin or etidronate ) known to affect bone density ; were not receiving st and ard thyroid or adrenal hormone replacement therapy if the patient was deficient in those hormones ; or had begun receiving adrenal , gonadal , or thyroid hormone replacement therapy within 6 months before study enrollment . Growth hormone deficiency was caused by a clinical ly nonfunctioning pituitary adenoma in 12 patients , prolactinoma in 9 patients , craniopharyngioma in 9 patients , pituitary apoplexy in 4 patients , Cushing disease in 1 patient , and adult-onset idiopathic hypopituitarism in 1 patient . Twenty-one patients were deficient in adrenocorticotropin , thyroid-stimulating hormone , and gonadotropins . Five patients had two of these deficiencies , 5 patients had one , and 1 patient had none . Twenty-five patients were treated surgically ( 16 of the 25 were also treated with radiation or bromocriptine , or both ) . Five patients received bromocriptine with or without radiation therapy , and 2 were treated with hormonal replacement only . The Subcommittee on Human Studies of the Massachusetts General Hospital approved the study , and all patients gave written informed consent . Protocol Patients were r and omly assigned to receive recombinant human growth hormone ( Nutropin , Genentech , Inc. , South San Francisco , California ) at a daily dose of 10 g/kg subcutaneously or a placebo . The computerized r and omization , done by statisticians at Genentech , Inc. , stratified patients to assure balance between the groups with respect to age . Staff at Genentech , Inc. , informed the primary investigator of treatment assignment by telephone ; the study physician kept the information in a private computer data base . Only the study physician was aware of the treatment assignment . Patients were admitted to the General Clinical Research Center for measurements of bone mineral density of the lumbar spine , femoral neck , and proximal radius . Body mass index , lean body mass , and percentage of body fat were also measured . Patients had echocardiography and were tested for strength and exercise capacity . Urine was collected for 24 hours for measurement of pyridinoline , deoxypyridinoline , calcium , and creatinine excretion . Fasting blood sample s were drawn at 0900 hours for measurement of IGF-1 , glucose , insulin , lipids , and hemoglobin A1c values . Patients returned at 1 week , 1 month , and 3 months for outpatient measurement of serum IGF-1 , glucose , insulin , lipid ( at 1 and 3 months ) , and hemoglobin A1c ( at 3 months only ) values . Patients were readmitted at 6 , 12 , and 18 months so that the baseline evaluation could be repeated . Echocardiography and tests of strength and exercise capacity were repeated only at the 18-month visit . The growth hormone dose was reduced by 25 % if the patient 's serum IGF-1 level was found to be elevated at the 6- or 12-month visit ; serum IGF-1 levels were remeasured approximately 1 month after the dose was decreased . The dose was further adjusted if necessary . To maintain patient blinding , each placebo recipient was asked to reduce his dose by 25 % during the first 6 months of the study . Bone Density Bone mineral density of the lumbar spine , femoral neck , radius , and total body was determined by dual-energy x-ray absorptiometry ( Hologic QDR-2000 , Waltham , Massachusetts ) . Density of the nondominant radius was measured at the junction of the proximal two thirds and the distal one third of the radial shaft ; the coefficient of variation for this measurement is 1.5 % [ 22 ] . The bone mineral density of the lumbar spine was assessed in the anteroposterior projection in all patients and in the lateral projection in the 22 patients whose body thickness did not exceed the manufacturer 's specified limit for the lateral measurement . Because lateral measurements of bone density in the spine eliminate the contribution of the posterior vertebral elements , they estimate trabecular bone mass better than do measurements made in the anteroposterior projection [ 23 ] . In 50 persons with paired measurements , the SDs for the anteroposterior and lateral measurements were 0.010 g/cm2 and 0.013 g/cm2 , respectively ; these values did not vary with bone density . The coefficient of variation for bone density at the femoral neck was 2.1 % in 51 persons with paired measurements [ 24 ] . All scans were review ed by one physician who did not know the patients ' treatment assignment . Follow-up scans were matched to baseline scans to ensure that identical bone regions were measured . Body Composition A research dietitian determined body mass index . Lean body mass and percentage of body fat were measured by dual-energy x-ray absorptiometry ( Hologic QDR-2000 ) . According to the manufacturer , the coefficient of variation is 1.0 % for lean mass and 1.5 % for percentage of body fat . This compares favorably with the coefficients of variation of other techniques for determining body composition , such as bioelectrical impedance ( 5 % ) , 40 K counting ( 3 % ) , and deuterium oxide dilation ( 3 % ) [ 25 ] . Biochemical Assays Serum IGF-1 levels were measured by radioimmunoassay after acid-alcohol extraction ( Nichols Institute , San Juan Capistrano , California ) . The ageadjusted normal ranges for this assay were 83.3 to 378.0 mg/L for men 20 to 40 years of age and 54.0 to 328.5 mg/L for men older than 40 years of age . Interassay coefficients of variation were 5.2 % at 121.5 mg/L and 15.2 % at 84.5 mg/L. Serum osteocalcin levels were measured by immunoradiometric assay ( SmithKline Beecham , Van Nuys , California ) . The intra-assay coefficients of variation were 11.5 % for low control serum pools ( 3 to 6 mg/L ) , 11.6 % for medium pools ( 6 to 10 mg/L ) , and 10.6 % for high pools ( 25 to 35 mg/L ) . Urinary excretion of total pyridinoline and deoxypyridinoline was measured using high-performance liquid chromatography ( SmithKline Beecham ) . The intra-assay coefficients of variation for measurement of pyridinoline levels were 9.5 % at 13.8 nmol/mmol of creatinine , 9.6 % at 37.0 nmol/mmol of creatinine , and 10.7 % at 47.5 nmol/mmol of creatinine . The intra-assay coefficients of variation for measurement of deoxypyridinoline excretion were 15.8 % at 3.2 nmol/mmol of creatinine , 13.5 % at 6.7 nmol/mmol of creatinine , and 9.8 % at 10.7 nmol/mmol of creatinine . Other assays were done at the Massachusetts General Hospital as described elsewhere [ 26 ] . Echocardiography Transthoracic two-dimensional echocardiography was done while patients were in the left lateral decubitus ",
"Abdominal obesity is associated with blunted GH secretion and a cluster of cardiovascular risk factors that characterize the metabolic syndrome . GH treatment in abdominally obese men reduces visceral adipose tissue and has beneficial effects on the metabolic profile . There are no long-term data on the effects of GH treatment on postmenopausal women with abdominal obesity . Forty postmenopausal women with abdominal obesity participated in a r and omized , double-blind , placebo-controlled , 12-month trial with GH ( 0.67 mg/d ) . The primary aim was to study the effect of GH treatment on insulin sensitivity . Measurements of glucose disposal rate ( GDR ) using a euglycemic , hyperinsulinemic glucose clamp ; abdominal fat , hepatic fat content , and thigh muscle area using computed tomography ; and total body fat and fat-free mass derived from (40)K measurements were performed at baseline and at 6 and 12 months . GH treatment reduced visceral fat mass , increased thigh muscle area , and reduced total and low-density lipoprotein cholesterol compared with placebo . Insulin sensitivity was increased at 12 months compared with baseline values in the GH-treated group . In the GH-treated group only , a low baseline GDR was correlated with a more marked improvement in insulin sensitivity ( r = -0.68 ; P GDR and liver attenuation as a measure of hepatic fat content between baseline and 12 months ( r = 0.7 ; P postmenopausal women with abdominal obesity , 1 yr of GH treatment improved insulin sensitivity and reduced abdominal visceral fat and total and low-density lipoprotein cholesterol concentrations . The improvement in insulin sensitivity was associated with reduced hepatic fat content",
"The expression of two isoforms of insulin-like growth factor-I ( IGF-I ) : mechano growth factor ( MGF ) and IGF-IEa were studied in muscle in response to growth hormone ( GH ) administration with and without resistance training in healthy elderly men . A third isoform , IGF-IEb was also investigated in response to resistance training only . The subjects ( age 74 + /- 1 years , mean + /- S.E.M ) were assigned to either resistance training with placebo , resistance training combined with GH administration or GH administration alone . Real-time quantitative RT-PCR was used to determine mRNA levels in biopsies from the vastus lateralis muscle at baseline , after 5 and 12 weeks in the three groups . GH administration did not change MGF mRNA at 5 weeks , but significantly increased IGF-IEa mRNA ( 237 % ) . After 12 weeks , MGF mRNA was significantly increased ( 80 % ) compared to baseline . Five weeks of resistance training significantly increased the mRNA expression of MGF ( 163 % ) , IGF-IEa ( 68 % ) and IGF-IEb ( 75 % ) . No further changes were observed after 12 weeks . However , after 5 weeks of training combined with GH treatment , MGF mRNA increased significantly ( 456 % ) and IGF-IEa mRNA by ( 167 % ) . No further significant changes were noted at 12 weeks . The data suggest that when mechanical loading in the form of resistance training is combined with GH , MGF mRNA levels are enhanced . This may reflect an overall up-regulation of transcription of the IGF-I gene prior to splicing",
"GH administration , either alone or combined with resistance exercise training ( RT ) , has attracted interest as a means of increasing muscle mass and strength in the elderly . In the present study , 31 healthy , elderly men [ age , 74 + /- 1 yr ( mean + /- SEM ) ] were assigned to either RT [ 3 sessions/wk , 3 - 5 sets of 8 - 12 repetition maximum (RM)/session ] + placebo ( n = 8) , RT + GH ( n = 8) , GH ( n = 8) , or placebo ( n = 7 ) in a r and omized , placebo-controlled , double-blinded ( RT + placebo and RT + GH ) or single-blinded ( GH or placebo ) design . Measurements of : 1 ) isokinetic quadriceps muscle strength ; 2 ) quadriceps muscle power ; 3 ) quadriceps muscle fiber type , size , and myosin heavy chain ( MHC ) composition ; 4 ) quadriceps cross-sectional area ( CSA ) [ nuclear magnetic resonance imaging ( NMRI ) ] ; 5 ) body composition ( dual-energy x-ray absorptiometry scanning ) ; and 6 ) GH-related serum markers were performed at baseline and after 12 wk . The final GH dose was 1.77 + /- 0.18 IU x d(-1 ) ( approximately 7.2 + /- 0.8 microg x kg(-1 ) x d(-1 ) ) . GH alone had no effect on isokinetic quadriceps muscle strength , power , CSA , or fiber size . However , a substantial increase in MHC 2X isoform was observed with GH administration alone , and this may be regarded as a change into a more youthful MHC composition , possibly induced by the rejuvenating of systemic IGF-I levels . RT + placebo caused substantial increases in quadriceps isokinetic strength , power , and CSA ; but these RT induced improvements were not further augmented by additional GH administration . In the RT + GH group , there was a significant decrease in MHC 1 and 2X isoforms , whereas MHC 2A increased . RT , therefore , seems to overrule the changes in MHC composition induced by GH administration alone . Changes in body composition confirmed previous reports of decreased fat mass , increased fat-free mass , and unchanged bone mineral content with GH administration . A high incidence of side effects was reported . Our results do not support a role for GH as a means of increasing muscle strength or mass , either alone or combined with RT , in healthy elderly men ; although GH administration alone may induce changes in MHC composition",
"Adults with acquired GH deficiency ( GHD ) have been shown to have osteopenia associated with a 3-fold increase in fracture risk and exhibit increased body fat and decreased lean mass . Replacement of GH results in decreased fat mass , increased lean mass , and increased bone mineral density ( BMD ) . The possible differential effect of withdrawal of GH replacement on body composition compartments and regional bone mass is not known . We performed a r and omized , single blind , placebo-controlled 36-month cross-over study of GH vs. placebo ( PL ) in adults with GHD and now report the effect of withdrawal of GH on percent body fat , lean mass , and bone density , as measured by dual energy x-ray absorptiometry . Forty men ( median age , 51 yr ; range , 24 - 64 yr ) with pituitary disease and peak serum GH levels under 5 microg/L in response to two pharmacological stimuli were r and omized to GH therapy ( starting dose , 10 microg/kg x day , final dose 4 microg/kg x day ) vs. PL for 18 months . Replacement was provided in a physiological range by adjusting GH doses according to serum insulin-like growth factor I levels . After discontinuation of GH , body fat increased significantly ( mean + /- SEM , 3.18 + /- 0.44 % ; P = 0.0001 ) and returned to baseline . Lean mass decreased significantly ( mean loss , 2133 + /- 539 g ; P = 0.0016 ) , but remained slightly higher ( 1276 + /- 502 g above baseline ; P = 0.0258 ) than at study initiation . In contrast to the effect on body composition , BMD did not reverse toward pretreatment baseline after discontinuation of GH . Bone density at the hip continued to rise during PL administration , showing a significant increase ( 0.0014 + /- 0.00042 , g/cm2 x month ; P = 0.005 ) between months 18 - 36 . Every bone site except two ( radial BMD and total bone mineral content ) , including those without a significant increase in BMD during the 18 months of GH administration , showed a net increase over the entire 36 months . Therefore , there is a critical differential response of the duration of GH action on different body composition compartments . Physiological GH administration has a persistent effect on bone mass 18 months after discontinuation of GH",
"Aging is associated with alterations in body composition and a decline in functional status . Healthy older persons have decreased muscle mass , increased fat mass , and decreased strength [ 1 - 3 ] . The muscle strength of 70-year-old men is about half that of young adults [ 3 ] . The risk for falls , fractures , and frailty increases with age-related decreases in muscle strength [ 4 - 6 ] . Pituitary secretion of growth hormone and circulating levels of insulin-like growth factor 1 decrease with aging [ 7 ] ; these events are called somatopause . Growth hormone is both anabolic and lipolytic [ 8 - 10 ] , and the action of growth hormone on peripheral tissues is mediated , in part , by circulating insulin-like growth factor 1 [ 11 ] . Growth hormone deficiency results in body composition changes that are similar to the changes seen with aging [ 1 , 7 ] . Growth hormone replacement in patients with hypopituitarism and in older men reverses some of the body composition changes associated with both growth hormone deficiency and aging [ 12 - 14 ] . In a study by Rudman and colleagues [ 14 ] on the effects of growth hormone replacement therapy on body composition , the administration of growth hormone to 12 men 61 to 73 years of age for 6 months increased lean body mass by 9 % and decreased adipose tissue mass by 15 % ( P Circulating insulin-like growth factor 1 levels increase similarly in young and old men after exogenous administration of either growth hormone or growth hormone-releasing hormone [ 7 , 11 ] . Therefore , low insulin-like growth factor 1 levels reflect decreased growth hormone secretion rather than a loss of hepatic responsiveness to the hormone . On the basis of these data , it has been proposed that diminished secretion of growth hormone is responsible , in part , for the somatic changes of aging [ 14 ] . Growth hormone replacement has been shown to improve muscle volume , isometric strength , and exercise capacity in young adults with hypopituitarism [ 12 , 13 ] . In one study of growth hormone-deficient young adults treated with growth hormone [ 12 ] , thigh muscle volume increased by 6 % ( P isometric strength increased by 8 % ( P = 0.08 ) compared with controls . Increases in isometric strength were associated with increases in muscle volume ( r = 0.75 ; P Exercise capacity also increased by 12 % ( P growth hormone replacement therapy on strength or function are not available for older persons . To test the hypothesis that the muscle weakness and functional decline associated with aging are in part due to decreased growth hormone secretion , we conducted a 6-month r and omized , controlled , double-blind trial comparing recombinant human growth hormone therapy with placebo in 56 elderly men whose baseline insulin-like growth factor 1 levels were less than the tenth percentile found in younger healthy adults . Methods Participants We recruited healthy , ambulatory , community-dwelling men older than 69 years of age . Because growth hormone secretion is pulsatile and diurnal , a more convenient measure of growth hormone secretion is insulin-like growth factor 1 , which has constant and nonpulsatile plasma levels [ 1 , 7 , 15 , 16 ] . Inclusion criteria included two fasting morning plasma insulin-like growth factor 1 levels ( assayed after plasma was extracted with acid ethanol by the Nichols Institute [ 17 ] ) less than 161 ng/mL that were obtained at least 2 weeks apart , a fasting blood glucose level less than 8.4 mmol/L ( 140 mg/dL ) , stable body weight between 80 % and 120 % of ideal body weight [ 18 ] during the previous year , and a normal complete blood count at baseline . Participants had to be able to follow the study instructions and perform the strength measurements . Exclusion criteria included diseases that might contraindicate the use of growth hormone ( such as carcinoma within the previous 5 years , diabetes mellitus , and the carpal tunnel syndrome ) , uncontrolled hypertension ( blood pressure more than 180/100 mm Hg ) , oral corticosteroid use within the previous year , or a recent change in ambulatory status ( for example , as the result of a stroke ) . Design After the participants gave informed written consent , the following baseline measurements were obtained : question naires ( demographic characteristics and medical conditions ) ; fasting blood chemistry ( levels of electrolytes , urea nitrogen , creatinine , glucose , calcium , phosphate , and albumin ) ; complete blood count ; serum and rogen levels ( total and free testosterone and dehydroepi and rosterone ) ; fasting lipoprotein levels ( total cholesterol , high-density lipoprotein cholesterol , low-density lipoprotein cholesterol , and triglycerides ) and thyroid-stimulating hormone and free thyroxine levels ; 24-hour urinary calcium excretion ; and creatinine clearance . At baseline , we also measured the body composition , strength , and functional ability of all participants . We then used a computer-generated r and omization table to assign each participant to receive either growth hormone or placebo . Participants , investigators who had contact with the participants , and laboratory personnel were blinded to treatment status . Treatment consisted of recombinant human growth hormone ( somatropin [ Nutropin , Genentech ] ) , 0.03 mg/kg of body weight , or an equivalent placebo volume ( supplied in identical vials by Genentech ) injected subcutaneously three times per week in the morning for 6 months . We evaluated the participants after 2 , 4 , 8 , 12 , 18 , and 24 weeks of treatment to determine whether side effects developed and to ensure compliance . Participants were examined and specifically asked about the presence of the following side effects : malaise , fatigue , edema , arthralgias , arthritis , the carpal tunnel syndrome , muscle discomfort , dyspnea , depression , polydipsia , polyuria , nocturia , and tender or enlarged breasts . At each visit , we measured fasting morning plasma insulin-like growth factor 1 levels 48 hours after the last treatment dose and repeated most of the baseline blood and urinary tests . We adjusted the dose of recombinant human growth hormone to maintain serum insulin-like growth factor 1 levels between 190 and 350 ng/mL ( the 25th to 75th percentiles of a young adult population ) 48 hours after a dose . To preserve blinding , each growth hormone recipient was paired with a placebo recipient . An unblinded physician who had not had contact with the participants review ed insulin-like growth factor 1 levels during the trial . If the levels were less than 190 ng/mL or greater than 350 ng/mL , the unblinded physician instructed study personnel to make identical dose adjustments for both participants in the pair . The dose was also decreased in any participant who reported troublesome side effects that were potentially attributable to growth hormone . We repeated all study outcome measurements after 6 months of treatment . We also measured fasting plasma renin activity , cortisol and aldosterone levels , and 24-hour urine aldosterone excretion . The investigational review boards of the University of California , San Francisco , and the Department of Veterans Affairs Medical Center , San Francisco , approved the study protocol . Measurements Body Composition We used dual-energy x-ray absorptiometry ( Lunar DPX-Plus , Madison , Wisconsin ) total-body composition scans to measure lean tissue mass and fat mass , and we used anterior-posterior lumbar scans to measure bone mineral content . We measured skin thickness using ultrasonography with a 10-MHz transducer ( Diasonics , Milpitas , California ) that was positioned transversely 5 cm below the umbilicus . Using the same transducer , we made two ultrasonographic measurements on each participant . The average of the two measurements was used for analysis . The study radiologist , who was blinded to the participants ' treatment status , interpreted all test results . Muscle Strength The study 's physical therapist measured the muscle strength of the participants ' knee flexor and extensor muscles using an isokinetic dynamometer ( Cybex 340 , Lumex , Bay Shore , New York ) . Using a st and ard protocol , we measured peak torque of knee flexion and extension at joint speeds of 90 , 120 , and 180 degrees per second . We measured h and grip strength according to a st and ardized protocol using a grip dynamometer ( Smedley Grip Dynamometer , JA Preston , Jackson , Mississippi ) . The greater of the two measurements was used for analysis . Systemic Endurance To assess systemic endurance , we measured maximal oxygen consumption ( Vo 2 max ) during exercise cycle testing . Upright exercise testing was done using an electronically braked cycle ergometer ( Erich Jaeger , Rockford , Illinois ) . Exercise was initially done unloaded and was then increased by 25 watts every 2 minutes . Participants continued to exercise until they were exhausted or unable to maintain critical pedal frequency ( greater than 50 revolutions per minute ) . During exercise cycle testing , we continuously measured respiratory gas exchange to determine Vo 2 max ( Ergopneumotest , Erich Jaeger ) . Physical Performance The study 's physical therapist used the Physical Performance Test [ 19 ] to assess the participants ' performance on nine physical functions . Participants were asked to write a prescribed sentence , transfer kidney beans using a teaspoon , place a heavy book on a shelf , remove a jacket , pick up a penny from the floor , turn 360 degrees , walk a 50-foot walking test course , and climb stairs to determine speed and the number of flights climbed before the development of fatigue . The test score is based on the time required to complete each task . Higher scores ( the best performance is a maximum score of 36 ) are associated with the shortest time required to complete a task and with better functional status . Cognitive Function and Mood Each participant completed the Trails B Test , the Mini-Mental State Examination , the Digit Symbol Substitution Test , and the Geriatric Depression Scale [ 20 - 23 ] . The Trails B Test ( from the Halstead-Reitan Neuropsychological Test ",
"In the present study , the effect of endurance training alone and endurance training combined with recombinant human growth hormone ( rhGH ) administration on subcutaneous abdominal adipose tissue lipolysis was investigated . Sixteen healthy women [ age 75 + /- 2 yr ( mean + /- SE ) ] underwent a 12-wk endurance training program on a cycle ergometer . rhGH was administered in a r and omized , double-blinded , placebo-controlled design in addition to the training program . Subcutaneous abdominal adipose tissue lipolysis was estimated by means of microdialysis combined with measurements of subcutaneous abdominal adipose tissue blood flow ( ATBF ; (133)Xe washout ) . Whole body fat oxidation was estimated simultaneously by indirect calorimetry . Before and after completion of the training program , measurements were performed both at rest and during 60 min of continuous cycling at a workload corresponding to 60 % of pretraining peak oxygen uptake . Endurance training alone did not affect subcutaneous abdominal adipose tissue lipolysis either at rest or during exercise , as reflected by identical levels of interstitial adipose tissue glycerol , subcutaneous abdominal ATBF , and plasma nonesterified fatty acids before and after completion of the training program . Similarly , no effect on subcutaneous abdominal adipose tissue lipolysis was observed when combining endurance training with rhGH administration . However , in both the placebo and the GH groups , fat oxidation was significantly increased during exercise performed at the same absolute workload after completion of the training program . We conclude that the changed lipid metabolism during exercise observed after endurance training alone or after endurance training combined with rhGH administration is not due to alterations in subcutaneous abdominal adipose tissue metabolism in elderly women",
"Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists",
"To assess the effects of 16 weeks of heavy resistance exercise training ( RE ) on insulin sensitivity and secretion in healthy older men aged 64 to 75 years ( N = 15 ) , stable-label ( [6,6,2H2]glucose ) intravenous glucose tolerance tests ( IVGTTs ) were performed before and 7 days after the last bout of exercise . Glucose disappearance rate ( Rd ) and an index of insulin sensitivity ( Si * ) were derived using the minimal model of labeled glucose disappearance , and insulin secretion parameters were derived from C-peptide and glucose concentrations measured during the IVGTT , using a minimal model of C-peptide secretion and kinetics . Each subject trained at an intensity of 70 % to 95 % maximum strength 4 d/wk for 16 weeks on Nautilus ( DeL and , FL ) weight-training equipment . In conjunction with exercise , six men received daily injections of recombinant human growth hormone ( [ rhGH ] 12.5 to 24 microg/kg/d ) and the other nine received placebo injections . GH/placebo injections were administered in a double-blind r and omized fashion . The RE program was supervised and progressive in nature , consisting of both upper- and lower-body exercises , and significantly increased muscle strength ( P fat-free mass ( FFM ) in the RE + GH group ( P = .06 ) . Peak glucose Rd increased following RE ( P Si * ( ie , from 6.79 + /- 1.14 to 8.42 + /- 0.89 x 10(4 ) per min/[microU/mL ] , P = .06 ) . Peak glucose Rd and Si * were unchanged in the RE + GH group following treatment . First- and second-phase insulin secretion were not affected by RE or RE + GH . Glucose tolerance , quantified as the glucose disappearance constant ( Kg ) between 10 and 32 minutes of the IVGTT , was unchanged by exercise or hormone treatment . These findings support those of a recent study that used the hyperinsulinemic-euglycemic clamp technique ( Miller et al , J Appl Physiol 77:1122 - 1127 , 1994 ) , and suggest that when healthy older men engage in RE , whole-body glucose Rd and Si * are improved , and these beneficial effects are not only due to the acute effects of the last bout of exercise . Additionally , in six subjects who received GH , glucose Rd and Si * were not significantly improved following the RE program . Although this may suggest that GH can diminish improvements in glucose Rd and Si * that result from RE , further study is needed to confirm this observation",
"Adult GH deficiency ( AGHD ) is characterized by an altered body composition , an atherogenic lipid profile , decreased exercise capacity , and diminished quality of life . We performed a r and omized , double-blind , placebo-controlled , multicenter study in 166 subjects with AGHD to assess the effects of GH on these outcomes . GH was initiated at 0.0125 mg/kg.d , increased to 0.025 mg/kg.d as tolerated , or decreased to 0.00625 mg/kg.d for 12 months . Primary measures of efficacy included body composition , strength and endurance , and quality of life . Additional parameters included serum IGF-I concentrations , serum lipids , and bone mineral density . After 12 months , 79 % of subjects remained on GH 0.0125 mg/kg.d , whereas 21 % received 0.00625 mg/kg.d . GH-treated men and women demonstrated significant decreases in total body and trunk fat and increases in lean body mass over baseline . In GH-treated men , mean IGF-I SD scores exceeded age-adjusted normal ranges , whereas similar doses produced a smaller response in women . GH treatment was associated with significant improvements in total cholesterol and low-density lipoprotein ( P strength and endurance , quality of life , or bone mineral density . GH treatment was generally well tolerated . Subjects with AGHD should receive individualized GH therapy to maintain IGF-I between the mean value and + 2 SD and improve body composition and cardiovascular risk factors",
"To determine the effects of GH and insulin-like growth factor I ( IGF-I ) administration , diet , and exercise on weight loss , body composition , basal metabolic rate ( BMR ) , muscle strength , and psychological status , 33 moderately obese postmenopausal women ( 67.1 + /- 5.2 yr ) participated in a 12-week r and omized , double blind study . Participants were placed on a diet that provided 500 Cal/day less than that needed for weight maintenance , and they walked 3 days and strength trained 2 days each week . Subjects also self-injected GH ( 0.025 mg/kg BW.day ) , IGF-I ( 0.015 mg/kg BW.day ) , a combination of these doses of GH and IGF-I , or placebo ( P ) . Twenty-eight women completed the study , as five subjects dropped out due to intolerable side-effects ( e.g. edema ) . Weight loss occurred in all groups , with the largest decrease occurring in the GH plus IGF-I group ( 5.6 + /- 1.4 kg ) . Fat mass significantly decreased in all groups , with the largest losses observed in GH and GH plus IGF-I groups ( 6.3 + /- 1.8 and 8.4 + /- 2.8 kg , respectively ) . Despite weight loss , BMR was maintained in all groups . Muscle strength increased with training for all groups , and depression and anxiety scores decreased in groups receiving IGF-I. These data show that obese postmenopausal women can lose weight and fat without compromising fat free mass , BMR , or gains in muscle strength , and that GH and IGF-I given together may enhance fat loss over either given alone",
"Vastus lateralis muscle sample s were obtained by needle biopsy from 18 healthy elderly men ( 65 - 82 yr ) participating in a double blind , placebo (PL)-controlled trial of recombinant human GH ( rhGH ) and exercise and assessed for muscle morphology and skeletal muscle tissue expression of GH and insulin-like growth factors ( IGFs ) . Subjects initially underwent progressive resistance training for 14 weeks and were then r and omized to receive either rhGH ( 0.02 mg/kg BW.day , sc ) or PL while undertaking a further 10 weeks of training . Muscle sample s were obtained at baseline and at 14 and 24 weeks . The mean ( + /- SEM ) cross-sectional areas of type I and II fibers were similar ( type I , 3891 + /- 167 microns2 ; type II , 3985 + /- 200 microns2 ) at baseline and increased ( P in cross-sectional area for the PL group was significant ( P = 0.01 ) for type I ( 11.5 + /- 3.6 % ) and approached significance ( P = 0.06 ) for type II fibers ( 11.1 + /- 5.6 % ) . For rhGH , the change in type I ( 6.3 + /- 5.9 % ) and II ( 7.1 + /- 5.2 % ) fiber area was not significant . No apparent change in tissue GH receptor , IGF-I , IGF-I receptor , IGF-II , or IGF-II receptor messenger ribonucleic acids occurred as a result of exercise after the 14-week pretreatment period or after treatment with rhGH or PL . These results indicate that rhGH administration in exercising elderly men does not augment muscle fiber hypertrophy or tissue GH-IGF expression and suggests that deficits in the GH-IGF-I axis with aging do not inhibit the skeletal muscle tissue response to training",
"1 . The purpose of this study was to determine the suitability of ratios derived from dual-energy X-ray absorptiometry ( DXA ) whole body scans to assess regional fat distribution in older men and women by comparing them with the waist-to-hip ratio ( WHR ) and to evaluate their clinical utility by applying them in a clinical trial involving resistance exercise and recombinant human growth hormone . 2 . Sixty-four healthy older adults ( 39 women and 25 men ) , aged 65 - 82 years , served as subjects . The ratios of trunk fat-to-total fat , trunk fat-to-body weight , trunk fat-to-limb fat and trunk fat % were determined by DXA . WHR was assessed on the same day , as was the ratio of subscapular/triceps skinfolds in men . Cardiovascular disease risk factors , functional capacity and serum lipids were also assessed . 3 . A moderate relationship ( r = 0.36 - 0.54 ) between the WHR- and DXA-derived ratios were observed for both men and women . Both DXA and WHR showed similar associations with cardiovascular disease risk factors . However , in men , all DXA ratios were able to detect subtle changes in regional fat distribution result ing from daily administration of recombinant human growth hormone in conjunction with resistance exercise for 10 weeks , whereas the WHR or subscapular/triceps ratios did not . 4 . This suggests that DXA-derived ratios may be more sensitive than conventional anthropometric methods in the assessment and categorization of body fat distribution",
"OBJECTIVE Decline in growth hormone ( GH ) secretion and serum levels of insulin-like growth factor-1 ( IGF-1 ) during ageing may be a causal factor in the development of osteopenia . The purpose of this study was to test the effects of GH-replacement therapy on bone metabolism and mineral density in healthy men over 40 years old . MATERIAL 18 healthy men aged 60.2 + /- 2.4 ( avg + /- SEM ) with mean body weight 78.6 + /- 4.6 kg and body mass index ( BMI ) 26.5 + /- 1.4 kg/m2 . Diagnosis of growth hormone deficiency was based on serum IGF-1 levels below 200 micrograms/L ( 138.1 + /- 9.2 ) , abolished GH nocturnal surge and diminished glucagon-stimulated GH secretion compared to reference group of young men ( 16.2 + /- 1.8 to 30.6 + /- 4.7 micrograms/L/hour ; p Nine healthy men aged 27.5 + /- 1.3 were recruited as a control subjects . Their body weight was 76.3 + /- 2.2 kg and BMI 21.3 + /- 0.6 kg/m2 . METHODS The subjects received human , recombinant GH ( rhGH ) daily subcutaneously during 12 months in dose individually adjusted to maintain optimal ( 280 - 350 micrograms/L ) serum IGF-1 level . Initial dose was 0.125 IU/kg b.w./week . Before and after 6 and 12 months of therapy clinical and laboratory exams , including serum GH , IGF-1 , calcium , phosphate , osteocalcin , glucose , insulin levels and alkaline phosphatase ( AP ) activity were obtained . Lumbar spine and femoral neck bone mineral density ( BMD ) were measured by dual-energy X-ray absorptiometry . RESULTS rhGH administration for 12 months led to a significant increase in mean serum IGF-1 levels , from 138.1 + /- 9.2 to 279.4 + /- 26.3 micrograms/L ( p Mean serum osteocalcin concentration rose from 19.4 + /- 1.7 to 34.4 + /- 4.7 micrograms/L ( p serum AP activity changed nearly significantly , from 78.0 + /- 4.8 to 88.1 + /- 7.2 U/L. Lumbar spine and femur neck BMD increased significantly after 12 months , from 1.092 + /- 0.05 to 1.119 + /- 0.06 g/cm2 ( p Growth hormone replacement therapy in elderly men may be regarded as a method useful to protect against osteoporosis progression",
"OBJECTIVE Although the nature of the side‐effects of G H replacement In adults are well described , the factors Influencing their development are III understood . The aim of this study was to determine whether there were any characteristics of adults with G H deficiency that predicted whether or not they developed side‐effects of G H",
"Growth hormone ( GH ) replacement therapy in several controlled short-term trials have shown unanimous beneficial effects on body composition and other features . To evaluate more long-term effects we report data from 3 years of uninterrupted GH therapy in 10 GH-deficient adults who had all completed a previous double-blind placebo-controlled study and who also had been studied after 16 months of open GH therapy . No further increase in linear height was observed . The initial increase in thigh muscle volume was maintained after 3 years of GH therapy . A slight increase in body weight and thigh fat volume was recorded . Exercise capacity and isometric muscle strength were increased significantly compared to the initial placebo period . This was associated with stabilized levels of resting heart rate and blood pressure . Glycosylated hemoglobin levels were normal and did not change during the study . A st and ard oral glucose tolerance test performed at the end of the study revealed no evidence of glucose intolerance . No side-effects were reported . Compared to an age- and sex-matched group of healthy untreated subjects , thigh muscle volume , exercise capacity and isometric muscle strength had become normalized from subnormal levels after 3 years of GH therapy . We conclude that long-term GH replacement therapy in GH-deficient adults is associated with preserved beneficial effects on body composition and physical performance , result ing in a near normalization of several previously abnormal features and adding new merits to this treatment modality",
"GH deficiency ( GHD ) in adulthood is accompanied by physical and psychological impairments . One hundred fifteen patients ( 67 male , 48 female ) with pronounced GHD were enrolled in a r and omized , double-blind , placebo-controlled study with objectives that included effects on body composition , cardiac structure , and function and safety of replacement therapy with recombinant human GH ( Saizen ) . Sixty patients ( 31 male , 29 female ) received GH at a dose of 0.005 - 0.010 mg/kg.d , and 55 patients ( 36 male , 19 female ) received placebo for 6 months . Assessment of body composition by dual-energy x-ray absorptiometry demonstrated a treatment difference in lean body mass increase of 2.1 kg ( between-group comparison , P fat mass of 2.8 kg ( between-group comparison , P left ventricular systolic function after GH treatment in both genders . End-systolic volume decreased by 4.3 + /- 10.5 ml ( from 35.8 + /- 17.6 ml ; between-group comparison , P = 0.035 ) and ejection fraction increased by 5.1 + /- 10.0 % ( from 55.0 + /- 11.2 % ; between-group comparison , P = 0.048 ) , approaching normalcy . Diastolic function did not change as assessed by isovolumic relaxation time , early diastolic flow , diastolic flow secondary to atrial contraction , or ratio of peak mitral early diastolic and atrial contraction velocity . GH treatment was well tolerated , with adverse events primarily related to effects on fluid balance . No apparent relationship between IGF-I levels and the occurrence or severity of adverse events was identified . In conclusion , GH replacement therapy in adults with GHD demonstrated beneficial effects on lean body mass composition that was more pronounced in males than females . In contrast , cardiac function improvement appears to benefit both genders equally",
"BACKGROUND AND OBJECTIVES GH administration results in increased lean body mass ( LBM ) , decreased fat mass ( FM ) and increased energy expenditure ( EE ) . GH therapy may therefore have potential benefits , especially in the elderly , who are known to have decreased function of the GH/IGF‐I axis . Several studies have focused on effects of GH administration in the elderly in the last decade . However , very limited information is available regarding changes in body composition and EE upon GH discontinuation in the elderly . The present study therefore investigated the effects of 12 weeks of GH administration and subsequent discontinuation on body composition , resting oxygen uptake ( VO2 ) , resting heart rate ( HR ) and GH related serum markers in healthy elderly men",
"In a double blind , cross-over placebo-controlled trial , we studied the effects of 26 weeks of replacement therapy with recombinant human GH on body composition , metabolic parameters , and well-being in 10 patients with adult-onset GH deficiency ( GHD ) . All patients received appropriate thyroid , adrenal , and gonadal replacement therapy . The dose of recombinant human GH was 0.25 - 0.5 U/kg.week ( 0.013 - 0.026 mg/kg.day ) and was administered sc daily at bedtime . One patient was withdrawn from the study because of edema and atrial fibrillation . Body composition was estimated with three independent methods : computed tomography , bioelectric impedance , and total body potassium combined with total body water assessment s. The Comprehensive Psychological Rating Scale and the Symptom Check List-90 were used to assess any change in psychopathology . After 26 weeks of treatment , adipose tissue ( AT ) mass decreased 4.7 kg ( P Subcutaneous AT decreased by an average of 13 % , whereas visceral AT was reduced by 30 % . Muscle volume increased by 2.5 kg ( 5 % ; P body cell mass and extracellular fluid volume increased significantly by 1.6 and 3.0 kg , whereas body fat decreased by 6.1 kg . Results obtained by the bioelectric impedance technique were similar . The mean ( + /- SD ) concentrations of insulin-like growth factor-I increased from 0.26 ( 0.06 ) at baseline to 2.56 ( 1.55 ) and 2.09 ( 1.03 ) kU/L after 6 and 26 weeks of treatment . Calcium and serum phosphate , osteocalcin , and procollagen-III concentrations were significantly higher , and intact PTH concentrations were reduced after 6 and 26 weeks of treatment , respectively . Total and free T3 concentrations were significantly increased after 6 and 26 weeks of treatment , whereas free T4 concentrations were reduced at 6 weeks , but after 26 weeks , free T4 concentrations had returned to pretreatment values . Finally , after 26 weeks of treatment , there was a decrease in the Comprehensive Psychological Rating Scale score ( P body composition , fat distribution , and bone and mineral metabolism and reduces psychiatric symptoms . Finally , we conclude that the observed beneficial effects of replacement therapy with GH are of sufficient magnitude to consider treatment of GHD adults",
"The aim of GH replacement therapy in GH-deficient adults is to optimize response with minimum incidence of adverse reactions , but optimal therapy regimens are still to be established . This two-arm parallel study examined effects of two GH dose algorithms in adults with GH deficiency of adult or childhood onset . Patients on low dose ( LD ; n = 302 ) received GH at 3 microg/kg per day for 3 months increasing to 6 microg/kg per day for 3 months , and those on conventional dose ( CD ; n = 293 ) started on 6 microg/kg per day for 3 months increasing to 12 microg/kg per day for 3 months . The proportion of patients completing therapy was greater for the LD group than the CD group for the first 3 months ( 93.0 % vs. 88.1 % ; P = 0.037 ) and overall for the 6 months ( 90.7 % vs. 84.0 % ; P = 0.013 ) . Both dose groups showed significant increases in lean body mass and decreases in fat mass for all time points . Percent increase in lean body mass was less with LD than CD over the first 3 months ( 2.43 + /- 4.33 vs. 3.58 + /- 4.69 % ; P = 0.006 ) but not overall for the 6-month period ( 4.38 % + /- 5.34 % vs. 5.21 % + /- 5.99 % ; P = 0.141 ) . Percent decrease in fat mass was less with LD than CD for the first 3 months ( -2.81 % + /- 7.81 % vs. -5.53 % + /- 8.64 % ; P IGF-I SD score increased less with LD than CD for 0 to 3 and 0 to 6 months , although for IGF-binding protein-3 SD score , there was no significant difference between doses at any time . Arthralgia was the only adverse event that occurred significantly less frequently with LD than with CD . Calculated changes based on gender and onset indicated greater changes in males than females for body composition , but there was little difference in GH-related adverse events between males and females . The lower starting dose with dose titration appeared more favorable , but differences in response between genders and onset of GH deficiency need to be taken into account when setting an individual dose regimen",
"OBJECTIVE Reduced muscle mass and strength are characteristic findings of growth hormone deficiency ( GHD ) and aging . We evaluated measures of muscle strength , muscle fiber type , and cross sectional area in response to treatment with recombinant human growth hormone ( rhGH ) with or without a structured resistance exercise program in frail older subjects . DESIGN Placebo-controlled , r and omized , double blind trial . SETTING Outpatient clinical research center at an urban university-affiliated teaching hospital . PARTICIPANTS Thirty-one consenting older subjects ( mean age 71.3 + /- 4.5 years ) recruited as a subset of a larger project evaluating rhGH and exercise in older people , who underwent 62 quadricep-muscle biopsies . INTERVENTION R and om assignment to a 6-month course of one of four protocol s : rhGH administered subcutaneously daily at bedtime , rhGH and a structured resistance exercise program , structured resistance exercise with placebo injections , or placebo injections only . MEASUREMENTS Muscle biopsy specimens were obtained from the vastus lateralis muscle . Isokinetic dynamometry strength tests were used to monitor individual progress and to adjust the weights used in the exercise program . Serum insulin-like growth factor-I ( IGF-I ) was measured and body composition was measured using a Hologic QDR 1000W dual X-ray densitometer . RESULTS The administration of rhGH result ed in significant increase in circulating IGF-I levels in the individuals receiving rhGH treatment . Muscle strength increased significantly in both the rhGH/exercise ( + 55.6 % , P = .0004 ) as well as the exercise alone ( + 47.8 % , P = .0005 ) groups . There was a significant increase in the proportion of type 2 fibers between baseline and six months in the combined rhGH treated subjects versus those not receiving rhGH ( P = .027 ) . CONCLUSIONS Our results are encouraging in that they suggest an effect of growth hormone on a specific aging-correlated deficit . IGF-I was increased by administrating rhGH and muscle strength was increased by exercise . The administration of rhGH to frail older individuals in this study result ed in significant changes in the proportions of fiber types . Whether changes in fiber cross-sectional area or absolute number occur with long-term growth hormone administration requires further study",
"The purpose of this study was to determine whether growth hormone ( GH ) administration enhances the muscle protein anabolism associated with heavy-resistance exercise training in older men . Twenty-three healthy , sedentary men ( 67 + /- 1 yr ) with low serum insulin-like growth factor I levels followed a 16-wk progressive resistance exercise program ( 75 - 90 % max strength , 4 days/wk ) after r and om assignment to either a GH ( 12.5 - 24 micrograms.kg-1.day-1 ; n = 8) or placebo ( n = 15 ) group . Fat-free mass ( FFM ) and total body water increased more in the GH group . Whole body protein synthesis and breakdown rates increased in the GH group after treatment . However , increments in vastus lateralis muscle protein synthesis rate , urinary creatinine excretion , and training-specific isotonic and isokinetic muscle strength were similar in both groups , while 24-h urinary 3-methylhistidine excretion was unchanged after treatment . These observations suggest that resistance exercise training improved muscle strength and anabolism in older men , but these improvements were not enhanced when exercise was combined with daily GH administration . The greater increase in FFM with GH treatment may have been due to an increase in noncontractile protein and fluid retention",
"Aging is associated with reduced activities of the growth hormone ( GH ) , insulin-like growth factor I ( IGF-I ) , and sex steroid axes , and with decreased lean body mass and protein synthesis . Using a r and omized , double-blinded , placebo-controlled design , we studied the effects of 6 months of administration of GH alone , sex hormone alone ( hormone replacement therapy in women , testosterone enanthate [ T ] in men ) , or GH plus sex hormone on protein turnover in healthy men ( n=60 ) and women ( n=43 ) , aged 65 to 88 years ( mean , 71+/-4.4 years ) . Growth hormone administration significantly increased IGF-I levels in both sexes , more markedly in men . Sex steroid administration increased the levels of estrogen and testosterone in women and men , respectively ( P=.05 ) . Protein turnover was measured before and after the 26-week treatment period by means of a primed , constant l-[1-(13)C]leucine infusion . In men , GH plus T administration increased leucine flux from 80.2+/-2.8 to 93.6+/-4.2 micromol.h-1.kg-1 ( P=.02 ) . Leucine oxidation did not change significantly after hormone treatment in either sex . Growth hormone treatment led to nonsignificant upward trends in nonoxidative leucine disposal in men ( 9.1+/-5.2 mol.h-1.kg-1 ) and women ( 7.6+/-7.1 mol.h-1.kg-1 ) . Among all groups combined , changes in nonoxidative leucine disposal were directly related to those of serum IGF-I level ( r=0.248 , P Whole-body protein turnover increased in GH plus T-treated men ( 0.6+/-0.2 g protein.kg-1.d-1 ; P GH administration increases protein synthesis in healthy aged women and men , and that the coadministration of testosterone plus GH enhances this effect in elderly men",
"Aging is associated with reduced GH , IGF-I , and sex steroid axis activity and with increased abdominal fat . We employed a r and omized , double-masked , placebo-controlled , noncross-over design to study the effects of 6 months of administration of GH alone ( 20 microg/kg BW ) , sex hormone alone ( hormone replacement therapy in women , testosterone enanthate in men ) , or GH + sex hormone on total abdominal area , abdominal sc fat , and visceral fat in 110 healthy women ( n = 46 ) and men ( n = 64 ) , 65 - 88 yr old ( mean , 72 yr ) . GH administration increased IGF-I levels in women ( P = 0.05 ) and men ( P = 0.0001 ) , with the increment in IGF-I levels being higher in men ( P = 0.05 ) . Sex steroid administration increased levels of estrogen and testosterone in women and men , respectively ( P = 0.05 ) . In women , neither GH , hormone replacement therapy , nor GH + hormone replacement therapy altered total abdominal area , sc fat , or visceral fat significantly . In contrast , in men , administration of GH and GH + testosterone enanthate decreased total abdominal area by 3.9 % and 3.8 % , respectively , within group and vs. placebo ( P = 0.05 ) . Within-group comparisons revealed that sc fat decreased by 10 % ( P = 0.01 ) after GH , and by 14 % ( P = 0.0005 ) after GH + testosterone enanthate . Compared with placebo , sc fat decreased by 14 % ( P = 0.05 ) after GH , by 7 % ( P = 0.05 ) after testosterone enanthate , and by 16 % ( P = 0.0005 ) after GH + testosterone enanthate . Compared with placebo , visceral fat did not decrease significantly after administration of GH , testosterone enanthate , or GH + testosterone enanthate . These data suggest that in healthy older individuals , GH and /or sex hormone administration elicits a sexually dimorphic response on sc abdominal fat . The generally proportionate reductions we observed in sc and visceral fat , after 6 months of GH administration in healthy aged men , contrast with the disproportionate reduction of visceral fat reported after a similar period of GH treatment of nonelderly GH deficient men and women . Whether longer term administration of GH or testosterone enanthate , alone or in combination , will reduce abdominal fat distribution-related cardiovascular risk in healthy older men remains to be eluci date",
"The purpose of this study was to evaluate whether 16 weeks of heavy resistance exercise training combined with daily growth hormone administration ( GH ) increases bone mineral density in 64–75‐year‐old men greater than resistance exercise training without GH supplementation",
"CONTEXT Hormone administration to elderly individuals can increase lean body mass ( LBM ) and decrease fat , but interactive effects of growth hormone ( GH ) and sex steroids and their influence on strength and endurance are unknown . OBJECTIVE To evaluate the effects of recombinant human GH and /or sex steroids on body composition , strength , endurance , and adverse outcomes in aged persons . DESIGN , SETTING , AND PARTICIPANTS A 26-week r and omized , double-blind , placebo-controlled parallel-group trial in healthy , ambulatory , community-dwelling US women ( n = 57 ) and men ( n = 74 ) aged 65 to 88 years recruited between June 1992 and July 1998 . INTERVENTIONS Participants were r and omized to receive GH ( starting dose , 30 micro g/kg , reduced to 20 micro g/kg , subcutaneously 3 times/wk ) + sex steroids ( women : transdermal estradiol , 100 micro g/d , plus oral medroxyprogesterone acetate , 10 mg/d , during the last 10 days of each 28-day cycle [ HRT ] ; men : testosterone enanthate , biweekly intramuscular injections of 100 mg ) ( n = 35 ) ; GH + placebo sex steroid ( n = 30 ) ; sex steroid + placebo GH ( n = 35 ) ; or placebo GH + placebo sex steroid ( n = 31 ) in a 2 x 2 factorial design . MAIN OUTCOME MEASURES Lean body mass , fat mass , muscle strength , maximum oxygen uptake ( VO(2)max ) during treadmill test , and adverse effects . RESULTS In women , LBM increased by 0.4 kg with placebo , 1.2 kg with HRT ( P = .09 ) , 1.0 kg with GH ( P = .001 ) , and 2.1 kg with GH + HRT ( P Fat mass decreased significantly in the GH and GH + HRT groups . In men , LBM increased by 0.1 kg with placebo , 1.4 kg with testosterone ( P = .06 ) , 3.1 kg with GH ( P Fat mass decreased significantly with GH and GH + testosterone . Women 's strength decreased in the placebo group and increased nonsignificantly with HRT ( P = .09 ) , GH ( P = .29 ) , and GH + HRT ( P = .14 ) . Men 's strength also did not increase significantly except for a marginally significant increase of 13.5 kg with GH + testosterone ( P = .05 ) . Women 's VO(2)max declined by 0.4 mL/min/kg in the placebo and HRT groups but increased with GH ( P = .07 ) and GH + HRT ( P = .06 ) . Men 's VO(2)max declined by 1.2 mL/min/kg with placebo and by 0.4 mL/min/kg with testosterone ( P = .49 ) but increased with GH ( P = .11 ) and with GH + testosterone ( P strength ( r = 0.355 ; P VO(2)max ( r = 0.320 ; P = .002 ) were directly related to changes in LBM . Edema was significantly more common in women taking GH ( 39 % vs 0 % ) and GH + HRT ( 38 % vs 0 % ) . Carpal tunnel symptoms were more common in men taking GH + testosterone ( 32 % vs 0 % ) and arthralgias were more common in men taking GH ( 41 % vs 0 % ) . Diabetes or glucose intolerance occurred in 18 GH-treated men vs 7 not receiving GH ( P = .006 ) . CONCLUSIONS In this study , GH with or without sex steroids in healthy , aged women and men increased LBM and decreased fat mass . Sex steroid + GH increased muscle strength marginally and VO ( 2)max in men , but women had no significant change in strength or cardiovascular endurance . Because adverse effects were frequent ( importantly , diabetes and glucose intolerance ) , GH interventions in the elderly should be confined to controlled studies",
"Our objective was to study the effect of recombinant human growth hormone ( rhGH ) on hepatic cytochrome P450 ( CYP ) activity in 30 healthy elderly men",
"We examined the effect of recombinant human growth hormone ( rhGH ) and /or recombinant human insulin-like growth factor-I ( rhIGF-l ) on regional fat loss in postmenopausal women undergoing a weight loss regimen of diet plus exercise . Twenty-seven women aged 59 - 79 years , 20 - 40 % above ideal body weight , completed a 12-week program consisting of resistance training 2 days/week and walking 3 days/week , while consuming a diet that was 500 kcal/day less than that required for weight maintenance . Participants were r and omly assigned in a double-blind fashion to receive rhGH ( 0.025 mg/kg BW/day ; n = 7 ) , rhIGF-I ( 0.015 mg/kg BW/day ; n = 7 ) , rhGH + rhIGF-I ( n = 6 ) , or placebo ( PL ; n = 7 ) . Regional and whole body fat mass were determined by dual X-ray absorptiometry . Body fat distribution was assessed by the ratios of trunk fat-to-limb fat ( TrF/LimbF ) and trunk fat-to-total fat ( TrF/TotF ) . Limb and trunk fat decreased in all groups ( p ratios of fat distribution , the rhGH treated group experienced an enhanced loss of truncal compared to peripheral fat ( p in fat distribution and indices of cardiovascular disease risk as determined by serum lipidilipoprotein levels and maximal aerobic capacity . These results suggest that administration of rhGH facilitates a decrease in central compared to peripheral fat in older women undertaking a weight loss program that combines exercise and moderate caloric restriction , although no beneficial effects are conferred to lipid/lipoprotein profiles . Further , the effect of rhGH is not enhanced by combining rhGH with rhIGF-I administration . In addition , rhIGF-I does not augment the loss of trunk fat when administered alone"
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INTRODUCTION The effectiveness of a tourniquet in the case of life-threatening hemorrhages of the extremities is well recognized and led to the recommendations on " Tourniquet " of the German Society of Anaesthesiology and Intensive Care ( DGAI ) in 2016 . The aim of this systematic review was to re-evaluate the current medical literature in relation to the published DGAI recommendations . MATERIAL AND METHODS Based on the analysis of all studies published from January 2015 until January 2018 in the PubMed data bases , the publicized recommendations for action on " Tourniquet " of the DGAI were critically re-evaluated . For this purpose , 17 questions on 6 subjects were formulated in advance . The systematic review followed the PRISMA recommendations and is registered in PROSPERO ( International prospect i ve register of systematic review s , Reg.-ID : CRD42018091528 ) . RESULTS Of the 284 studies identified with the keywords tourniquet and trauma in the period from January 2015 to January 2018 in PubMed , 50 original papers discussing the prehospital application of tourniquet for life-threatening hemorrhage of the extremities were included . The overall level of evidence is low . No article addressed any of the formulated questions with a prospect i ve r and omized interventional study . Scientific deductions could be found only in an indirect way in a descriptive manner . CONCLUSION The 50 original articles included in this qualitative , systematic review revealed that the recommendations " Tourniquet " of the DGAI published in 2016 are mostly still up to date despite an inhomogeneous study situation . A deviation occurred in the conversion of a tourniquet but due to the short prehospital treatment time in the civilian setting this is of little importance ; however , in the future a strict distinction should be made between tourniquets which were placed for tactical reasons and those placed as a medical necessity
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"Abstract Introduction The clinical success of total knee arthroplasty ( TKA ) depends substantially on the quadriceps muscle function . A frequently applied thigh tourniquet during TKA may induce ischemia related injuries to quadriceps muscle cells . Animal limb muscles subjected to 2–5 h ischemia revealed dysfunctional mitochondria , which in turn compromised the cellular bioenergetics and increased the level of reactive oxygen species . The hypothesis of the present study was that tourniquet application during TKA for 60 min ( min ) affects the amount and function of mitochondria within musculus vastus medialis cells . Material s and methods In a r and omized clinical trial , 10 patients enrolled to undergo primary TKA . The patients were r and omly assigned to the tourniquet ( n = 5 ) or non-tourniquet group ( n = 5 ) after obtaining a written informed consent . For each of the groups , the first muscle biopsy was harvested immediately after performing the surgical approach and the second biopsy exactly 60 min later . All biopsies ( 5 × 5 × 5 mm ) 125 mm3 were harvested from musculus vastus medialis and snap-frozen in liquid nitrogen . The biochemical analysis of the prepared muscle tissues included the measurement of activities of mitochondrial respiratory chain enzyme complexes I – III and citrate synthase . Results Tourniquet-induced 60 min ischemia time did not significantly change the activities of the mitochondrial respiratory chain enzymes complexes I – III of the skeletal muscle cells . The citrate synthase activities found to be not significantly different between both groups . Conclusions The use of tourniquet during TKA within a limited time period of 60 min remained without substantial effects on the amount and function of mitochondria within human skeletal muscle cells",
"Tourniquet pain is a common source of complaint for patients undergoing carpal tunnel decompression and practice varies as to the tourniquet position used . There is little evidence to suggest benefit of one position over another . Our aim was to compare patient and surgeon experience of forearm and arm tourniquets . Following a power calculation , 100 patients undergoing open carpal tunnel decompression under local anaesthetic were r and omized to either an arm or a forearm tourniquet . Measurements of blood pressure , heart rate and pain were taken at 2.5 min intervals . The operating surgeon also provided a visual analogue scale rating for the extent of bloodless field achieved and for any obstruction caused by the tourniquet . There was no statistically significant inter-group difference in patient pain or physiological response , tourniquet time , bloodless field or length of procedure . The degree of obstruction caused by the tourniquet was significantly higher in the forearm group . Level of Evidence : I. Prospect i ve R and omized Controlled",
"OBJECTIVE Lactate levels are increasingly used to guide resuscitation efforts . Some surgical literature suggests that tourniquet use during phlebotomy falsely elevates results , although studies in healthy volunteers have not demonstrated this . The purpose of this study was to determine in clinical practice whether tourniquet use during the drawing of a lactate results in significantly altered levels compared to the result of a level drawn without a tourniquet . METHODS A prospect i ve cohort study was carried out on emergency department patients whose clinical presentation led a physician to order a lactate level . Written informed consent was obtained from patients or their proxies . Study lactates were obtained using a tourniquet during the draw sequence of other laboratory studies . Lactate levels for clinical use were drawn per hospital protocol with no tourniquet . The time of lactate measurements and patient demographic information were recorded . Lactate levels for each patient were compared with the Wilcoxon Rank-Sum Test . RESULTS 40 patients were consented and enrolled . The median clinical lactate level was 1.9 ( interquartile range 1.5 - 2.6 ) , and the median study lactate level was 1.9 ( interquartile range 1.4 - 2.7 ) . There was no difference between paired lactate values ( p=0.95 ) . CONCLUSIONS Tourniquet use appears to have no impact on measured lactate levels . Our findings suggest that current practice s at many institutions regarding lactate collection are likely too stringent and should be changed",
"AIM Thigh pain following tourniquet application is a common complaint in early post operative period following total knee arthroplasty . METHOD Post operative Thigh pain was evaluated in 30 consecutive simultaneous bilateral total knee arthroplasty patients between July 2013 and January 2014 . Patient thigh pain was evaluated with the VAS score . The scale was applied on first , second , third day & second and six weeks after surgery . RESULT There were statistically significant difference in VAS score in non-tourniquet group on first , second , third post operative day . We did not find statistically significant difference at Second and Six weeks post operatively . CONCLUSION This R and omized trial demonstrates that non-tourniquet use in TKA has less early postoperative pain and leads to better recovery",
"Background In a care under fire situation , a first line response to haemorrhage is to apply a tourniquet and return fire . However , there is little underst and ing of how tourniquets and other haemorrhage control devices impact marksmanship . Methods We compared the impact of the iTClamp and the Combat Application Tourniquet ( CAT ) on marksmanship . Following r and omisation ( iTClamp or CAT ) , trained marksmen fired an AR15 at a scaled silhouette target in prone unsupported position ( shooting task ) . Subjects then attempted to complete the shooting task at 5 , 10 , 15 , 30 and 60 min post-haemorrhage control device application . Results All of the clamp groups ( n=7 ) completed the 60 min shooting task . Five CAT groups ( n=6 ) completed the 5 min shooting task and one completed the 5 and 10 min shooting task before withdrawing . Four CAT groups were stopped due to unsafe h and ling ; two stopped due to pain . When examining hits on mass ( HOM ) for the entire shooting task , there was no significant difference between tourniquet and iTClamp HOM at 5 min ( p=0.18 ) . However , there was a significant difference at 10 min , p=0.003 with tourniquet having significantly fewer HOM ( 1.7±2.7 HOM ) than the iTClamp ( 8.1±3.3 HOM ) group . The total effective HOM for the entire 60 min shooting task showed that the iTClamp group achieved significantly ( p=0.001 ) more HOM than the tourniquet group . Over the entire 60 min shooting exercise , the iTClamp group achieved a median 72 % ( 52/72 ) of available HOM while the tourniquet group obtained 19 % ( 14/72 ) . Conclusions Application of a tourniquet to the dominant arm negates effective return of fire in a care under fire setting after a brief time window . Haemorrhage control devices that preserve function may have a role in care under fire situations , as preserving effectiveness in returning fire has obvious operational merits",
"BACKGROUND The widespread application of tourniquets has reduced battlefield mortality related to extremity exsanguinations . Tourniquet-induced ischemia-reperfusion injury ( I/R ) can contribute to muscle loss . Postischemic conditioning ( PostC ) confers protection against I/R in cardiac muscle and skeletal muscle flaps . The objective of this study was to determine the effect of PostC on extremity muscle viability in an established rat hindlimb tourniquet model . METHODS Rats were r and omly assigned to PostC-1 , PostC-2 , or no conditioning ischemic groups ( n = 10 per group ) . Postischemic conditioning , performed immediately after tourniquet release , consisted of four 15-second cycles ( PostC-1 ) or eight 15-second cycles ( PostC-2 ) of alternating occlusion and perfusion of hindlimbs . Twenty-four hours later , muscles were excised . The primary end points were muscle edema and viability ; secondary end points were histologic and markers of oxidative stress . RESULTS Ischemia-reperfusion injury decreased viability in all tourniquet limbs , but viability was not improved in either PostC group . Likewise , I/R result ed in substantial muscle edema that was not reduced by PostC. The predominant histologic feature was necrosis , but no significant differences were found among groups . Markers of oxidative stress were increased similarly among groups after I/R , although myeloperoxidase activity was significantly increased only in the no conditioning ischemic group . A protective effect from PostC was not observed in our model suggesting that PostC was not effective in reducing I/R skeletal muscle injury or any benefits of PostC were not sustained for 24 hours when tissues were assessed . CONCLUSION These negative findings are pertinent as the military investigates different strategies to extend the safe time for tourniquet application",
"OBJECTIVE To determine whether a color-coded tourniquet design ed for public use increases successful tourniquet application by laypeople . METHODS This was a r and omized study conducted on April 25 , 2015 . The study occurred during the Maryl and Day activity at the University of Maryl and in College Park , Maryl and . Investigators recruited participants with posters displayed at major crosswalks around a central testing area . A total of 157 volunteers aged 18 years or older and without prior military service or medical training were enrolled . A participant stood in front of a waist-down mannequin with an isolated leg injury while an investigator read aloud a mass causality scenario . The investigator then asked the participant to apply a tourniquet to the mannequin 's leg . All participants received a 4-step illustrated just-in-time ( JiT ) instruction card design ed to facilitate layperson tourniquet application . Test participants received a color-coded tourniquet design ed for layperson use with instructions printed on the device . Control participants received a black Combat Application Tourniquet ( C-A-T ; Composite Re sources , Rock Hill , SC ) . Participants were r and omized in a 1:1 ratio in blocks of 50 . The primary outcome was the proportion of successful tourniquet applications by those who received color-coded tourniquets compared to those who received black tourniquets . Secondary outcomes included validation of previous data analyzing layperson success with tourniquet application , time for successful placement , reasons for failed applications , and participant self-willingness and comfort using tourniquets . We also analyzed demographic data on the study population and inter-rater reliability regarding the assessment of successful tourniquet application . RESULTS Participants supplied with color-coded tourniquets successfully placed the device 51.38 % of the time , compared to 44.71 % of the time for controls using a black tourniquet ( risk ratio : 1.15 ; 95 % confidence interval : 0.83 - 1.59 ; P=0.404 ) . Participants ' self-reported willingness to use a tourniquet rose from 40.8 % before the study to 80.3 % after the study ( P color-coded device did not significantly increase laypeople 's proportion of successful tourniquet applications when compared with a st and ard black device . However , this study reproduced pilot study data showing that laypeople can successfully apply tourniquets about half the time if provided JiT instructions . Age , sex , race , income , and highest level of education were not found to impact one 's ability to properly apply a tourniquet . Laypeople 's willingness to apply tourniquets doubled to 80 % after brief exposure to the device . These results affirm the feasibility of engaging laypeople as immediate lifesavers of trauma victims and justify further efforts to boost rates of proper application",
"BACKGROUND Trauma procedural and management skills are often learned on live tissue . However , there is increasing pressure to use simulators because their fidelity improves and as ethical concerns increase . We r and omized military medical technicians ( medics ) to training on either simulators or live tissue to learn combat casualty care skills to determine if the choice of modality was associated with differences in skill uptake . METHODS Twenty medics were r and omized to trauma training using either simulators or live tissue . Medics were trained to perform five combat casualty care tasks ( surgical airway , needle decompression , tourniquet application , wound packing , and intraosseous line insertion ) . We measured skill uptake using a structured assessment tool . The medics also completed exit question naires and interviews to determine which modality they preferred . RESULTS We found no difference between groups trained with live tissue versus simulators in how they completed each combat casualty care skill . However , we did find that the modality of assessment affected the assessment score . Finally , we found that medics preferred trauma training on live tissue because of the fidelity of tissue h and ling in live tissue models . However , they also felt that training on simulators also provided additional training value . CONCLUSION We found no difference in performance between medics trained on simulators versus live tissue models . Even so , medics preferred live tissue training over simulation . However , more studies are required , and future studies need to address the measurement bias of measuring outcomes in the same model on which the study participants are trained . LEVEL OF EVIDENCE Therapeutic/care management study , level II",
"Abstract Purpose Recent data suggest diminished post-operative quadriceps muscle strength after tourniquet application during total knee arthroplasty ( TKA ) . The metabolic effects of the commonly utilized intraoperative tourniquet with consecutive ischaemia on the skeletal muscle cells were unknown . Ubiquitin proteasome system represents one of the main pathways involved in muscle protein breakdown contributing to muscle atrophy . Therefore , the purpose of the present study was to quantify the acute effects of the tourniquet application during TKA on the ( 1 ) concentrations of free/conjugated ubiquitin , ( 2 ) total ubiquitin-protein ligase activity , ( 3 ) proteasome-dependent and ( 4 ) proteasome-independent peptidase activities in the cells of vastus medialis . Methods The r and omized , controlled , monocentric trial included 34 patients scheduled to undergo primary TKA . Each patient was r and omly assigned to the tourniquet ( n = 17 ) or non-tourniquet group ( n = 17 ) after receiving a written consent . Muscle biopsies of ( 5 × 5 × 5 mm ) 125 mm3 were obtained from vastus medialis immediately after performing the surgical approach and exactly 60 min later . After preparation of the muscle tissue specimen , the concentrations of the free/conjugated ubiquitin ( Ub ) were measured by western blot analyses . The ubiquitination was determined as biotinylated Ub incorporated into the sum of the cytosolic proteins and expressed as total ubiquitin-protein ligase activity ( tUbPL ) . The quantification of the proteasome-dependent and proteasome-independent peptidase activities was performed with peptidase assays . Results Tourniquet application did not influence the concentration of the free/conjugated Ub . There were no differences in tUbPL activities between groups and time points . Tourniquet-induced ischaemia result ed in statistically significant higher proteasome-dependent ( caspase-like p = 0.0034 ; chymotryptic-like p = 0.0013 ; tryptic-like p = 0.0036 ) and proteasome-independent ( caspase-like p = 0.03 ; chymotryptic-like p = 0.0001 ; tryptic-like p = 0.0062 ) peptidase activities . Conclusion Tourniquet application did not affect the free/conjugated Ub as well as tUbPL significantly , emphasizing the sophisticated regulation of ubiquitination . The proteasome-dependent peptidase activities were significantly upregulated during tourniquet application , suggesting an increase in protein degradation , which in turn might explain the skeletal muscle atrophy occurring after TKA . These findings add further knowledge and should raise the awareness of surgeons about the effects of tourniquet-induced ischaemia at the molecular level . Additional high- quality research may be warranted to examine the short- and long-term clinical significance of the present data .Level of evidence",
"AIM To assess the clinical effects and the morphological grade of nerve compression . METHODS In a prospect i ve single-center r and omized , open study we assessed the clinical effects and the morphological grade of nerve compression during 20 min of either a silicon ring ( group A ) or pneumatic tourniquet ( group B ) placement variantly on the upper non-dominant limb in 14 healthy human volunteers . Before and during compression , the median and radial nerves were visualized in both groups by 3 Tesla MR imaging , using high resolutional ( 2.5 mm slice thickness ) axial T2-weighted sequences . RESULTS In group A , Visual analog pain scale was 5.4 ± 2.2 compared to results of group B , 2.9 ± 2.5 , showing a significant difference ( P = 0.028 ) . FPS levels in group A were 2.6 ± 0.9 compared to levels in group B 1.6 ± 1 , showing a significant difference ( P = 0.039 ) . Results related to measureable effect on median and radial nerve function were equal in both groups . No undue pressure signs on the skin , redness or nerve damage occurred in either group . There was no significant difference in the diameters of the nerves without and under compression in either group on T2 weighted images . CONCLUSION Based on our results , no differences between narrow and wide tourniquets were identified . Silicon ring tourniquets can be regarded as safe for short time application",
"Introduction Haemorrhage from the injured extremity is a significant cause of preventable death in military setting s. This study evaluated the effect of training on the efficacy of the combat application tourniquet ( CAT ) and to define st and ards for military personnel . Method Participants from a training tank battalion were r and omised . Data collected included age , body mass index , mean arterial pressure , h and dominance , femoral artery diameter and skin thickness . The study involved tourniquet application times ( AT ) and application success rates in basic , after-training and eyes-closed phases . Doppler ultrasound was used to identify the presence or absence of popliteal , radial and ulnar artery pulses . Results A total of 102 trainees participated . In the after-training phase , the left and right upper extremity ATs were 35±13.1 s , and 34.8±13.5 s and the right and left lower extremity ATs were 20.6±6.0 s and 20.5±5.5 s , respectively . The overall tourniquet success rates in three successive study phases were 69.6 % , 82.4 % and 91.2 % , respectively . A negative significant relationship was found between extremity circumference and tourniquet success . Discussion The results show that the efficacy of CAT application increases with training . Further studies are required to investigate the reasons underlying application failures . This single group prospect i ve r and omised study involves level of evidence 4",
"INTRODUCTION Optimal teaching and assessment methods and models for emergency airway , breathing , and hemorrhage interventions are not currently known . The University of Minnesota Combat Casualty Training consortium ( UMN CCTC ) was formed to explore the strengths and weaknesses of synthetic training models ( STMs ) versus live tissue ( LT ) models . In this study , we compare the effectiveness of best in class STMs versus an anesthetized caprine ( goat ) model for training and assessing seven procedures : junctional hemorrhage control , tourniquet ( TQ ) placement , chest seal , needle thoracostomy ( NCD ) , nasopharyngeal airway ( NPA ) , tube thoracostomy , and cricothyrotomy ( Cric ) . METHODS Army combat medics were r and omized to one of four groups : 1 ) LT trained-LT tested ( LT-LT ) , 2 ) LT trained-STM tested ( LT-STM ) , 3 ) STM trained-LT tested ( STM-LT ) , and 4 ) STM trained-STM tested ( STM-STM ) . Participants trained in small groups for 3 to 4 hours and were evaluated individually . LT-LT was the \" control \" to which other groups were compared , as this is the current military predeployment st and ard . The mean procedural scores ( PSs ) were compared using a pairwise t-test with a Dunnett 's correction . Logistic regression was used to compare critical fails ( CFs ) and skipped tasks . RESULTS There were 559 subjects included . Junctional hemorrhage control revealed no difference in CFs , but LT-tested subjects ( LT-LT and STM-LT ) skipped this task more than STM-tested subjects ( LT-STM and STM-STM ; p higher PSs than LT-LT ( p more CFs than LT-LT ( p lower PSs than LT-LT ( p CFs than LT-LT ( p = 0.001 ) and lower PSs ( p = 0.001 ) . There was no difference in CFs for NPA , but all groups had worse PSs versus LT-LT ( p CFs ( p = 0.08 ) , and STM-STM had higher PSs than LT-LT ( p Tube thoracostomy revealed that STM-LT had higher CFs than LT-LT ( p lower PSs ( p on STM or LT did not demonstrate a difference in subsequent performance for five of seven procedures ( junctional hemorrhage , TQ , chest seal , NPA , and NCD ) . Until STMs are developed with improved anthropomorphic and tissue fidelity , there may still be a role for LT for training tube thoracostomy and potentially Cric . For assessment , our STM appears more challenging for TQ and potentially for NCD than LT . For junctional hemorrhage , the increased \" skips \" with LT may be explained by the differences in anatomic fidelity . While these results begin to uncover the effects of training and assessing these procedures on various models , further study is needed to ascertain how well performance on an STM or LT model translates to the human model",
"BACKGROUND There is a need for a prospect i ve registry design ed to capture trauma-specific , in-hospital , and long-term outcomes related to vascular injury . METHODS The American Association for the Surgery of Trauma PROspect i ve Vascular Injury Treatment ( PROOVIT ) registry was used to collect demographic , diagnostic , treatment , and outcome data on vascular injuries . RESULTS A total of 542 injuries from 14 centers ( 13 American College of Surgeons – verified Level I and 1 American College of Surgeons – verified Level II ) have been captured since February 2013 . The majority of patients are male ( 70.5 % ) , with an Injury Severity Score ( ISS ) of 15 or greater among 32.1 % . Penetrating mechanisms account for 36.5 % . Arterial injuries to the head/neck ( 26.7 % ) , thorax ( 10.4 % ) , abdomen/pelvis ( 7.8 % ) , upper extremity ( 18.4 % ) , and lower extremity ( 26.0 % ) were identified , along with 98 major venous injuries . Hard signs of vascular injury , including hypotension ( systolic blood pressure Prehospital tourniquet use for extremity injuries occurred in 20.2 % ( 47 of 233 ) . Diagnostic modalities included exploration ( 28.8 % ) , computed tomographic angiography ( 38.9 % ) , duplex ultrasound ( 3.1 % ) , and angiography ( 10.7 % ) . Arterial injuries included transection ( 24.3 % ) , occlusion ( 17.3 % ) , partial transection/flow limiting defect ( 24.5 % ) , pseudoaneurysm ( 9.0 % ) , and other injuries including intimal defects ( 22.7 % ) . Nonoperative management was undertaken in 276 ( 50.9 % ) , with failure in 4.0 % . Definitive endovascular and open repair were used in 40 ( 7.4 % ) and 126 ( 23.2 % ) patients , respectively . Damage-control maneuvers were used in 57 ( 10.5 % ) , including ligation ( 31 , 5.7 % ) and shunting ( 14 , 2.6 % ) . Reintervention of initial repair was required in 42 ( 7.7 % ) . Amputation was performed in 7.7 % of extremity vascular injuries , and overall hospital mortality was 12.7 % . Follow-up ranging from 1 month to 7 months is available for 48 patients via a variety of modalities , with reintervention required in 1 patient . CONCLUSION The PROOVIT registry provides a contemporary picture of the management of vascular injury . This re source promises to provide needed information required to answer questions about optimal diagnosis and management of these patients —including much needed long-term outcome data . LEVEL OF EVIDENCE Epidemiologic study , level",
"BACKGROUND Military enthusiasm for limb tourniquet use in combat casualty care has result ed in acceptance by the trauma community for use in the prehospital care of civilian limb injuries . To date , there has been no report synthesizing the published data on civilian tourniquet use . The objective of this systematic review was to compile and analyze the content and quality of published data on the civilian use of tourniquets in limb trauma . METHODS The MEDLINE data base was search ed for studies on civilian limb tourniquet use in adults published between 2001 and 2017 . Search terms were tourniquet , trauma , and injury . Military reports and case series lacking systematic data collection were excluded . Counts and percentages were aggregated and weighted for analysis . RESULTS Reports were included from six regional trauma centers and one interregional collaboration ( total of 572 cases ) . One national prehospital data base report was included but analyzed separately ( 2,048 cases ) . All were retrospective cohort studies without prospect i ve data collection . Three reports defined a primary outcome , two had a nontourniquet control group , and no two articles reported the same variables . Limb injury severity and characteristics were inconsistently and incompletely described across reports , as were tourniquet indications and effectiveness . Arterial injury was reported in two studies and was infrequent among cases of tourniquet use . Mortality was low , and limb-specific complications were infrequent but variably reported . CONCLUSION The rapid increase in the civilian use of tourniquets for limb hemorrhage control has occurred without a large amount or high quality of data . Adoption of a multicenter registry with st and ardized data collection specific to limb trauma and tourniquet use can serve to improve the trauma community 's underst and ing of the safety and effectiveness of tourniquet use in civilian trauma setting s. LEVEL OF EVIDENCE Systematic review , level IV"
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A growing body of evidence suggests yogic practice s may benefit adults with type 2 diabetes ( DM2 ) . In this systematic review , we evaluate available evidence from prospect i ve controlled trials regarding the effects of yoga-based programs on specific health outcomes pertinent to DM2 management . To identify qualifying studies , we search ed nine data bases and scanned bibliographies of relevant review papers and all identified articles . Controlled trials that did not target adults with diabetes , included only adults with type 1 diabetes , were under two-week duration , or did not include quantitative outcome data were excluded . Study quality was evaluated using the PEDro scale . Thirty-three papers reporting findings from 25 controlled trials ( 13 nonr and omized , 12 r and omized ) met our inclusion criteria ( N = 2170 participants ) . Collectively , findings suggest that yogic practice s may promote significant improvements in several indices of importance in DM2 management , including glycemic control , lipid levels , and body composition . More limited data suggest that yoga may also lower oxidative stress and blood pressure ; enhance pulmonary and autonomic function , mood , sleep , and quality of life ; and reduce medication use in adults with DM2 . However , given the method ological limitations of existing studies , additional high- quality investigations are required to confirm and further eluci date the potential benefits of yoga programs in population s with DM2
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"Objective . To examine the effects of yoga versus an educational film program on sleep , mood , perceived stress , and sympathetic activation in older women with RLS . Methods . Participants were drawn from a larger trial regarding the effects of yoga on cardiovascular disease risk profiles in overweight , sedentary postmenopausal women . Seventy-five women were r and omized to receive either an 8-week yoga ( n = 38 ) or educational film ( n = 37 ) program . All 75 participants completed an RLS screening question naire . The 20 women who met all four diagnostic criteria for RLS ( n = 10 yoga , 10 film group ) comprised the population for this nested study . Main outcomes assessed pre- and post-treatment included : sleep ( Pittsburgh Sleep Quality Index ) , stress ( Perceived Stress Scale ) , mood ( Profile of Mood States , State-Trait Anxiety Inventory ) , blood pressure , and heart rate . Results . The yoga group demonstrated significantly greater improvements than controls in multiple domains of sleep quality and mood , and significantly greater reductions in insomnia prevalence , anxiety , perceived stress , and blood pressure ( all P's≤0.05 ) . Adjusted intergroup effect sizes for psychosocial variables were large , ranging from 1.9 for state anxiety to 2.6 for sleep quality . Conclusions . These preliminary findings suggest yoga may offer an effective intervention for improving sleep , mood , perceived stress , and blood pressure in older women with RLS",
"This is the first in vivo demonstration of an association between endogenous neurotransmitter release and conscious experience . Using 11C-raclopride PET we demonstrated increased endogenous dopamine release in the ventral striatum during Yoga Nidra meditation . Yoga Nidra is characterized by a depressed level of desire for action , associated with decreased blood flow in prefrontal , cerebellar and subcortical regions , structures thought to be organized in open loops subserving executive control . In the striatum , dopamine modulates excitatory glutamatergic synapses of the projections from the frontal cortex to striatal neurons , which in turn project back to the frontal cortex via the pallidum and ventral thalamus . The present study was design ed to investigate whether endogenous dopamine release increases during loss of executive control in meditation . Participants underwent two 11C-raclopride PET scans : one while attending to speech with eyes closed , and one during active meditation . The tracer competes with endogenous dopamine for access to dopamine D2 receptors predominantly found in the basal ganglia . During meditation , 11C-raclopride binding in ventral striatum decreased by 7.9 % . This corresponds to a 65 % increase in endogenous dopamine release . The reduced raclopride binding correlated significantly with a concomitant increase in EEG theta activity , a characteristic feature of meditation . All participants reported a decreased desire for action during meditation , along with heightened sensory imagery . The level of gratification and the depth of relaxation did not differ between the attention and meditation conditions . Here we show increased striatal dopamine release during meditation associated with the experience of reduced readiness for action . It is suggested that being in the conscious state of meditation causes a suppression of cortico-striatal glutamatergic transmission . To our knowledge this is the first time in vivo evidence has been provided for regulation of conscious states at a synaptic level",
"Type 2 diabetes is a global public health crisis that threatens the economies of all nations , particularly developing countries . Fueled by rapid urbanization , nutrition transition , and increasingly sedentary lifestyles , the epidemic has grown in parallel with the worldwide rise in obesity . Asia 's large population and rapid economic development have made it an epicenter of the epidemic . Asian population s tend to develop diabetes at younger ages and lower BMI levels than Caucasians . Several factors contribute to accelerated diabetes epidemic in Asians , including the “ normal-weight metabolically obese ” phenotype ; high prevalence of smoking and heavy alcohol use ; high intake of refined carbohydrates ( e.g. , white rice ) ; and dramatically decreased physical activity levels . Poor nutrition in utero and in early life combined with overnutrition in later life may also play a role in Asia 's diabetes epidemic . Recent advances in genome-wide association studies have contributed substantially to our underst and ing of diabetes pathophysiology , but currently identified genetic loci are insufficient to explain ethnic differences in diabetes risk . Nonetheless , interactions between Westernized diet and lifestyle and genetic background may accelerate the growth of diabetes in the context of rapid nutrition transition . Epidemiologic studies and r and omized clinical trials show that type 2 diabetes is largely preventable through diet and lifestyle modifications . Translating these findings into practice , however , requires fundamental changes in public policies , the food and built environments , and health systems . To curb the escalating diabetes epidemic , primary prevention through promotion of a healthy diet and lifestyle should be a global public policy priority",
"OBJECTIVES Yoga and exercise have beneficial effects on mood and anxiety . γ-Aminobutyric acid (GABA)-ergic activity is reduced in mood and anxiety disorders . The practice of yoga postures is associated with increased brain GABA levels . This study addresses the question of whether changes in mood , anxiety , and GABA levels are specific to yoga or related to physical activity . METHODS Healthy subjects with no significant medical/psychiatric disorders were r and omized to yoga or a metabolically matched walking intervention for 60 minutes 3 times a week for 12 weeks . Mood and anxiety scales were taken at weeks 0 , 4 , 8 , 12 , and before each magnetic resonance spectroscopy scan . Scan 1 was at baseline . Scan 2 , obtained after the 12-week intervention , was followed by a 60-minute yoga or walking intervention , which was immediately followed by Scan 3 . RESULTS The yoga subjects ( n = 19 ) reported greater improvement in mood and greater decreases in anxiety than the walking group ( n = 15 ) . There were positive correlations between improved mood and decreased anxiety and thalamic GABA levels . The yoga group had positive correlations between changes in mood scales and changes in GABA levels . CONCLUSIONS The 12-week yoga intervention was associated with greater improvements in mood and anxiety than a metabolically matched walking exercise . This is the first study to demonstrate that increased thalamic GABA levels are associated with improved mood and decreased anxiety . It is also the first time that a behavioral intervention ( i.e. , yoga postures ) has been associated with a positive correlation between acute increases in thalamic GABA levels and improvements in mood and anxiety scales . Given that pharmacologic agents that increase the activity of the GABA system are prescribed to improve mood and decrease anxiety , the reported correlations are in the expected direction . The possible role of GABA in mediating the beneficial effects of yoga on mood and anxiety warrants further study",
"BACKGROUND This study examined the effects of brief daily yogic meditation on mental health , cognitive functioning , and immune cell telomerase activity in family dementia caregivers with mild depressive symptoms . METHODS Thirty-nine family dementia caregivers ( mean age 60.3 years old ( SD = 10.2 ) ) were r and omized to practicing Kirtan Kriya or listening to relaxation music for 12 min per day for 8 weeks . The severity of depressive symptoms , mental and cognitive functioning were assessed at baseline and follow-up . Telomerase activity in peripheral blood mononuclear cells ( PMBC ) was examined in peripheral P BMC pre-intervention and post-intervention . RESULTS The meditation group showed significantly lower levels of depressive symptoms and greater improvement in mental health and cognitive functioning compared with the relaxation group . In the meditation group , 65.2 % showed 50 % improvement on the Hamilton Depression Rating scale and 52 % of the participants showed 50 % improvement on the Mental Health Composite Summary score of the Short Form-36 scale compared with 31.2 % and 19 % , respectively , in the relaxation group ( p telomerase activity compared with 3.7 % in the relaxation group ( p = 0.05 ) . CONCLUSION This pilot study found that brief daily meditation practice s by family dementia caregivers can lead to improved mental and cognitive functioning and lower levels of depressive symptoms . This improvement is accompanied by an increase in telomerase activity suggesting improvement in stress-induced cellular aging . These results need to be confirmed in a larger sample",
"PURPOSE Recent evidence suggests that depression is linked to increased mortality among patients with diabetes . This study examines the association of depression with all-cause and cause-specific mortality in diabetes . METHODS We conducted a prospect i ve cohort study of primary care patients with type 2 diabetes at Group Health Cooperative in Washington state . We used the Patient Health Question naire ( PHQ-9 ) to assess depression at baseline and review ed medical records supplemented by the Washington state mortality registry to ascertain the causes of death . RESULTS Among a cohort of 4,184 patients , 581 patients died during the follow-up period . Deaths occurred among 428 ( 12.9 % ) patients with no depression , among 88 ( 17.8 % ) patients with major depression , and among 65 ( 18.2 % ) patients with minor depression . Causes of death were grouped as cardiovascular disease , 42.7 % ; cancer , 26.9 % ; and deaths that were not due to cardiovascular disease or cancer , 30.5 % . Infections , dementia , renal failure , and chronic obstructive pulmonary disease were the most frequent causes in the latter group . Adjusting for demographic characteristics , baseline major depression ( relative to no depression ) was significantly associated with all-cause mortality ( hazard ratio [HR]=2.26 , 95 % confidence interval [ CI ] , 1.79–2.85 ) , with cardiovascular mortality ( HR = 2.00 ; 95 % CI , 1.37–2.94 ) , and with noncardiovascular , noncancer mortality ( HR = 3.35 ; 95 % CI , 2.30–4.89 ) . After additional adjustment for baseline clinical characteristics and health habits , major depression was significantly associated only with all-cause mortality ( HR = 1.52 ; 95 % CI , 1.19–1.95 ) and with death not caused by cancer or atherosclerotic cardiovascular disease ( HR = 2.15 ; 95 % CI , 1.43–3.24 ) . Minor depression showed similar but nonsignificant associations . CONCLUSIONS Patients with diabetes and coexisting depression face substantially elevated mortality risks beyond cardiovascular deaths ",
"OBJECTIVE Cross-sectional and longitudinal associations among regimen distress ( RD ) , self-management , and glycemic control were undertaken to explore mechanisms of operation among these variables . RESEARCH DESIGN AND METHODS In a behavioral r and omized control trial ( RCT ) to reduce RD , 392 adults with type 2 diabetes were assessed for RD , diet , exercise , medication adherence , and HbA1c at baseline and at 4 and 12 months . Associations among RD , self-management , and HbA1c were examined in cross-sectional analyses at baseline , in prospect i ve analyses using baseline values to predict change over time , and in time-varying analyses . RESULTS At baseline , greater RD and poorer medication adherence were independently associated with higher HbA1c ( P = 0.05 and P poorer medication adherence ( P = 0.03 ) . No consistent pattern of significant prospect i ve associations was found . Significant time-varying findings showed that decreases in RD were associated with improvements in medication adherence ( P physical activity ( P HbA1c ( P = 0.02 ) over time following intervention . Changes in self-management were not associated with changes in HbA1c over time . CONCLUSIONS In the context of an RCT to reduce distress , RD , self-management , and HbA1c were interrelated in cross-sectional and time-varying analyses . Decreases in RD were associated with improvements in both self-management and HbA1c over 12 months . Findings point to the complex and likely multifaceted pathways of association among these key constructs , with results indicating significant linkages between RD and both self-management and glycemic control over time",
"OBJECTIVE There is conflicting evidence regarding the utility of stress management training in the treatment of diabetes . The few studies that have shown a therapeutic effect of stress management have used time-intensive individual therapy . Unfortunately , widespread use of such interventions is not practical . The aim of the present investigation is to determine whether a cost-effective , group-based stress management training program can improve glucose metabolism in patients with type 2 diabetes and to determine whether a particular subset of patients is more likely to get positive results . RESEARCH DESIGN AND METHODS Patients with type 2 diabetes were r and omized to undergo a five-session group diabetes education program with or without stress management training . Participants ( n = 108 ) were followed for 1 year , during which HbA(1c ) tests and question naires assessing perceived stress , anxiety , and psychological health were administered at regular intervals to evaluate treatment effects . RESULTS Stress management training was associated with a small ( 0.5 % ) but significant reduction in HbA(1c ) . Compliance with the treatment regimen decreased over time but was similar to that seen in patients receiving stress management for other reasons in the clinic . Trait anxiety ( a measure of stable individual differences in anxiety proneness ) did not predict response to treatment , showing that highly anxious patients did not derive more benefit from training . CONCLUSIONS The current results indicate that a cost-effective , group stress management program in a \" real-world \" setting can result in clinical ly significant benefits for patients with type 2 diabetes",
"OBJECTIVE Sleep deprivation in healthy men has been experimentally found to result in disturbances in glucose metabolism and in sympathovagal imbalance . The aim of the present study was to investigate whether sleep disturbances and elevated resting heart rate are associated with increased risk of developing diabetes . RESEARCH DESIGN AND METHODS A group of 6,599 initially healthy , nondiabetic men aged 44.5 + /- 4.0 years took part in a prospect i ve , population -based study in Malmö , Sweden . The incidence of diabetes during a mean follow-up of 14.8 + /- 2.4 years was examined in relation to self-reported difficulties in falling asleep and resting heart rate at baseline . Diabetes was assessed at follow-up in all subjects by question naire and in a subgroup of 1,551 men by blood glucose measurement . RESULTS A total of 615 ( 9.3 % ) subjects reported either difficulties in falling asleep or regular use of hypnotics ( seen as markers of sleep disturbances ) , and 158 ( 2.4 % ) subjects reported both of these . Altogether , 281 ( 4.3 % ) of the men developed diabetes during the follow-up period . Logistic regression models showed difficulties in falling asleep or regular use of hypnotics ( odds ratio [ OR ] 1.52 [ 95 % CI 1.05 - 2.20 ] ) and resting heart rate ( OR per 10 bpm 1.13 [ 0.99 - 1.30 ] ) to be associated with development of diabetes when full adjustments were made for baseline age , biological risk factors , lifestyle , family history of diabetes , and social class . CONCLUSIONS The results suggest that sleep disturbances and , possibly , elevated resting heart rate , in middle-aged men , are associated with an increased risk of diabetes",
"Twenty Type 2 diabetic subjects between the age group of 30 - 60 years were studied to see the effect of 40 days of Yoga asanas on the nerve conduction velocity . The duration of diabetes ranged from 0 - 10 years . Subject suffering from cardiac , renal and proliferative retinal complications were excluded from the study Yoga asanas included Suryanamskar . Tadasan , Konasan , Padmasan Pranayam , Paschimottansan Ardhmatsyendrasan , Shavasan , Pavanmukthasan , Sarpasan and Shavasan . Subjects were called to the cardio-respiratory laboratory in the morning time and were given training by the Yoga expert . The Yoga exercises were performed for 30 - 40 minutes every day for 40 days in the above sequence . The subjects were prescribed certain medicines and diet . The basal blood glucose , nerve conduction velocity of the median nerve was measured and repeated after 40 days of Yogic regime . Another group of 20 Type 2 diabetes subjects of comparable age and severity , called the control group , were kept on prescribed medication and light physical exercises like walking . Their basal & post 40 days parameters were recorded for comparison . Right h and and left h and median nerve conduction velocity increased from 52.81 + /- 1.1 m/sec to 53.87 + /- 1.1 m/sec and 52.46 + /- 1.0 to 54.75 + /- 1/1 m/sec respectively . Control group nerve function parameters deteriorated over the period of study , indicating that diabetes is a slowly progressive disease involving the nerves . Yoga asanas have a beneficial effect on glycaemic control and improve nerve function in mild to moderate Type 2 diabetes with sub- clinical neuropathy",
"Background Yoga is a popular therapy for diabetes but its efficacy is contested . The aim of this study was to explore the feasibility of research ing community based yoga classes in Type 2 diabetes with a view to informing the design of a definitive , multi-centre trial Methods The study design was an exploratory r and omised controlled trial with in-depth process evaluation . The setting was two multi-ethnic boroughs in London , UK ; one with average and one with low mean socio-economic deprivation score . Classes were held at a sports centre or GP surgery . Participants were 59 people with Type 2 diabetes not taking insulin , recruited from general practice lists or opportunistically by general practice staff . The intervention group were offered 12 weeks of a twice-weekly 90-minute yoga class ; the control group was a waiting list for the yoga classes . Both groups received advice and leaflets on healthy lifestyle and were encouraged to exercise . Primary outcome measure was HbA1c . Secondary outcome measures included attendance , weight , waist circumference , lipid levels , blood pressure , UKPDS cardiovascular risk score , diabetes-related quality of life ( ADDQoL ) , and self-efficacy . Process measures were attendance at yoga sessions , self-reported frequency of practice between taught sessions , and qualitative data ( interviews with patients and therapists , ethnographic observation of the yoga classes , and analysis of documents including minutes of meetings , correspondence , and exercise plans ) . Results Despite broad inclusion criteria , around two-thirds of the patients on GP diabetic registers proved ineligible , and 90 % of the remainder declined to participate . Mean age of participants was 60 + /- 10 years . Attendance at yoga classes was around 50 % . Nobody did the exercises regularly at home . Yoga teachers felt that most participants were unsuitable for ' st and ard ' yoga exercises because of limited flexibility , lack of basic fitness , co-morbidity , and lack of confidence . There was a small fall in HbA1c in the yoga group which was not statistically significant and which was not sustained six months later , and no significant change in other outcome measures . Conclusion The benefits of yoga in type 2 diabetes suggested in some previous studies were not confirmed . Possible explanations ( apart from lack of efficacy ) include recruitment challenges ; practical and motivational barriers to class attendance ; physical and motivational barriers to engaging in the exercises ; inadequate intensity and /or duration of yoga intervention ; and insufficient personalisation of exercises to individual needs . All these factors should be considered when design ing future trials . Trial registration National Research Register ( 1410 ) and Current Controlled Trials ( IS RCT N63637211 )",
"Background : The dem and for clinical ly efficacious , safe , patient acceptable , and cost-effective forms of treatment for mental illness is growing . Several studies have demonstrated benefit from yoga in specific psychiatric symptoms and a general sense of well-being . Objective : To systematic ally examine the evidence for efficacy of yoga in the treatment of selected major psychiatric disorders . Methods : Electronic search es of The Cochrane Central Register of Controlled Trials and the st and ard bibliographic data bases , MEDLINE , EMBASE , and PsycINFO , were performed through April 2011 and an up date d in June 2011 using the keywords yoga AND psychiatry OR depression OR anxiety OR schizophrenia OR cognition OR memory OR attention AND r and omized controlled trial ( RCT ) . Studies with yoga as the independent variable and one of the above mentioned terms as the dependent variable were included and exclusion criteria were applied . Results : The search yielded a total of 124 trials , of which 16 met rigorous criteria for the final review . Grade B evidence supporting a potential acute benefit for yoga exists in depression ( four RCTs ) , as an adjunct to pharmacotherapy in schizophrenia ( three RCTs ) , in children with ADHD ( two RCTs ) , and Grade C evidence in sleep complaints ( three RCTs ) . RCTs in cognitive disorders and eating disorders yielded conflicting results . No studies looked at primary prevention , relapse prevention , or comparative effectiveness versus pharmacotherapy . Conclusion : There is emerging evidence from r and omized trials to support popular beliefs about yoga for depression , sleep disorders , and as an augmentation therapy . Limitations of literature include inability to do double-blind studies , multiplicity of comparisons within small studies , and lack of replication . Biomarker and neuroimaging studies , those comparing yoga with st and ard pharmaco- and psychotherapies , and studies of long-term efficacy are needed to fully translate the promise of yoga for enhancing mental health",
"BACKGROUND Although yoga and meditation have been used for stress reduction with reported improvement in inflammation , little is known about the biological mechanisms mediating such effects . The present study examined if a yogic meditation might alter the activity of inflammatory and antiviral transcription control pathways that shape immune cell gene expression . METHODS Forty-five family dementia caregivers were r and omized to either Kirtan Kriya Meditation ( KKM ) or Relaxing Music ( RM ) listening for 12 min daily for 8 weeks and 39 caregivers completed the study . Genome-wide transcriptional profiles were collected from peripheral blood leukocytes sample d at baseline and 8-week follow-up . Promoter-based bioinformatics analyses tested the hypothesis that observed transcriptional alterations were structured by reduced activity of the pro-inflammatory nuclear factor (NF)-κB family of transcription factors and increased activity of Interferon Response Factors ( IRFs ; i.e. , reversal of patterns previously linked to stress ) . RESULTS In response to KKM treatment , 68 genes were found to be differentially expressed ( 19 up-regulated , 49 down-regulated ) after adjusting for potentially confounded differences in sex , illness burden , and BMI . Up-regulated genes included immunoglobulin-related transcripts . Down-regulated transcripts included pro-inflammatory cytokines and activation-related immediate-early genes . Transcript origin analyses identified plasmacytoid dendritic cells and B lymphocytes as the primary cellular context of these transcriptional alterations ( both p NF-κB signaling and increased activity of IRF1 in structuring those effects ( both p daily yogic meditation intervention may reverse the pattern of increased NF-κB-related transcription of pro-inflammatory cytokines and decreased IRF1-related transcription of innate antiviral response genes previously observed in healthy individuals confronting a significant life stressor",
"OBJECTIVE To examine prospect ively the relationship between diabetes , glycemic control , and spirometric measures . RESEARCH DESIGN AND METHODS From a community-based cohort , 495 Europid ( i.e. , of European descent ) patients with type 2 diabetes who had no history of pulmonary disease underwent baseline spirometry between 1993 and 1994 . A subset of 125 patients was restudied a mean of 7.0 years later . The main outcome measures included forced vital capacity ( FVC ) , forced expiratory volume in 1 s ( FEV1 ) , vital capacity ( VC ) , and peak expiratory flow ( PEF ) corrected for body temperature , air pressure , and water saturation and were expressed either in absolute terms or as percentage-predicted value for age , sex , and height . RESULTS Mean percentage-predicted values of each spirometric measure were decreased > 10 % in the whole cohort at baseline and absolute measures continued to decline at an annual rate of 68 , 71 , and 84 ml/year and 17 l/min for FVC , FEV1 , VC , and PEF , respectively , in the 125 prospect ively studied patients . Declining lung function measures were consistently predicted by poor glycemic control in the form of a higher up date d mean HbA1c , follow-up HbA1c , or follow-up fasting plasma glucose . In a Cox proportional hazards model , decreased FEV1 percentage-predicted value was an independent predictor of all-cause mortality . CONCLUSIONS Reduced lung volumes and airflow limitation are likely to be chronic complications of type 2 diabetes , the severity of which relates to glycemic exposure . Airflow limitation is a predictor of death in type 2 diabetes after adjusting for other recognized risk factors",
"Background Yoga has been shown to be a simple and economical therapeutic modality that may be considered as a beneficial adjuvant for type 2 diabetes mellitus . This study investigated the impact of Hatha yoga and conventional physical training ( PT ) exercise regimens on biochemical , oxidative stress indicators and oxidant status in patients with type 2 diabetes . Methods This prospect i ve r and omized study consisted of 77 type 2 diabetic patients in the Hatha yoga exercise group that were matched with a similar number of type 2 diabetic patients in the conventional PT exercise and control groups . Biochemical parameters such as fasting blood glucose ( FBG ) , serum total cholesterol ( TC ) , triglycerides , low-density lipoprotein ( LDL ) , very low-density lipoproteins ( VLDL ) and high-density lipoprotein ( HDL ) were determined at baseline and at two consecutive three monthly intervals . The oxidative stress indicators ( malondialdehyde – MDA , protein oxidation – POX , phospholipase A2 – PLA2 activity ) and oxidative status [ superoxide dismutase ( SOD ) and catalase activities ] were measured . Results The concentrations of FBG in the Hatha yoga and conventional PT exercise groups after six months decreased by 29.48 % and 27.43 % respectively ( P serum TC in both groups ( P concentrations of VLDL in the managed groups after six months differed significantly from baseline values ( P = 0.036 ) . Lipid peroxidation as indicated by MDA significantly decreased by 19.9 % and 18.1 % in the Hatha yoga and conventional PT exercise groups respectively ( P activity of SOD significantly increased by 24.08 % and 20.18 % respectively ( P = 0.031 ) . There was no significant difference in the baseline and 6 months activities of PLA2 and catalase after six months although the latter increased by 13.68 % and 13.19 % in the Hatha yoga and conventional PT exercise groups respectively ( P = 0.144 ) . Conclusion The study demonstrate the efficacy of Hatha yoga exercise on fasting blood glucose , lipid profile , oxidative stress markers and antioxidant status in patients with type 2 diabetes and suggest that Hatha yoga exercise and conventional PT exercise may have therapeutic preventative and protective effects on diabetes mellitus by decreasing oxidative stress and improving antioxidant status . Trial Registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) :",
"BACKGROUND Sleep disturbances , depression , and low perception of health status are commonly seen in elderly population ; however , clinicians tend to underestimate or overlook the presence of these symptoms and assume them to be a part of normal aging . Non-pharmacological methods that promote a mind-body interaction should be tested to enhance the mental health of older adults . OBJECTIVE To test the effects of 6 months of silver yoga exercises in promoting the mental health of older adults in senior activity centers , especially their sleep quality , depression , and self-perception of health status . DESIGN Cluster r and omized trial . SETTING S Eight senior activity centers , southern Taiwan . PARTICIPANTS A sample of 139 participants was recruited , and 128 of them completed the study . INCLUSION CRITERIA ( 1 ) community-dwelling older adults ages 60 and over , ( 2 ) no previous training in yoga , ( 3 ) able to walk without assistance , ( 4 ) cognitively alert based on the Short Portable Mental Status Question naire ( SPMSQ ) score of eight or higher , and ( 5 ) independent or mildly dependent in self-care based on a Barthel Index ( BI ) score of 91 or higher . The mean age of the participants was 69.20 + /- 6.23 years , and the average number of chronic illness was 0.83 + /- 0.90 . The average BI score of the participants was 99.92 + /- 0.62 , and the mean SPMSQ score was 9.90 + /- 0.30 . METHODS Participants were r and omly assigned into either the experimental ( n=62 ) or the control ( n=66 ) group based on attendance at selected senior activity centers . A 70-min silver yoga exercise program was implemented three times per week for 6 months as the intervention for the participants in the experimental group . RESULTS Most of the mental health indicators of the participants in the experimental group had significantly improved after the silver yoga interventions , and many of the indicators improved after 3 months of intervention and were maintained throughout the 6 months study . The mental health indicators of the participants in the experimental group were all better than the participants in the control group ( all p silver yoga exercises , the sleep quality , depression , and health status of older adults were all improved",
"Objective : To test feasibility of yoga within a high school curriculum and evaluate preventive efficacy for psychosocial well-being . Methods : Grade 11 or 12 students ( N = 51 ) who registered for physical education ( PE ) were cluster-r and omized by class 2:1 yoga : PE-as-usual . A Kripalu-based yoga program of physical postures , breathing exercises , relaxation , and meditation was taught 2 to 3 times a week for 10 weeks . Self-report question naires were administered to students 1 week before and after . Primary outcome measures of psychosocial well-being were Profile of Mood States — Short Form and Positive and Negative Affect Schedule for Children . Additional measures of psychosocial well-being included Perceived Stress Scale and Inventory of Positive Psychological Attitudes . Secondary measures of self-regulatory skills included Resilience Scale , State Trait Anger Expression Inventory-2 ™ , and Child Acceptance Mindfulness Measure . To assess feasibility , yoga students completed a program evaluation . Analyses of covariance were conducted between groups with baseline as the covariate . Results : Although PE-as-usual students showed decreases in primary outcomes , yoga students maintained or improved . Total mood disturbance improved in yoga students and worsened in controls ( p = .015 ) , as did Profile of Mood States-Short Form ( POMS-SF ) Tension-Anxiety subscale ( p = .002 ) . Although positive affect remained unchanged in both , negative affect significantly worsened in controls while improving in yoga students ( p = .006 ) . Secondary outcomes were not significant . Students rated yoga fairly high , despite moderate attendance . Conclusions : Implementation was feasible and students generally found it beneficial . Although not causal due to small , uneven sample size , this preliminary study suggests preventive benefits in psychosocial well-being from Kripalu yoga during high school PE . These results are consistent with previously published studies of yoga in school setting",
"OBJECTIVE To test cognitive behavioral therapy for adherence and depression ( CBT-AD ) in type 2 diabetes . We hypothesized that CBT-AD would improve adherence ; depression ; and , secondarily , hemoglobin A1c ( A1C ) . RESEARCH DESIGN AND METHODS Eighty-seven adults with unipolar depression and uncontrolled type 2 diabetes received enhanced treatment as usual ( ETAU ) , including medication adherence , self-monitoring of blood glucose ( SMBG ) , and lifestyle counseling ; a provider letter documented psychiatric diagnoses . Those r and omized to the intervention arm also received 9–11 sessions of CBT-AD . RESULTS Immediately after acute treatment ( 4 months ) , adjusting for baseline , CBT-AD had 20.7 percentage points greater oral medication adherence on electronic pill cap ( 95 % CI −31.14 to −10.22 , P = 0.000 ) ; 30.2 percentage points greater SMBG adherence through glucometer downloads ( 95 % CI −42.95 to −17.37 , P = 0.000 ) ; 6.44 points lower depression scores on the Montgomery-Asberg Depression Rating Scale ( 95 % CI 2.33–10.56 , P = 0.002 ) ; 0.74 points lower on the Clinical Global Impression ( 95 % CI 0.16–1.32 , P = 0.01 ) ; and 0.72 units lower A1C ( 95 % CI 0.29–1.15 , P = 0.001 ) relative to ETAU . Analyses of 4- , 8- , and 12-month follow-up time points indicated that CBT-AD maintained 16.3 percentage points higher medication adherence ( 95 % CI −26.1 to −6.5 , P = 0.001 ) ; 22.3 percentage points greater SMBG adherence ( 95 % CI −36.1 to −8.6 , P = 0.002 ) ; and 0.63 units lower A1C ( 95 % CI 0.06–1.2 , P = 0.03 ) after acute treatment ended . For depression , there was some evidence of continued improvement posttreatment , but no between-group differences . CONCLUSIONS CBT-AD is an effective intervention for adherence , depression , and glycemic control , with enduring and clinical ly meaningful benefits for diabetes self-management and glycemic control in adults with type 2 diabetes and depression",
"OBJECTIVE To determine whether impaired pulmonary function is a significant predictor of the incidence of diabetes . RESEARCH DESIGN AND METHODS Using data from the National Health and Nutrition Examination Survey Epidemiologic Follow-Up Study , a cohort study of a representative sample of U.S. adults , we examined the prospect i ve associations between pulmonary function and incidence of diabetes . Our analyses included 4,830 U.S. men and women aged 25 - 74 years who had a baseline interview and examination ( including spirometry ) from 1971 through 1975 and were followed through 1992 - 1993 . Incident diabetes ( n=443 ) was based on self- or proxy reports , hospitalization , or death certificates . RESULTS After multiple adjustment , forced expiratory volume in 1 s ( FEV1 ) , forced vital capacity ( FVC ) , percentage of predicted FEV1 , and percentage of predicted FVC were significantly and inversely associated with the incidence of diabetes , but the ratio of FEV1 to FVC was not . Obstructive lung disease ( defined by the Global Initiative for Chronic Obstructive Lung Disease classification ) was not significantly associated with the incidence of diabetes , but restrictive lung disease was ( hazard ratio=1.45 , 95 % CI 1.04 - 2.03 ) . The association did not differ significantly by smoking status . CONCLUSIONS Although several prospect i ve studies have found that impaired pulmonary function may increase the risk for developing diabetes , additional research is needed to better underst and these relationships and their possible implication",
"BACKGROUND A growing body of research shows that mindfulness meditation can alter neural , behavioral and biochemical processes . However , the mechanisms responsible for such clinical ly relevant effects remain elusive . METHODS Here we explored the impact of a day of intensive practice of mindfulness meditation in experienced subjects ( n=19 ) on the expression of circadian , chromatin modulatory and inflammatory genes in peripheral blood mononuclear cells ( P BMC ) . In parallel , we analyzed a control group of subjects with no meditation experience who engaged in leisure activities in the same environment ( n=21 ) . P BMC from all participants were obtained before ( t1 ) and after ( t2 ) the intervention ( t2-t1=8h ) and gene expression was analyzed using custom pathway focused quantitative-real time PCR assays . Both groups were also presented with the Trier Social Stress Test ( TSST ) . RESULTS Core clock gene expression at baseline ( t1 ) was similar between groups and their rhythmicity was not influenced in meditators by the intensive day of practice . Similarly , we found that all the epigenetic regulatory enzymes and inflammatory genes analyzed exhibited similar basal expression levels in the two groups . In contrast , after the brief intervention we detected reduced expression of histone deacetylase genes ( HDAC 2 , 3 and 9 ) , alterations in global modification of histones ( H4ac ; H3K4me3 ) and decreased expression of pro-inflammatory genes ( RIPK2 and COX2 ) in meditators compared with controls . We found that the expression of RIPK2 and HDAC2 genes was associated with a faster cortisol recovery to the TSST in both groups . CONCLUSIONS The regulation of HDACs and inflammatory pathways may represent some of the mechanisms underlying the therapeutic potential of mindfulness-based interventions . Our findings set the foundation for future studies to further assess meditation strategies for the treatment of chronic inflammatory conditions",
"OBJECTIVES Recent research has indicated concern for the degree of stress and emotional well-being among university staff . This study examined the effectiveness of yoga in enhancing emotional well-being and resilience to stress among university employees . METHODS In a r and omized controlled trial at a British university , we recruited 48 employees and r and omized them into either a yoga or a wait-list control group . The yoga group was offered six weeks of Dru Yoga , comprising one 60-minute class per week . These classes were offered by a certified Dru Yoga instructor at lunchtime from January-March 2008 . The wait-list control group received no intervention during this six-week study . Baseline and end-program measurements of self-reported mood and well-being were self-assessed with the Profile of Mood States - Bipolar ( POMS-Bi ) and the Inventory of Positive Psychological Attitudes ( IPPA ) . RESULTS This six-week yoga intervention result ed in significantly improved POMS-Bi and IPPA scores for the yoga compared to the wait-list control group for seven of eight measures of mood and well-being . In comparison to the wait-list control group at baseline and the end of the program , the yoga group reported marked improvements in feelings of clear-mindedness , composure , elation , energy , and confidence . In addition , the yoga group reported increased life purpose and satisfaction , and feelings of greater self-confidence during stressful situations . CONCLUSION These results show that even a short program of yoga is effective for enhancing emotional well-being and resilience to stress in the workplace . We suggest that employers should consider offering yoga classes to their employees",
"BACKGROUND Restless legs syndrome ( RLS ) is a common and highly burdensome sleep disorder . While relaxation therapies , including yoga , are often recommended for RLS management , rigorous supporting research is sparse . The goal of this preliminary study was to assess the effects of yoga on RLS symptoms and related outcomes in women with RLS . METHODS Participants were 13 nonsmoking women with moderate to severe RLS , who did not have diabetes , sleep apnea , or other serious concomitant chronic conditions , and who were not pregnant . The intervention was a gentle , 8-week Iyengar yoga program . Core outcomes assessed pre- and post-treatment were RLS symptoms and symptom severity ( International RLS Scale [ IRLS ] and RLS ordinal scale ) , sleep quality ( Medical Outcomes Study Sleep Scale ) , mood ( Profile of Mood States ) , and perceived stress ( Perceived Stress Scale ) . Participants also completed yoga logs and a brief exit question naire regarding their experience with the study . RESULTS Ten ( 10 ) women , aged 32 - 66 years , completed the study . Participants attended an average 13.4±0.5 ( of 16 possible ) classes , and completed a mean of 4.1±0.3 ( of 5 possible ) homework sessions/week . At follow-up , participants demonstrated striking reductions in RLS symptoms and symptom severity , with symptoms decreasing to minimal/mild in all but 1 woman and no participant scoring in the severe range by week 8 . Effect sizes ( Cohen 's d ) were large : 1.6 for IRLS total , and 2.2 for RLS ordinal scale . IRLS scores declined significantly with increasing minutes of homework practice per session ( r=0.70 , p=0.025 ) and total homework minutes ( r=0.64 , p improvements in sleep , perceived stress , and mood ( all p's≤0.02 ) , with effect sizes ranging from 1.0 to 1.6 . CONCLUSIONS These preliminary findings suggest that yoga may be effective in attenuating RLS symptoms and symptom severity , reducing perceived stress , and improving sleep and mood in women with RLS",
"OBJECTIVE Recent research has shown that depression may predict incident diabetes . The aims of the study are to investigate if symptoms of depression and anxiety precede the onset of diabetes or vice versa and to examine if mediating factors may explain such associations . METHODS A prospect i ve population -based study ( N=37,291 ) investigating the associations between symptoms of depression/anxiety and diabetes was conducted . RESULTS Individuals reporting symptoms of depression and anxiety at baseline had increased risk of onset of type 2 diabetes at 10-year follow-up . No gender differences were found . The analyses did not reveal underlying factors that mediated the association . Baseline diagnosis of diabetes was not associated with subsequent symptoms of anxiety or depression among males or females . CONCLUSION Diabetes did not predict symptoms of depression or anxiety . Symptoms of depression and anxiety emerged as significant risk factors for onset of type 2 diabetes independent of established risk factors for diabetes , such as socioeconomic factors , lifestyle factors , and markers of the metabolic syndrome . The comorbidity between depression and anxiety may be the most important factor",
"INTRODUCTION / PURPOSE Negative mood symptoms occur frequently in sedentary population s , but individual vulnerability factors for developing these complaints have not been systematic ally evaluated . This investigation examined whether the autonomic nervous system ( ANS ) serves a role in the development of negative mood after controlled exercise withdrawal . METHODS Forty participants ( mean age of 31.3 + /- 7.5 yr , 55 % women ) who exercised regularly ( > or= 30 min of continuous aerobic exercise at least three times a week during the past 6 months ) were r and omized either to withdrawal from regular aerobic exercise ( N=20 ) or to continue regular aerobic exercise ( N=20 ) for 2 wk . Measurements were taken before exercise withdrawal and at 2-wk follow-up . Various dimensions of negative mood were measured with the multidimensional fatigue inventory , profile of mood states , and Beck depression inventory-II . ANS activity was assessed by heart rate variability ( HRV ) analyses , examining low-frequency ( 0.04 - 0.15 Hz : lf ) and high-frequency ( hf ) domains ( 0.15 - 0.40 Hz ) . The lf/hf ratio was used as index of sympathovagal balance . Protocol adherence was documented by ambulatory activity monitoring . RESULTS Exercise withdrawal result ed in significantly higher negative mood scores at follow-up compared with control ( P lf/hf ratios correlated with the increases in symptoms ( r>0.4 ; P exercise-withdrawal group independently of gender , age , weight , baseline fitness level , and baseline symptom status . The exercise-withdrawal and control groups displayed no significant change in hf HRV , lf HRV , or lf/hf HRV during the 2 wk . CONCLUSION Reduced parasympathetic ANS activity as measured by HRV is predictive of the development of negative mood after deprivation of usual exercise activities . No significant changes in HRV were observed during the 2-wk exercise deprivation period . These findings are relevant to the underst and ing of mood changes in response to short-term exercise withdrawal , such as sports injuries and recovery from medical procedures",
"Autonomic functions , such as increased sympathetic and parasympathetic activity and the brain 's suprachiasmatic nucleus , higher nervous centres , depression , hostility and aggression appear to be important determinants of heart rate variability ( HRV ) , which is , itself , an important risk factor of myocardial infa rct ion , arrhythmias , sudden death , heart failure and atherosclerosis . The circadian rhythm of these complications with an increased occurrence in the second quarter of the day may be due to autonomic dysfunction as well as to the presence of excitatory brain and heart tissues . While increased sympathetic activity is associated with increased levels of cortisol , catecholamines , serotonin , renin , aldosterone , angiotensin and free radicals ; increased parasympathetic activity may be associated with greater levels of acetylecholine , dopamine , nitric oxide , endorphins , coenzyme Q10 , antioxidants and other protective factors . Recent studies indicate that hyperglycemia , diabetes , hyperlipidemia , ambient pollution , insulin resistance and mental stress can increase the risk of low HRV . These risk factors , which are known to favour cardiovascular disease , seem to act by decreasing HRV . There is evidence that regular fasting may modulate HRV and other risk factors of heart attack . While exercise is known to decrease HRV , exercise training may not have any adverse effect on HRV . In a recent study among 202 patients with acute myocardial infa rct ion ( AMI ) , the incidence of onset of chest pain was highest in the second quarter of the day ( 41.0 % ) , mainly between 4.0 - 8.0 AM , followed by the fourth quarter , usually after large meals ( 28.2 % ) . Emotion was the second most common trigger ( 43.5 % ) . Cold weather was a predisposing factor in 29.2 % and hot temperature ( > 40 degrees celsius ) was common in 24.7 % of the patients . Dietary n-3 fatty acids and coenzyme Q10 have been found to prevent the increased circadian occurrence of cardiac events in our r and omized controlled trials , possibly by increasing HRV . We have also found that n-3 fatty acids plus CoQ can decrease TNF-alpha and IL-6 in AMI which are pro-inflammatory agents . There is evidence that dietary n-3 fatty acids canenhance hippocampal acetylecholine levels , which may be protective . Similarly , the stimulation of the vagus nerve may inhibit TNF synthesis in the liver and acetylecholine , the principal vagal neurotransmitter , significantly attenuates the release of pro-inflammatory cytokines TNF-alpha , interleukin 1,6 and 18 , but not the anti-inflammatory cytokine IL-10 in experiments . Therefore , any agent which can enhance brain acetylecholine levels , may be used as a therapeutic agent in protecting the suprachiasmatic nucleus , higher nervous centres , vagal activity and sympathetic nerve activity which are known to regulate the body clock and HRV and the risk of SCD and heart attack",
"BACKGROUND In chronic heart failure ( CHF ) , impaired pulmonary function can independently contribute to oxygen desaturation and reduced physical activity . We investigated the effect of breathing rate on oxygen saturation and other respiratory indices . METHODS Arterial oxygen saturation ( SaO2 ) and respiratory indices were recorded during spontaneous breathing ( baseline ) and during controlled breathing at 15 , six , and three breaths per min in 50 patients with CHF and in 11 healthy volunteers ( controls ) . 15 patients with CHF were r and omly allocated 1 month of respiratory training to decrease their respiratory rate to six breaths per min . Respiratory indices were recorded before training , at the end of training , and 1 month after training . FINDINGS During spontaneous breathing , mean SaO2 was lower in CHF patients than in controls ( 91 - 4 % [ SD 0.4 ] vs 95.4 % [ 0.2 ] , p Controlled breathing increased SaO2 at all breathing rates in patients with CHF . Compared with baseline , minute ventilation increased at 15 breaths per min ( + 45.9 % [ 9.8 ] , p resting SaO2 increased from 92.5 % ( 0.3 ) at baseline to 93.2 % ( 0.4 ) ( p breathing rate per min decreased from 13.4 ( 1.5 ) to 7.6 ( 1.9 ) ( p peak oxygen consumption increased from 1157 ( 83 ) to 1368 ( 110 ) L/min ( p exercise time increased from 583 ( 29 ) to 615 ( 23 ) min/s ( p perception of dyspnoea reduced from a score of 19.0 ( 0.4 ) to 17.3 ( 0.9 ) on the Borg scale ( p the respiratory indices in the patients who did not have respiratory training . INTERPRETATION Slowing respiratory rate reduces dyspnoea and improves both resting pulmonary gas exchange and exercise performance in patients with CHF",
"OBJECTIVES The purpose of this study was to pilot a brief ( 6-week ) group curriculum for providing mindfulness training to obese individuals , called Mindful Eating and Living ( MEAL ) . SETTING AND DESIGN Participants were recruited through a local Young Men 's Christian Association ( YMCA ) in spring 2006 . Data was collected at three time points : baseline , completion of intervention ( 6 weeks ) , and 3-month follow-up ( 12 weeks ) . INTERVENTION Six weekly two-hour group classes ( with two monthly follow-up classes ) . Content included training in mindfulness meditation , mindful eating , and group discussion , with emphasis on awareness of body sensations , emotions , and triggers to overeat . MAIN OUTCOME MEASURES Key variables assessed included changes in weight , body-mass index ( BMI ) , eating behavior , and psychological distress . In addition , physiological markers of cardiovascular risk were evaluated including C-reactive protein ( hsCRP ) , adiponectin , low-density lipoprotein ( LDL ) , and plasminogen activator inhibitor-1 ( PAI-1 ) . RESULTS Ten obese patients enrolled with a mean BMI of 36.9 kg/m² [ SD±6.2 ] . The mean weight was 101 kg/m² and the mean age was 44 years ( SD=8.7 ; range=31 - 62 ) . Compared to baseline data , participants showed statistically significant increases in measures of mindfulness and cognitive restraint around eating , and statistically significant decreases in weight , eating disinhibition , binge eating , depression , perceived stress , physical symptoms , negative affect , and C-reactive protein . CONCLUSIONS This study provides preliminary evidence that a eating focused mindfulness-based intervention can result in significant changes in weight , eating behavior , and psychological distress in obese individuals",
"Background : Being relocated to an assisted living facility can result in sleep disturbances and depression in elders . This may be attributed to or worsened by lack of regular physical activity . Appropriate exercise programs may be an important component of quality of life in this group of transitional frail elders . Purpose : This study aim ed to test the effects of a 6-month yoga exercise program in improving sleep quality and decreasing depression in transitional frail elders living in assisted living facilities . Methods : A quasi-experimental pretest- and -posttest design was used . A convenience sample of 69 elderly residents of assisted living facilities was divided r and omly into a yoga exercise ( n = 38 ) and control group ( n = 31 ) based on residence location . A total of 55 participants completed the study . The intervention was implemented in three small groups , and each practice group was led by two pretrained certified yoga instructors three times per week at 70 min per practice session for 24 weeks . The outcome measures of sleep quality ( Pittsburgh Sleep Quality Index ) and depression state ( Taiwanese Depression Question naire ) were examined at baseline , at the 12th week , and at the 24th week of the study . Results : After 6 months of performing yoga exercises , participants ' overall sleep quality had significantly improved , whereas depression , sleep disturbances , and daytime dysfunction had decreased significantly ( p outcome indicators than those of participants in the control group ( p yoga exercise be incorporated as an activity program in assisted living facilities or in other long-term care facilities to improve sleep quality and decrease depression in institutionalized elders",
"Objective : To assess the effect of a comprehensive yogic breathing program on glycemic control and quality of life ( QOL ) in patients with diabetes . Material s and Methods : This is a prospect i ve r and omized controlled intervention trial . Patients having HbA1c between 6 and 9 % for at least 3 months with lifestyle modification and oral antidiabetic medication were included . They were followed-up and r and omized at 6 months into two groups : one group receiving st and ard treatment of diabetes and the other group receiving st and ard treatment of diabetes and taught and told to regularly practice the comprehensive yogic breathing program ( Sudarshan Kriya Yoga and Pranayam ) . Change in fasting and post-pr and ial blood sugars , glycated hemoglobin and QOL as assessed by the World Health Organization QOL WHOQOL BREF question naire were assessed . Results : There was a trend toward improvement in glycemic control in the group practicing the comprehensive yogic breathing program compared with the group following st and ard treatment alone , although this was not significant . There was significant improvement in physical , psychological and social domains and total QOL post-intervention in the group practicing the comprehensive yogic breathing program as compared with the group following st and ard treatment alone . Conclusion : There was significant improvement in the QOL and a non-significant trend toward improvement in glycemic control in the group practicing the comprehensive yogic breathing program compared with the group that was following st and ard treatment alone",
"To determine the effectiveness of a yoga program on blood pressure and stress , a group of hypertensive patients in Thail and were studied , with the experimental group showing significantly decreased mean stress scores and blood pressure , heart rate , and body mass index levels compared with the control group . Further studies are suggested to determine the effects of yoga on hypertension in Thail and",
"OBJECTIVES To explore the feasibility and outcomes of a resilience-based diabetes self-management education ( RB-DSME ) program to improve psychological and physiological health in African-American adults with type 2 diabetes . METHODS An experimental group ( N = 32 ) received RB-DSME and a comparison group ( N = 33 ) received st and ard DSME . Psychological and physiological measures were taken at baseline and 6 months . ANCOVAs assessed whether the experimental group improved its overall outcome relative to the comparison group , while controlling for baseline scores . RESULTS The experimental group 's outcomes were significantly improved vis-à-vis the comparison group for diabetes knowledge , positive meaning , HDL cholesterol , and fasting blood glucose . CONCLUSIONS The RB-DSME shows feasibility and promise for enhancing health ; a full-scale r and omized trial is warranted",
"OBJECTIVE The present study was conducted to assess the effectiveness of yoga in the management of dyslipidemia in patients of type 2 diabetes mellitus . METHODS This r and omized parallel study was carried out in Medical College Triv and rum , Kerala , India . Hundred type 2 diabetics with dyslipidemia were r and omized into control and yoga groups . The control group was prescribed oral hypoglycemic drugs . The yoga group practice d yoga daily for 1 h duration along with oral hypoglycemic drugs for 3 months . The lipid profiles of both the groups were compared at the start and at the end of 3 months . RESULTS After intervention with yoga for a period of 3 months the study group showed a decrease in total cholesterol , triglycerides and LDL , with an improvement in HDL . CONCLUSION Yoga , being a lifestyle incorporating exercise and stress management training , targets the elevated lipid levels in patients with diabetes through integrated approaches",
"Diabetes is a metabolic disorder , which has become a major health challenge worldwide . South East Asian countries have a highest burden of diabetes . In India the prevalence of diabetes is rising rapidly especially in the urban population because of increasing obesity and reduced physical activity . An objective of this study is to evaluate the effect of Yoga-Nidra on blood glucose level in diabetic patients . This study was conducted on 41 , middle aged , type-2 diabetic patients , who were on oral hypoglycaemic . These patients were divided in to two groups : ( a ) 20 patients on oral hypoglycaemic with yoga-nidra , and ( b ) 21 were on oral hypoglycaemic alone . Yoga-nidra practice d for 30 minutes daily up to 90 days , parameters were recorded every . 30th day . Results of this study showed that most of the symptoms were subsided ( P mean blood glucose level was significant after 3-month of Yoga-nidra . This fall was 21.3 mg/dl , P pr and ial glucose level . Results of this study suggest that subjects on Yoga-nidra with drug regimen had better control in their fluctuating blood glucose and symptoms associated with diabetes , compared to those were on oral hypoglycaemics alone ",
"BACKGROUND The objective of this study was to assess the effect of a yoga intervention on psychological health in older adults . METHOD A r and omized controlled trial study , conducted at 2 North Florida facilities for older adults . Subjects were 98 older adults , ages 65 to 92 . Participants were r and omly assigned to chair yoga , chair exercise , and control groups and assessed preintervention , postintervention , and 1-month follow-up on the State Anger Expression Inventory , State Anxiety Inventory , Geriatric Depression Scale , Lawton 's PGC Morale Scale , General Self-Efficacy Scale , Chronic Disease Self-Efficacy Scales , and Self- Control Schedule . RESULTS Yoga participants improved more than both exercise and control participants in anger ( Cohen 's d = 0.89 for yoga versus exercise , and 0.90 for yoga versus control , pretest to posttest ; and d = 0.90 and 0.72 , pretest to follow-up ) , anxiety ( d = 0.27 , 0.39 and 0.62 , 0.63 ) , depression ( d = 0.47 , 0.49 and 0.53 , 0.51 ) , well-being ( d = 0.14 , 0.49 and 0.25 , 0.61 ) , general self-efficacy ( d = 0.63 , 1.10 and 0.30 , 0.85 ) , and self-efficacy for daily living ( d = 0.52 , 0.81 and 0.27 , 0.42 ) . Changes in self-control moderated changes in psychological health . CONCLUSIONS Over a 6-week period , our findings indicate yoga 's potential for improving psychological health in older adults ",
"Background : The aim of this study was to observe the effect comprehensive yogic breathing ( Sudarshan Kriya Yoga [ SKY ] and Pranayam ) had on cardiac autonomic functions in patients with diabetes . Material s and Methods : This is a prospect i ve r and omized controlled intervention trial . Cardiac autonomic functions were assessed in 64 diabetics . Patients were r and omized into two groups , one group receiving st and ard therapy for diabetes and the other group receiving st and ard therapy for diabetes and comprehensive yogic breathing program . St and ard therapy included dietary advice , brisk walking for 45 min daily , and administration of oral antidiabetic drugs . Comprehensive yogic breathing program was introduced to the participants through a course of 12 h spread over 3 days . It was an interactive session in which SKY , a rhythmic cyclical breathing , preceded by Pranayam is taught under the guidance of a certified teacher . Cardiac autonomic function tests were done before and after 6 months of intervention . Results : In the intervention group , after practicing the breathing techniques for 6 months , the improvement in sympathetic functions was statistically significant ( P 0.04 ) . The change in sympathetic functions in the st and ard therapy group was not significant ( P 0.75 ) . Parasympathetic functions did not show any significant change in either group . When both parasympathetic and sympathetic cardiac autonomic functions were considered , there was a trend toward improvement in patients following comprehensive yogic breathing program ( P 0.06 ) . In the st and ard therapy group , no change in cardiac autonomic functions was noted ( P 0.99 ) . Conclusion : Cardiac autonomic functions improved in patients with diabetes on st and ard treatment who followed the comprehensive yogic breathing program compared to patients who were on st and ard therapy alone",
"Background : Yoga has been shown to be beneficial in diabetes in many studies , though r and omized control trials are few . The aim of this r and omized control trial was to see the effect of Sudarshan Kriya and related practice s ( comprehensive yogic breathing program ) on quality of life , glycemic control , and cardiac autonomic functions in diabetes . Diabetes mellitus is a risk factor for sudden cardiac death . Cardiac autonomic neuropathy has been implicated in the causation of sudden cardiac death . Therefore , a maneuver to prevent progression of cardiac autonomic neuropathy holds significance . Material s and Methods : A total of 120 patients of diabetes on oral medication and diet and exercise advice were r and omized into two groups : ( 1 ) Continued to receive st and ard treatment for diabetes . ( 2 ) Patients administered comprehensive yogic breathing program and monitored to regularly practice yoga in addition to st and ard treatment of diabetes . At 6 months , quality of life and postpr and ial plasma glucose significantly improved in the group practicing yoga compared to baseline , but there was no significant improvement in the fasting plasma glucose and glycated hemoglobin . Results : On per protocol analysis , sympathetic cardiac autonomic functions significantly improved from baseline in the group practicing comprehensive yogic breathing . Conclusion : This r and omized control trial points towards the beneficial effect of yogic breathing program in preventing progression of cardiac neuropathy . This has important implication s as cardiac autonomic neuropathy has been considered as one of the factors for sudden cardiac deaths",
"This report summarizes the current evidence on the effects of yoga interventions on various components of mental and physical health , by focussing on the evidence described in review articles . Collectively , these review s suggest a number of areas where yoga may well be beneficial , but more research is required for virtually all of them to firmly establish such benefits . The heterogeneity among interventions and conditions studied has hampered the use of meta- analysis as an appropriate tool for summarizing the current literature . Nevertheless , there are some meta-analyses which indicate beneficial effects of yoga interventions , and there are several r and omized clinical trials ( RCT 's ) of relatively high quality indicating beneficial effects of yoga for pain-associated disability and mental health . Yoga may well be effective as a supportive adjunct to mitigate some medical conditions , but not yet a proven st and -alone , curative treatment . Larger-scale and more rigorous research with higher method ological quality and adequate control interventions is highly encouraged because yoga may have potential to be implemented as a beneficial supportive/adjunct treatment that is relatively cost-effective , may be practice d at least in part as a self-care behavioral treatment , provides a life-long behavioural skill , enhances self-efficacy and self-confidence and is often associated with additional positive side effects"
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41170a82-06ff-11f0-808a-c43d1ab1c353
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The aim of the present study was to compare the root canal preparation ability of rotary nickel-titanium ( NiTi ) Hero 642 and K3 files in curved m and ibular or maxillary molars . A total of 40 extracted m and ibular molars with two separate mesial canals , an apical width of approximately size ≤15 and a root canal curvature of 15 - 30 ° were r and omly divided into two groups and instrumented using Hero 642 ( n=20 ) or K3 files ( n=20 ) . Canal straightening , working length , transportation , cross-sectional area , minimum dentin thickness and the canal angle curvature degree were examined , and a systematic review of the literature was conducted . No statistically significant differences were observed between the two groups with regard to the mean degree of straightening , mean change in working length , mean transportation , amount of dentin removed or remaining minimum dentin thickness ( P>0.05 ) . The canal angle curvature decreased in the two groups postoperatively . The systematic review identified six studies , and overall the two files performed similarly in the majority of categories examined . Therefore , the rotary NiTi Hero 642 and K3 files demonstrated comparable shaping abilities and maintenance of working length
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[
"OBJECTIVE To evaluate the changes in cross-sectional area morphology of curved canals after instrumentation with Profile((R ) ) , Hero 642((R ) ) , and K3((R ) ) using digital imaging analysis . Study design Thirty mesial m and ibular curved canals were used ( 25 - 40 degrees ) . The molars were embedded in resin and the roots were sectioned transversely at three levels : apical , middle , and coronal . The canals were r and omly distributed into 3 groups for instrumentation using Profile.04 and .06 , Hero 642 , and K3 . The pre- and postinstrumentation sections were digitized and areas corresponding to the canals were measured with image-processing software . RESULTS Hero eliminated significantly more dentine than K3 and Profile in all 3 sections ( P .05 , Student-Newman-Keuls test ) . All 3 systems yielded a rounded canal morphology in the coronal , middle , and apical thirds . CONCLUSION Hero rotary instruments produced more changes in cross-sectional area of the root canal",
"INTRODUCTION : The aim of this study was to evaluate the amount of dentine removed after canal preparation using stainless steel ( SS ) h and instruments or rotary ProFile instruments . MATERIAL S AND METHODS : Thirty-six extracted human teeth with root canal curvatures less than 30º were embedded in clear polyester resin . The roots were cut horizontally at apical 2 , 4 and 7 mm . Dentin thickness was measured at each section and the sections were accurately reassembled using a muffle . Root canals were r and omly prepared by SS h and instruments or rotary ProFile instruments . Root sections were again separated , and the remaining dentin thickness was measured . Mann-Whitney U and t tests were performed for analytic comparison of the results . RESULTS : The thickness of removed dentin was significantly different between the two used methods ( P greater amounts of dentin was removed mesially in all sections in h and instrumentation group ( P ProFile rotary instrumentation prepares root canals with a greater conservation of tooth structure",
"OBJECTIVE The present study was design ed to test the None hypothesis that there is no significant difference in debridement quality promoted by 3 nickel-titanium ( NiTi ) rotary systems . STUDY DESIGN Sixty-seven vital m and ibular molars that were prospect ively collected in vivo were used . The teeth were extracted and then pulp tissue fixed by 10 % formalin . The use of different NiTi rotary systems result ed in 3 experimental groups with 20 specimens each : G1 : Hero 642 ; G2 : K3 ; and G3 : ProTaper Universal . Afterward , the specimens were histologically prepared and serial 0.5 microm cross-sections were obtained every 0.2 mm from the 1 - 3 mm apical levels . The remaining pulp tissue was assessed using a morphometric approach . The cross-sectional area of each root canal and remaining pulp tissue were measured ( mcirom(2 ) ) . Thus , the percentages of remaining pulp tissue area were calculated for each root canal . RESULTS Overall , the pooled data obtained from all levels revealed a variable amount of remaining pulp tissue for all experimental groups . Remaining pulp tissue existed in every specimen . However , the Kruskal-Wallis H test was unable to show significant differences among the experimental groups ( P > .05 ) for the pooled data from all levels . CONCLUSIONS The present study did not find a significant difference in the quality of canal debridement between different NiTi rotary systems , because an adequate tapered shape is obtained",
"This study compared preparations of curved canals , using Profile , GT file and Hero 642 rotary files . A total of 30 mesiobuccal canals of extracted first and second m and ibular molars were used in this study . The teeth were embedded in resin and a pre-operative radiograph was taken . The specimens were then r and omly divided into three instrument groups . Pre- and post-instrumentation radiographic images were scanned and superimposed using the VISI CAD/CAM program . At nine horizontal sections at 1 mm increments from the apex , it calculated pre- and post-instrumentation cross sectional areas ( mm(2 ) ) and enlargements to the inner aspect and outer aspects ( mm ) . A Kruskal-Wallis test found no statistical difference among the groups in terms of total areas removed by each instrument ( P > 0.05 ) . It also found no significant difference in any group between the total of the inner and outer enlargements ( P > 0.05 ) . However the GT file removed significantly more material from the outer side of the canal than the inside at sections 3 - 5 , and the Hero removed significantly more material from the outer side at sections 7 - 9 ( P < 0.05 ) . All instruments produced preparations that maintained original canal curvatures"
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41170abe-06ff-11f0-808a-c43d1ab1c353
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ABSTRACT R and omized controlled trials ( RCTs ) have demonstrated that alpha lipoic acid ( ALA ) may change lipid profile , but their results are contradictory . The aim of this study is to conduct a meta‐ analysis to assess the effects of ALA on lipid profile . Electronic data bases including ISI web of science , Ovid , PubMed / Medline , SCOPUS , and Google Scholar were search ed up to February 2018 . RCTs which assessed ALA effects on lipid profile were selected . Weighted mean difference ( WMD ) and 95 % confidence intervals ( CIs ) in serum lipids concentrations were defined as intervention effects . R and om effects model was used to estimate the pooled effect . Heterogeneity was measured by using I2 test . The protocol was registered with PROSPERO ( No. CRD42017072365 ) . Data base search retrieved 12 articles . Serum total cholesterol ( TC ) and low density lipoprotein‐cholesterol ( LDL‐ ) levels were significantly lower in subjects supplemented with alpha‐lipoic acid compared with controls ( WMD=−10.18mg/dL ; 95 % CI : −16.16 , −4.20mg/dL ; P=0.001 and WMD=−9.22mg/dL ; 95 % CI : −18.28 , −0.16mg/dL ; P=0.001 , respectively ) , but no significant changes were found for high density lipoprotein‐cholesterol ( HDL‐c ) ( WMD : 3.02mg/dL ; 95 % CI : −0.39 , 6.43 ; P=0.082 ) . The overall effect of ALA on serum triglyceride did not reveal any significant change , but in subgroup analysis based on health status ( diabetic vs. non‐diabetic ) , ALA decreased serum triglyceride levels in both diabetic and non‐diabetic groups compared with controls . This meta‐ analysis revealed that ALA might favorably affect lipid profile especially LDL and TC . However , for confirming these results , more studies particularly among hyperlipidemic patients are needed
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"OBJECTIVE To evaluate the potential body weight-lowering effects of dietary supplementation with eicosapentaenoic acid ( EPA ) and α-lipoic acid separately or combined in healthy overweight/obese women following a hypocaloric diet . METHODS This is a short-term double-blind placebo-controlled study with parallel design that lasted 10 weeks . Of the r and omized participants , 97 women received the allocated treatment [ Control , EPA ( 1.3 g/d ) , α-lipoic acid ( 0.3 g/d ) , and EPA+α-lipoic acid ( 1.3 g/d+0.3 g/d ) ] , and 77 volunteers completed the study . All groups followed an energy-restricted diet of 30 % less than total energy expenditure . Body weight , anthropometric measurements , body composition , resting energy expenditure , blood pressure , serum glucose , and insulin and lipid profile , as well as leptin and ghrelin levels , were assessed at baseline and after nutritional intervention . RESULTS Body weight loss was significantly higher ( P with α-lipoic acid . EPA supplementation significantly attenuated ( P in leptin levels that occurs during weight loss . Body weight loss improved lipid and glucose metabolism parameters but without significant differences between groups . CONCLUSIONS The intervention suggests that α-lipoic acid supplementation alone or in combination with EPA may help to promote body weight loss in healthy overweight/obese women following energy-restricted diets",
"AIM To determine an influence of alpha-lipoic acid to reduction of body weight and regulation of total cholesterol concentration , triglycerides and glucose serum levels in obese patients with diabetes mellitus type 2 . METHODS A prospect i ve study includes two groups of obese patients with diabetes mellitus and signs of peripheral polyneuropathia : examined group ( 30 patients ; 15 females and 15 males ) , and control group ( 30 patients ; 12 females and 18 males ) . All were treated with metformin ( 850 - 1700 mg/day ) . Examined patients were additionally treated with alpha-lipoic acid 600 mg/day during 20 weeks . Body mass index and concentrations of total cholesterol , triglycerides and glucose in serum were compared before and after the treatment . RESULTS The group treated with 600 mg alpha-lipoic acid lost significantly more weight , and had lower triglyceride level than the control group . There were no significant differences in total cholesterol and glucose serum levels between the groups . CONCLUSION Alpha-lipoic acid of 600 mg/day treatment have influenced weight and triglycerides loss in obese patients with diabetes mellitus type 2 . It should be considered as an important additive therapy in obese patients with diabetes mellitus type 2",
"Weight gain and other metabolic disturbances have now become discouraging , major side effects of atypical antipsychotic drugs ( AAPDs ) . The novel strategies required to counteract these serious consequences , however , should avoid modulating the activities of the neurotransmitter receptors involved because those receptors are the therapeutic targets of AAPDs . Adenosine monophosphate-activated protein kinase is an enzyme that plays a pivotal role in energy homeostasis . We hypothesized that & agr;-lipoic acid ( ALA ) , which is known to modulate adenosine monophosphate-activated protein kinase activity in the hypothalamus and peripheral tissues , would ameliorate AAPD-induced weight gain . We describe the case series of a 12-week ALA trial in schizophrenia patients treated with AAPDs . Two of 7 enrolled subjects were dropped from the study because of noncompliance and dem and for new medication to treat depressive symptoms , respectively . The mean ( SD ) weight loss was 3.16 ( 3.20 ) kg ( P = 0.043 , last observation carried forward ; median , 3.03 kg ; range , 0 - 8.85 kg ) . On average , body mass index showed a significant reduction ( P = 0.028 ) over the 12 weeks . During the same period , a statistically significant reduction was also observed in total cholesterol levels ( P = 0.042 ) , and there was a weak trend toward the reduction in insulin resistance ( homeostasis model assessment of insulin resistance ) ( P = 0.080 ) . Three subjects reported increased energy subjectively . The total scores on the Brief Psychiatric Rating Scale and the Montgomery-Asberg Depression Rating Scale did not vary significantly during the study . These preliminary data suggest the possibility that ALA can ameliorate the adverse metabolic effects induced by AAPDs . To confirm the benefits of ALA , more extended study is warranted",
"The purpose of this study was to investigate the effects of α-lipoic acid on body weight and lipid profiles in Sprague-Dawley rats fed a high fat diet ( HFD ) . After 4 weeks of feeding , rats on the HFD were divided into three groups by r and omized block design ; the first group received the high-fat-diet ( n = 10 ) , and the second group received the HFD administered with 0.25 % α-lipoic acid ( 0.25LA ) , and the third group received the high-fat diet with 0.5 % α-lipoic acid ( 0.5LA ) . The high fat diet with α-lipoic acid supplemented groups had significantly inhibited body weight gain , compared to that in the HFD group ( P 0.05 ) . Organ weights of rats were also significantly reduced in liver , kidney , spleen , and visible fat tissues in rats supplemented with α-lipoic acid ( P in plasma lipid profiles , such as total lipids , total cholesterol , triglycerides , low-density lipoprotein , and high-density lipoprotein , were observed between the HFD and 0.5LA groups . The atherogenic index and the plasma high density lipoprotein-cholesterol/total cholesterol ratio improved significantly with α-lipoic acid supplementation in a dose-dependent manner ( P 0.05 ) . Total hepatic cholesterol and total lipid concentration decreased significantly in high fat fed rats supplemented with α-lipoic acid in a dose-dependent manner ( P whereas liver triglyceride content was not affected . In conclusion , α-lipoic acid supplementation had a positive effect on weight gain and plasma and liver lipid profiles in rats",
"PURPOSE alpha-lipoic acid is an essential cofactor for mitochondrial respiratory enzymes that improves mitochondrial function . We previously reported that alpha-lipoic acid markedly reduced body weight gain in rodents . The purpose of this study was to determine whether alpha-lipoic acid reduces body weight in obese human subjects . METHODS in this r and omized , double-blind , placebo-controlled , 20-week trial , 360 obese individuals ( body mass index [ BMI ] ≥ 30 kg/m(2 ) or BMI 27 - 30 kg/m(2 ) plus hypertension , diabetes mellitus , or hypercholesterolemia ) were r and omized to alpha-lipoic acid 1200 or 1800 mg/d or placebo . The primary end point was body weight change from baseline to end point . RESULTS the 1800 mg alpha-lipoic acid group lost significantly more weight than the placebo group ( 2.1 % ; 95 % confidence interval , 1.4 - 2.8 ; P ) . Urticaria and itching sensation were the most common adverse events in the alpha-lipoic acid groups , but these were generally mild and transient . CONCLUSION alpha-lipoic acid 1800 mg/d led to a modest weight loss in obese subjects . Alpha-lipoic acid may be considered as adjunctive therapy for obesity",
"To evaluate the protective effects of α-lipoic acid on the kidneys of Goto-Kakisaki ( GK ) diabetic rats , ten GK diabetic rats were r and omly divided into a diabetic control group and a lipoic acid-treated diabetic group with α-lipoic acid 35 mg·Kg−1 intraperitoneal injections . Four healthy Wistar rats served as normal controls . Malonaldehyde ( MDA ) , ascorbic acid ( vitamin C ) , vitamin E , glutathione ( GSH ) and superoxide dismutase ( SOD ) levels in renal homogenate , and urine protein excretion were measured . The expression of mRNA for NF-κB , NADPH oxidase subunits p22phox and p47phox in renal tissue was examined by realtime PCR . Pathological changes in renal tissue were evaluated by light and electron microscopy . There were significant increases in urine protein excretion , MDA levels and the expression of mRNA of NF-κB , p22phox and p47phox , and significant decreases in GSH , SOD , vitamin C and vitamin E levels in the diabetic control group compared with the normal control group . Pathological changes of renal tissue were more progressive in the diabetic control group than in the normal control group . All the parameters above were improved in the α-lipoic acid-treated diabetic group . Oxidative stress is increased in the kidney of type 2 diabetic GK rats . It is associated with the progression of diabetic nephropathy . α-lipoic acid can protect renal function in diabetic rats via its antioxidant activity",
"OBJECTIVE The aim of this study was to investigate the effect of alpha-lipoic acid ( ALA ) treatment on endothelium-dependent and -independent vasodilatation , assessed by forearm blood flow ( FBF ) , in patients with type 2 diabetes mellitus . RESEARCH DESIGN AND METHODS A total of 30 subjects with type 2 diabetes were included in this r and omized , controlled , double-blinded , parallel group study . FBF responses to intra-arterial acetylcholine ( ACh ) and glycerol trinitrate ( GTN ) were measured before and after 21 days of intravenous treatment with 600 mg alpha-lipoic acid or placebo . RESULTS FBF responses were comparable at baseline . After treatment , FBF reactivity to ACh and GTN was unchanged in subjects receiving placebo . By contrast , ALA treatment increased endothelium-dependent vasodilatation to ACh ( P ALA treatment improves endothelium-dependent vasodilatation in patients with type 2 diabetes , in the absence of effects on forearm vasomotor function . If this salutary action translates into vascular risk reduction remains to be established",
"Background : Quercetin , which is considered as a health-promoting antioxidant , belongs to the broad flavonoids group . Numerous experimental studies have proved that quercetin and vitamin C provide anti-inflammatory and antioxidant properties . The aim of this study is to assess the effects of both quercetin and vitamin C on lipid profile and muscle damage in human subjects . Methods : A r and omized , placebo-controlled , double-blind clinical trial was carried out on 60 males for eight weeks . The subjects were r and omly assigned to one of the four groups : 1 ) quercetin + vitamin C ( 500 mg/day quercetin + 200 mg/day vitamin C ) 2 ) quercetin ( 500 mg/day quercetin + 200 mg/day placebo ) 3 ) vitamin C ( 500 mg/day vitamin C + 200 mg/day placebo ) and 4 ) placebo ( 500 mg/day placebo + 200 mg/day placebo ) . Blood sample s , body weight and percent of body fat were measured before and after intervention . In addition , dietary intake was estimated using 24-h recall . Results : No significant changes occurred in high-density lipoprotein levels between groups and in the four groups before and after supplementation . Low density lipoprotein values decreased significantly ( P = 0.048 ) in the “ Quercetin + Vit C ” group but decrease was not considerable in other groups before and after intervention and among groups . Fat-soluble vitamins ' intake was significantly high among 4 groups . Conclusions : Quercetin and vitamin C supplementation may not be beneficial in lipid profile improvement , although it may reduce induce muscle damage and body fat percent",
"Most systematic review s rely substantially on the assessment of the method ological quality of the individual trials . The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of r and omized clinical trials ( RCTs ) . The invited participants were experts in the field of quality assessment of RCTs . The initial item pool contained all items from existing criteria lists . Subsequently , we reduced the number of items by using the Delphi consensus technique . Each Delphi round comprised a question naire , an analysis , and a feedback report . The feedback report included staff team decisions made on the basis of the analysis and their justification . A total of 33 international experts agreed to participate , of whom 21 completed all question naires . The initial item pool of 206 items was reduced to 9 items in three Delphi rounds . The final criteria list ( the Delphi list ) was satisfactory to all participants . It is a starting point on the way to a minimum reference st and ard for RCTs on many different research topics . This list is not intended to replace , but rather to be used alongside , existing criteria lists",
"OBJECTIVES Type 2 diabetes ( T2D ) may be caused by elevated oxidative stress , inflammation , and hyperglycemia . The phytochemicals in several herbal medicines are reported to effectively improve diabetes and to ameliorate diabetic complications . The aim of the present study was to determine the effects of cinnamon , cardamom , saffron , and ginger as supplementary remedies in T2D . METHODS This r and omized controlled , clinical trial included 204 T2D patients . The participants were r and omly assigned to four intervention groups receiving 3 glasses of black tea and either 3 g cardamom , or cinnamon , or ginger , or 1 g saffron and one control group which consumed only 3 tea glasses without any herbal medicine for 8 weeks . Markers of inflammation , oxidative stress , fasting blood sugar , lipid profile , and anthropometric measures were evaluated at baseline and after 8 weeks of intervention . RESULTS After 8 weeks of intervention , cinnamon , cardamom , ginger , and saffron consumption had significant effects on total cholesterol , LDL , and HDL levels ( p measures of glycemic control , anthropometry , inflammation , and oxidative stress . In within-group comparisons only , cinnamon intake significantly decreased fasting blood sugar ( FBS ) . CONCLUSIONS The herbal remedies examined had significantly beneficial effects on cholesterol , but not on measures of glycemic control , oxidative stress , and inflammation . Based on the contradictory results reported in the literature , the effects of herbal medicine in diabetic patients should undergo further detailed investigation",
"Background / Aims : Supplementation with antioxidants is of special interest in preventing or delaying the development and progression of age-related macular degeneration ( AMD ) . This investigation aim ed to assess the effect of α- lipoic acid ( LA ) on serum lipids , serum malondialdehyde ( MDA ) and superoxide dismutase ( SOD ) in patients with AMD . Methods : A total of 62 patients ( 50–75 years old ) with early and intermediate dry form of AMD were r and omly assigned to two groups , i.e. LA administration ( n = 32 ) and placebo ( n = 30 ) . The levels of serum lipids and MDA and SOD activity were measured before and after LA and placebo intervention . Results : Compared with the parameters at baseline , serum total cholesterol ( CHO ) , triglyceride and high- and low-density lipoprotein CHO ( HDL and LDL ) levels were not significantly different after LA and placebo intervention . There was a slight but statistically nonsignificant decrease in serum MDA levels and a statistically significant increase in serum SOD activity after LA intervention . There were no statistically significant differences in serum MDA levels or SOD activity after placebo intervention . Conclusion : The apparent increase in SOD activity caused by LA supplementation indicates that LA may have a possible preventive effect in the development of AMD through an antioxidant mechanism",
"Background / Aim : Endothelial dysfunction due to reduced nitric oxide ( NO ) availability precedes the development of atherosclerosis . Asymmetric dimethylarginine ( ADMA ) , an endogenous inhibitor of NO synthase , is not only a cause of endothelial dysfunction , but also a predictor of the cardiovascular outcome in end-stage renal disease ( ESRD ) patients on hemodialysis ( HD ) . α-Lipoic acid ( ALA ) , a strong antioxidant , increases NO-mediated vasodilation in diabetic patients . We investigated whether ALA could decrease the plasma level of ADMA in diabetic ESRD patients on HD . Methods : Fifty patients undergoing HD three times per week were r and omized to a treatment group receiving ALA 600 mg/day for 12 weeks or a control group . We measured the plasma levels of cholesterol , albumin , high-sensitivity C-reactive protein , oxidized low-density lipoprotein , hemoglobin A1c , and ADMA in both groups at baseline and at 12 weeks . Results : In the control group , the levels of total cholesterol , serum albumin , high-sensitivity C-reactive protein , oxidized low-density lipoprotein , hemoglobin A1c , and ADMA did not change . In the treatment group , the plasma levels of ADMA decreased significantly from a median of 1.68 ( range 0.45–3.78 ) µM to a median of 1.31 ( range 0.25–3.19 ) µM ( p = 0.001 ) . Conclusion : Considering that ADMA is an independent risk factor for cardiovascular outcome in ESRD patients , ALA may have the potential of a beneficial effect in them , in part by decreasing the plasma level of ADMA ",
"OBJECTIVE We examined the effects of alpha-lipoic acid ( ALA ) supplementation on inflammation , oxidative stress , and serum lipid profile levels in hemodialysis ( HD ) patients . DESIGN This was a double-blinded , r and omized , placebo-controlled clinical trial . SETTING The present study involved HD centers in Tabriz , Iran . PATIENTS Participants included 63 patients with end-stage renal disease ( 43 men and 20 women ; age range : 22 - 79 years ) undergoing maintenance HD . INTERVENTION HD patients were r and omly assigned into the supplemented group ( n = 31 ) , receiving a daily dose of ALA ( 600 mg ) , or a control group ( n = 32 ) , receiving placebo for 8 weeks . MAIN OUTCOME MEASURES High sensitivity C-reactive protein ( hsCRP ) , malondialdehyde , total antioxidant status , total cholesterol , triglyceride , high-density lipoprotein cholesterol ( HDL-C ) , and low-density lipoprotein cholesterol ( LDL-C ) were measured at baseline and after 8 weeks of supplementation . RESULTS At the end of intervention , 11 patients were excluded from the study . HsCRP levels decreased by 18.7 % in the supplemented group after 8 weeks of supplementation , and the reduction was significant in comparison with the placebo group ( P mean malondialdehyde and total antioxidant status levels did not change significantly in the 2 groups during the study . The mean high-density lipoprotein cholesterol concentrations increased significantly in the supplemented group at the end of the study ( P lipid profile parameters within each group during the study . CONCLUSION ALA supplementation significantly reduced hsCRP levels , which is a risk factor for cardiovascular disease in HD patients",
"OBJECTIVE We previously found that lipoic acid ( LA ) improved high-fat diet (HFD)-induced dyslipidemia in rats . To eluci date the molecular mechanisms of that effect , we carried out experiments aim ed at analyzing biochemical parameters and gene expression profiles . METHODS C57BL/6 mice were r and omly assigned to one of three groups ( n = 8) . The control group consumed an ordinary diet ( 4.89 % fat , w/w ) . The other two experimental groups were fed with an HFD ( 21.45 % fat , w/w ) or an HFD plus 0.1 % LA . After 6 wk , plasma lipid level and antioxidant status were examined . To investigate the molecular mechanisms underlying the effects of LA on lipid metabolism and oxidative stress , we examined gene expression profiles in liver using the GeneChip microarray system . The differential expression of genes of interest identified by microarray technique was vali date d by real-time reverse transcription-polymerase chain reaction . RESULTS HFD result ed in significant alterations in lipid profiles and a depressed antioxidant defense system . LA supplementation induced decreases in lipid peroxidation , plasma cholesterol , triacylglycerols , and low-density lipoprotein cholesterol and an increase in high-density lipoprotein in HFD-fed mice . DNA microarray analysis of the liver showed that LA ingestion upregulated the expression of genes related to beta-oxidation and free radical scavenger enzymes , whereas those involved in cholesterol synthesis were downregulated . CONCLUSION LA can prevent HFD-induced dyslipidemia by modulating lipid metabolism , especially by increasing beta-oxidation and decreasing cholesterol synthesis , and oxidative stress by increasing those of free radical scavenger enzyme gene expression",
"Probiotic therapies are going to be an effective alternative therapeutic strategy in the treatment and management of diabetes . The mechanism behind the essential effects of probiotic therapies in diabetic patients was not fully understood . The objective of this study was to evaluate the effects of probiotic soy milk containing Lactobacillus planetarum A7 on inflammation , lipid profile , fasting blood glucose , and serum adiponectin among patients with type 2 diabetes mellitus . Forty patients with type 2 diabetes , at the age of 35–68 years old , were assigned to two groups in this r and omized , double-blind , controlled clinical trial . The patients in the intervention group consumed 200 ml/day of probiotic soy milk containing L. planetarum A7 and those in control group consumed 200 ml/day of pure soy milk for 8 weeks . Serum TNF-α , C reactive protein , adiponectin , lipid profile , and fasting blood glucose were determined before and after intervention . In intervention group , serum adiponectin in pre- and post-treatment did not show any significant changes ( 2.52 ± 0.74 vs 2.84 ± 0.61 , P = 0.658 ) , as well as changes in serum TNF-α and C reactive protein ( 172.44 ± 5.7 vs 172.83 ± 7.6 , P = 0.278 , 4.2 ± 1.4 vs 4.5 ± 1.9 , P = 0.765 , respectively ) . Low-density cholesterol and high-density cholesterol changed significantly ( P = 0.023 , P = 0.017 , respectively ) , but fasting blood glucose did not show any significant changes . The results of this study showed that consumption of probiotic soy milk and soy milk has no effect on serum adiponectin and inflammation , but it can change lipid profile among type 2 diabetic patients",
"In vitro studies have shown that alpha-lipoic acid ( LA ) is an antioxidant . There is a paucity of studies on LA supplementation in humans . Therefore , the aim of this study was to assess the effect of oral supplementation with LA alone and in combination with alpha-tocopherol ( AT ) on measures of oxidative stress . A total of 31 healthy adults were supplemented for 2 months either with LA ( 600 mg/d , n = 16 ) , or with AT ( 400 IU/d , n = 15 ) alone , and then with the combination of both for 2 additional months . At baseline , after 2 and 4 months of supplementation , urine for F2-isoprostanes , plasma for protein carbonyl measurement and low-density lipoprotein ( LDL ) oxidative susceptibility was collected . Plasma oxidizability was assessed after incubation with 100 mM 2,2'-azobis ( 2-amidinopropane ) hydrochloride ( AAPH ) for 4 h at 37 degrees C. LDL was subjected to copper- and AAPH-catalyzed oxidation at 37 degrees C over 5 h and the lag time was computed . LA significantly increased the lag time of LDL lipid peroxide formation for both copper-catalyzed and AAPH-induced LDL oxidalion ( p urinary F2-isoprostanes levels ( p plasma carbonyl levels after AAPH oxidation ( p LDL lag time of lipid peroxide formation ( p conjugated dienes ( p urinary F2-isoprostanes ( p plasma carbonyls . The addition of LA to AT did not produce an additional significant improvement in the measures of oxidative stress . In conclusion , LA supplementation functions as an antioxidant , because it decreases plasma- and LDL-oxidation and urinary isoprostanes",
"There is a growing evidence that excess generation of highly reactive free radicals , largely due to hyperglycemia , causes oxidative stress , which further exacerbates the development and progression of diabetes and its complications . The purpose of this study was to evaluate the impact of ALA on lipid profile , oxidative pattern and inflammation in patients with controlled non-insulin dependent diabetes mellitus ( NIDDM ) . ALA , 400mg/day was investigated in NIDDM patients over a period of 4 weeks using a r and omized , placebo-(PLA)-controlled study with two parallel groups . The marker of oxidative stress was the concentration of reactive oxygen metabolites , evaluated using a commercially available test , called d-ROMs test , and the biological antioxidant potential ( BAP ) ; besides , the lipid profile ( total cholesterol = TC , high-density lipoprotein-cholesterol = HDL-C ; low-density lipoprotein-cholesterol = LDL-C , and triglycerides = TG ) and the C-reactive protein ( CRP ) , marker of inflammation were measured at the beginning and at the end of the treatment . A total of 14 patients were r and omly assigned to the two groups . ALA was safe and well tolerated in the only oral daily administration . The d-ROMs test ( p=0.03 ) and HDL-C ( p=0.04 ) showed a significant difference between the two groups . BAP ( p=0.06 ) tended to be higher in the treated patients , while LDL-C ( p=0.07 ) presented a moderate decline . There were no significant differences in TC ( p=0.65 ) , TG ( p=0.78 ) and CRP ( p=0.96 ) between the ALA and PLA groups . ALA therapy appears to reduce significantly d-ROMs and to improve HDL-C value , especially in men with metabolic syndrome treated with oral hypoglycemic drugs . These findings will be useful in patient selection in future clinical trials with ALA in long term studies"
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41170afa-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Acute appendicitis is one of the most common causes of acute abdominal pain . Present day treatment of choice for acute appendicitis is appendectomy , however complications are inherent to operative treatment . Though surgical appendectomy remains the st and ard treatment , several investigators have investigated conservative antibiotic treatment of acute appendicitis and reported good results . OBJECTIVES Is antibiotic treatment as effective as surgical appendectomy ( laparoscopic or open ) in patients with acute appendicitis on recovery within two weeks , without major complications ( including recurrence ) within one year ? SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( The Cochrane Library Issue 6 , 2011 ) ; MEDLINE ( until June 2011 ) ; EMBASE ( until June 2011 ) ; Prospect i ve Trial Registers ( June 2011 ) and reference lists of articles . SELECTION CRITERIA R and omised and quasi-r and omised clinical trials ( RCT and q RCT ) comparing antibiotic treatment with appendectomy in patients with suspected appendicitis were included . Excluded were studies which primarily focused on the complications of acute appendicitis . DATA COLLECTION AND ANALYSIS Two authors independently assessed trial quality and extracted data . The review authors contacted the trial authors for additional information if required . Statistical analysis was carried out using Review Manager and MetaAnalyst . A non-inferiority analysis was performed , comparing antibiotic treatment ( ABT ) to the gold st and ard ( appendectomy ) . By consensus , a 20 % margin of non-inferiority was considered clinical ly relevant . MAIN RESULTS Five RCT 's ( 901 patients ) were assessed . In total 73.4 % ( 95 % CI 62.7 to 81.9 ) of patients who were treated with antibiotics and 97.4 ( 95 % CI 94.4 to 98.8 ) patients who directly got an appendectomy were cured within two weeks without major complications ( including recurrence ) within one year . The lower 95 % CI was 15.2 % below the 20 % margin for the primary outcome . AUTHORS ' CONCLUSIONS The upper bound of the 95 % CI of ABT for cure within two weeks without major complications crosses the 20 % margin of appendectomy , so the outcome is inconclusive . Also the quality of the studies was low to moderate , for that reason the results should be interpret with caution and definite conclusions can not be made . Therefore we conclude that appendectomy remains the st and ard treatment for acute appendicitis . Antibiotic treatment might be used as an alternative treatment in a good quality RCT or in specific patients or conditions were surgery is contraindicated
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[
"Objective : To compare length of hospital stay , in-hospital complications , in-hospital mortality , and rate of routine discharge between laparoscopic and open appendectomy based on a representative , nationwide data base . Summary Background Data : Numerous single-institutional r and omized clinical trials have assessed the efficacy of laparoscopic and open appendectomy . The results , however , are conflicting , and a consensus concerning the relative advantages of each procedure has not yet been reached . Methods : Patients with primary ICD-9 procedure codes for laparoscopic and open appendectomy were selected from the 1997 Nationwide Inpatient Sample , a data base that approximates 20 % of all US community hospital discharges . Multiple linear and logistic regression analyses were used to assess the risk-adjusted endpoints . Results : Discharge abstract s of 43,757 patients were used for our analyses . 7618 patients ( 17.4 % ) underwent laparoscopic and 36,139 patients ( 82.6 % ) open appendectomy . Patients had an average age of 30.7 years and were predominantly white ( 58.1 % ) and male ( 58.6 % ) . After adjusting for other covariates , laparoscopic appendectomy was associated with shorter median hospital stay ( laparoscopic appendectomy : 2.06 days , open appendectomy : 2.88 days , P lower rate of infections ( odds ratio [ OR ] = 0.5 [ 0.38 , 0.66 ] , P decreased gastrointestinal complications ( OR = 0.8 [ 0.68 , 0.96 ] , P = 0.02 ) , lower overall complications ( OR = 0.84 [ 0.75 , 0.94 ] , P = 0.002 ) , and higher rate of routine discharge ( OR = 3.22 [ 2.47 , 4.46 ] , P Laparoscopic appendectomy has significant advantages over open appendectomy with respect to length of hospital stay , rate of routine discharge , and postoperative in-hospital morbidity",
"BACKGROUND / PURPOSE Imaging techniques are used widely to diagnose appendicitis . However , the negative appendectomy rate remains at about 15 % . The authors assessed ultrasound-based decision making in the treatment of acute appendicitis in children . METHODS The authors prospect ively studied 165 consecutive children ( 3 to 15 years old ) evaluated for appendicitis . Diagnosis and treatment were based solely on ultrasound scan findings . Criterion for appendicitis was a diameter exceeding 6 mm . Severity was classified into 4 grade s based on the appearance of intramural appendiceal structure . Patients with grade s I or II received antibiotic therapy . Patients with grade s III or IV underwent appendectomy . RESULTS Ultrasound scan diagnosed appendicitis in 93 children ( grade I , 7 ; grade II , 17 ; grade III , 41 ; and grade IV , 28 ) . All but 2 patients with grade s I or II underwent antibiotic therapy without complication . All grade s III or IV patients underwent appendectomy . There was no negative appendectomy among 76 appendectomies during this period . Ultrasound-based prediction of severity was correct in 67 cases ( 88 % ) . Ultrasonography identified other pathology in 39 . CONCLUSIONS Ultrasonography in children can not only visualize all inflamed appendices but also predict severity of disease . Treatment based entirely on ultrasound scan identified patients who required surgery for severe appendicitis and permitted successful conservative treatment for mild appendicitis",
"Background The acute appendicitis is the most common abdominal emergency , and the primary treatment has been appendicectomy . Antibiotics are started preoperatively and continued postoperatively as needed . Methods This prospect i ve study was carried out at Sher-i-Kashmir Institute of Medical Sciences , Soura , Srinagar , Kashmir , India to determine the role of antibiotics as the only treatment in acute appendicitis and the analgesic consumption needed . Total of 80 patients were included in the study with a duration of abdominal pain less than 72 h. Out of 80 patients , 40 patients received antibiotics intravenously for 2 days followed by oral treatment for 7 days , while another 40 patients considered as controls were r and omized to surgery . Results Patients managed conservatively were discharged within 3 days except for two— patients who required surgery after 12 and 24 h , respectively , because of peritonitis due to perforated appendicitis . Four patients were readmitted within 1 year as a result of recurrent appendicitis and had to undergo surgery when appendicitis was confirmed . The diagnostic accuracy within the operated group was 90 % . Two patients had perforated appendicitis at operation . Conclusion Our conclusion is that antibiotic treatment in the patients with acute appendicitis is quite effective , and these patients may not need surgery . The patients managed conservatively with antibiotics alone experience less pain and require less analgesia but have high recurrent rate",
"BACKGROUND Research ers have suggested that antibiotics could cure acute appendicitis . We assessed the efficacy of amoxicillin plus clavulanic acid by comparison with emergency appendicectomy for treatment of patients with uncomplicated acute appendicitis . METHODS In this open-label , non-inferiority , r and omised trial , adult patients ( aged 18 - 68 years ) with uncomplicated acute appendicitis , as assessed by CT scan , were enrolled at six university hospitals in France . A computer-generated r and omisation sequence was used to allocate patients r and omly in a 1:1 ratio to receive amoxicillin plus clavulanic acid ( 3 g per day ) for 8 - 15 days or emergency appendicectomy . The primary endpoint was occurrence of postintervention peritonitis within 30 days of treatment initiation . Non-inferiority was shown if the upper limit of the two-sided 95 % CI for the difference in rates was lower than 10 percentage points . Both intention-to-treat and per- protocol analyses were done . This trial is registered with Clinical Trials.gov , number NCT00135603 . FINDINGS Of 243 patients r and omised , 123 were allocated to the antibiotic group and 120 to the appendicectomy group . Four were excluded from analysis because of early dropout before receiving the intervention , leaving 239 ( antibiotic group , 120 ; appendicectomy group , 119 ) patients for intention-to-treat analysis . 30-day postintervention peritonitis was significantly more frequent in the antibiotic group ( 8 % , n=9 ) than in the appendicectomy group ( 2 % , n=2 ; treatment difference 5·8 ; 95 % CI 0·3 - 12·1 ) . In the appendicectomy group , despite CT-scan assessment , 21 ( 18 % ) of 119 patients were unexpectedly identified at surgery to have complicated appendicitis with peritonitis . In the antibiotic group , 14 ( 12 % [ 7·1 - 18·6 ] ) of 120 underwent an appendicectomy during the first 30 days and 30 ( 29 % [ 21·4 - 38·9 ] ) of 102 underwent appendicectomy between 1 month and 1 year , 26 of whom had acute appendicitis ( recurrence rate 26 % ; 18·0 - 34·7 ) . INTERPRETATION Amoxicillin plus clavulanic acid was not non-inferior to emergency appendicectomy for treatment of acute appendicitis . Identification of predictive markers on CT scans might enable improved targeting of antibiotic treatment . FUNDING French Ministry of Health , Programme Hospitalier de Recherche Clinique 2002",
"BACKGROUND In this prospect i ve study , operative and nonoperative management of acute appendicitis were evaluated regarding their safety and cost effectiveness . METHODS Two hundred ninety patients presenting to our Emergency Department between March 2005 and March 2006 with acute appendicitis were included in this prospect i ve study . Nonoperative medical therapy was performed in 107 patients ( Group 1 ) , and 183 patients were treated surgically ( Group 2 ) . Routine follow-up controls were done on the 10th day , at the 3rd and 6th months and at the first year after discharge in Group 1 . Both groups were compared regarding age , gender , mean hospital stay , modified Alvarado score , morbidity , mortality , and cost effectiveness . RESULTS The male/female ratio of Groups 1 and 2 were 65/42 ( mean age : 30.98+/-1.30 ) and 125/58 ( mean age : 26.25+/-0.79 ) , respectively . In Group 1 , 19 patients were operated . Operation indications were resistance to therapy , patient 's request , and operation in another hospital . Although the mean hospital stay of Group 1 was statistically significantly longer than Group 2 , the mean cost of the therapy was $ 559 in Group 2 and $ 433 in Group 1 . Morbidity rates were similar , with no mortality in either group . CONCLUSION With its high success rate and cost effectiveness , medical treatment seems to be a good alternative to the gold st and ard therapy of surgery in management of acute appendicitis"
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41170b36-06ff-11f0-808a-c43d1ab1c353
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Background A scoping search identified systematic review s on diagnostic accuracy and predictive ability of frailty measures in older adults . In most cases , research was confined to specific assessment measures related to a specific clinical model . Objectives To summarize the best available evidence from systematic review s in relation to reliability , validity , diagnostic accuracy and predictive ability of frailty measures in older adults . Inclusion criteria Population Older adults aged 60 years or older recruited from community , primary care , long-term residential care and hospitals . Index test Available frailty measures in older adults . Reference test Cardiovascular Health Study phenotype model , the Canadian Study of Health and Aging cumulative deficit model , Comprehensive Geriatric Assessment or other reference tests . Diagnosis of interest Frailty defined as an age-related state of decreased physiological reserves characterized by an increased risk of poor clinical outcomes . Types of studies Quantitative systematic review s. Search strategy A three-step search strategy was utilized to find systematic review s , available in English , published between January 2001 and October 2015 . Method ological quality Assessed by two independent review ers using the Joanna Briggs Institute critical appraisal checklist for systematic review s and research synthesis . Data extraction Two independent review ers extracted data using the st and ardized data extraction tool design ed for umbrella review s. Data synthesis Data were only presented in a narrative form due to the heterogeneity of included review s. Results Five review s with a total of 227,381 participants were included in this umbrella review . Two review s focused on reliability , validity and diagnostic accuracy ; two examined predictive ability for adverse health outcomes ; and one investigated validity , diagnostic accuracy and predictive ability . In total , 26 question naires and brief assessment s and eight frailty indicators were analyzed , most of which were applied to community-dwelling older people . The Frailty Index was examined in almost all these dimensions , with the exception of reliability , and its diagnostic and predictive characteristics were shown to be satisfactory . Gait speed showed high sensitivity , but only moderate specificity , and excellent predictive ability for future disability in activities of daily living . The Tilburg Frailty Indicator was shown to be a reliable and valid measure for frailty screening , but its diagnostic accuracy was not evaluated . Screening Letter , Timed-up- and -go test and PRISMA 7 ( Preferred Reporting Items for Systematic Review s and Meta-Analyses ) demonstrated high sensitivity and moderate specificity for identifying frailty . In general , low physical activity , variously measured , was one of the most powerful predictors of future decline in activities of daily living . Conclusion Only a few frailty measures seem to be demonstrably valid , reliable and diagnostically accurate , and have good predictive ability . Among them , the Frailty Index and gait speed emerged as the most useful in routine care and community setting s. However , none of the included systematic review s provided responses that met all of our research questions on their own and there is a need for studies that could fill this gap , covering all these issues within the same study . Nevertheless , it was clear that no suitable tool for assessing frailty appropriately in emergency departments was identified
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"Purpose Frailty is a recent concept used for evaluating elderly individuals . Our study determined the prevalence of frailty in intensive care unit ( ICU ) patients and its impact on the rate of mortality . Methods A multicenter , prospect i ve , observational study performed in four ICUs in France included 196 patients aged ≥65 years hospitalized for > 24 h during a 6-month study period . Frailty was determined using the frailty phenotype ( FP ) and the clinical frailty score ( CFS ) . The patients were separated as follows : FP score the Simplified Acute Physiology Score II ( SAPS II ) and Sequential Organ Failure Assessment ( SOFA ) scores did not differ between the frail and nonfrail patients . In the multivariate analysis , the risk factors for ICU mortality were FP score ≥3 [ hazard ratio ( HR ) , 3.3 ; 95 % confidence interval ( CI ) , 1.6–6.6 ; p cardiac arrest before admission ( HR , 2.8 ; 95 % CI , 1.1–7.4 ; p = 0.036 ) , SAPS II score ≥46 ( HR , 2.6 ; 95 % CI , 1.2–5.3 ; p = 0.011 ) , and brain injury before admission ( HR , 3.5 ; 95 % CI , 1.6–7.7 ; p = 0.002 ) . The risk factors for 6-month mortality were a CFS ≥5 ( HR , 2.4 ; 95 % CI , 1.49–3.87 ; p and a SOFA score ≥7 ( HR , 2.2 ; 95 % CI , 1.35–3.64 ; p = 0.002 ) . An increased CFS was associated with significant incremental hospital and 6-month mortalities . Conclusions Frailty is a frequent occurrence and is independently associated with increased ICU and 6-month mortalities . Notably , the CFS predicts outcomes more effectively than the commonly used ICU illness scores",
"To investigate the prevalence of frailty in a Dutch elderly population and to identify adverse health outcomes associated with the frailty phenotype independent of the comorbidities . Cross-sectional and longitudinal analyses within the Rotterdam Study ( the Netherl and s ) , a prospect i ve population -based cohort study in persons aged ≥55 years . Frailty was defined as meeting three or more of five established criteria for frailty , evaluating nutritional status , physical activity , mobility , grip strength and exhaustion . Intermediate frailty was defined as meeting one or two frailty criteria . Comorbidities were objective ly measured . Health outcomes were assessed by means of question naires , physical examinations and continuous follow-up through general practitioners and municipal health authorities for mortality . Of 2,833 participants ( median age 74.0 years , inter quartile range 9 ) with sufficiently evaluated frailty criteria , 163 ( 5.8 % ) participants were frail and 1,454 ( 51.3 % ) intermediate frail . Frail elderly were more likely to be older and female , to have an impaired quality of life and to have fallen or to have been hospitalized . 108 ( 72.0 % ) frail participants had ≥2 comorbidities , compared to 777 ( 54.4 % ) intermediate frail and 522 ( 44.8 % ) non-frail participants . Adjusted for age , sex and comorbidities , frail elderly had a significantly increased risk of dying within 3 years ( HR 3.4 ; 95 % CI 1.9–6.4 ) , compared to the non-frail elderly . This study in a general Dutch population of community-dwelling elderly able to perform the frailty tests , demonstrates that frailty is common and that frail elderly are at increased risk of death independent of comorbidities",
"Background : There is no single generally accepted clinical definition of frailty . Previously developed tools to assess frailty that have been shown to be predictive of death or need for entry into an institutional facility have not gained acceptance among practising clinicians . We aim ed to develop a tool that would be both predictive and easy to use . Methods : We developed the 7-point Clinical Frailty Scale and applied it and other established tools that measure frailty to 2305 elderly patients who participated in the second stage of the Canadian Study of Health and Aging ( CSHA ) . We followed this cohort prospect ively ; after 5 years , we determined the ability of the Clinical Frailty Scale to predict death or need for institutional care , and correlated the results with those obtained from other established tools . Results : The CSHA Clinical Frailty Scale was highly correlated ( r = 0.80 ) with the Frailty Index . Each 1-category increment of our scale significantly increased the medium-term risks of death ( 21.2 % within about 70 mo , 95 % confidence interval [ CI ] 12.5%–30.6 % ) and entry into an institution ( 23.9 % , 95 % CI 8.8%–41.2 % ) in multivariable models that adjusted for age , sex and education . Analyses of receiver operating characteristic curves showed that our Clinical Frailty Scale performed better than measures of cognition , function or comorbidity in assessing risk for death ( area under the curve 0.77 for 18-month and 0.70 for 70-month mortality ) . Interpretation : Frailty is a valid and clinical ly important construct that is recognizable by physicians . Clinical judgments about frailty can yield useful predictive information",
"BACKGROUND In community-dwelling older adults , global cognitive function predicts longitudinal gait speed decline . Few prospect i ve studies have evaluated whether specific executive cognitive deficits in aging may account for gait slowing over time . METHODS Multiple cognitive tasks were administered at baseline in 909 participants in the Health , Aging , and Body Composition Study Cognitive Vitality Sub study ( mean age 75.2 ± 2.8 years , 50.6 % women , 48.4 % black ) . Usual gait speed ( m/s ) over 20 minutes was assessed at baseline and over a 5-year follow-up . RESULTS Poorer performance in each cognitive task was cross-sectionally associated with slower gait independent of demographic and health characteristics . In longitudinal analyses , each 1 SD poorer performance in global function , verbal memory , and executive function was associated with 0.003 - 0.004 m/s greater gait speed decline per year ( p = .03-.05 ) after adjustment for baseline gait speed , demographic , and health characteristics . CONCLUSIONS In this well-functioning cohort , several cognitive tasks were associated with gait speed cross-sectionally and predicted longitudinal gait speed decline . These data are consistent with a shared pathology underlying cognitive and motor declines but do not suggest that specific executive cognitive deficits account for slowing of usual gait in aging",
"Background Frailty is a well known and accepted term to clinicians working with older people . The study aim was to determine whether an intervention could reduce frailty and improve mobility . Methods We conducted a single center , r and omized , controlled trial among older people who were frail in Sydney , Australia . One group received an intervention targeting the identified characteristics of frailty , whereas the comparison group received the usual health care and support services . Outcomes were assessed by raters masked to treatment allocation at 3 and 12 months after study entry . The primary outcomes were frailty as assessed by the Cardiovascular Health Study criteria , and mobility as assessed by the Short Physical Performance Battery . Secondary outcome measures included disability , depressive symptoms and health-related quality of life . Results A total of 216 participants ( 90 % ) completed the study . Overall , 68 % of participants were women and the mean age was 83.3 years ( st and ard deviation , 5.9 ) . In the intention-to-treat analysis , the between-group difference in frailty was 14.7 % at 12 months ( 95 % confidence interval : 2.4 % , 27.0 % ; P = 0.02 ) . The score on the Short Physical Performance Battery , in which higher scores indicate better physical status , was stable in the intervention group and had declined in the control group ; with the mean difference between groups being 1.44 ( 95 % confidence interval , 0.80 , 2.07 ; P exercise-associated musculoskeletal symptoms . Conclusions Frailty and mobility disability can be successfully treated using an interdisciplinary multifaceted treatment program . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) :",
"Background Disease management programs ( DMP ) improve outcomes in patients with heart failure . Because older heart failure patients represent a heterogeneous population , the aim of this study was to determine which patients benefit mostly from a DMP , by means of their frailty profile . Setting Heart failure outpatient clinic . Methods Consecutive ( n = 173 ) patients aged more than 70 years were r and omized to a multidisciplinary DMP ( n = 86 ) or usual care ( n = 87 ) . A modified frailty score ( range 1–6 ) was used as an index of global functional impairment . Results Mild to moderate frailty ( frailty score = 2–3 ) was associated with significant improvements in outcomes ( death and /or heart failure admission , heart failure admissions and all-cause admissions ) in DMP patients vs. usual care . Even in more frail patients ( frailty score = 4–6 ) a significant reduction in heart failure admissions was observed . By contrast , nonfrail patients ( frailty score = 1 ) did not derive significant benefit . In the cost-effectiveness analysis , the mean savings per patient , stratified according to their frailty score , were & U20AC ; −1003.31 for frailty score 1 ( 95 % confidence interval −3717.00–1709.00 ) , & U20AC ; 1104.72 for frailty score 2 ( −280.6–2491.00 ) , & U20AC ; 2635.42 for frailty score 3 ( 352.60–4917.00 , P = 0.025 ) and & U20AC ; 419.53 for frailty score 4–6 ( −1909.00–2749.00 ) . Intervention was therefore significantly cost saving in moderately frail , but not in nonfrail or severely frail patients . Thus , DMP was dominant ( i.e. both less costly and more effective than usual care ) in moderately frail patients . At sensitivity analysis , DMP remained dominant even to changes in cost of intervention and hospitalizations . Conclusion This suggests that an intensive , hospital-based DMP appears to be more effective in older patients with mild-to-moderate levels of frailty . Thus , a multidimensional assessment of frailty seems to be a useful tool for appropriate selection of model of care",
"BACKGROUND The frailty syndrome is as a well-established condition of risk for disability . Aim of the study is to explore whether a physical activity ( PA ) intervention can reduce prevalence and severity of frailty in a community-dwelling elders at risk of disability . METHODS Exploratory analyses from the Lifestyle Interventions and Independence for Elders pilot , a r and omized controlled trial enrolling 424 community-dwelling persons ( mean age=76.8 years ) with sedentary lifestyle and at risk of mobility disability . Participants were r and omized to a 12-month PA intervention versus a successful aging education group . The frailty phenotype ( ie , ≥3 of the following defining criteria : involuntary weight loss , exhaustion , sedentary behavior , slow gait speed , poor h and grip strength ) was measured at baseline , 6 months , and 12 months . Repeated measures generalized linear models were conducted . RESULTS A significant ( p = .01 ) difference in frailty prevalence was observed at 12 months in the PA intervention group ( 10.0 % ; 95 % confidence interval = 6.5 % , 15.1 % ) , relative to the successful aging group ( 19.1 % ; 95 % confidence interval = 13.9%,15.6 % ) . Over follow-up , in comparison to successful aging participants , the mean number of frailty criteria in the PA group was notably reduced for younger subjects , blacks , participants with frailty , and those with multimorbidity . Among the frailty criteria , the sedentary behavior was the one most affected by the intervention . CONCLUSIONS Regular PA may reduce frailty , especially in individuals at higher risk of disability . Future studies should be aim ed at testing the possible benefits produced by multidomain interventions on frailty",
"Background and aims : Objectives were to develop a frailty index ( FI ) based on a st and ard comprehensive geriatric assessment ( CGA ) derived from a clinical examination ; to assess the validity of the FI-CGA and to compare its precision with other frailty measures . Methods : Design : Secondary analysis of a prospect i ve cohort study , with five-year follow-up data . Setting : Second phase of the Canadian Study of Health and Aging ( CSHA-2 ) ; clinical examinations were performed in clinics , nursing homes , and patients ’ homes . Participants : People selected ( as either cognitively impaired cases or unimpaired controls ) to receive the CSHA-2 clinical examination ( n=2305 ; women=1431 ) . Measurements : Clinical and performance-based measures and diagnostic data were extracted to correspond to the 10 impairment domains and the single comorbidity domain of a CGA . The proportion of deficits accumulated in each domain was calculated to yield the FI-CGA . The FI-CGA was vali date d and its predictive ability compared with other frailty measures . Results : Within the seven grade s of fitness/frailty identified , subjects with greater frailty were older , less educated , and more likely to be women . The FI-CGA correlated highly with a previously vali date d , empirically-derived frailty index ( r=0.76 ) . Frailty was associated with higher risk of death ( for each increment in frailty , the hazard ratio , adjusted for age , sex and education , was 1.23 ( 95 % CI 1.18–1.29 ) and institutionalization ( HR 1.20 ; 1.10–1.32 ) . Conclusions : In a population survey , the FI-CGA is a valid means of quantifying frailty from routinely collected data"
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41170b72-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES Ageing in men is associated with a gradual decline in serum testosterone levels and a concomitant loss of muscle mass , accumulation of central adiposity , impaired mobility and increased risk of bone fractures . Whether and rogen treatment might be beneficial in these subjects is still under debate . We have carried out a systematic review of r and omized controlled trials ( RCTs ) evaluating the effects of testosterone ( T ) administration to middle-aged and ageing men on body composition , muscle strength , bone density , markers of bone metabolism and serum lipid profile . DATA SOURCE A comprehensive search of all published r and omized clinical trials was performed using the MEDLINE , Cochrane Library , EMBASE and Current Contents data bases . REVIEW METHODS Guided by prespecified criteria , software-assisted data abstract ion and quality assessed by two independent review ers , 29 RCTs were found to be eligible . For each investigated variable , we reported the results of pooled estimates of testosterone treatment using the r and om effect model of meta- analysis . Heterogeneity , reproducibility and consistency of the findings across studies were explored using sensitivity and meta-regression analysis . RESULTS Overall , 1,083 subjects were evaluated , 625 r and omized to T , 427 to placebo and 31 to observation ( control group ) . Weighted mean age was 64.5 years ( range 49.9 - -77.6 ) and mean serum testosterone was 10.9 nmol/l ( range 7.8 - -19 ) . Testosterone treatment produced : ( i ) a reduction of 1.6 kg ( CI : 2.5 - -0.6 ) of total body fat , corresponding to -6.2 % ( CI : 9.2 - -3.3 ) variation of initial body fat , ( ii ) an increase in fat free mass of 1.6 kg ( CI : 0.6 - -2.6 ) , corresponding to + 2.7 % ( CI : 1.1 - -4.4 ) increase over baseline and ( iii ) no change in body weight . The effects of T on muscle strength were heterogeneous , showing a tendency towards improvement only at the leg/knee extension and h and grip of the dominant arm ( pooled effect size=0.3 st and ard mean difference ( SMD ) , CI : -0.0 to 0.6 ) . Testosterone improved bone mineral density ( BMD ) at the lumbar spine by + 3.7 % ( CI : 1.0 - -6.4 % ) compared to placebo , but not at the femoral neck , and produced a consistent reduction in bone resorption markers ( pooled effect size = -0.6 SMD , CI : -1.0 to -0.2 ) . Testosterone also reduced total cholesterol by 0.23 mmol/l ( CI : -0.37 to -0.10 ) , especially in men with lower baseline T concentrations , with no change in low density lipoprotein (LDL)-cholesterol . A significant reduction of high density lipoprotein (HDL)-cholesterol was found only in studies with higher mean T-values at baseline ( -0.085 mmol/l , CI : -0.017 to -0.003 ) . Sensitivity and meta-regression analysis revealed that the dose/type of T used , in particular the possibility of aromatization , explained the heterogeneity in findings observed on bone density and HDL-cholesterol among studies . CONCLUSION The present analysis provides an estimate of the average treatment effects of testosterone therapy in middle-aged men . Our findings are sufficiently strong to justify further interventional studies focused on alternative targets of and rogenic treatment carrying more stringent clinical implication s , in particular the cardiovascular , metabolic and neurological systems
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"Serum and rogen levels decline with aging in normal males , such that a significant number of men over 60 yr of age will have a mean serum total testosterone ( T ) level near the low end of the normal adult range . It is not known whether lower T levels in older men have an effect on and rogen-responsive organ systems , such as muscle , bone , bone marrow , and prostate , nor are there data to evaluate the relative benefits and risks of T supplementation in older men . We assessed the physiological and biochemical effects of T therapy in 13 healthy men , 57 - 76 yr old , who had low or borderline low serum T levels ( Intramuscular testosterone enanthate ( TE ; 100 mg weekly ) and placebo injections were given for 3 months each . Before treatment and at the end of both 3-month treatment regimens , lean body mass , body fat , biochemical parameters of bone turnover , hematological parameters , lipoprotein profiles , and prostate parameters [ such as prostate-specific antigen ( PSA ) ] were evaluated . Serum T levels rose in all subjects with TE treatment , such that the lowest level of T during a week 's period was 19.7 + /- 0.7 nmol/L ( mean + /- SE ) . After 3 months of TE treatment , lean body mass was significantly increased , and urinary hydroxyproline excretion was significantly depressed . With TE treatment , there was a significant increase in hematocrit , a decline in total cholesterol and low density lipoprotein cholesterol , and a sustained increase in serum PSA levels . Placebo treatment led to no significant changes in any of these parameters . We conclude that short term ( 3 months ) TE supplementation to healthy older men who have serum T levels near or below the lower limit of normal for young adult men results in an increase in lean body mass and possibly a decline in bone resorption , as assessed by urinary hydroxyproline excretion , with some effect on serum lipoproteins , hematological parameters , and PSA . The sustained stimulation of PSA and the increase in hematocrit that occur with physiological TE supplementation suggest that older men should be screened carefully and followed periodically throughout T therapy",
"Older men , particularly those with low serum testosterone ( T ) levels , might benefit from T therapy to improve bone mineral density ( BMD ) and reduce fracture risk . Concerns exist , however , about the impact of T therapy on the prostate in older men . We hypothesized that the combination of T and finasteride ( F ) , a 5 alpha-reductase inhibitor , might increase BMD in older men without adverse effects on the prostate . Seventy men aged 65 yr or older , with a serum T less than 12.1 nmol/liter on two occasions , were r and omly assigned to receive one of three regimens for 36 months : T enanthate , 200 mg i m every 2 wk with placebo pills daily ( T-only ) ; T enanthate , 200 mg every 2 wk with 5 mg F daily ( T+F ) ; or placebo injections and pills ( placebo ) . Low BMD was not an inclusion criterion . We obtained serial measurements of BMD of the lumbar spine and hip by dual x-ray absorptiometry . Prostate-specific antigen ( PSA ) and prostate size were measured at baseline and during treatment to assess the impact of therapy on the prostate . Fifty men completed the 36-month protocol . By an intent-to-treat analysis including all men for as long as they contributed data , T therapy for 36 months increased BMD in these men at the lumbar spine [ 10.2 + /- 1.4 % ( mean percentage increase from baseline + /- SEM ; T-only ) and 9.3 + /- 1.4 % ( T+F ) vs. 1.3 + /- 1.4 % for placebo ( P hip [ 2.7 + /- 0.7 % ( T-only ) and 2.2 + /- 0.7 % ( T+F ) vs. -0.2 + /- 0.7 % for placebo , ( P increases in BMD were seen also in the intertrochanteric and trochanteric regions of the hip . After 6 months of therapy , urinary deoxypyridinoline ( a bone-resorption marker ) decreased significantly compared with baseline in both the T-only and T+F groups ( P PSA increased significantly from baseline in the T-only group ( P Prostate volume increased in all groups during the 36-month treatment period , but this increase was significantly less in the T+F group compared with both the T-only and placebo groups ( P = 0.02 ) . These results demonstrate that T therapy in older men with low serum T increases vertebral and hip BMD over 36 months , both when administered alone and when combined with F. This finding suggests that dihydrotestosterone is not essential for the beneficial effects of T on BMD in men . In addition , the concomitant administration of F with T appears to attenuate the impact of T therapy on prostate size and PSA and might reduce the chance of benign prostatic hypertrophy or other prostate-related complications in older men on T therapy . These findings have important implication s for the prevention and treatment of osteoporosis in older men with low T levels",
"The objective of this study was to assess the effects of oral testosterone supplementation therapy on glucose homeostasis , obesity and sexual function in middle-aged men with type 2 diabetes and mild and rogen deficiency . Forty-eight middle-aged men , with type 2 diabetes , ( visceral ) obesity and symptoms of and rogen deficiency , were included in this open-label study . Twenty-four subjects received testosterone undecanoate ( TU ; 120 mg daily , for 3 months ) ; 24 subjects received no treatment . Body composition was analyzed by bio-impedance . Parameters of metabolic control were determined . Symptoms of and rogen deficiency and erectile dysfunction were scored by self-administered question naires . TU had a positive effect on ( visceral ) obesity : statistically significant reduction in body weight ( 2.66 % ) , waist-hip ratio ( -3.96 % ) and body fat ( -5.65 % ) ; negligible changes were found in the control group . TU significantly improved metabolic control : decrease in blood glucose values and mean glycated hemoglobin ( HbA1c ) ( from 10.4 to 8.6 % ) . TU treatment significantly improved symptoms of and rogen deficiency ( including erectile dysfunction ) , with virtually no change in the control group . There were no adverse effects on blood pressure or hematological , biochemical and lipid parameters , and no adverse events . Oral TU treatment of type 2 diabetic men with and rogen deficiency improves glucose homeostasis and body composition ( decrease in visceral obesity ) , and improves symptoms of and rogen deficiency ( including erectile dysfunction ) . In these men , the benefit of testosterone supplementation therapy exceeds the correction of symptoms of and rogen deficiency and also includes glucose homeostasis and metabolic control",
"Nutritional depletion commonly occurs in patients with COPD , causing muscle wasting and impaired physiologic function . Two hundred seventeen patients with COPD participated in a placebo-controlled , r and omized trial investigating the physiologic effects of nutritional intervention alone ( N ) for 8 wk or combined with the anabolic steroid n and rolone decanoate ( N + A ) . N and rolone decanoate or placebo ( P ) was injected intramuscularly ( women , 25 mg ; men , 50 mg ) in a double-blind fashion on Days 1 , 15 , 29 , and 43 . Nutritional intervention consisted of a daily high caloric supplement ( 420 kcal ; 200 ml ) . Also , all patients participated in an exercise program . In the depleted patients , both treatment regimens induced a similar significant body weight gain ( 2.6 kg ) but different body compositional changes . Particularly in the last 4 wk of treatment , weight gain in the N group was predominantly due to an expansion of fat mass ( p changes in fat-free mass ( FFM ) and other measures of muscle mass were more favorable in the N + A group ( p Maximal inspiratory mouth pressure improved within both treatment groups in the first 4 wk of treatment , but after 8 wk only N + A was significantly different from P ( p Nutritional supplementation in combination with a short course of anabolic steroids may enhance the gain in FFM and respiratory muscle function in depleted patients with COPD without causing adverse side effects",
"We conducted a prospect i ve , r and omized study in chronic hemodialysis patients in order to determine whether the erythropoietic response to low dose recombinant human erythropoietin ( rHuEpo ) could be enhanced by administration with and rogens . Patients received rHuEpo 40 U/kg intravenously three times weekly either alone ( Group 1 , n = 6 ) or with weekly intramuscular injection of 2 mg/kg n and rolone decanoate ( Group 2 , n = 6 ) for up to 16 weeks . Baseline hct , ferritin , N-terminal parathyroid hormone , and aluminum levels were similar . The mean weekly rate of rise in hct was 0.32 + /- 0.13 % in Group 1 and 0.37 + /- 0.11 % in Group 2 , p = NS . Three of 6 patients in Group 1 , but only 1 of 6 patients in Group 2 , reached the target hct of 30 % within 16 weeks . Two patients in Group 2 requested that the n and rolone decanoate be stopped prior to reaching target hct because of unacceptable side effects ( acne ) . We conclude that many chronic hemodialysis patients appear to respond adequately to rHuEpo at the dose used in our study . N and rolone decanoate does not enhance the response rate to this rHuEpo dose and is associated with significant side effects",
"BACKGROUND A large proportion of men over 65 years of age have bioavailable testosterone levels below the reference range of young adult men . The impact of this on musculoskeletal health and the potential for improvement in function in this group with testosterone supplementation require investigation . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - -87 ) with bioavailable testosterone levels below 4.44 nmol/l ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( two 2.5-mg patches per day ) or placebo patches for 1 year . All men received 500 mg supplemental calcium and 400 IU vitamin D. Outcome measures included sex hormones ( testosterone , bioavailable testosterone , sex-hormone binding globulin [ SHBG ] , estradiol , and estrone ) , bone mineral density ( BMD ; femoral neck , Ward 's triangle , trochanter , lumbar spine , and total body ) , bone turnover markers , lower extremity muscle strength , percent body fat , lean body mass , hemoglobin , hematocrit , prostate symptoms , and prostate specific antigen ( PSA ) levels . RESULTS Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial . In these men , bioavailable testosterone levels increased from 3.2 + /- 1.2 nmol/l ( SD ) to 5.6 + /- 3.5 nmol/l ( p estradiol levels in either group , estrone levels increased in the testosterone group ( 103 + /- 26 pmol/l to 117 + /- 33 pmol/l ; p femoral neck BMD , whereas the control group lost 1.6 % over 12 months ( p = .015 ) . No significant changes were seen in markers of bone turnover in either group . Improvements in muscle strength were seen in both groups at 12 months compared with baseline scores . Strength increased 38 % ( p = .017 ) in the testosterone group and 27 % in the control group ( p = .06 ) , with no statistical difference between the groups . In the testosterone group , body fat decreased from 26.3 + /- 5.8 % to 24.6 + /- 6.5 % ( p = .001 ) , and lean body mass increased from 56.2 + /- 5.3 kg to 57.2 + /- 5.1 kg ( p = .001 ) , whereas body mass did not change . Men receiving testosterone had an increase in PSA from 2.0 + /- 1.4 microg/l to 2.6 + /- 1.8 microg/l ( p = .04 ) , whereas men receiving placebo had an increase in PSA from 1.9 + /- 1.0 microg/l to 2.2 + /- 1.5 microg/l ( p = .09 ) . No significant differences between groups were seen in hemoglobin , hematocrit , symptoms or signs of benign prostate hyperplasia , or PSA levels . CONCLUSIONS Transdermal testosterone ( 5 mg/d ) prevented bone loss at the femoral neck , decreased body fat , and increased lean body mass in a group of healthy men over age 65 with low bioavailable testosterone levels . In addition , both testosterone and placebo groups demonstrated gains in lower extremity muscle strength , possibly due to the beneficial effects of vitamin D. Testosterone did result in a modest increase in PSA levels but result ed in no change in signs or symptoms of prostate hyperplasia",
"Long-term glucocorticoid therapy in men is associated with loss of bone and muscle mass as well as a decrease in serum testosterone . We tested the effect of two and rogens , testosterone and its minimally aromatizable analog n and rolone , on muscle mass ( dual x-ray absorptiometry ) , muscle strength ( knee flexion and extension by isokinetic dynamometry ) , bone mineral density ( BMD ) , and quality of life ( Qualeffo-41 question naire ) in 51 men on a mean daily prednisone dose of 12.6 + /- 2.2 mg . Men were r and omized , double blind , to testosterone ( 200 mg mixed esters ) , n and rolone decanoate ( 200 mg ) , or placebo given every fortnight by i m injection for 12 months . At 12 months , both and rogens increased muscle mass ( mean change from baseline + 3.5 % , + 5.8 % , and -0.9 % in testosterone , n and rolone , and placebo groups , respectively , P muscle strength ( P Lumbar spine BMD increased significantly only in men treated with testosterone ( 4.7 + /- 1.1 % , P hip or total body BMD . Testosterone , but not n and rolone or placebo , improved overall quality of life ( P and rogen therapy may have a role in ameliorating adverse effects of glucocorticoid therapy such as muscle and bone loss and aromatization is necessary for and rogen action on bone but not on muscle",
"Although weight loss associated with human immunodeficiency virus ( HIV ) infection is multifactorial in its pathogenesis , it has been speculated that hypogonadism , a common occurrence in HIV disease , contributes to depletion of lean tissue and muscle dysfunction . We , therefore , examined the effects of testosterone replacement by means of And roderm , a permeation-enhanced , nongenital transdermal system , on lean body mass , body weight , muscle strength , health-related quality of life , and HIV-disease markers . We r and omly assigned 41 HIV-infected , ambulatory men , 18 - 60 yr of age , with serum testosterone levels below 400 ng/dL , to 1 of 2 treatment groups : group I , two placebo patches ( n = 21 ) ; or group II , two testosterone patches design ed to release 5 mg testosterone over 24 h. Eighteen men in the placebo group and 14 men in the testosterone group completed the 12-week treatment . Serum total and free testosterone and dihydrotestosterone levels increased , and LH and FSH levels decreased in the testosterone-treated , but not in the placebo-treated , men . Lean body mass and fat-free mass , measured by dual energy x-ray absorptiometry , increased significantly in men receiving testosterone patches [ change in lean body mass , + 1.345 + /- 0.533 kg ( P = 0.02 compared to no change ) ; change in fat-free mass , + 1.364 + /- 0.525 kg ( P = 0.02 compared to no change ) ] , but did not change in the placebo group [ change in lean body mass , 0.189 + /- 0.470 kg ( P = NS compared to no change ) ; change in fat-free mass , 0.186 + /- 0.470 kg ( P = NS compared to no change ) ] . However , there was no significant difference between the 2 treatment groups in the change in lean body mass . The change in lean body mass during treatment was moderately correlated with the increment in serum testosterone levels ( r = 0.41 ; P = 0.02 ) . The testosterone-treated men experienced a greater decrease in fat mass than those receiving placebo patches ( P = 0.04 ) . There was no significant change in body weight in either treatment group . Changes in overall quality of life scores did not correlate with testosterone treatment ; however , in the subcategory of role limitation due to emotional problems , the men in the testosterone group improved an average of 43 points of a 0 - 100 possible score , whereas those in the placebo group did not change . Red cell count increased in the testosterone group ( change in red cell count , + 0.1 + /- 0.1 10(12)/L ) but decreased in the placebo group ( change in red cell count , -0.2 + /- 0.1 10(12)/L ) . CD4 + and CD8 + T cell counts and plasma HIV copy number did not significantly change during treatment . Serum prostate-specific antigen and plasma lipid levels did not change in either treatment group . Testosterone replacement in HIV-infected men with low testosterone levels is safe and is associated with a 1.35-kg gain in lean body mass , a significantly greater reduction in fat mass than that achieved with placebo treatment , an increased red cell count , and an improvement in role limitation due to emotional problems . Further studies are needed to assess whether testosterone supplementation can produce clinical ly meaningful changes in muscle function and disease outcome in HIV-infected men",
"As men age , their serum testosterone concentrations decrease , as do their bone densities . Because bone density is also low in hypogonadal men , we hypothesized that increasing the serum testosterone concentrations of men over 65 yr to those found in young men would increase their bone densities . We r and omized 108 men over 65 yr of age to wear either a testosterone patch or a placebo patch double blindly for 36 months . We measured bone mineral density by dual energy x-ray absorptiometry before and during treatment . Ninety-six men completed the entire 36-month protocol . The mean serum testosterone concentration in the men treated with testosterone increased from 367 + /- 79 ng/dL ( + /-SD ; 12.7 + /- 2.7 nmol/L ) before treatment to 625 + /- 249 ng/dL ( 21.7 + /- 8.6 nmol/L ; P mean bone mineral density of the lumbar spine increased ( P placebo-treated ( 2.5 + /- 0.6 % ) and testosterone-treated ( 4.2 + /- 0.8 % ) groups , but the mean changes did not differ between the groups . Linear regression analysis , however , demonstrated that the lower the pretreatment serum testosterone concentration , the greater the effect of testosterone treatment on lumbar spine bone density from 0 - 36 months ( P = 0.02 ) . This analysis showed a minimal effect ( 0.9 + /- 1.0 % ) of testosterone treatment on bone mineral density for a pretreatment serum testosterone concentration of 400 ng/dL ( 13.9 nmol/L ) , but an increase of 5.9 + /- 2.2 % for a pretreatment testosterone concentration of 200 ng/dL ( 6.9 nmol/L ) . Increasing the serum testosterone concentrations of normal men over 65 yr of age to the midnormal range for young men did not increase lumbar spine bone density overall , but did increase it in those men with low pretreatment serum testosterone concentrations",
"BACKGROUND Many men older than 50 years have bioavailable testosterone levels below the reference range for young adult men . The impact of the decreased and rogen levels on cognition and health perception has received little attention . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - 87 ) with bioavailable testosterone levels below 128 ng/dl ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( 2 - 2.5 mg patches/d ) or placebo patches for 1 year . All men received 500 mg supplemental calcium and 400 IU vitamin D. Outcome measures included sex hormones [ testosterone , bioavailable testosterone , sex hormone binding globulin ( SHBG ) , estradiol , and estrone ] , cognitive tests ( Digit Symbol , Digit Span , Trailmaking A and B ) , health perception ( Medical Outcome Survey Short-form 36 or SF-36 ) , lower extremity muscle strength and power , and calcium intake . RESULTS Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial . Bioavailable testosterone levels increased from 93 + /- 34 ( SD ) to 162 + /- 100 ng/dl ( p estradiol levels in either group , estrone levels increased in the testosterone group ( 28 + /- 7 to 32 + /- 9 pg/dl , p = .017 ) . Scores on the Digit Symbol test improved in both the testosterone and placebo groups . Scores on Trailmaking B improved in men treated with testosterone ( p Trailmaking B for the entire group were correlated with 12-month testosterone levels ( p = .016 ) . Scores for health perception measured by SF-36 did not change significantly , though scores of mental and general health declined in both groups during the 12-month intervention . Twelve-month bioavailable testosterone scores were directly correlated with scores for physical role ( p = .022 ) , vitality ( p = .036 ) , and the physical composite score ( p = .010 ) . CONCLUSIONS Transdermal testosterone treatment in men with low bioavailable testosterone levels does not impair and may improve cognitive function . Treatment did not improve health perception but this may have been due to the side effects of skin irritation suggested by similar reactions in both the testosterone and placebo groups",
"The interaction between testosterone and exogenous amino acids was studied in older men before and after 6 months of testosterone administration . Twelve healthy older male subjects were r and omly assigned in double-blind fashion to receive either testosterone enanthate [ T ; n = 7 ; 68 + /- 3 ( + /-SE ) yr ] or placebo ( n = 5 ; 67 + /- 3 yr ) for 6 months . Muscle protein kinetics were determined using stable isotope methodology , arterial-venous difference across leg muscle , and muscle biopsies . In addition , ubiquitin-proteasome activity was measured in muscle biopsies as an indicator of muscle protein breakdown . T improved fasting net protein balance , although it remained significantly negative . The improvement in net balance was due to a decrease in muscle protein breakdown , as protein synthesis was unchanged . Ubiquitin-proteasome activity was also decreased with T. Exogenous amino acids increased protein synthesis in both placebo and T groups , but to a lesser degree after 6 months of T treatment . These results indicate that prolonged T administration increases net protein balance in the fasted state , but no additive effect is demonstrated when combined with amino acid feedings . Taken together , however , these diverse stimulatory effects can increase lean body mass and muscle strength over time",
"Dysfunction of the muscles of ambulation contributes to exercise intolerance in chronic obstructive pulmonary disease ( COPD ) . Men with COPD have high prevalence of low testosterone levels , which may contribute to muscle weakness . We determined effects of testosterone supplementation ( 100 mg of testosterone enanthate injected weekly ) with or without resistance training ( 45 minutes three times weekly ) on body composition and muscle function in 47 men with COPD ( mean FEV(1 ) = 40 % predicted ) and low testosterone levels ( mean = 320 ng/dl ) . Subjects were r and omized to 10 weeks of placebo injections + no training , testosterone injections + no training , placebo injections + resistance training , or testosterone injections + resistance training . Testosterone injections yielded a mean increase of 271 ng/dl in the nadir serum testosterone concentration ( to the middle of the normal range for young men ) . The lean body mass ( by dual-energy X-ray absorptiometry ) increase averaged 2.3 kg with testosterone alone and 3.3 kg with combined testosterone and resistance training ( p Increase in one-repetition maximum leg press strength averaged 17.2 % with testosterone alone , 17.4 % with resistance training alone , and 26.8 % with testosterone + resistance training ( p tolerated with no abnormalities in safety measures . Further studies are required to determine long-term benefits of adding testosterone supplementation and resistance training to rehabilitative programs for carefully screened men with COPD and low testosterone levels",
"BACKGROUND Sex hormones are known to affect cholesterol levels and vascular tone in women . The effects of testosterone on cholesterol and vascular tone in men are less well understood . Low testosterone levels have been associated with higher cholesterol levels in epidemiologic studies , but testosterone replacement has result ed in variable changes in cholesterol levels . Similarly , clinical studies suggest that testosterone may be vasodilatory , but few studies have directly evaluated the effects of testosterone on vascular tone . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - 87 ) with bioavailable testosterone levels below 4.44 nmol/l ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( 2 - 2.5 mg patches/d ) or placebo patches for 1 year . Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial . RESULTS While total cholesterol , triglyceride , and low-density lipoprotein cholesterol levels did not significantly change during the year of therapy , high-density lipoprotein ( HDL ) levels ( p = .004 ) and , specifically , HDL(2 ) subfraction ( p = .02 ) decreased in men receiving testosterone supplementation . Vascular tone was measured by brachial artery reactivity in 36 men . Endothelium-dependent brachial artery reactivity did not change from baseline measurements in men receiving transdermal testosterone ( 0.3 + /- 6.7 % to 1.6 + /- 4.6 % ; p = .58 ) or in the placebo group ( 3.2 + /- 5.5 % to 0.7 + /- 5.5 % ; p = .23 ) . CONCLUSIONS Transdermal testosterone decreased HDL(2 ) cholesterol but did not affect vascular reactivity in men older than 65 years selected for low testosterone levels . No study to date has addressed the direct relationship between testosterone replacement and cardiovascular events",
"Testosterone ( T ) therapy in older men with low serum T levels increases lean body mass and decreases fat mass . These changes might improve physical performance and strength ; however , it has not been established whether T therapy improves functional outcome in older men . Moreover , concerns exist about the impact of T therapy on the prostate in older men . The administration of finasteride ( F ) , which partially blocks the conversion of T to the more potent and rogen , dihydrotestosterone , attenuates the impact of T replacement on prostate size and prostate-specific antigen . We hypothesized that T replacement in older , hypogonadal men would improve physical function and that the addition of F to this regimen would continue to provide the T-induced improvements in physical performance , strength , and body composition . Seventy men with low serum T ( , were r and omly assigned to receive one of three regimens for 36 months : 1 ) T enanthate , 200 mg i m every 2 wk , with placebo pills daily ( T-only ) ; 2 ) T enanthate , 200 mg every 2 wk , with 5 mg F daily ( T + F ) ; or 3 ) placebo injections and pills ( placebo ) . We obtained serial measurements of timed physical performance , grip strength , lower extremity strength , body composition ( by dual-energy x-ray absorptiometry ) , fasting cholesterol profiles , and hormones . Fifty men completed the 36-month protocol . After 36 months , T therapy significantly improved performance in a timed functional test when compared with baseline and placebo [ 4.3 + /- 1.6 % ( mean + /- sem , T-only ) and 3.8 + /- 1.0 % ( T + F ) vs. -5.6 + /- 1.9 % for placebo ( P h and grip strength compared with baseline and placebo ( P lean body mass [ 3.77 + /- 0.55 kg ( T-only ) and 3.64 + /- 0.56 kg ( T + F ) vs. -0.21 + /- 0.55 kg for placebo ( P decreased fat mass , and significantly decreased total cholesterol , low-density lipoprotein , and leptin , without affecting high-density lipoprotein , adiponectin , or fasting insulin levels . These results demonstrate that T therapy in older men with low serum T improves physical performance and strength over 36 months , when administered alone or when combined with F , and suggest that high serum levels of dihydrotestosterone are not essential for these beneficial effects of T in men",
"We investigated the effects of 6 mo of near-physiological testosterone administration to older men on skeletal muscle function and muscle protein metabolism . Twelve older men ( > or = 60 yr ) with serum total testosterone concentrations were r and omly assigned in double-blind manner to receive either placebo ( n = 5 ) or testosterone enanthate ( TE ; n = 7 ) injections . Weekly intramuscular injections were given for the 1st mo to establish increased blood testosterone concentrations at 1 mo and then changed to biweekly injections until the 6-mo time point . TE doses were adjusted to maintain nadir serum testosterone concentrations between 17 and 28 nmol/l . Lean body mass ( LBM ) , muscle volume , prostate size , and urinary flow were measured at baseline and at 6 mo . Protein expression of and rogen receptor ( AR ) and insulin-like growth factor I , along with muscle strength and muscle protein metabolism , were measured at baseline and at 1 and 6 mo of treatment . Hematological parameters were followed monthly throughout the study . Older men receiving testosterone increased total and leg LBM , muscle volume , and leg and arm muscle strength after 6 mo . LBM accretion result ed from an increase in muscle protein net balance , due to a decrease in muscle protein breakdown . TE treatment increased expression of AR protein at 1 mo , but expression returned to pre-TE treatment levels by 6 mo . IGF-I protein expression increased at 1 mo and remained increased throughout TE administration . We conclude that physiological and near-physiological increases of testosterone in older men will increase muscle protein anabolism and muscle strength",
"Dynamic hyperinflation contributes to exertional breathlessness and reduced exercise tolerance in chronic obstructive pulmonary disease ( COPD ) patients . This study examined whether oxygen supplementation results in a dose-dependent decrease in hyperinflation associated with functional and symptomatic improvement . Ten severe COPD patients without clinical ly significant oxygen ( O2 ) desaturation during exercise , and seven healthy subjects , performed five exercise tests at 75 % of maximally tolerated work rate . Inspired oxygen fraction ( FI , O2 ) was varied ( 0.21 , 0.3 , 0.5 , 0.75 and 1.0 ) among tests in a r and omized order . Ventilation ( V'E ) was measured , and end-inspiratory ( EILV ) and end-expiratory ( EELV ) lung volume changes were assessed from inspiratory capacity manoeuvres . In the patients , compared to room air , endurance time increased with FI , O2=0.3 ( mean+/-SEM 92+/-20 % ) and increased further with FI , O2=0.5 ( 157+/-30 % ) . At isotime , compared to room air , there were significant reductions in dyspnoea score , EELV , EILV , V'E and respiratory frequency ( fR ) with FI , O2=0.3 . Improved endurance time negatively correlated with change in EELV ( r=0.48 , p=0.002 ) and EILV ( r=0.43 , p=0.005 ) . The dyspnoea rating decrease correlated with fR decrease . In healthy subjects , smaller V'E and fR decreases were observed at FI , O2=0.5 , accompanied by more modestly increased endurance . Oxygen supplementation during exercise induced dose-dependent improvement in endurance and symptom perception in nonhypoxaemic chronic obstructive pulmonary disease patients , which may be partly related to decreased hyperinflation and slower breathing pattern . This effect is maximized at an inspired oxygen fraction of 0.5",
"BACKGROUND Athletes often take and rogenic steroids in an attempt to increase their strength . The efficacy of these substances for this purpose is unsubstantiated , however . METHODS We r and omly assigned 43 normal men to one of four groups : placebo with no exercise ; testosterone with no exercise ; placebo plus exercise ; and testosterone plus exercise . The men received injections of 600 mg of testosterone enanthate or placebo weekly for 10 weeks . The men in the exercise groups performed st and ardized weight-lifting exercises three times weekly . Before and after the treatment period , fat-free mass was determined by underwater weighing , muscle size was measured by magnetic resonance imaging , and the strength of the arms and legs was assessed by bench-press and squatting exercises , respectively . RESULTS Among the men in the no-exercise groups , those given testosterone had greater increases than those given placebo in muscle size in their arms ( mean [ + /-SE ] change in triceps area , 424 + /- 104 vs. -81 + /- 109 square millimeters ; P legs ( change in quadriceps area , 607 + /- 123 vs. -131 + /- 111 square millimeters ; P increases in strength in the bench-press ( 9 + /- 4 vs. -1 + /- 1 kg , P squatting exercises ( 16 + /- 4 vs. 3 + /- 1 kg , P exercise had greater increases in fat-free mass ( 6.1 + /- 0.6 kg ) and muscle size ( triceps area , 501 + /- 104 square millimeters ; quadriceps area , 1174 + /- 91 square millimeters ) than those assigned to either no-exercise group , and greater increases in muscle strength ( bench-press strength , 22 + /- 2 kg ; squatting-exercise capacity , 38 + /- 4 kg ) than either no-exercise group . Neither mood nor behavior was altered in any group . CONCLUSIONS Supraphysiologic doses of testosterone , especially when combined with strength training , increase fat-free mass and muscle size and strength in normal men",
"objectives We have recently shown that , in men with erectile dysfunction ( ED ) , free testosterone ( FT ) directly correlates with penile arterial inflow . This led us to further investigate the effect(s ) of and rogen administration on cavernous arteries in patients failing sildenafil treatment",
"Testosterone ( T ) therapy for hypogonadal men should correct the clinical abnormalities of T deficiency , including improvement of sexual function , increase in muscle mass and strength , and decrease in fat mass , with minimal adverse effects . We have shown that administration of a new transdermal T gel formulation to hypogonadal men provided dose proportional increases in serum T levels to the normal adult male range . We now report the effects of 180 days of treatment with this 1 % T gel preparation ( 50 or 100 mg/day , contained in 5 or 10 g gel , respectively ) compared to those of a permeation-enhanced T patch ( 5 mg/day ) on defined efficacy parameters in 227 hypogonadal men . In the T gel groups , the T dose was adjusted up or down to 75 mg/day ( contained in 7.5 g gel ) on day 90 if serum T concentrations were below or above the normal male range . No dose adjustment was made with the T patch group . Sexual function and mood changes were monitored by question naire , body composition was determined by dual energy x-ray absorptiometry , and muscle strength was measured by the one repetitive maximum technique on bench and leg press exercises . Sexual function and mood improved maximally on day 30 of treatment , without differences across groups , and showed no further improvement with continuation of treatment . Mean muscle strength in the leg press exercise increased by 11 to 13 kg in all treatment groups by 90 days and did not improve further at 180 days of treatment . Moderate increases were also observed in arm/chest muscle strength . At 90 days of treatment , lean body mass increased more in the 100 mg/day T gel group ( 2.74 + /- 0.28 kg ; P = 0.0002 ) than in the 50 mg/day T gel ( 1.28 + /- 0.32 kg ) and T patch groups ( 1.20 + /- 0.26 kg ) . Fat mass and percent fat were not significantly decreased in the T patch group , but showed decreases in the T gel groups ( 50 mg/day , -0.90 + /- 0.32 kg ; 100 mg/day , - 1.05 + /- 0.22 kg ) . The increase in lean mass and the decrease in fat mass were correlated with the changes in average serum T levels attained after transdermal T replacement . These beneficial effects of T replacement were accompanied by the anticipated increases in hematocrit and hemoglobin but without significant changes in the lipid profile . The increase in mean serum prostate-specific antigen levels ( within the normal range ) was correlated with serum levels of T. The greatest increases were noted in the 100 mg/day T gel group . Skin irritation was reported in 5.5 % of subjects treated with T gel and in 66 % of subjects in the permeation-enhanced T patch group . We conclude that T gel replacement improved sexual function and mood , increased lean mass and muscle strength ( principally in the legs ) , and decreased fat mass in hypogonadal men with less skin irritation and discontinuation compared with the recommended dose of the permeation-enhanced T patch ",
"BACKGROUND AND METHODS In order to assess the effects of testosterone undecanoate ( TU ; 120 mg/d orally for 2 months ) on serum lipid , lipoprotein , and apolipoprotein levels in healthy elderly men , the placebo ( PL ) controlled study was performed on 37 elderly men , aged between 53 and 89 years . In all subjects venous blood sample s were taken after an overnight ( 10 hours ) fast and sera were stored -70 degrees C until analysis . RESULTS In PL group , neither hormonal data nor lipid , lipoprotein , and apolipoprotein levels showed significant changes . After TU supplementation , serum total cholesterol ( TC ) , low-density lipoprotein cholesterol ( LDL-C ) , and estradiol ( E2 ) levels decreased from 198 + /- 30.7 mg/dl to 174 + /- 41.9 mg/dl ( p serum triglyceride ( TG ) , high-density lipoprotein cholesterol ( HDL-C ) , and apolipoprotein ( apo ) A-1 and apo B levels after TU treatment . The mean ratios TC/HDL-C and LDL-C/HDL-C as coronary risk factor criteria decreased significantly in the TU but not in the PL group . No obvious side effect was observed in those who took TU except for reported pyrosis in 2 of 17 elderly men . CONCLUSIONS These data indicate that the increased serum levels of total testosterone ( TT ) produced by administration of TU , 120 mg/d orally for 2 months lead to suppressed levels of TC and LDL-C and E2 but not significantly changed levels of TC , HDL-C , apo A-1 and apo B. Thus , we conclude that TU may be an effective drug for protecting coronary heart disease in healthy elderly men with lowered TT and FT levels . It may also have beneficial effects for sexual function and behavior",
"The AIDS wasting syndrome is characterized by loss of lean body mass out of proportion to weight [ 1 , 2 ] . The few effective treatments that have been identified are short-term pharmacologic agonists . Because loss of lean body mass is associated with decreased survival in men with the AIDS wasting syndrome [ 3 ] , development of therapeutic strategies to increase lean body mass is of critical importance . Half of all men with AIDS are hypogonadal [ 4 ] , and serum and rogen levels correlate with lean body mass among hypogonadal men with the AIDS wasting syndrome [ 5 ] . Previous studies in non-HIV-infected hypogonadal men show that and rogen administration has a significant anabolic effect on body composition [ 6 - 10 ] . We hypothesized that loss of the potent anabolic hormone testosterone in men with the AIDS wasting syndrome may contribute to the critical loss of lean body mass . Therefore , we investigated the effects of physiologic testosterone administration in men with the AIDS wasting syndrome . Methods Patients In 1995 and 1996 , 51 HIV-positive men ( 42 8 years of age ) were recruited from the multidisciplinary HIV practice at the Massachusetts General Hospital and from newspaper , television , and radio advertisements . Weight , testosterone levels , and medication history were determined at a screening assessment . To be included in the study , patients had to have decreased free testosterone levels , defined as less than 42 pmol/L at screening ( normal range for men 18 to 49 years of age , 42 to 121 pmol/L [ 12.0 to 35.0 pg/mL ] ) , and wasting , defined as weight less than 90 % of ideal body weight or involuntary weight loss greater than 10 % of baseline weight [ 11 ] . The CD4 count was not an inclusion criterion . We excluded patients with severe diarrhea ( > 6 stools/d ) ; hemoglobin value less than 5.0 mmol/L ( 2 mg/dL ) ; new opportunistic infection within 6 weeks of screening ; use of testosterone , anabolic steroids , growth hormone , ketoconazole , or systemic steroid therapy within 3 months before screening ; or history of prostate cancer . In addition , patients receiving antiretroviral agents , including protease inhibitors , were required to be receiving a stable regimen for at least 6 weeks before study entry . Ten patients were receiving long-term , stable therapy with megestrol acetate for at least 8 weeks before study entry and were equally distributed between the two treatment groups ( 5 in the testosterone group and 5 in the placebo group ) . All patients gave written consent , and the study was approved by the Human Studies Committee of the Massachusetts General Hospital . Protocol Patients were r and omly assigned to receive testosterone enanthate , 300 mg ( Bio-Technology General Corp. , Iselin , New Jersey ) , or placebo intramuscularly every 3 weeks by self-injection . Participants were stratified for weight less than or greater than 90 % of ideal body weight and megestrol acetate use before r and omization . R and omization was performed by the Massachusetts General Hospital Pharmacy by using a permuted block algorithm . The correspondence between patient code number and drug was generated by the study statistician ; this list was available to the hospital pharmacist but not to the investigators or patients . The placebo contained sesame oil with chlorobutanol as a preservative and matched testosterone enanthate in color and consistency . The study drug was bottled by the Massachusetts General Hospital Pharmacy in containers labeled with the study name , expiration date , and patient code . Before the first injection , participants returned within approximately 2 weeks of the screening visit for a 3-day baseline inpatient visit to the General Clinical Research Center at the Massachusetts General Hospital for hormonal , nutritional , immune function , and body composition analysis , which included assessment by dual-energy x-ray absorptiometry , bioimpedance analysis , potassium-4040 K ) isotope analysis , and measurement of urinary creatinine excretion . No patient experienced the onset of a new opportunistic infection , other complication , or substantial weight change between the screening and baseline visits . Patients were instructed on the proper technique for intramuscular injection ; those who were unable to self-administer the study drug received injections every 3 weeks from the nursing staff of the General Clinical Research Center . Patients returned for an outpatient visit at 3 months for assessment of weight and determination of total-body potassium content and for a 3-day inpatient visit at 6 months ; this visit was identical to the baseline evaluation . Patients also reported on response to therapy at the 6-month visit . Baseline data from 26 patients have been reported elsewhere [ 5 ] . Subsequent study visits were timed to correspond to the midpoint between study drug injections . Study drug compliance was confirmed by history , medication diaries , outpatient injection records , empty vial counts , and serum testosterone levels . History of medication use was assessed at each visit . The change in fat-free mass assessed by dual-energy x-ray absorptiometry was the primary clinical end point ; changes in weight , muscle mass , total body potassium content , and quality of life were secondary end points . Body Composition Analysis Body composition was determined by four methods : 1 ) dual-energy x-ray absorptiometry to assess fat and fat-free mass ( Hologic-2000 densitometer , Hologic , Inc. , Waltham , Massachusetts ; precision error , 3 % for fat and 1.5 % for fat-free mass [ 12 ] , 2 ) 40 K isotope analysis to assess total-body potassium content in a whole-body counter with sodium iodide detectors fixed above and below the patient at the xiphoid level ( Canberra Nuclear , Meriden , Connecticut ; precision error creatinine excretion averaged over 3 days ( during which the patient received a meat-free diet ) multiplied by a constant of 18 kg of muscle per gram of urinary creatinine and indexed for height to determine the percentage of predicted muscle mass [ 13 , 14 ] , and 4 ) bioimpedance analysis to determine total-body water content ( Bioelectrical Impedance Analyzer Model BIA-101 , RJL Systems , Clinton Turnpike , Michigan ; correlation with deuterium oxide equivalent to R = 0.99 [ 15 ] ) . Lean body mass was derived from total-body potassium content by using the Equation of Forbes and Lewis of 68.1 mEq of potassium per kg of lean body mass [ 16 ] . Nutritional Assessment Weight was measured on the first day of each visit after an overnight fast . The percentage of ideal body weight was calculated on the basis of st and ard height and weight tables [ 17 ] . Patients were instructed on completion of a 4-day food record , which was analyzed for total calorie , fat , protein , and carbohydrate content ( Minnesota Nutrition Data Systems , version 8A/2.6 , Minneapolis , Minnesota ) by the Clinical Research Center dietitian . Patients received an isocaloric , meat-free , protein-substituted diet 3 days before and during the inpatient assessment s at baseline and at 6 months , during which creatinine excretion and nitrogen balance were measured . Total urinary nitrogen excretion was measured by the Kjeldal technique from consecutive 24-hour collection s averaged over 3 days . Nonurinary nitrogen losses were assumed to be constant at 4 g/d [ 13 , 18 , 19 ] . Nitrogen intake was derived from total protein intake divided by a constant of 6.25 g of protein per g of nitrogen [ 19 ] . Calorie and protein intake were monitored on a daily basis and were modified to match the reports in the outpatient food records immediately before these visits . Resting energy expenditure was measured by indirect calorimetry with a metabolic cart . Energy requirements were calculated by using the Harris-Benedict equation [ 20 ] . Patient Reports of Response to Therapy Each patient 's perceived well-being was assessed at the end of the study by using nine linear analogue-scale questions on the overall treatment effect , change in quality of life , personal appearance , weight , and appetite ( Table 1 ) [ 21 ] . A Karnofsky score was also determined at each visit . Table 1 . Assessment of Patient Response to Therapy * Exercise Functional Testing Exercise history was assessed by a st and ardized question naire adapted from the study by Kohl and coworkers [ 22 ] . Exercise functional status was determined at the baseline and final visits by the physical therapy department of the Massachusetts General Hospital by using the 6-minute walk test , the timed sit-to-st and test , and the timed get-up- and -go test [ 23 - 25 ] . The distance covered in 6 minutes , the number of times the patient was able to move from a sitting to st and ing position in 10 seconds , and the time to cover a distance of 3 meters after st and ing from a seated position was recorded for each patient . Biochemical and Immunologic Assays Hematocrit and serum levels of follicle-stimulating hormone , luteinizing hormone , sex hormone-binding globulin , and prolactin were measured at the baseline and final visits by using published methods [ 26 ] . Serum levels of total and free testosterone were measured by radioimmunoassay kit ( Diagnostics Products Corp. , Los Angeles , California ) with intra-assay coefficients of variation of 5 % to 12 % for total testosterone and 3.2 % to 4.3 % for free testosterone . CD4 cell counts were measured by flow cytometry ( Becton Dickinson Immunocytochemistry Systems , San Jose , California ) . Viral burden was determined by using the Amplicor HIV-1 monitor test ( Roche Molecular Systems , Branchburg , New Jersey ) . Statistical Analysis Sample size was based on the change in lean body mass in response to testosterone administration among adult men with acquired hypogonadism [ 8 ] . A change of 3.2 % 4.0 % was expected over 6 months . With 20 patients in each group , the study had an 80 % chance of seeing an effect of testosterone at a",
"The present study examined lifestyle and behavioral correlates of the change in total testosterone over 13 years in 66 men aged 41 - 61 years who were former participants of the Multiple Risk Factor Intervention Trial ( MRFIT ) at the Pittsburgh , Pennsylvania , center . The authors also determined in these men if changes in total testosterone are related to changes in cardiovascular disease risk factors . The mean total testosterone level was 751 ( st and ard deviation , 248 ) ng/dl at baseline and decreased by 41 ( st and ard deviation , 314 ) ng/dl during follow-up . The correlation between measures was r = 0.44 ( p MRFIT special intervention group were associated with larger decreases in total testosterone . Age , body weight , weight change , leisure time activity level , and alcohol intake were not related to the change in total testosterone . The decrease in endogenous testosterone was associated with an increase in triglycerides and a decrease in high density lipoprotein cholesterol in multivariate analysis controlling for obesity and other lifestyle covariates . There was little relation between change in testosterone and change in total and low density lipoprotein cholesterol or blood pressure . This longitudinal study confirms a gradual decline in total testosterone levels with advancing age in older men and provides evidence that lifestyle and psychosocial factors are related to this decline . Decreases in endogenous testosterone levels with age in men are associated with potentially unfavorable changes in triglycerides and high density lipoprotein cholesterol",
"Stanozolol , an oral 17 alpha-alkylated and rogen , increases hepatic triglyceride lipase activity ( HTGLA ) and decreases high-density lipoprotein cholesterol ( HDL-C ) levels , whereas intramuscular testosterone has comparatively little effect . In the present study , we tested the hypothesis that aromatization of and rogen to estrogen blunts the lipid and lipase effects of exogenous testosterone . Fourteen male weightlifters received testosterone enanthate ( 200 mg/wk intramuscularly ) , the aromatase inhibitor testolactone ( 250 mg four times per day ) , or both drugs together in a r and omized cross-over design . Serum testosterone level increased during all three drug treatments , whereas estradiol level increased only with testosterone alone ( + 47 % , P Testosterone decreased HDL-C(-16 % , P HDL2-C(-23 % , NS ) , and apoprotein ( apo ) A-I ( -12 % , P testosterone and testolactone administration ( HDL-C , -20 % ; HDL2-C , -30 % ; apo A-I , -15 % ; P HDL3-C levels by 13 % ( P HTGLA increased 21 % during testosterone treatment and 38 % during combined testosterone and testolactone treatment ( P Lipoprotein lipase activity ( LPLA ) increased only during combined testosterone and testolactone treatment ( + 31 % , P < .01 ) , suggesting that estrogen production may counteract the effects of testosterone on LPLA . Testolactone alone had little effect on any lipid , lipoprotein , apoprotein , or lipase concentration . ( ABSTRACT TRUNCATED AT 250 WORDS",
"In a single-blind , placebo-controlled study , the effects of a 3-month oral administration of 160 mg/day testosterone undecanoate ( And riol ® ) on the quality of life of men with testosterone deficiency were evaluated . The subjects included ten men with primary hypogonadism and 29 with and ropause with sexual dysfunction as the most common problem . The changes in subjective symptoms were evaluated by the PNUH QoL scoring system and the St. Louis University Question naire for and rogen deficiency in aging males ( ADAM ) . Digital rectal examination ( DRE ) was performed and serum testosterone , prostate-specific antigen ( PSA ) and liver profile were monitored . Testosterone undecanoate treatment ( n = 33 ) significantly improved sexual dysfunction and symptom scores of metabolic , cardiopulmonary , musculo-skeletal and gastrointestinal functions compared to baseline and to placebo ( n = 6 ) . ADAM score also significantly improved after 3 months of treatment . Serum testosterone was significantly increased compared to pretreatment levels only in the testosterone undecanoate group . In the placebo group , no significant changes compared to baseline were found for testosterone levels and QoL question naires . No abnormal findings were detected on DRE or laboratory findings in either group . Adverse events , such as gastrointestinal problems and fatigue , were mild and self-limiting . It is concluded that and rogen supplement therapy with oral testosterone undecanoate ( And riol ) restores the quality of life through improvement of general body functions in men with testosterone deficiency",
"As men age , serum testosterone concentrations decrease , the percentage of body mass that is fat increases , the percentage of lean body mass decreases , and muscle strength decreases . Because these changes are similar to those that occur in hypogonadal men , we hypothesized that increasing the serum testosterone concentration of men over 65 yr of age to that in young men would decrease their fat mass , increase their lean mass , and increase their muscle strength . We r and omized 108 men over 65 yr of age to wear either a testosterone patch or a placebo patch in a double blind study for 36 months . We measured body composition by dual energy x-ray absorptiometry and muscle strength by dynamometer before and during treatment . Ninety-six men completed the entire 36-month protocol . Fat mass decreased ( -3.0+/-0.5 kg ) in the testosterone-treated men during the 36 months of treatment , which was significantly different ( P = 0.001 ) from the decrease ( -0.7+/-0.5 kg ) in the placebo-treated men . Lean mass increased ( 1.9+/-0.3 kg ) in the testosterone-treated men , which was significantly different ( P decrease in fat mass in the testosterone-treated men was principally in the arms ( -0.7+/-0.1 kg ; P lean mass was principally in the trunk ( 1.9+/-0.3 kg ; P strength of knee extension and flexion at 60 degrees and 180 degrees angular velocity during treatment , however , was not significantly different between the two groups . We conclude that increasing the serum testosterone concentrations of normal men over 65 yr of age to the midnormal range for young men decreased fat mass , principally in the arms and legs , and increased lean mass , principally in the trunk , but did not increase the strength of knee extension and flexion , as measured by dynamometer",
"A decline in testicular function is recognized as a common occurrence in older men . However data are sparse regarding the effects of hypogonadism on age-associated physical and cognitive declines . This study was undertaken to examine the year-long effects of testosterone administration in this patient population . Fifteen hypogonadal men ( mean age 68 + /- 6 yr ) were r and omly assigned to receive a placebo , and 17 hypogonadal men ( mean age 65 + /- 7 yr ) were r and omly assigned to receive testosterone . Hypogonadism was defined as a bioavailable testosterone placebo or 200 mg testosterone cypionate biweekly for 12 months . The main outcomes measured included grip strength , hemoglobin , prostate-specific antigen , leptin , and memory . Testosterone improved bilateral grip strength ( P hemoglobin ( P testosterone had greater decreases in leptin than those assigned to the control group ( mean + /- SEM : -2.0 + /- 0.9 ng/dL vs. 0.8 + /- 0.7 ng/dL ; P prostate-specific antigen or memory . Three subjects receiving placebo and seven subjects receiving testosterone withdrew from the study . Three of those seven withdrew because of an abnormal elevation in hematocrit . Testosterone supplementation improved strength , increased hemoglobin , and lowered leptin levels in older hypogonadal men . Testosterone may have a role in the treatment of frailty in males with hypogonadism ; however , older men receiving testosterone must be carefully monitored because of its potential risks",
"Muscle wasting in older men may be related to and rogen deficiency . We have assessed the effect of testosterone replacement therapy on muscle function in the upper and lower limbs of older ( age > 60 years ) men with blood testosterone levels received testosterone enanthate 200 mg i.m . or placebo every 2 weeks in a double blind study over a 12-week period and underwent muscle testing every 4 weeks . A significant increase in blood levels of testosterone and a reduction in levels of sex hormone binding globulin occurred in the treatment group . Total body mass , haemoglobin and packed cell volume also increased significantly ( p h and grip strength , isometric strength of knee flexors and extensors or leg extensor power were seen in either group . Wide variability in all measures of muscle function were observed in these elderly men suggesting that very large study groups would be required to determine potential treatment benefits on muscle function",
"Transdermal testosterone ( T ) delivery represents an effective alternative to injectable and rogens . We studied 163 hypogonadal men who applied 5 , 7.5 , or 10 g And roGel ( T gel ) 1 % CIII per day for up to 42 months . Efficacy data were presented in 123 subjects considered evaluable . Continuous And roGel treatment normalized mean serum T and free T levels . Mean serum 5alpha-dihydrotestosterone concentrations and 5alpha-dihydrotestosterone/T ratio slightly increased , mean serum estradiol/T ratio doubled , and mean serum FSH and LH levels were suppressed by T replacement . Sexual function and mood parameters improved rapidly and were maintained throughout T treatment . Lean body mass increased ( P = 0.0001 ) and fat mass decreased ( P = 0.0001 ) , and these changes were maintained with treatment but were not accompanied by significant increases in muscle strength . Increases in serum bone markers suggestive of increased bone formation were followed by gradual and progressive increases in bone mineral density more in the spine ( P = 0.0001 ) than the hip ( P = 0.0004 ) . Mild local skin irritation occurred in 12 subjects , result ing in discontinuation in only one subject . Except for the anticipated increase in hematocrit and hemoglobin , there were no clinical ly significant changes in blood counts or biochemistry . In three subjects with elevated serum prostate-specific antigen , prostate biopsies showed cancer . We conclude that continued application of And roGel result ed in beneficial effects similar to those with injectables and other transdermal preparations . This study was neither placebo controlled nor powered to determine the effects of T treatment on prostate cancer risk . Thus , monitoring for prostatic disease and assessment for erythrocytosis are strongly advised to reduce the risk of adverse events with T treatment of hypogonadal men",
"PURPOSE Because the effects of and rogen replacement on lipoprotein levels are uncertain , we sought to determine the effect of transdermal testosterone treatment on serum lipid and apolipoprotein levels in elderly men . SUBJECTS AND METHODS One hundred and eight healthy men more than 65 years of age who had serum testosterone concentrations > 1 SD below the mean for young men were r and omly assigned to receive either testosterone ( 54 men ; 6 mg/day ) or placebo ( 54 men ) transdermally in a double-blind fashion for 36 months . Serum concentrations of lipids and apolipoproteins were measured , and cardiovascular events recorded . RESULTS Serum total cholesterol concentrations decreased in both the testosterone-treated men and placebo-treated men , but the 3-year mean ( + /- SD ) decreases in the two groups ( testosterone treated , -17 + /- 29 mg/dL ; placebo treated , -12 + /- 38 mg/dL ) were not significantly different from each other ( P = 0.4 ) . Similarly , serum low-density lipoprotein ( LDL ) cholesterol levels decreased in both treatment groups , but the decreases in the two groups ( testosterone treated , -16 + /- 24 mg/dL ; placebo treated , -16 + /- 33 mg/dL ) were similar ( P = 1.0 ) . Levels of high-density lipoprotein ( HDL ) cholesterol , triglycerides , and apolipoproteins A-I and B did not change . Lipoprotein(a ) levels increased in both groups by similar amounts ( testosterone treated , 3 + /- 9 mg/dL ; placebo treated , 4 + /- 6 mg/dL ; P = 1.0 ) . The number of cardiovascular events was small and did not differ significantly between the testosterone-treated men ( 9 events ) and the placebo-treated men ( 5 events ) during the 3-year study ( relative risk = 1.8 ; 95 % confidence interval : 0.7 to 5.0 ) . CONCLUSIONS As compared with placebo , transdermal testosterone treatment of healthy elderly men for 3 years did not affect any of the lipid or apolipoprotein parameters that we measured . The effect of testosterone treatment on cardiovascular events was unclear , because the number of events was small",
"Treatment of hypogonadal men with testosterone has been shown to ameliorate the effects of testosterone deficiency on bone , muscle , erythropoiesis , and the prostate . Most previous studies , however , have employed somewhat pharmacological doses of testosterone esters , which could result in exaggerated effects , and /or have been of relatively short duration or employed previously treated men , which could result in dampened effects . The goal of this study was to determine the magnitude and time course of the effects of physiological testosterone replacement for 3 yr on bone density , muscle mass and strength , erythropoiesis , prostate volume , energy , sexual function , and lipids in previously untreated hypogonadal men . We selected 18 men who were hypogonadal ( mean serum testosterone + /- SD , 78 + /- 77 ng/dL ; 2.7 + /- 2.7 nmol/L ) due to organic disease and had never previously been treated for hypogonadism . We treated them with testosterone transdermally for 3 yr . Sixteen men completed 12 months of the protocol , and 14 men completed 36 months . The mean serum testosterone concentration reached the normal range by 3 months of treatment and remained there for the duration of treatment . Bone mineral density of the lumbar spine ( L2-L4 ) increased by 7.7 + /- 7.6 % ( P femoral trochanter increased by 4.0 + /- 5.4 % ( P = 0.02 ) ; both reached maximum values by 24 months . Fat-free mass increased 3.1 kg ( P = 0.004 ) , and fat-free mass of the arms and legs individually increased , principally within the first 6 months . The decrease in fat mass was not statistically significant . Strength of knee flexion and extension did not change . Hematocrit increased dramatically , from mildly anemic ( 38.0 + /- 3.0 % ) to midnormal ( 43.1 + /- 4.0 % ; P = 0.002 ) within 3 months , and remained at that level for the duration of treatment . Prostate volume also increased dramatically , from subnormal ( 12.0 + /- 6.0 mL ) before treatment to normal ( 22.4 + /- 8.4 mL ; P = 0.004 ) , principally during the first 6 months . Self-reported sense of energy ( 49 + /- 19 % to 66 + /- 24 % ; P = 0.01 ) and sexual function ( 24 + /- 20 % to 66 + /- 24 % ; P Lipids did not change . We conclude from this study that replacing testosterone in hypogonadal men increases bone mineral density of the spine and hip , fat-free mass , prostate volume , erythropoiesis , energy , and sexual function . The full effect of testosterone on bone mineral density took 24 months , but the full effects on the other tissues took only 3 - 6 months . These results provide the basis for monitoring the magnitude and the time course of the effects of testosterone replacement in hypogonadal men",
"BACKGROUND Loss of muscle mass ( sarcopenia ) leads to frailty in older men . The decline in testosterone over the life span may contribute to this muscle loss . We studied the ability of oral testosterone to prevent muscle loss in older men over a 12-month period . METHODS A st and ard dose ( 80 mg twice daily ) of testosterone undecanoate or placebo was administered for 1 year to 76 healthy men aged 60 years or older . All men had a free testosterone index of 0.3 - 0.5 , which represents a value below the normal lower limit for young men ( 19 - 30 years ) , but remains within the overall normal male range . Measurements of body composition , muscle strength , hormones , and safety parameters were obtained at 0 , 6 , and 12 months . RESULTS Lean body mass increased ( p = .0001 ) and fat mass decreased ( p = .02 ) in the testosterone as compared with the placebo-treated group . There were no significant effects on muscle strength . There was a significant increase in hematocrit ( 0.02 % ) in the testosterone-treated group ( p = .03 ) . Plasma triglycerides , total cholesterol , and low-density lipoprotein cholesterol levels were similar in both groups , but there was a decrease in high-density lipoprotein cholesterol ( -0.1 mmol/L ) at 12 months in the testosterone group as compared to the placebo group ( p = 0.026 ) . There were no differences in prostate-specific antigen or systolic or diastolic blood pressure between the groups . CONCLUSION Oral testosterone administration to older relatively hypogonadal men results in an increase in muscle mass and a decrease in body fat",
"Several r and omized trials of and rogen supplementation in older men have been undertaken . However , the relative contributions of testosterone ( T ) and estrogens on bone metabolism in aging men are controversial . Within the setting of two double-blind , placebo-controlled studies , we evaluated the effect of dihydrotestosterone ( DHT ) and recombinant human chorionic gonadotropin ( rhCG ) on bone turnover in healthy , community-dwelling older men with partial and rogen deficiency ( total T In the first study , 35 men ( age 68.3 + /- 6.8 yr ; baseline T , 13.9 + /- 3.3 nmol/liter ) were r and omized to receive either daily transdermal DHT ( n = 17 ) or placebo for 3 months . In the second study , 40 men ( age 67.4 + /- 5.4 yr ; baseline T , 11.4 + /- 2.2 nmol/liter ) were r and omized to receive either rhCG s.c . ( n = 20 ) , two injections weekly , or placebo for 3 months . The following parameters were measured before , monthly during , and 1 month after treatment : serum T , estradiol ( E2 ) , and LH ; markers of bone formation , serum amino-terminal propeptide of type I procollagen ( S-PINP ) and osteocalcin ; markers of bone resorption , serum carboxyterminal cross-linked telopeptide of type I collagen and urinary deoxypyridinoline . Compared with placebo , treatment with DHT significantly increased serum DHT and suppressed LH and T levels , whereas E2 concentrations and markers of bone turnover did not change . In contrast , rhCG therapy significantly increased both T and E2 , with the increases in E2 being supraphysiological . At the same time , rhCG significantly increased S-PINP concentrations with peak levels after 1 month ( Delta40 % ; P = 0.02 compared with placebo ) . In contrast , serum osteocalcin and carboxyterminal cross-linked telopeptide of type I collagen and urinary deoxypyridinoline levels did not change . The change in S-PINP levels correlated with the change in E2 levels ( r = 0.59 ; P = 0.02 ) but not with a change in T. We conclude that in older men with partial age-related and rogen deficiency , rhCG treatment stimulates osteoblastic collagen formation proportionally to increased E2 concentrations but does not alter markers of mature osteoblastic function or bone resorption . In contrast , treatment with a pure , nonaromatizable and rogen ( DHT ) has no effect on bone turnover despite a 20-fold increase in serum levels . Bone resorption was not accelerated during unchanged ( DHT ) or increased ( rhCG ) E2 levels , suggesting that minimal E2 levels are needed to maintain stable resorption , although direct and rogen receptor-mediated effects can not be excluded . If and rogen supplementation is required for aging men , aromatizable and rogens with sufficient endogenous estrogenic activity may have the most beneficial effects on bone",
"And rogen therapy may precipitate obstructive sleep apnea in men . Despite increasing and rogen use in older men , few studies have examined sleep and breathing . R and omized , double-blind , placebo-controlled studies examining effects of testosterone simultaneously on sleep , breathing , and function in older men are not available . Seventeen community-dwelling healthy men over the age of 60 yr were r and omized to receive three injections of i m testosterone esters at weekly intervals ( 500 mg , 250 mg , and 250 mg ) or matching oil-based placebo and then crossed over to the other treatment after 8 wk of washout . Polysomnography , anthropometry , and physical , mental , and metabolic function were assessed at baseline and after each treatment period . Testosterone treatment reduced total time slept ( approximately 1 h ) , increased the duration of hypoxemia ( approximately 5 min/night ) , and disrupted breathing during sleep ( total and non-rapid eye movement respiratory disturbance indices both increased by approximately seven events per hour ) ( all P body composition ( increase in total and lean mass , reduction in fat mass , P bioimpedance method ) , upper airway dimensions did not change ( acoustic reflectometry ) . Driving ability ( computer simulation ) , physical activity ( accelerometry , Physical Activity Scale in the Elderly ) , quality of life ( SF36 , Functional Outcomes of Sleep Question naire ) , mood ( Profile of Mood States Question naire ) , sleepiness ( Epworth , Stanford scales ) , and insulin resistance ( homeostasis model ) also were not changed by treatment . Short-term administration of high-dose testosterone shortens sleep and worsens sleep apnea in older men but did not alter physical , mental , or metabolic function . These changes did not appear to be due to upper airway narrowing . Further study of longer-term lower-dose and rogen therapy on sleep and breathing is needed to evaluate its safety in older men",
"CONTEXT Hormone administration to elderly individuals can increase lean body mass ( LBM ) and decrease fat , but interactive effects of growth hormone ( GH ) and sex steroids and their influence on strength and endurance are unknown . OBJECTIVE To evaluate the effects of recombinant human GH and /or sex steroids on body composition , strength , endurance , and adverse outcomes in aged persons . DESIGN , SETTING , AND PARTICIPANTS A 26-week r and omized , double-blind , placebo-controlled parallel-group trial in healthy , ambulatory , community-dwelling US women ( n = 57 ) and men ( n = 74 ) aged 65 to 88 years recruited between June 1992 and July 1998 . INTERVENTIONS Participants were r and omized to receive GH ( starting dose , 30 micro g/kg , reduced to 20 micro g/kg , subcutaneously 3 times/wk ) + sex steroids ( women : transdermal estradiol , 100 micro g/d , plus oral medroxyprogesterone acetate , 10 mg/d , during the last 10 days of each 28-day cycle [ HRT ] ; men : testosterone enanthate , biweekly intramuscular injections of 100 mg ) ( n = 35 ) ; GH + placebo sex steroid ( n = 30 ) ; sex steroid + placebo GH ( n = 35 ) ; or placebo GH + placebo sex steroid ( n = 31 ) in a 2 x 2 factorial design . MAIN OUTCOME MEASURES Lean body mass , fat mass , muscle strength , maximum oxygen uptake ( VO(2)max ) during treadmill test , and adverse effects . RESULTS In women , LBM increased by 0.4 kg with placebo , 1.2 kg with HRT ( P = .09 ) , 1.0 kg with GH ( P = .001 ) , and 2.1 kg with GH + HRT ( P Fat mass decreased significantly in the GH and GH + HRT groups . In men , LBM increased by 0.1 kg with placebo , 1.4 kg with testosterone ( P = .06 ) , 3.1 kg with GH ( P Fat mass decreased significantly with GH and GH + testosterone . Women 's strength decreased in the placebo group and increased nonsignificantly with HRT ( P = .09 ) , GH ( P = .29 ) , and GH + HRT ( P = .14 ) . Men 's strength also did not increase significantly except for a marginally significant increase of 13.5 kg with GH + testosterone ( P = .05 ) . Women 's VO(2)max declined by 0.4 mL/min/kg in the placebo and HRT groups but increased with GH ( P = .07 ) and GH + HRT ( P = .06 ) . Men 's VO(2)max declined by 1.2 mL/min/kg with placebo and by 0.4 mL/min/kg with testosterone ( P = .49 ) but increased with GH ( P = .11 ) and with GH + testosterone ( P strength ( r = 0.355 ; P VO(2)max ( r = 0.320 ; P = .002 ) were directly related to changes in LBM . Edema was significantly more common in women taking GH ( 39 % vs 0 % ) and GH + HRT ( 38 % vs 0 % ) . Carpal tunnel symptoms were more common in men taking GH + testosterone ( 32 % vs 0 % ) and arthralgias were more common in men taking GH ( 41 % vs 0 % ) . Diabetes or glucose intolerance occurred in 18 GH-treated men vs 7 not receiving GH ( P = .006 ) . CONCLUSIONS In this study , GH with or without sex steroids in healthy , aged women and men increased LBM and decreased fat mass . Sex steroid + GH increased muscle strength marginally and VO ( 2)max in men , but women had no significant change in strength or cardiovascular endurance . Because adverse effects were frequent ( importantly , diabetes and glucose intolerance ) , GH interventions in the elderly should be confined to controlled studies",
"CONTEXT Previous studies of testosterone supplementation in HIV-infected men failed to demonstrate improvement in muscle strength . The effects of resistance exercise combined with testosterone supplementation in HIV-infected men are unknown . OBJECTIVE To determine the effects of testosterone replacement with and without resistance exercise on muscle strength and body composition in HIV-infected men with low testosterone levels and weight loss . DESIGN AND SETTING Placebo-controlled , double-blind , r and omized clinical trial conducted from September 1995 to July 1998 at a general clinical research center . PARTICIPANTS Sixty-one HIV-infected men aged 18 to 50 years with serum testosterone levels of less than 12.1 nmol/L ( 349 ng/dL ) and weight loss of 5 % or more in the previous 6 months , 49 of whom completed the study . INTERVENTIONS Participants were r and omly assigned to 1 of 4 groups : placebo , no exercise ( n = 14 ) ; testosterone enanthate ( 100 mg/wk intramuscularly ) , no exercise ( n = 17 ) ; placebo and exercise ( n = 15 ) ; or testosterone and exercise ( n = 15 ) . Treatment duration was 16 weeks . MAIN OUTCOME MEASURES Changes in muscle strength , body weight , thigh muscle volume , and lean body mass compared among the 4 treatment groups . RESULTS Body weight increased significantly by 2.6 kg ( P testosterone alone and by 2.2 kg ( P = .02 ) in men who exercised alone but did not change in men receiving placebo alone ( -0.5 kg ; P = .55 ) or testosterone and exercise ( 0.7 kg ; P = .08 ) . Men treated with testosterone alone , exercise alone , or both experienced significant increases in maximum voluntary muscle strength in leg press ( range , 22%-30 % ) , leg curls ( range , 18%-36 % ) , bench press ( range , 19%-33 % ) , and latissimus pulls ( range , 17%-33 % ) . Gains in strength in all exercise categories were greater in men assigned to the testosterone-exercise group or to the exercise-alone group than in those assigned to the placebo-alone group . There was a greater increase in thigh muscle volume in men receiving testosterone alone ( mean change , 40 cm3 ; P placebo alone ( 5 cm3 ; P = .70 ) . Average lean body mass increased by 2.3 kg ( P = .004 ) and 2.6 kg ( P testosterone alone or testosterone and exercise but did not change in men receiving placebo alone ( 0.9 kg ; P = .21 ) . Hemoglobin levels increased in men receiving testosterone but not in those receiving placebo . CONCLUSION Our data suggest that testosterone and resistance exercise promote gains in body weight , muscle mass , muscle strength , and lean body mass in HIV-infected men with weight loss and low testosterone levels . Testosterone and exercise together did not produce greater gains than either intervention alone",
"The efficacy and safety of and rogen supplementation in older men remains controversial . Despite biochemical evidence of partial and rogen deficiency in older men , controlled studies using T demonstrate equivocal benefits . Furthermore , the importance of aromatization and 5alpha reduction in and rogen actions among older men remains unclear . Dihydrotestosterone is the highest potency natural and rogen with the additional features that it is neither aromatizable nor susceptible to potency amplification by 5alpha reduction . Therefore , the effects of dihydrotestosterone may differ from those of T in older men . This study evaluated the efficacy and safety of 3 months treatment with transdermal dihydrotestosterone gel on muscle strength , mobility , and quality of life in ambulant , community-dwelling men aged 60 yr or older . Eligible men ( plasma T were r and omized to undergo daily dermal application of 70 mg dihydrotestosterone gel ( n = 18 ) or vehicle ( n = 19 ) and were studied before , monthly during , and 1 month after treatment . Among 33 ( 17 dihydrotestosterone , 16 placebo ) men completing the study with a high degree of compliance , dihydrotestosterone had significant effects on circulating hormones ( increased dihydrotestosterone ; decreased total and free testosterone , LH , and FSH ; unchanged SHBG and estradiol ) , lipid profiles ( decreased total and low-density lipoprotein cholesterols ; unchanged high-density lipoprotein cholesterol and triglycerides ) , hematopoiesis ( increased hemoglobin , hematocrit , and red cell counts ) , and body composition ( decreased skinfold thickness and fat mass ; unchanged lean mass and waist to hip ratio ) . Muscle strength measured by isokinetic peak torque was increased in flexion of the dominant knee but not in knee extension or shoulder contraction , nor was there any significant change in gait , balance , or mobility tests , in cognitive function , or in quality of life scales . Dihydrotestosterone treatment had no adverse effects on prostate ( unchanged prostate volumes and prostate-specific antigen ) and cardiovascular ( no adverse change in vascular reactivity or lipids ) safety markers . We conclude that 3 months treatment with transdermal dihydrotestosterone gel demonstrates expected and rogenic effects , short-term safety , and limited improvement in lower limb muscle strength but no change in physical functioning or cognitive function",
"CONTEXT Patients receiving dialysis commonly experience malnutrition , reduced muscle mass ( sarcopenia ) , and fatigue for which no effective treatment has been identified . Anabolic steroids are known to increase muscle mass and strength in healthy individuals , but their effect on the sarcopenia and fatigue associated with long-term dialysis has not been evaluated . OBJECTIVE To assess the effects of an anabolic steroid , n and rolone decanoate , on lean body mass ( LBM ) , functional status , and quality of life in dialysis patients . DESIGN R and omized , double-blind , placebo-controlled trial conducted between April 1996 and July 1997 . SETTING Hospital-based outpatient dialysis unit . PATIENTS Twenty-nine patients undergoing dialysis for at least 3 months . INTERVENTION N and rolone decanoate , 100 mg ( n = 14 ) , or placebo ( n = 15 ) by intramuscular injection once a week for 6 months . MAIN OUTCOME MEASURES Weight , LBM , fatigue , grip strength , walking and stair-climbing times , and treadmill performance after 3 and 6 months of treatment . RESULTS Lean body mass increased significantly in patients given n and rolone compared with patients given placebo ( mean change [ SD ] , + 4.5 [ 2.3 ] kg ; P LBM in the placebo group ( mean change [ SD ] , + 1.9 [ 1.6 ] kg ; P = .003 compared with baseline ; P = .005 compared with n and rolone group ) . Serum creatinine levels increased in the n and rolone group ( + 168 [ 203 ] mmol/L [ 1.9 [ 2.3 ] mg/dL ] ; P = .02 ) but not in the placebo group ( -4.0 [ 177 ] mmol/L [ 0.04 [ 2.0 ] mg/dL ] ; P = .95 ) , suggesting an increase in muscle mass . Time to complete the walking and stair-climbing test decreased from 36.5 to 32.7 seconds in the n and rolone group , while those in the placebo group increased from 38.7 to 42.1 seconds ( P = .05 ) . Peak oxygen consumption increased in the individuals in the n and rolone group who performed treadmill tests , but not to a statistically significant degree . Grip strength did not change in either group . CONCLUSIONS Treatment with n and rolone for 6 months result ed in a significant increase in LBM associated with functional improvement in patients undergoing dialysis"
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41170bae-06ff-11f0-808a-c43d1ab1c353
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QUESTION Can physical activity in adults aged 40 - 65 years enhance strength and balance and prevent falls ? DESIGN Systematic review with meta- analysis of r and omised clinical trials . PARTICIPANTS Healthy adults aged 40 - 65 years . INTERVENTION Programs that involved the performance of any physical activity in community setting s and workplaces . OUTCOME MEASURES Strength , balance , endurance , and falls rate . RESULTS Twenty-three eligible trials were identified and 17 of these were pooled in the meta-analyses . The meta- analysis of strength outcomes found a moderate effect of physical activity on strength ( SMD=0.54 , 95 % CI 0.38 to 0.70 ) . Larger effects were observed from programs that specifically targeted strength ( SMD=0.68 , 95 % CI 0.49 to 0.87 ) , when compared to those that did not ( SMD=0.32 , 95 % CI 0.09 to 0.55 ) . This difference was statistically significant ( effect of strength in meta-regression p=0.045 ) . Physical activity also had a moderate effect on both balance ( SMD=0.52 , 95 % CI 0.24 to 0.79 ) and endurance ( SMD=0.73 , 95 % CI 0.50 to 0.96 ) . No trials reported effects of physical activity on falls soon after receiving the intervention . A statistically non-significant effect on falls 15 years after receiving a physical activity intervention was found in one trial ( RR=0.82 , 95 % CI 0.53 to 1.26 ) . CONCLUSIONS This review found that muscle strength , balance , and endurance can be improved by physical activity in people aged 40 - 65 years . There were bigger effects on muscle strength from programs that used resistance exercises , indicating the need to include a resistance training component if strength enhancement is the goal
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"The effects of 12 wk of exercise training using weighted vests on bone turnover and isokinetic strength were evaluated in postmenopausal women r and omly assigned as exercisers ( EX ; n = 9 ) or controls ( CON ; n = 7 ) . Training included 3 multimodal exercise sessions per wk wearing weighted vests . The vest load was progressively increased each wk to a maximum of 15 % of body weight . Bone turnover was determined from resting levels of serum osteocalcin and NTx . Knee and ankle strength were measured at 60 degrees/s and 180 degrees/s using an isokinetic dynamometer . After 12 wk , NTx decreased by 14.5 % ( P no significant changes in osteocalcin . EX also showed a 40 % ( P improvement in ankle plantar-flexion strength at 60 degrees/s . Relative body fat significantly decreased and fat-free mass increased in EX . Exercise compliance was 80 % . These findings support the use of progressive exercise training using weighted vests in postmenopausal women",
"BACKGROUND Falls warrant investigation as a risk factor for nursing home admission because falls are common and are associated with functional disability and because they may be preventable . METHODS We conducted a prospect i ve study of a probability sample of 1103 people over 71 years of age who were living in the community . Data on demographic and medical characteristics , use of health care , and cognitive , functional , psychological , and social functioning were obtained at base line and one year later during assessment s in the participants ' homes . The primary outcome studied was the number of days from the initial assessment to a first long-term admission to a skilled-nursing facility during three years of follow-up . Patients were assigned to four categories during follow-up : those who had no falls , those who had one fall without serious injury , those who had two or more falls without serious injury , and those who had at least one fall causing serious injury . RESULTS A total of 133 participants ( 12.1 percent ) had long-term admissions to nursing homes . In an unadjusted model , the risk of admission increased progressively , as compared with that for the patients with no falls , for those with a single noninjurious fall ( relative risk , 4.9 ; 95 percent confidence interval , 3.2 to 7.5 ) , those with multiple noninjurious falls ( relative risk , 8.5 ; 95 percent confidence interval , 3.4 to 21.2 ) , and those with at least one fall causing serious injury ( relative risk , 19.9 ; 95 percent confidence interval , 12.2 to 32.6 ) . Adjustment for other risk factors lowered these ratios to 3.1 ( 95 percent confidence interval , 1.9 to 4.9 ) for one noninjurious fall , 5.5 ( 95 percent confidence interval , 2.1 to 14.2 ) for two or more noninjurious falls , and 10.2 ( 95 percent confidence interval , 5.8 to 17.9 ) for at least one fall causing serious injury , but the association between falls and admission to a nursing home remained strong and significant . The population attributable risk of long-term admission to a nursing home for these three groups ( the proportion of admissions directly attributable to the three categories of falls ) was 13 percent , 3 percent , and 10 percent , respectively . CONCLUSIONS Among older people living in the community falls are a strong predictor of placement in a skilled-nursing facility ; interventions that prevent falls and their sequelae may therefore delay or reduce the frequency of nursing home admissions",
"BACKGROUND It is important to determine if permanent lifestyle changes may result from physical activity interventions and whether health may be affected by these changes . OBJECTIVE To conduct a 10-year follow-up of physical activity and self-reported health status in participants of a r and omized clinical trial of walking intervention . METHODS Of the original 229 volunteer postmenopausal women who participated in the original clinical trial , 196 ( N = 96 intervention and 100 controls ) completed the 10-year follow-up telephone interview . The interview protocol included questions on self-reported walking for exercise and purpose s other than exercise , the Paffenbarger sport and exercise index , functional status , and various chronic diseases and conditions . RESULTS The median values for both usual walking for exercise and total walking were significantly higher for walkers compared with controls ( for both , P = .01 ) , with median differences of 706 and 420 kcal/wk , respectively . After excluding women who reported heart disease during the original trial , 2 women in the walking group ( 2 % ) and 11 women in the control group ( 12 % ) reported physician-diagnosed heart disease over the last 10 years ( P = .07 ) . There were also fewer hospitalizations , surgeries , and falls among women in the walking group , although these differences were not statistically significant ( P>.05 ) . CONCLUSIONS Although limited by self-report , this study may be the first to demonstrate long-term exercise compliance to a r and omized control trial in older women and to suggest that health benefits may have ensued as a result of these increased activity levels",
"BACKGROUND AND PURPOSE Menopause may induce a phase of rapid decreases in bone mineral density , aerobic fitness , muscle strength , and balance , especially in sedentary women . The purpose of this study was to examine the effects and feasibility of an exercise program of 1 or 2 bouts of walking and resistance training on lower-extremity muscle strength ( the force-generating capacity of muscle ) , balance , and walking performance in women who recently went through menopause . SUBJECTS AND METHODS The subjects were 134 women who recently went through menopause . The study was a 15-week , r and omized , controlled trial with continuous and fractionated exercise groups . The outcomes assessed were lower-extremity muscle strength , balance , and walking time over 2 km . Feasibility was assessed by question naires , interviews , and training logs . RESULTS One hundred twenty-eight women completed the study . Adherence to the study protocol was 92 % . Both continuous and fractionated exercise groups improved equally in lower-extremity muscle strength and walking time but not in balance . Almost 70 % of the subjects considered the program to be feasible . Two daily walking sessions caused fewer lower-extremity problems than did continuous walking . DISCUSSION AND CONCLUSION Brisk walking combined with moderate resistance training is feasible and effective . Fractionating the walking into 2 daily sessions is more feasible than continuous walking",
"Physical activity ( PA ) helps to prevent osteoporosis , but older women are often sedentary . This study used a pre-post r and omized controlled design to evaluate a 12-week exercise education intervention program based on the stages of change ( SoC ) and processes of change from the transtheoretical change model ( TTM ) to improve adherence with strength and balance training recommendations at levels sufficient to prevent osteoporosis in Iranian women aged 40 - 65 years . The home-based exercise prescription consisted of strength and balance training that was progressive , individually tailored and included a walking program . Individuals in the training group ( n=61 ) had a positive , significant progression in psychological SoC ( P control group ( n=55 ) . After the intervention , the training group demonstrated significant improvements in PA , lower body muscle strength , static and dynamic balance , with no significant changes in the control group . These results support the applicability of the TTM for a PA intervention and indicate that this training program is very effective in improving balance and lower body strength in older women",
"Objective To assess the effectiveness of a primary care based programme of exercise on prescription among relatively inactive women over a two year period . Design R and omised controlled trial . Setting 17 primary care practice s in Wellington , New Zeal and Participants 1089 women aged 40 - 74 not undertaking 30 minutes of moderate intensity physical activity on at least five days of the week Intervention Brief physical activity intervention led by nurse with six month follow-up visit and monthly telephone support over nine months . Main outcome measure Physical activity assessed at baseline and 12 and 24 months . Secondary outcomes were quality of life ( SF-36 ) , weight , waist circumference , blood pressure , concentrations of fasting serum lipids , glycated haemoglobin ( HbA1c ) , glucose , insulin , and physical fitness . Results Mean age was 58.9 ( SD 7 ) years . Trial retention rates were 93 % and 89 % at 12 and 24 months , respectively . At baseline , 10 % of intervention participants and 11 % of control participants were achieving 150 minutes of at least moderate intensity physical activity a week . At 12 months rates increased to 43 % and 30 % and at 24 months to 39.3 % and 32.8 % ( P SF-36 physical functioning ( P=0.03 ) and mental health ( P role physical scores were significantly lower ( P falls ( P injuries ( P=0.03 ) were recorded in the intervention group . Conclusions This programme of exercise on prescription increased physical activity and quality of life over two years , although falls and injuries also increased . This finding supports the use of exercise on prescription programmes as part of population strategies to reduce physical inactivity . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) ANZCTRN012605000490673",
"This study was aim ed at investigating the effects of a 21-week period of progressive strength or endurance training on peripheral blood mononuclear cells ( P BMC ) antioxidant enzyme gene expression and activity in healthy middle-aged untrained men . Strength ( n=11 ) and endurance ( n=12 ) training were performed twice a week , including resistance exercises to activate all the main muscle groups or cycle-ergometer pedaling , respectively . mRNA levels of catalase , glutathione peroxidase ( GPx ) , mitochondrial superoxide dismutase ( MnSOD ) and cytosolic superoxide dismutase ( CuZnSOD ) were increased after 21 weeks of strength training , while endurance training induced significant changes only in MnSOD and GPx mRNA levels . CuZnSOD protein content was significantly increased only in strength-trained subjects . The program of strength or endurance exercise training had no significant effects on the activity of any of the antioxidant enzymes . In conclusion , in a middle-aged population , 21 weeks of strength or endurance training was a sufficient stimulus to up-regulate mRNA levels of P BMC antioxidant enzymes , the strength training being a more optimal stimulus . However , the discrepancies between enzyme protein and mRNA levels suggest that the present systematic strength or endurance training period had no beneficial effects on enzymatic antioxidant defense mechanisms in previously untrained middle-aged men",
"With advancing age , the postural balance function deteriorates as a consequence of decreased functional capacity . Deteriorating balance is a risk factor for bone fractures due to increased risks of falls . It has been suggested that the loss of estrogen , which occurs in relation to the menopause , may be associated with loss of balance . Regular physical exercise without balance training has , in some studies , been shown to have positive effects on the postural balance . The aim of the present study was to examine balance function during the perimenopausal period , and evaluate the effect of estrogen plus progesterone therapy ( EPT ) or aerobic training on balance . Sixty perimenopausal women were recruited to the study . The subjects were then r and omised to either physical training ( n = 20 ) , EPT ( n = 20 ) , or to a control group ( n = 20 ) . The study period was 18 months . Postural stability was measured every third month using a custom‐made force platform . The women using EPT achieved better results in 3 of 6 parameters , after 18 months",
"Properly conducted r and omised trials can aid clinical decision-making by providing unbiased estimates of the average size of treatment effects . This paper , the first of two , discusses how readers of clinical trials can extract simple estimates of treatment effect size from trial reports when trial outcomes are measured on a continuous scale . When making decisions about therapy for individual patients , these estimates can be modified on the basis of patient characteristics . Modified estimates of treatment effect size can be used to determine if the effect of treatment is likely to be large enough to be \" clinical ly worthwhile \" . This approach optimises clinical decision-making by combining unbiased estimates of the size of treatment effect from clinical trials with clinical intuition and patient preferences",
"OBJECTIVES To examine the association between physical activity and the risk of incident disability , including impairment in activities of daily living ( ADLs ) and instrumental activities of daily living ( IADLs ) , in community-based older persons free of dementia . DESIGN Prospect i ve , observational cohort study . SETTING Approximately 40 retirement communities across the Chicago metropolitan area . PARTICIPANTS More than 1,000 older persons from the Rush Memory and Aging Project , an ongoing longitudinal clinical -pathological study of common chronic conditions of old age . MEASUREMENTS All participants underwent detailed annual clinical evaluations that included assessment s of physical activity , ADLs , IADLs , and gait performance . The associations between physical activity , mortality , and incident disability were examined using a series of Cox proportional hazards models controlled for age , sex , education , and baseline gait . RESULTS At baseline , participants spent a mean+/-st and ard deviation of 3.0+/-3.5 hours per week engaging in physical activity ( range 0 - 35 ) . In a proportional hazards model , the risk of death decreased 11 % ( hazard ratio (HR)=0.89 , 95 % confidence interval (CI)=0.83 - 0.95 ) for each additional hour of physical activity per week . For those who were not disabled at baseline , the risk of developing disability in ADLs decreased 7 % ( HR=0.93 , 95 % CI=0.88 - 0.98 ) for each additional hour of physical activity per week . Similarly , the risk of disability in IADLs decreased 7 % ( HR=0.93 , 95 % CI=0.89 - 0.99 ) for each additional hour of physical activity . CONCLUSION For community-based older persons without dementia , physical activity is associated with maintenance of functional status , including a reduced risk of developing impairment in ADLs and IADLs",
"Objective : To explore associations between physical activity and the risk of falls and fractured bones in community-dwelling older women . Design , setting and participants : A prospect i ve observational survey with three and six-year follow-ups . The sample included 8188 healthy , community-dwelling women , aged 70–75 years in 1996 , who completed surveys as participants in the Australian Longitudinal Study on Women ’s Health . Women who reported a recent serious injury from falling were excluded . Outcomes were reports of a fall to the ground , injury from a fall , and a fractured bone in 1999 and 2002 . The main predictor variable was physical activity level in 1996 , categorised on the basis of weekly frequency as none/very low , low , moderate , high and very high . Covariates were demographic and health-related variables . Logistic regression models were computed separately for each outcome in 1999 and 2002 . Main results : In multivariable models , very high physical activity was associated with a decreased risk of reporting a fall in 1999 ( odds ratio ( OR ) 0.67 ; 95 % CI 0.47 to 0.95 ) and in 2002 ( OR 0.64 ; 95 % CI 0.43 to 0.96 ) . High/very high physical activity was associated with a decreased risk of a fractured bone in 2002 ( OR 0.53 ; 95 % CI 0.34 to 0.83 ) . No significant association was found between physical activity and injury from a fall . Conclusions : The results suggest that at least daily moderate to vigorous-intensity physical activity is required for the primary prevention of falls to the ground and fractured bones in women aged 70–75 years",
"Some have observed maximal strength of simultaneous bilateral homologous limb contraction is less than the sum of strengths of right and left limbs contracting alone ; a phenomenon referred to as the bilateral deficit ( BLD ) . There is controversy on whether there is a BLD for all exercises . We assessed whether a BLD occurs across different exercises ( leg press , knee extension , and lat pull-down ) , whether the BLD could be altered with unilateral or bilateral training , and whether unilateral versus bilateral training was more beneficial for increasing lean tissue mass ( LTM ) . Post-menopausal women ( ~57 years ) were r and omized to bilateral ( n=14 ) and unilateral ( n=12 ) training , or non-training control ( n=24 ) groups . Bilateral training involved seven exercises performed with bilateral contractions ( two sets , 3 days week−1 , 26 weeks ) . Unilateral training involved the same exercises performed with one limb at a time . A BLD was found for leg press and lat pull-down , but not for knee extension . Bilateral training decreased the BLD ; whereas unilateral training had minimal effect on the BLD . The unilateral-training group had a greater increase in lower-body LTM compared to the control group ( P between unilateral and bilateral training groups . Both training groups had greater increases in LTM of the upper- and whole-body compared to the control group . We conclude that the BLD is apparent for some exercises ( i.e. , the leg press and lat pull-down ) but not others ( i.e. , knee extension ) . Bilateral training reduces the BLD ; whereas unilateral training has minimal effect on the BLD",
"BACKGROUND Guidelines established by the National Cholesterol Education Program ( NCEP ) promote exercise and weight loss for the treatment of abnormal lipoprotein levels . Little is known , however , about the effects of exercise or the NCEP diet , which is moderately low in fat and cholesterol , in persons with lipoprotein levels that place them at high risk for coronary heart disease . METHODS We studied plasma lipoprotein levels in 180 postmenopausal women , 45 through 64 years of age , and 197 men , 30 through 64 years of age , who had low high-density lipoprotein ( HDL ) cholesterol levels ( lipoprotein ( LDL ) cholesterol ( > 125 mg per deciliter but 125 mg per deciliter but The subjects were r and omly assigned to aerobic exercise , the NCEP Step 2 diet , or diet plus exercise , or to a control group , which received no intervention . RESULTS Dietary intake of fat and cholesterol decreased during the one-year study ( P body weight , in women and men in either the diet group or the diet-plus-exercise group , as compared with the controls ( P dietary intake and body weight were unchanged . Changes in HDL cholesterol and triglyceride levels and the ratio of total to HDL cholesterol did not differ significantly among the treatment groups , for subjects of either sex . The serum level of LDL cholesterol was significantly reduced among women ( a decrease of 14.5+/-22.2 mg per deciliter ) and men ( a decrease of 20.0+/-17.3 mg per deciliter ) in the diet-plus-exercise group , as compared with the control group ( women had a decrease of 2.5+/-16.6 mg per deciliter , P reduction in LDL cholesterol in men in the diet-plus-exercise group was also significant as compared with that among the men in the exercise group ( 3.6+/-18.8 mg per deciliter , P LDL cholesterol levels were not significant among the women ( a decrease of 7.3+/-18.9 mg per deciliter ) or the men ( 10.8+/-18.8 mg per deciliter ) in the diet group , as compared with the controls . CONCLUSIONS The NCEP Step 2 diet failed to lower LDL cholesterol levels in men or women with high-risk lipoprotein levels who did not engage in aerobic exercise . This finding highlights the importance of physical activity in the treatment of elevated LDL cholesterol levels",
"Seven hundred and four women aged between 65 and 99 years ( mean age 74.6 years ) , who were r and omly selected from the community , took part in a study to determine whether health and lifestyle factors were associated with falls . In the 12 months before the survey , 66.1 per cent of the subjects experienced no falls , 19.7 per cent fell once and 14.2 per cent fell on two or more occasions . The proportion of women who fell outside the home decreased with age , with a corresponding increase in the proportion who fell inside the home on a level surface . The most common causes of falls reported were trips , slips and loss of balance . Some ( 27 per cent ) suffered injuries as a result of a fall , and the proportion suffering injuries increased with age . Those who rated their health and balance as impaired , those with a limitation in activities of daily living , those receiving community services , those taking psychoactive drugs , and those taking four or more drugs had significantly more falls . On the other h and , those taking part in planned exercise and those active for seven or more hours per week had fewer falls . Smoking and alcohol consumption were not significantly associated with falls . Stepwise logistic regression analysis revealed poor vision , inactivity and subjective fall risk as variables that were independently and significantly associated with falling . These findings highlight possible intervention strategies for reducing falls risk in older people",
"PURPOSE The aim of this study was to investigate the effect of 8 wk of exercise training on functional capacity , muscular strength , body composition , and vascular function in sedentary but healthy subjects by using a r and omized , crossover protocol . METHODS After familiarization sessions , 19 subjects aged 47 + /- 2 yr ( mean + /- SE ) undertook a r and omized , crossover design study of the effect of 8 wk of supervised circuit training consisting of combined aerobic and resistance exercise . Peak oxygen uptake ( .VO(2peak ) ) , sum of 7 maximal voluntary contractions and the sum of 8 skinfolds and 5 segment girths were determined at entry , crossover , and 16 wk . Endothelium-dependent and -independent vascular function were determined by forearm strain-gauge plethysmography and intrabrachial infusions of acetylcholine ( ACh ) and sodium nitroprusside ( SNP ) in 16 subjects . RESULTS Training did not alter ACh or SNP responses . .VO(2peak ) , ( 28.6 + /- 1.1 to 32.6 + /- 1.3 mL.kg(-1).min(-1 ) , P exercise test duration ( 17.4 + /- 1.1 to 22.1 + /- 1.2 min , P muscular strength ( 465 + /- 27 to 535 + /- 27 kg , P skinfolds decreased ( 144 + /- 10 vs 134 + /- 9 mm , P circuit training design ed to minimize the involvement of the arms improves functional capacity , body composition , and strength in healthy , middle-aged subjects without significantly influencing upper limb vascular function . This finding contrasts with previous studies in subjects with type 2 diabetes and heart failure that employed an identical training program",
"Objective : To assess the effects of a moderate exercise program with and without oral estrogen replacement on levels of lipids and lipoproteins in postmenopausal women . Methods : One hundred one postmenopausal women were r and omized into four groups : control or sedentary ( N=20 ) , exercise alone ( N=25 ) , estrogen replacement using 0.625 mg conjugated equine estrogen ( N=28 ) , and exercise supplemented with conjugated equine estrogen ( N=28 ) . The exercise groups were placed on a moderate exercise program . Following baseline testing , each group returned at 3 and 6 months for cardiorespiratory fitness testing and serum lipid and lipoprotein profiles . Results : We found a significant decrease in systolic blood pressure ( P maximum oxygen uptake increased by 9.0 and 7.8 % in the exercise and conjugated equine estrogen/ exercise groups , respectively , compared to the other groups ( P Total exercise time ( time spent on the treadmill until exhaustion during testing ) significantly increased in the exercise group by 21 % ( P total cholesterol ( 5.2 % P triglycerides ( 2percnt ; P low-density lipoprotein ( LDL ) cholesterol ( 10 % P high-density lipoprotein ( HDL ) cholesterol-LDL ratio ( 17.2 % P HDL cholesterol ( 16 and 14.8 % P apolipoprotein Aj ( 25.6 and 26.5 % P exercise performance and the changes seen in lipids and lipoproteins . Conclusions : Estrogen therapy alone had the greatest beneficial effect on lipids and lipoproteins . Exercise alone result ed in a significant reduction in cholesterol , triglycerides , and LDL cholesterol , and an increase in the HDL-LDL ratio . However , combined conjugated equine estrogen and exercise did not demonstrate an added improvement in lipid metabolism . Physical fitness levels increased in the exercise groups , but not in the control group or the estrogen-alone treated women . ( Obstet Gynecol 1994;83:167 - 72",
"OBJECTIVE To assess the effect of 9 months of strength training on total body and regional bone mineral density ( BMD , g/cm(2 ) ) in 58 premenopausal women aged 30 - 50 years . METHODS Participants were r and omized to either twice weekly supervised strength training for 15 weeks followed by 24 weeks of unsupervised training ( treatment group ) or control group . Height , weight , maximal muscular strength , nutrient intake and physical activity were assessed . Total body dual energy X-ray absorptiometry ( DXA , Lunar Prodigy ) scans were taken and analyzed for body composition ( lean and fat mass ) , and BMD for total body and its sub-regions ( spine , hip , arms and legs ) . All measurements were performed at baseline , 15 and 39 weeks . Analysis of covariance was used to assess group differences in BMD change adjusted for baseline BMD , weight , energy and calcium intake . RESULTS At baseline , the two groups had similar BMD and body size characteristics ( P change in BMD over 15 weeks ( 0.5 % vs. 0.4 % ) or 39 weeks ( 0.9 % vs. 1.2 % ) did not differ significantly between the exercise and control groups , respectively . The exercise group increased BMD at the spine and legs ( 1 - 2.2 % ) , while there was no change in the controls , but differences between groups were not significant . CONCLUSION Strength training over 9 months did not lead to significantly greater change in total body or regional BMD in premenopausal women",
"In this r and omized , double-blind , placebo-controlled 12-month trial we evaluated effects of weight- bearing jumping exercise and oral alendronate , alone or in combination , on the mass and structure of bone , risk factors for falling ( muscle strength and power , postural sway , and dynamic balance ) , and cardiorespiratory fitness in postmenopausal women . A total of 164 healthy , sedentary , early postmenopausal women were r and omly assigned to one of four experimental groups : ( 1 ) 5 mg of alendronate daily plus progressive jumping exercise , ( 2 ) 5 mg alendronate , ( 3 ) placebo plus progressive jumping exercise , or ( 4 ) placebo . The primary endpoint was 12-month change in bone mass and geometry ( measured with dual-energy X-ray absorptiometry and peripheral computed tomography at several axial and limb sites ) and physical performance ; the secondary endpoint was change in biochemical markers of bone turnover . The jumping exercise was conducted an average 1.6 + /- 0.9 ( mean + /- SD ) times a week . Alendronate daily was effective in increasing bone mass at the lumbar spine ( alendronate vs placebo 3.5 % ; 95 % CI , 2.2 - 4.9 % ) and femoral neck ( 1.3 % ; 95 % CI , 0.2 - 2.4 % ) but did not affect other bone sites . Exercise alone had no effect on bone mass at the lumbar spine or femoral neck ; it had neither an additive nor an interactive effect with alendronate at these bone sites . However , at the distal tibia the mean increase of 3.6 % ( 0.3 - 7.1 % ) in the section modulus ( that is , bone strength ) and 3.7 % ( 0.1 - 7.3 % ) increase in the ratio of cortical bone to total bone area were statistically significant in the exercise group compared to the nonexercise group , indicating exercise-induced thickening of the bone cortex . Bone turnover was reduced in alendronate groups only . Alendronate had no effect on physical performance while the jumping exercise improved leg extensor power , dynamic balance , and cardiorespiratory fitness . As conclusion Alendronate is effective in increasing bone mass at the lumbar spine and femoral neck , while exercise is effective in increasing the mechanical properties of bone at some of the most loaded bone sites , as well as improving the participants ' muscular performance and dynamic balance . Together alendronate and exercise may effectively decrease the risk of osteoporotic fractures",
"OBJECTIVES This study was design ed to determine the effect of exercise on the physical fitness level and quality of life in postmenopausal women . 81 volunteer postmenopausal women who entered the menopause naturally and have been taking hormone replacement treatment ( HRT ) were divided r and omly into two groups : exercise ( n=41 ) and control ( n=40 ) . METHODS Physical fitness tests and the Nottingham Health Profile ( NHP ) were used to assess physical fitness and quality of life in both groups , both before and after 6 weeks . The study group participated in an exercise programme , which was composed of sub-maximal aerobic exercises for a 6-week period 3 times a week . The statistical analyses were done by paired sample s t-test and independent sample s t-test . RESULTS At the end of 6 weeks exercise period , when the two groups were compared after the exercise period , we found statistically significant differences in strength , endurance , flexibility and balance parameters in the exercise group ( P quality of life ( P fitness level and quality of life on postmenopausal women could be improved by a regular and controlled exercise programme of 6 weeks",
"The aim of this r and omized controlled trial was to evaluate the effects of 18 months of calisthenics and endurance training regimens on bone mineral density ( BMD ) in perimenopausal women . Clinical ly healthy sedentary female volunteers ( n = 105 ) aged 52 - 53 years were r and omly assigned to a calisthenics ( n = 36 ) , endurance ( n = 34 ) , or control ( n = 35 ) group . The calisthenics training ( 2.6 times per week on average , 50 minutes per session ) consisted of rhythmic strength-endurance exercises by large muscle groups , and the endurance training ( 3.2 times per week , 50 minutes ) consisted of walking , stair climbing , ergometer cycling , and jogging at a controlled heart rate zone corresponding to 55 - 75 % of the individual maximal oxygen uptake ( VO2max ) of the subjects . The control subjects performed a light stretching program once a week The BMD of the lumbar spine ( L2-L4 ) , right femoral neck , calcaneus , and distal radius was measured by dual-energy X-ray absorptiometry at 0 , 4 , 8 , 10 , 14 , and 18 months , and the maximal isometric strength during trunk extension and flexion , leg extension , and arm flexion and the VO2max by ergospirometry were evaluated at 0 , 8 , 10 , and 18 months of intervention . The VO2max improved significantly ( p = 0.021 ) in the endurance group . The linear trend of the femoral neck BMD in the endurance group , as determined by generalized linear models , was significantly different ( p = 0.043 ) from that of the control group , the trend indicating a maintenance of the pre study BMD . In the calisthenics group , the training effect was not significant . However , the distal radius BMD of the endurance group showed a significant negative trend ( p = 0.006 ) . These results suggest that multiexercise endurance training maintains the BMD the clinical ly important femoral neck of perimenopausal women . This form of endurance training proved also to be feasible for healthy perimenopausal women",
"Objective To evaluate effectiveness and long-term benefits of a specific balance- strategy training program in sedentary women aged 40–60 years and whether participation leads to adoption of a more active lifestyle . Method Fifty healthy women were admitted to the r and omized , controlled trial on the basis of their activity level . Subjects were r and omly assigned to an intervention or control group , with the former attending twice-weekly for 12 weeks . Assessment s made pre- and post-intervention and at 9 months follow-up included : personal demographics , hormone replacement therapy medication , activity level , balance measures , somatosensory function , ankle flexibility and leg muscle strength . Results The intervention group showed improvement in balance measures ( p right ankle tactile sensation ( p = 0.027 ) , ankle flexibility ( p and muscle strength ( p hip abductors and external rotators , compared with the control group immediately after intervention . At 9 months follow-up , the intervention effect was maintained for all measures and a latent improvement of somatosensory measures ( tactile acuity of foot ( p joint repositioning sense ( p and vibration threshold of the left knee ( p more active lifestyle ( p = 0.000 ) . Conclusion These results provide evidence that this physiotherapist- design ed program preserves/reverses the balance decline associated with age and leads to adoption of a more active lifestyle",
"OBJECTIVES To determine whether an individualized falls prevention program comprising exercise , visual , and counseling interventions can reduce physiological falls risk and falls in older people . DESIGN R and omized , controlled trial of 12 months ' duration . SETTING Falls Clinic , Royal North Shore Hospital , Sydney , Australia . PARTICIPANTS Six hundred twenty people aged 75 and older recruited from a health insurance company membership data base . INTERVENTIONS Participants in the extensive intervention group ( EIG ) received individualized interventions comprising exercise and strategies for maximizing vision and sensation ; the minimal intervention group ( MIG ) received brief advice ; and the control group ( CG ) received no intervention . MEASUREMENTS Accidental falls , vision , postural sway , coordinated stability , reaction time , lower limb muscle strength , sit-to-st and performance , and physiological profile assessment ( PPA ) falls risk scores . RESULTS At the 6-month follow-up , PPA falls risk scores were significantly lower in the EIG than in the CG . EIG subjects assigned to the extensive exercise intervention group showed significant improvements in tests of knee flexion strength and sit-to-st and times but no improvements in balance . EIG subjects assigned to the extensive visual intervention group showed significant improvements in tests of visual acuity and contrast sensitivity . The rate of falls and injurious falls within the trial period were similar in the three groups . CONCLUSION The individualized intervention program reduced some falls risk factors but did not prevent falls . The lack of an effect on falls may reflect insufficient targeting of the intervention to an at-risk group",
"OBJECTIVE --To determine the effectiveness of group- vs home-based exercise training of higher and lower intensities among healthy , sedentary older adults . DESIGN --Year-long r and omized , controlled trial comparing ( 1 ) higher-intensity group-based exercise training ; ( 2 ) higher-intensity home-based exercise training ; ( 3 ) lower-intensity home-based exercise training ; or ( 4 ) assessment -only control . SETTING --General community located in northern California . PARTICIPANTS --One hundred sixty women and 197 men 50 to 65 years of age who were sedentary and free of cardiovascular disease . One out of nine persons contacted through a community r and om-digit-dial telephone survey and citywide promotion were r and omized . INTERVENTIONS --For higher-intensity exercise training , three 40-minute endurance training sessions per week were prescribed at 73 % to 88 % of peak treadmill heart rate . For lower-intensity exercise training , five 30-minute endurance training sessions per week were prescribed at 60 % to 73 % of peak treadmill heart rate . MAIN OUTCOME MEASURES --Treadmill exercise test performance , exercise participation rates , and heart disease risk factors . RESULTS --Compared with controls , subjects in all three exercise training conditions showed significant improvements in treadmill exercise test performance at 6 and 12 months ( P less than .03 ) . Lower-intensity exercise training achieved changes comparable with those of higher-intensity exercise training . Twelve-month exercise adherence rates were better for the two home-based exercise training conditions relative to the group-based exercise training condition ( P less than .0005 ) . There were no significant training-induced changes in lipid levels , weight , or blood pressure . CONCLUSIONS --We conclude that ( 1 ) this community-based exercise training program improved fitness but not heart disease risk factors among sedentary , healthy older adults ; ( 2 ) home-based exercise was as effective as group exercise in producing these changes ; ( 3 ) lower-intensity exercise training was as effective as higher-intensity exercise training in the home setting ; and ( 4 ) the exercise programs were relatively safe"
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41170bea-06ff-11f0-808a-c43d1ab1c353
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Background : There are few data regarding the effectiveness of remote monitoring for older people with heart failure . We conducted a post-hoc sub- analysis of a previously published large Cochrane systematic review and meta- analysis of relevant r and omized controlled trials to determine whether structured telephone support and telemonitoring were effective in this population . Methods : A post hoc sub- analysis of a systematic review and meta- analysis that applied the Cochrane methodology was conducted . Meta-analyses of all-cause mortality , all-cause hospitalizations and heart failure-related hospitalizations were performed for studies where the mean or median age of participants was 70 or more years . Results : The mean or median age of participants was 70 or more years in eight of the 16 ( n=2659/5613 ; 47 % ) structured telephone support studies and four of the 11 ( n=894/2710 ; 33 % ) telemonitoring studies . Structured telephone support ( RR 0.80 ; 95 % CI=0.63–1.00 ) and telemonitoring ( RR 0.56 ; 95 % CI=0.41–0.76 ) interventions reduced mortality . Structured telephone support interventions reduced heart failure-related hospitalizations ( RR 0.81 ; 95 % CI=0.67–0.99 ) . Conclusion : Despite a systematic bias towards recruitment of individuals younger than the epidemiological average into the r and omized controlled trials , older people with heart failure did benefit from structured telephone support and telemonitoring . These post-hoc sub- analysis results were similar to overall effects observed in the main meta- analysis . While further research is required to confirm these observational findings , the evidence at h and indicates that discrimination by age alone may be not be appropriate when inviting participation in a remote monitoring service for heart failure
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"BACKGROUND Case management is believed to promote continuity of care and decrease hospitalization rates , although few controlled trials have tested this approach . OBJECTIVE To assess the effectiveness of a st and ardized telephonic case-management intervention in decreasing re source use in patients with chronic heart failure . METHODS A r and omized controlled clinical trial was used to assess the effect of telephonic case management on re source use . Patients were identified at hospitalization and assigned to receive 6 months of intervention ( n = 130 ) or usual care ( n = 228 ) based on the group to which their physician was r and omized . Hospitalization rates , readmission rates , hospital days , days to first rehospitalization , multiple readmissions , emergency department visits , inpatient costs , outpatient re source use , and patient satisfaction were measured at 3 and 6 months . RESULTS The heart failure hospitalization rate was 45.7 % lower in the intervention group at 3 months ( P = .03 ) and 47.8 % lower at 6 months ( P = .01 ) . Heart failure hospital days ( P = .03 ) and multiple readmissions ( P = .03 ) were significantly lower in the intervention group at 6 months . Inpatient heart failure costs were 45.5 % lower at 6 months ( P = .04 ) . A cost saving was realized even after intervention costs were deducted . There was no evidence of cost shifting to the outpatient setting . Patient satisfaction with care was higher in the intervention group . CONCLUSIONS The reduction in hospitalizations , costs , and other re source use achieved using st and ardized telephonic case management in the early months after a heart failure admission is greater than that usually achieved with pharmaceutical therapy and comparable with other disease management approaches",
"We studied the effects of home telemonitoring in elderly patients with congestive heart failure ( CHF ) on mortality and rate of hospitalization , compliance with treatment , quality of life and costs of CHF management , by comparison with a group receiving usual care . Fifty-seven elderly CHF patients were r and omized to st and ard care or to home telemonitoring-based care and followed for 12 months . In the subjects who were monitored , weekly reports on their clinical status were obtained and their management was modified accordingly . Home telemonitoring was associated with improvements in the composite endpoint of mortality and rate of hospitalizations ( P = 0.006 ) , a better compliance with therapy , more frequent use of beta-blockers and statins , lower total cholesterol level and a better reported health perception score . The improved results with home telemonitoring in CHF were probably due to better compliance and to closer monitoring of the patients",
"OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r and omly assigned , 48 % were aged > 70 years , mean LVEF was 25 % ( SD , 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml ( interquartile range 1,285 to 6,749 pg/ml ) . During 240 days of follow-up , 19.5 % , 15.9 % , and 12.7 % of days were lost as the result of death or hospitalization for UC , NTS , and HTM , respectively ( no significant difference ) . The number of admissions and mortality were similar among patients r and omly assigned to NTS or HTM , but the mean duration of admissions was reduced by 6 days ( 95 % confidence interval 1 to 11 ) with HTM . Patients r and omly assigned to receive UC had higher one-year mortality ( 45 % ) than patients assigned to receive NTS ( 27 % ) or HTM ( 29 % ) ( p = 0.032 ) . CONCLUSIONS Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure",
"Background —Because of the prevalence and expense of congestive heart failure ( CHF ) , significant efforts have been made to develop disease management ( DM ) programs that will improve clinical and financial outcomes . The effectiveness of such programs in a large , heterogeneous population of CHF patients remains unknown . Methods and Results —We r and omized 1069 patients ( aged 70.9±10.3 years ) with systolic ( ejection fraction 35±9 % ) or echocardiographically confirmed diastolic heart failure ( HF ) to assess telephonic DM over an 18-month period . Data were collected at baseline and at 6-month intervals . Survival analysis was performed by Kaplan-Meier and Cox regression methods . Healthcare utilization was defined after extensive record review , with an attempt to account for all inpatient and outpatient visits , medications , and diagnostic tests . We obtained data on 92 % of the patients , from nearly 53 000 health-related encounters . Total cost per patient was defined by adding estimated costs for the observed encounters , excluding the cost of the DM . Kaplan-Meier analysis showed that DM patients had a reduced mortality rate ( P=0.037 ) , with DM patients surviving an average of 76 days longer than controls . Subgroup analysis showed that DM had beneficial outcomes in patients with systolic HF ( hazard ratio 0.62 ; P=0.040 ) , which was more pronounced in NYHA classes III and IV . Although improvements in NYHA class were more likely with DM ( P from DM ( P=0.08 ) . Total and CHF-related healthcare utilization , including medications , office or emergency department visits , procedures , or hospitalizations , was not decreased by DM . Repeated- measures ANOVA for cost by group showed no significant differences , even in the higher NYHA class groups . Conclusions —Participation in DM result ed in a significant survival benefit , most notably in symptomatic systolic HF patients . Although DM was associated with improved NYHA class , 6-minute walk test results did not improve . Healthcare utilization was not reduced by DM , and it conferred no cost savings . DM in HF results in improved life expectancy but does not improve objective measures of functional capacity and does not reduce cost",
"OBJECTIVE To estimate the prevalence of heart failure ( HF ) and left ventricular ( LV ) systolic dysfunction in a population -based sample of older Australians . DESIGN , SETTING AND PARTICIPANTS A cross-sectional survey of 2000 r and omly selected residents of Canberra , aged 60 - 86 years , conducted between February 2002 and June 2003 . Participants were assessed by history , physical examination by a cardiologist , and echocardiography . MAIN OUTCOME MEASURES Age- and sex-specific prevalence rates of clinical HF and LV systolic dysfunction ( defined as LV ejection fraction 1846 people eligible for our study , 1388 ( 75 % ) agreed to participate and 1275 completed all investigations ( mean age , 69.4 years ; 50 % men ) . In the study sample , 72 subjects ( 5.6 % ; 95 % CI , 4.4%-7.1 % ) had clinical HF that had been previously diagnosed and was confirmed by our assessment . A further 0.6 % ( 95 % CI , 0.3%-1.2 % ) had undiagnosed clinical HF ( ie , evidence of structural heart disease and symptoms/signs of cardiac insufficiency without a previous diagnosis of clinical HF ) . Thus , the overall prevalence of clinical HF in the sample was 6.3 % ( 95 % CI , 5.0%-7.7 % ) . Clinical HF increased in prevalence with advancing age ( a 4.4-fold increase from the 60 - 64-years age group to the 80 - 86-years age group ; P LV systolic dysfunction , 44 ( 59 % ) were in the pre clinical stage of disease . CONCLUSION Diagnosed HF cases represent the \" tip of the iceberg \" for the national burden of HF and LV systolic dysfunction . Clinical ly identifiable HF cases can remain undiagnosed , and the majority of people with LV systolic dysfunction are in a pre clinical stage of the disease",
"BACKGROUND Despite the availability of proven therapies , outcomes in patients with heart failure ( HF ) remain poor . In this 2-stage , multicenter trial , we evaluated the effect of a disease management program on clinical and economic outcomes in patients with HF . METHODS AND RESULTS In Stage 1 , a pharmacist or nurse assessed each patient and made recommendations to the physician to add or adjust angiotensin-converting enzyme ( ACE ) inhibitors and other HF medications . Before discharge ( Stage 2 ) , patients were r and omized to a patient support program ( PSP ) ( education about HF , self-monitoring , adherence aids , newsletters , telephone hotline , and follow-up at 2 weeks , then monthly for 6 months after discharge ) or usual care . In Stage 1 ( 766 patients ) ACE inhibitor use increased from 58 % on admission to 83 % at discharge ( P dose ( in enalapril equivalents ) increased from 11.3 + /- 8.8 mg to 14.5 + /- 8.8 mg ( P Stage 2 ( 276 patients ) there was no difference in ACE inhibitor adherence , but a reduction in cardiovascular-related emergency room visits ( 49 versus 20 , P = .030 ) , hospitalization days ( 812 versus 341 , P = .003 ) , and cost of care ( 2,531 Canadian dollars less per patient ) in favor of the PSP . CONCLUSION Simple interventions can improve ACE inhibitor use and patient outcomes",
"The Home or Hospital in Heart failure ( HHH ) study was a European Community‐funded , multinational , r and omized controlled clinical trial , conducted in the UK , Pol and , and Italy , to assess the feasibility of a new system of home telemonitoring ( HT ) . The HT system was used to monitor clinical and physiological parameters , and its effectiveness ( compared with usual care ) in reducing cardiac events in heart failure ( HF ) patients was evaluated . Measurements were patient‐managed",
"BACKGROUND Disease management is effective in the general population , but it has not been tested prospect ively in a sample of solely Hispanics with heart failure ( HF ) . We tested the effectiveness of telephone case management in decreasing hospitalizations and improving health-related quality of life ( HRQL ) and depression in Hispanics of Mexican origin with HF . METHODS AND RESULTS Hospitalized Hispanics with chronic HF ( n = 134 ) were enrolled and r and omized to intervention ( n = 69 ) or usual care ( n = 65 ) . The sample was elderly ( 72 + /- 11 years ) , New York Heart Association class III/IV ( 81.3 % ) , and poorly educated ( 78.4 % less than high school education ) . Most ( 55 % ) were unacculturated into US society . Bilingual/bicultural Mexican-American registered nurses provided 6 months of st and ardized telephone case management . Data on hospitalizations were collected from automated systems at 1 , 3 , and 6 months after the index hospital discharge . Health-related quality of life and depression were measured by self-report at enrollment , 3 , and 6 months . Intention to treat analysis was used . No significant group differences were found in HF hospitalizations , the primary outcome variable ( usual care : 0.49 + /- 0.81 [ CI 0.25 - 0.73 ] ; intervention : 0.55 + /- 1.1 [ CI 0.32 - 0.78 ] at 6 months ) . No significant group differences were found in HF readmission rate , HF days in the hospital , HF cost of care , all-cause hospitalizations or cost , mortality , HRQL , or depression . CONCLUSION These results have important implication s because of the current widespread enthusiasm for disease management . Although disease management is effective in the mainstream HF patient population , in Hispanics this ill , elderly , and poorly educated , a different approach may be needed",
"BACKGROUND Prior studies suggest that disease management programs may be effective in improving clinical outcomes in patients with heart failure ( HF ) . However , the use of these programs in setting s with limited sources and among diverse population is not know . Thus the present study was design ed to assess the impact of a computer-based home disease management program ( Alere DayLink HF Monitoring System [ HFMS ] ) on the clinical outcomes of Medicare beneficiaries with HF who were elderly , women , and non-white males who received the care from a community-based primary care practitioner . METHODS AND RESULTS The Heart Failure Home Care ( HFHC ) trial was a multicenter , r and omized , controlled trial of HFMS versus st and ard heart failure care ( SC : enhanced patient education , education to clinicians , and follow-up ) . The primary study end point was treatment failure , defined as a composite of cardiovascular death or rehospitalization for heart failure within 6 months of enrollment . Among patients rehospitalized for HF , length of hospital stay was also considered a primary end point . A total of 315 patients were r and omized : 160 to HFMS and 155 to SC . Although the incidence of the primary outcome was somewhat higher in the SC arm ( 28.8 % versus 21.2 % , P = .15 ) , the difference was not statistically different . The length of hospital stay was also similar in both groups . CONCLUSIONS Our study results suggest that enhanced patient education and follow-up is as successful as a sophisticated home monitoring device with an interactive program in patients with HF who are elderly , women and non-Caucasian males and receive the care from a community-based primary care practitioner",
"BACKGROUND Both r and omized and nonr and omized controlled studies have linked congestive heart failure ( CHF ) case management ( CM ) to decreased readmissions and improved outcomes in mostly homogeneous setting s. The objective of this r and omized controlled trial was to test the effect of CHF CM on the 90-day readmission rate in a more heterogeneous setting . METHODS A total of 287 patients admitted to the hospital with the primary or secondary diagnosis of CHF , left ventricular dysfunction of less than 40 % , or radiologic evidence of pulmonary edema for which they underwent diuresis were r and omized . The intervention consisted of 4 major components : early discharge planning , patient and family CHF education , 12 weeks of telephone follow-up , and promotion of optimal CHF medications . RESULTS The 90-day readmission rates were equal for the CM and usual care groups ( 37 % ) . Total inpatient and outpatient median costs and readmission median cost were reduced 14 % and 26 % , respectively , for the intervention group . Patients in the CM group were more likely to be taking CHF medication at target doses , but dosages did not increase significantly throughout 12 weeks . Although both groups took their medications as prescribed equally well , the rest of the adherence to treatment plan was significantly better in the CM group . Subgroup analysis of patients who lived locally and saw a cardiologist showed a significant decrease in CHF readmissions for the intervention group ( P = .03 ) . CONCLUSIONS These results suggest several limitations to the generalizability of the CHF CM-improved outcome link in a heterogeneous setting . One explanation is that the lack of coordinated system supports and varied accessibility to care in an extended , nonnetworked physician setting limits the effectiveness of the CM",
"BACKGROUND AND OBJECTIVE The rising prevalence of chronic heart failure ( CHF ) has led to an increase in total treatment expenditures . A medical care programme of telemetry was developed to reduce the number of patients with decompensated CHF , hospital admissions and overall treatment cost . PATIENTS AND METHODS As part of a prospect i ve controlled study the body weight of 251 patients with CHF was monitored over one year . The supervising center contacted the patients whenever their body weight exceeded a threshold value . Patients were phoned by a design ated personal adviser and received regular informative material and advice by specialist medical personnel . Patients ' general practitioners had been involved in recruiting patients and by regularly sending them follow-up reports . Another group of 251 patients who had not received the described telemetric intervention served as control . RESULTS The mean age of the patients was 71.7 years , lower than the 76.4 years of the control group . More patients in the intervention groups were in NYHA class III and IV than in the control group ( 52 % vs 36 % ) . After an average observation period of 12 months the duration of hospital stay had been reduced by 48 % ( p = 0.01 ) , the hospital costs by EUR 7128 per patient p = 0.01 ) , while drug expenditure had increased by EUR 245 per patient ( not significant ) . The total costs had thus fallen by EUR 6993 per patient ( -39.5 % ; p = 0.05 ) . The mortality rate of 14.7 % in the intervention group was significantly lower than that of the control group of 27.1 % ( p = 0.001 ) . The reduction in costs and mortality rate was clearly greater for men than women . Total expenditure had been highest for patients who had died . CONCLUSION The results indicate that total treatment costs and mortality rate can be reduced by telemetric monitoring of patients in CHF , especially in men",
"Patients with a diagnosis of heart failure , registered at the study practice , were recruited into the study . First , they had a cardiologist 's assessment . They were then r and omised into telemonitored patients who measured pulse , BP , weight and video consulted , and controls"
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Background Insulin resistance ( IR ) is a physiological condition related to type 2 diabetes mellitus ( T2DM ) and obesity , which is associated with high blood insulin and glucose . Inulin-type carbohydrate ( ITC ) is a kind of fermentable fructan that can reduce glucose and ameliorate IR in an animal model , but the effect in clinical trials is controversial . Objective The authors conducted a systematic literature review to evaluate the effect of ITC supplementation in ameliorating IR in T2DM and obese patients . Methods Multiple data bases were queried for studies before December 25 , 2018 , which involved supplementation with ITC in ameliorating IR in T2DM and obese patients . Studies that involved meta- analysis of the body mass index ( BMI ) , fasting plasma glucose ( FPG ) , fasting insulin ( FI ) , HbA1c , homeostatic model assessment IR ( HOMA-IR ) , and quantitative insulin sensitivity check index ( QUICKI ) of T2DM subjects were included . HOMA-IR and QUICKI were identified as the primary outcomes . A systematic review was performed to evaluate the effect of ITC on IR in obese patients . Results The data base search yielded 25 studies , which met the inclusion criteria ; 11 articles were meta-analyzed , and 5 other articles on T2DM and 9 articles on simple obesity were systematic ally review ed . Our results did not find ITC supplementation decrease postintervention and reduction data of BMI ( P = 0.08 ) . However , it can significantly decrease postintervention and reduction data of FPG , FI , HbA1c , and HOMA-IR . Heterogeneity was eliminated by subgroup analysis according to baseline BMI . There was no significant difference in the amelioration of QUICKI between the ITC and control groups . However , the difference was statistically significant and the heterogeneity was eliminated after subgroup analysis according to intakes of ITC . 14 articles for a systematic review found that the results of blood glucose , insulin , and HbA1c were controversial . Only one of the seven studies on simple obesity concluded that ITC intervention significantly ameliorated HOMA-IR , while the other six did not . Conclusion Supplementation of ITC can ameliorate IR in T2DM , especially in obese T2DM patients , but the effects are controversial in obese patients
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"Objective To highlight the contribution of the gut microbiota to the modulation of host metabolism by dietary inulin-type fructans ( ITF prebiotics ) in obese women . Methods A double blind , placebo controlled , intervention study was performed with 30 obese women treated with ITF prebiotics ( inulin/oligofructose 50/50 mix ; n=15 ) or placebo ( maltodextrin ; n=15 ) for 3 months ( 16 g/day ) . Blood , faeces and urine sampling , oral glucose tolerance test , homeostasis model assessment and impedancemetry were performed before and after treatment . The gut microbial composition in faeces was analysed by phylogenetic microarray and qPCR analysis of 16S rDNA . Plasma and urine metabolic profiles were analysed by 1H-NMR spectroscopy . Results Treatment with ITF prebiotics , but not the placebo , led to an increase in Bifidobacterium and Faecalibacterium prausnitzii ; both bacteria negatively correlated with serum lipopolysaccharide levels . ITF prebiotics also decreased Bacteroides intestinalis , Bacteroides vulgatus and Propionibacterium , an effect associated with a slight decrease in fat mass and with plasma lactate and phosphatidylcholine levels . No clear treatment clustering could be detected for gut microbial analysis or plasma and urine metabolomic profile analyses . However , ITF prebiotics led to subtle changes in the gut microbiota that may importantly impact on several key metabolites implicated in obesity and /or diabetes . Conclusions ITF prebiotics selectively changed the gut microbiota composition in obese women , leading to modest changes in host metabolism , as suggested by the correlation between some bacterial species and metabolic endotoxaemia or metabolomic signatures",
"PURPOSE This trial was conducted to evaluate the effects of oligofructose-enriched inulin on some of cardiovascular disease risk factors in women with type 2 diabetes . METHODS 52 females ( 25 were r and omly assigned to two groups . Participants received 10g/d oligofructose-enriched inulin ( n=27 ) or 10g/d placebo ( n=25 ) for 8 weeks . Fasting blood sample s were taken to measure metabolic profiles , malondialdehyd and antioxidant enzymes at baseline and after the 8 weeks intervention . Paired , unpaired sample t-test and analysis of covariance were used to comparison of quantitative variables . RESULTS After 8 weeks , in the oligofructose-enriched inulin group there was a significant increase in total antioxidant capacity ( 0.2 mmol/l , 20.0 % ) and a significant decrease in fasting plasma glucose ( 19.2 mg/dL , 9.4 % ) HbA1c ( 0.5 % , 8.4 % ) , total cholesterol ( TC ) ( 28.0 mg/dL , 14.1 % ) , low-density lipoprotein cholesterol ( LDL-c ) ( 22.0 mg/dL , 21.7 % ) , TC/HDL-c ratio ( 0.73 , 20.7 % ) , LDL-c/HDL-c ratio ( 0.55 , 27.5 % ) and malondialdehyd ( 1.7 nmol/ml , 39.7 % ) compared to the placebo group . Changes in concentrations of triglycerides , high-density lipoprotein cholesterol ( HDLc ) , superoxide dismutase , catalase and glutathione peroxidase were not significant in oligofructose-enriched inulin group compared to the placebo group . CONCLUSION Oligofructose-enriched inulin may improve glycemic indices , lipid profile , antioxidant status and malondialdehyd in women with type 2 diabetes",
"Background Fat infiltration of the liver , muscle and pancreas is associated with insulin resistance and risk of diabetes . Weight loss reduces ectopic fat deposition and risk of diabetes , but is difficult to sustain to due to compensatory increases in appetite . Fermentable carbohydrates have been shown to decrease appetite and food intake , and promote weight loss in overweight subjects . In animal studies , fermentable carbohydrate reduces ectopic fat independent of weight loss . We aim ed to investigate the effect of the fermentable carbohydrate inulin on weight maintenance , appetite and ectopic fat in subjects with prediabetes . Methods Forty-four subjects with prediabetes were r and omized to 18 weeks ’ inulin or cellulose supplementation . During weeks 1–9 ( weight loss phase ) all subjects had four visits with a dietitian to guide them towards a 5 % weight loss . During weeks 10–18 ( weight maintenance phase ) subjects continued taking their assigned supplementation and were asked to maintain the weight they had lost but were offered no further support . All subjects attended study sessions at baseline , 9 and 18 weeks for measurement of weight ; assessment of adipose tissue and ectopic fat content by magnetic resonance imaging and magnetic resonance spectroscopy ; glucose , insulin and GLP-1 levels following a meal tolerance test ; and appetite by ad libitum meal test and visual analogue scales . Results Both groups lost approximately 5 % of their body weight by week nine ( −5.3 ± 0.1 % vs −4.3 ± 0.4 % , p = 0.13 , but the inulin group lost significantly more weight between 9 and 18 weeks ( −2.3 ± 0.5 % vs −0.6 ± 0.4 % , p = 0.012 ) . Subjects taking inulin had lower hepatic ( p = 0.02 ) and soleus muscle ( p fat content at 18 weeks compared to control even after controlling for weight loss and consumed less at the ad libitum meal test ( p = 0.027 ) . Fasting glucose significantly decreased at week nine only ( p = 0.005 ) , insulin concentrations did not change , and there was a significant increase in GLP-1 in the cellulose group at 9 and 18 weeks ( p Conclusion Inulin may have a two-pronged effect on the risk of diabetes by 1 ) promoting weight loss 2 ) reducing intrahepatocellular and intramyocellular lipid in people with prediabetes independent of weight loss . Trial registration Clinical trial number : NCT01841073",
"BACKGROUND Fructooligosaccharides have been cl aim ed to lower fasting glycemia and serum total cholesterol concentrations , possibly via effects of short-chain fatty acids produced during fermentation . OBJECTIVE We studied the effects of fructooligosaccharides on blood glucose , serum lipids , and serum acetate in 20 patients with type 2 diabetes . DESIGN In a r and omized , single-blind , crossover design , patients consumed either glucose as a placebo ( 4 g/d ) or fructooligosaccharides ( 15 g/d ) for 20 d each . Average daily intakes of energy , macronutrients , and dietary fiber were similar with both treatments . RESULTS Compliance , expressed as the proportion of supplements not returned , was near 100 % during both treatments . Fructooligosaccharides did not significantly affect fasting concentrations ( mmol/L ) of serum total cholesterol ( 95 % CI : -0.07 , 0.48 ) , HDL cholesterol ( -0.04 , 0.04 ) , LDL cholesterol ( -0.06 , 0.34 ) , serum triacylglycerols ( -0.21 , 0.44 ) , serum free fatty acids ( -0.08 , 0.04 ) , serum acetate ( -0.01 , 0.01 ) , or blood glucose ( -0.37 , 0.40 ) . CONCLUSIONS We conclude that 20 d of dietary supplementation with fructooligosaccharides had no major effect on blood glucose , serum lipids , or serum acetate in patients with type 2 diabetes . This lack of effect was not due to changes in dietary intake , insufficient statistical power , or noncompliance of the patients",
"Short-chain fructooligosaccharides ( FOS ) are prebiotics , which escape digestion in the small intestine and are fermented by the colonic microflora into short-chain fatty acids . Recently , we found that the daily consumption of 20 g FOS decreased basal hepatic glucose production in healthy subjects without any effect on insulin-stimulated glucose metabolism . In this study , we evaluated the effects of the chronic ingestion of FOS on plasma lipid and glucose concentrations , hepatic glucose production and insulin resistance in type 2 diabetics . Type 2 diabetic volunteers ( n = 10 ; 6 men , 4 women ) received either 20 g/d FOS or sucrose for 4 wk in a double-blind crossover design . FOS did not modify fasting plasma glucose and insulin concentrations or basal hepatic glucose production . The plasma glucose response to a fixed exogenous insulin bolus did not differ at the end of the two periods . Erythrocyte insulin binding also did not differ . Serum triacylglycerol , total and HDL cholesterol , free fatty acid , apolipoproteins A1 and B and lipoprotein ( a ) concentrations were not modified by the chronic ingestion of FOS . We conclude that 4 wk of 20 g/d of FOS had no effect on glucose and lipid metabolism in type 2 diabetics",
"Purpose : The worldwide prevalence of metabolic disorders such as diabetes is increasing rapidly . Currently , the complications of diabetes are the major health concern . The aim of this study was to investigate the effect of high performance ( HP ) inulin supplementation on glucose homeostasis via KLF5 mRNA expression in adults with type 2 diabetes . Methods : In the present clinical trial conducted for a duration of 6 weeks , 46 volunteers diabetic patients referring to diabetes clinic in Tabriz , Iran , were r and omly assigned into intervention ( n= 23 , consuming 10 gr/d HP inulin ) and control groups ( n= 23 , consuming 10 gr/ d starch ) . We assessed glycemic and anthropometric indices , blood lipids and plasmatic level of miR-375 as well as KLF5 mRNA expression before and after the intervention . Results : Findings indicated that inulin supplementation significantly decreased fasting plasma glucose ( FPG ) in comparison to the placebo group ( P that inulin supplementation result ed in significant decrease in KLF5 mRNA expression in peripheral blood mononuclear cells ( P BMC s ) ( Fold change : 0.61± 0.11 ; P-value= 0.001 ) and significant increase in plasmatic level of miR-375 ( Fold change : 3.75± 0.70 ; P-value=0.004 ) . Conclusion : Considering the improvements of FPG level in diabetic patients , it seems that HP inulin supplementation may be beneficial in controlling diabetes via the expression of some genes . However , further studies are needed to achieve concise conclusions",
"BACKGROUND S AND AIMS Type 2 diabetic mellitus ( T2DM ) as one of the main causes of morbidity and mortality is associated with immune system disturbances and metabolic abnormalities . In the current study we aim ed to evaluate the effects of enriched chicory inulin supplementation on liver enzymes , serum calcium and phosphorous concentrations and hematological parameters in patients with T2DM . METHODS Forty-six diabetic females patients were r and omly allocated into intervention ( n=27 ) and control ( n=22 ) groups . Subjects in the intervention group received a daily dose of 10 g of chicory and subjects in control group received a placebo for two months . Anthropometric variables , glucose homeostasis , hematological parameters and metabolic indices including serum alanine aminotransfersae ( ALT ) , aspartate aminotransferase ( AST ) , alkaline phosphatase ( ALP ) , calcium and phosphorous as well as creatinine concentrations , glomerular filtration rate ( GFR ) and blood pressure were assessed at the beginning and end of the trial . RESULTS Significant reductions in fasting serum glucose ( FSG ) , Hb A1C , AST and ALP concentrations were observed in chicory-treated group . Systolic and diastolic blood pressures were also reduced in chicory-treated group . Serum calcium significantly increased after chicory supplementation but no change in placebo treated group has been occurred ( P=0.014 ) . Supplementation with enriched chicory for two months significantly reduced hematocrit and mean corpuscular volume ( MCV ) values ( P in serum insulin , creatinine and GFR were not significant . CONCLUSION The present study showed beneficial effects of oligofructose-enriched chicory on the improvement of the glucose and calcium homeostasis , liver function tests , blood pressure and reduction in hematologic risk factors of diabetes in female patients with T2DM . Further studies in both genders are needed to generalize these findings to total population",
"Background The purpose of this study was to evaluate the effects of high performance inulin supplementation on blood glycemic control and antioxidant status in women with type 2 diabetes . Methods In a r and omized , triple-blind controlled trial , 49 females ( fiber intake The participants were divided into one of two groups in which the participants either received 10 g/day of inulin ( intervention , n=24 ) or maltodextrin ( control , n=25 ) for 2 months . Fasting blood sample s were obtained and both glycemic control and antioxidant status were determined at baseline and at the end of the study . Results At the end of the study period , there were significant decreases in fasting plasma glucose ( 8.47 % ) , glycosylated hemoglobin ( 10.43 % ) , and malondialdehyde ( 37.21 % ) levels and significant increases in total antioxidant capacity ( 18.82 % ) and superoxide dismutase activity ( 4.36 % ) in the inulin group when compared to the maltodextrin group ( P in fasting insulin , homeostasis model assessment of insulin resistance , and catalase activity were not significant in the inulin group when compared with the maltodextrin group . Glutathione peroxidase activity remained unchanged in both groups . Conclusion Inulin supplementation may improve some glycemic and antioxidant indices and decrease malondialdehyde levels in women with type 2 diabetes . Further investigations are needed in order to confirm the positive effects that inulin may have on the glycemic and antioxidant indices of patients with type 2 diabetes",
"Background Obesity is a major public health problem in many poor countries where micronutrient deficiencies are prevalent . A partial meal replacement may be an effective strategy to decrease obesity and increase micronutrient intake in such population s. The objective was to evaluate the efficacy of a partial meal replacement with and without inulin on weight reduction , blood lipids and micronutrients intake in obese Mexican women . Methods In a r and omized controlled clinical trial 144 women ( 18–50 y ) with BMI ≥ 25 kg/m2 , were allocated into one of the following treatments during 3 months : 1 ) Two doses/d of a partial meal replacement ( PMR ) , 2 ) Two doses/d of PMR with inulin ( PMR + I ) , 3 ) Two doses/d of 5 g of inulin ( INU ) and 4 ) Control group ( CON ) . All groups received a low calorie diet ( LCD ) . Weight , height , hip and waist circumference were measured every 2 weeks and body composition , lipids and glucose concentration and nutrient intake were assessed at baseline and after 3 months . Results All groups significantly reduced weight , BMI , waist and hip circumference . Differences between groups were only observed in BMI and weight adjusted changes : At 45 days PMR group lost more weight than INU and CON groups by 0.9 and 1.2Kg , respectively . At 60 days , PMR + I and PMR groups lost more weight than in INU by 0.7 and 1Kg , respectively . Subjects in PMR , PMR + I and INU significantly decreased triglycerides . Energy intake was reduced in all groups . Fiber intake increased in PMR + I and INU groups . Some minerals and vitamins intakes were higher in PMR and PMR + I compared with INU and CON groups . Conclusion Inclusion of PMR with and without inulin to a LCD had no additional effect on weight reduction than a LCD alone but reduced triglycerides and improved intake of micronutrients during caloric restriction . PMR could be a good alternative for obese population s with micronutrient deficiencies . Clinical Trials . Gov",
"INTRODUCTION It is essential to determine which snack foods are most affective for appetite control . The objective of the current study was to assess the responses of two different cookies on satiety and cardiovascular risk factors . MATERIAL AND METHODS 38 patients were r and omized : group I ( FOS enriched cookie , n=19 ) and group II ( control cookie , n=19 ) . Previous and after 1 month , the subjects rated their feelings of satiety/hunger with a test meal of 5 cookies . RESULTS After the test meal , the basal area under curve of the first hunger/satiety score was higher with satiety cookie than with control cookie , the data after 1 month of treatment was higher with satiety cookie than with control cookie , too . The score was higher than the fasting level for 20 minutes with satiety cookie and for 40 minutes with the same cookie , too . In satiety group , these scores ( 20 min and 40 min ) were higher than control group before and after 1 month of treatment . The results were in the same way with the 100 mm 5-point visual satiety scale . Cardiovascular risk factors and dietary intake remained unchanged after dietary intervention . CONCLUSION A FOS enriched cookie produced greater ratings of satiety than a control cookie , without effects on cardiovascular risk factors or dietary intakes",
"Introduction : Inflammation has a crucial role in the progression of cardiovascular disease in diabetes . Tumour necrosis factor-α ( TNF-α ) as an inflammatory marker induces angiotensin II ( Ang II ) related hypertension pathway in diabetic patients . Gut modulation via prebiotics may ameliorate hypertension caused by inflammation . The aim of this study was to investigate the role of sodium butyrate ( NaBut ) and inulin supplements on inflammatory and oxidative stress parameters in type 2 diabetic patients . Methods : In this clinical trial , 60 overweight and obese diabetic patients were recruited and r and omly allocated into four groups . The groups received , respectively , 600 mg/d NaBut ( group A ) , 10 g/d inulin powder ( group B ) , both inulin and NaBut ( group C ) , or placebo ( group D ) for 45 consecutive days . Blood and stool sample s were collected at baseline and after intervention . Quantitative real-time PCR analysis targeting the 16S rRNA gene of Akkermansia muciniphila was done . We assessed the TNF-α mRNA expression and the serum levels of the high sensitive C-reactive protein ( hs-CRP ) and malondialdehyde ( MDA ) . Results : There was a significant increase in A. muciniphila percent change in inulin and butyrate supplemented groups ( P in TNF-α mRNA expression in group A ( fold change 0.88 ± 0.16 , P Also hs-CRP , MDA and diastolic blood pressure levels decreased significantly in these groups ( P on inflammatory and oxidative stress parameters and led to improvement of hypertension . However , further investigations are needed to make concise conclusions",
"OBJECTIVE The objective of this study was to examine the effects of a gastrointestinal microbiome modulator ( GIMM ) containing inulin , β-glucan , blueberry anthocyanins , and blueberry polyphenols on metabolic parameters , fecal markers of gut microbiota , and satiety . DESIGN AND METHODS Thirty overweight or obese individuals aged 18 to 70years , were enrolled in a r and omized controlled trial . Participants consumed the test product or placebo daily for four weeks . Stool sample s were collected and blood was drawn at baseline and week four for assessment s of gut microbiota , satiety hormones , glucose control , and lipid measures . Subjective satiety was assessed weekly . Linear models were used to compare differences from baseline to week four . RESULTS GIMM consumption improved blood glucose tolerance ( p=0.008 ) , and increased satiety ( p=0.03 ) . There were no statistically significant differences in insulin sensitivity , fecal markers of gut microbiota , plasma satiety hormones , or serum lipid concentrations between the groups . However , plasma satiety hormones and fecal short chain fatty acid concentrations increased in the test group compared to the placebo . CONCLUSIONS GIMM consumption for four weeks , increases satiety , and improves glucose tolerance possibly through insulin-independent pathways",
"Studies on humans with diabetes mellitus showed that the crosstalk between the intestinal microbiota and the host has a key role in controlling the disease . The aim of this study was to evaluate the effects of sodium butyrate and high performance inulin supplementation simultaneously or singly on glycemic status , lipid profile , and glucagon-like peptide 1 level in adults with type 2 diabetes mellitus . Sixty patients were recruited for the study . The participants were r and omly allocated , using r and omized block procedure , to one of the four treatment groups ( A , B , C , or D ) . Group A received sodium butyrate capsules , group B received inulin supplement powder , group C was exposed to the concomitant use of inulin and sodium butyrate , and group D consumed placebo for 45 consecutive days . Markers of glycemia , lipid profile , and glucagon-like peptide 1 were measured pre- and post-intervention . Dietary supplementation in groups A , B , and C significantly reduced diastolic blood pressure in comparison with the placebo group ( p sodium butyrate + inulin ( group C ) significantly reduced fasting blood sugar ( p=0.049 ) and waist to hip ratio ( p=0.020 ) . Waist circumference in groups B and C reduced significantly after the intervention ( p=0.007 and p=0.011 ; respectively ) . The post hoc Tukey tests showed significant increase in glucagon-like peptide 1 concentration in groups A and C in comparison with group D ( p that inulin supplementation may be useful to diabetic patients and these effects could be increased with butyrate supplement",
"OBJECTIVE To investigate the effect of nutrient stimulation of gut hormones by oligofructose supplementation on appetite , energy intake ( EI ) , body weight ( BW ) and adiposity in overweight and obese volunteers . METHODS In a parallel , single-blind and placebo-controlled study , 22 healthy overweight and obese volunteers were r and omly allocated to receive 30 g day(-1 ) oligofructose or cellulose for 6 weeks following a 2-week run-in . Subjective appetite and side effect scores , breath hydrogen , serum short chain fatty acids ( SCFAs ) , plasma gut hormones , glucose and insulin concentrations , EI , BW and adiposity were quantified at baseline and post-supplementation . RESULTS Oligofructose increased breath hydrogen ( P late acetate concentrations ( P = 0.024 ) , tended to increase total area under the curve (tAUC)420 mins peptide YY ( PYY ) ( P = 0.056 ) and reduced tAUC450 mins hunger ( P = 0.034 ) and motivation to eat ( P = 0.013 ) when compared with cellulose . However , there was no significant difference between the groups in other parameters although within group analyses showed an increase in glucagon-like peptide 1 ( GLP-1 ) ( P = 0.006 ) in the cellulose group and a decrease in EI during ad libitum meal in both groups . CONCLUSIONS Oligofructose increased plasma PYY concentrations and suppressed appetite , while cellulose increased GLP-1 concentrations . EI decreased in both groups . However , these positive effects did not translate into changes in BW or adiposity",
"BACKGROUND Type 2 diabetes mellitus , as a noncommunicable disease , is the main public health challenge in the 21st century . The prevalence of diabetes mellitus adjusted for the world population in Iran was 8 % until the year 2010.Lipid levels are considered as important parameters to be evaluated , as high serum lipid levels are often reported as a complication in patients with diabetes mellitus . It is cl aim ed that functional foods may improve complications of diabetes mellitus , so this study was design ed to evaluate the effects of high performance inulin on glycemic status and lipid profile of women with type 2 diabetes . METHODS The study was a r and omized controlled clinical trial . Forty-nine type 2 diabetic females ( fiber intake were divided into two groups . Patients in the intervention group ( n=24 ) received 10g/d inulin and patients in the control group ( n=25 ) received 10g/d maltodextrin for 8 weeks . Glycemic status and lipid profile indices were measured pre and post intervention . Data were analyzed using SPSS software ( verision11.5 ) . Paired , unpaired t-test and ANCOVA were used to compare quantitative variables . RESULTS Supplementation with inulin caused a significant reduction in FBS ( 8.50 % ) , HbA1c ( 10.40 % ) , total cholesterol ( 12.90 % ) , triglyceride ( 23.60 % ) , LDL-c ( 35.30 % ) , LDL-c/HDL-c ratio ( 16.25 % ) and TC/HDL-c ratio ( 25.20 % ) and increased HDL-c ( 19.90 % ) . The changes for the control group parameters were not significant at the end of study . CONCLUSION Inulin may help to control diabetes and its complications via improving glycemic and lipid parameters",
"BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin",
"SCOPE The objective of the present study is to evaluate the effects of milk powder co-supplemented with inulin and resistant dextrin ( MPCIR ) on elderly patients with type 2 diabetes mellitus ( T2DM ) . METHODS AND RESULTS A r and omized , double-blind , placebo-controlled clinical trial is carried out among elderly T2DM patients . The subjects recruited from the community are r and omly assigned to either the MPCIR group or placebo group for 12 weeks intervention . Each group receives 45 g milk powder with or without inulin and resistant dextrin . Anthropometric and metabolic variables are measured . For the MPCIR group , systolic blood pressure ( BP ) and diastolic BP are reduced significantly by 5.45 and 4.56 mm Hg ( p the fasting and 2-h postpr and ial plasma glucose levels , glycosylated serum protein , and insulin resistance index of the MPCIR group are significantly decreased by 0.96 mmol L-1 , 1.47 mmol L-1 , 16.33 μmol L-1 , and 0.65 respectively ( p in 2-h postpr and ial insulin ( p = 0.016 ) and β-cell function index ( p CONCLUSION MPCIR supplementation helps to improve glycemic control , insulin resistance , and blood pressure",
"BACKGROUND S AND AIMS Type 2 diabetic mellitus ( T2DM ) asone of the main causes of morbidity and mortality is associated with immune system disturbances and metabolic abnormalities . In the current study we aim ed to evaluate the effects of oligofructose-enriched inulin on T-cell subsets and their related cytokines , anthropometric and metabolic parameters in patients with T2DM . METHODS Forty-six diabetic females patients were r and omly allocated into intervention ( n=27 ) and control ( n=22 ) groups . Subjects in the intervention group received a daily dose of 10 g of oligofructose-enriched inulin and subjects in control group received a placebo for two months . Anthropometric variables , metabolic parameters including fasting serum glucose ( FSG ) , hemoglobin A1c ( HbA1c ) , lipid profile and blood pressure were measured at the beginning and after two months . Immune markers also included serum interleukin (IL)-4 , IL-12 and interferon (IFN)-γ concentrations were assessed and CD3(+ ) , CD4(+ ) , CD8(+ ) and CD11b(+)T-cell counts were determined by flow cytometry at baseline and end of the trial . RESULTS After two months intervention , significant improvements in anthropometric variables , blood pressure and serum lipids occurred in prebiotic-treated group ( P ) . Serum IL-4 , IL-12 and IFN-γ concentrationsalso significantly decreased in intervention group ( P in CD3(+ ) , CD4(+ ) , CD8(+ ) and CD11b(+ ) T-cell counts were observed in treatment groups after intervention . CONCLUSION The present study showed several beneficial effects of oligofructose-enriched inulin on the improvement of the glycemic status , lipid profile , and immune markers in patients with T2DM . Further studies are needed to confirming our findings and to better clarify the underlying mechanisms",
"BACKGROUND Rodent studies show that oligofructose promotes weight loss , stimulates satiety hormone secretion , reduces energy intake , and improves lipid profiles . OBJECTIVE Our objective was to examine the effects of oligofructose supplementation on body weight and satiety hormone concentrations in overweight and obese adults . DESIGN This study was a r and omized , double-blind , placebo-controlled trial . Forty-eight otherwise healthy adults with a body mass index ( in kg/m2 ) > 25 were r and omly assigned to receive 21 g oligofructose/d or a placebo ( maltodextrin ) for 12 wk . Body composition ( by dual-energy X-ray absorptiometry ) ; meal tolerance tests , including satiety hormone response ; food intake ; and subjective appetite ratings were determined . RESULTS There was a reduction in body weight of 1.03 + /- 0.43 kg with oligofructose supplementation , whereas the control group experienced an increase in body weight of 0.45 + /- 0.31 kg over 12 wk ( P = 0.01 ) . A lower area under the curve ( AUC ) for ghrelin ( P = 0.004 ) and a higher AUC for peptide YY ( PYY ) with oligofructose ( P = 0.03 ) coincided with a reduction in self-reported caloric intake ( P Glucose decreased in the oligofructose group and increased in the control group between initial and final tests ( P Insulin concentrations mirrored this pattern ( P Oligofructose supplementation did not affect plasma active glucagon-like peptide 1 secretion . According to a visual analog scale design ed to assess side effects , oligofructose was well tolerated . CONCLUSIONS Independent of other lifestyle changes , oligofructose supplementation has the potential to promote weight loss and improve glucose regulation in overweight adults . Suppressed ghrelin and enhanced PYY may contribute in part to the reduction in energy intake . The trial was registered at clinical trials.gov as NCT00522353",
"Background : Fermentable carbohydrates ( FCHO ) have been shown to improve insulin sensitivity in normoglycaemic and insulin-resistant subjects . However , there are no data on subjects with prediabetes . We aim ed to investigate the effect of the FCHO inulin , on glucose homeostasis in subjects with prediabetes . Methods : In a double-blind and placebo-controlled crossover study , 40 volunteers with prediabetes were r and omly allocated to take 30 g/day of inulin or cellulose for 2 weeks in a crossover trial , following a 4-week dose-escalation run-in . Fasting insulin and glucose were measured for all subjects . Fifteen of the 40 subjects also underwent a meal tolerance test to assess insulin sensitivity , free fatty acids and glucagon-like peptide-1 concentrations . A sub analysis was carried out to examine any differences between the prediabetes subtypes . Results : Inulin was associated with a significant increase in ( 0 - 30 min)incremental AUC ( iAUC ) for insulin ( treatment : p 60 min)iAUC for insulin ( treatment : p insulin resistance measured by the homeostatic model assessment in the isolated-impaired fasting glucose ( p FCHO , inulin , may have unique metabolic effects that are of particular benefit to people at risk of diabetes , which warrant further investigation"
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41170c62-06ff-11f0-808a-c43d1ab1c353
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Oral submucous fibrosis is a chronic , progressive scarring disease associated with both significant morbidity including pain and limited mouth opening and an increased risk for malignancy . This systematic review evaluated the different medicinal ( i.e. nonsurgical ) interventions available for the management of oral submucous fibrosis . An automated literature search es of online data bases from January 1960 to December 2013 were performed and only studies with high level of evidence based on the guidelines of the Oxford Centre for evidence -based medicine were selected . Thirteen studies ( 3 r and omized controlled trials and 10 clinical trials/controlled clinical trials ) were included and drugs like steroids , hyaluronidase , human placenta extracts , chymotrypsin and collagenase , pentoxifylline , nylidrin hydrochloride , iron and multivitamin supplements including lycopene were used . There is a clear lack of evidence on the available drug treatment for oral submucous fibrosis and further high quality r and omized controlled trials are needed to evaluate the different therapeutic agents
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[
"OBJECTIVES To evaluate the efficacy of oral lycopene therapy in patients with oral submucous fibrosis and to compare these effects with a placebo . STUDY DESIGN Fifty-eight patients with oral submucous fibrosis formed the population for the study and were r and omly divided into 3 groups , evaluated weekly over a 2-month period . Patients of group A ( n = 21 ) received 16 mg of lycopene , those of group B ( n = 19 ) received 16 mg of lycopene along with biweekly intralesional steroid injections , and those of group C ( n = 18 ) were given a placebo . Paired and unpaired t tests were used for statistical evaluation . RESULTS Mouth-opening values for the patients showed an average increase of 3.4 mm , 4.6 mm , and 0.0 mm for patients in groups A , B , and C , respectively . These values were statistically found to be highly significant . CONCLUSIONS The observed effects suggest that lycopene can and should be used as a first line of therapy in the initial management of oral submucous fibrosis",
"Oral submucous fibrosis ( OSF ) is a chronic disease of the oral cavity and oropharyngx characterised by fibrosis in the submucosa leading to progressive limitation of the mouth opening . Interferon gamma ( IFN-gamma ) is a known anti-fibrotic cytokine . In this study we have investigated : a ) the effect of IFN-gamma on collagen synthesis by arecoline-stimulated OSF fibroblasts in vitro ( n=5 ) , b ) the effect of intra-lesional IFN-gamma on the fibrosis of OSF patients ( n=29 ) and c ) the immunohistochemical analysis of pre- and post-treatment inflammatory cell infiltrates and cytokine levels in the lesional tissue ( n=29 ) . The results show that the increased collagen synthesis in vitro in response to arecoline was inhibited in the presence of IFN-gamma ( 0.01 - 10.0 U/ ml ) in a dose-related way . In an open uncontrolled study intra-lesional IFN-gamma treatment showed improvement in the patients mouth opening from an inter-incisal distance before treatment of 21 + /- 7 mm , to 30 + /- 7 mm immediately after treatment and 30 + /- 8 mm 6-months later , giving a net gain of 8 + /- 4 mm ( 42 % ) ( range 4 - 15 mm ) . Patients also reported reduced burning dysaesthesia and increased suppleness of the buccal mucosa . The post-treatment immunohistochemistry showed a decreased amount of inflammatory cell infiltrate and an altered level of cytokines compared with the pre-treatment lesional tissue . The effect of IFN-gamma on collagen synthesis appears to be a key to the treatment of these patients , and intra-lesional injections of the cytokine may have a significant therapeutic effect on OSF",
"Oral submucous fibrosis ( OSF ) is an oral precancerous condition characterized by symptoms such as intolerance to spicy food , altered salivation , progressive difficulty in opening the mouth , and signs like vesiculation , ulceration , blanching , rigidity , and stiffening of the oral mucosa and depapillation and altered mobility of the tongue . It is seen mostly among people of Indian subcontinent origin . The major structural change is extensive fibroelastic scarring of the lamina propria and deeper connective tissues . A combination of micronutrients ( vitamins A , B complex , C , D , and E ) and minerals ( iron , calcium , copper , zinc , magnesium , and others ) was evaluated for its efficacy in controlling the symptoms and signs of OSF in 117 compliant subjects in Karachi , Pakistan , in a single-arm preliminary study . The subjects received supplementation for one to three years . Significant improvement in symptoms , notably intolerance to spicy food , burning sensation , and mouth opening , was observed at exit . The interincisor distance deteriorated in 11 subjects ( 10 % ) at exit ; it was stable in 56 subjects ( 49 % ) and improved in 48 ( 41 % ) . The mean interincisor distance was 19.1 + /- 10.8 ( SD ) mm at exit compared with 16.2 + /- 7.5 mm at baseline . A significant proportion of concomitant lesions like leukoplakia also regressed at exit . The major outcome from this study was a beneficial clinical response in subjects with OSF to multiple micronutrient intervention , which justifies its further evaluation in well- design ed r and omized controlled trials in other setting s in South Asia",
"OBJECTIVE Turmeric extract and turmeric oil have shown chemoprotective effect against chemically-induced malignancies in experimental animals . They can reverse precancerous changes in oral submucous fibrosis in humans . The use of turmeric or Curcuma longa Linn as a spice and household remedy has been known to be safe for centuries . In view of the long term administration required for cancer prevention a Phase I clinical trial of turmeric oil ( TO ) was design ed to study the safety and tolerance of TO in volunteers for a period of 3 months . MATERIAL AND METHODS Nine healthy volunteers between 20 and 33 years of age were tested for haemoglobin , blood counts , liver and kidney functions , bleeding and clotting time and serum electrolytes initially and at 1 and 3 months of treatment . They were administered 0.6 ml of TO three times a day for 1 month and 1 ml in 3 divided doses for 2 months . The acute tolerability study on Day 1 was conducted in a Clinical Pharmacology daycare Unit . Blood pressure and pulse were recorded frequently on Day 1 and at 24 , 48 , 72 and 96 hours and fortnightly till 12 weeks . Volunteers were daily supervised for TO intake as well as for any side effects throughout the study period . RESULTS Nine volunteers were enrolled for the study . One discontinued on 3rd day for allergic skin rashes which , on discontinuation of TO , gradually disappeared by two weeks . Another discontinued on 7th day for intercurrent fever requiring antibiotic treatment . Seven volunteers completed the study . There was no effect of TO , in two doses , on pulse and blood pressure and no side effects in acute tolerability study on Day 1 . There was no effect of TO intake on weight , blood pressure , symptoms and signs upto 12 weeks . There was no clinical , haematological , renal or hepatic-toxicity of TO at 1 month and 3 months . Serum lipids did not show significant change except in one volunteer ( reversible ) . CONCLUSIONS In view of the potential for reversing oral submucous fibrosis , a precancerous condition for oral cancer , TO , can be recommended directly for a Phase II trial in patients",
"BACKGROUND Previous studies have shown that the local and systemic upregulation of fibrogenic cytokines and downregulation of antifibrotic cytokine are central to the pathogenesis of oral submucous fibrosis ( OSF ) . The milk from cows immunized with human intestinal bacteria ( immune milk ) contains an anti-inflammatory component that may suppress the inflammatory reaction and modulate cytokine production . Therefore , it was decided to test whether immune milk may have some beneficial effects on controlling the symptoms and signs in OSF patients . METHODS In this preliminary study , 26 OSF patients who received immune milk treatment ( 45 g of immune milk powder twice a day ) for 3 months and oral habit intervention were included in the experimental group . Another 20 OSF patients who received only oral habit intervention served as the control group . RESULTS We found that the interincisor distance was significantly improved ( > or =3 mm of the baseline measurement ) in 18 of the 26 ( 69.2 % ) OSF patients in the experimental group at exit . However , in the control group none of the OSF patients had an increase in interincisor distance greater than 2 mm . In addition , disappearance or significant improvement of symptoms at exit was observed in 80 % ( 16/20 ) of the patients with intolerance to spicy foods ( P regression of concomitant oral leukoplakia or erythroplakia ( judged from the size reduction of the lesions ) at exit was noted in 71.4 % ( 5/7 ) of the patients in the experimental group ( P immune milk leads to significant improvements of symptoms and signs in OSF patients",
"Conventional therapies practised in the treatment of asymptomatic neuralgia , oral submucous fibrosis and paraesthesic numbness , are empirical and symptomatic in nature . These are usually prolonged and may be inadequate , impractical with complete or incomplete remissions associated with or without relapses . High dosages of drugs administered for longer duration , are also not infrequently without side-effects . With these problems in view , the clinical use of nylidrin hydrochloride a peripheral vasodilator , was experienced for over 10 years . Irrespective of age , sex and status , 97 cases were r and omly extracted from the hospital and oral surgery clinical records . The projected sample included 33 cases of asymptomatic neuralgia , 58 cases of oral submucous fibrosis and 6 cases of numbness . Neuralgia , where mean age was 50 years , was treated with nylidrin hydrochloride , vitamin B-complex and carbamazepine . Oral submucous fibrosis where mean age was 38 years , was treated with nylidrin hydrochloride , vitamins A , E , B-complex , iodine , placental extract , local and systemic corticosteroids and physiotherapy . Paraesthesic numbness , following iatrogenic or accidental trauma to the affected nerve , was treated with nylidrin hydrochloride and B-complex therapy . Peripheral vasodilator administered in all 97 cases , initially contained low divided doses , which steadily were increased or decreased as per individual response . There were reportedly no side-effects , except complaints of flushingly warm skin . Supportive therapy with antibacterials , tranquilizers and analgesics , along with minor dental surgery , were given as and when required . The success rate was 72.16 % in total , while individually it varied from 84.85 % in neuralgia , 62.07 % in oral submucous fibrosis and 100 % in numbness . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE This study was design ed to determine the effect of pentoxifylline ( Trental ) on the clinical and pathologic course of oral submucous fibrosis . This drug is a methylxanthine derivative that has vasodilating properties and was envisaged to increase mucosal vascularity . STUDY DESIGN This investigation was conducted as a r and omized clinical trial incorporating a control group ( St and ard drug group SDG , multivitamin , and local heat therapy ) in comparison to pentoxifylline test cases ( Experimental drug group EDG , 400 mg 3 times daily , as coated , sustained release tablets ) . The stipulated treatment period was 7 months and a total of 29 cases of advanced fibrosis ( 14 test subjects and 15 age and sex matched diseased controls ) were included in this study and 100 % compliance was reported at the end ofthe test period . RESULTS Mild gastric irritation that could be managed by diet protocol s was the only untoward symptom reported during this trial . Review of the patients and controls was done at an interval of 30 days and subjective and objective measurements were recorded . The follow up data at each visit with respect to each other and to base-line values was calibrated using a nonparametric test of Mann-Whitney ( Kruskal-Wallis test ) . Significant comparisons with regard to improvement were recorded as objective criteria of mouth opening ( t=11.285 , p= 0.000 ) , tongue protrusion ( t= 3.898 , p = 0.002 ) , and relief from perioral fibrotic b and s ( p = 0.0001554 ) . Subjective symptoms of intolerance to spices ( p = 0.0063218 ) , burning sensation of mouth ( p = 0.0005797 ) , tinnitus ( p=0.000042 ) , difficulty in swallowing ( p=0.0000714 ) . and difficulty in speech ( p=0.0000020 ) were also recorded significant improvement at the end of the trial period . CONCLUSION This pilot investigation points to the effectiveness of pentoxifylline as an adjunct therapy in the routine management of oral submucous fibrosis"
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41170ca8-06ff-11f0-808a-c43d1ab1c353
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We conducted this systematic review and meta- analysis of prospect i ve studies to determine the effect of probiotic administration on serum C-reactive protein ( CRP ) concentrations . We search ed PubMed - Medline , Web of Science , the Cochrane , and Google Scholar data bases ( until May 2016 ) to identify prospect i ve studies evaluating the impact of probiotic administration on CRP . We used a r and om effects models and generic inverse variance methods to synthesize quantitative data , followed by a leave-one-out method for sensitivity analysis . The systematic review registration number was : CRD42016039457 . From a total of 425 entries identified via search es , 20 studies were included in the final analysis . The meta- analysis indicated a significant reduction in serum CRP following probiotic administration with a weighted mean difference ( WMD ) of -1.35 mg/L , ( 95 % confidence interval ( CI ) -2.15 to -0.55 , I² 65.1 % ) . The WMDs for interleukin 10 ( IL10 ) was -1.65 pg/dL , ( 95 % CI -3.45 to 0.14 , I² 3.1 % ) , and -0.45 pg/mL , ( 95 % CI -1.38 to 0.48 , I² 10.2 % ) for tumor necrosis factor alpha ( TNF-α ) . These findings were robust in sensitivity analyses . This meta- analysis suggests that probiotic administration may significantly reduce serum CRP while having no significant effect on serum IL10 and TNF-α
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"Background : Bacterial translocation occurs in surgical patients and may predispose to postoperative septic morbidity . Many factors are thought to influence the prevalence of bacterial translocation , one of which is the composition of the gut microflora . The aim of this prospect i ve and r and omised study was to assess the effect of the probiotic Lactobacillus plantarum 299v on the incidence of bacterial translocation , gastric colonisation , and septic complications in elective surgical patients . Methods : Patients undergoing elective major abdominal surgery were r and omised to either a treatment or control group . The treatment group received an oral preparation containing Lactobacillus plantarum 299v ( Proviva ) for at least one week preoperatively and also in the postoperative period . Bacterial translocation was determined by culture of a mesenteric lymph node and serosal scraping obtained at laparotomy . Gastric colonisation was assessed by microbiological culture of nasogastric aspirates . All postoperative septic complications were recorded . Results : A total of 129 patients completed the study ( probiotic group n=64 ) . There was no significant difference between the two groups in terms of bacterial translocation ( 12 % v 12 % ; p=0.82 ) , gastric colonisation with enteric organisms ( 11 % v 17 % ; p=0.42 ) , or septic morbidity ( 13 % v 15 % ; p=0.74 ) . Conclusions : Administration of Lactobacillus plantarum 299v in elective surgical patients does not influence the rate of bacterial translocation , gastric colonisation , or incidence of postoperative septic morbidity",
"BACKGROUND The aging process can lead to a decline in cellular immunity . Therefore , the elderly could benefit from safe and effective interventions that restore cellular immune functions . OBJECTIVE We determined whether dietary supplementation with the known immunostimulating probiotic Bifidobacterium lactis HN019 could enhance aspects of cellular immunity in elderly subjects . DESIGN Thirty healthy elderly volunteers ( age range : 63 - 84 y ; median : 69 y ) participated in a 3-stage dietary supplementation trial lasting 9 wk . During stage 1 ( run-in ) , subjects consumed low-fat milk ( 200 mL twice daily for 3 wk ) as a base-diet control . During stage 2 ( intervention ) , they consumed milk supplemented with B. lactis HN019 in a typical dose ( 5 x 10(10 ) organisms/d ) or a low dose ( 5 x 10(9 ) organisms/d ) for 3 wk . During stage 3 ( washout ) , they consumed low-fat milk for 3 wk . Changes in the relative proportions of leukocyte subsets and ex vivo leukocyte phagocytic and tumor-cell-killing activity were determined longitudinally by assaying peripheral blood sample s. RESULTS Increases in the proportions of total , helper ( CD4(+ ) ) , and activated ( CD25(+ ) ) T lymphocytes and natural killer cells were measured in the subjects ' blood after consumption of B. lactis HN019 . The ex vivo phagocytic capacity of mononuclear and polymorphonuclear phagocytes and the tumoricidal activity of natural killer cells were also elevated after B. lactis HN019 consumption . The greatest changes in immunity were found in subjects who had poor pretreatment immune responses . In general , the 2 doses of B. lactis HN019 had similar effectiveness . CONCLUSION B. lactis HN019 could be an effective probiotic dietary supplement for enhancing some aspects of cellular immunity in the elderly",
"BACKGROUND The optimal source and amount of dietary carbohydrate for managing type 2 diabetes ( T2DM ) are unknown . OBJECTIVE We aim ed to compare the effects of altering the glycemic index or the amount of carbohydrate on glycated hemoglobin ( HbA1c ) , plasma glucose , lipids , and C-reactive protein ( CRP ) in T2DM patients . DESIGN Subjects with T2DM managed by diet alone ( n=162 ) were r and omly assigned to receive high-carbohydrate , high-glycemic-index ( high-GI ) , high-carbohydrate , low-glycemic-index ( low-GI ) , or low-carbohydrate , high-monounsaturated-fat ( low-CHO ) diets for 1 y. RESULTS The high-GI , low-GI , and low-CHO diets contained , respectively , 47 % , 52 % , and 39 % of energy as carbohydrate and 31 % , 27 % , and 40 % of energy as fat ; they had GIs of 63 , 55 , and 59 , respectively . Body weight and HbA1c did not differ significantly between diets . Fasting glucose was higher ( P=0.041 ) , but 2-h postload glucose was lower ( P=0.010 ) after 12 mo of the low-GI diet . With the low-GI diet , overall mean triacylglycerol was 12 % higher and HDL cholesterol 4 % lower than with the low-CHO diet ( P ratio of total to HDL cholesterol disappeared by 6 mo ( time x diet interaction , P=0.044 ) . Overall mean CRP with the low-GI diet , 1.95 mg/L , was 30 % less than that with the high-GI diet , 2.75 mg/L ( P=0.0078 ) ; the concentration with the low-CHO diet , 2.35 mg/L , was intermediate . CONCLUSIONS In subjects with T2DM managed by diet alone with optimal glycemic control , long-term HbA1c was not affected by altering the GI or the amount of dietary carbohydrate . Differences in total : HDL cholesterol among diets had disappeared by 6 mo . However , because of sustained reductions in postpr and ial glucose and CRP , a low-GI diet may be preferred for the dietary management of T2DM",
"Background : The dramatic increase in the incidence of diabetes and its associated complications require a natural and safe solution to control and delay such complications . The present study tested the hypothesis that probiotics may affect biochemical indices of diabetic patients Methods : Thirty four types 2 diabetic patients aged between 25 to 65 years , and diagnosed with diabetes for less than 15 years were selected for this single- blinded clinical trial . Using balanced block r and om sampling , the patients were divided into two groups of intervention ( probiotics ) and placebo . Blood sample s tested for baseline glucose , insulin , TG , total cholesterol , LDL-C , HDL-C , malondialdehyde , high sensitive CRP ( hs-CRP ) and IL-6 . After six weeks of experiment , fasting blood sample s were re-tested and the data obtained were analyzed using SPSS software . Results : There were no significant differences between anthropometric data including body mass index and waist to hip ratio in placebo and treatment groups . There was no significant difference in FBS , Serum TG concentration total cholesterol and LDL-C levels between placebo and treatment groups . HDL-C levels were slightly elevated after probiotic treatment , which were not statistically significant . Insulin , MDA and IL-6 levels were reduced and high sensitive CRP hs . CRP levels were elevated , although , not statistically significant . Conclusion : The result of this study indicates a non- significant declining trend in the level of TG , MDA and IL-6 and insulin resistance after consumption of probiotics",
"OBJECTIVE : The aim of this study was to determine the effects of synbiotic food consumption on glycemic status and serum high sensitivity C-reactive protein ( hs-CRP ) levels of Iranian pregnant women . DESIGN : This r and omized placebo-controlled clinical trial was performed among 52 pregnant women , primigravida , aged 18–35 year old , in their third trimester . After a 2-wk run-in period , subjects were r and omly assigned to consume either a synbiotic ( n=26 ) or control food ( n=26 ) for 9 weeks . The synbiotic food consisted of a probiotic Lactobacillus sporogenes ( 1 × 107 CFU ) , 0.04 g inulin as prebiotic with 0.38 g isomalt , 0.36 g sorbitol and 0.05 g stevia as sweetener per 1 g. Control food ( the same substance without probiotic bacteria and inulin ) was packed in identical 9-gram packages . Patients were asked to consume the synbiotic and control foods two times a day . Fasting blood sample s were taken at baseline and after a 9-wk intervention for quantification of related factors . RESULTS : Consumption of a synbiotic food did not show any significant change regarding the impact of insulin actions in the synbiotic group ; nonetheless , compared to the control food , it result ed in a significant decrease in serum insulin levels ( −0.26 vs. 6.34 µIU/mL , P=0.014 ) and HOMA-IR ( −0.13 vs. 1.13 , P=0.033 ) , a significant difference in HOMA-B ( 5.30 vs. 34.22 , P=0.040 ) and a significant rise in QUICKI score ( 0.002 vs. −0.02 , P=0.022 ) . CONCLUSIONS : Consumption of a synbiotic food for 9 weeks by pregnant women had beneficial effects on insulin actions compared to the control food , but did not affect FPG and serum hs-CRP concentrations ",
"ABSTRACT Aim : This was a pilot clinical trial to assess biochemical and clinical effects of an oral probiotic dietary supplement in chronic kidney disease ( CKD ) patients ( stages 3 and 4 ) . Methods : A prospect i ve , r and omized , double-blind , crossover , placebo-controlled , 6-month trial of probiotic bacteria was conducted in 16 out patients in Ontario , Canada . Primary endpoints included effect on hematologic , biochemical , and fecal variables , and on general well-being as assessed by quality of life ( QOL ) . These outcomes were evaluated from biochemical parameters , mainly blood urea nitrogen ( BUN ) , creatinine , uric acid , and C-reactive protein ( CRP ) as a general inflammatory marker . QOL was assessed on a subjective scale of 1 to 10 as the secondary parameter . Trial registration : This pilot study forms part of registered trial NCT00760162 . Results : A total of 13 patients completed the study . Three patients dropped out : one was the receiver of a transplant . The second dropped out for unknown reasons and the third died of myocardial infa rct ion ( unrelated to probiotic bacteria or the protocol ) . Among the 13 patients who completed the trial , the mean change in BUN concentration during the probiotic treatment period ( −2.93 mmol/L ) differed significantly ( p = 0.002 ) from the mean change in BUN concentration during the placebo period ( 4.52 mmol/L ) . In addition , the mean changes in uric acid concentration were moderate during the KB period ( 24.70 μmol/L ) versus during the placebo period ( 50.62 μmol/L , p = 0.050 ) , and the changes in serum creatinine concentration were insignificant . Neither gastrointestinal nor infectious complications were noted in any subject with improved QOL . Conclusion : Orally administered probiotic bacteria selected to metabolize nitrogenous wastes may be tolerated for as long as 6 months . A major limitation of this trial is its small size that may have precluded detection of changes in other biochemical or hematologic parameters that would be evident in larger cohorts . Extension of the evaluation of this probiotic bacterial mixture will include a dose escalation trial in a similar prospect i ve , placebo-controlled , and double-blind study site",
"Background —Inflammatory mediators regulate key aspects of lipid metabolism . We hypothesized that inflammation could diminish the cholesterol-lowering effect of a reduced-fat/low-cholesterol diet . Methods and Results —After a 2-week run-in period on a control diet ( 37 % total fat , 16 % saturated fat ) , 100 participants were r and omized to the control or DASH diet ( 27 % total fat , 6 % saturated fat ) for 12 weeks . Median C-reactive protein ( CRP ) at baseline was 2.37 mg/L ( interquartile range , 1.20 , 3.79 ) . The DASH diet , net of control , had no effect on CRP . Overall , there were significant net reductions in total ( −0.34 mmol/L ) , LDL ( −0.29 mmol/L ) , and HDL ( −0.12 mmol/L ) cholesterol from the DASH diet ( each , P change in triglycerides ( + 0.05 mmol/L , P = 0.21 ) . Baseline CRP was strongly associated with lipid responsiveness to the DASH diet . Total and LDL cholesterol were reduced to a greater degree in those with a “ low ” ( below median ) compared with a “ high ” ( above median ) baseline CRP ( total , −9.8 % versus −3 % ; P for interaction=0.006 ; LDL cholesterol , −11.8 % versus −3 % ; P for interaction=0.009 ) . Reductions in HDL cholesterol ( −8.8 % ) were similar in persons with low versus high CRP . Triglycerides were increased in those with a high CRP but not in those with a low CRP ( 19.8 % versus + 0 % ; P for interaction=0.019 ) . Conclusions —In this study , the presence of increased CRP was associated with less total and LDL cholesterol reduction and a greater increase in triglycerides from a reduced-fat/low-cholesterol diet . These findings document an additional mechanism by which inflammation might increase cardiovascular disease risk",
"Background and aims : Ulcerative colitis ( UC ) is an acute and chronic inflammatory disease of the large bowel with unknown aetiology . The immune response against normal commensal microorganisms is believed to drive inflammatory processes associated with UC . Therefore , modulation of bacterial communities on the gut mucosa , through the use of probiotics and prebiotics , may be used to modify the disease state . Methods : A synbiotic was developed for use in UC patients combining a probiotic , Bifidobacterium longum , isolated from healthy rectal epithelium , and a prebiotic ( Synergy 1 ) , a preferential inulin-oligofructose growth substrate for the probiotic strain . Treatment was employed in a double blinded r and omised controlled trial using 18 patients with active UC for a period of one month . Clinical status was scored and rectal biopsies were collected before and after treatment , and transcription levels of epithelium related immune markers were measured . Results : Sigmoidoscopy scores ( scale 0–6 ) were reduced in the test group ( start 4.5 ( 1.4 ) , end 3.1 ( 2.5 ) ) compared with placebo ( start 2.6 ( 2.1 ) , end 3.2 ( 2.2 ) ) ( p = 0.06 ) . mRNA levels for human beta defensins 2 , 3 , and 4 , which are strongly upregulated in active UC , were significantly reduced in the test group after treatment ( p = 0.016 , 0.038 , and 0.008 , respectively ) . Tumour necrosis factor α and interleukin 1α , which are inflammatory cytokines that drive inflammation and induce defensin expression , were also significantly reduced after treatment ( p = 0.018 and 0.023 , respectively ) . Biopsies in the test group had reduced inflammation and regeneration of epithelial tissue . Conclusions : Short term synbiotic treatment of active UC result ed in improvement of the full clinical appearance of chronic inflammation in patients receiving this therapy",
"Background : It is possible to manipulate the composition of the gastrointestinal microflora by administration of pre- and probiotics . This may help to preserve gut barrier function and reduce the incidence of septic morbidity . Aims : To assess the effects of a combination of pre- and probiotics ( synbiotic ) on bacterial translocation , gastric colonisation , systemic inflammation , and septic morbidity in elective surgical patients . Patients : Patients were enrolled two weeks prior to elective abdominal surgery . Seventy two patients were r and omised to the synbiotic group and 65 to the placebo group . Patients were well matched regarding age and sex distribution , diagnoses , and POSSUM scores . Methods : Patients in the synbiotic group received a two week preoperative course of Lactobacillus acidophilus La5 , Bifidobacterium lactis Bb-12 , Streptococcus thermophilus , and Lactobacillus bulgaricus , together with the prebiotic oligofructose . Patients in the placebo group received placebo capsules and sucrose powder . At surgery , a nasogastric aspirate , mesenteric lymph node , and scrapings of the terminal ileum were harvested for microbiological analysis . Serum was collected preoperatively and on postoperative days 1 and 7 for measurement of C reactive protein , interleukin 6 , and antiendotoxin antibodies . Septic morbidity and mortality were recorded . Results : There were no significant differences between the synbiotic and control groups in bacterial translocation ( 12.1 % v 10.7 % ; p = 0.808 , χ2 ) , gastric colonisation ( 41 % v 44 % ; p = 0.719 ) , systemic inflammation , or septic complications ( 32 % v 31 % ; p = 0.882 ) . Conclusions : In this study , synbiotics had no measurable effect on gut barrier function in elective surgical patients . Further studies investigating the place of pre- and probiotics in clinical practice are required",
"Objectives : The purpose of this study was to investigate whether probiotics had an effect on proinflammatory markers and cytokines in overweight and obese individuals and whether they could have synergistic effects with weight-loss diets . Methods : A total of 75 healthy overweight and obese individuals completed this r and omized doubled-blind controlled clinical trial . Participants were r and omly assigned to groups consuming regular yogurt with a low-calorie diet ( LCD , RLCD ; n = 25 ) or receiving probiotic yogurt with LCD ( PLCD ; n = 25 ) or consuming probiotic yogurt without LCD ( PWLCD ; n = 25 ) for 8 weeks . The pribiotic regimen contained 200 g/day yogurt , enriched by Lactobacillus acidophilus La5 , Bifidobacterium BB12 , and Lactobacillus casei DN001 108 colony-forming units/g . Body fat percentage , high-sensitive C-reactive protein ( hs-CRP ) , tumor necrosis factor-alpha ( TNF-α ) , leptin , and mRNA levels of inflammation-related genes ( TNF-α and RAR-related orphan receptor gamma [ ROR-γt ] ) in peripheral blood mononuclear cells ( P BMC s ) were measured . Results : A reduction in body mass index ( BMI ) , fat percentage , and leptin level was observed that was more obvious in groups who received the weight-loss diet with probiotic yogurt . Reduction in the gene expression of ROR-γt was significant in the PLCD group ( p The expression of TNF-α did not change among all groups after intervention . The mean concentration of leptin was significantly decreased in all groups after the dietary intervention , but the mean changes in leptin level in the PLCD group was more prominent compared to the other two groups ( −2.38 , p The reduction in serum levels of hs-CRP was more evident in the PWLCD group compared to the PLCD and RLCD groups after the 8-week intervention ( −3.4 , p = 0.03 vs −1.76 , p the weight-loss diet and probiotic yogurt had synergistic effects on T-cells subset specific gene expression in P BMC s , fat percentage , and body weight among overweight and obese individuals",
"To evaluate the effects of probiotic ( VSL#3 ) and omega-3 fatty acid on insulin sensitivity , blood lipids , and inflammation , we conducted a clinical trial in 60 overweight ( BMI > 25 ) , healthy adults , aged 40–60 years . After initial screening the subjects were r and omized into four groups with 15 per group . The four groups received , respectively , placebo , omega-3 fatty acid , probiotic VSL#3 , or both omega-3 and probiotic , for 6 weeks . Blood and fecal sample s were collected at baseline and after 6 weeks . The probiotic ( VSL#3 ) supplemented group had significant reduction in total cholesterol , triglyceride , LDL , and VLDL and had increased HDL ( P VSL#3 improved insulin sensitivity ( P decreased hsCRP , and favorably affected the composition of gut microbiota . Omega-3 had significant effect on insulin sensitivity and hsCRP but had no effect on gut microbiota . Addition of omega-3 fatty acid with VSL#3 had more pronounced effect on HDL , insulin sensitivity and hsCRP . Subjects with low HDL , insulin resistance , and high hsCRP had significantly lower total lactobacilli and bifidobacteria count and higher E. coli and bacteroides count ",
"Background . Primary goal of this r and omized , double-blind , placebo-controlled crossover study of Renadyl in end-stage renal disease patients was to assess the safety and efficacy of Renadyl measured through improvement in quality of life or reduction in levels of known uremic toxins . Secondary goal was to investigate the effects on several biomarkers of inflammation and oxidative stress . Methods . Two 2-month treatment periods separated by 2-month washout and crossover , with physical examinations , venous blood testing , and quality of life question naires completed at each visit . Data were analyzed with SAS V9.2 . Results . 22 subjects ( 79 % ) completed the study . Observed trends were as follows ( none reaching statistical significance ): decline in WBC count ( −0.51 × 109/L , P = 0.057 ) and reductions in levels of C-reactive protein ( −8.61 mg/L , P = 0.071 ) and total indoxyl glucuronide ( −0.11 mg% , P = 0.058 ) . No statistically significant changes were observed in other uremic toxin levels or measures of QOL . Conclusions . Renadyl appeared to be safe to administer to ESRD patients on hemodialysis . Stability in QOL assessment is an encouraging result for a patient cohort in such advanced stage of kidney disease . Efficacy could not be confirmed definitively , primarily due to small sample size and low statistical power — further studies are warranted",
"Introduction Traumatic brain injury ( TBI ) is associated with a profound immunological dysfunction manifested by a severe shift from T-helper type 1 ( Th1 ) to T-helper type 2 ( Th2 ) response . This predisposes patients to infections , sepsis , and adverse outcomes . Probiotic bacteria have been shown to balance the Th1/Th2 cytokines in allergic murine models and patients . For the present study , we hypothesized that the enteral administration of probiotics would adjust the Th1/Th2 imbalance and improve clinical outcomes in TBI patients . Methods We design ed a prospect i ve , r and omized , single-blind study . Patients with severe TBI and Glasgow Coma Scale scores between 5 and 8 were included , result ing in 26 patients in the control group and 26 patients in the probiotic group . All patients received enteral nutrition via a nasogastric tube within 24 to 48 hours following admission . In addition , the probiotic group received 109 bacteria of viable probiotics per day for 21 days . The associated serum levels of Th1/Th2 cytokines , Acute Physiology and Chronic Health Evaluation ( APACHE ) II and Sequential Organ Failure Assessment ( SOFA ) scores , nosocomial infections , length of ICU stay , and 28-day mortality rate were studied . Results The patients responded to viable probiotics , and showed a significantly higher increase in serum IL-12p70 and IFNγ levels while also experiencing a dramatic decrease in IL-4 and IL-10 concentrations . APACHE II and SOFA scores were not significantly affected by probiotic treatment . Patients in the probiotic group experienced a decreased incidence of nosocomial infections towards the end of the study . Shorter ICU stays were also observed among patients treated with probiotic therapy . However , the 28-day mortality rate was unaffected . Conclusions The present study showed that daily prophylactic administration of probiotics could attenuate the deviated Th1/Th2 response induced by severe TBI , and could result in a decreased nosocomial infection rate , especially in the late period . Trial registration ChiCTR-TRC-10000835",
"OBJECTIVES To assess the impact of a personalized diet , with or without addition of VSL#3 preparation , on biomarkers of inflammation , nutrition , oxidative stress and intestinal microbiota in 62 healthy persons aged 65 - 85 years . DESIGN Open label , r and omized , multicenter study . PRIMARY ENDPOINT High-sensitivity C-reactive protein . SETTING Community . INTERVENTIONS Eight week web-based dietary advice ( RISTOMED platform ) alone or with supplementation of VSL#3 ( 2 capsules per day ) . The RISTOMED diet was optimized to reduce inflammation and oxidative stress . MEASUREMENTS Blood and stool sample s were collected on days 1 and 56 . RESULTS Diet alone reduced ESR ( p = 0.02 ) , plasma levels of cholesterol ( p and glucose ( p = 0.03 ) . Addition of VSL#3 reduced ESR ( p = 0.05 ) and improved folate ( p = 0.007 ) , vitamin B12 ( p = 0.001 ) and homocysteine ( p . Neither intervention demonstrated any further effects on inflammation . Subgroup analysis showed 40 participants without signs of low- grade inflammation ( hsCRP mg/l , subgroup 1 ) and 21 participants with low- grade inflammation at baseline ( hsCRP≥3 mg/l , subgroup 2 ) . In subgroup 2 addition of VSL#3 increased bifidobacteria ( p = 0.005 ) in more participants and improved both folate ( p = 0.015 ) and vitamin B12 ( p = 0.035 ) levels compared with subgroup 1 . The increases were positively correlated to the change in the bifidobacteria concentration for folate ( p = 0.023 ) and vitamin B12 ( p = 0.001 ) . As expected change in homocysteine correlated negatively to change in folate ( r = -0.629 , p = 0.002 ) and vitamin B12 ( r = -0.482 , p = 0.026 ) . CONCLUSIONS Addition of VSL#3 increased bifidobacteria and supported adequate folate and vitamin B12 concentrations in subjects with low- grade inflammation . Decrease in homocysteine with VSL#3 was clinical ly relevant . suggesting protective potentials for aging-associated conditions , e.g. cardiovascular or neurological diseases . Clinical Trials.gov : NCT01069445-NCT01179789",
"Objective . To investigate the effect of an orally administered probiotic on disease activity , fatigue , quality of life , and intestinal symptoms in patients with active spondyloarthritis . Methods . Patients with active spondyloarthritis [ defined as Bath Ankylosing Spondylitis Disease Activity Index ( BASDAI ) ≥ 3 , Bath Ankylosing Spondylitis Functional Index ( BASFI ) ≥ 3 , Maastricht Ankylosing Spondylitis Enthesitis Score ( MASES ) ≥ 2 , or peripheral joint count ≥ 2 ] were r and omized to oral probiotic or placebo for 12 weeks . Patients and assessors were blinded to treatment allocation . The primary outcome measure was 10 % improvement in the BASFI . Additional outcome measures were improvements in the ASsessment s in Ankylosing Spondylitis (ASAS)-endorsed core domains : pain , spinal mobility , patient global , peripheral joint and entheseal scores , stiffness , C-reactive protein , and fatigue . The ASAS20 criteria , a composite measure of response , were also applied . Quality of life and bowel symptoms were quantified using the Ankylosing Spondylitis Quality of Life Question naire ( ASQoL ) and Dudley Inflammatory Bowel Symptom Question naire ( DISQ ) . Results . Sixty-three patients were r and omized to oral probiotic ( n = 32 ) or placebo ( n = 31 ) . All patients completed the trial . No significant difference was noted between groups in any of the core domains . The mean BASFI fell from 3.5 ± 2.0 to 2.9 ± 1.9 in the probiotic group and from 3.6 ± 1.9 to 3.1 ± 2.2 in the placebo group ( p = 0.839 ) . The mean BASDAI fell from 4.2 ± 2.2 to 3.2 ± 2.1 in the probiotic group and 4.5 ± 2.0 to 3.9 ± 2.2 in the placebo group ( p = 0.182 ) . No significant adverse events were recorded in the probiotic-treated group . Conclusion . In this r and omized controlled trial , the probiotic combination administered did not demonstrate significant benefit over placebo , despite a theoretical rationale for this therapy",
"Objective : To study the effects of Lactobacillus rhamnosus GG ( LGG ) on rheumatoid arthritis ( RA ) . Methods : Twenty‐one RA patients were r and omised to receive 2 capsules of LGG or a placebo twice daily in double‐blind fashion for 12 months . Arthritis activity was evaluated by clinical examination , HAQ index , and laboratory tests ( e.g. ESR , CRP , pro‐ and anti‐inflammatory cytokines ) . Results : There were no statistical differences in the clinical parameters , biochemical variables and HAQ index between the study groups over the intervention period . The mean number of tender and swollen joints decreased from 8.3 to 4.6 in the Lactobacillus group and from 5.5 to 4.8 in the placebo group ( p=0.41 ) . According to the global assessment the RA activity was reduced in 71 % ( LGG group ) vs. 30 % ( controls ) ( p=0.15 ) . Serum IL‐1β increased slightly in the LGG group ( p=0.07 ) , but no differences were seen in IL‐6 , TNF‐α , MPO , IL‐10 or 1L‐12 . Conclusions : Although there were no statistical significant differences in the activity of RA , more subjects in the LGG group reported subjective well being . More studies on the effects of probiotic bacteria in RA are needed",
"Background : Polycystic ovary syndrome ( PCOS ) is a polygenic endocrine disorder in women of reproductive age that lead to infertility . The aim of this study was to investigate the effects of probiotic on pancreatic β-cell function and C-reactive protein ( CRP ) in PCOS patients . Methods : This r and omized double-blind placebo-controlled clinical trial was conducted among 72 women aged 15–40 years old diagnosed with PCOS . Participants were r and omly assigned to two groups receiving : ( 1 ) Probiotic supplements ( n = 36 ) , ( 2 ) placebo ( n = 36 ) for 8-week . Fasting blood sample s were taken at baseline and after 8-week of intervention . Results : Probiotic supplementation , compare with placebo , reduced fasting blood sugar ( −4.15 ± 2.87 vs. 2.57 ± 5.66 mg/dL , respectively P = 0.7 ) , serum insulin levels in crude model ( −0.49 ± 0.67 vs. 0.34 ± 0.82 μIU/mL , respectively , P = 0.09 ) , homeostasis model of assessment -insulin resistance score ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) nonsignificantly . Serum insulin levels after adjustment with covariates reduced significantly in probiotic group ( P = 0.02 ) . We did not found any significant differences in mean changes of CRP between groups ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) . Conclusions : A 8-week multispecies probiotics supplementation had nonsignificantly beneficial effect on pancreatic β-cell function and CRP in PCOS patients . After adjustment for some covariates , serum insulin changes were significantly different between groups",
"Background : Microbial translocation has been associated with an increase in immune activation and inflammation in HIV infection despite effective highly active antiretroviral therapy . It has been shown that some probiotics have a beneficial effect by reducing intestinal permeability and , consequently , microbial translocation . Objectives : To assess changes in microbial translocation and inflammation after treatment with probiotics ( Saccharomyces boulardii ) in HIV-1–infected patients with virologic suppression . Methods : A double-blind , r and omized , placebo-controlled trial was conducted in 44 nonconsecutive HIV-1–infected patients with viral load of Patients were r and omized to oral supplementation with probiotics or placebo during 12 weeks . Markers of microbial translocation ( lipopolysaccharide-binding protein [ LBP ] and soluble CD14 ) , inflammation ( interleukin 6 [ IL-6 ] , tumor necrosis factor alpha , interferon gamma , high-sensitivity C-reactive protein ) , and immunological and clinical data were determined before and after the intervention and 3 months after treatment discontinuation . Quantitative variables were compared using the Mann – Whitney U test , and categorical variables were compared using the Fisher exact test . Results : After 12 weeks of treatment , differences between the probiotic arm and the placebo arm were observed in LBP values ( −0.30 vs + 0.70 pg/mL ) and IL-6 ( −0.60 vs + 0.78 pg/mL ) . These differences were also noted at 3 months after treatment withdrawal . Qualitative analysis was performed , defining a variable as “ decreased ” or “ increased ” from baseline LBP . A significant decrease of LBP at 12 weeks of treatment was observed ( 57.9 % patients in the probiotic group vs 6.2 % in the placebo group , P = 0.002 ) . Conclusions : Treatment with S. boulardii decreases microbial translocation ( LBP ) and inflammation parameters ( IL-6 ) in HIV-1–infected patients with long-term virologic suppression",
"We evaluated the effect of Saccharomyces boulardii administration in otherwise healthy children aged between 6 months and 10 years who were admitted for acute diarrhoea ( 15 males , 12 females ) . The patients were r and omized into two groups : group 1 ( n = 16 ) received 250 mg S. boulardii dissolved in 5 ml of water orally twice daily for 7 days and group 2 ( n = 11 ) received placebo . Clinical and laboratory assessment s were performed on admission and on day 7 of follow-up . Both groups experienced reduced daily stool frequency , the decrease being significantly greater in group 1 on days 3 and 4 compared with group 2 . Group 1 demonstrated significant increases in serum immunoglobulin A and decreases in C-reactive protein levels on day 7 . The percentage of CD8 lymphocytes on day 7 was significantly higher in group 1 than group 2 . This study confirmed the efficacy of S. boulardii in paediatric acute gastroenteritis and the findings suggest that S. boulardii treatment enhances the immune response",
"Goals To study the role of probiotics on gut permeability and endotoxemia in patients with acute pancreatitis ( AP ) . Background Bacterial translocation has been implicated in infective complications in AP , which has been shown to be prevented by probiotics . Study A double-blind , r and omized placebo-controlled trial was conducted . Consecutive patients with AP presenting within 72 hours after the onset of abdominal pain or who had been nil orally at the time of presentation for up to 5 days were included in the study . The probiotic group received 4 sachets of Probiotics ( 2.5 billion bacteria per sachet ) whereas the placebo group received 4 sachets of placebo for 7 days . Primary outcome measures were effect on gut permeability [ assessed by lactulose/mannitol ( L/M ) excretion in urine ] and endotoxemia assessed by endotoxin-core antibody types IgG and IgM ( EndoCab IgG and IgM ) . Secondary outcome measures were mortality , total hospital/intensive care unit stay , abdominal discomfort , organ failure , C-reactive protein , and prealbumin levels . The study was prematurely stopped after the publication of probiotic prophylaxis in patients with predicted severe acute pancreatitis trial . Results From March 2007 to May 2008 , 50 patients with AP were included in the study ( 26 in placebo group and 24 in probiotic group ) . There was no difference after intervention in gut permeability , whereas values of C-reactive protein and immunoglobulins decreased significantly [ IgG : 140 ( 20–920 ) to 90 ( 20–600 ) GGU/mL and IgM : 65 ( 13–230 ) to 51 ( 9–240 ) GMU/mL ] in the probiotic group . No difference was observed in prealbumin values , duration of hospital/intensive care unit stay , and mortality in both the groups . Conclusions No significant trend was identified for an effect of probiotics on gut permeability or endotoxemia in AP . However , the study was underpowered owing to premature study termination",
"Gut microflora and dysbiosis as an environmental factor has been linked to the pathogenesis of enthesitis‐related arthritis ( JIA‐ERA ) ; thus , we performed a proof‐of‐concept study of probiotics to modulate the gut‐flora and study the effects on immune and clinical parameters of children having JIA‐ERA . Forty‐six children with active JIA‐ERA were r and omized to placebo or probiotic therapy along with non‐steroidal anti‐inflammatory drugs ( NSAIDs ) for 12 weeks . Patients were assessed using a six‐point composite disease activity index ( mJSpADA ) based on morning stiffness , joint count , enthesitis count , sacroiliitis/inflammatory back pain , uveitis and erythrocyte sedimentation rate/C‐reactive protein ( ESR/CRP ) . Frequencies of T helper type 1 ( Th1 ) , Th2 , Th17 and regulatory T cells in blood were measured using flow cytometry . Serum cytokines interferon (IFN)‐γ , interleukin (IL)−4 , IL‐17 , IL‐10 , tumour necrosis factor (TNF)‐α and IL‐6 were measured by cytokine bead array using flow cytometer . The average age of 46 children ( 44 boys ) was 15 ± 2.5 years and duration of disease was 3.5 ± 3 years . There was no significant difference in improvement in mJSpADA between the two groups ( P = 0·16 ) . Serum IL‐6 levels showed a decrease ( P probiotic‐group . Th2 cell frequency ( P 0·05 ) and serum IL‐10 levels ( P in immune parameters when compared to the placebo . Adverse effects among the probiotic and placebo groups were diarrhea ( 36 versus 45 % ) , abdominal pain ( 9 versus 20 % ) , minor infections ( 4·5 versus 20 % ) and flatulence ( 23 versus 15 % ) , respectively . Thus , we can conclude that probiotic therapy in JIA‐ERA children is well tolerated , but failed to show any significant immune or clinical effects over NSAID therapy",
"Previous studies have shown that inflammatory factors increases in pregnancy and is associated with several complications of pregnancy . The aim of this study was to assess effects of daily consumption of probiotic yoghurt on inflammatory factors in pregnant women . In a r and omized clinical trial , seventy primigravid ( the first pregnancy ) and singleton pregnant women aged 18 - 30 years were assigned to two groups . Subjects consumed daily 200 g probiotic yoghurt containing Lactobacillus acidophilus La5 and Bifidobacterium animalis BB12 ( 10(7 ) CFU g(-1 ) for each ) or 200 g conventional yoghurt for 9 weeks . Fasting blood sample s were collected at baseline ( 28 weeks of gestation ) and after intervention ( 37 weeks of gestation ) . Inflammatory factors , hs-CRP and TNF-alpha , were measured by Enzyme-linked Immunosorbent Assay ( ELISA ) . Independent t-test was used to compare the two groups after intervention and paired- sample t-test compared variables before and after treatment . The results showed that the probiotic yogurt brought about a decrease in the serum hs-CRP level , from 10.44 + /- 1.56 to 7.44 + /- 1.03 microg mL(-1 ) ( p = 0.041 ) . There was no significant change in the conventional yogurt group in the serum hs-CRP level ( 12.55 + /- 1.57 to 14.51 + /- 1.62 microg mL(-1 ) , p = 0.202 ) . The probiotic yogurt had no effect on TNF-alpha ( from 73.75 + /- 6.59 to 77.91 + /- 5.61 pg mL(-1 ) , p = 0.633 ) . Serum TNF-alpha did not change in the conventional yogurt group ( p = 0.134 ) . In conclusion probiotic yogurt significantly decreased hs-CRP in pregnant women but had no effect on TNF-alpha",
"Summary Background Data : Use of synbiotics has been reported to benefit human health , but clinical value in surgical patients remains unclear . Objective : To investigate the effect of perioperative oral administration of synbiotics upon intestinal barrier function , immune responses , systemic inflammatory responses , microflora , and surgical outcome in patients undergoing high-risk hepatobiliary resection . Methods : Patients with biliary cancer involving the hepatic hilus ( n = 101 ) were r and omized before hepatectomy , into a group receiving postoperative enteral feeding with synbiotics ( group A ) ; or another receiving preoperative plus postoperative synbiotics ( group B ) . Lactulose-mannitol ( L/M ) ratio , serum diamine oxidase ( DAO ) activity , natural killer ( NK ) cell activity , interleukin-6 ( IL-6 ) , fecal microflora , and fecal organic acid concentrations were determined before and after hepatectomy . Postoperative infectious complications were recorded . Results : Of 101 patients , 81 completed the trial . Preoperative and postoperative changes in L/M ratio and DAO activity were similar between groups . Preoperatively in group B , NK activity , and lymphocyte counts increased , while IL-6 decreased significantly ( P Postoperative serum IL-6 , white blood cell counts , and C-reactive protein in group B were significantly lower than in group A ( P numbers of Bifidobacterium colonies cultured from and total organic acid concentrations measured in feces increased significantly in group B ( P Postoperative concentrations of total organic acids and acetic acid in feces were significantly higher in group B than in group A ( P Incidence of postoperative infectious complications was 30.0 % ( 12 of 40 ) in group A and 12.1 % ( 5 of 41 ) in group B ( P synbiotics can enhance immune responses , attenuate systemic postoperative inflammatory responses , and improve intestinal microbial environment . These beneficial effects likely reduce postoperative infectious complications after hepatobiliary resection for biliary tract cancer",
"AIM To demonstrate the therapeutic effect of probiotics in patients with ulcerative colitis ( UC ) , and their effect on inflammatory mediators and nuclear factor (NF)-kappaB activation in these patients . METHODS Thirty patients with mild to moderate UC were r and omly classified into two groups : sulfasalazine group , who received sulfasalazine 2400 mg/d ; and probiotic group , who received sulfasalazine 2400 mg/d with probiotic . The patients were investigated before and after 8 wk of treatment with probiotic ( Lactobacillus delbruekii and Lactobacillus fermentum ) . Colonic activity of myeloperoxidase ( MPO ) was assayed with UV spectrophotometry , the colonic content of interleukin (IL)-6 was determined by enzyme-linked immunosorbent assay ( ELISA ) , fecal calprotectin was determined by ELISA , and expression of NF-kappaB p65 and tumor necrosis factor (TNF)-alpha proteins in colonic tissue was identified by immunohistochemistry and reverse transcription polymerase chain reaction , respectively . RESULTS At the start of the study , colonic mucosal injury and inflammation were demonstrated in UC patients by hematoxylin and eosin staining , and an increase in colonic MPO activity , fecal calprotectin , and expression of colonic TNF-alpha and NF-kappaB p65 proteins . The use of probiotic for 8 wk significantly ameliorated the inflammation by decreasing the colonic concentration of IL-6 , expression of TNF-alpha and NF-kappaB p65 , leukocyte recruitment , as demonstrated by a decrease in colonic MPO activity , and the level of fecal calprotectin compared to sulfasalazine group and the control group ( P supplementation with probiotics could be helpful in maintaining remission and preventing relapse of UC",
"Background : Microbial translocation and chronic inflammation may contribute to non-AIDS morbidity in patients with HIV . This study assessed the impact of probiotic intervention on microbial translocation and inflammation in patients on antiretroviral therapy with viral suppression and subnormal CD4 count . Methods : Thirty-two patients receiving antiretroviral therapy ( CD4 were r and omized in a double-blind fashion to multistrain daily probiotics ( n = 15 ) , placebo ( n = 9 ) , or controls ( n = 8) for 8 weeks . Soluble inflammation markers , D-dimer , lipopolysaccharide ( LPS ) , sCD14 , T-cell activation , tryptophan metabolites , and gut microbiota composition were analyzed at baseline and end of study . Nonparametric statistics were applied . Results : Twenty-four participants completed the study and were included in as-treated analyses . In patients receiving probiotics , there was a significant reduction in D-dimer levels ( median change 33 % , P = 0.03 ) and a tendency to reduced levels of C-reactive protein ( CRP ) ( P = 0.05 ) and interleukin (IL)-6 ( P = 0.06 ) . The changes in CRP and IL-6 were highly correlated ( r = 0.95 , P changes in D-dimer did not correlate with changes in CRP or IL-6 . Increases in Bifidobacteria ( P = 0.04 ) and Lactobacilli ( P = 0.06 ) were observed in the probiotic group , whereas the relative abundance of Bacteroides decreased ( P ⩽ 0.01 ) . No significant changes were seen in markers of microbial translocation or T-cell activation . However , the expansion of Bifidobacteria correlated negatively with differences in LPS ( r = −0.77 , P = 0.01 ) , whereas the reduction in Bacteroides correlated positively with changes in LPS during the study period ( r = 0.72 , P = 0.02 ) . Conclusions : Probiotic intervention seemed to reduce markers of coagulation and inflammation without overt changes in microbial translocation . These findings warrant further studies in larger cohorts with long-term follow-up"
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Accelerometers objective ly monitor physical activity and sedentary patterns and are increasingly used in the research setting . It is important to maintain consistency in data analysis and reporting , therefore , we : ( 1 ) systematic ally identified studies using accelerometry ( ActiGraph , Pensacola , FL , USA ) to measure moderate-to-vigorous physical activity ( MVPA ) and sedentary time in older adults , and ( 2 ) based on the review findings , we used different cut-points obtained to analyze accelerometry data from a sample of community-dwelling older women . We identified 59 articles with cut-points ranging between 574 and 3,250 counts/min for MVPA and 50 and 500 counts/min for sedentary time . Using these cut-points and data from women ( mean age , 70 years ) , the median MVPA minutes per day ranged between 4 and 80 min while percentage of sedentary time per day ranged between 62 % and 86 % . These data highlight ( 1 ) the importance of reporting detailed information on the analysis assumptions and ( 2 ) that results can differ greatly depending on analysis parameters
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"Background Few studies have investigated both the self-perceived and measured environment with objective ly determined physical activity in older adults . Accordingly , the aim of this study was to examine measured and perceived environmental associations with physical activity of older adults residing across different neighborhood types . Methods One-hundred and forty-eight older individuals , mean age 64.3 ± 8.4 , were r and omly recruited from one of four neighborhoods that were pre-determined as either having high- or low walkable characteristics . Individual residences were geocoded and 200 m network buffers established . Both objective environment audit , and self-perceived environmental measures were collected , in conjunction with accelerometer derived physical activity behavior . Using both perceived and objective environment data , analysis consisted of a macro-level comparison of physical activity levels across neighborhood , and a micro-level analysis of individual environmental predictors of physical activity levels . Results Individuals residing in high-walkable neighborhoods on average engaged in 11 min of moderate to vigorous physical activity per day more than individuals residing in low-walkable neighborhoods . Both measured access to non-residential destinations ( b = .11 , p self-perceived access to non-residential uses ( b = 2.89 , p = .031 ) were significant predictors of time spent in moderate to vigorous physical activity . Other environmental variables significantly predicting components of physical activity behavior included presence of measured neighborhood crime signage ( b = .4785 , p = .031 ) , measured street safety ( b = 26.8 , p = .006 ) , and perceived neighborhood satisfaction ( b = .5.8 , p = .003 ) . Conclusions Older adult residents who live in high-walkable neighborhoods , who have easy and close access to nonresidential destinations , have lower social dysfunction pertinent to crime , and generally perceive the neighborhood to a higher overall satisfaction are likely to engage in higher levels of physical activity behavior . Efforts aim ed at promoting more walkable neighborhoods could influence activity levels in older adults",
"This study tested whether the lower economy of walking in healthy elderly subjects is due to greater gait instability . We compared the energy cost of walking and gait instability ( assessed by stride to stride changes in the stride time ) in octogenarians ( G80 , n = 10 ) , 65-yr-olds ( G65 , n = 10 ) , and young controls ( G25 , n = 10 ) walking on a treadmill at six different speeds . The energy cost of walking was higher for G80 than for G25 across the different walking speeds ( P Stride time variability at preferred walking speed was significantly greater in G80 ( 2.31 + /- 0.68 % ) and G65 ( 1.93 + /- 0.39 % ) compared with G25 ( 1.40 + /- 0.30 % ; P gait instability and energy cost of walking at preferred walking speed . These findings demonstrated greater energy expenditure in healthy elderly subjects while walking and increased gait instability . However , no relationship was noted between these two variables . The increase in energy cost is probably multifactorial , and our results suggest that gait instability is probably not the main contributing factor in this population . We thus concluded that other mechanisms , such as the energy expenditure associated with walking movements and related to mechanical work , or neuromuscular factors , are more likely involved in the higher cost of walking in elderly people",
"In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old . Such investigations are often analysed inappropriately , notably by using correlation coefficients . The use of correlation is misleading . An alternative approach , based on graphical techniques and simple calculations , is described , together with the relation between this analysis and the assessment of repeatability",
"This study examined the predictive validity of accelerometers ( ACC ) to estimate physical activity intensity ( PAI ) across age and differences in intensity predictions when expressed in relative and absolute PAI terms . Ninety adults categorized into 3 age groups ( 20 - 29 , 40 - 49 , and 60 - 69 yr ) completed a treadmill calibration study with simultaneous ACC ( 7164 Actigraph ) and oxygen-consumption assessment . Results revealed strong linear relations between ACC output and measured PAI ( R2 = .62-.89 ) across age and similar ACC cut-point ranges across age delineating absolute PAI ranges compared with previous findings . Comparing measured metabolic equivalents ( METs ) with estimated METs derived from previously published regression equations revealed that age did not affect predictive validity of ACC estimates of absolute PAI . Comparing ACC output expressed in relative vs. absolute terms across age revealed substantial differences in PAI ACC count ranges . Further work is warranted to increase the applicability ofACC use relative to PAI differences associated with physiological changes with age",
"BACKGROUND Cognitive decline among seniors is a pressing health care issue . Specific exercise training may combat cognitive decline . We compared the effect of once-weekly and twice-weekly resistance training with that of twice-weekly balance and tone exercise training on the performance of executive cognitive functions in senior women . METHODS In this single-blinded r and omized trial , 155 community-dwelling women aged 65 to 75 years living in Vancouver were r and omly allocated to once-weekly ( n = 54 ) or twice-weekly ( n = 52 ) resistance training or twice-weekly balance and tone training ( control group ) ( n = 49 ) . The primary outcome measure was performance on the Stroop test , an executive cognitive test of selective attention and conflict resolution . Secondary outcomes of executive cognitive functions included set shifting as measured by the Trail Making Tests ( parts A and B ) and working memory as assessed by verbal digit span forward and backward tests . Gait speed , muscular function , and whole-brain volume were also secondary outcome measures . RESULTS Both resistance training groups significantly improved their performance on the Stroop test compared with those in the balance and tone group ( P Task performance improved by 12.6 % and 10.9 % in the once-weekly and twice-weekly resistance training groups , respectively ; it deteriorated by 0.5 % in the balance and tone group . Enhanced selective attention and conflict resolution was significantly associated with increased gait speed . Both resistance training groups demonstrated reductions in whole-brain volume compared with the balance and tone group at the end of the study ( P resistance training benefited the executive cognitive function of selective attention and conflict resolution among senior women . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00426881",
"Over the ensuing seven months she had three more clinical relapses , each accompanied by reappearance in the stools of either the organism or its cytotoxin , or both . Each improvement after vancomycin ( eight to 14-daycourses ) was accompanied by disappearance of the organism . At one point she was given cholestyramine , but she was unable to tolerate it . Her illness was punctuated by malnutrition and episodes of heart failure . She was given no other antibiotics . After the sixth relapse maintenance treatment with oral vancomycin 125 mg eight-hourly was begun . With this regimen diarrhoea was controlled and stools over the next 10 weeks remained negative for C difficile and its cytotoxin . There was no adverse reaction to vancomycin throughout",
"BACKGROUND Objective physical activity data analyses focus on moderate-to-vigorous physical activity ( MVPA ) without considering lower intensity lifestyle-type activities ( LA ) . We describe 1 ) quantity of LA ( minutes and steps per day ) across demographic groups , 2 ) proportion of LA to total physical activity , and 3 ) relationships between LA and MVPA using NHANES 2005 - 2006 accelerometer adult data ( n = 3744 ) . METHODS LA was defined as 760 to 2019 counts per minute ( cpm ) and MVPA as ≥2020 cpm . LA was compared within gender , ethnicity , age , and BMI groups . Regression analyses examined independent effects . Correlations were evaluated between LA and MVPA . All analyses incorporated sampling weights to represent national estimates . RESULTS Adults spent 110.4 ± 1.6 minutes and took 3476 ± 54 steps per day in LA . Similar to MVPA , LA was highest in men , Mexican Americans , and lowest in adults ≥60 years or obese . When LA was held constant , ethnic differences no longer predicted MVPA minutes , and age no longer predicted MVPA steps . LA and MVPA minutes ( r = .84 ) and steps per day ( r = .72 ) were significantly correlated , but attenuated with MVPA modified bouts ( ≥10 minutes sustained activity ) . CONCLUSIONS LA accumulation differs between demographic subgroups and is related to MVPA : adults who spend more minutes and steps in MVPA also spend them in LA",
"Physical exercise is advised as a preventive and therapeutic strategy against aging-induced bone weakness . In this study we examined the effects of 8-month multicomponent training with weight-bearing exercises on different risk factors of falling , including muscle strength , balance , agility , and bone mineral density ( BMD ) in older women . Participants were r and omly assigned to either an exercise-training group ( ET , n = 30 ) or a control group ( CON , n = 30 ) . Twenty-seven subjects in the ET group and 22 in the CON group completed the study . Training was performed twice a week and was design ed to load bones with intermittent and multidirectional compressive forces and to improve physical function . Outcome measures included lumbar spine and proximal femoral BMD ( by dual X-ray absorptiometry ) , muscle strength , balance , h and grip strength , walking performance , fat mass , and anthropometric data . Potential confounding variables included dietary intake , accelerometer-based physical activity , and molecularly defined lactase nonpersistence . After 8 months , the ET group decreased percent fat mass and improved h and grip strength , postural sway , strength on knee flexion at 180 ° /s , and BMD at the femoral neck ( + 2.8 % ) . Both groups decreased waist circumference and improved dynamic balance , chair st and performance , strength on knee extension for the right leg at 180 ° /s , and knee flexion for both legs at 60 ° /s . No associations were found between lactase nonpersistence and BMD changes . Data suggest that 8 months of moderate-impact weight-bearing and multicomponent exercises reduces the potential risk factors for falls and related fractures in older women",
"Research into daily physical activity ( PA ) patterns of older adults ( ≥70 years ) has primarily relied on self-report . This study used accelerometry , an objective measure of minute-by-minute movement , to assess PA volume and intensity performed by older adults recruited to the Better Ageing project . Results were used to estimate the degree to which current health recommendations for PA were met . Participants [ 91 older females ( OF ) aged 76.0 ± 4.0 years ( mean ± SD ) , 70 older males ( OM ) 76.3 ± 3.9 years , 23 young females ( YF ) 26.8 ± 4.1 years and 22 young males ( YM ) 27.0 ± 4.2 years ] wore an MTI actigraph model 7164 recording activity in 1-min epochs for 7 days . Only those with at least 5 days , and 10 h of actigraph data per day , were included in the analysis , using Caloric . Bas ( CSA Inc. 1999 ) software and a tailored Microsoft Access 2000 macro . Mean counts min-1 day-1 were 37 % lower for older adults than for young adults [ OF 236.1 ± 84.4 vs. YF 370.0 ± 81.1 counts min-1 day-1t(114 ) = −6.86 , P in activity intensity range performing significantly fewer minutes of moderate to vigorous ( MV ) PA day-1 than young adults [ OF 16.7 ± 12.2 vs. YF 38.4 ± 18.4 MVPA min day-1 , t(114 ) = −6.90 , P any sustained 10-min MVPA bouts ( OF 48.4 % vs. YF 13.0 % , χ2 = 8.10 , P = 0.004 ; OM 44.3 % vs. YM 4.5 % , χ2 = 9.97 , P = 0.002 ) , and none met current PA recommendations for health . This study is the first to provide objective data on a large sample of adults aged 70 years and over and indicates low levels of daily movement that are likely to be inadequate for optimal health benefit",
"A Physical Activity Scale for the Elderly ( PASE ) was evaluated in a sample of community-dwelling , older adults . Respondents were r and omly assigned to complete the PASE by mail or telephone before or after a home visit assessment . Item weights for the PASE were derived by regressing a physical activity principal component score on responses to the PASE . The component score was based on 3-day motion sensor counts , a 3-day physical activity dairy and a global activity self- assessment . Test-retest reliability , assessed over a 3 - 7 week interval , was 0.75 ( 95 % CI = 0.69 - 0.80 ) . Reliability for mail administration ( r = 0.84 ) was higher than for telephone administration ( r = 0.68 ) . Construct validity was established by correlating PASE scores with health status and physiologic measures . As hypothesized , PASE scores were positively associated with grip strength ( r = 0.37 ) , static balance ( r = + 0.33 ) , leg strength ( r = 0.25 ) and negatively correlated with resting heart rate ( r = -0.13 ) , age ( r = -0.34 ) and perceived health status ( r = -0.34 ) ; and overall Sickness Impact Profile score ( r = -0.42 ) . The PASE is a brief , easily scored , reliable and valid instrument for the assessment of physical activity in epidemiologic studies of older people",
"This study compared the effects of a resistance training protocol and a moderate-impact aerobic training protocol on bone mineral density ( BMD ) , physical ability , serum osteoprotegerin ( OPG ) , and receptor activator of nuclear factor kappa B lig and ( RANKL ) levels . Seventy-one older women were r and omly assigned to resistance exercise ( RE ) , aerobic exercise ( AE ) or a control group ( CON ) . Both interventions were conducted 3 times per week for 8 months . Outcome measures included proximal femur BMD , muscle strength , balance , body composition , serum OPG , and RANKL levels . Potential confounding variables included dietary intake , accelerometer-based physical activity ( PA ) , and molecularly defined lactase nonpersistence . After 8 months , only RE group exhibited increases in BMD at the trochanter ( 2.9 % ) and total hip ( 1.5 % ) , and improved body composition . Both RE and AE groups improved balance . No significant changes were observed in OPG and RANKL levels , and OPG/RANKL ratio . Lactase nonpersistence was not associated with BMD changes . No group differences were observed in baseline values or change in dietary intakes and daily PA . Data suggest that 8 months of RE may be more effective than AE for inducing favourable changes in BMD and muscle strength , whilst both interventions demonstrate to protect against the functional balance control that is strongly related to fall risk",
"Adequate daily physical activity ( PA ) is important for maintaining functional capacity and independence in older adults . However , most older adults in Canada do not engage in enough PA to sustain fitness and functional independence . Environmental influences , such as warmer daytime temperatures , may influence PA participation ; however , few studies have examined the effect of summertime temperatures on PA levels in older adults . This investigation measured the influence of summertime weather variables on PA in 48 community-dwelling older adults who were r and omly recruited from a local seniors ' community centre . Each participant wore an accelerometer for a single 7-consecutive-day period ( between 30 May and 9 August 2006 ) during waking hours , and completed a PA logbook to remark on major daily PA events . Local weather variables were collected from a national weather service and compared with PA counts per minute . Regression analysis revealed a curvilinear relationship between log-transformed PA and mean daily temperature ( r2 = 0.025 ; p PA as the dependent variable . Age and Air Quality Index remained significant variables within the model . Higher fitness levels had no effect on allowing individuals to perform more vigorous PA in warmer temperatures",
"PURPOSE We established accelerometer count ranges for the Computer Science and Applications , Inc. ( CSA ) activity monitor corresponding to commonly employed MET categories . METHODS Data were obtained from 50 adults ( 25 males , 25 females ) during treadmill exercise at three different speeds ( 4.8 , 6.4 , and 9.7 km x h(-1 ) ) . RESULTS Activity counts and steady-state oxygen consumption were highly correlated ( r = 0.88 ) , and count ranges corresponding to light , moderate , hard , and very hard intensity levels were or = 9499 cnts x min(-1 ) , respectively . A model to predict energy expenditure from activity counts and body mass was developed using data from a r and om sample of 35 subjects ( r2 = 0.82 , SEE = 1.40 kcal x min(-1 ) ) . Cross validation with data from the remaining 15 subjects revealed no significant differences between actual and predicted energy expenditure at any treadmill speed ( SEE = 0.50 - 1.40 kcal x min(-1 ) ) . CONCLUSIONS These data provide a template on which patterns of activity can be classified into intensity levels using the CSA accelerometer",
"Inspiratory muscle training ( IMT ) has been shown to improve exercise capacity in diseased population s. We chose to examine the effects of eight weeks of IMT on exercise capacity and spontaneous physical activity in elderly individuals . Eighteen moderately active elderly subjects ( 68.1 + /- 6.8 years [ mean + /- SD ] ; range 58 - 78 years ) were r and omly assigned to either an experimental group ( n = 9 ) or a control group ( n = 9 ) in a double-blind manner . All subjects underwent inspiratory muscle testing , treadmill exercise testing and a four-day measurement period of spontaneous physical activity ( using accelerometry ) both pre- and post-intervention . The experimental group underwent eight weeks of incremental IMT using a pressure threshold device , while the control group underwent sham training using identical devices . After IMT training , inspiratory muscle strength ( mean + 21.5 cm H (2)O ; 95 % CI : 9.3 , 33.7 ; p = 0.002 ) , V.O ( 2peak ) ( + 2.8 ml x min ( -1 ) x kg ( -1 ) ; 95 % CI : 0.5 , 5.2 ; p = 0.022 ) , time to exhaustion during a fixed workload treadmill test ( + 7.1 min ; 95 % CI : 1.8 , 2.4 ; p = 0.013 ) and time engaged in moderate-to-vigorous physical activity ( + 59 min ; 95 % CI : 15 , 78 ; p = 0.008 ) improved . Except for a decline in moderate-to-vigorous physical activity , no significant changes were seen in the control group . Therefore , IMT may be a useful technique for positively influencing exercise capacity and physical activity in elderly individuals",
"INTRODUCTION Strong evidence suggests a link between physical inactivity and chronic disease prevalence in the adult population . To target the right groups for interventions in a population , accurate assessment of physical activity is important . The objective of this study was to assess the levels and pattern of physical activity and inactivity in an adult population sample using an objective method . METHODS In total , 1114 adults ( 56 % women , 45+/-15 yr ) , r and omly recruited from the Swedish population across a year , used an accelerometer ( Actigraph MTI ) for seven consecutive days . Inactivity was defined as 5724 counts per minute , respectively . Average intensity was measured as counts per minute . RESULTS The adults were active in at least moderate-intensity activity for a median ( intraquartile range ) of 31 ( 18 - 47 ) min.d(-1 ) . Fifty-two percent accumulated 30 min.d(-1 ) of at least moderate-intensity physical activity . Only 1 % achieved those 30 min from three or more bouts of at least 10 min . Average intensity , moderate and vigorous physical activity was lower with higher age or body mass index ( BMI ) . Men spent more time than women in moderate and vigorous physical activity , but there was no gender difference in average intensity . The variation in inactivity could not be explained by gender , age , or BMI . CONCLUSION Objective ly obtained estimates of physical activity yielded lower values and a different activity pattern compared with those obtained by commonly used self-reports . This highlights the need to better underst and the nature and measurement issues of health-enhancing physical activity of adults",
"Previous studies have reported a decrease in muscle torque per cross-sectional area in old age . This investigation aim ed at determining the influence of agonists muscle activation and antagonists co-activation on the specific torque of the plantarflexors ( PF ) in recreationally active elderly males ( EM ) and , for comparison , in young men ( YM ) . Twenty-one EM , aged 70–82 years , and 14 YM , aged 19–35 years , performed isometric maximum voluntary contractions ( MVC ) . Activation was assessed by comparing the amplitude of interpolated supramaximal twitch doublets at MVC , with post-tetanic doublet peak torque . Co-activation of the tibialis anterior ( TA ) was evaluated as the ratio of TA-integrated EMG ( IEMG ) activity during PF MVC compared to TA IEMG during maximal voluntary dorsiflexion . Triceps surae muscle volume ( VOL ) was assessed using magnetic resonance imaging ( MRI ) , and PF peak torque was normalised to VOL ( PT/VOL ) since the later approximates physiological cross-sectional area ( CSA ) more closely than anatomical CSA . Also , physical activity level , assessed by accelerometry , was significantly lower ( 21 % ) in the elderly males . In comparison to the YM group , a greater difference in PT ( 39 % ) than VOL ( 19 % ) was found in the EM group . PT/VOL and activation capacity were respectively lower by 25 % and 21 % in EM compared to YM , whereas co-activation was not significantly different . In EM PT/VOL correlated with activation ( R2=0.31 , P in activation capacity may contribute significantly to the decline in specific torque in the plantar flexors of elderly males . The hypothesis is put forward that reduced physical activity is partialy responsible for the reduced activation capacity in the elderly",
"Increasing evidence suggests that physical activity can prevent some aspects of mental illness in older people such as depression , dementia and Alzheimer ’s disease . Additionally , limited research has shown that engagement in structured exercise can improve aspects of psychological well-being such as mood and self-perceptions in older adults . However , the relationship between incidental daily activity such as walking or time spent sedentary , with psychological well-being has not been investigated . The Better Ageing Project provided an opportunity to assess well-being and quality of life using st and ardised question naires with 176 adults aged 70 and over . Accelerometry was used to objective ly assess daily energy expended in physical activity at different levels of intensity . In addition , an assessment of the impact of the 12-month Better Ageing structured group exercise programme was assessed through question naires and interviews . Total daily physical activity energy expenditure ( joules/day ) and amount of time spent in activity of at least moderate intensity were weakly related ( r = 0.20–0.28 ) to quality of life , subjective well-being and physical self-perceptions . Time spent sedentary ( min/day ) was weakly and negatively related to several mental health indicators . The quantitative data showed only minor psychological benefits of the exercise intervention . In contrast , interviews with 27 research participants and 4 exercise leaders suggested that important improvements in perceived function and social benefits had been experienced",
"Objectives : To assess physical activity ( PA ) levels measured objective ly using accelerometers in community-dwelling older people and to examine the associations with health , disability , anthropometric measures and psychosocial factors . Design : Cross-sectional survey . Setting : Single general practice ( primary care centre ) , United Kingdom . Participants : R and om selection of 560 community-dwelling older people at least 65 years old , registered with the practice . 43 % ( 238/560 ) participated . Assessment of risk factors : Participants completed a question naire assessing health , disability , psychosocial factors and PA levels ; underwent anthropometric assessment ; and wore an accelerometer ( Actigraph ) for 7 days . Main outcome measures : Average daily accelerometer step-counts and time spent in different PA levels . Associations between step-counts and other factors were examined using linear regression . Results : Average daily step-count was 6443 ( 95 % CI 6032 to 6853 ) . Men achieved 754 ( 84 to 1424 ) more steps daily than women . Step-count declined steadily with age . Independent predictors of average daily step-count were : age ; general health ; disability ; diabetes ; body mass index ; exercise self-efficacy ; and perceived exercise control . Activities associated independently with higher step-counts included number of long walks and dog-walking . Only 2.5 % ( 6/238 ) of participants achieved the recommended 150 minutes weekly of at least moderate-intensity activity in ⩾10 minute bouts ; 62 % ( 147/238 ) achieved none . Conclusions : This is the first population -based sample of older people with objective PA and anthropometric measures . PA levels in older people are well below recommended levels , emphasising the need to increase PA in this age group , particularly in those who are overweight/obese or have diabetes . The independent effects of exercise self-efficacy and exercise control on PA levels highlight their role as potential mediators for intervention studies"
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EXECUTIVE SUMMARY Background As a chronic condition , the prevalence of Type 2 diabetes is increasing worldwide and adherence to oral medications , an essential component of self-management , has been shown to improve glycaemic control . However compliance with oral medication adherence remains poor . Educating people with Type 2 diabetes is an important strategy to enhance self-management ability , including medication-taking behaviour . Objectives The overall objective of the review was to determine the effectiveness of educational interventions to promote oral hypoglycaemic adherence in adults with Type 2 diabetes . INCLUSION CRITERIA Types of participants Studies involving adults over 18 years old with Type 2 diabetes , with or without co-morbidities , currently taking oral hypoglycaemic medication without insulin treatment , and with aglycated haemoglobin ( HbA1c ) > 7.0 % prior to the intervention were considered . Aglycated haemoglobin ( HbA1c ) concentration of less than 7.0 % , is important in order to delay or prevent diabetes-related complications . Participants could be from the primary , tertiary or acute care setting .Types of intervention The review focused on various forms of educational interventions delivered by healthcare professionals aim ed at improving participants ' knowledge . Types of outcomes The review evaluated outcomes measuring oral hypoglycaemic adherence including HbA1c , fasting blood glucose levels and other relevant indicators . Types of studies Studies that were r and omized controlled trials ( RCTs ) or case-control studies were considered . Search strategy A three-stage search strategy was employed . Papers in English and between the years 1990 - 2009 were search ed in the following data bases : CINAHL , Medline , Mosby 's Nursing Consult , PsycINFO , PubMed , ScienceDirect , Scopus , TRIP and Web of Science . Full text was retrieved when the titles and abstract s of studies fulfilled the inclusion criteria . Method ological quality Full papers were assessed for method ological quality independently by two review ers using critical appraisal checklists from the Joanna Briggs Institute ( JBI ) . A third review er was consulted whenever there were disagreements between the two review ers . Data collection / extraction Details of each study included in the review were extracted using st and ardized data extraction forms developed by JBI . Extraction was conducted independently by two review ers . Data synthesis Meta- analysis was not possible due to method ological and statistical heterogeneity of the included studies . Hence study findings are presented in narrative form . Results Seven studies included in the final review consisted of seven RCTs . Five studies concluded that the educational intervention was effective in promoting oral hypoglycaemic adherence compared to usual care . These included pharmacist-led interventions , individual diabetes education provided by nurses and diabetes group education based on a self-management approach . Similarities among these interventions were provision of information on oral hypoglycaemic medication and the need for regular education sessions . However , small sample s in some studies limited generalization of results . CONCLUSIONS Implication s for practice Increased knowledge of oral hypoglycaemic issues and reinforcement of the importance of medication adherence were useful in promoting adherence . Regular education sessions allow individuals to reinforce information and educators to identify barriers to medication adherence . Educational interventions focusing on self-management strategies appear more likely to achieve positive outcomes . Implication s for research Further trials involving larger sample s and population s with poor glycaemic control are needed . The effects of educational interventions , influence of additional take-home written material , the optimal interval length of follow-up and duration of education sessions , and specific processes of individual or group education which have been identified as effective need further exploration
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"AIMS To determine whether an extended pharmacy service would improve glycaemic control and cardiovascular risks in diabetic Muslims . METHODS Ambulatory literate adult diabetic Muslims with A1C > 7 % were r and omly assigned to either a study group ( usual care plus added pharmacist input , N=63 ) or a control group ( usual care only , N=67 ) . On four consecutive visits , at 2-month intervals , the study group met a pharmacist who educated and discussed with each patient regarding medication uses and diabetic treatment . This was accompanied by providing a diabetic pamphlet . Changes in A1C ( mg/dL ) , lipid parameters ( mg/dL ) , medication adherence ( % pill count ) and diabetic knowledge scores were measured . RESULTS There was no difference in A1C reduction between the study and the control groups ( -0.8 vs. -0.6 , p=0.56 ) . Total cholesterol and LDL-C improvements were greater in the study group than in the control group ( -31.6 vs. -1.2 , p=0.000 ; -15.0 vs. + 9.1 , p=0.002 , respectively ) . The percent pill count ( + 6.8 vs. -2.8 , p=0.004 ) and diabetic knowledge scores ( + 2.1 vs. + 0.6 , p=0.002 ) were increased in the study group but not in the control group . CONCLUSION The pharmacist ' s one-on-one education on diabetes accompanied by its pamphlet , in Muslim patients with diabetes did not affect glycaemic outcome but reduction in cardiovascular risks through lowering total cholesterol and LDL-C was found . The strategies may also improve diabetic knowledge and medication adherence",
"BACKGROUND type 2 diabetes mellitus continues to increase in prevalence worldwide . Many factors have been cited as contributing to compliance , such as family and social support , education , number of tablets per dose , frequency of administration and health care provider communication . Toward these goals , the present study was developed to measure the effect offactors on glycemic control such as diabetes education by pharmacists , a diabetes disease booklet and special medication containers . MATERIAL AND METHOD A total of 360 volunteers with type 2 DM patients were recruited , participants were simple r and omized to control 180 and intervention 180 patients . Which intervention categorized to 4 groups ; all intervention groups received diabetes drug counseling by a pharmacist , one group received plus a diabetes booklet , one received plus special medical containers and the last group received all of them . The interventions were done at the 1st time of visit . Both the control and intervention groups were monitored for fasting plasma glucose and HbA1c at 0 , 3 , 6 months and glycemic level in both groups was compared . RESULTS After 3 months , mean fasting plasma glucose and HbA1c decreased wiih the intervention group vs. control group ( 152.36 + /- 39.73 to 131.52 + /- 35.22 mg% ) and ( 150.16 + /- 41.78 to 153.98 + /- 47.95 mg% ) respectively ; ( p HbA1c level 8.16 + /- 1.44 to 7.72 + /- 1.26 vs 8.01 + /- 1.51 to 8.38 + /- 1.46 respectively ; ( p mean fasting plasma glucose and HbA1c decreased with the intervention group vs. control group ( 152.36 + /- 39.73 to 145.20 + /- 46.07 mg% ) and ( 150.16 + /- 41.78 to 159.16 + /- 54.90 mg% ) respectively ; ( p HbA1c level 8.16 + /- 1.44 to 7.91 + /- 1.27 vs. 8.01 + /- 1.51 to 8.80 + /- 1.36 respectively ; ( p favorable glycemic outcome was the group that received all of the interventions ; mean FPG was reduced from 147.46 + /- 36.07 to 125.38 + /- 31.12 mg% ( p FPG from 147.46 + /- 36.07 to 130.21 + /- 33.96 mg% ( p HbA 1c level . The group that received only drug counseling by pharmacist had no significant reduction in FPG and HbA1c . ( p > 0.05 ) . CONCLUSION Drug counseling by a pharmacist has little beneficial effect on diabetes management outcome compared to the diabetes booklet and special drug container . To improve glycemic control of type 2 DM is to integrate self-management in daily life , wide a variety of education , drug taken behavior and health care provider available communication produce improvement in patient management and is somewhat better when used in combination",
"OBJECTIVE To examine the effect of a 12-month pharmaceutical care ( PC ) program on vascular risk in type 2 diabetes . RESEARCH DESIGN AND METHODS We recruited 198 community-based patients r and omized to PC or usual care . PC patients had face-to-face goal -directed medication and lifestyle counseling at baseline and at 6 and 12 months plus 6-weekly telephone assessment s and provision of other educational material . Clinical , biochemical , and medication-related data were sent regularly to each patient 's physician(s ) . The main outcome measure was change in HbA(1c ) . A diabetes-specific risk engine was used to estimate changes in 10-year coronary heart disease ( CHD ) and stroke risk in patients without a history of cardiovascular disease . RESULTS At total of 180 patients ( 91 % ) completed the study . Mean ( 95 % CI ) reductions were greater in PC case subjects ( n = 92 ) than control subjects ( n = 88 ) for HbA(1c ) ( -0.5 % [ 95 % CI -0.7 to -0.3 ] vs. 0 [ -0.2 to 0.2 ] ) and systolic ( -14 mmHg [ -19 to -9 ] vs. -7 [ -11 to -2 ] ) and diastolic ( -5 mmHg [ -8 to -3 ] vs. -2 [ -4 to 1 ] ) blood pressure ( P HbA(1c ) persisted after adjustment for baseline value and demographic and treatment-specific variables . The median ( interquartile range ) 10-year estimated risk of a first CHD event decreased in the PC case subjects ( 25.1 % [ 15.6 - 36.2 ] to 20.3 [ 14.6 - 30.2 ] ; n = 42 , P = 0.002 ) but not in the control subjects ( 26.1 % [ 17.2 - 39.4 ] vs. 26.4 [ 16.7 - 38.0 ] ; n = 52 , P = 0.17 ) . CONCLUSIONS A 12-month PC program in type 2 diabetes reduced glycemia and blood pressure . Pharmacist involvement contributed to improvement in HbA(1c ) independently of pharmacotherapeutic changes . PC could prove a valuable component of community-based multidisciplinary diabetes care",
"BACKGROUND Patient involvement in the choice of antihyperglycemic agents could improve adherence and optimize glycemic control in patients with type 2 diabetes mellitus . METHODS We conducted a pilot , cluster r and omized trial of Diabetes Medication Choice , a decision aid that describes 5 antihyperglycemic drugs , their treatment burden ( adverse effects , administration , and self-monitoring dem and s ) , and impact on hemoglobin A(1c ) ( HbA(1c ) ) levels . Twenty-one clinicians were r and omized to use the decision aid during the clinical encounter and 19 to dispense usual care and an educational pamphlet . We used surveys and video analysis to assess postvisit decisional outcomes , and medical and pharmacy records to assess 6-month medication adherence and HbA(1c ) levels . RESULTS Compared with usual care patients ( n = 37 ) , patients receiving the decision aid ( n = 48 ) found the tool more helpful ( clustered-adjusted mean difference [ AMD ] in a 7-point scale , 0.38 ; 95 % confidence interval [ CI ] , 0.04 - 0.72 ) ; had improved knowledge ( AMD , 1.10 of 10 questions ; 95 % CI , 0.11 - 2.09 ) ; and had more involvement in making decisions about diabetes medications ( AMD , 21.8 of 100 ; 95 % CI , 13.0 - 30.5 ) . At 6-month follow-up , both groups had nearly perfect medication use ( median , 100 % of days covered ) , with better adherence ( AMD , 9 % more days covered ; 95 % CI , 4%-14 % ) and persistence ( AMD , 12 more days covered ; 95 % CI , 3 - 21 days ) in the usual care group , and no significant impact on HbA(1c ) levels ( AMD , 0.01 ; 95 % CI , -0.49 to 0.50 ) . CONCLUSION An innovative decision aid effectively involved patients with type 2 diabetes mellitus in decisions about their medications but did not improve adherence or HbA(1c ) levels . Trial Registration clinical trials.gov Identifier : NCT00388050",
"BACKGROUND Nurse 's education using telemedicine results in a decrease in blood glucose levels in patients with type 2 diabetes . OBJECTIVE To investigate the effectiveness of an educational intervention that used both the cellular phone and the Internet to provide a short-messaging service ( SMS ) relating to plasma glucose levels . METHODS Twenty-five patients were r and omly assigned to an intervention group and 26 to a control group . The intervention was applied for 12 weeks . The goal of the intervention was to keep blood glucose concentrations close to the normal range . Patients in the intervention group were asked to access a website by using a cellular phone or to wiring the Internet and input their blood glucose levels every day . Participants were sent the optimal recommendations by both cellular phone and the Internet weekly . RESULTS Patients in the intervention group had a mean decrease in glycosylated haemoglobin ( HbA(1)c ) levels of 1.15 % and those in the control group had a mean increase of HbA(1)c levels of 0.07 % ( p=0.005 ) . There was a significant mean change in the 2hrs post-meal glucose ( 2HPMG ) level for the intervention group ( p educational intervention using the Internet and an SMS by cellular phone improved levels of HbA(1)c and 2HPMG",
"OBJECTIVE To determine the effects of a culturally competent diabetes self-management intervention in Mexican Americans with type 2 diabetes . RESEARCH DESIGN AND METHODS A prospect i ve , r and omized , repeated measures study was conducted on the Texas-Mexico border in Starr County . A total of 256 r and omly selected individuals with type 2 diabetes between 35 and 70 years of age , diagnosed with type 2 diabetes after 35 years of age , and accompanied by a family member or friend were included . The intervention consisted of 52 contact hours over 12 months and was provided by bilingual Mexican American nurses , dietitians , and community workers . The intervention involved 3 months of weekly instructional sessions on nutrition , self-monitoring of blood glucose , exercise , and other self-care topics and 6 months of biweekly support group sessions to promote behavior changes . The approach was culturally competent in terms of language , diet , social emphasis , family participation , and incorporation of cultural health beliefs . Outcomes included indicators of metabolic control ( HbA(1c ) and fasting blood glucose ) , diabetes knowledge , and diabetes-related health beliefs . RESULTS Experimental groups showed significantly lower levels of HbA(1c ) and fasting blood glucose at 6 and 12 months and higher diabetes knowledge scores . At 6 months , the mean HbA(1c ) of the experimental subjects was 1.4 % below the mean of the control group ; however , the mean level of the experimental subjects was still high ( > 10 % ) . CONCLUSIONS This study confirms the effectiveness of culturally competent diabetes self-management education on improving health outcomes of Mexican Americans , particularly for those individuals with HbA(1c ) levels > 10 %",
"OBJECTIVE We evaluated automated telephone disease management ( ATDM ) with telephone nurse follow-up as a strategy for improving diabetes treatment processes and outcomes in Department of Veterans Affairs ( VA ) clinics . We also compared the results with those of a prior ATDM trial conducted in a county health care system . RESEARCH DESIGN AND METHODS A total of 272 VA patients with diabetes using hypoglycemic medications were r and omized . During the 1-year study period , intervention patients received biweekly ATDM health assessment and self-care education calls , and a nurse educator followed up with patients based on their ATDM assessment reports . Telephone surveys were used to measure patients ' self-care , symptoms , and satisfaction with care . Outpatient service use was evaluated using electronic data bases and self-reports , and glycemic control was measured by HbA1c and serum glucose testing . RESULTS At 12 months , intervention patients reported more frequent glucose self-monitoring and foot inspections than patients receiving usual care and were more likely to be seen in podiatry and diabetes specialty clinics . Intervention patients also were more likely than control patients to have had a cholesterol test . Among patients with baseline HbA1c levels > or = 8 % , mean end-point values were lower among intervention patients than control patients ( 8.7 vs. 9.2 % , respectively ; P = 0.04 ) . Among intervention and control patients with baseline values > or = 9 % , mean end-point values were 9.1 and 10.2 % , respectively ( P = 0.04 ) . At follow-up , intervention patients reported fewer symptoms of poor glycemic control than control patients and greater satisfaction with their health care . CONCLUSIONS This intervention improved the quality of VA diabetes care . Intervention effects for most end points replicated findings from the prior county clinic trial , although intervention-control differences in the current study were smaller because of the relatively good self-care and health status among the current study 's enrollees",
"The purpose of this study was to evaluate the efficacy of a home-based nursing program in the diabetic control of elderly people with diabetes mellitus living alone . Patients meeting the sampling criteria were recruited from a medical center and 10 health centers in Taipei for this quasi-experimental study . By matching the effects of age , sex , education , and history of diabetes , subjects were assigned semir and omly to two groups based on the intensity of home-based nursing care visitations . Group I was defined as daily visits to supervise diet , exercise , medication , and self-monitoring blood sugar ( n = 15 ) and Group II as weekly visits to supervise diet , exercise , medication education , and self-monitoring blood sugar ( n = 15 ) . Patients who agreed only to receive blood examination were assigned to the control group ( n = 14 ) . The results of the study showed that reductions in fasting blood sugar , postmeal blood sugar , and hemoglobin A1c ( HbA1c ) in Groups I and II were significantly greater than those in the control group . The reduction in the total cholesterol and low-density lipoprotein in Groups I and II was significantly greater than that in the control group . There were no significant differences among the three groups in the improvement of high-density lipoprotein ( HDL ) and triglycerides ( TGs ) . Group I revealed a significantly greater weight reduction compared to Group II . There was no significant difference between Groups I and II in the improvements of diabetes knowledge , depression level , or quality of life . From the research findings , based on cost-effectiveness , it is recommend that Program II be implemented",
"AIMS To explore differences in self-care behaviour according to demographic and illness characteristics ; and relationships among self-care behaviour and demographic and illness characteristics , efficacy expectations and outcome expectations of people with type 2 diabetes in Taiwan . BACKGROUND Most people with diabetes do not control their disease appropriately in Taiwan . Enhanced self-efficacy towards managing diseases can be an effective way of improving disease control as proposed by the self-efficacy model which provides a useful framework for underst and ing adherence to self-care behaviours . DESIGN AND METHODS The sample comprised 145 patients with type 2 diabetes aged 30 years or more from diabetes outpatient clinics in Taipei . Data were collected using a self-administered question naire for this study . One-way anova , t-tests , Pearson product moment correlation and hierarchical regression were analysed for the study . RESULTS Significant differences were found : between self-care behaviour and complications ( t = -2.52 , p patient education ( t = -1.96 , p Self-care behaviour was significantly and positively correlated with duration of diabetes ( r = 0.36 , p efficacy expectations ( r = 0.54 , p outcome expectations ( r = 0.44 , p self-care behaviour can be explained by duration of diabetes , efficacy expectations and outcome expectations . CONCLUSIONS Findings support the use of the self-efficacy model as a framework for underst and ing adherence to self-care behaviour . RELEVANCE TO CLINICAL PRACTICE Using self-efficacy theory when design ing patient education interventions for people with type 2 diabetes will enhance self-management routines and assist in reducing major complications in the future",
"This study investigated the effects of a nurse-coordinated intervention on patients with type 2 diabetes in Korea . Fifteen patients were r and omly assigned to an intervention group and 10 to a control group . The intervention was implemented for 12 weeks by telephone . Patients in the intervention group had a mean decrease of 1.2 % in glycosylated hemoglobin ( HbA1c ) levels and those in the control group had a mean increase of 0.5 % . Patients ' satisfaction with care was higher in the intervention group than in the control group after the intervention . These findings indicated that the nurse-coordinated intervention could improve HbA1c levels and satisfaction with care in patients with type 2 diabetes in Korea",
"AIMS To examine the influence of a pharmaceutical care programme on disease control and health-related quality of life in Type 2 diabetes patients in the United Arab Emirates . METHODS A total of 240 Type 2 diabetes patients were recruited into a r and omized , controlled , prospect i ve clinical trial with a 12-month follow-up . A range of clinical measures , medication adherence and health-related quality of life ( Short Form 36 ) were evaluated at baseline and up to 12 months . Intervention group patients received pharmaceutical care from a clinical pharmacist , whereas control group patients received their usual care from medical and nursing staff . The primary outcome measure was change in HbA(1c ) . British National Formulary and Framingham scoring methods were used to estimate changes in 10-year coronary heart disease risk scores in all patients . RESULTS A total of 234 patients completed the study . Significant reductions ( P HbA(1c)[8.5 % ( 8.3 , 8.7 ) vs. 6.9 % ( 6.7 , 7.1 ) ] , systolic [ 131.4 mmHg ( 128.1 , 134.7 ) vs. 127.2 mmHg ( 124.4 , 130.1 ) ] and diastolic blood pressure [ 85.2 mmHg ( 83.5 , 86.8 ) vs. 76.3 mmHg ( 74.9 , 77.7 ) ] were observed in the intervention group ; no significant changes were noted in the control group . The mean Framingham risk prediction score in the intervention group was 10.56 % ( 9.7 , 11.4 ) at baseline ; this decreased to 7.7 % ( 6.9 , 8.5 ) ( P pharmaceutical care programme result ed in better glycaemic control and reduced cardiovascular risk scores in Type 2 diabetes patients over a 12-month period",
"Objective Poor metabolic control and high associated morbidity and mortality among type 2 diabetic patients require a level of care from the pharmacist that goes beyond usual dispensing . The aim of the present study was to evaluate the improvement in metabolic control , the resolution of drug-related problems ( DRPs ) and the increase in patient awareness of diabetes as outcomes of a pharmacotherapy follow-up program in type 2 diabetic patients . Method R and omized controlled trial conducted in 14 community pharmacies in the province of Pontevedra ( Spain ) with 112 patients between February 2003 and March 2004 . The control group received the usual care , and the intervention group patients were included in a pharmacotherapy follow-up program . This individualized program , which consists of the detection and resolution of DRPs and diabetes education , involves patients in their own care in order to obtain maximum benefit from the medication they use . Main outcome measures HbA1c , Fasting Blood Glucose ( FBG ) , lipid profile , blood pressure , body mass index ( BMI ) , DRPs and knowledge were evaluated at the onset of the program and periodically until conclusion . Results There was a significant difference in changes from baseline between the intervention and the control group in DRPs ( 1.7±1.2 versus 3.1±1.2 P ( 17.9±3.7 versus 11.4±6.7 points P ) , HbA1c ( 7.9±1.7 versus 8.5±1.9 % P ) , FBG ( 154±61.3 versus 168±57.8 mg/dl P=0.0004 ) , total cholesterol ( 202±41.5 versus 217±43.5 mg/dl P=0.0054 ) and SBP ( 135±16.4 versus 150±19.9 mmHg P=0.0006 ) . Conclusions A substantial number of patients showed an improvement in their outcomes for the chosen metabolic indicators . Pharmacotherapy follow-up programs conducted by community pharmacists can play an important role in achieving therapeutic goals in patients with type 2 diabetes . This study shows that the incorporation of type 2 diabetic patients in a pharmacotherapy follow-up program may contribute to achieve positive clinical outcomes and will contribute to the implementation and progress of pharmacotherapy follow-up programs in community pharmacies",
"PURPOSE We sought to evaluate the effect of automated telephone assessment and self-care education calls with nurse follow-up on the management of diabetes . SUBJECTS AND METHODS We enrolled 280 English- or Spanish-speaking adults with diabetes who were using hypoglycemic medications and who were treated in a county health care system . Patients were r and omly assigned to usual care or to receive an intervention that consisted of usual care plus bi-weekly automated assessment and self-care education calls with telephone follow-up by a nurse educator . Outcomes measured at 12 months included survey-reported self-care , perceived glycemic control , and symptoms , as well as glycosylated hemoglobin ( Hb A1c ) and serum glucose levels . RESULTS We collected follow-up data for 89 % of enrollees ( 248 patients ) . Compared with usual care patients , intervention patients reported more frequent glucose monitoring , foot inspection , and weight monitoring , and fewer problems with medication adherence ( all P -0.03 ) . Follow-up Hb A , , levels were 0.3 % lower in the intervention group ( P = 0.1 ) , and about twice as many intervention patients had Hb A1c levels within the normal range ( P = 0.04 ) . Serum glucose levels were 41 mg/dL lower among intervention patients than usual care patients ( P = 0.002 ) . Intervention patients also reported better glycemic control ( P = 0.005 ) and fewer diabetic symptoms ( P symptoms of hyperglycemia and hypoglycemia . CONCLUSIONS Automated calls with telephone nurse follow-up may be an effective strategy for improving self-care behavior and glycemic control , and for decreasing symptoms among vulnerable patients with diabetes",
"OBJECTIVE : To assess the effectiveness of a pharmaceutical care model on the management of non-insulin-dependent diabetes mellitus ( NIDDM ) in urban African-American patients . DESIGN : Eligible patients were r and omized to either a pharmacist intervention or control group and followed over a 4-month period . Patients in the intervention group received diabetes education , medication counseling , instructions on dietary regulation , exercise , and home blood glucose monitoring , and evaluation and adjustment of their hypoglycemic regimen . Patients in the control group continued to receive st and ard medical care provided by their physicians . SETTING : A university-affiliated internal medicine outpatient clinic . PARTICIPANTS : The study population consisted of urban African-American patients with NIDDM currently attending the clinic . MAIN OUTCOME MEASURES : Primary outcome measures included fasting plasma glucose and glycated hemoglobin concentrations . Secondary outcome endpoints included blood pressure , serum creatinine , creatinine clearance , microalbumin to creatinine ratio , total cholesterol , triglycerides , high-density lipoprotein , and low-density lipoprotein concentrations . Quality -of-life assessment s were performed in both groups at baseline and at the end of the study . RESULTS : Thirty-nine patients ( 17 intervention , 22 control ) completed the study . The intervention group consisted of 12 women and 5 men with a mean ± SD age of 59 ± 12 years , total body weight ( TBW ) of 93 ± 22 kg , body mass index ( BMI ) of 34 ± 7 kg/m2 , and duration of NIDDM 6.8 ± 6.5 years . The control group consisted of 15 women and 7 men with a mean age of 65 ± 12 years , TBW of 88 ± 19 kg , BMI of 33 ± 7 kg/m2 , and a duration of NIDDM of 6.2 ± 4.8 y. Significant improvement in glycated hemoglobin ( p = 0.003 ) and fasting plasma glucose ( p = 0.015 ) was achieved in the intervention group . No change in glycemia was observed in the control subjects . Statistically significant differences in the final glycated hemoglobin ( p = 0.003 ) and fasting plasma glucose ( p = 0.022 ) concentrations were noted between groups . No significant changes in blood pressure control , lipid profile , renal function parameters , weight , or quality -of-life measures were noted within or between groups . CONCLUSIONS : Our data demonstrate the effectiveness of pharmaceutical care in the reduction of hyperglycemia associated with NIDDM in a group of urban African-American patients",
"A multi-center prospect i ve study was conducted to assess the function and impact of diabetic education programs on diabetic control . A total of 208 subjects with type 2 diabetes were recruited . Diabetes self-care , assessed by question naire , was evaluated before , and 4 months after attending a diabetes education course . A total of 121 subjects who received advanced diabetes education courses were design ated as the experimental group . A second group of 87 cases receiving a basic course served as controls . In addition to basic knowledge , the advanced education programs included dietary control , blood glucose monitoring , management of hypoglycemia , medication compliance , foot care and exercise . Diabetes self-care techniques were significantly improved in the experimental group . The overall score for diabetes self-care techniques improved in both groups at the 4th month over baseline values . The change was significant with the controls ' ( P diabetic education was the only significant variable correlated with the decrease of fasting blood glucose and systolic blood pressure . In conclusion , integrated and intensive diabetes education program in diabetes education centers provides an effective method for improving diabetes self-care techniques and metabolic outcome",
"AIMS Patient education is a very important part of diabetes care . However , until now , little data has been presented about the long-term effectiveness of structured intensive diabetes education programmes ( SIDEP ) for people with Type 2 diabetes mellitus . METHODS People with Type 2 diabetes ( n = 547 ) hospitalized from December 1999 to December 2000 were r and omly assigned to two groups . Two hundred and nineteen patients undertook an inpatient SIDEP and the remaining patients received conventional glycaemic control without intensive education . After discharge , all patients were monitored regularly . Laboratory data were obtained , and adherence to self-care behaviour was determined on a five-point scale by question naires completed annually . RESULTS Of the patients who completed the SIDEP , 160 ( 73.1 % ) were followed up for more than 4 years . The mean HbA(1c ) ( 7.9 + /- 1.2 vs. 8.7 + /- 1.6 % ; P frequency of hospitalization related to diabetes per patient per year ( 0.3 + /- 0.6 vs. 0.8 + /- 0.9 ; P adhered more closely to self-care behaviour than the control group over 4 years ( P People with Type 2 diabetes mellitus of longer duration and those treated with insulin had poorer HbA(1c ) at follow-up . CONCLUSIONS A well- design ed , intensive patient education programme is necessary for people with diabetes . However , regular and sustained reinforcement with encouragement is also required to maintain optimal glycaemic control , especially in insulin-treated patients ",
"BACKGROUND Type 2 diabetes mellitus is increasing in incidence and research has shown that normalization of blood glucose levels can moderate the risk of microvascular and neurological complications . AIM The purpose of this study was to investigate the effect of nurse telephone calls on glycosylated haemoglobin ( HbA1c ) levels and adherence to diabetes control recommendations . METHODS A r and omized design with control and experimental groups being assessed pre- and post intervention was used to assess the effectiveness of nurse telephone calls . Twenty patients were r and omly assigned to an intervention group and 16 to a control group . The goal of the intervention was to keep blood glucose concentrations close to the normal range ( HbA1c continued education and reinforcement of diet , exercise , medication adjustment recommendations , as well as frequent self-monitoring of blood glucose levels . Telephone intervention was performed twice per week for the first month and then weekly for the second and third month . Participants were requested to write self-management logs including blood glucose levels , diet and an exercise diary . A dietitian analysed the diet diaries and participants were informed about their results by telephone or mail . All medication adjustments were communicated to participants ' doctors . The HbA1c and diabetes adherence were measured before and after the intervention . RESULTS Patients in the intervention group had a mean decrease of 1.2 % in HbA1c levels and those in the control group had a mean increase of 0.6 % in HbA1c levels . The intervention group had greater diet and blood glucose testing adherence than the control group . CONCLUSION These findings indicate that a nurse telephone intervention can improve HbA1c , and diet and blood glucose testing adherence",
"A r and omized controlled trial was conducted to evaluate the impact of an automated telephone intervention on glycemic control in patients with type 2 diabetes . One hundred twenty participants were r and omly assigned to a treatment group that received a daily , automated telephone message regarding diabetes or to a control group that received usual care . The treatment group demonstrated a significant improvement in the frequency of self-monitoring of blood glucose levels compared with the control group ( P positive attitudes toward diabetes and a reduction in perceived monitoring and exercise barriers were seen in the intervention group compared with the control group",
"OBJECTIVE To test trial design issues related to measuring the effectiveness of a peer telephone intervention to enhance self-efficacy in type 2 diabetes ; evaluate the impact on self-efficacy and clinical outcome ; and describe patient and peer experience . METHODS Eligible patients had raised HbA1c ( initial threshold > 8 % , reduced to > 7.4 % mid-way through trial ) . Patients were recruited from 40 general practice s and r and omised ( 40:40:20 ratio ) to receive routine care alone or , in addition , motivational telephone support from a peer supporter or a diabetes specialist nurse ( 9 peers and 12 DSNs ) for a period of up to 6 months . The primary outcome measure was self-efficacy score , and secondary outcome measures included HbA1c . Patient and telecare supporter satisfaction and experience were evaluated . RESULTS In all , 231 patients participated . At 6 months there were no statistically significant differences in self-efficacy scores ( p=0.68 ) , HbA1c ( p=0.87 ) or other secondary outcome measures . There was evidence of a high level of acceptability , but peer telecare support was less highly valued than that from a DSN . Some patients stated that they would have valued more information and advice . CONCLUSIONS Further consideration needs to be given to the targeting of the telecare peer support , its intensity , the training and ongoing supervision of peer supporters , and the extent to which information and advice should be incorporated . PRACTICE IMPLICATION S While some patients with poorly controlled type 2 diabetes value peer telephone support , this approach appears not to suit all patients . Further intervention development and evaluation is required before widespread adoption can be recommended"
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Supplemental Digital Content is available in the text . Objective Pain is frequently reported by patients with inflammatory bowel disease ( IBD ) . Pain in IBD is not fully explained by disease activity or other clinical findings , and a recent systematic review suggested that psychosocial factors have an important role in IBD-pain . The aim of this study was to investigate psychosocial factors associated with pain in IBD . Methods 297 adults ( > 16 years ) with IBD were recruited from outpatient clinics ( n = 114 ) and online ( n = 183 ) . Participants completed vali date d question naires assessing pain and potential emotional , cognitive and behavioural correlates . Socio-demographic and clinical factors including disease activity were also recorded . Results 243 ( 81.8 % ) of participants reported pain . Of these 243 , mean age was 36 years ; 153 ( 63 % ) had Crohn ’s disease , 90 ( 37 % ) had ulcerative colitis , and 165 ( 67.9 % ) were female . 62.6 % reported mild , 31.6 % moderate and 5.8 % severe pain . 40.3 % of participants with pain met established criteria for chronic pain and 18.5 % reported opioid use . Female gender , smoking , surgery and steroid use were associated with greater pain severity . Psychosocial factors associated with pain-related interference included depression , catastrophising , fear avoidance , lower self-efficacy and worse mental well-being . Regression models explained 45.6 % of the variance in pain severity and 49.7 % of pain interference . Psychosocial factors explained 9.5 % and 24 % of this variance respectively when controlling for demographic and clinical variables . Conclusions Pain in IBD is significantly associated with cognitive and behavioural factors as well as low mood . This study contributes to a biopsychosocial underst and ing of pain in IBD and identifies important targets for future interventions
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"BACKGROUND AND AIMS Psychological interventions are used in patients with inflammatory bowel disease ( IBD ) but there is uncertainty about who the optimal target population is . Multi-convergent therapy ( MCT ) is a form of psychotherapy that combines mindfulness meditation with aspects of cognitive behavioural therapy and has been used in the management of irritable bowel syndrome ( IBS ) . This study aim ed to assess the feasibility and efficacy of MCT in the management of IBD patients with either functional abdominal symptoms or high perceived stress levels . METHODS Sixty-six IBD patients in clinical remission with either IBS-type symptoms or high perceived stress levels were r and omly allocated to a 16-week MCT course or waiting list control group . Patients were followed-up for one year with the Inflammatory Bowel Disease Question naire ( IBDQ ) as the primary outcome measurement . RESULTS A higher mean IBDQ score was observed in the active group compared to controls at the 4-month assessment ( 167 vs. 156 , p=0.081 ) , but this was not statistically significant nor did it reached the predefined clinical ly significant difference of 20 . In patients with IBS-type symptoms at baseline there was a significantly higher mean IBDQ score in the active group compared to controls ( 161 vs. 145 , p=0.021 ) . There was no difference between groups in relapse rate based on faecal calprotectin measurement . CONCLUSIONS IBS-type symptoms in patients with IBD represent a potential therapeutic target to improve quality of life . This study suggests that MCT may be useful in the management of these symptoms but larger studies are required to confirm this . CLINICAL TRIAL REGISTRATION NUMBER NCT01426568",
"OBJECTIVE A previous r and omised controlled trial demonstrated that a cognitive behavioural therapy ( CBT ) self-management intervention significantly improved irritable bowel syndrome ( IBS ) symptoms and disability compared to treatment as usual ( TAU ) . The current study analysed additional data to establish whether ; 1 ) cognitive , behavioural and emotional factors hypothesized to perpetuate IBS symptoms and disability changed following CBT and , 2 ) ascertain if changes in these factors over the intervention period mediated treatment effects 6-months later . METHOD IBS patients ( CBT = 31 , TAU = 33 ) completed measures pre- and -post intervention including : Brief Illness Perception Question naire , Hospital Anxiety & Depression Scale and Cognitive and Behavioural Responses to Symptoms Question naire . Path models were evaluated to determine whether changes in cognitive and behavioural factors over the treatment period mediated treatment effects . RESULTS Compared to TAU , CBT patients showed significant positive changes on several cognitive variables but not anxiety and depression following intervention . Positive change in illness perceptions following intervention mediated the treatment effect on improved IBS symptom severity and social adjustment six months later . Changes in damaging beliefs mediated the effect on social adjustment . CONCLUSIONS Change in cognition rather than mood mediated treatment related improvements . Changing negative perceptions of IBS appears to be a particularly important treatment mechanism",
"Abstract Inflammatory bowel disease ( IBD ) is frequently associated with chronic abdominal pain ( CAP ) . Transcranial direct current stimulation ( tDCS ) has been proven to reduce chronic pain . This study aim ed to investigate the effects of tDCS in patients with CAP due to IBD . This r and omized , sham-controlled , double blind , parallel- design ed study included 20 patients with either Crohn disease or ulcerative colitis with CAP ( ≥3/10 on the visual analog scale ( VAS ) in 3/6 months ) . Anodal or sham tDCS was applied over the primary motor cortex for 5 consecutive days ( 2 mA , 20 minutes ) . Assessment s included VAS , pressure pain threshold , inflammatory markers , and question naires on quality of life , functional and disease specific symptoms ( Irritable Bowel Syndrome – Severity Scoring System [ IBS – SSS ] ) , disease activity , and pain catastrophizing . Follow-up data were collected 1 week after the end of the stimulation . Statistical analyses were performed using analysis of variance and t tests . There was a significant reduction of abdominal pain in the anodal tDCS group compared with sham tDCS . This effect was evident in changes in VAS and pressure pain threshold on the left and right sides of the abdomen . In addition , 1 week after stimulation , pain reduction remained significantly decreased in the right side of the abdomen . There was also a significant reduction in scores on pain catastrophizing and on IBS – SSS when comparing both groups . Inflammatory markers and disease activity did not differ significantly between groups throughout the experiment . Transcranial direct current stimulation proved to be an effective and clinical ly relevant therapeutic strategy for CAP in IBD . The analgesic effects observed are unrelated to inflammation and disease activity , which emphasizes central pain mechanisms in CAP",
"OBJECTIVES Despite the toll of inflammatory bowel disease ( IBD ) on adjustment , many patients are resilient to the challenges associated with living with IBD , and successfully cope with their illness and thrive . Yet there is little research on why some individuals with IBD enter a trajectory of growth , while others may struggle to adapt . The aim of this study was to investigate the adjustment-related factors that distinguished thriving , resilience , and loss in people with IBD across personal growth , life satisfaction , and relationship quality domains . DESIGN Prospect i ve cohort design with two data collection points , 6 months apart . METHODS From a sample of 420 people with active IBD who completed an online survey , 152 participants completed the follow-up survey and were included in the analyses . Participants completed measures of thriving , and cognitive , affective , social , and disease-related variables known to predict adjustment . RESULTS Time 1 ANCOVAs and pairwise comparisons controlling for demographics distinguished loss from resilience and thriving on the four outcomes - coping efficacy , illness acceptance , depressive symptoms , and perceived social support - for all three domains . Time 2 ANCOVAs and pairwise comparisons controlling for baseline outcomes revealed that the Time thriving categories predicted differences in Time 2 adjustment , mainly for the life satisfaction domain , with those experiencing loss reporting poorer adjustment than those experiencing resilience and thriving . CONCLUSIONS Findings highlight the distinctions among profiles of thriving , resilience , and loss in adjustment to IBD , and suggest that strategies that enhance coping and address depressive symptoms may optimize thriving in the context of IBD . Statement of contribution What is already known on this subject ? Inflammatory bowel disease ( IBD ) is associated with depression , poor coping , and stressful symptoms . Previous research has focused mainly on poor adjustment to IBD rather than on positive growth . There is little research on why some patients with IBD thrive or are resilient , while others struggle to adapt . What does this study add ? This study is the first to longitudinally examine the profiles of thriving , resilience , and loss in individuals with IBD . The thriving profiles differed in coping efficacy , illness acceptance , depressive symptoms , and social support outcomes at Time 1 , and predicted adjustment at T2 mainly for the life satisfaction domain . Strategies that enhance coping and social support may optimize thriving in the context of IBD",
"Background Inflammatory bowel disease ( IBD ; Crohn ’s disease , CD and Ulcerative colitis , UC ) and irritable bowel syndrome ( IBS ) have overlapping symptoms . Few prevalence studies of IBS in quiescent IBD have used colonoscopy with histology to confirm inactive disease . The aims were ( 1 ) to determine the percentage of IBD patients in deep remission whose persistent IBS-like symptoms ( IBD/IBS+ ) would cause them to be classified as having active disease , based on the calculation of Harvey Bradshaw Index ( HBI ) or UC disease activity index ( UCDAI ) ; ( 2 ) to identify demographic and disease characteristics that are associated with IBD/IBS+ . Methods This was a prospect i ve study at a single tertiary care IBD center . 96/112 patients with colonoscopy and histology confirmed quiescent disease consented and completed Rome III criteria for IBS Survey , and the hospital anxiety and depression scale ( HADS ) . Other demographic and disease specific data were collected . Results 36 % ( 28/77 ) and 37 % ( 7/19 ) of CD and UC patients , respectively , met diagnostic criteria for IBS . Significantly higher HBI/UCDAI scores ( p = 0.005 ) and low short inflammatory bowel disease question naire ( SIBDQ ) scores ( p ≤ 0.0001 ) were seen in IBD/IBS+ patients . 29 % of patients in deep remission were mis-categorized by HBI/UCDAI as having active disease when they fulfilled Rome III criteria for IBS . Psychiatric diagnosis ( OR 3.53 95 % CI 1.2–10.2 ) and earlier onset of IBD ( OR 1.056 95 % CI 1.015–1.096 ) were associated with IBD/IBS+ . Patients fulfilling IBS criteria had higher hospital anxiety and depression scale ( HADS ) . Conclusion IBD/IBS+ affect scoring of IBD disease activity scales and become less useful in guiding treatment plans",
"Objective To evaluate the clinical effectiveness of two modes of cognitive – behavioural therapy ( CBT ) for IBS compared with treatment as usual ( TAU ) in refractory IBS . Design A three-arm r and omised controlled trial assessing telephone-delivered CBT ( TCBT ) , web-based CBT ( WCBT ) with minimal therapist support , and TAU . Blinding participants and therapists was not possible . Chief investigator , assessors and statisticians were blinded . Participants were adults with refractory IBS ( clinical ly significant symptoms for ≥12 months despite first-line therapies ) , recruited by letter and opportunistically from 74 general practice s and three gastroenterology centres in London and South of Engl and between May 2014 to March 2016 . Co- primary outcomes were IBS Symptom Severity Score ( IBS-SSS ) and Work and Social Adjustment Scale ( WSAS ) at 12 months . Results 558/1452 ( 38.4 % ) patients screened for eligibility were r and omised : 76 % female : 91 % white : mean age 43 years . ( 391/558 ) 70.1 % completed 12 months of follow-up . Primary outcomes : Compared with TAU ( IBS-SSS 205.6 at 12 months ) , IBS-SSS was 61.6 ( 95 % CI 33.8 to 89.5 ) points lower ( p TAU ( WSAS score 10.8 at 12 months ) WSAS was 3.5 ( 95 % CI 1.9 to 5.1 ) points lower ( p with TAU . There were no serious adverse reactions to treatment . Conclusion Both CBT interventions were superior to TAU up to 12 months of follow-up . Trial registration number IS RCT N44427879"
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BACKGROUND Diuretics are widely prescribed for hypertension not only as a first-line drug but also as a second-line drug . Therefore , it is essential to determine the effects of diuretics on blood pressure ( BP ) , heart rate and withdrawals due to adverse effects ( WDAEs ) when given as a second-line drug . OBJECTIVES To quantify the additional reduction in systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) of diuretic therapy as a second-line drug in patients with primary hypertension SEARCH STRATEGY CENTRAL ( The Cochrane Library 2008 , Issue 2 ) , MEDLINE ( 1966-July 2008 ) , EMBASE ( 1988-July 2008 ) and bibliographic citations of articles and review s were search ed . SELECTION CRITERIA Double-blind , r and omized , controlled trials evaluating the BP lowering efficacy of a diuretic in combination therapy with another class of anti-hypertensive drugs compared with the respective monotherapy ( without a diuretic ) for a duration of 3 to 12 weeks in patients with primary hypertension . DATA COLLECTION AND ANALYSIS Two review authors independently extracted the data and assessed trial quality . MAIN RESULTS Fifty-three double-blind RCTs evaluating a thiazide in 15129 hypertensive patients ( baseline BP of 156/101 mmHg ) were included . Hydrochlorothiazide was the thiazide used in 49/53 ( 92 % ) of the included studies . The additional BP reduction caused by the thiazide as a second drug was estimated by comparing the difference in BP reduction between the combination and monotherapy groups . Thiazides as a second-line drug reduced BP by 6/3 and 8/4 mmHg at doses of 1 and 2 times the manufacturer 's recommended starting dose respectively . The BP lowering effect was dose related . The effect was similar to that obtained when thiazides are used as a single agent . Only 3 double-blind RCTs evaluating loop diuretics were identified . These RCTs showed a BP lowering effect of a starting dose of about 6/3 mmHg . AUTHORS ' CONCLUSIONS Thiazides when given as a second-line drug have a dose related effect to lower blood pressure that is similar to when they are added as a first-line drug . This means that the BP lowering effect of thiazides is additive . Loop diuretics appear to have a similar blood pressure lowering effect as thiazides at 1 times the recommended starting dose . Because of the short duration of the trials and lack of reporting of adverse events , this review does not provide a good estimate of the incidence of adverse effects of diuretics given as a second-line drug
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"A multicentre , r and omised , placebo-controlled parallel group study comparing various doses of the combination diltiazem SR ( DTZ SR)/hydrochlorothiazide ( HCTZ ) with the monotherapies was performed to delineate the optimal antihypertensive dosage of the two drug combinations . The study was carried out in 298 patients with mild to moderate essential hypertension ( stable supine diastolic blood pressure , DBP , greater than or equal to 95 and less than or equal to 110 mmHg ) . After a single-blind placebo lead-in period lasting 4 - 6 weeks to establish stable baseline BP , the patients were r and omised to receive either placebo ( n = 75 ) , HCTZ ( n = 76 ) , DTZ SR ( n = 72 ) , or the combination of DTZ SR/HCTZ ( n = 75 ) . There were three 4-week evaluation periods with forced escalation of therapy as follows : HCTZ ( 6.25 , 6.25 , 12.5 mg twice daily ) , DTZ SR ( 60 , 90 , 120 mg twice daily ) , and the combination of DTZ SR/HCTZ ( 60/6.25 , 90/6.25 , 120/12.5 mg twice daily ) . DTZ SR/HCTZ ( 120/12.5 mg ) produced statistically significantly greater reductions in supine DBP compared with each monotherapy and placebo . The lower doses of DTZ SR/HCTZ ( 60/6.25 mg and 90/6.25 mg ) produced statistically significantly greater supine DBP reductions compared with DTZ SR monotherapy and placebo , but not compared with HCTZ monotherapy . A comparison of reduction in supine DBP between evaluation periods demonstrated a dose-response relationship for the combination therapy in reducing BP over the dosage range studied . Adverse clinical and laboratory events were not significantly different between the therapies . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND AND PURPOSE Converting enzyme inhibition and calcium blockade alter large arteries in hypertension . However , the heterogeneity of the response according to the site of cardiovascular measurements has never been investigated . METHODS In a double-blind study , we compared for 180 days 3 hypertensive patient groups treated with verapamil , tr and olapril , or their combination . Using echo-Doppler technique and applanation tonometry , we independently measured mean pressure , local pulse pressure , arterial diameter , and distensibility at 3 arterial sites ( brachial and common carotid arteries and abdominal aorta ) , as well as cardiac and carotid wall structure . RESULTS Mean and pulse pressure decreased significantly to a greater extent with the drug combination . Regarding arterial and cardiac hemodynamics , significant and similar changes were noted in the 3 groups : decreases in abdominal aorta and carotid but not brachial diameter ; increases in carotid artery , abdominal aorta , and brachial distensibility even after adjustment to mean blood pressure reduction ; and more substantial regression of cardiac mass than carotid wall thickness . CONCLUSIONS This study shows that both compounds and more significantly combination therapy decreased mean and pulse pressures measured independently and that the changes in diameter , thickness , and stiffness were influenced primarily by the site of cardiovascular measurements , result ing in a predominant increase in distensibility of muscular arteries , little change in carotid wall thickness , but a significant regression of cardiac hypertrophy",
"The efficacy and safety of enalapril and hydrochlorothiazide was investigated in a multicenter study of 81 patients with mild to moderate essential hypertension . The subjects were r and omly assigned to one of three groups and , following a placebo period , given enalapril maleate ( 20 mg ) , hydrochlorothiazide ( 12.5 mg ) , or a combination of the two drugs ( 32.5 mg ) . A significant decrease in blood pressure was observed after only 2 weeks in the enalapril and enalapril-hydrochlorothiazide groups . A double dose was required to achieve a satisfactory response in one-third of the patients in both the enalapril ( 9 of 27 ) and the enalapril-hydrochlorothiazide groups ( 8 of 27 ) . Adverse reactions included cough in one patient and mild hyperkalemia in another , both of whom received enalapril . Two patients on the drug combination developed side effects -- symptomatic orthostatic hypotension in one and impotence in the second . Enalapril alone and in combination with hydrochlorothiazide appears to be effective and well tolerated",
"The efficacy , tolerability and metabolic effects of a fixed combination of lisinopril 10 mg and hydrochlorothiazide 12.5 mg ( L/HCTZ ) and those of the monocomponents were compared in 286 mild to moderate hypertensive patients in a 17-centre study using a double-blind , r and omized , parallel-group design . After 2 weeks of placebo run-in , patients were r and omized to one of the three treatments for 8 weeks . Supine and st and ing BPs were measured at peak blood levels ( 4 - 8 hours post dose ) after 4 weeks , and at trough blood levels ( 24 - 28 hours post dose ) after 8 weeks . The BP reduction from baseline was greater with L/HCTZ than with the monocomponents at weeks 4 and 8 ; at week 8 the reduction was statistically significant vs lisinopril for st and ing DBP ( P less than 0.027 ) but not for st and ing SBP ; the reduction was significant with L/HCTZ vs hydrochlorothiazide at week 4 [ P = 0.0002/0.0001 ( SBP/DBP ) supine ; P = 0.0002/0.0002 st and ing ] and at week 8 ( P = 0.0001/0.0001 supine and st and ing ) . Response at week 8 ( supine DBP less than or equal to 90 mm Hg ) with L/HCTZ ( 87.0 % ) was greater than with hydrochlorothiazide ( 29.0 % ; P less than 0.0001 ) and marginally greater than with lisinopril ( 74.2 % ; P = 0.069 ) . Heart rate fell statistically significantly more with L/HCTZ ( by 3.3 beats/minute ) than with HCTZ ( by 0.86 beats/minute ; P = 0.018 ) . L/HCTZ treatment significantly increased plasma uric acid levels compared with lisinopril . L/HCTZ decreased potassium , while lisinopril increased potassium . L/HCTZ decreased cholesterol ; HCTZ increased it . Adverse effects were more common on L/HCTZ vs lisinopril ( P = 0.033 ) but not vs hydrochlorothiazide . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Summary The efficacy of cilazapril monotherapy and in combination with hydrochlorothiazide 12.5 mg was compared in a multicentre , double blind , r and omised parallel group study in 87 patients with mild to moderate essential hypertension over 8 weeks . After a 2 week single blind placebo run-in period , patients received either 2.5 mg cilazapril or 2.5 mg cilazapril plus 12.5 mg hydrochlorothiazide once daily . At Week 4 the cilazapril dose was increased from 2.5 mg to 5.0 mg if the mean sitting diastolic blood pressure was greater than 90 mmHg or had not decreased by more than 10 mmHg . After 8 weeks treatment 72 % of patients responded to 2.5 mg cilazapril increasing to 88 % with cilazapril 5.0 mg . For cilazapril plus hydrochlorothiazide , 83 % responded to 2.5 mg cilazapril increasing to 96 % on 5.0 mg cilazapril . The high response rate to low dose cilazapril monotherapy and hydrochlorothiazide combination therapy has important implication s for minimising the cost of therapy with ACE inhibitors",
"Two hundred and eleven patients with mild or moderate hypertension , mean age 53.5 + /- 9.5 years ( range 24 - 70 ) were r and omised double-blind to treatment with either captopril 50 mg ( C50 ) , hydrochlorothiazide 25 mg ( HCTZ 25 ) , the fixed combination of captopril 50 mg and hydrochlorothiazide 25 mg ( C50/HCTZ 25 ) or placebo . Blood pressure , heart rate , body weight and side effects were assessed at the end of the run-in period on placebo and after 4 , 6 , 8 weeks treatment at the same time , 20 - 24 h after the last dosing . Routine biochemical examinations were carried out on all patients after the placebo period as well as after 4 and 8 weeks . Blood pressure significantly decreased in all groups , but the mean percentage change from baseline was highly statistically significant at 8 weeks , for C50 and C50/HCTZ 25 groups . The incidence of clinical side effects was low and not statistically different for the four groups with few specific adverse effects ( one transient alteration of taste in captopril group ) . No patient was withdrawn from the study due to side effects . A better anti-hypertensive efficacy was obtained with the fixed combination captopril 50 mg/hydrochlorothiazide 25 mg once daily compared to placebo or each component alone , and without any difference in side effects",
"Summary : In an 8-week , double-blind , r and omized , active-controlled , multicenter study with three parallel treatment groups , we compared the efficacy and safety of once-daily 20 mg quinapril plus 12.5 mg hydrochlorothi-azide ( HCTZ ) with each drug as monotherapy in patients with moderate to severe hypertension . Hypertensive out patients with supine diastolic blood pressure ( DBF ) ≤105 and ≥120 mm Hg at the end of a 2− to 4-week placebo-baseline period were r and omly assigned to one of the treatment groups . Of the 323 patients who were r and omized to double-blind medication , 297 completed the study , but 6 patients were excluded for violations of protocol ; therefore , statistical analysis was performed in 291 patients . Only 7 patients withdrew owing to lack of efficacy ( 2 receiving combination therapy ) . In all three treatment groups , clinical ly significant reductions in DBF were achieved . Combination therapy was statistically more effective than each component in both evaluable data and intent-to-treat analyses . The incidence of adverse events ( AE ) was 24 % in the quinapril monotherapy group , 14 % in the combination therapy group , and 11 % in the HCTZ monotherapy group . Orthostatic hypotension with related symptoms was observed in 4 patients ( 2 receiving quinapril monotherapy , 1 receiving HCTZ monotherapy , and 1 receiving combination therapy ) . Once-daily quinapril plus HCTZ provided increased reduction of DBF as compared with the monotherapies and was well tolerated in patients with moderate to severe hypertension",
"BACKGROUND Most patients with hypertension require more than one agent to control blood pressure ( BP ) . The purpose of this study was to assess the efficacy and safety of the angiotensin II receptor blocker olmesartan medoxomil in combination with hydrochlorothiazide ( HCTZ ) . METHODS This was a r and omized , double-blind , factorial design study . After a placebo run-in period , eligible patients ( n = 502 ) with a baseline mean seated diastolic blood pressure ( SeDBP ) of 100 to 115 mm Hg were r and omized to one of 12 groups : placebo , olmesartan medoxomil monotherapy ( 10 , 20 , or 40 mg/day , HCTZ monotherapy ( 12.5 or 25 mg/day ) , or one of six groups of olmesartan medoxomil/HCTZ combination therapy . The primary endpoint was the change in mean trough SeDBP from baseline at week 8 . Statistical analyses were conducted to determine whether at least one combination produced a larger reduction in SeDBP at week 8 than the individual corresponding component doses , but did not compare BP reductions with different combination doses . RESULTS Olmesartan medoxomil plus HCTZ produced greater reductions in both SeDBP and seated systolic blood pressure ( SeSBP ) at week 8 than did monotherapy with either component . All olmesartan medoxomil/HCTZ combinations significantly reduced SeDBP and SeSBP compared with placebo in a dose-dependent manner . Reductions from baseline in mean trough SeSBP/SeDBP were 3.3/8.2 mm Hg , 20.1/16.4 mm Hg , and 26.8/21.9 mm Hg with placebo , olmesartan medoxomil/HCTZ 20/12.5 mg , and olmesartan medoxomil/HCTZ 40/25 mg , respectively . All treatments were well tolerated . CONCLUSIONS Olmesartan medoxomil/HCTZ combination therapy produced BP reductions of up to 26.8/21.9 mm Hg and was well tolerated",
"BACKGROUND Combination therapy with at least 2 antihypertensive agents is usually needed to achieve appropriate blood pressure ( BP ) control in patients with isolated or predominant systolic hypertension . A currently recommended combination is a diuretic added to an angiotensin-receptor blocker . OBJECTIVE This was a study of the effects on sitting systolic BP (SBP)of 2 combinations of valsartan and hydrochlorothiazide ( HCTZ ) compared with valsartan monotherapy in patients with stage 2 or 3 systolic hypertension ( SBP > or = 160 mm Hg and METHODS After a placebo run-in period , patients were r and omized to receive double-blind treatment with either valsartan 80 mg OD(monotherapy group ) or valsartan 160 mg OD ( combination-therapy groups ) for 4 weeks , followed by forced titration to valsartan 160 mg OD ( V160 ) , valsartan 160 mg plus HCTZ 12.5 mg OD ( V160 + HCTZ12.5 ) , or valsartan 160 mg plus HCTZ 25 mg OD ( V160 + HCTZ25 ) for an additional 4 weeks . End points were the change in SBP between the groups receiving combination therapy and the monotherapy group , between-group changes in diastolic BP ( DBP ) , responder rates ( SBP or a reduction in SBP of > or = 20 mm Hg ) , and tolerability . RESULTS A total of 774 patients were r and omized to treatment : 261 to V160 , 258 to V160+HCTZ12.5 , and 255 to V160 + HCTZ25 . The intent-to-treat population consisted of 767 patients ( 411 men , 356 women ; mean age , 60 years ; mean weight , 84 kg ; clinic mean [ SD ] baseline BP , 167.5 [8.1]/93.4 [ 9.1 ] mm Hg ) . All treatments produced significant reductions in SBP from baseline ( mean [ SD ] reduction , 20.7 [ 15.7 ] mm Hg with V160 , 27.9 [ 13.8 ] mm Hg with V160 + HCTZ12.5 , and 28.3 [ 13.1 ] mm Hg with V160+HCTZ25 ; all , P DBP was reduced by 6.6 ( 8.9 ) mm Hg in the V160 group and by 10.2 ( 7.7 ) and 10.1 ( 7.8 ) mm Hg in the V160+HCTZ12.5 and V160 + HCTZ25 groups , respectively ( all , P V160+HCTZ25 did not reach statistical significance compared with V160+HCTZ12.5 . Responder rates were 56.9 % in the V160 group , 74.4 % in the V160+HCTZ12.5 group , and 75.0 % in the V160 + HCTZ25 group P Adverse events were reported by 27.5 % of patients in the monotherapy group , compared with 28.6 % and 34.0 % in the groups that received V160+HCTZ12.5 and V160+HCTZ25 , respectively ; the differences were not significant between treatment groups . CONCLUSIONS Monotherapy with V160 was effective in these patients with stage 2 or 3 systolic hypertension . Significant additional reductions in SBP and DBP and an increase in responder rates were achieved with the addition to V160 of HCTZ12.5 and HCTZ25 , with no significant effect on tolerability",
"The effect of atenolol , a new beta-1-adrenergic receptor blocking agent , was studied in a double-blind cross-over trial in 24 carefully selected hypertensive out patients . After a four-week run-in period on matching placebo each patient received atenolol 200 mg/day , atenolol 400 mg/day , a combination of atenolol 200/mg day with bendrofluazide 5 mg/day , and bendrofluazide 5 mg/day alone , according to a r and om sequence . Atenolol at either dose produced a significantly greater reduction in all blood pressure levels except st and ing systolic pressure than bendrofluazide alone . There was no statistically significant difference between the effects of the two atenolol doses on either blood pressure or pulse rate . The addition of bendrofluazide to atenolol result ed in a further significant lowering of the blood pressure . A significant effect of thiazide on weight was noted . The study shows that atenolol , a cardioselective beta-blocker of similar potency to propranolol in animals but without membrane-stabilizing or partial agonist acitivity , is an effective and well-tolerated hypotensive agent",
"1 . The antihypertensive efficacy and tolerability of a low dose combination of the angiotensin converting enzyme inhibitor ramipril ( 2.5 mg ) and the extended release formulation of the dihydropyridine calcium channel antagonist felodipine ( 5 mg ) were assessed in a double-blind , double dummy placebo controlled , r and omised , crossover study in 20 patients ( mean age 55.4 years ; range 46 - 69 ) with uncomplicated mild to moderate hypertension ( supine diastolic > 90 mmHg placebo ) . The four r and omised , double-blind , crossover study phases evaluated the response to 4 weeks of once daily treatment with placebo , monotherapy with each drug and the combination . Noninvasive ambulatory blood pressure monitoring ( Spacelabs 90207 ) was performed for 24 h at the end of each phase . 2 . The mean 24 h ambulatory blood pressure ( mmHg ) was 147.9/92.0 following placebo , 141.3/87.8 following monotherapy with ramipril 2.5 mg , 136.8/85.8 following monotherapy with felodipine ER 5 mg and 131.1/82.6 following the combination of ramipril 2.5 mg and felodipine ER 5 mg . All active treatment phases significantly reduced mean 24 h ambulatory diastolic pressure by comparison with placebo . The antihypertensive efficacy of the combination was additive . 3 . The coadministration of ramipril did not attenuate the incidence of headache attributable to felodipine ER",
"Objective : This study compares the antihypertensive efficacy and tolerability of valsartan , a novel angiotensin II antagonist , given with hydrochlorothiazide ( HCTZ ) vs placebo or vs valsartan or HCTZ alone . Design : 871 adult out- patients with essential hypertension participated in this double-blind study . Patients were r and omised in equal number to receive either combination therapy of valsartan ( 80 mg or 160 mg ) and HCTZ ( 12.5 mg or 25 mg ) , or valsartan ( 80 mg or 160 mg ) or HCTZ ( 12.5 mg or 25 mg ) alone , or placebo . Patients were treated once daily for 8 weeks and assessed at 2 , 4 and 8 weeks after r and omisation . Main outcome measures : The primary efficacy variable was change from baseline in mean sitting diastolic blood pressure ( MSDBP ) at end-point . The secondary variable was change in mean sitting systolic blood pressure ( MSSBP ) from baseline to end-point . Results : All active treatments produced a statistically significant difference in MSDBP ( P placebo . similar results were obtained for mssbp . all combination regimens produced a statistically significantly greater reduction in msdpb and mssbp than the corresponding monotherapies . dizziness and headache were the most common treatment-related adverse experiences reported . hypokalaemia , associated with the use of thiazide diuretics , was more commonly reported in the higher dose hctz 25 mg groups . Conclusions : Valsartan 80 mg and 160 mg act additively with HCTZ 12.5 mg or 25 mg to lower MSDBP and MSSBP in patients with essential hypertension . The addition of HCTZ to valsartan 80 mg or 160 mg was well tolerated",
"In order to evaluate the antihypertensive effect and the tolerability of combination therapy with an angiotensin converting enzyme inhibitor ( captopril ) and a dihydropyridine calcium antagonist ( nifedipine ) compared with monotherapy and placebo , we studied 32 uncomplicated essential hypertensives . At the end of a 1-month placebo washout period , their diastolic blood pressure was > 105 and The subjects then received , according to a double-blind r and omized crossover design , captopril ( 50 mg twice daily ) , nifedipine ( 20 mg twice daily ) , captopril plus nifedipine at the same doses and the corresponding placebo , each treatment being given for 1 month . Both captopril and nifedipine significantly reduced mean blood pressure , which was further and significantly reduced by the combination of the two drugs . The decreases in mean blood pressure induced by nifedipine were significantly greater than those induced by captopril , and those induced by the combined therapy were significantly greater than those induced by either drug on monotherapy . The heart rate was significantly increased only by nifedipine , and to a similar , but not significant , extent by the combination therapy . Plasma renin activity was similarly and significantly increased and urinary aldosterone tended to decrease to a similar extent under the three active treatments . Adverse effects were mild to moderate in intensity ; their incidence under captopril was lower than that under placebo , while the incidence under nifedipine and combined therapy was greater than under placebo . Ankle oedema disappeared under the combined therapy in three out of four patients who developed this side effect under nifedipine , although one additional patient developed ankle oedema under combination therapy . These data indicate that : ( 1 ) captopril and nifedipine are effective antihypertensive drugs with a balanced cost-benefit ratio , since even if nifedipine alone was more effective in reducing blood pressure , it was less well tolerated than captopril ; ( 2 ) the combination of captopril and nifedipine exerted an additive antihypertensive effect without aggravating , and possibly even reducing , the incidence of adverse effects due to nifedipine . These findings confirm that the association of an angiotensin converting enzyme inhibitor with a dihydropyridine calcium antagonist can be useful in the treatment of essential hypertension",
"Objective To identify appropriate dosages of ramipril and hydrochlorothiazide ( HCT ) when given in combination once a day for the treatment of essential hypertension . Design A 2- or 4-week placebo run-in followed by 6-week , double-blind , parallel-group phase : 4 x 3 factorial ( 2.5 , 5 and 10 mg ramipril ; 12.5 and 25 mg HCT ; all six combinations ; placebo ) . Setting Office practice ( 21 centres ) . Patients and participants Patients with mild-to-moderate essential hypertension ( World Health Organization stage I — II ; supine diastolic blood pressure 100—115 mmHg in last 2 weeks of run-in ) : 581 enrolled , 534 r and omly assigned to double-blind therapy and 517 completed . Main outcome measures Reduction in supine and st and ing blood pressure . Results In pairwise comparisons , the combinations of 5 mg ramipril with 12.5 and 25 mg HCT and 10 mg ramipril with 12.5 mg HCT consistently produced significantly greater blood pressure reductions than their respective components . Response surface analyses were performed , and a stairstep model was constructed to characterize the shape of the dose-response surface . The combinations involving 5 and 10 mg ramipril with 12.5 and 25 mg HCT were again more effective than their components . Withdrawals and adverse effects were minimal for all treatments . A large drop in serum potassium was observed on 25 mg HCT , but not on combination therapy . Addition of ramipril appeared to reduce the hyperuricaemic effect of HCT . Conclusions Several dosage combinations of ramipril plus HCT produced significantly greater blood pressure reductions than the monotherapies at the same dosages . Overall , the combination of 5 mg ramipril and 25 mg HCT gave the best mean reduction . Combination therapy with ramipril plus HCT was safe and effective for patients with mild-to-moderate essential hypertension",
"The combination of angiotensin converting enzyme ( ACE ) inhibitor and thiazide diuretic has advantages over monotherapy for the treatment of hypertension . Previous study design s have often been inadequate to demonstrate the details of interactions between these antihypertensive agents . This study used a modified 4 x 4 factorial r and omized , double-blind , placebo-controlled , parallel group design to study the efficacy of 17 different doses of fosinopril ( Fos ) , a phosphinic acid derived ACE inhibitor , and hydrochlorothiazide ( HCTZ ) in 550 patients with mild to moderate hypertension . Data from these variables were fit to quadratic response surface models ( QRSM ) using polynomial functions in the doses of the two components . Using QRSM , seated systolic ( SeSBP ) and diastolic blood pressure ( SeDBP ) responses at 8 weeks were predicted for actual doses and interpolated for intermediate doses not studied . Fos and HCTZ alone and in combination produced a dose-related reduction in SeSBP and SeDBP . Using 10 mg Fos + 12.5 mg HCTZ reduced the adjusted mean SeDBP 6.3 mm Hg and 20 mg Fos + 12.5 mg HCTZ lowered the same measure 9.1 mm Hg . Coadministration of Fos and HCTZ produced an additive antihypertensive effect . This study of combination agents for hypertension using a factorial design with QRSM accurately predicts dose responses and is a valuable clinical trial methodology",
"Background Additive hemodynamic effects of combined blockade of the renin – angiotensin system by an angiotensin I converting enzyme inhibitor and an angiotensin II antagonist have been observed in sodium-depleted normotensive volunteers and in patients with congestive heart failure . Objective To investigate whether the same additive hemodynamic effects occur in patients with hypertension and to verify the safety of such an approach . Design Multicenter , r and omized , double-blind , parallel-group , pilot study . Patients 177 patients with mild-to-moderate hypertension [ diastolic blood pressure ( DBP ) : 95–115 mmHg after a 4-week placebo run-in period ] were included in the study . Intervention Combination therapy consisting of 50 mg losartan daily and 10 mg enalapril daily was administered for 6 weeks . The effects of this therapeutic regimen was compared with similar groups of patients who received either 50 mg losartan daily or 10 mg enalapril daily Main outcome measures 24-hour ambulatory mean DBP and clinic DBP measured at trough after 6 weeks of treatment . Results 24-hour ambulatory mean DBP did not significantly differ between treatment groups although the combination tended to lower BP more . The combination therapy was more effective on clinic DBP measured at trough than was losartan by 3.2 mmHg [ confidence interval ( 95 % , CI ) 0.7–5.7 mmHg , P = 0.012 ] , and more effective than enalapril by 4.0 mmHg ( 95 % CI , 1.5–6.4 mmHg , P = 0.002 ) . In a subgroup of 28 patients , higher plasma active renin and angiotensin I levels during blockade by the combination therapy were observed . This finding confirmed that the combination of the two agents inhibited the renin – angiotensin system to a greater extent than did either agent alone . Conclusion A combination of 10 mg enalapril daily and 50 mg losartan daily safely induces a supplementary , although modest , fall in clinic DBP in patients with mild-to-moderate essential hypertension",
"This r and omised , double-blind study was design ed to investigate the efficacy of a once-daily ( OD ) combination of the AT1 receptor blocker , eprosartan 600 mg , and the thiazide diuretic , hydrochlorothiazide ( HCTZ ) 12.5 mg , in patients with mild to moderate hypertension ( sitting diastolic blood pressure ( sitDBP ) ⩾98 mm Hg and ⩽114 mm Hg ) not adequately controlled with eprosartan 600 mg OD . A total of 494 patients entered the open-label monotherapy run-in phase , which consisted of eprosartan 600 mg OD for 3 weeks . Patients who responded to monotherapy were not eligible to enter the r and omised phase of the study and were withdrawn . The remaining 309 patients were then r and omised to either eprosartan 600 mg plus HCTZ 12.5 mg OD or to continue on eprosartan 600 mg OD . In the eprosartan plus HCTZ combination group , both sitDBP and sitting systolic blood pressure ( sitSBP ) were significantly reduced compared with the eprosartan monotherapy group . In addition , the response rate was higher in the combination group compared with the monotherapy group . There were no significant effects on reduction of sitDBP due to gender , prior use of antihypertensives or baseline severity of hypertension . The tolerability profile for the combination group was similar to that for the monotherapy group . Headache was the most frequent adverse event in both treatment groups . The majority of adverse events were mild to moderate in intensity . In this study of patients who were unresponsive to eprosartan monotherapy for 3 weeks , a combination product of eprosartan 600 mg and HCTZ 12.5 mg was shown to be an effective and well tolerated treatment",
"Monotherapy frequently does not cause adequate blood pressure ( BP ) reduction and goal BP is not achieved . This double-blind , r and omized , crossover , placebo-controlled study investigated , using a factorial design , the interaction between a dihydropyridine calcium channel blocking drug ( felodipine 5 mg ) and an angiotensin type I receptor blocking drug ( c and esartan 16 mg ) on the control of BP as assessed by 24-h ambulatory monitoring . A total of 31 elderly patients with systolic hypertension completed all four arms of the study . C and esartan and felodipine lowered mean 24-h BP to a similar extent ( c and esartan 12.2 + /- 2.6/7.5 + /- 1.8 ; felodipine 11.9 + /- 2.2/5.7 + /- 1.4 mm Hg ) . The combination lowered it by 21.0 + /- 2.1/11.2 + /- 1.2 mm Hg , and this fall was significantly greater than with either of the monotherapies ( P responder rate with the combination ( 90 % ) was greater than with c and esartan ( 61 % ) or felodipine ( 55 % ) . Microalbuminuria or proteinuria was present in 12 of 31 patients at r and omization despite previous BP control . C and esartan and the combination both reduced urinary albumin excretion . Albumin excretion was not reduced by felodipine despite BP control similar to that achieved with c and esartan . Side effects were infrequent and were fewer on the combination than on placebo or on the monotherapies . The combination of felodipine 5 mg and c and esartan 16 mg has additive effects on BP in elderly patients with systolic hypertension . The combination was well tolerated and is suitable for use in patients who do not have an adequate response to monotherapy",
"In a double-blind crossover study , 13 patients with pretreatment diastolic blood pressure between 95 and 109 mm Hg received nadolol , 80 mg/day , plus placebo of hydrochlorothiazide and nadolol , plus three different doses of active hydrochlorothiazide . Patients remained on each active regimen for 3 weeks , with an intervening placebo period of 2 to 4 weeks . With 12.5 mg of hydrochlorothiazide daily plus nadolol , there was no greater reduction of blood pressure than with nadolol alone . A dose of 25 mg of hydrochlorothiazide was associated with a significantly greater decrease in systolic but not diastolic pressure , as compared with nadolol alone . A significantly greater reduction in both systolic and diastolic blood pressure was obtained only with the 50 mg/day dose of hydrochlorothiazide . Extension to 6 weeks of treatment with 12.5 mg/day failed to lower the blood pressure more than the level seen at 3 weeks . These results suggest that in combination with nadolol , 12.5 mg of hydrochlorothiazide per day has no significant antihypertensive effect . There was no evidence of a flat doseresponse curve in the daily dose range of 12.5 to 50 mg . For most patients , a dose of 50 mg of hydrochlorothiazide was required to lower both systolic and diastolic blood pressure significantly below the level obtained with nadolol alone",
"AIM To determine , in a multicenter study , whether the fixed combination of verapamil retard ( 240 mg ) and hydrochlorothiazide ( 12.5 mg ) is capable of lowering blood pressure more effectively than either of the substances alone or placebo , while retaining good tolerability . METHOD A total of 173 patients who , after a four-week run-in period had a diastolic blood pressure of at least 100 and not more than 115 mm Hg , were r and omized to six weeks of monotherapy with one of the two substances , placebo or the fixed combination . RESULTS Combination treatment proved superior to monotherapy with either substance in lowering the diastolic blood pressure ( p diastolic pressure side effects beyond those associated with the single substances , occurred",
"The purpose of this study was to assess the safety and antihypertensive dose-response effects of irbesartan and hydrochlorothiazide ( HCTZ ) in patients with mild-to-moderate hypertension . After a 4- to 5-week single-blind placebo lead-in period , 683 patients with seated diastolic blood pressure ( SeDBP ) between 95 and 110 mm Hg were r and omized to receive once-daily dosing with one of 16 different double-blind , fixed combinations of irbesartan ( 0 , 37.5 , 100 , and 300 mg irbesartan ) and HCTZ ( 0 , 6.25 , 12.5 , and 25 mg HCTZ ) for 8 weeks . The primary efficacy variable was the change from baseline in trough SeDBP after 8 weeks of therapy . Data were analyzed by response surface modeling . At Week 8 , mean changes from baseline in trough SeDBP ( mm Hg ) ranged from -3.5 for placebo , -7.1 to -10.2 for the irbesartan monotherapy groups , -5.1 to -8.3 for the HCTZ monotherapy groups , and -8.1 to -15.0 for the combination groups . Irbesartan plus HCTZ produced additive reductions in both SeDBP and seated systolic BP , with at least one combination producing greater BP reduction than either drug alone ( P tolerated ; there were no treatment-related serious adverse events . Irbesartan tended to ameliorate the dose-related biochemical abnormalities associated with HCTZ alone . In conclusion , the combination of HCTZ in doses up to 25 mg with irbesartan , in doses up to 300 mg , is safe and produces dose-dependent reductions in BP",
"The efficacy of a new angiotensin converting enzyme inhibitor , lisinopril , used alone ( group A ) was compared with lisinopril plus hydrochlorothiazide ( group B ) in 26 patients with essential hypertension . Therapy with both regimens was equally effective in lowering blood pressure compared to placebo . Mean antihypertensive dose of lisinopril was lower when given in combination with hydrochlorothiazide than when given alone ( 48 + /- 6 vs 68 + /- 12 mg daily ) . Plasma renin activity increased in both groups of patients , but more in group B ( p less than 0.05 ) . Plasma aldosterone concentrations and serum uric acid levels were also higher in the group receiving lisinopril plus hydrochlorothiazide ( p less than 0.05 ) . Serum potassium concentrations were unaffected in either group . The incidence of side effects was similar in groups A and B ( 44 % and 38 % , respectively ) . This study suggests that lisinopril alone or in combination with hydrochlorothiazide effectively lowers blood pressure in patients with essential hypertension without any major side effects",
"OBJECTIVE To compare the antihypertensive efficacy and tolerability of a new combination preparation of diltiazem ( 150 mg ) and hydrochlorothiazide ( 12.5 mg ) with the individual constituents in patients with mild/moderate hypertension . DESIGN Multi-centre , double-blind , r and omised parallel group study . PATIENTS Seventy-one patients with essential hypertension were recruited to the study . TREATMENT Following completion of the placebo run-in period 63 patients fulfilled the prer and omisation criteria and entered the 10 week treatment period . Patients were r and omised to receive either the combination preparation ( D 150 mg/H 12.5 mg ) , diltiazem ( 150 mg ) or hydrochlorthiazide ( 12.5 mg ) . The dosage was increased in three patients who had not attained target blood pressure ( BP ) control after 6 weeks . OUTCOME MEASURES Response to treatment assessed by change from baseline in clinic and 24 h ambulatory BP . RESULTS The proportion of patients achieving target BP ( a reduction in resting supine diastolic blood pressure ( DBP ) to below 90 mm Hg or a reduction of 10 mm Hg from baseline ) was 80 % in the combination group , 55 % in the diltiazem group , and 38 % in the hydrochlorothiazide group . The respective figures for reduction in supine DBP from baseline were 13.5 mm Hg , 11.2 mm Hg and 5.9 mm Hg . A similar treatment order appeared throughout each of the efficacy variables . BP control throughout the 24 h dosing interval was demonstrated by ambulatory BP monitoring . Each treatment was well tolerated . CONCLUSION This study provides clear evidence of the efficacy of combination therapy with diltiazem and hydrochlorothiazide in the management of patients with hypertension",
"Fixed-dose combination therapy has received increased interest since publication of JNC-VI report and WHO/ISH guidelines 1999 . We compared in a r and omized , double-blind study the efficacy and tolerability of valsartan 80 mg combined with hydrochlorothiazide ( HCTZ ) 12.5 mg to monotherapy with either HCTZ 12.5 mg or 25 mg in patients with essential hypertension inadequately controlled by previous HCTZ 12.5 mg monotherapy . Two hundred and seventeen patients whose blood pressure ( BP ) control remained poor ( 95 mmHg h sitting diastolic BP HCTZ 12.5 mg were r and omized to receive either combination therapy with valsartan 80 mg plus HCTZ 12.5 mg ( V/HCTZ ) or monotherapy with HCTZ 12.5 mg or HCTZ 25 mg for 8 weeks . Reduction of sitting trough diastolic BP between baseline and week 8 as well as tolerability was evaluated . Reduction in trough diastolic BP was most pronounced in the V/HCTZ group ( –11.3 mmHg ) and significantly greater than in the HCTZ 12.5 mg group ( –2.9 mmHg , p HCTZ 25 mg group ( –5.7 mmHg , p . Tolerability of study medication was comparable between all three groups . In conclusion , switching to V/HCTZ combination therapy provides an additional lowering of BP compared to dosage increase of the thiazide in patients with BP insufficiently controlled by HCTZ 12.5 mg monotherapy",
"In this double-blind , r and omised , three-way crossover ( latin square design ) , multicentre study , the aim was to compare the efficacy and tolerability of the fixed combination of felodipine and metoprolol with the individual components as monotherapy . A total of 58 patients with supine diastolic blood pressure of 100 - 115 mmHg were treated with ( 1 ) a fixed combination of felodipine plus metoprolol 5/50 - 10/100 mg ( FM ) , ( 2 ) felodipine 5 - 10 mg ( F ) or ( 3 ) metoprolol 50 - 100 mg ( M ) , for 12 weeks each . All treatments were extended-release formulations administered once daily and blood pressure was measured 24 h after dosing . Dose titration was performed after 6 weeks if diastolic blood pressure was > 90 mmHg . After 12 weeks of active treatment , the mean supine blood pressures were 153/89 , 159/93 and 163/94 mmHg with FM , F and M , respectively . The mean differences in systolic/diastolic blood pressure were -5.6/-3.1 mmHg ( p = 0.007/p = 0.002 ) , -10.2/-4.4 mmHg ( p Blood pressure control ( supine diastolic blood pressure < or = 90 mmHg ) after 12 weeks was achieved in a significantly greater proportion of patients during treatment with FM than with F or M ; 71 % , 45 % and 40 % were controlled with the respective treatments . With FM , 45 % of the patients were taking the higher dose after 12 weeks of treatment . The corresponding figures for F and M were 60 % and 67 % , respectively . Thirteen of the 58 patients ( 22 % ) were controlled only with FM . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Thirty patients with essential hypertension participated in a double blind crossover trial in which they were r and omly allocated to treatment with either once daily slow release metoprolol ( 200 mg ) with placebo or once daily slow release metoprolol ( 200 mg ) with chlorthalidone ( 25 mg ) . Ambulatory intra-arterial blood pressure was recorded continuously for 24 - 48 hours before treatment and two months after each change in regimen . The response of blood pressure and pulse rate to a st and ard exercise protocol that included supine rest and tilt , isometric , and dynamic bicycle exercise was measured during the same recording periods . Both treatments appreciably reduced blood pressure and pulse rate ; mean daytime intra-arterial blood pressure was reduced from 174/95 mm Hg to 158/85 mm Hg by metoprolol plus placebo and to 143/78 mm Hg by metoprolol plus chlorthalidone . This reduction with the combined treatment was significantly greater than with metoprolol and placebo ( p systolic = 0.001 , p diastolic = 0.004 ) . Mean night time pressures were reduced from 148/78 mm Hg to 139/75 mm Hg by metoprolol plus placebo and to 116/61 mm Hg by metoprolol plus chlorthalidone . Again the reduction in blood pressure was significantly greater with combined treatment ( p less than 0.001 ) than with metoprolol plus placebo . Once daily slow release metoprolol is effective in controlling blood pressure , but this effect is greatly enhanced by the addition of a diuretic",
"This 8-week , double-blind , multicentre study compared the efficacy and safety of the combination of quinapril and hydrochlorothiazide ( HCTZ ) with each drug as monotherapy . Out patients with moderate to severe hypertension defined as supine diastolic blood pressure ( DBP ) > or = 105 mmHg and placebo-baseline period were r and omly assigned to one of the three treatments : once-daily 10 mg quinapril plus 12.5 mg HCTZ or monotherapy with these doses . After 4 weeks , the doses were to be doubled for the remaining 4 weeks . Three hundred and sixty-eight patients were r and omized to double-blind medication ; 346 completed the study . Seven patients withdrew due to lack of efficacy . Four patients withdrew due to side effects . In all three treatment groups , clinical ly significant reductions in DBP were achieved . Combination therapy was statistically more effective than each component taken as monotherapy . Adverse events were infrequent in all treatment groups . No patients experienced symptomatic hypotension or orthostatic hypotension",
"In 15 patients with mild to moderate essential hypertension , the effects of diltiazem ( 120 mg twice daily ) were compared with those of atenolol ( 50 mg once daily ) , the two drugs in combination , and placebo in a r and omized double-blind cross-over study with treatment phases of 4 weeks duration . Blood pressure was reduced in the active treatment phases ( supine blood pressure : diltiazem , 172/92 mmHg ; atenolol , 172/92 mmHg ; diltiazem plus atenolol , 164/88 mmHg ; pooled estimate of s.e.m . by analysis of variance = 3/1 ) compared with placebo ( 180/101 mmHg ) . Factorial analysis confirmed fully additive antihypertensive effects of the drugs in combination . The time interval from the beginning of the P wave to the beginning of the QRS complex ( P-R interval ) was longer during combination therapy ( 0.184s ) compared with either diltiazem ( 0.175s ) or atenolol ( 0.174s ) alone , or placebo ( 0.164s ) ; s.e.m . by analysis of variance = 0.003 . No clinical ly significant conduction disturbances occurred . Plasma atrial natriuretic peptide was elevated by atenolol but not diltiazem . Thus , in subjects with uncomplicated essential hypertension , diltiazem and atenolol had equal antihypertensive efficacy when used alone , and fully additive effects in combination , on both blood pressure and cardiac conduction",
"Summary Sixteen patients with essential hypertension completed a double blind factorial trial comparing the effects of indapamide ( 2.5 mg daily ) and pindolol ( 10 mg daily ) on blood pressure , heart rate , plasma renin activity and plasma aldosterone concentration . There were four r and omised test phases of eight weeks each during which patients received indapamide alone , pindolol alone , indapamide plus pindolol and no active treatment ( placebo ) . Blood pressure and heart rate were measured every two weeks . Supine mean arterial pressure fell from 117 mm Hg in the placebo phase to 111 mm Hg in the indapamide phase , 106 mm Hg in the pindolol phase and 103 mm Hg in the combined indapamide plus pindolol phase . Factorial analysis confirmed that the hypotensive effects of the two drugs were additive , without evidence of potentiation or antagonism . Indapamide caused significant reductions in plasma potassium and chloride , and increases in plasma bicarbonate and urate concentrations ; it also caused increases in plasma renin activity and aldosterone concentration . These changes are similar to those observed with thiazide diuretics",
"AIMS It has been suggested that the adverse metabolic effects of antihypertensive therapy offset some of the benefits of blood pressure reduction . It has also been suggested that angiotensin converting enzyme ( ACE ) inhibitors reduce insulin resistance and that , if used together with thiazide diuretics , the adverse effects of thiazides on insulin sensitivity may be eliminated . We examined the effects on insulin sensitivity of captopril either alone or in combination with bendrofluazide in 11 hypertensive Type 2 diabetic patients . METHODS Insulin action was assessed using an isoglycaemic hyperinsulinaemic clamp in a double-blind , r and omized , crossover study after a 6-week placebo run-in and following two 12-week treatment periods with captopril ( C ) ( 100 mg ) alone or in combination with bendrofluazide ( CB ) ( 2.5 mg ) . RESULTS Blood pressure was lower following CB compared to C ( 128/82 vs. 144/ 88 mmHg ; P fasting plasma glucose compared to C ( 9.7+/-0.8 vs. 8.5+/-0.6 mmol/ ; P Exogenous glucose infusion rates required to maintain isoglycaemia during hyperinsulinaemia were lower after CB compared to C ( 22.3+/-2.4 vs. 27.4+/-4.2 mol x kg(-1 ) x min(-1 ) ; P Suppression of endogenous glucose production was reduced after CB compared to baseline ( 4.0+/-0.6 vs. 2.4+/-0.5 mol x kg(-1 ) x min(-1 ) ; P bendrofluazide with captopril lowered blood pressure but result ed in deleterious effects on insulin action compared to captopril alone",
"Context Hypertension is a recognized risk factor for the development of congestive heart failure ( CHF ) . By measuring blood pressure , however , we have not yet been able to underst and the significance of pulse pressure as a contributor to CHF in middle-aged men and women . Contribution Using data from the Framingham Heart Study , the authors found that although elevations of systolic , diastolic , and pulse pressure were all related to the risk for CHF , the relation was strongest for systolic and pulse pressure . Caution s Underst and ing the relationships between systolic , diastolic , and pulse pressure and risk for CHF is helpful ; however , they do not help determine the increased risk faced by a person with systolic hypertension who also has increased pulse pressure . The Editors Hypertension is the most common risk factor for congestive heart failure ( CHF ) . It confers a twofold risk for the occurrence of CHF and also carries the highest population attributable risk among all risk factors for CHF ( 1 , 2 ) . Placebo-controlled clinical trials in patients with hypertension have demonstrated a consistent reduction in risk for CHF attributable to the lowering of elevated blood pressure ( 3 - 6 ) . The causal role of hypertension in the pathogenesis of CHF underscores the need to identify high-risk patients because early treatment may prevent or delay the occurrence of CHF ( 2 , 7 ) . The prognostic significance of systolic and diastolic blood pressure in CHF has been reported . However , blood pressure may also be divided into two other components : steady ( mean arterial pressure ) and pulsatile ( pulse arterial pressure ) ( 8 - 10 ) . Pulse pressure , a simple correlate of conduit vessel stiffness , is associated with left ventricular hypertrophy ( 11 ) . Increased pulse pressure has also been implicated in the development and progression of large-vessel atherosclerosis and small-vessel disease ( 12 - 14 ) . Accumulating evidence indicates that pulse pressure ( defined as the difference between systolic and diastolic blood pressure ) may be an important predictor of cardiovascular events ( 15 - 18 ) . Pulse pressure predicts the risk for CHF in elderly persons ( 19 , 20 ) ; however , the association of pulse pressure with CHF in middle-aged men and women has not been examined . The Framingham Heart Study provides an opportunity to examine the long-term associations of systolic , diastolic , and pulse pressure with the new onset of CHF in middle-aged and elderly men and women . Blood pressure and traditional risk factors have been measured repeatedly at serial examinations in this community-based cohort with long-term follow-up . We examined systolic blood pressure , diastolic blood pressure , and pulse pressure as predictors of risk for CHF in the Framingham Heart Study . Methods The Framingham Heart Study , which began in 1948 , has followed 5209 participants ( 28 to 62 years of age at entry to the study ) as part of a prospect i ve epidemiologic study of cardiovascular disease . Enrollment criteria and study design have been published previously ( 21 ) . Biennial follow-up visits included a medical history , physical examination , blood pressure measurements , 12-lead electrocardiography , and laboratory tests . Eligibility requirements for inclusion in our study were as follows : Participants had to be free of coronary heart disease and CHF and not be receiving antihypertensive therapy at Framingham Heart Study clinic baseline examinations 10 , 11 , or 12 ( 1968 to 1973 ) . Participants were followed for onset of CHF through mid-1994 . We obtained data for selected risk factors from the baseline examination . Methods for assessing risk factors have been published previously ( 21 , 22 ) . Risk factors , including age , sex , cigarette smoking , heart rate , antihypertensive medication use , and total and high-density lipoprotein cholesterol levels , were assessed . Sitting systolic and diastolic blood pressure were measured twice by the examining physician ( using a mercury column sphygmomanometer ) and averaged . We used body mass index ( kg/m2 ) as a measure of obesity . Participants were categorized as smokers if they smoked cigarettes regularly within the 1-year period before the baseline examination . Electrocardiography revealed left ventricular hypertrophy when increased voltage was associated with major ST-T repolarization changes ( strain pattern ) ( 22 ) . Diabetes mellitus was defined on the basis of a fasting blood glucose level greater than 7.77 mmol/L ( > 140 mg/dL ) , two r and om nonfasting blood glucose levels greater than 11.10 mmol/L ( > 200 mg/dL ) , or the use of insulin or an oral hypoglycemic agent . Diagnostic criteria for CHF have been described previously ( 21 , 22 ) . At each clinic examination , a history of interim hospitalizations and symptoms of CHF were obtained . Outside medical records of participants who did not attend an examination were evaluated for incident CHF . All suspected interim events were review ed by a panel of three physicians who evaluated relevant Framingham Heart Study clinic notes , outside physician reports , and hospitalization records . Congestive heart failure was diagnosed when at least two major or one major and two minor criteria were present . Minor criteria were considered only if their presence could not be attributed to another disease process . Major criteria were paroxysmal nocturnal dyspnea , pulmonary rales , distended jugular veins , enlarging heart size on chest radiography , acute pulmonary edema , hepatojugular reflux , third heart sound , jugular venous pressure of 16 cm or greater , and weight loss of 4.5 kg or greater in response to diuresis . Major criteria also included pulmonary edema , visceral congestion , or cardiomegaly on autopsy . Minor criteria were bilateral ankle edema , nocturnal cough , shortness of breath on ordinary exertion , hepatomegaly , pleural effusion , decrease in vital capacity by one third from the previous maximum recorded value , and heart rate of 120 beats/min or more . Statistical Analysis We used multivariable Cox proportional-hazards regression models to examine the relations of systolic , diastolic , and pulse pressure with CHF . After accounting for age and sex and using a P value less than 0.15 as the selection criterion , we determined covariates by stepwise selection from the following list : body mass index , diabetes , smoking status , total cholesterol level , high-density lipoprotein ( HDL ) cholesterol level , totalHDL cholesterol ratio , left ventricular hypertrophy , and heart rate . Only total cholesterol level and totalHDL cholesterol ratio did not enter the model . After accounting for relevant covariates , we used Cox proportional-hazards models to obtain hazard ratio estimates with 95 % CIs for st and ardized values of systolic , diastolic , and pulse pressure . These estimates were obtained individually and pairwise by using SAS software ( SAS Institute , Inc. , Cary , North Carolina ) ( 23 ) . We repeated analyses for participants stratified according to hypertension status and sex . Because blood pressure and age are correlated , we conducted separate analyses for participants younger than 60 years of age and 60 years of age and older . To examine constancy of effects over time , follow-up was divided into early and late periods ( blood pressure as a time-varying covariate and assessed the effect of antihypertensive treatment after the baseline blood pressure measurements . We used the KaplanMeier method to plot age- and sex-st and ardized cumulative incidence rates for CHF as a function of pulse pressure tertile at baseline . Descriptive data are presented as percentages or means ( SD ) . A P value less than 0.05 was considered statistically significant . Role of the Funding Sources The funding sources had no role in the design , conduct , analyses , and reporting of the study or in the decision to su bmi t the manuscript for publication . Results A total of 894 men and 1146 women , age 50 to 79 years , fulfilled criteria for inclusion in our study . Table 1 presents baseline clinical characteristics for these persons . During 35 497 person-years of follow-up ( mean , 17.4 years [ range , 0.06 to 24 years ] ) , CHF developed in 234 ( 11.8 % ) persons . Myocardial infa rct ion preceded CHF in 59 ( 25 % ) persons . Table 1 . Baseline Clinical Characteristics of the Study Participants Increments of 1 SD in systolic pressure , pulse pressure , and diastolic pressure were associated with hazard ratios for congestive failure of 1.56 , 1.55 , and 1.24 , respectively , after adjustment for age , sex , smoking , left ventricular hypertrophy , body mass index , diabetes mellitus , HDL cholesterol level , and heart rate ( Table 2 ) . When blood pressure tertiles were used , similar associations were observed among various components of blood pressure and CHF . No threshold effect or J-shaped association was documented ( Table 2 ) . The cumulative incidence of CHF according to tertiles of baseline pulse pressure is plotted in the Figure . Table 2 . Risk FactorAdjusted Association of Blood Pressure with Congestive Heart Failure Figure . Cumulative incidence of congestive heart failure according to pulse pressure tertiles at the baseline examination . The joint influences of different blood pressure components were also examined , with adjustment for the covariates mentioned previously . Of note , correlations among the blood pressure variables ranged from modest to very high ( r = 0.20 for diastolic and pulse pressure , r = 0.65 for diastolic and systolic pressure , and r = 0.88 for systolic and pulse pressure ) . Diastolic pressure was not significant ( hazard ratio , 1.12 [ CI , 0.98 to 1.29 ] ) in conjunction with pulse pressure ( hazard ratio , 1.51 [ CI , 1.33 to 1.72 ] ) . Likewise , diastolic pressure was not significant ( hazard ratio , 0.86 [ CI , 0.72 to 1.03 ] ) in conjunction with systolic pressure ( hazard ratio , 1.71 [ CI , 1.45 to 2.01 ] ) , but joint estimates were less stable than those obtained for individual pressure variables . Finally",
"Summary The pharmacodynamic effects and acceptability of perindopril ( 4 mg daily ) and hydrochlorothiazide ( 25 mg daily ) given alone or in combination for 1 month were investigated in a double-blind , placebo controlled , parallel group study . The pharmacokinetics of perindopril and its active metabolite perindoprilat and the time course of angiotensin converting enzyme inhibition were studied for 72 h following the last dose of treatment in the two appropriate groups . Similar decreases in blood pressure were seen 24 h after the last dose of perindopril or hydrochlorothiazide ( 11/7 mm Hg supine ) given alone at these doses . The effect of these drugs given together was additive on diastolic blood pressure and synergistic on systolic blood pressure ( 24.5/12.6 mm Hg supine ) taking into account the placebo response . The significant increase in plasma renin activity produced by perindopril alone was potentiated by concurrent administration of hydrochlorothiazide . The formation of perindoprilat was slightly reduced in the group also receiving hydrochlorothiazide and there was a very small reduction in ACE inhibition in this group . Perindopril , whether given alone or in combination with hydrochlorothiazide , was well tolerated and produced no clinical ly significant change in routine haematology or serum biochemistry . The additive or synergistic effects of perindopril and hydrochlorothiazide on blood pressure must be due to their complementary physiological actions and not to a pharmacokinetic interaction",
"To investigate the concept of initiating therapy with low doses of a calcium antagonist and an ACE inhibitor , a fixed combination of isradipine 2.5 mg plus the ACE inhibitor spirapril 3 mg was compared with its components , with the full-dose monotherapies ( isradipine 5 mg or spirapril 6 mg ) , and with placebo . After a 2-week wash out phase in pretreated patients and a subsequent 2-week placebo period , 405 patients with a diastolic blood pressure ( DBP ) between 100 and 114 mmHg were r and omly allocated to 12-week once-daily double-blind treatment in one of the six treatment arms . In patients whose blood pressure was not normalized ( defined as DBP≤90 mmHg ) after 6 weeks of treatment , the dosage of either medication was doubled or , in the placebo group , was switched to the fixed combination . After week 6 , the mean reductions from baseline in sitting systolic/diastolic blood pressure 24 hours after dosing ( trough ) for the fixed combination or the monotherapies isradipine 5 mg , isradipine 2.5 mg , spirapril 6 mg , spirapril 3 mg , and placebo were10.4/8.7 , 10.0/9.4 , 6.5/6.7 , 10.0/8.3 , 7.0/5.8 , and 2.2/4.7 mmHg , respectively . The blood pressure changes obtained with the low-dose fixed combination were essentially identical to those observed with the full-dose monotherapies , thus showing an additive effect of low-dose isradipine and spirapril . In terms of tolerability , the lowest rate of any adverse events was found in the combination group . In this group , typical adverse events of calcium antagonists , such as headache , flushing , ankle edema , or palpitations , were observed only in 5 % , 2 % , 1 % , and 0 % , respectively , dry cough , considered typical for ACE inhibitors , was observed in only 1 % of the combination group . In conclusion , the low-dose components isradipine 2.5 mg and spirapril 3 mg were shown to have an additive effect when combined , exerting a blood pressure – lowering effect comparable with the full doses and a trend to a better tolerability profile in comparison with the st and ard doses . Thus , low-dose combination therapy with these drugs appears to be a rational alternative to conventional monotherapy in the first-line treatment of hypertension",
"To determine whether the combination of nifedipine + chlorthalidone exerts an additive antihypertensive effect when compared with single-drug treatment , we studied 66 uncomplicated essential hypertensives , with diastolic blood pressure of greater than 100 and less than 115 mmHg . At the end of a 1-month washout placebo period , using a double-blind crossover design , the patients were r and omly allocated to nifedipine ( 20 mg twice a day ) , chlorthalidone ( 25 mg once a day ) , the two drugs combined at the same doses and the corresponding placebo . Compared with the r and omly allocated placebo , the three active treatments significantly reduced blood pressure without changing the heart rate or body weight . Both the absolute and percentage decreases in mean blood pressure induced by nifedipine and the combination compared with placebo were similar and significantly greater than those induced by chlorthalidone . Taken together , these data show that the combination of nifedipine + chlorthalidone does not exert any additive antihypertensive effect compared with nifedipine alone . This finding indicates that the combination of a dihydropyridine calcium antagonist + a thiazide diuretic is probably devoid of any particular clinical significance in the treatment of uncomplicated essential hypertensives",
"Most hypertensive patients require more than one medication to effectively control elevated blood pressure ( BP ) values . This multicenter , r and omized , double-blind study was aim ed at testing the efficacy and safety of the combination of low-dose nifedipine GITS 20 mg/ losartan 50 mg compared with either monotherapy in patients with grade 1 to 3 hypertension over an eight-week period . Of 352 patients enrolled in the study , 300 were r and omized . All the three treatments lowered elevated BP without clinical ly relevant changes in heart rate . All the three treatments lowered mean 24-hour diastolic BP : nifedipine GITS/losartan −10.6 mm Hg , losartan −5.4 mm Hg , nifedipine GITS 20 mg −8.0 mm Hg . There was a statistically significant difference of diastolic BP change between patients receiving losartan compared with those receiving combination treatment ( P were highest in the patient group receiving combination therapy ( 70 % ) . Nifedipine GITS monotherapy had the highest systolic BP trough-to-peak ratio of all treatment arms ( 78 % ) and higher diastolic BP trough-to-peak ratio and smoothness index than losartan monotherapy . All treatments were safe . These data provide evidence that in hypertensive patients combination of nifedipine GITS 20 mg and losartan 50 mg improves control of systolic and diastolic BP compared with either monotherapy",
"The importance of concomitant low-dose hydrochlorothiazide was assessed in black hypertensive patients treated with enalapril . Left ventricular ( LV ) mass and function , metabolic parameters , 24-hour ambulatory blood pressure ( BP ) , exercise duration , and systolic BP response were evaluated before and after drug therapy . Enalapril 20 mg ( group 1 ) or enalapril 20 mg plus hydrochlorothiazide 12.5 mg ( single tablet ; group 2 ) was given to 38 patients for 9 weeks in a double-blind , placebo-controlled , r and omized study . LV mass measured 61 + /- 17 versus 102 + /- 23 g/m2 , and 24-hour ambulatory BP measured 120 + /- 8/75 + /- 6 versus 155 + /- 12/100 + /- 6 mm Hg in matched control subjects ( n = 40 ) versus hypertensive patients , respectively . No clinical ly important changes occurred in total cholesterol , serum uric acid or potassium in either group . Enalapril slightly reduced 24-hour ambulatory BP from 154 + /- 15/100 + /- 7 mm Hg to 148 + /- 19/96 + /- 11 mm Hg after treatment ( p systolic BP load ( 70 % to 59 % , p diastolic BP load ( 67 % to 60 % , p = NS ) decreased . Baseline BP decreased from 157 + /- 9/101 + /- 6 to 132 + /- 13/86 + /- 8 mm Hg ( p systolic BP load ( 64 % to 29 % , p diastolic BP load ( 64 % to 33 % , p < 0.0001 ) decreased in group 2 . Exercise systolic BP was attenuated ( p = 0.007 , group 2 ; p = NS , group 1 ) and duration increased ( p = NS ) only in group 2 . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND The safety and effectiveness of different dosages and combinations of antihypertensive agents can be efficiently studied using a multifactorial trial design . In consultation with the Cardio-Renal Division of the Food and Drug Administration , we conducted a r and omized , double-blind , placebo-controlled , 3 x 4 factorial trial of bisoprolol , a beta 1-selective adrenergic blocking agent , and hydrochlorothiazide . METHODS A total of 512 patients with mild to moderate essential hypertension were r and omized to once-daily treatment with bisoprolol ( 0 , 2.5 , 10 , or 40 mg ) , hydrochlorothiazide ( 0 , 6.25 , or 25 mg ) , and all possible combinations . Diastolic and systolic blood pressures were monitored during this 12-week trial . RESULTS The effects of bisoprolol and hydrochlorothiazide were additive with respect to reductions in diastolic and systolic blood pressures over the dosage ranges studied . The addition of hydrochlorothiazide ( or bisoprolol ) to therapy with bisoprolol ( or hydrochlorothiazide ) produced an incremental reduction in blood pressure . Dosages of hydrochlorothiazide as low as 6.25 mg/d contributed a significant antihypertensive effect . A hydrochlorothiazide dosage of 6.25 mg/d produced significantly less hypokalemia and less of an increase in uric acid levels than a dosage of 25 mg/d . The low-dose combination of bisoprolol , 2.5 mg/d , and hydrochlorothiazide , 6.25 mg/d , reduced diastolic blood pressure to lower than 90 mm Hg in 61 % of patients and demonstrated a safety profile that compared favorably with that of placebo . CONCLUSIONS The utility of factorial design trials to characterize dose-response relationships and to test the potential interactions between various antihypertensive agents has been demonstrated . The combination of low dosages of bisoprolol and hydrochlorothiazide may be a rational alternative to conventional stepped-care therapy for the initial treatment of patients with mild to moderate hypertension",
"& NA ; This r and omized , double-blind , placebo-controlled , parallel-group study evaluated the efficacy and safety of single daily dose diltiazem extended-release ( XR ) and indapamide , given alone and combined , in 255 male and 170 female patients with mild to moderate hypertension . Blood pressure was assessed both manually in the office and by 24-hour ambulatory blood pressure monitoring ( ABPM ) techniques . Between-treatment efficacy comparisons were based on ABPM plots and changes from baseline in supine systolic ( SuSBP ) and diastolic ( SuDBP ) blood pressure after 6 weeks of doubleblind treatment . Periodic 12-lead electrocardiograms ( ECG ) , clinical laboratory tests , and physical examinations were used to assess safety . Both diltiazem XR 180 , 240 , and 360 mg and indapamide 2.5 mg monotherapy reduced ambulatory blood pressure to a greater extent than placebo . The ABPM data demonstrate that 2.5 mg indapamide produces an additional reduction in diastolic blood pressure when combined with fixed doses of diltiazem XR ( 120 , 180 , and 240 mg ) . The reduction was consistent over the entire 24-hour recording period for all combinations . Compared with monotherapy groups , higher therapeutic response rates ( SuDBP ≤ 90 mm Hg or & Dgr ; SuDBP ≥ 10 mm Hg decrease from baseline ) were also observed with combination therapy . Office blood pressure data qualitatively and quantitatively supported the observations made from the ABPM data . There were no unexpected adverse events or side-effect trends and no dose-response or clinical ly significant laboratory , ECG , or physical examination adverse effects . The combination therapy regimens were well tolerated with safety profiles comparable with those of the individual therapies",
"BACKGROUND Angiotensin II acts at the cellular level through specific angiotensin II subtype I , AT-1 receptors . Losartan is the first of a new class of antihypertensive agents that specifically block angiotensin II at AT-1 receptors . By acting on complementary and different pharmacologic mechanisms , the concomitant use of low doses of hydrochlorothiazide with losartan may offer an additive antihypertensive activity with fewer adverse experiences . METHODS This double-blind study evaluated losartan concomitantly administered with hydrochlorothiazide as initial therapy in 703 patients with essential hypertension . RESULTS The greatest reduction in blood pressure was observed in the 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide group ( 17.2 mm Hg in sitting systolic blood pressure and 13.2 mm Hg in sitting diastolic blood pressure [ P losartan potassium and 12.5 mg of hydrochlorothiazide had an excellent or good antihypertensive response ( sitting diastolic blood pressure or = 90 mm Hg with a reduction of 10 mm Hg or more ) . Peak ( 6 hours after dosing ) and trough placebo-adjusted ratios for the losartan-hydrochlorothiazide groups ranged from 62 % to 85 % , indicating that there was a smooth reduction in sitting diastolic blood pressure that was sustained over 24 hours . The most common clinical adverse experiences ( > or = 4 % ) that occurred with an incidence slightly greater than that reported by the placebo-treated patients were headache , asthenia or fatigue , dizziness , sinusitis , and upper respiratory infection . CONCLUSION The concomitant administration of losartan potassium , 50 mg , with 12.5 mg of hydrochlorothiazide once daily produced an additive reduction in trough sitting systolic and diastolic blood pressure and was well tolerated",
"In a r and omised , crossover study of patients with moderate to severe essential hypertension , the effects of the calcium entry antagonist nifedipine and the beta-receptor blocking drug acebutolol were studied on their own , and in combination . After 4 weeks of nifedipine tablets 20 mg twice daily ( Adalat , Bayer ) , mean supine blood pressure ( BP ) fell by 20 mmHg and after 4 weeks of acebutolol 200 mg twice a day ( Sectral , May & Baker ) by 11 mmHg . When nifedipine and acebutolol were given in combination in the above doses for 4 weeks , there was a significantly greater fall in BP than with either agent alone , supine mean arterial pressure falling by 27 mmHg . The above BPs were measured 2 h after the last dose of tablets . Measurements 12 h after the last dose showed smaller falls in BP , with a significantly greater fall with combination treatment than with acebutolol alone . The fall in BP 12 h after the last dose of the combination was greater than with nifedipine alone but this difference was not statistically significant . This r and omised , controlled study showed that nifedipine and acebutolol have a marked additive effect on BP which is sustained for at least 12 h after treatment",
"Aim : To review the efficacy and safety of losartan and hydrochlorothiazide compared to losartan alone , hydrochlorothiazide alone or placebo in the treatment of mild to moderate hypertension in a clinical trial Patients and methods : A r and omly allocated , placebo-controlled , double-blind parallel study was performed in 40 clinical centers throughout the United States . A total of 703 males and females aged 18–75 years with a sitting diastolic blood pressure of 95–115 mmHg entered the trial and 604 completed the 12-week protocol . The participants were r and omly assigned to concomitant therapy once a day with : ( 1 ) 50 mg losartan and 6.25 mg hydrochlorothiazide , ( 2 ) 50 mg losartan and 12.5 mg hydrochlorothiazide , ( 3 ) 50 mg losartan alone , ( 4 ) 12.5 mg hydrochlorothiazide alone or ( 5 ) placebo . All participants were followed for 12 weeks Results : At baseline , mean trough sitting diastolic blood pressure was 100.9 - 101.7 mmHg , with no significant difference between treatment groups . Sitting diastolic blood pressure fell 4.0 mmHg with placebo , 7.2 mmHg with 12.5 mg hydrochlorothiazide , 7.2 mmHg with 50 mg losartan , 9.3 mmHg with 50 mg losartan + 6.25 mg hydrochlorothiazide , and 13.2 mmHg with 50 mg losartan + 12.5 mg hydrochlorothiazide . The fall in mean trough sitting systolic blood pressure was 2.4 , 9.3 , 10.7 , 12.0 and 17.9 mmHg for the respective groups . After subtracting the placebo effect , the reductions in blood pressure induced by losartan and hydrochlorothiazide were additive for both sitting diastolic and systolic blood pressures and approximately equaled the reduction seen with the combination of losartan and hydrochlorothiazide . There were no significant differences in adverse events between treatment groups Conclusions : The concomitant administration of 50 mg losartan + 12.5 mg hydrochlorothiazide produced additive falls in sitting diastolic and systolic blood pressures which were greater than that achieved with either drug alone . On the basis of the adverse effects reported , the combination was well",
"STUDY OBJECTIVES To compare the efficacy of combination therapy with sustained-release diltiazem and hydrochlorothiazide ( DTZ SR-HCTZ ) with that of monotherapy with DTZ SR , HCTZ , or placebo in the treatment of essential hypertension ; and to determine whether the addition of a diuretic to diltiazem at apparent optimum doses of each agent significantly enhances their antihypertensive effects . DESIGN Multicenter , r and omized , double-blind , placebo-controlled , parallel-group trial with a 6-week treatment phase . SETTING Private and university-based clinics . PATIENTS AND PARTICIPANTS Subjects of either sex , ranging in age from 18 - 70 years , with a diagnosis of stable essential hypertension made from two consecutive weekly mean supine diastolic blood pressure ( DBP ) readings of 95 mm Hg or above to 110 mm Hg or less that varied 7 mm Hg or less after 4 - 6 weeks in the baseline phase . Of the patients enrolled , 298 met the inclusion criteria . INTERVENTIONS Combination therapy with DTZ SR-HCTZ 120 mg-12.5 mg , or monotherapy with DTZ SR 120 mg or HCTZ 12.5 mg , or placebo was administered twice daily . MEASUREMENTS AND MAIN RESULTS Combination therapy with DTZ SR-HCTZ lowered both supine DBP and SBP significantly ( p DBP and SBP significantly more than either monotherapy . During a 12-hour in-clinic monitoring period spanning a dosing interval , both the combination and DTZ SR therapies maintained efficacy , whereas the antihypertensive effects of HCTZ dissipated after 8 hours . Treatment-related adverse events for the combination and HCTZ were similar but slightly greater than those for DTZ SR and placebo . CONCLUSIONS The addition of a diuretic to sustained-release diltiazem produced an enhanced antihypertensive effect compared with monotherapy with either individual agent",
"The combination of an angiotensin converting enzyme inhibitor with a calcium antagonist has become a common way of treating patients with essential hypertension who respond insufficiently to monotherapy . This double-blind , r and omized , parallel , placebo-controlled , multicenter , outpatient study evaluated the antihypertensive efficacy and safety of a calcium antagonist ( verapamil SR ) and an angiotensin converting enzyme inhibitor ( tr and olapril ) in patients with mild-to-moderate ( stages I and II ) essential hypertension . Six hundred thirty-one patients were enrolled in this 10-week study . After a 4-week single-blind placebo phase , patients received one of the following daily dosage regimens in a double-blind fashion for 6 weeks : placebo , 4 mg of tr and olapril , 240 mg of verapamil SR , or a combination of 4 mg of tr and olapril and 240 mg of verapamil SR . Trough sitting diastolic blood pressure was lowered by 4.5 mm Hg , 4.3 mm Hg , and 8.1 mm Hg more than placebo in the tr and olapril , verapamil SR , and combination groups , respectively . In the combination group , sitting diastolic blood pressure was significantly lowered ( P tr and olapril group and by 3.8 mm Hg more than in the verapamil SR group . An analysis of the trough-to-peak ratio for sitting diastolic blood pressure revealed values of 0.75 and 0.67 , for the 4-mg tr and olapril and the combination groups , respectively , at end point . The overall incidence of adverse reactions was similar for all treatment groups . In this study the combination of an angiotensin converting enzyme inhibitor and calcium antagonist was well tolerated and more effective than either agent administered alone for the treatment of mild-to-moderate essential hypertension",
"Summary : In a double-blind , r and omized , multicenter trial , we compared the efficacy and safety of the fixed combination of 5 mg ramipril and 6 mg piretanide and the respective component monotherapies in hypertensive patients [ supine diastolic blood pressure ( DBP ) 100–114 mm Hg ] . After a single-blind run-in period on placebo , 611 patients were r and omized to ramipril ( n = 209 ) , piretanide ( n = 201 ) , or the combination therapy ( n = 201 ) . At r and omization , the three groups had the same characteristics ( 51 % men , age 55 ± 10 years , BP 165 ± 18/104 ± 6 mm Hg ) . At 4 weeks , BP decreased more with combined therapy than with monotherapy . As compared with piretanide monotherapy , the gain in the antihypertensive effect in the supine position averaged 2.1 mm Hg [ 90 % confidence interval ( CI ) - 0.8–5.0 mm Hg ; p = 0.07 ] systolic BP ( SBP ) and 1.9 mm Hg ( CI 0.3–3.5 mm Hg , p = 0.02 ) DBP and , as compared with ramipril monotherapy , these differences were 4.2 mm Hg ( CI 1.3–7.0 mm Hg , p = 0.008 ) and 2.0 mm Hg ( CI 0.5–3.6 mm Hg , p = 0.009 ) . The incidence of adverse events ( AE ) and the changes in biochemical measurements were similar in the three treatment groups with the exception of spontaneously reported polyuria and serum uric acid concentration . Polyuria was reported more frequently ( p ) with piretanide therapy ( n = 23 ) and combined therapy ( n = 19 ) than with ramipril therapy ( n = 1 ) . Similarly , serum uric acid increased more ( p the piretanide group ( + 24 μM ) and in the group receiving combined therapy ( + 18 μM ) as compared with the ramipril group ( + 0 μM ) . However , serum uric acid levels and the incidence of polyuria were similar with piretanide and combined therapy . As compared with the respective monotherapies , combined treatment with ramipril and piretanide produced an additional BP-lowering effect and did not lead to more frequent side effects ",
"Summary In a multicentre , double-blind , crossover , placebo-controlled study , the antihypertensive effect of labetalol 100 mg and chlorthalidone 10 mg , given alone or in combination , has been assessed in 32 hypertensive patients . The combination had a greater effect in reducing blood pressure than did its separate components . This was particularly evident after exercise . Heart rate increased during chlorthalidone therapy , decreased during labetalol therapy , and a summation effect was observed during treatment with the combination . In most cases additivity was observed , as no interaction between the single components was observed , except for heart rate after exercise , and for diastolic blood pressure in the upright position . No interaction was observed either in the biochemical indices or in the clinical side-effects",
"In a double-blind , parallel-group multicentre study , the efficacy and safety of a fixed low-dose combination of ramipril 2.5 mg and hydrochlorothiazide ( HCT ) 12.5 mg was compared with each of the component drugs when given as monotherapy . After a four-week placebo run-in , patients were r and omized to receive either ramipril 2.5 mg ( n = 218 ) or HCT 12.5 mg ( n = 220 ) , or the fixed-dose combination of ramipril 2.5 mg and HCT 12.5 mg ( n = 222 ) , for a period of eight weeks . At the end of the study , in which 624 patients had completed treatment , it was found that the decrease in supine diastolic blood pressure ( the main efficacy parameter ) was greater in the ramipril-HCT combination group than in either the ramipril or the HCT monotherapy groups , the difference being statistically significant when compared with the HCT group ( -14.3 , -13.1 and -12.4 mm Hg , respectively ) . Reductions in st and ing DBP and supine and st and ing systolic blood pressure ( SBP ) were also greatest in the combination group . The incidence of adverse events was lower in the combination group than in either of the monotherapy groups , and there were no serious clinical ly significant laboratory abnormalities in the combination group",
"In 16 patients with essential hypertension the effects of enalapril 20 mg once daily were compared with those of atenolol 50 mg once daily , with the two drugs in combination and with placebo using a double-blind cross-over design with allocation of treatment order by r and omised Latin squares . For each patient there were four treatment phases , each of four weeks duration , which together comprised a 2 x 2 factorial experiment . All blood pressure parameters were reduced in the three active treatment phases compared to placebo ( p less than 0.001 ) . Supine blood pressures ( group means ) were 171/97 ( placebo ) , 147/85 ( enalapril ) , 154/84 ( atenolol ) and 144/78 ( enalapril plus atenolol ) ( S.E.M. + /- 2/+/- 1-ANOVA ) , and st and ing blood pressures were 170/105 ( placebo ) , 146/92 ( enalapril ) , 154/92 ( atenolol ) and 147/86 ( enalapril plus atenolol ) ( S.E.M. + /- 3/+/- 1 ) . In the combination phase there was an additional hypotensive response but the potential fully additive effects of the two agents were attenuated by 30 - 50 % . The mechanism of the attenuated hypotensive effect of the combined agents has not been determined . Plasma atrial natriuretic peptide ( ANP ) concentration was doubled in the presence of atenolol ( P less than 0.01 ) suggesting that ANP may contribute to the hypotensive effect of the beta-blocker",
"1 A placebo-controlled , r and omised double-blind comparison of captopril 25 mg three times a day , hydrochlorothiazide 15 mg three times a day , and the combination was conducted in 207 patients with essential hypertension with supine diastolic blood pressures of 92 - 110 mm Hg . Significant decreases in blood pressure were seen in all three groups ; the magnitude of decrease seen with captopril and hydrochlorothiazide was similar , while the combination produced an additive response greater ( p less than 0.001 ) than captopril or hydrochlorothiazide alone . 2 The major side effect reported was a rash in fewer than 6 % of patients taking captopril alone or in combination . Loss of taste or proteinuria was not observed . 3 The addition of captopril of hydrochlorothiazide blunted the hypokalaemia and hyperuricaemia observed with hydrochlorothiazide alone in addition to its antihypertensive synergy . These observations indicate that this relatively low dose of captopril is safe and efficacious in the treatment of mild to moderate hypertension alone and particularly when combined with a thiazide diuretic",
"AIMS To investigate the dose-response relationship and contribution of verapamil SR and tr and olapril given in combination once a day for the treatment of essential hypertension . METHODS A r and omized , double-blind , placebo controlled , factorial , 12 arm parallel group comparison with placebo , verapamil SR ( 120 , 180 mg ) , tr and olapril ( 0.5 , 1.0 , 2.0 mg ) covering all combinations of both drugs . A 4 week placebo run-in period followed by 6 weeks of treatment . Four hundred and fifty-six patients from office practice ( 22 centres ) with mild to moderate hypertension enrolled and 426 with diastolic pressure > or = 100 mm Hg at the end of run-in period were r and omized . Main outcome measures were reduction in sitting systolic ( SBP ) and sitting diastolic ( DBP ) blood pressure . RESULTS The combination of verapamil SR and tr and olapril , particularly verapamil SR 180 mg and tr and olapril 0.5 or 1.0 mg was significantly superior to both monocomponents at the same dose ( P reductions in DBP from baseline to last visit were 14.1 and 16.0 mm Hg , respectively . Response surface analysis provided further evidence that these combinations were optimal for antihypertensive efficacy . All treatments were well tolerated . The incidence of adverse events did not differ significantly between treatment groups ; the profile of adverse events on combination therapy was mild and consistent with that of each monocomponent . CONCLUSIONS All dosage combinations of verapamil SR and tr and olapril produced significantly greater reduction of blood pressure than the monotherapy at the same dosage . However , verapamil SR 180 mg in combination with tr and olapril 1.0 mg was the dosage with the greatest blood pressure reduction and had the greatest effects compared with the monocomponents",
"The aim of the study was to identify the most appropriate dosage combination of ramipril and felodipine ER ( an extended release tablet ) for mild-to-moderate hypertension . Hypertensive patients ( N = 507 ) with supinediastolic blood pressure ( DBP ) values between 100 - 115 mm Hg were included in a r and omized , multicenter , double-blind study of 3x4 factorial design with a 2 - 4 week single-blind , placebo run-in and 6 week active treatment phase . The patients were r and omized to 12 groups : placebo , ramipril ( 2.5 , 5 , 10 mg ) , felodipine ER ( 5 , 10 mg ) , or ramipril-felodipine ER combinations ( 2.5/5 mg , 2.5/10 mg , 5/5 mg , 5/10 mg , 10/5 mg , 10/10 mg ) . Although the greatest reductions in blood pressure were observed with ramipril-felodipine ER ( 10/10 mg ) , consideration of the antihypertensive efficacy and safety factors suggest that the ramipril-felodipine ER ( 5/5 mg ) combination has the best efficacy/tolerability ratio of the combinations tested . The incidence of adverse events with ramipril-felodipine ER combination therapy was similar to that with felodipine ER monotherapy , but peripheral edema , tachycardia and vasodilatation occurred less frequently with ramipril-felodipine ER ( 5/5 mg ) combination than with felodipine ER monotherapy . The combination of ramipril-felodipine ER ( 5/5 mg ) can be considered to be the most suitable option for hypertensive patients with an inadequate response to either of the monocomponents",
"Fifteen out- patients with moderate hypertension were r and omly and sequentially treated with atenolol , indapamide and a combination of the two drugs after a wash-out period of at least 1 week and a 2-week placebo run-in period . The duration of treatment was 4 weeks in each case . The dosage was 2.5 mg indapamide and 100 mg atenolol , in single tablets which were taken at 11.00 hours . All the treatment regimens produced a highly significant ( p less than 0.001 ) reduction in systolic and diastolic , supine and st and ing blood pressure ; these reductions were not significantly different for the single drugs but were significantly greater for the combined therapy . The number of patients reaching the end-point of a diastolic blood pressure of 95 mmHg or less was the same with either atenolol or indapamide , i.e. 7 ( 46.6 % ) , but was greater with the combined therapy , i.e. 10 ( 66.6 % ) . A significant ( p less than 0.001 ) reduction in pulse rate was observed with the treatments involving atenolol . Acceptability of the treatments was very good ; the number of volunteered and elicited complaints during the different treatments being less compared to the placebo period , particularly for the combined treatment . No significant difference was observed in the blood biochemistry tests . The results are discussed in light of the mechanisms of action of the two drugs , which seem well integrated with each other , and the duration of the antihypertensive effect , which allows a single administration with consequent good treatment compliance",
" Thirty-six patients ( 33 male , 3 female ) with a mean age of 67 years and a diastolic blood pressure between 95 and 115 mm Hg , after a four-week placebo run-in period entered a double-blind crossover study comparing felodipine 5 and 10 mg with enalapril 5 and 10 mg and their combination ( enalapril 5 mg + felodipine 5 mg ) . Combined therapy caused a fall in blood pressure of 24/16 mm Hg at trough level that was greater than the falls with the higher doses of monotherapy . The fall with felodipine was greater than with enalapril . Similar patients responded to felodipine and enalapril but more patients achieved blood pressure control with felodipine . When patients not controlled with enalapril 5 mg had felodipine 5 mg or enalapril 5 mg added , felodipine was more effective at lowering blood pressure than the increase in enalapril dosage . A similar effect occurred in those not controlled with felodipine 5 mg . Adverse effects occurred in 22 patients on felodipine , 14 patients on enalapril and 8 on combined therapy . The lipoprotein profile was not altered significantly . Glomerular filtration rates as assessed by 24-hour creatinine clearance were 90 ml/min at r and omization , 125 ml/min on felodipine , 108 ml/min on enalapril and 120 ml/min on the combination . Felodipine and enalapril in low doses are effective antihypertensive agents in elderly people . Felodipine monotherapy is more effective than enalapril monotherapy but a greater blood pressure lowering effect can be obtained with the combination of low doses of enalapril and felodipine . This has the advantage that the number of side effects is less",
"A factorial design was applied in this multicenter , double-blind , placebo-controlled trial of the calcium-channel blocker verapamil and the ACE inhibitor enalapril to assess the hypotensive effects of the combination compared with monotherapy , to evaluate safety , and to determine the effects on quality of life ( QOL ) of both drugs , alone and in combination . The study consisted of a 3 x 2 factorial design wherein 186 men and women with a sitting diastolic blood pressure ( BP ) of between 95 mm Hg and 114 mm Hg , after a 4-week placebo washout , were r and omized to one of six treatment groups for 4 weeks of active treatment . Monotherapy with both 240 mg verapamil and 10 mg enalapril reduced systolic and diastolic BP to a similar extent and significantly more than placebo . The 240 mg verapamil + 10 mg enalapril combination was additive for both systolic and diastolic blood pressure ; 120 mg verapamil + 10 mg enalapril was additive for systolic BP only . The total number of adverse events reported was similar for all six treatment groups . QOL scores were unchanged from baseline and not different between treatment groups . The combination of 240 mg verapamil and 10 mg enalapril was significantly more effective at reducing BP than either drug alone ; this additivity of effect was not linked to a higher rate of adverse experiences or to a deterioration in QOL . Thus , combination therapy at lower doses may offer an alternative treatment option to higher dose monotherapy",
"Two hundred thirty-four patients with supine diastolic blood pressure of between 95 and 114 mm Hg were enrolled into a double-blind , r and omized , parallel , multicenter trial . The patients were r and omized to either nicardipine 30 mg tid , propranolol 40 mg tid , or nicardipine 30 mg tid and propranolol 40 mg tid for six weeks . Two hundred six patients yielded data for analyses . Of the 28 not included , seven had missing data , whereas the remaining 21 were excluded because they either failed to meet inclusion criteria or were noncompliant at endpoint . Both nicardipine and propranolol as monotherapies and in combination achieved statistically significant , ( P less than .01 ) , supine diastolic blood pressure reduction relative to baseline . The combination of nicardipine and propranolol showed a greater reduction in supine diastolic and systolic measurements than either of the monotherapies . Nicardipine produced greater blood pressure reductions one hour after dosing , whereas the propranolol treatment tended to produce slightly greater blood pressure decreases eight hours after dose . The combination always result ed in the greatest blood pressure reduction , independent of time after dose . Adverse experiences were reported by 26 % of patients in the nicardipine-treated group , most often transient vasodilatory effects , by 17 % of the propranolol-treated patients , and by 18 % of the combination-treated group . This study demonstrated at the doses studied that nicardipine alone produced equivalent blood pressure reductions to those obtained by propranolol alone , but that the combination of these two drugs produced greater reductions in blood pressures than either of the monotherapies",
"The antihypertensive effect and safety of fosinopril and hydrochlorothiazide combined were compared with each drug singly and placebo in a controlled manner . After a 4- to 5-week placebo lead-in period , 67 mild to moderate essential hypertensive patients ( seated diastolic blood pressure £ 95 and £ 110 mm Hg ) were r and omized in a double-blind fashion into four parallel treatment groups : 20 mg fosinopril plus 12.5 mg hydrochlorothiazide , 20 mg fosinopril , 12.5 mg hydrochlorothiazide , and placebo during 8 weeks . Patients were seen biweekly . Sitting diastolic blood pressure was the outcome variable defining therapeutic response . The efficacy of fosinopril plus hydrochlorothiazide as a combined therapy was superior to any single drug ( P hypertension . Mean adjusted systolic/diastolic blood pressure decrements at week 8 were −18.8/−13.7 , −12.9/−11.8 , −8.5/−9.3 , and −2.11−6.9 mm Hg for the fosinopril plus hydrochlorothiazide , fosinopril , hydrochlorothiazide , and placebo groups , respectively . Clinical adverse events and laboratory changes documented throughout the study were similar to placebo and were mild in severity in all groups",
"Lisinopril ( LIS ) is a lysine analog of enalaprilat , the active metabolite of enalapril , an angiotensin-converting enzyme inhibitor ( ACEI ) . Unlike enalapril , the precursor of enalaprilat , LIS is not a prodrug but has equal ACEI efficacy and potency and a slightly longer duration of action after oral administration . Short-term ( 12 weeks ) and long-term ( 24 weeks ) blood pressure control has been studied with LIS , hydrochlorothiazide ( HCTZ ) , and LIS + HCTZ when given once a day . Drug treatment had three phases : ( i ) 2–4 weeks of single-blind placebo washout ; ( ii ) 12 weeks of double-blind comparison therapy with LIS 20 , 40 . and 80 mg vs. HCTZ 12.5 , 25 , and 50 mg , vs. LIS + HCTZ 20 + 12.5 , 40 + 25 . and 80 + 50 mg ; ( iii ) 13–24 weeks single-blind LIS vs. LIS + HCTZ . Starting double-blind therapy at the lowest dose , all three groups doubled the dose at weeks 4 and 8 if BP was not controlled with sitting diastolic BP ( SDBP ) HCTZ-only and LIS-only treatment groups were advanced to combination LIS + HCTZ therapy but uncontrolled LIS + HCTZ patients were dropped . Mean BP reductions ( systolic/diastolic , mm Hg ) for all three groups after 12 weeks of double-blind comparison therapy were : ( i ) LIS ( n = 162 ) , – 16.6/-12.5 ; ( ii ) HCTZ ( n = 155 ) , – 10.4/-6.8 : ( iii ) LIS + HCTZ ( n = 74 ) . −23.9/- 18.2 with p with all therapies were seen regardless of race , but nonblack patients responded better than black patients to LIS alone . During the second treatment period ( weeks 13–24 ) , 89 % of patients ( 177/199 ) at week 24 had SDBP ≤ 85 mm Hg or ≥ 10 mm Hg SDBP reduction . By 24 weeks , 82 % ( 72/88 ) of LIS-treated patients maintained this BP control , whereas 84 % ( 48/57 ) of LIS + HCTZ-treated patients and 67 % ( 36/54 ) of HCTZ-treated patients sustained identical BP control . By 22 weeks , 68 % ( 81/119 ) of patients maintained BP control on LIS monotherapy . With ≤ 20 mg LIS therapy , 41 % ( 33/81 ) achieved long-term BP control , whereas 65 % and 72 % of these patients responded to ≤ 40 mg and ≥ 80 mg LIS doses , respectively . Serious adverse clinical effects in all groups were rare ( , LIS therapy alone ( 20–80 mg q.d . ) is more efficacious than HCTZ therapy alone ( 12.5–50 mg q.d . ) . LIS + HCTZ [ ( 20 + 12.5)-(80 + 50 ) mg q.d . ] is more efficacious than either LIS therapy alone ( 20–80 mg q.d . ) or HCTZ therapy alone ( 12.5–50 mg q.d . ) . Lisinopril and LIS + HCTZ are effective and well tolerated antihypertensive agents in both short- and long-term therapy",
"BACKGROUND To attain goal blood pressure ( BP ) , many hypertensive patients require combination antihypertensive therapy . Thiazide diuretic/beta-blocker regimens lower BP , and clinical studies indicate that they reduce the risk for cardiovascular consequences of hypertension . Fixed-dose combination tablets can simplify multidrug treatment regimens . METHODS This multicenter , r and omized , double-blind , placebo-controlled , unbalanced factorial study ( N = 1571 ) was design ed to determine whether hydrochlorothiazide ( HCT ) and extended release ( ER ) metoprolol both contribute to an antihypertensive effect . Hypertensive adults with sitting diastolic BP ( SiDBP ) 95 to 114 mm Hg and systolic BP ( SiSBP ) received one of three hydrochlorothiazide doses ( 6.25 mg , 12.5 mg , or 25 mg ) , one of four ER-metoprolol doses ( 25 mg , 50 mg , 100 mg , 200 mg ) , or one of nine of the combinations or placebo for 8 weeks . RESULTS Blood pressure decreased with all combinations ( P Reductions with placebo were 5.3 ( SiDBP ) and 4.2 mm Hg ( SiSBP ) . Both active agents contributed to the combination effect ( P = .0015 for SiDBP ; P = .0006 for SiSBP ) . Several low-dose combinations were approximately as effective as high doses of the individual agents ( differences within 1 to 2.5 mm Hg ) . The adverse event discontinuation rate was 2.9 % . Serum potassium decreased and uric acid increased with increasing doses of HCT . CONCLUSIONS Extended-release metoprolol/hydrochlorothiazide is an effective antihypertensive combination that offers additive antihypertensive contributions from both components",
"After a control period on a placebo , 45 patients with mild to moderate hypertension were treated with metoprolol , 100 mg twice daily alone and in free combination with chlorthalidone 50 mg daily using a double-blind crossover technique . The beta-blocker alone induced a significant fall in blood pressure ; the diastolic pressure was reduced to 100 mg Hg or less in 37 of the 45 patients and to 95 mm Hg or less in 19 patients . The addition of chlorthalidone enhanced the antihypertensive effect so that in 33 patients diastolic pressure fell to 95 mm Hg or less . The drugs were well tolerated even by a small number of patients with chronic bronchitis and diabetes mellitus . None of the patients developed cardiac failure . Adding a diuretic caused a small reduction in serum potassium concentrations , and the relevance of this observation is discussed",
"BACKGROUND By blocking the renin-angiotensin-aldosterone system ( RAAS ) at its rate-limiting step , renin inhibition may provide improved RAAS suppression . We investigated the blood pressure (BP)-lowering effects of the oral direct renin inhibitor aliskiren , alone or in combination with the angiotensin receptor blocker valsartan . METHODS In this multicenter , r and omized , placebo-controlled , 8-week trial , 1123 patients with mild-to-moderate hypertension underwent a 3 to 4 week single-blind placebo run-in and were then r and omized in a modified factorial study design to receive once-daily , double-blind oral treatment with placebo , aliskiren monotherapy ( 75 , 150 , or 300 mg ) , valsartan monotherapy ( 80 , 160 , or 320 mg ) , aliskiren and valsartan in combination , or valsartan/hydrochlorothiazide ( 160/12.5 mg ) . The primary efficacy variable was the change from baseline in mean sitting diastolic BP ( DBP ) at endpoint . RESULTS Once-daily oral treatment with aliskiren 300 mg significantly ( P mean sitting DBP and systolic BP ( SBP ) compared with placebo ; aliskiren monotherapy demonstrated a safety and tolerability profile comparable to placebo . Changes in DBP and SBP were fitted to a first-order dose-response surface ( lack-of-fit test , P = .65 ) , which showed that aliskiren and valsartan alone and in combination produced dose-related reductions in DBP and SBP . Coadministration of aliskiren and valsartan produced a greater antihypertensive effect than either drug alone , comparable in magnitude to the effect of valsartan/hydrochlorothiazide , with similar tolerability to the component monotherapies and to placebo . CONCLUSIONS Aliskiren monotherapy provides antihypertensive efficacy and placebo-like tolerability in patients with hypertension . Aliskiren and valsartan in combination may provide additive BP-lowering effects with maintained tolerability",
"The tolerance and antihypertensive action of acebutolol , as a sole drug and in combination with a diuretic , were studied in a population of 34 female subjects aged over 65 years , with a mean of 81 years , suffering from well tolerated essential hypertension . The study was carried out in the form of double blind permutations , each subject receiving successively in an order determined by r and om selection each of three therapeutic phases : acebutolol , acebutolol in combination with a diuretic and a placebo . The results showed that in the elderly acebutolol had a moderate diuretic action which was remarkably potentialised by diuretics . The tolerance of this beta-blocker was excellent : no cases of cardiac failure , and no disturbances in atrioventricular conduction developed during the phases with active treatment",
"In a double-blind , crossover study , five white men with mild-to-moderate hypertension received placebo and fixed doses of atenolol , metoprolol , chlorthalidone , verapamil , and the combination of atenolol and chlorthalidone in a quasi-r and om order . Daily dosages were : atenolol , 100 mg ; metoprolol , 200 mg ; chlorthalidone , 50 mg ; verapamil , 240 mg ; and the same doses of atenolol and chlorthalidone in combination . St and ard office and daytime ambulatory blood pressures were assessed at the end of each month-long trial . Atenolol , metoprolol , chlorthalidone , and verapamil controlled office blood pressure with similar reductions . Verapamil did not lower ambulatory blood pressure at this dose ( which is lower than is now commonly used ) , but reductions in ambulatory blood pressure were similar for atenolol , metoprolol , and chlorthalidone . The combination of atenolol and chlorthalidone maintained blood pressure control more effectively than the single drug treatments in both office and ambulatory setting s , and the combined hypotensive effects were additive . However , reductions in the office due to the combination appeared to overestimate hypotensive effectiveness in the ambulatory setting . This study suggests that the effectiveness of commonly prescribed antihypertensive regimens varies according to setting as well as drug , and that assessment of treatment effectiveness can be improved by automated ambulatory blood pressure monitoring",
"BACKGROUND Characteristics such as age and race are often cited as determinants of the response of blood pressure to specific antihypertensive agents , but this clinical ly important issue has not been examined in sufficiently large trials , involving all st and ard treatments , to determine the effect of such factors . METHODS In a r and omized , double-blind study at 15 clinics , we assigned 1292 men with diastolic blood pressures of 95 to 109 mm Hg , after a placebo washout period , to receive placebo or one of six drugs : hydrochlorothiazide ( 12.5 to 50 mg per day ) , atenolol ( 25 to 100 mg per day ) , captopril ( 25 to 100 mg per day ) , clonidine ( 0.2 to 0.6 mg per day ) , a sustained-release preparation of diltiazem ( 120 to 360 mg per day ) , or prazosin ( 4 to 20 mg per day ) . The drug doses were titrated to a goal of less than 90 mm Hg for maximal diastolic pressure , and the patients continued to receive therapy for at least one year . RESULTS The mean ( + /- SD ) age of the r and omized patients was 59 + /- 10 years , and 48 percent were black . The average blood pressure at base line was 152 + /- 14/99 + /- 3 mm Hg . Diltiazem therapy had the highest rate of success : 59 percent of the treated patients had reached the blood-pressure goal at the end of the titration phase and had a diastolic blood pressure of less than 95 mm Hg at one year . Atenolol was successful by this definition in 51 percent of the patients , clonidine in 50 percent , hydrochlorothiazide in 46 percent , captopril in 42 percent , and prazosin in 42 percent ; all these agents were superior to placebo ( success rate , 25 percent ) . Diltiazem ranked first for younger blacks ( ) and older blacks ( > or = 60 years ) , among whom the success rate was 64 percent , captopril for younger whites ( success rate , 55 percent ) , and atenolol for older whites ( 68 percent ) . Drug intolerance was more frequent with clonidine ( 14 percent ) and prazosin ( 12 percent ) than with the other drugs . CONCLUSIONS Among men , race and age have an important effect on the response to single-drug therapy for hypertension . In addition to cost and quality of life , these factors should be considered in the initial choice of a drug",
"Using a placebo baseline , positive controlled , double-blind , r and omized titration to effect our study protocol , we assessed the antihypertensive actions of enalapril , hydrochlorothiazide , and their combination in 37 patients with moderate essential hypertension . Patients were maintained on their regular diets and received a placebo for 4 weeks . Patients with moderate systemic hypertension were r and omized to receive enalapril monotherapy at a dose of 10 mg twice daily ( n = 16 ) , hydrochlorothiazide monotherapy at a dose of 25 mg twice daily ( n = 15 ) , or combination therapy consisting of 10 mg enalapril and 25 mg hydrochlorothiazide twice daily ( n = 6 ) . Therapy could be titrated to twice the starting dose . All treatment regimens reduced blood pressure , but only one patient had blood pressure normalized ( diastolic blood pressure less than or equal to 90 mmHg ) with enalapril ( 7 % ) , two patients with hydrochlorothiazide ( 15 % ) , and 80 % of patients with combination therapy . The patients who had not achieved normal blood pressure received combination treatment , and after 8 additional weeks , more than 70 % showed normal blood pressure . After one year of combination therapy , 92 % of the patients continue to have normal blood pressure . Both the monotherapy and combination regimens were very well tolerated in this study . In conclusion , enalapril , hydrochlorothiazide , and their combination are effective in reducing blood pressure in patients with moderate hypertension . However , monotherapy is successful in normalizing blood pressure only in a small percentage of patients . Combination therapy achieved normalization of blood pressure in almost all patients , suggesting that most patients on regular diets with moderate hypertension may require a diuretic-ACE inhibitor combination rather than monotherapy to achieve effective blood pressure control",
"Objectives Aliskiren is a novel , orally active renin inhibitor . Its antihypertensive efficacy and safety , alone and in combination with hydrochlorothiazide ( HCTZ ) , were investigated in an 8-week , double-blind , placebo-controlled trial in hypertensive patients . The effects of these treatments on plasma renin activity ( PRA ) were also assessed . Methods A total of 2776 patients aged ≥ 18 years with mean sitting diastolic blood pressure ( MSDBP ) 95–109 mmHg were r and omized to receive once-daily treatment with aliskiren ( 75 , 150 or 300 mg ) , HCTZ ( 6.25 , 12.5 or 25 mg ) , the combination of aliskiren and HCTZ , or placebo , in a factorial design . The primary endpoint was the change in MSDBP from baseline to week 8 . PRA was assessed at these timepoints at selected study centers . Results Aliskiren monotherapy was superior to placebo ( P reducing MSDBP and mean sitting systolic blood pressure ( MSSBP ) . Combination treatment was superior to both component monotherapies in reducing BP ( maximum MSSBP/MSDBP reduction of 21.2/14.3 mmHg from baseline with aliskiren/HCTZ 300/25 mg ) , and result ed in more responders ( patients with MSDBP . Aliskiren monotherapy reduced PRA by up to 65 % from baseline . Although HCTZ monotherapy increased PRA by up to 72 % , PRA decreased in all of the combination therapy groups . All active treatments were well tolerated . Conclusions Aliskiren monotherapy demonstrated significant BP lowering , and its effect was considerably greater when combined with HCTZ . Renin inhibition with aliskiren neutralized the compensatory rise in PRA induced by HCTZ ",
"A double-blind , crossover study was carried out in 32 Sudanese patients with essential hypertension to assess the effectiveness of single daily doses of 400 mg acebutolol when given alone and in combination with single daily doses of hydroclorothiazide/amiloride diuretic . The results show that in both groups there was a statistically significant reduction in systolic and diastolic levels throughout the treatment period . After crossover at 6 weeks , those patients initiated on acebutolol alone showed a further reduction in both systolic and diastolic pressures when the hydrochlorothiazide/amiloride combination was added . Both treatment regimens were well-tolerated and only a few side-effects were reported",
"This prospect i ve , double-blind , parallel-group study r and omized patients with moderate hypertension ( seated systolic blood pressure ( SeSBP ) 160–179 mm Hg when seated diastolic blood pressure ( SeDBP ) with irbesartan 300 mg/hydrochlorothiazide ( HCTZ ) 25 mg combination therapy ( n=328 ) , irbesartan 300 mg monotherapy ( n=106 ) or HCTZ monotherapy 25 mg ( n=104 ) . Treatment was initiated at half dose , with forced titration to full dose after two weeks followed by ten further weeks ' treatment . The primary efficacy variable was the mean reduction in SeSBP from baseline to week 8 . Baseline characteristics were similar between groups , with mean baseline blood pressure approximately 162/98 mm Hg ; the mean age was 55 years . At week 8 there was a reduction in SeSBP of 27.1 mm Hg with irbesartan/HCTZ , compared with 22.1 mm Hg with irbesartan monotherapy ( P=0.0016 ) and 15.7 mm Hg with HCTZ ( P rate of decline and the total degree of decline achieved were greatest with irbesartan/HCTZ and least with HCTZ . A significantly greater percentage of patients reached a treatment goal of SeSBP with irbesartan/HCTZ ( 53.4 % ) , compared with irbesartan ( 40.6 % ; P=0.0254 ) and HCTZ ( 20.2 % ; P tolerated in all three-treatment groups with a slight increase in adverse events in the combination therapy group . In conclusion , irbesartan/HCTZ ( 300/25 mg ) is well tolerated and achieves rapid and sustained reductions in both systolic blood pressure and diastolic blood pressure in patients with moderate hypertension",
"In 101 hypertensive patients , the effects of a combination of propranolol and bendrofluazide were compared with those of each drug alone . After an introductory period with a placebo , the patients received , in a double-blind r and omized trial , propranolol 80 mg twice a day , bendrofluazide 2.5 mg twice a day , or both drugs together twice daily . The combination produced significantly greater reductions in lying , st and ing , and post-exercise systolic and diastolic blood pressure than either drug separately . Side-effects were minimal and the combination was well accepted by patients",
"1 The hypotensive effect of single daily dosing with atenolol 100 mg and chlorthalidone 25 mg given alone or in combination has been assessed in a double-blind , crossover , placebo controlled trial in fifteen hypertensive patients . 2 Average lying blood pressures were : Placebo 155.4/103.9 mm Hg , atenolol 134.6/85.8 mm Hg , chlorthalidone 139.5/90.1 mm Hg , combination 127.7/82.5 mm Hg . 3 The effect of the combination therapy in reducing lying diastolic pressure compared with placebo ( a fall of 21.4 mm Hg ) was significantly less than the 31.9 mm Hg fall predicted from the sum of the individual effects ( P = 0.01 ) . 4 Observations on blood pressure at rest and under mental , isometric and bicycle ergometer stress were made pre-dose and post-dose for a 12 h period at the end of the last treatment period . 5 Lying blood pressure declined from the zero hour ( pre-dose ) reading on all treatments to a low at 15.00 - -18.00 h and then rose again . 6 The rise in systolic blood pressure after isometric exercise and mental stress was of a similar magnitude with all four treatment regimes . 7 Atenolol , alone and in combination with chlorthalidone , reduced the blood pressure and the pulse rate increase on exercise 2 h post-dose when compared with readings 24 h post-dose . 8 Once daily dosing with a combination of atenolol and chlorthalidone produced a fall in supine blood pressure over a 24 h period but the effect on exercise induced changes was not uniform over this period",
"OBJECTIVE To assess the efficacy and safety of several combinations of benazepril , an angiotensin-converting enzyme inhibitor , and hydrochlorothiazide , as compared with placebo , in the treatment of patients with essential hypertension . DESIGN A 6-week , r and omized , double-blind , parallel study conducted at 24 centers . A placebo run-in period of 1 to 4 weeks preceded the double-blind phase . PARTICIPANTS AND SETTING Male and female out patients , aged 18 years and older , were eligible to participate if their sitting diastolic blood pressure was between 95 and 114 mm Hg at the last two consecutive visits during the placebo phase . Among the 334 patients who entered the double-blind phase , 17 % were aged 65 years or older and 26 % were black . Eleven patients withdrew because of adverse experiences , including two patients receiving placebo . INTERVENTIONS Patients received placebo ; benazepril , 20 mg ; hydrochlorothiazide , 25 mg ; or combination therapy with benazepril/hydrochlorothiazide , 5/6.25 mg , 10/12.5 mg , 20/25 mg , 20/6.25 mg , or 5/25 mg , once daily for 6 weeks . MAIN OUTCOME MEASURES The mean change from baseline in sitting diastolic blood pressure at end point ( last postr and omization measurement carried forward ) in the double-blind phase . Combination therapy with benazepril/hydrochlorothiazide , 20/25 mg , was compared with benazepril , 20 mg alone , and hydrochlorothiazide , 25 mg alone . Sitting systolic blood pressure and the effect of race and age on treatment efficacy were also evaluated . RESULTS Compared with placebo , all benazepril/hydrochlorothiazide combinations produced statistically significant reductions from baseline in sitting diastolic and systolic blood pressures at study end point . In the benazepril/hydrochlorothiazide , 20/25 mg , group , the adjusted mean changes in sitting diastolic blood pressure at end point were statistically significantly greater than those in the monotherapy treatment groups ( benazepril , 20 mg , P hydrochlorothiazide , 25 mg , P tolerated . Decreases in mean serum potassium level with hydrochlorothiazide monotherapy were reduced or eliminated with combination therapy . CONCLUSION Benazepril in combination with hydrochlorothiazide , including a low-dose combination of 5/6.25 mg , is effective in reducing sitting diastolic and systolic blood pressure in patients with hypertension",
"BACKGROUND One third of patients treated for hypertension attain adequate blood pressure ( BP ) control , and multidrug regimens are often required . Given the lifelong nature of hypertension , there is a need to evaluate the long-term efficacy and tolerability of higher doses of combination anti-hypertensive therapies . OBJECTIVE This study investigated the efficacy and tolerability of valsartan ( VAL ) or hydrochlorothiazide (HCTZ)-monotherapy and higher-dose combinations in patients with essential hypertension . METHODS The first part of this study was an 8-week , multicenter , r and omized , double-blind , placebo controlled , parallel-group trial . Patients with essential hypertension ( mean sitting diastolic BP [ MSDBP ] , > or = 95 mm Hg and were r and omized to 1 of 8 treatment groups : VAL 160 or 320 mg ; HCTZ 12.5 or 25 mg ; VAL/HCTZ 160/12.5 , 320/12.5 , or 320/25 mg ; or placebo . Mean changes in MSDBP and mean sitting systolic BP ( MSSBP ) were analyzed at the 8-week core study end point . VAL/HCTZ 320/12.5 and 320/25 mg were further investigated in a 54-week , open-label extension . Response was defined as MSDBP or = 10 mm Hg decrease compared to baseline . Control was defined as MSDBP Tolerability was assessed by monitoring adverse events at r and omization and all subsequent study visits and regular evaluation of hematology and blood chemistry . RESULTS A total of 1346 patients were r and omized into the 8-week core study ( 734 men , 612 women ; 924 white , 291 black , 23 Asian , 108 other ; mean age , 52.7 years ; mean weight , 92.6 kg ) . All active treatments were associated with significantly reduced MSSBP and MSDBP during the core 8-week study , with each monotherapy significantly contributing to the overall effect of combination therapy ( VAL and HCTZ , P reductions in MSSBP and MSDBP compared with the monotherapies and placebo ( all , P mean reduction in MSSBP/MSDBP with VAL/HCTZ 320/25 mg was 24.7/16.6 mm Hg , compared with 5.9/7.0 mm Hg with placebo . The reduction in MSSBP was significantly greater with VAL/HCTZ 320/25 mg compared with VAL/HCTZ 160/12.5 mg ( P Rates of response and BP control were significantly higher in the groups that received combination treatment compared with those that received monotherapy . The incidence of hypokalemia was lower with VAL/HCTZ combinations ( 1.8%-6.1 % ) than with HCTZ monotherapies ( 7.1%-13.3 % ) . The majority of adverse events in the core study were of mild to moderate severity . The efficacy and tolerability of VAL/HCTZ combinations were maintained during the extension ( 797 patients ) . CONCLUSIONS In this study population , combination therapies with VAL/HCTZ were associated with significantly greater BP reductions compared with either monotherapy , were well tolerated , and were associated with less hypokalemia than HCTZ alone",
"The fixed combination of lisinopril 20 mg and hydrochlorothiazide 12.5 mg ( L/HCTZ ) was compared with each of the monocomponents in a multicentre , double-blind , r and omized , parallel-group study involving elderly patients with mild to severe hypertension . At the end of the trial , a total of 278 patients had completed 8 weeks of treatment . SBP reduction from baseline in the L/HCTZ group was significantly greater , sitting and st and ing , compared with both the monotherapy groups . Sitting DBP reduction from baseline in the L/HCTZ group was significantly greater than in the hydrochlorothiazide group . Uric acid levels were raised significantly more in the L/HCTZ group compared with the lisinopril group , and the fall in potassium levels were significantly smaller in the L/HCTZ group compared with the hydrochlorothiazide group . Safety and tolerability were equivalent for the three groups",
"1 . The effects of timolol alone and in combination with a fixed dose of hydrochlorothiazide and amiloride have been studied in a double-blind , controlled study in fifty-four patients with mild to moderate essential hypertension . 2 . After a 4 weeks placebo period patients were r and omly assigned to enter groups receiving timolol alone ( group A ) , hydrochlorothiazide + amiloride ( group B ) or timolol + hydrochlorothiazide + amiloride ( group C ) . Each treatment was carried out for 6 weeks . 3 . The use of timolol ( 10 mg ) , hydrochlorothiazide ( 25 mg ) and amiloride ( 2 - 5 mg ) in a combination tablet given twice daily gave better control of blood pressure in patients with mild to moderate essential hypertension than did equivalent dosages of timolol alone or of hydrochlorothiazide and amiloride . 4 . Clinical and laboratory side effects were minimal",
"A multicenter , double-blind , placebo-controlled trial with multifactorial design was conducted to evaluate the safety and efficacy of the calcium-channel blocker diltiazem , in a sustained release preparation , and the angiotensin converting enzyme inhibitor , lisinopril , in the treatment of elderly Chinese patients with mild-to-moderate hypertension . In addition to the hypotensive effects of combinations of both drugs compared with monotherapy , all given once daily , the effect on quality of life was also evaluated . This study consisted of a 3 x 2 multifactorial design in which 156 women and men with a sitting diastolic pressure of between 95 mm Hg and 114 mm Hg , after a 4-week placebo washout phase , were r and omized to one of six treatment groups for 12 weeks of active treatment . Monotherapy with diltiazem 120 or 240 mg produced increasing reductions of systolic and diastolic blood pressure . Compared with placebo , lisinopril 10 mg had an effect intermediate between the diltiazem doses . The combinations of diltiazem 240 mg + lisinopril 10 mg and diltiazem 120 mg + lisinopril 10 mg showed increased efficacy in reducing systolic and diastolic blood pressure compared to these drug doses used in monotherapy , but the effect of the combinations was less than predicted by an additive model . Although the total number of other adverse events reported was similar for all active treatment groups compared to placebo , lisinopril-induced cough was common with an incidence of 31 % after rechallenge . Premature drug withdrawal was necessary in four of 78 patients receiving lisinopril , due to intractable cough . The combination of diltiazem 240 mg and lisinopril 10 mg was significantly more effective at reducing blood pressure than either drug alone ; this additive effect did not result in a higher rate of adverse effects or impairment of quality of life . Thus , combination therapy with these agents was well tolerated and result ed in increased efficacy in these elderly patients",
"In a r and omized , double-blind , within-patient study , 28 out- patients with mild to moderate hypertension were given , at the end of a 3-week placebo wash-out period , four different antihypertensive treatments for 3 weeks each . the treatments were 50 mg atenolol , 100 mg atenolol , 12.5 mg chlorthalidone and a fixed combination of 50 mg atenolol and 12.5 mg chlorthalidone . All treatments were given once daily . Visits were scheduled for the last day of each treatment period , 24 - 26 hours after the last dose , and there was an intermediary wash-out period between each pair of active treatments . Supine systolic/diastolic blood pressure was 165/102 on placebo , 153/93 mmHg on 50 mg atenolol , 155/91 mmHg on 100 mg atenolol , 148/93 mmHg on 12.5 mg chlorthalidone and 144/89 mmHg on the combination . All the changes in pressure were significant ( p less than 0.01 ) versus placebo . Supine systolic blood pressure was lower on the combination than on 100 mg atenolol alone ( p less than 0.05 ) and upright systolic pressure was lower on the combination than on 100 mg atenolol ( p less than 0.05 ) or 50 mg atenolol ( p less than 0.05 ) alone . The heart rate was lowered by atenolol alone or combined with chlorthalidone but did not fall below 56 bpm in any patient . Serum potassium levels were lower on 12.5 mg chlorthalidone than on placebo ( 3.88 mEq/l vs 4.09 mEq/l -- p less than 0.05 ) but the difference was trivial ; on the combination of atenolol-chlorthalidone there was no significant difference versus placebo ( 3.97 mEq/l vs 4.09 mEq/l -- NS ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Thirty-nine patients were entered into a 12-week , r and omized , double-blind , parallel protocol to assess the safety and efficacy of enalapril ( MK-421 , 10 to 20 mg bid ) , hydrochlorothiazide ( HCTZ , 25 to 50 mg bid ) , or combined drug therapy ( MK-421 + HCTZ ) for the treatment of primary hypertension . Specifically monitored were the effects of each drug program on BP and pulse , serum chemistries , body fluid composition and weight , renal function , and the renin-angiotensin-aldosterone axis . Results indicate that MK-421 , HCTZ , and combined therapy were equally effective in lowering BP ; none of the therapies significantly altered glomerular filtration rate or effective renal plasma flow . Patients on MK-421 experienced no change in volume , an increase in plasma potassium , no change in fractional sodium or potassium excretion , and a decreased urine osmolality associated with an enhanced free-water clearance . Plasma renin activity was increased , plasma angiotensin II was decreased , and plasma aldosterone was unchanged . In contrast , patients on HCTZ developed volume contraction , hypokalemia associated with an increase in fractional sodium and potassium excretion , and an increased urine osmolality associated with a decreased free-water clearance . Plasma renin activity was increased , however , plasma angiotensin II and plasma aldosterone were unchanged . Patients on combined therapy with MK-421 + HCTZ demonstrated qualitatively similar changes in serum chemistries , body fluid volumes , and renal function compared with patients receiving HCTZ alone , whereas changes in the renin-angiotensin-aldosterone system in these patients were qualitatively similar , but more marked , compared with those occurring in patients receiving MK-421 alone . We conclude that MK-421 is an effective first-step antihypertensive agent that does not produce adverse metabolic , volume , or renal effects",
"Ninety four patients with mild hypertension ( average supine diastolic blood pressure ( phase V ) 95 - 110 mm Hg ) were allocated at r and om to receive restriction of dietary sodium ( maximum allowed 70 mmol(mEq)/24 h ) or a normal diet . In addition , they received in r and om order 25 mg chlorthalidone , 200 mg metoprolol ( slow release ) , and a fixed combination of these two drugs . Each drug treatment was given for four weeks and alternated with four weeks of placebo . Forty four patients were allocated to sodium restriction ( group 1 ) and 50 to normal diet ( group 2 ) . The mean 24 hour urinary sodium excretion in group 1 was 74 ( SD 31 ) mmol(mEq)/24 h , and in group 2 132 ( 51 ) mmol/24 h. Compared with the screening blood pressure the average decrement of the supine blood pressure in group 1 was 16.0/8.6 mm Hg with placebo , 21.7/11.5 mm Hg with the diuretic , 28.5/17.8 mm Hg with the beta blocker , and 28.9/18.4 mm Hg with the combined agent ; in group 2 these values were 13.3/6.1 , 20.3/9.7 , 21.3/12.9 , and 29.4/16.8 mm Hg , respectively . There was a sharp decrease of the average potassium concentration during chlorthalidone and combination treatment periods ( average value 3.3 mmol(mEq)/1 ) . These results suggest that moderate salt restriction used as sole treatment has a limited though demonstrable blood pressure lowering effect but that when it is used as an adjuvant to beta blocker treatment its value is greatly enhanced",
"The antihypertensive effect of a fixed dosage combination of the cardioselective beta-adrenoceptor blocker , atenolol , and the oral thiazide-like diuretic , chlorthalidone ( Tenoretic ) was studied in 24 hypertensive Nigerians in a double-blind , cross-over comparison with three other treatments . These were atenolol alone , 100 mg daily , chlorthalidone alone , 25 mg daily , and atenolol ( 100 mg ) plus chlorthalidone ( 25 mg ) daily taken as separate formulations . Tenoretic was taken as a once-daily tablet containing 100 mg atenolol plus 25 mg chlorthalidone . The order of administration of the drugs was r and omized . Each drug was taken for 4 weeks . The results showed that atenolol and chlorthalidone lowered blood pressure to the same extent . Combination of the two drugs whether taken separately or in fixed-dosage combination was better than either product singly . The drugs were well tolerated",
"The efficacy and safety of verapamil and propranolol were examined in 14 hypertensive patients ( mean age 51.2 , range 30 to 65 ) in a double-blind , r and omized , crossover study of verapamil , 360 mg , propranolol , 240 mg , these 2 formulations in combination and placebo , each given for 4 weeks . Supine blood pressure , heart rate , atrioventricular conduction ( PR interval ) and left ventricular function were measured . All treatments reduced diastolic blood pressure ( mean + /- st and ard deviation ) ( p less than 0.001 ) : placebo to 106.6 + /- 8.1 mm Hg ; propranolol to 93.8 + /- 7.7 ; verapamil to 89.8 + /- 7.8 ; the combination to 84.1 + /- 6.1 , but the effect of the combination was significantly greater than that of either drug alone ( p less than 0.05 ) . Heart rate at rest ( placebo , 80.2 + /- 12.2 beats/min ) was reduced by propranolol ( 63.3 + /- 9.4 , p less than 0.001 ) , but not by verapamil ( 79.0 + /- 8.9 ) . However , the addition of verapamil to propranolol led to a further reduction in heart rate ( 56.9 + /- 8.4 , p less than 0.005 ) . PR interval was prolonged significantly by the combination ( 185.5 + /- 35.3 ms ) when compared with placebo ( 154.0 + /- 22.7 ) ; propranolol ( 159.1 + /- 21.2 ) and verapamil ( 165.5 + /- 32.4 ) ( p less than 0.005 for each ) . The active drugs increased end-diastolic dimension and end-systolic dimension . For each variable , the effect of the combination was statistically significant ( p less than 0.01 ) . Fractional shortening was not altered significantly by any of the treatments . Thus verapamil plus propranolol is a very effective antihypertensive combination but heart rate , atrioventricular conduction and left ventricular function may be affected adversely , necessitating careful monitoring of therapy",
"A r and omized , double-blind , placebo-controlled , parallel-group multicenter study was conducted to evaluate the antihypertensive efficacy and safety of 8-week treatment with one of three fixed-dose combinations — losartan 50 mg plus hydrochlorothiazide 12.5 mg , losartan 50 mg plus hydrochlorothiazide 6.25 mg , or losartan 25 mg plus hydrochlorothiazide 6.25 mg — in comparison with those of hydrochlorothiazide 12.5 mg alone , losartan 50 mg alone , or placebo in Japanese patients with essential hypertension . Significant reductions in sitting diastolic blood pressure ( DBP ) and systolic blood pressure ( SBP ) were seen in all three combination groups compared with the placebo group ( each p DBP and SBP were observed in the losartan 50 mg plus hydrochlorothiazide 12.5 mg group ( 12.7 and 18.0 mmHg , respectively ) . The reductions in the losartan 50 mg plus hydrochlorothiazide 12.5 mg group were significantly greater ( each p incidences of clinical and laboratory drug-related adverse events between any of the combination groups and the placebo group . All combination groups showed improved hypokalemia and hyperuricemia compared to the hydrochlorothiazide 12.5 mg group . These results demonstrated that once-daily , fixed-dose combination therapy with losartan 50 mg plus hydrochlorothiazide 12.5 mg is well tolerated and more efficacious in lowering DBP and SBP than monotherapy in Japanese hypertensive patients",
"BACKGROUND Recent surveys reveal continuing deficiencies in the awareness , treatment , and control of hypertension . In many cases , failure to achieve blood pressure targets may be attributable to the use of antihypertensive monotherapy . OBJECTIVES This study was undertaken to identify combinations of telmisartan , a new oral angiotensin II type 1-receptor antagonist , and hydrochlorothiazide ( HCTZ ) that might provide greater antihypertensive efficacy than monotherapy with either agent in the treatment of mild to moderate hypertension . It also examined the dose-response surface for the 2 drugs alone and in combination . METHODS This was a multicenter , r and omized , double-blind , placebo-controlled , parallel-group study that employed all cells of a 4 x 5 factorial design . After a 4-week , single-blind , placebo run-in period , men and women between 18 and 80 years of age with mild to moderate hypertension ( defined as mean supine diastolic blood pressure [ DBP ] between 95 and 114 mm Hg during the last 2 weeks of the placebo run-in period and systolic blood pressure [ SBP ] between 114 and 200 mm Hg immediately before r and omization ) were eligible to enter the 8-week , double-blind , double-dummy treatment period . Study comparisons were between once-daily telmisartan monotherapy ( 20 , 40 , 80 , or 160 mg ) , HCTZ monotherapy ( 6.25 , 12.5 , or 25 mg ) , 12 combinations of these telmisartan/HCTZ doses , and placebo . The focus was on 2 combinations : telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg . The primary efficacy variable was change in supine trough DBP from baseline to the last evaluable measurement during double-blind treatment . Plasma renin activity and safety parameters , including treatment-emergent adverse events , physical findings , electrocardiograms , and serum electrolyte levels ( which are known to increase with HCTZ treatment ) , were also assessed . RESULTS Of 1293 patients screened , 818 ( 63.3 % ) were enrolled at 47 centers . Of these 818 , 749 ( 91.6 % ) completed the study . The intent-to-treat population ( r and omized with > or = 1 postr and omization blood pressure measurement ) consisted of 807 patients ( 98.7 % ) . Telmisartan 80 mg/HCTZ 12.5 mg significantly decreased mean supine trough SBP/DBP by 23.9/14.9 mm Hg , a benefit of 8.5/3.4 mm Hg compared with telmisartan 80 mg and of 17.0/7.6 mm Hg compared with HCTZ 12.5 mg ( both comparisons , P Telmisartan 40 mg/HCTZ 12.5 mg significantly reduced mean supine SBP by 18.8 mm Hg , a benefit of 6.6 mm Hg compared with telmisartan 40 mg and 11.9 mm Hg compared with HCTZ 12.5 mg ( both , P mean supine DBP by 12.6 mm Hg , a benefit of 5.3 mm Hg compared with HCTZ 12.5 mg ( P telmisartan 40 mg . Telmisartan 80 mg/HCTZ 12.5 mg was significantly more effective than telmisartan 40 mg/HCTZ 12.5 mg in reducing mean supine DBP and SBP ( both , P antihypertensive efficacy of the combination of telmisartan and HCTZ . All regimens were well tolerated . CONCLUSIONS Once-daily telmisartan 80 mg/HCTZ 12.5 mg was effective and well tolerated when used to reduce SBP and DBP in patients with mild to moderate hypertension . In addition to enhancing efficacy , this combination protected against potassium depletion , a common side effect of thiazide monotherapy",
"This study compared with placebo the efficacy and tolerability of optimised doses of felodipine 5 - 20 mg daily , metoprolol 50 - 200 mg daily and their combination in subjects 60 years or over with isolated systolic hypertension . The study employed a r and omised double-blind crossover design with allocation of treatment order within subjects by Latin squares . For each subject , after a single-blind run-in placebo phase , there were four r and omised treatment phases each of six weeks duration , with a dose titration step at three weeks if necessary . Twenty-eight subjects entered the r and omised phases of the study and twenty-one completed all four phases--13 male , 8 female ( ages : median 71 , range 59 - 85 years ) . At the end of both the felodipine and metoprolol phases systolic and diastolic pressure were reduced at 2 hours postdose compared with the placebo phase ( p blood pressure reduction with felodipine ( -40/-20 mmHg ) being greater than that with metoprolol ( -15/-9 mmHg ) ( p supine systolic blood pressure ( -17 mmHg ) with felodipine ( p metoprolol . At both measurement times the two drugs when in combination had an additive effect on blood pressure . There was a 20 % increase in reported symptoms during each of the active treatment phases . Four subjects withdrew during the r and omised phases because of probable drug-related adverse events and six subjects required dosage reductions during the felodipine or combination phases . ( ABSTRACT TRUNCATED AT 250 WORDS",
"This 30-center , r and omized , double-blind , placebo-controlled , parallel-group study was design ed to ( 1 ) establish that 6.25 mg of hydrochlorothiazide ( HCTZ ) given once daily with 5 mg of bisoprolol fumarate can contribute to antihypertensive effectiveness in patients with stage I and stage II ( mild to moderate ) systemic hypertension ; and ( 2 ) assess whether this formulation was more effective or possessed a safety advantage over st and ard monotherapy with bisoprolol or 25 mg of HCTZ . Results showed that HCTZ 6.25 mg contributed significantly to the antihypertensive effectiveness of bisoprolol 5 mg . Bisoprolol 5 mg/HCTZ 6.25 mg ( B5/H6.25 ) produced significantly greater mean reductions from baseline in sitting systolic and diastolic blood pressure ( -15.8 mm Hg/-12.6 mm Hg ) than bisoprolol 5 mg alone ( -10.0 mm Hg/-10.5 mm Hg ) and HCTZ 25 mg alone ( -10.2 mm Hg/-8.5 mm Hg ) . A 73 % response rate was achieved with the low-dose formulation compared with 61 % for the bisoprolol 5 mg ( B5 ) group and 47 % for the HCTZ 25 mg ( H25 ) group . B5/H6.25 was found to be significantly more effective than B5 or H25 in all subgroups of patients , regardless of gender , race , age , or smoking history . Antihypertensive effects were maintained during the 24-hour dosing interval . The incremental effectiveness of B5/H6.25 was not accompanied by an increase in the frequency or severity of adverse experiences ; the incidence of adverse experiences in the B5/H6.25 group was comparable to that in the placebo group . B5/H6.25 was shown to provide safety advantages over H25 , as shown by less hypokalemia ( < 1 % with B5/H6.25 versus 6.5 % with H25 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Objective : We have shown previously that the combination of captopril and nifedipine was effective at peak response but was very short acting . We therefore decided to study the longer-acting angiotensin converting enzyme inhibitor lisinopril and the long-acting calcium antagonist amlodipine , each alone and in combination , in a double-blind , r and omized crossover study in which blood pressures were measured at peak and trough . This study provided the opportunity to investigate what parameters in these patients might possibly predict the fall in blood pressure with the individual drugs and with the combination Methods : Fifteen patients with essential hypertension ( eight male , 10 Caucasian ; mean age 53 years ) were studied . After 1 month observation on no treatment they were entered into a single-blind run-in of placebo given once a day for 1 month . Patients were then allocated r and omly to amlodipine ( 5 mg once a day ) , lisinopril ( 10 mg once a day ) or their combination ( once a day ) for 1 month in a double-blind crossover study . All patients were studied on their usual diet and no dietary advice was given . Blood pressure was measured by semi-automatic ultrasound sphygmomanometer both 24 h and 6 h ( trough and peak ) after the last dose Results : During the crossover part of the study there was a significant additional blood pressure-lowering effect ( at trough ) of the combination compared with either amlodipine or lisinopril alone . Similar results were observed for the blood pressures at peak . The fall in blood pressure with lisinopril was related to baseline plasma renin activity , whereas when amlodipine was given , either alone or in combination , the fall in blood pressure was independent of baseline renin activity . The Blacks ( n=5 ) appeared not to respond as well to lisinopril as the Caucasians ( n=10 ) . Finally , the blood pressure response to amlodipine tended to be associated with the severity of hypertension Conclusions : The results of the present study indicate that : amlodipine and lisinopril in combination have a marked additional effect on blood pressure compared with either given as a monotherapy ; their potentiation of action is long-acting ; Black patients tend not to respond to the monotherapy with lisinopril as well as Caucasian patients , although they respond similarly to the combination ; the response to amlodipine tends to be greater the higher the initial blood pressure ; and , finally , the response to lisinopril is greater the higher the plasma renin",
"The hypotensive and hormonal effects of the angiotensin converting enzyme ( ACE ) inhibitor enalapril ( 10 mg twice daily ) were compared with those of hydrochlorothiazide ( 25 mg twice daily ) , with the two drugs in combination and with placebo in 21 patients with essential hypertension . For each patient there were four r and omised double-blind treatment phases , each of four weeks ' duration , which comprised a 2 X 2 factorial experiment . All blood pressure parameters were reduced in the three active treatment phases compared to placebo ( p less than 0.001 ) . Supine mean blood pressures were 119 mmHg ( placebo ) , 113 mmHg ( hydrochlorothiazide ) , 108 mmHg ( enalapril ) , and 98 mmHg ( hydrochlorothiazide plus enalapril ) ( SEM 3 mmHg , ANOVA ) . Enalapril and hydrochlorothiazide were equally effective and well tolerated and their hypotensive effects were additive . Enalapril increased plasma renin activity ( PRA ) , reduced plasma angiotensin II ( AII ) and aldosterone concentrations , and reduced ACE activity , whereas hydrochlorothiazide increased PRA , plasma AII , and aldosterone concentrations without altering ACE activity . With combination treatment the effects of enalapril on PRA and plasma AII concentrations were potentiated whereas those on plasma aldosterone concentration and ACE activity were additive . Atrial natriuretic factor plasma concentration in the placebo phase was 92 pg/ml and increased to 145 pg/ml in the hydrochlorothiazide phase ( p less than 0.001 , SEM 13 pg/ml ) , but there was no significant change in either the enalapril or combination phases",
"The effects of nebivolol , a new beta-blocker with vasodilating properties , and hydrochlorothiazide ( HCTZ ) as monotherapies and in combination on BP and plasma lipids , lipoproteins and apolipoproteins were compared with placebo in a parallel 3 x 4 factorial design study . After an eight week wash-out period , 240 patients with primary hypertension were r and omised to receive either placebo , nebivolol 1 , 5 or 10 mg , HCTZ 12.5 or 25 mg or one of the six possible combinations of nebivolol and HCTZ . Twenty patients were assigned to each of the 12 parallel groups . After 12 weeks of treatment , there was a significant dose-related reduction in BP among all active treatment groups . Apart from a slight and isolated increase in triglycerides with HCTZ 12.5 mg , lipid , lipoprotein and apolipoprotein levels as well as lipoprotein and apolipoprotein ratios were not significantly modified by 12 week active treatments when compared with placebo treatment . The results of this multifactorial study with 12 small sample size groups , suggest that nebivolol as monotherapy and in combination with HCTZ does not cause deleterious effects on the lipid profile",
"To test the dose responses of piretanide , ramipril , and their combination in patients with essential hypertension , a prospect i ve , r and omized , double-blind , placebo-controlled trial was conducted in 480 patients . Twelve separate groups were studied : placebo , piretanide 3 mg , piretanide 6 mg , ramipril 2.5 mg , ramipril 5 mg , ramipril 10 mg , and their combinations , as single daily morning doses . Patients were r and omized after a 2-week run-in period without drugs ; treatment was given for 6 weeks . A dose response compared with placebo was found for both drugs ; the combination was more effective than either drug alone . Piretanide 6 mg , combined with ramipril 5 mg , provided optimal blood pressure reduction . Self-reported adverse effects of both drugs and their combinations did not exceed those reported for placebo . A surface analysis suggested that piretanide primarily reduced systolic blood pressure , whereas ramipril was more effective in reducing diastolic blood pressure . The data attest to a combined efficacy of piretanide and ramipril in decreasing arterial blood pressure",
"To evaluate whether the combination of nifedipine with chlorthalidone exerts an additive antihypertensive effect when compared to single-drug treatment , 66 uncomplicated essential hypertensives , whose diastolic blood pressure was > 100 and placebo period , received , according to a r and omized , double-blind , crossover design , nifedipine ( 20 mg b.i.d . ) , chlorthalidone ( 25 mg o.d . ) , the two drugs combined at the same doses , and the corresponding placebo . When compared to the r and omized placebo the three active treatments significantly ( p blood pressure without changing heart rate and body weight . However , blood prssure values were similarly reduced under nifedipine and the combination and were significantly lower ( p chlorthalidone . Moreover , the percentage of responders and normalized patients under nifedipine and the two drugs combined were similar and significantly ( normalized , p chlorthalidone . Under chlorthalidone and its combination with nifedipine , plasma potassium tended to decrease and blood glucose and serum uric acid were significantly ( p nifedipine with chlorthalidone does not exert any additive antihypertensive effect when compared to nifedipine alone and that this combination increases both blood glucose and serum uric acid . Taken together these findings indicate that the combination of a dihydropyridine calcium antagonist with a thiazide diuretic is devoid of any clinical significance in the treatment of uncomplicated essential hypertensives",
"The antihypertensive efficacy and tolerability of losartan/hydrochlorothiazide ( HCTZ ) and losartan monotherapy as initial treatment were compared in a double-blind trial in Chinese patients with mild to moderate essential hypertension . Patients were r and omised to initial treatment with either losartan/HCTZ ( 50 mg/12.5 mg ) or losartan alone ( 50 mg ) . The doses were doubled after four weeks if diastolic blood pressure (SiDBP)was > 90 mmHg . Both losartan/HCTZ and losartan alone significantly reduced SiDBP and SiSBP from baseline at the first measurement at 4 weeks ( -10.1/-15.3 and -6.1/-6.9 mmHg , respectively ; p reductions with losartan/HCTZ were significantly greater than with losartan alone at weeks 4 and 8 ( p tolerated . In conclusion , initial therapy with losartan/HCTZ is effective and well tolerated in the treatment of Chinese patients with mild to moderate essential hypertension and produces a greater reduction in blood pressure than losartan alone",
"The antihypertensive effect and tolerance of the combined low doses of felodipine and enalapril ( 5 + 5 mg daily ) were compared with those of either drug at a higher dose level ( 10 mg daily ) . Our double-blind , three-way crossover study ( balanced Latin square design ) involved 36 elderly subjects ( mean age 67 + /- 6 years ) with essential hypertension . After a 4-week placebo run-in phase the subjects were r and omized to the active treatment periods , starting with 5 mg felodipine plus 5 mg enalapril , 5 mg felodipine , or 5 mg enalapril daily for the first 4 weeks . The doses in the felodipine and enalapril periods were then doubled for another 2 weeks . All medication was given once daily in the morning , and blood pressure was measured 24 h after a previous dose . The supine blood pressure for subjects given placebo was 178/101 mm Hg . After 6 weeks ' treatment systolic and diastolic supine blood pressures were significantly lower with 5 mg felodipine plus 5 mg enalapril ( 154/85 mg Hg ) than with 10 mg felodipine ( 159/88 mm Hg ) or with 10 mg enalapril ( 162/91 mm Hg ) , and the diastolic blood pressure was significantly lower with felodipine than with enalapril . At the end of the felodipine plus enalapril , felodipine , and enalapril treatment periods , 75 , 69 , and 56 % of the subjects , respectively , had a supine diastolic blood pressure 90 mm Hg or less . The combination was tolerated better than either monotherapy . The most commonly reported adverse event was swollen ankles , which occurred in one , nine , and five subjects during felodipine plus enalapril , felodipine , and enalapril treatment , respectively . ( ABSTRACT TRUNCATED AT 250 WORDS",
"41 patients ( 35 males and 6 females ) with moderate hypertension were treated with a combination of methyldopa/hydrochlorothiazide/amiloride ( M/HCT/A ) . In a double blind study the blood-pressure-lowering effect of this combination was compared with the effect of M or HCT/A alone . After 8 weeks of treatment , the combination of M/HCT/A lowered the elevated blood pressure more efficiently than the two monotherapies . M counteracted the potassium-loosing effect of HCT/A , but did not prevent the elevation of serum urea , creatinine and uric acid which is observed under treatment with",
" Forty-one patients completed a r and omized , double-blind , between-group comparison of a combination of penbutolol and frusemide , with penbutolol alone , and frusemide alone in the management of mild to moderate essential hypertension . The results suggest that the combination caused a superior reduction in systolic and diastolic pressure compared with penbutolol and a superior reduction in systolic blood pressure compared with frusemide",
"OBJECTIVE To test the antihypertensive and metabolic effects of lisinopril , 10 mg/d ( L ) ; hydrochlorothiazide , 12.5 and 25 mg/d ( H12.5 and H25 ) ; and its combination with lisinopril ( L/H12.5 and L/H25 ) against placebo in patients with mild to moderate ( stage I and stage II ) hypertension . DESIGN Multicenter , double-blind , placebo-controlled outpatient study of 12 weeks ' duration . PATIENTS After 4 weeks of single-blind placebo treatment , 505 patients whose sitting diastolic blood pressure was 100 to 114 mm Hg were r and omized into the study --467 patients completed it ( placebo , 71 ; L , 80 ; H12.5 , 79 ; H25 , 77 ; L/H12.5 , 79 ; and L/H25 , 81 ) . The patients were seen in the clinic every 2 weeks , where measurements of their sitting and upright blood pressure and heart rate were taken 24 + /- 2 hours after drug administration . Complete blood cell counts with differential cell counts , blood chemistry studies , urinalyses , and electrocardiograms were done at baseline and during the study . Roentgenograms were done once at baseline . RESULTS Compared with placebo , all drug regimens decreased sitting and upright blood pressure ( P sitting and upright heart rate . The greatest effect was obtained with the combinations of L/H12.5 and L/H25 . There was no difference between L/H12.5 and L/H25 or between H12.5 and H25 . There were no serious clinical side effects except cough , which was slightly higher with L , L/H12.5 , and L/H25 . The only metabolic side effects were in serum potassium level , which was lower with H25 ( P serum glucose level , which was higher with H25 and L/H25 ( P L , H12.5 , H25 , L/H12.5 , and L/H25 was effective and well tolerated ; ( 2 ) the best results were achieved with L/H12.5 and L/H25 ; ( 3 ) lower doses of hydrochlorothiazide either alone or in combination with lisinopril were equipotent with higher doses and were free of metabolic side effects",
"The antihypertensive characteristics of the angiotensin-converting enzyme inhibitor moexipril were evaluated in 413 patients with baseline sitting diastolic blood pressures between 95 and 114 mm Hg . The study was double blind , with patients r and omized to placebo or to differing doses of moexipril alone or in combination with a low dose of hydrochlorothiazide . Compared with placebo , moexipril 3.75 mg daily was not different , but single daily doses of 7.5 , 15 , and 30 mg were significantly more effective ( as measured at trough , approximately 24 h after dosing ) in decreasing the diastolic blood pressuring during an 8-week treatment period . The dose – response relationship indicated that no additional blood-pressure-lowering effect occurred above 15 mg daily . Hydrochlorothiazide 12.5 mg was not significantly more effective than placebo , but the combinations of the diuretic with moexipril doses of 3.75 , 7.5 , and 15 mg all produced significant antihypertensive actions . Interestingly , the 3.75-mg moexipril-hydrochlorothiazide combination was equally as efficacious as the higher doses . The combinations were all more effective than their respective moexipril and hydrochlorothiazide monotherapies . There were no meaningful laboratory changes except for decreased potassium concentrations in the patients on diuretic alone ; this effect was attenuated in the low-dose moexipril combination . Only 14 of the 413 patients who entered the double-blind study period ( 3 % ) discontinued treatment because of adverse experiences . Thus , moexipril is a well-tolerated drug that has clear antihypertensive efficacy as a single agent in once-daily doses of 7.5–30 mg . When combined with hydrochlorothiazide 12.5 mg , it is effective in daily doses as low as 3.75 mg",
"A multiclinic , double-blind , r and omized study in 361 patients with essential hypertension compared Aldoretic , ( Merck & Co. , Inc. , New Jersey ) , a combination of methyldopa , hydrochlorothiazide , and amiloride with the combination of hydrochlorothiazide and amiloride and with methyldopa alone . At the end of week 12 , the proportion of patients who were classified as normotensive ( diastolic less than or equal to 90 mm Hg ) was 61 % in the group treated with Aldoretic , which was statistically significantly greater than the 48 % in the hydrochlorothiazide/amiloride group and the 35 % in the methyldopa group",
"The antihypertensive effect of Inderectic , a new combination capsule of propranolol 80 mg and bendrofluazide 2.5 mg , given twice daily was investigated in 21 hypertensive patients using a double-blind r and omized crossover method . Inderectic was compared with either agent used alone and with the same combination given as separate tablets . It gave a greater fall in mean lying and st and ing systolic and diastolic blood pressure than either agent alone . There was no statistically significant difference for the effect on these variables between the free combination and combined formulation . Only minor side-effects were recorded , no patient having to be withdrawn from the study and no biochemical changes were observed",
"This study was design ed as a multicenter , double-blind , placebo-controlled , parallel-group , prospect ively r and omized study comparing , after a 4-week placebo run-in phase , moxonidine 0.4 mg once daily ( o.d . ) , hydrochlorothiazide 25 mg o.d . , and the combination of the two with placebo . A total of 160 patients were analyzed in an intent-to-treat analysis . Moxonidine 0.4 mg o.d . was effective in significantly lowering blood pressure in this group of mild-to-moderate hypertensive patients in comparison with placebo . The efficacy and the side-effect profile of moxonidine were comparable to those of the first-line antihypertensive agent hydrochlorothiazide . The combination of moxonidine and hydrochlorothiazide in the same dosage as a monotherapy improves efficacy significantly without additive effects on the safety profile . Response rate after monotherapies was calculated with 70.3 and 70.0 % , respectively , after combination treatment in 87.8 % of all patients in the treatment group . The trial gives support to a recommended dosage regimen of moxonidine 0.4 mg o.d . This profile of moxonidine is highly comparable to a st and ard first-line antihypertensive drug such as hydrochlorothiazide , without sacrificing tolerance and safety for increased efficacy , in combination with hydrochlorothiazide",
"Enalapril is a new , oral , long-acting nonsulfhydral angiotensin converting enzyme inhibitor . Thirty-nine patients with primary hypertension were entered into a r and omized , double-blind protocol to assess the efficacy of enalapril ( 10 to 20 mg bid ) , hydrochlorothiazide ( 25 to 50 mg bid ) , or combined drug therapy . Enalapril , either alone or in combination with hydrochlorothiazide , effectively controlled blood pressure . Enalapril monotherapy was associated with an increase in plasma renin activity and a decrease in angiotensin II concentration ; in patients with an initial inulin clearance less than or equal to 80 mL/min/1.73 m2 , inulin and para-aminohippurate clearances were markedly improved , without producing adverse effects on salt and water excretion or body fluid composition . Combination therapy was associated with a marked increase in plasma renin activity ; however , only those patients with an initial inulin clearance less than or equal to 80 mL/min/1.73 m2 demonstrated suppression of angiotensin II concentration and marked improvement in inulin and para-aminohippurate clearances . These observations suggest that enalapril , either alone or in combination with a diuretic , has the potential to reverse renal function abnormalities encountered in the hypertensive state"
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INTRODUCTION Given that vitamin D has a role in immunomodulation , and its levels appear to correlate with the development of Multiple Sclerosis ( MS ) , it is conceivable that vitamin D may also influence disease activity in MS patients . In this regard , we conducted a systematic review investigating the evidence for : ( 1 ) the role of vitamin D in disease activity in MS , and ( 2 ) the therapeutic supplementation of vitamin D in MS . METHODS A comprehensive search of Medline , Embase , Pubmed , clinical trials registries , and conference proceedings , followed by screening and application of inclusion and exclusion criteria , yielded 57 studies for detailed appraisal . Following careful data extraction , studies addressing the role of vitamin D in disease activity were appraised on the basis of common epidemiological principles , while those involving vitamin D supplementation were assessed for potential bias using Cochrane guidelines . The overall evidence was interpreted in the context of the Bradford-Hill criteria of causation , and the number needed to treat ( NNT ) to prevent one patient from relapsing over a year was calculated for each supplementation study examining relapse rate . RESULTS / DISCUSSION Both cross-sectional and longitudinal studies have fairly consistently demonstrated a strong positive correlation between vitamin D deficiency and subsequent relapse and /or disability in patients with MS . As well , there appears to be a negative correlation between vitamin D levels and inflammatory markers in MS patients , suggesting that vitamin D modifies serum cytokines to a more anti-inflammatory profile . Therefore , vitamin D fulfills the Bradford-Hill criteria for strong and consistent association , biological plausibility , and coherence . However , the criteria of temporality , dose-response , and experimental evidence are yet to be adequately met , although there is preliminary evidence from longitudinal studies and r and omized clinical trials ( RCTs ) of supplementation that vitamin D can attenuate the autoimmune response in patients , and potentially reduce relapse rates and burden of disease . Currently published data on relapse prevention with vitamin D indicates the possibility of small NNTs in the range of 1.36 - 25.00 , but they arise from very heterogeneously design ed studies . CONCLUSIONS Ultimately , the current evidence does not permit inference of a causal relationship between vitamin D deficiency and disease activity in MS . Vitamin D supplementation appears to be a promising treatment worthy of further exploration , but owing to the paucity of RCTs with placebo or comparator arms , the evidence is not definitive and appropriate dosing remains uncertain
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" A group of young patients having multiple sclerosis was treated with dietary supplements containing calcium , magnesium and vitamin D for a period of one to two years . The experimental design employed self-pairing : the response of each patient was compared with his/her own case history as control . The number of exacerbations observed during the program was less than one half the number expected from case histories . No side effects were apparent . The dietary regimen may offer a new means of controlling the exacerbation rate in MS , at least for younger patients . The results tend to support a theory of MS which states that calcium and magnesium are important in the development , structure and stability of myelin",
"Background A poor vitamin D status has been associated with a high disease activity of multiple sclerosis ( MS ) . Recently , we described associations between vitamin D status and peripheral T cell characteristics in relapsing remitting MS ( RRMS ) patients . In the present study , we studied the effects of high dose vitamin D3 supplementation on safety and T cell related outcome measures . Methodology /Principal Findings Fifteen RRMS patients were supplemented with 20 000 IU/d vitamin D3 for 12 weeks . Vitamin D and calcium metabolism were carefully monitored , and T cell characteristics were studied by flowcytometry . All patients finished the protocol without side-effects , hypercalcaemia , or hypercalciuria . The median vitamin D status increased from 50 nmol/L ( 31–175 ) at week 0 to 380 nmol/L ( 151–535 ) at week 12 ( P an exacerbation of MS and was censored from the T cell analysis . The proportions of ( naïve and memory ) CD4 + Tregs remained unaffected . Although Treg suppressive function improved in several subjects , this effect was not significant in the total cohort ( P = 0.143 ) . An increased proportion of IL-10 + CD4 + T cells was found after supplementation ( P = 0.021 ) . Additionally , a decrease of the ratio between IFN-γ+ and IL-4 + CD4 + T cells was observed ( P = 0.035 ) . Conclusion / Significance Twelve week supplementation of high dose vitamin D3 in RRMS patients was well tolerated and did not induce decompensation of calcium metabolism . The skewing towards an anti-inflammatory cytokine profile supports the evidence on vitamin D as an immune-modulator , and may be used as outcome measure for upcoming r and omized placebo-controlled trials . Trial Registration Clinical trials.gov",
"Objective : To determine whether interferon-β ( IFN-β ) medication use is associated with vitamin D levels and whether the two interact in exerting effects on relapse risk . Methods : In a prospect i ve cohort of 178 persons with clinical ly definite multiple sclerosis ( MS ) living in southern Tasmania in 2002–2005 , serum 25-hydroxyvitamin D [ 25(OH)D ] was measured biannually , with assessment by question naire for relevant factors , including IFN-β treatment . Results : Subjects reporting IFN-β use had significantly higher mean 25(OH)D than persons who did not ( p IFN-β , with treated persons realizing nearly three times 25(OH)D per hour of sun exposure of persons not on therapy . The association between 25(OH)D and 1,25-dihydroxyvitamin D did not differ by IFN-β therapy ( p = 0.82 ) . 25(OH)D was associated with a reduced relapse risk only among persons on IFN-β ( p , IFN-β was only protective against relapse among persons with higher 25(OH)D ( hazard ratio [ HR ] 0.58 [ 95 % confidence interval ( CI ) 0.35–0.98 ] ) , while among 25(OH)D-insufficient persons , IFN-β increased relapse risk ( HR 2.01 [ 95 % CI 1.22–3.32 ] ) . Conclusion : In this study , we found that IFN-β therapy is associated with greater production of vitamin D from sun exposure , suggesting part of the therapeutic effects of IFN-β on relapse in MS may be through modulation of vitamin D metabolism . These findings suggest persons being treated with IFN-β should have vitamin D status monitored and maintained in the sufficiency range . Classification of evidence : This study provided Class III evidence that IFN-β is associated with reduced risk of relapse , and this effect may be modified by a positive effect of IFN-β on serum 25(OH)D levels",
"Background Multiple sclerosis is the most common chronic inflammatory disease of the central nervous system in young adults . Despite the fact that numerous lines of evidence link both the risk of disease development and the disease course to the serum level of 25-hydroxyvitamin D it still remains elusive whether multiple sclerosis patients benefit from boosting the serum level of 25-hydroxyvitamin D , mainly because interventional clinical trials that directly address the therapeutic effects of vitamin D in multiple sclerosis are sparse . We here present the protocol of an interventional clinical phase II study to test the hypothesis , that high-dose vitamin D supplementation of multiple sclerosis patients is safe and superior to low-dose supplementation with respect to beneficial therapeutic effects . Methods / Design The EVIDIMS trial is a German multi-center , stratified , r and omized , controlled and double-blind clinical phase II pilot study . Eighty patients with the diagnosis of definite multiple sclerosis or clinical ly isolated syndrome who are on a stable immunomodulatory treatment with interferon-β1b will be r and omized to additionally receive either high-dose ( average daily dose 10.200 IU ) or low-dose ( average daily dose 200 IU ) cholecalciferol for a total period of 18 months . The primary outcome measure is the number of new lesions detected on T2-weighted cranial MRI at 3 tesla . Secondary endpoints include additional magnetic resonance imaging and optical coherence tomography parameters for neuroinflammation and -degeneration , clinical parameters for disease activity , as well as cognition , fatigue , depression , and quality of life . Safety and tolerability of high-dose vitamin D supplementation are further outcome parameters . Discussion In light of the discrepancy between existing epidemiological and pre clinical data on the one h and and available clinical data on the other the EVIDIMS trial will substantially contribute to the evaluation of the efficacy of high-dose vitamin D supplementation in MS patients . The study design presented here fulfills the criteria of a high- quality clinical phase II trial in MS.Trial Registration Clinical Trials.gov Identifier :",
"CONTEXT Epidemiological and experimental evidence suggests that high levels of vitamin D , a potent immunomodulator , may decrease the risk of multiple sclerosis . There are no prospect i ve studies addressing this hypothesis . OBJECTIVE To examine whether levels of 25-hydroxyvitamin D are associated with risk of multiple sclerosis . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve , nested case-control study among more than 7 million US military personnel who have serum sample s stored in the Department of Defense Serum Repository . Multiple sclerosis cases were identified through Army and Navy physical disability data bases for 1992 through 2004 , and diagnoses were confirmed by medical record review . Each case ( n = 257 ) was matched to 2 controls by age , sex , race/ethnicity , and date s of blood collection . Vitamin D status was estimated by averaging 25-hydroxyvitamin D levels of 2 or more serum sample s collected before the date of initial multiple sclerosis symptoms . MAIN OUTCOME MEASURES Odds ratios of multiple sclerosis associated with continuous or categorical levels ( quantiles or a priori-defined categories ) of serum 25-hydroxyvitamin D within each racial/ethnic group . RESULTS Among whites ( 148 cases , 296 controls ) , the risk of multiple sclerosis significantly decreased with increasing levels of 25-hydroxyvitamin D ( odds ratio [ OR ] for a 50-nmol/L increase in 25-hydroxyvitamin D , 0.59 ; 95 % confidence interval , 0.36 - 0.97 ) . In categorical analyses using the lowest quintile ( 25-hydroxyvitamin D levels higher than 99.1 nmol/L , was significantly different from 1.00 ( OR , 0.38 ; 95 % confidence interval , 0.19 - 0.75 ; P = .006 ) . The inverse relation with multiple sclerosis risk was particularly strong for 25-hydroxyvitamin D levels measured before age 20 years . Among blacks and Hispanics ( 109 cases , 218 controls ) , who had lower 25-hydroxyvitamin D levels than whites , no significant associations between vitamin D and multiple sclerosis risk were found . CONCLUSION The results of our study suggest that high circulating levels of vitamin D are associated with a lower risk of multiple sclerosis",
"OBJECTIVE To determine whether low levels of 25-hydroxyvitamin D ( 25[OH]D ) contribute to the increased risk of postpartum multiple sclerosis ( MS ) relapses . DESIGN Prospect i ve cohort study . SETTING Out patients identified through membership records of Kaiser Permanente Northern California or Stanford University outpatient neurology clinics . PATIENTS Twenty-eight pregnant women with MS . INTERVENTIONS We prospect ively followed up patients through the postpartum year and assessed exposures and symptoms through structured interviews . Total serum 25(OH)D levels were measured using the DiaSorin Liaison Assay during the third trimester and 2 , 4 , and 6 months after giving birth . The data were analyzed using longitudinal multivariable methods . MAIN OUTCOME MEASURES Levels of 25(OH)D and relapse rate . RESULTS Fourteen ( 50 % ) women breastfed exclusively , and 12 women ( 43 % ) relapsed within 6 months after giving birth . During pregnancy , the average 25(OH)D levels were 25.4 ng/mL ( range , 13.7 - 42.6 ) and were affected only by season ( P=.009 ) . In contrast , in the postpartum period , 25(OH)D levels were significantly affected by breastfeeding and relapse status . Levels of 25(OH)D remained low in the exclusive breastfeeding group , yet rose significantly in the nonexclusive breastfeeding group regardless of season ( P=.007 , unadjusted ; P=.02 , adjusted for season ) . By 4 and 6 months after childbirth , 25(OH)D levels were , on average , 5 ng/mL lower in the women who breastfed exclusively compared with the nonbreastfeeding group ( P=.001 ) . CONCLUSIONS Pregnancy and exclusive breastfeeding are strongly associated with low 25(OH)D levels in women with MS . However , these lower vitamin D levels were not associated with an increased risk of postpartum MS relapses . These data suggest that low vitamin D in isolation is not an important risk factor for postpartum MS relapses",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Background Vitamin D is important for bone health and immune regulation , and has been shown to be low in multiple sclerosis ( MS ) . We sought to determine the effect of over the counter low dose cholecalciferol ( LDC ) and high dose ergocalciferol ( HDE ) on the vitamin D levels in MS patients . Methods We retrospectively evaluated serum 25-hydroxy-vitamin D [ 25(OH)D ] levels of 199 patients ( CIS , n = 32 ; RRMS , n = 115 ; PPMS , n = 10 ; SPMS , n = 16 ; Transverse Myelitis ( TM ) , n = 9 ; other neurological diseases , n = 16 ) attending our clinic between 2004 and 2008 . We examined the change in 25(OH)D levels in 40 MS patients who took either LDC ( ≤800 IU/day ) or HDE ( 50,000 IU/day for 7 - 10 days , followed by 50,000 IU weekly or biweekly ) . Results The average 25(OH)D level was 71 ± 39 nmol/L ( Mean ± SD ) , and 167(84 % ) patients had insufficient levels ( ≤100 nmol/L ) of 25(OH)D. The patients supplemented with LDC did not have a significant increase in their 25(OH)D levels . However , 25(OH)D levels increased by 42 nmol/L ( P = 0.01 ) in the patients originally taking LDC and then prescribed HDE . Optimal levels ( ≥100 nmol/L ) were only achieved in less than 40 % of patients . Conclusions We conclude that large numbers of patients with MS and TM in our cohort are deficient in vitamin D. HDE significantly elevated 25(OH)D levels in MS patients and was more effective at increasing 25(OH)D levels than LDC . Prospect i ve studies are required to determine appropriate dosing regimen to achieve optimal levels in the majority of MS patients and to ascertain the safety , immunological response , and ultimately the clinical efficacy of vitamin D replacement therapy",
"Objective : There is increasing evidence that vitamin D can be protective against the development of multiple sclerosis ( MS ) , but it may also be beneficial for the clinical course of the disease . Our objective was to prospect ively investigate if 25-hydroxy-vitamin D ( 25-OH-D ) levels are associated with exacerbation risk in MS in a study with frequent serum measurements . Methods : This was a prospect i ve longitudinal study in 73 patients with relapsing-remitting MS . Blood sample s for 25-OH-D measurements were taken every 8 weeks . Associations between 25-OH-D levels and exacerbation rates were assessed using Poisson regression ( generalized estimating equations ) with the individual serum levels as time-dependent variable . Results : During follow-up ( mean 1.7 years ) , 58 patients experienced a total of 139 exacerbations . Monthly moving averages of 25-OH-D levels were categorized into low ( 100 nmol/L ) levels . Exacerbation risk decreased significantly with higher serum vitamin D levels : respective relative exacerbation rates for the medium and high-level category as compared to the low-level category were 0.7 and 0.5 ( p value for trend : p = 0.007 ) . The association between 25-OH-D concentrations and exacerbation rate was log linear without a threshold . With each doubling of the serum 25-OH-D concentration the exacerbation rate decreased by 27 % ( 95 % confidence interval 8%–42 % , p = 0.008 ) . Conclusions : Our finding that higher vitamin D levels are associated with decreased exacerbation risk in relapsing-remitting MS suggests a beneficial effect of vitamin D on disease course in MS . However , the possibility of reverse causality can not be ruled out completely . R and omized intervention studies are therefore needed to investigate the effect of vitamin D supplementation in MS",
"Background The ' Hawthorne Effect ' may be an important factor affecting the generalisability of clinical research to routine practice , but has been little studied . Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge , no attempt has been made to quantify them . Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia . Methods Participants in a dementia trial were r and omised to intensive follow-up ( with comprehensive assessment visits at baseline and two , four and six months post r and omisation ) or minimal follow-up ( with an abbreviated assessment at baseline and a full assessment at six months ) . Our primary outcomes were cognitive functioning ( ADAS-Cog ) and participant and carer-rated quality of life ( QOL-AD ) . Results We recruited 176 participants , mainly through general practice s. The main analysis was based on Intention to treat ( ITT ) , with available data . In the ANCOVA model with baseline score as a co-variate , follow-up group had a significant effect on outcome at six months on the ADAS-Cog score ( n = 140 ; mean difference = -2.018 ; 95%CI -3.914 , -0.121 ; p = 0.037 favouring the intensive follow-up group ) , and on participant-rated quality of life score ( n = 142 ; mean difference = -1.382 ; 95%CI -2.642 , -0.122 ; p = 0.032 favouring minimal follow-up group ) . There was no significant difference on carer quality of life . Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia result ed in a better outcome than minimal follow-up , as measured by their cognitive functioning . Trial registration Current controlled trials : IS RCT",
"It is now acknowledged that seasonality is a main feature of the complex neurological disorder multiple sclerosis ( MS ) . Having a spring birthday and being exposed to low levels of sunshine significantly increase the risk of MS later in life.1,2 Although global environment is dominated by seasonality , the observation that vitamin D status is inversely associated with risk of MS later in life and that vitamin D regulates the expression of a large number of MS associated genes , strongly indicate that ultra-violet ( UV ) light exposure and consequent effects on vitamin D production are involved in MS etiology.3,4 Intriguingly this essential hormone appears to also play an important role in influencing MS disease course . Studies have shown an inverse association between 25-hydroxyvitamin D ( 25-OH-D ) levels and clinical MS severity and relapse rate.5 Furthermore , in a recent prospect i ve investigation of a large cohort of MS patients , vitamin D status inversely correlated with relapses over the subsequent 6 months.6 Similar",
"Objective : Low vitamin D status has been associated with multiple sclerosis ( MS ) prevalence and risk , but the therapeutic potential of vitamin D in established MS has not been explored . Our aim was to assess the tolerability of high-dose oral vitamin D and its impact on biochemical , immunologic , and clinical outcomes in patients with MS prospect ively . Methods : An open-label r and omized prospect i ve controlled 52-week trial matched patients with MS for demographic and disease characteristics , with r and omization to treatment or control groups . Treatment patients received escalating vitamin D doses up to 40,000 IU/day over 28 weeks to raise serum 25-hydroxyvitamin D [ 25(OH)D ] rapidly and assess tolerability , followed by 10,000 IU/day ( 12 weeks ) , and further downtitrated to 0 IU/day . Calcium ( 1,200 mg/day ) was given throughout the trial . Primary endpoints were mean change in serum calcium at each vitamin D dose and a comparison of serum calcium between groups . Secondary endpoints included 25(OH)D and other biochemical measures , immunologic biomarkers , relapse events , and Exp and ed Disability Status Scale ( EDSS ) score . Results : Forty-nine patients ( 25 treatment , 24 control ) were enrolled [ mean age 40.5 years , EDSS 1.34 , and 25(OH)D 78 nmol/L ] . All calcium-related measures within and between groups were normal . Despite a mean peak 25(OH)D of 413nmol/L , no significant adverse events occurred . Although there may have been confounding variables in clinical outcomes , treatment group patients appeared to have fewer relapse events and a persistent reduction in T-cell proliferation compared to controls . Conclusions : High-dose vitamin D ( ∼10,000 IU/day ) in multiple sclerosis is safe , with evidence of immunomodulatory effects . Classification of evidence : This trial provides Class II evidence that high-dose vitamin D use for 52 weeks in patients with multiple sclerosis does not significantly increase serum calcium levels when compared to patients not on high-dose supplementation . The trial , however , lacked statistical precision and the design requirements to adequately assess changes in clinical disease measures ( relapses and Exp and ed Disability Status Scale scores ) , providing only Class level IV evidence for these outcomes",
"The aim of this preliminary study was to evaluate the effect of low-dose oral vitamin D in combination with current disease-modifying therapy on the prevention of progression of relapsing-remitting multiple sclerosis ( RRMS ) . A phase II double-blind placebo-controlled r and omized clinical trial conducted between October 2007 and October 2008 included 50 patients with confirmed RRMS aged 25 to 57 years and normal serum 25-hydroxyvitamin D. They were r and omly allocated to receive 12 months of treatment with either escalating calcitriol doses up to 0.5 μg/day or placebo combined with disease-modifying therapy . Response to treatment was assessed at eight-week intervals . In both groups , the mean relapse rate decreased significantly ( P the mean ( SD ) Exp and ed Disability Status Scale ( EDSS ) increased from 1.70 ( 1.21 ) at baseline to 1.94 ( 1.41 ) at the end of study period ( P ) . Average EDSS and relapse rate at the end of trial did not differ between groups . Adding low-dose vitamin D to routine disease-modifying therapy had no significant effect on the EDSS score or relapse rate . A larger phase III multicenter study of vitamin D in RRMS is warranted to more assess the efficacy of this intervention",
"Vitamin D has been associated with multiple sclerosis ( MS ) and several markers of disease state in whites . There are limited reports of vitamin D ’s influence in MS in ethnic groups , such as in Hispanics . In this study , we compared vitamin D levels in Hispanics and whites with MS and tried to determine whether season or increasing disability influence hypovitaminosis D in Hispanics with MS . Serum 25-hydroxyvitamin D [ 25(OH)D ] levels and clinical characteristics were compared in a cross-sectional sample of Hispanics ( n = 80 ) and whites ( n = 80 ) with MS recruited from the University of Southern California . Serum 25(OH)D levels were significantly lower in Hispanics than whites with MS ( mean and st and ard deviation 25.1 ± 9.4 and 37.3 ± 19.8 ng/ml , respectively ; p Hispanics were significantly more likely than whites to be vitamin D insufficient ( ≤30 ng/ml ; 70 vs. 41 % , respectively ; p deficient ( ≤20 ng/ml ; 40 vs. 14 % , respectively , p , serum 25(OH)D levels were not influenced by season ( p = 0.8 ) or higher physical disability ( EDSS ≥6 , p = 0.7 ) . We found that the relationship between vitamin D and MS differs by Hispanic ethnicity . Hypovitaminosis D was significantly more common among Hispanics than among whites with MS , and the majority of Hispanics were vitamin D insufficient . Interestingly , there was no association between vitamin D levels and season or increasing disability in the Hispanics . Our findings imply that factors influencing vitamin D levels and possibly vitamin D requirements may vary by ethnicity in patients with MS . These results should be confirmed in larger , prospect i ve multi-ethnic cohort studies",
"Although Vitamin D is best known as a modulator of calcium homeostasis , it also has immune modulating potential . A protective effect of Vitamin D on Multiple Sclerosis ( MS ) is supported by the reduced risk associated with sun exposure and use of Vitamin D supplements . Moreover , high circulating levels of Vitamin D have been associated with lower risk of MS . To gain more insight into putative regulatory mechanisms of Vitamin D in MS pathogenesis , we studied 132 Hispanic patients with clinical ly definite MS , 58 with relapsing remitting MS ( RR MS ) during remission , 34 RR MS patients during relapse , and 40 primary progressive MS cases ( PP MS ) . Sixty healthy individuals matched with respect to place of residence , race/ethnicity , age and gender served as controls . Levels of 25(OH ) Vitamin D and 1,25(OH)(2 ) Vitamin D , measured by ELISA were significantly lower in RR MS patients than in controls . In addition , levels in patients suffering relapses were lower than during remissions . By contrast , PP MS patients showed similar values to controls . Proliferation of both freshly isolated CD4 + T cells and MBP-specific T cells was significantly inhibited by 1,25(OH)(2 ) Vitamin D. Moreover , activated Vitamin D enhanced the development of IL-10 producing cells , and reduced the number of IL-6 and IL-17 secreting cells . Notably , VDR expression was induced by 1,25(OH)(2 ) Vitamin D in both activated and resting cells . Interestingly , T cells were able to metabolize 25(OH ) Vitamin D into biologically active 1,25(OH)(2 ) Vitamin D , since T cells express 1α-hydroxylase constitutively . Finally , 1,25(OH)(2 ) Vitamin D also increased the expression and biological activity of IDO , triggering significant increase in the number of CD4+CD25 + T regulatory cells . Collectively , these findings suggest that 1,25(OH)(2 ) VitaminD plays an important role in T cell homeostasis during the course of MS , suggesting correction of its deficiency may be useful during treatment of the disease",
" Multiple sclerosis ( MS ) patients were r and omized , in a double blind design , and placed into either a vitamin D supplemented group or a placebo control group . As expected , serum 25-hydroxyvitamin D levels increased significantly following 6 month vitamin D supplementation ( 17+/-6 ng/ml at baseline to 28+/-8 ng/ml at 6 months ) . Vitamin D supplementation also significantly increased serum transforming growth factor (TGF)-beta 1 levels from 230+/-21 pg/ml at baseline to 295+/-40 pg/ml 6 months later . Placebo treatment had no effect on serum TGF-beta 1 levels . Tumor necrosis factor (TNF)-alpha , interferon (IFN)-gamma , and interleukin (IL)-13 were not different following vitamin D supplementation . IL-2 mRNA levels decreased following vitamin D supplementation but the differences did not reach significance . Vitamin D supplementation of MS patients for 6 months was associated with increased vitamin D status and serum TGF-beta 1",
" Seventy-one \" negative \" r and omized control trials were re-examined to determine if the investigators had studied large enough sample s to give a high probability ( greater than 0.90 ) of detecting a 25 per cent and 50 per cent therapeutic improvement in the response . Sixty-seven of the trials had a greater than 10 per cent risk of missing a true 25 per cent therapeutic improvement , and with the same risk , 50 of the trials could have missed a 50 per cent improvement . Estimates of 90 per cent confidence intervals for the true improvement in each trial showed that in 57 of these \" negative \" trials , a potential 25 per cent improvement was possible , and 34 of the trials showed a potential 50 per cent improvement . Many of the therapies labeled as \" no different from control \" in trials using inadequate sample s have not received a fair test . Concern for the probability of missing an important therapeutic improvement because of small sample sizes deserves more attention in the planning of clinical trials",
"Multiple sclerosis ( MS ) is a consequence of genetic and environmental factors . Geographic , genetic , and biological evidence suggests that an important immunopathogenic factor might be the insufficiency of vitamin D. The aim of our study was to investigate the immunomodulatory effect of alfacalcidol , a vitamin D analogue , on cytokine levels in RRMS patients in relapse . We investigated 15 patients suffering from RRMS relapse ( an RRMS group ) and two control groups : one control group of healthy subjects ( n=10 ) and a NIND group , consisting of patients with non-inflammatory neurological diseases ( n=10 ) . All of the MS patients were treated with 5 microgr/day of oral alfacalcidol for a period of five days . The serum cytokine levels of TNF-alpha , IL-10 , IL-4 , and IL-12 were measured in all the MS patients one day prior to and one day after therapy , and in all the control subjects ( ELISA , Quantikine human immunoassay , R&D Systems , UK ) . Our results showed significantly lower IL-4 and IL-12 levels in the RRMS patients group compared to the N group and the NIND group ( p TNF-alpha and IL-10 levels were found between the groups , and there was no influence of alfacalcidol on these cytokines in RRMS patients . High doses of oral alfacalcidol induced significant increases in IL-4 and IL-12 levels in RRMS patients ( p IL-4 and IL-12 levels compared to the N group and the NIND group . Alfacalcidol therapy in RRMS patients did not provoke any side effects . Vitamin D and its analogues , such as alfacalcidol , act as immunomodulatory agents , with potential therapeutic effects for patients with multiple sclerosis",
"Background : A protective effect of vitamin D on risk of multiple sclerosis ( MS ) has been proposed , but no prospect i ve studies have addressed this hypothesis . Methods : Dietary vitamin D intake was examined directly in relation to risk of MS in two large cohorts of women : the Nurses ’ Health Study ( NHS ; 92,253 women followed from 1980 to 2000 ) and Nurses ’ Health Study II ( NHS II ; 95,310 women followed from 1991 to 2001 ) . Diet was assessed at baseline and up date d every 4 years thereafter . During the follow-up , 173 cases of MS with onset of symptoms after baseline were confirmed . Results : The pooled age-adjusted relative risk ( RR ) comparing women in the highest quintile of total vitamin D intake at baseline with those in the lowest was 0.67 ( 95 % CI = 0.40 to 1.12 ; p for trend = 0.03 ) . Intake of vitamin D from supplements was also inversely associated with risk of MS ; the RR comparing women with intake of ≥400 IU/day with women with no supplemental vitamin D intake was 0.59 ( 95 % CI = 0.38 to 0.91 ; p for trend = 0.006 ) . No association was found between vitamin D from food and MS incidence . Conclusion : These results support a protective effect of vitamin D intake on risk of developing MS ",
"Background : High vitamin D levels may reduce the risk of relapses and disease progression in multiple sclerosis . Methods : This 96-week r and omised controlled trial was design ed to assess the effect of vitamin D3 supplementation on bone mineral density in persons with multiple sclerosis . Supplementation with 20,000 IU vitamin D3 weekly raised median serum 25-hydroxy vitamin D ( 25[OH]D ) to 121 nmol/L. The modified intention to treat analysis included 35 persons in the vitamin D3 group and 33 in the placebo group . Participants were age 21 to 50 years and fully ambulatory ( median Exp and ed Disability Status Scale ( EDSS ) 2.5 ) . We studied the effect of supplementing vitamin D3 on the exploratory outcomes annualised relapse rate ( ARR ) , EDSS , multiple sclerosis functional composite ( MSFC ) components , grip strength , and fatigue . Results : After 96 weeks , there was no significant difference between groups in ARR ( absolute difference 0.10 , 95 % CI -0.07 to 0.27 ; p = 0.25 ) , EDSS ( absolute difference -0.01 , 95 % CI -0.35 to 0.35 ; p = 0.97 ) , MSFC components , grip strength , or fatigue . Conclusion : Supplementation with 20,000 IU vitamin D3 weekly did not result in beneficial effects on the measured multiple sclerosis-related outcomes . This study was not powered to address clinical outcomes , but none of the results were suggestive of an effect in this unselected population of fully ambulatory persons with multiple sclerosis",
"CONTEXT The active metabolite of vitamin D , 1,25-dihydroxyvitamin D [ 1,25(OH)(2)D ] , is a potent modulator of immune cells in vitro . OBJECTIVE Our objective was to determine whether the sun-dependent nutrient , cholecalciferol , can alter disease-associated cellular immune abnormalities in patients with multiple sclerosis ( MS ) . DESIGN This was an open-label , 12-month , r and omized controlled trial . SETTING Patients with MS were recruited from the MS Clinic at St. Michael 's Hospital , Toronto . PATIENTS Forty-nine patients were matched ( for age , sex , disease duration , disease-modifying drug , and disability ) and enrolled ( treated n = 25 ; control n = 24 ) . Four patients were lost to follow-up ( n = 2 from each group ) . INTERVENTION Treated patients received increasing doses of cholecalciferol ( 4,000 - 40,000 IU/d ) plus calcium ( 1200 mg/d ) , followed by equilibration to a moderate , physiological intake ( 10,000 IU/d ) . Control patients did not receive supplements . MAIN OUTCOME MEASURES At enrollment and at 12 months , peripheral blood mononuclear cell ( P BMC ) proliferative responses to disease-associated , MS-relevant , and control antigens were measured , along with selected serum biochemical markers . RESULTS At 12 months , mean serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations were 83 ± 35 nmol/liter and 179 ± 76 nmol/liter in control and treated participants , respectively ( paired t , P Serum 1,25(OH)(2)D did not differ between baseline and 1 yr . In treated patients , 12-month P BMC proliferative responses to neuron antigens myelin basic protein and exon-2 were suppressed ( P = 0.002 ) . In controls , there were no significant changes in disease-associated P BMC responsiveness . There were no significant differences between groups in levels of selected biomarkers . INTERPRETATION MS-associated , abnormal T cell reactivities were suppressed in vivo by cholecalciferol at serum 25(OH)D concentrations higher than 100 nmol/liter"
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41170e1a-06ff-11f0-808a-c43d1ab1c353
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Background Relapse is high in lifestyle obesity interventions involving behavior and weight change . Identifying mediators of successful outcomes in these interventions is critical to improve effectiveness and to guide approaches to obesity treatment , including re source allocation . This article review s the most consistent self-regulation mediators of medium- and long-term weight control , physical activity , and dietary intake in clinical and community behavior change interventions targeting overweight/obese adults . Methods A comprehensive search of peer- review ed articles , published since 2000 , was conducted on electronic data bases ( for example , MEDLINE ) and journal reference lists . Experimental studies were eligible if they reported intervention effects on hypothesized mediators ( self-regulatory and psychological mechanisms ) and the association between these and the outcomes of interest ( weight change , physical activity , and dietary intake ) . Quality and content of selected studies were analyzed and findings summarized . Studies with formal mediation analyses were reported separately . Results Thirty-five studies were included testing 42 putative mediators . Ten studies used formal mediation analyses . Twenty-eight studies were r and omized controlled trials , mainly aim ing at weight loss or maintenance ( n = 21 ) . Targeted participants were obese ( n = 26 ) or overweight individuals , aged between 25 to 44 years ( n = 23 ) , and 13 studies targeted women only . In terms of study quality , 13 trials were rated as “ strong ” , 15 as “ moderate ” , and 7 studies as “ weak ” . In addition , method ological quality of formal mediation analyses was “ medium ” . Identified mediators for medium-/long-term weight control were higher levels of autonomous motivation , self-efficacy/barriers , self-regulation skills ( such as self-monitoring ) , flexible eating restraint , and positive body image . For physical activity , significant putative mediators were high autonomous motivation , self-efficacy , and use of self-regulation skills . For dietary intake , the evidence was much less clear , and no consistent mediators were identified . Conclusions This is the first systematic review of mediational psychological mechanisms of successful outcomes in obesity-related lifestyle change interventions . Despite limited evidence , higher autonomous motivation , self-efficacy , and self-regulation skills emerged as the best predictors of beneficial weight and physical activity outcomes ; for weight control , positive body image and flexible eating restraint may additionally improve outcomes . These variables represent possible targets for future lifestyle interventions in overweight/obese population
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"Background Intensive lifestyle interventions in well-controlled setting s are effective in lowering the risk of chronic diseases such as type 2 diabetes ( T2DM ) and cardiovascular diseases ( CVD ) , but there are still no effective lifestyle interventions for everyday practice . In the Hoorn Prevention Study we aim ed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality , and to motivate changes in lifestyle behaviors . Methods The Hoorn Prevention Study is a parallel group r and omized controlled trial , implemented in the region of West-Friesl and , the Netherl and s. 622 adults with ≥10 % estimated risk of T2DM and /or CVD mortality were r and omly assigned and monitored over a period of 12 months . The intervention group ( n=314 ) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment , provided by trained practice nurses in 12 general practice s. The control group ( n=308 ) received existing health brochures . Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities ( ARIC ) Study , and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation ( SCORE ) formula . Secondary outcomes included lifestyle behavior ( diet , physical activity and smoking ) . The research assistants , the principal investigator and the general practitioners were blinded to group assignment . Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure , adjusted for baseline values . Results 536 ( 86.2 % ) of the 622 participants ( age 43.5 years ) completed the 6-month follow-up , and 502 ( 81.2 % ) completed the 12-month follow-up . The mean baseline T2DM risk was 18.9 % ( SD 8.2 ) and the mean CVD mortality risk was 3.8 % ( SD 3.0 ) . The intervention group participated in a median of 2 sessions . Intention-to-treat analyses showed no significant differences in outcomes between the two groups at 6 or 12-months follow-up . Conclusions The lifestyle intervention was not more effective than health brochures in reducing risk scores for T2DM and CVD or improving lifestyle behavior in an at-risk population .Trial registration Current Controlled Trials : IS RCT",
"BACKGROUND The Diabetes Prevention Program ( DPP ) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes , but there is little information about the feasibility of offering such an intervention in community setting s. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA . METHODS This pilot cluster-r and omized trial was design ed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone ( control ) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI > or=24 kg/m2 , > or=2 diabetes risk factors , and a r and om capillary blood glucose of 110 - 199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight , blood pressures , HbA1c , total cholesterol , and HDL-cholesterol after 6 and 12 months . RESULTS Among 92 participants , controls were more often women ( 61 % vs 50 % ) and of nonwhite race ( 29 % vs 7 % ) . After 6 months , body weight decreased by 6.0 % ( 95 % CI=4.7 , 7.3 ) in intervention participants and 2.0 % ( 95 % CI=0.6 , 3.3 ) in controls ( p total cholesterol ( -22 mg/dL vs + 6 mg/dL controls ; p YMCA sites , it was not possible to adjust for potential clustering by site . CONCLUSIONS The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention",
"Data from two r and omized clinical trials ( RCT ) were used to examine the extent to which a health promotion intervention affected changes in growth trajectories of psychosocial constructs and if so , whether these constructs in turn explained changes in physical activity ( PA ) . PA and psychosocial measures on 842 overweight adults in the United States were collected in two RCTs evaluating Internet-based behavior change interventions with assessment s at baseline , 6 and 12 months . A physical activity latent variable at 12 months was created using indicators of self-reported walking and leisure time activities . Intervention-mediated effects on PA at 12 months were found via latent growth curves representing self-efficacy and behavioral strategies , where increasing growth curves across time were associated with higher PA values at 12 months . These findings provide some evidence that web-based self-help intervention programs worked through targeted behavior change constructs to influence physical activity levels in overweight adults",
"Background The Weight Loss Maintenance Trial tested strategies for maintenance of weight loss . Personal contact was superior to interactive technology and self-directed conditions . Purpose We aim ed to identify behavioral mediators of the superior effect of personal contact vs. interactive technology and of personal contact vs. self-directed arms . Methods Overweight/obese adults at risk for cardiovascular disease ( n = 1,032 ) who lost at least 4 kg were r and omized to personal contact , interactive technology , or self-directed . After 30 months , 880 participants had data on weight and behavioral strategies . Results Reported increase of intake of fruits and vegetables and physical activity and more frequent self-weighing met criteria as mediators of the better outcome of personal contact vs. interactive technology . Increased intake of fruits and vegetables , more frequent self-weighing , and decreased dessert consumption were mediators of the difference between personal contact vs. self-directed . Conclusion Inducing changes in the identified behaviors might yield better outcomes in future weight loss maintenance trials . ( Clinical Trials.gov number NCT00054925",
"Background Successfully transferring the findings of expensive and tightly controlled programmes of intensive lifestyle modification to the primary care setting is necessary if such knowledge is to be of clinical utility . The objective of this study was to test whether intensive lifestyle modification , shown previously in tightly-controlled clinical trials to be efficacious for diabetes risk-reduction among high-risk individuals , can reduce cardiovascular risk factor levels in the primary care setting . Methodology / Principal Findings The Swedish Björknäs study was a r and omized controlled trial conducted from 2003 to 2006 with follow-up on cardiovascular risk factors at 3 , 12 , 24 and 36 months . A total of 151 middle-aged men and women at moderate- to high-risk of cardiovascular disease from northern Sweden were r and omly assigned to either an intensive lifestyle intervention ( n = 75 ) or control ( n = 76 ) group . The intervention was based broadly on the protocol of the Diabetes Prevention Program . The three-month intervention period was administered in the primary care setting and consisted of supervised exercise sessions and diet counselling , followed by regular group meetings during three years . The control group was given general advice about diet and exercise and received st and ard clinical care . Outcomes were changes in anthropometrics , aerobic fitness , self-reported physical activity , blood pressure , and metabolic traits . At 36 months post-r and omisation , intensive lifestyle modification reduced waist circumference ( −2.2 cm : p = 0.001 ) , waist-hip ratio ( −0.02 : p ) , systolic blood pressure ( −4.9 mmHg : p = 0.036 ) , and diastolic blood pressure ( −1.6 mmHg : p = 0.005 ) , and improved aerobic fitness ( 5 % ; p = 0.038 ) . Changes in lipid or glucose values did not differ statistically between groups . At 36 months , self-reported time spent exercising and total physical activity had increased more in the intervention group than in the control group ( p intensive lifestyle modification undertaken in the primary health care setting can favourably influence cardiovascular risk-factor profiles in high-risk individuals . Trial Registration Clinical Trials.gov",
"Purpose . To determine the effects and mediating factors of a physical activity ( PA ) or vegetable and fruit ( VF ) group cohesion intervention . Design . Longitudinal design . Setting . Harris County and Travis County , Texas . Participants . Community-dwelling African-American and Hispanic or Latina women . Intervention . Three hundred ten women were r and omized to a PA ( n = 204 ) or VF ( n = 106 ) intervention group . Women met in groups six times over the course of 6 months and were exposed to a group cohesion intervention to promote walking or to increase VF consumption . Measures . Women completed the International PA Question naire , National Cancer Institute VF and fat screeners , PA Group Environment Question naire , and 7-day accelerometer protocol at baseline and post-intervention . Analyses . The direct and mediated effects of the intervention on outcomes were evaluated using a mediational chain model , controlling for baseline values and covariates using path analysis . Results . Women were middle aged ( mean = 44.4 years ) and overweight or obese ( mean body mass index = 34.0 kg/m2 ) . PA increased and fat consumption decreased for both groups , whereas VF consumption increased for women in VF group only ( all p task cohesion led to hypothesized increases in psychosocial factors in the PA group but not to behavioral changes . Conclusions . Group cohesion interventions may have psychological and physical health benefits for African-American and Hispanic or Latina women , but refinement of measures and intervention delivery is needed to determine whether hypothesized mediational pathways are valid",
"Long-term behavioral self-regulation is the hallmark of successful weight control . We tested mediators of weight loss and weight loss maintenance in middle-aged women who participated in a r and omized controlled 12-month weight management intervention . Overweight and obese women ( N = 225 , BMI = 31.3 + /- 4.1 kg/m(2 ) ) were r and omly assigned to a control or a 1-year group intervention design ed to promote autonomous self-regulation of body weight . Key exercise , eating behavior , and body image variables were assessed before and after the program , and tested as mediators of weight loss ( 12 months , 86 % retention ) and weight loss maintenance ( 24 months , 81 % retention ) . Multiple mediation was employed and an intention-to-treat analysis conducted . Treatment effects were observed for all putative mediators ( Effect size : 0.32 - 0.79 , P Weight change was -7.3 + /- 5.9 % ( 12-month ) and -5.5 + /- 5.0 % ( 24-month ) in the intervention group and -1.7 + /- 5.0 % and -2.2 + /- 7.5 % in controls . Change in most psychosocial variables was associated with 12-month weight change , but only flexible cognitive restraint ( P disinhibition ( P exercise self-efficacy ( P exercise intrinsic motivation ( P body dissatisfaction ( P 24-month weight change . Lower emotional eating , increased flexible cognitive restraint , and fewer exercise barriers mediated 12-month weight loss ( R(2 ) = 0.31 , P flexible restraint and exercise self-efficacy mediated 24-month weight loss ( R(2 ) = 0.17 , P weight loss and 2-year weight loss maintenance , in a large sample of overweight women . Results show that lowering emotional eating and adopting a flexible dietary restraint pattern are critical for sustained weight loss . For long-term success , interventions must also be effective in promoting exercise intrinsic motivation and self-efficacy",
"Theoretical approaches to behaviour change are now pervasive in the health psychology literature ( Abraham & Michie , 2008 ; Michie , Johnston , Francis , Hardeman , & Eccles , 2008 ) . Many are developed in the social psychology literature and applied in health context s to provide a hypothesis-testing framework for empirical investigations into health behaviours and outcomes ( Michie , Rothman , & Sheeran , 2007 ) . Numerous theoretical perspectives have been applied in the health sphere : the health action process model ( Schwartzer , 1992 ) , the health belief model ( Becker , 1974 ) , protection motivation theory ( PMT ; Rogers , 1975 ) , self-determination theory ( Deci & Ryan , 1985 ) , self-regulation theory ( Leventhal , Leventhal , & Contrada , 1998 ) , social cognitive theory ( B and ura , 1977 ) , subjective expected utility theory ( Edwards , 1954 ) , the theories of reasoned action ( Ajzen & Fishbein , 1980 ) and planned behaviour ( Ajzen , 1985 ) , the theory of interpersonal behaviour ( Tri and is , 1977 ) , and the transtheoretical model ( Prochaska & DiClemente , 1982 ) to name but a few . While meta-analytic review s of cross-sectional , prospect i ve , experimental , and intervention studies have indicated that these theories have varying degrees of utility in explaining variance in health behaviour and outcomes ( Armitage & Conner , 2001 ; Hardeman et al. , 2002 ; Milne , Sheeran , & Orbell , 2000 ; Sibley & Abraham , 2008 ) , a substantial variance in health behaviour remains unexplained ( Ogden , 2003 ; Weinstein , 2007 ) . There is a further problem ; when the impact of past behaviour or previous experience is accounted for , the efficacy of the theories in explaining health behaviour tends to fall dramatically ( Hagger , Chatzisarantis , & Biddle , 2002 ; Sutton , 1994 ) . This makes the identification of the psychological constructs that account for behaviour uniquely and independent of past behaviour paramount . Furthermore , theories of health behaviour have become increasingly complex , with additional variables being incorporated as additional predictors , mediators , or moderators to test , with increasing detail , the limitations and boundaries of each theory ( Ajzen , 1998 ; Armitage & Conner",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"PURPOSE This study evaluated exercise-related predictors of successful long-term weight control in women by analyzing the extent to which sustained exercise participation and self-determination theory (SDT)-based exercise motivation variables mediated the impact of a behavioral weight control intervention on 3-yr weight change . METHODS Longitudinal r and omized controlled trial consisting of a 1-yr SDT-based intervention and a 2-yr follow-up with 221 female participants ( means ± SD : age = 37.6 ± 7 yr , body mass index = 31.6 ± 4.1 kg·m(-2 ) ) . The tested model incorporated experimentally manipulated perceived need support , motivational regulations , and 2-yr exercise adherence as mediators of the intervention 's impact on 3-yr weight change . Paths were tested using partial least squares analysis . Where there were significant intervening paths , tests of mediation were conducted . RESULTS Treatment had significant effects on 1- and 2-yr autonomous regulations , 2-yr physical activity , and 3-yr weight change , fully mediated by the tested paths ( effect ratio = 0.10 - 0.61 ) . Moderate and vigorous exercise at 2 yr had a significant effect ( P on weight loss success at 3 yr and partially mediated the effect of treatment on weight change . The 2-yr autonomous regulation effects on follow-up weight change were only partially mediated by physical activity ( effect ratio = 0.42 ) . CONCLUSIONS This application of SDT to physical activity and weight management showed that not all types of motivation predict long-term behavioral outcomes and that sustained moderate and vigorous exercise mediated long-term weight change . It provides strong evidence for a link between experimentally increased autonomous motivation and exercise and long-term weight loss maintenance . Results highlight the importance of interventions targeting the internalization of exercise behavioral regulation and making exercise and physical activity positive and meaningful experiences rather than simply focusing on immediate behavior change in overweight/obese women",
"Objective To examine the behavioral processes through which lifestyle interventions impacted weight loss . Design and Methods We limited our analyses to overweight and obese Black and White adults r and omized to a PREMIER lifestyle intervention ( N = 501 ) . Structural equation modeling was conducted to test the direct and indirect relationships of session attendance , days of self-monitoring diet and exercise , change in diet composition and exercise , and six month weight change . Results Greater session attendance was associated with increased self-monitoring , which was in turn significantly related to reduction in percent energy from total fat consumed . Change in percent energy from fat and self-monitoring was associated with six-month percent change in weight . Both a decrease in fat intake and increase in self-monitoring are potential mediators of the relationship between attendance and weight change . Conclusions Our findings provide a reasonable model that suggests regular session attendance and use of behavioral strategies like self-monitoring are associated with improved behavioral outcomes that are associated with weight loss",
"OBJECTIVE Successful weight management relies on at least two health behaviors , eating and exercise . However , little is known about their interaction on a motivational and behavioral level . Based on the Hierarchical Model of Motivation the authors examined whether exercise-specific motivation can transfer to eating regulation during a lifestyle weight control program . The authors further investigated whether general , treatment-related , and exercise motivation underlie the relation between increased exercise and improved eating regulation . DESIGN Overweight/obese women participated in a 1-year r and omized controlled trial ( N = 239 ) . The intervention focused on promoting physical activity and internal motivation for exercise and weight loss , following Self-Determination Theory . The control group received general health education . MAIN OUTCOME MEASURES General and exercise specific self-determination , eating self-regulation variables , and physical activity behavior . RESULTS General self-determination and more autonomous exercise motivation predicted eating self-regulation over 12 months . Additionally , general and exercise self-determination fully mediated the relation between physical activity and eating self-regulation . CONCLUSION Increased general self-determination and exercise motivation seem to facilitate improvements in eating self-regulation during weight control in women . These motivational mechanisms also underlie the relationship between improvements in exercise behavior and eating regulation",
"Lack of success with behavioral weight-management treatments indicates a need for a better underst and ing of modifiable psychological correlates . Adults with class 2 and 3 obesity ( N = 183 ; Mean BMI = 42.0 kg/m2 ) volunteered for a 26-week nutrition and exercise treatment , based on social cognitive theory , that focused on self-efficacy and self-regulation applied to increasing cardiovascular exercise and fruit and vegetable consumption . Improved self-efficacy for controlled eating significantly predicted increased fruit and vegetable consumption ( R 2 = .15 ) . Improved self-efficacy for exercise significantly predicted increased exercise ( R 2 = .46 ) . When changes in self-regulatory skill usage were stepped into the 2 previous equations , the variances accounted for significantly increased . Increases in fruit and vegetable consumption and exercise significantly predicted weight loss ( R 2 = .38 ) . Findings suggest that behavioral theory should guide research on weight-loss treatment , and a focus on self-efficacy and self-regulatory skills applied to specific nutrition and exercise behaviors is warranted",
"Background A better underst and ing of interrelations of exercise and improved eating , and their psychosocial correlates of self-efficacy , mood , and self-regulation , may be useful for the architecture of improved weight loss treatments . Theory-based research within field setting s , with sample s possessing high probabilities of health risks , might enable rapid application of useful findings . Methods Adult volunteers with severe obesity ( body mass index [ BMI ] 35–50 kg/m2 ; age = 43.0 ± 9.5 y ; 83 % female ) were r and omly assigned to six monthly cognitive-behavioral exercise support sessions paired with either group-based nutrition education ( n = 145 ) or cognitive behavioral methods applied to improved eating ( n = 149 ) . After specification of mediation models using a bias-corrected bootstrapping procedure , a series of reciprocal effects analyses assessed : a ) the reciprocal effects of changes in exercise and fruit and vegetable intake , result ing from the treatments , b ) the reciprocal effects of changes in the three psychosocial variables tested ( i.e. self-efficacy , mood , and self-regulation ) and fruit and vegetable change , result ing from change in exercise volume , and c ) the reciprocal effects of changes in the three psychosocial variables and exercise change , result ing from change in fruit and vegetable intake . Results Mediation analyses suggested a reciprocal effect between changes in exercise volume and fruit and vegetable intake . After inclusion of psychosocial variables , also found were reciprocal effects between change in fruit and vegetable intake and change in mood , self-efficacy for controlled eating , and self-regulation for eating ; and change in exercise volume and change in mood and exercise-related self-regulation . Conclusion Findings had implication s for behavioral weight-loss theory and treatment . Specifically , results suggested that treatments should focus upon , and leverage , the transfer effects from each of the primary weight-loss behaviors ( exercise and healthy eating ) to the other . Findings on psychosocial correlates of these behavioral processes may also have practical applications",
"BACKGROUND Rural counties in the United States have higher rates of obesity , sedentary lifestyle , and associated chronic diseases than nonrural areas , yet the management of obesity in rural communities has received little attention from research ers . METHODS Obese women from rural communities who completed an initial 6-month weight-loss program at Cooperative Extension Service offices in 6 medically underserved rural counties ( n = 234 ) were r and omized to extended care or to an education control group . The extended-care programs entailed problem-solving counseling delivered in 26 biweekly sessions via telephone or face to face . Control group participants received 26 biweekly newsletters containing weight-control advice . RESULTS Mean weight at study entry was 96.4 kg . Mean weight loss during the initial 6-month intervention was 10.0 kg . One year after r and omization , participants in the telephone and face-to-face extended-care programs regained less weight ( mean [ SE ] , 1.2 [ 0.7 ] and 1.2 [ 0.6 ] kg , respectively ) than those in the education control group ( 3.7 [ 0.7 ] kg ; P = .03 and .02 , respectively ) . The beneficial effects of extended-care counseling were mediated by greater adherence to behavioral weight-management strategies , and cost analyses indicated that telephone counseling was less expensive than face-to-face intervention . CONCLUSIONS Extended care delivered either by telephone or in face-to-face sessions improved the 1-year maintenance of lost weight compared with education alone . Telephone counseling constitutes an effective and cost-efficient option for long-term weight management . Delivering lifestyle interventions via the existing infrastructure of the Cooperative Extension Service represents a viable means of adapting research for rural communities with limited access to preventive health services . Trial Registration clinical trials.gov Identifier : NCT00201006",
"This study aim ed to investigate factors associated with weight management , especially whether satiety value of food as a part of a weight-maintenance diet would affect self-regulation of food intake and weight management . Altogether 82 obese subjects completed the study consisting of weight-loss and weight-maintenance ( WM ) periods . During the WM , subjects were r and omized into higher- and lower-satiety food groups . No differences were observed in the changes in body weight , energy intake , or eating behaviour between the groups , even despite the different macronutrient compositions of the diets . However , when regarding all study subjects , success in WM was most strongly associated with a greater increase in the flexible control of eating and experience of greater easiness of WM and control of food intake and a greater decrease in uncontrollable eating and psychological distress . Psychobehavioural factors seem to be more strongly associated with successful weight management than the predetermined satiety effect or other characteristics of the diet",
"Few studies have examined predictors of weight regain after significant weight losses . This prospect i ve study examined behavioral and psychological predictors of weight regain in 261 successful weight losers who completed an 18-month trial of weight regain prevention that compared a control condition with self-regulation interventions delivered face-to-face or via the Internet . Linear mixed effect models were used to examine behavioral and psychological predictors of weight regain , both as main effects and as interactions with treatment group . Decreases in physical activity were related to weight regain across all 3 groups , and increased frequency of self-weighing was equally protective in the 2 intervention groups but not in the control group . Increases in depressive symptoms , disinhibition , and hunger were also related to weight regain in all groups . Although the impact of changes in restraint was greatest in the Internet group and weakest in the face-to-face group , the latter was the only group with increases in restraint over time and consequent decreases in magnitude of weight regain . Future programs should focus on maintaining physical activity , dietary restraints , and frequent self-weighing and should include stronger components to modify psychological parameters",
"OBJECTIVE To investigate the short- and long-term effectiveness and the predictors of weight loss in a mobile phone weight-loss programme among healthy overweight adults . DESIGN One hundred and twenty-five healthy , overweight ( BMI = 26 - 36 kg/m2 ) , 25 - 44-year-old , screened volunteers were r and omized to an experimental group ( n 62 ) to use a mobile phone-operated weight-loss programme or to a control group ( n 63 ) with no intervention . Via text messaging , the programme instructed a staggered reduction of food intake and daily weight reporting with immediate tailored feedback . Assessment s were at 0 , 3 , 6 , 9 and 12 months for the experimental group ; at 0 and 12 months for the control group . Main outcome variables were changes in body weight and waist circumference . RESULTS By 12 months the experimental group had lost significantly more weight than the control group ( 4.5 ( sd 5.0 ) v. 1.1 ( sd 5.8 ) kg ; F(1,80 ) = 8.0 , P = 0.006 ) and had a greater reduction in waist circumference ( 6.3 ( sd 5.3 ) v. 2.4 ( sd 5.4 ) cm ; F(1,80 ) = 55.2 , P = 0.0001 ) . Early weight loss , self-efficacy , contact frequency , attitudes towards the medium , changes in work and family life and changes made in dietary habits were the strongest predictors of weight loss . CONCLUSIONS This mobile phone weight-loss programme was effective in short- and long-term weight loss . As a minimum-advice , maximal-contact programme , it offers ideas for future weight-loss programmes",
"Cognitive changes are reported infrequently in programs targeting cardiovascular risk . We examined self-efficacy , behavioral barriers and health beliefs in a lifestyle program for drug-treated hypertensives that aim ed to reduce blood pressure , antihypertensive drug needs and cardiovascular risk . In a r and omized controlled trial , we compared usual care ( controls ) and a 4-month program focusing on weight loss , diet and exercise . Outcomes were assessed at baseline , 4 months and 1-year follow-up . Of 241 individuals r and omized , 102/123 in the program and 90/118 of controls completed follow-up . In the program group , dietary barriers fell by 14 % at 4 months ( controls 2 % , P = 0.025 ) and by 8 % at follow-up ( controls 3 % , P = 0.010 ) . Exercise barriers fell by 11 % at 4 months ( controls 3 % , P = 0.020 ) and 17 % ( controls 4 % , P = 0.002 ) at follow-up . Dietary self-efficacy improved by 3 % at 4 months ( controls -1 % , P = 0.003 ) and by 2 % at follow-up ( controls -1 % , P = 0.051 ) . Exercise self-efficacy increased by 8 % at 4 months ( controls 3 % , P Changes in cognitive variables predicted changes in health-related behaviors at 4 months and follow-up . A cognitively based lifestyle program in treated hypertensives is associated with improvements in cognitive measures in the shorter and longer term",
"PURPOSE : The present study evaluated the cross-section and prospect i ve associations between the Eating Inventory 's ( EI ) total , flexible and rigid dietary restraint scales and changes in weight and behaviors in a community sample of adults enrolled in a 3 y weight gain prevention study . METHODS : Subjects were participants in the Pound of Prevention ( POP ) study , a community-based weight gain prevention trial . RESULTS : Higher levels of baseline total , flexible and rigid dietary restraint were related to lower weight and more weight-controlling behaviors at the baseline assessment . Baseline restraint measures positively predicted increases in weighing frequency over the 3 y follow-up . Increases in restraint over the follow-up period were related to decreases in weight , energy intake and television watching , and increases in self-weighing and physical activity . CONCLUSION : The EI 's total , flexible and rigid restraint scales were not differently associated with weight and behaviors in this heterogeneous sample of adults who were attempting to lose weight . Developing methods to increase behavioral and cognitive strategies to control weight may help to prevent weight gain in clinical and community sample s . International Journal of Obesity ( 2001 ) 25 ,",
"BACKGROUND The associations among people 's level of autonomy in regulating their eating behaviors , food patterns , and degree of obesity have not been investigated in a general adult population . OBJECTIVES Our objectives were to cross-sectionally examine , in a nationally representative sample of adult New Zeal and women , the associations between different styles of eating behavior regulation and body mass index ( BMI ) , with specific food and eating habits as hypothesized mediators . DESIGN During May 2009 , a sample of 2,500 New Zeal and women aged 40 to 50 years was r and omly selected from the nationwide electoral rolls . A 66 % ( n=1,601 ) participation rate was achieved . Potential participants were mailed a self-administered question naire containing the Regulation of Eating Behavior scale , questions on specific food and eating habits ( frequency of binge eating , speed of eating , usual daily servings of fruits and vegetables , usual frequency of intake of several high-fat and /or high-sugar foods ) , and height and weight . STATISTICAL ANALYSES Univariate linear regression models were used to examine the associations among demographic , health and behavioral variables , and BMI . Multivariate linear regression models were developed to investigate the relationships between autonomous and controlled forms of eating behavior regulation and BMI , with specific food and eating habits as mediators . RESULTS After adjusting for potential confounders as well as specific food and eating habits that were potential mediators , BMI was statistically significantly lower by 2 % ( 95 % CI -2.7 % to -1.4 % ; P autonomous regulation and BMI as well as controlled regulation and BMI were only partially mediated by the specific food and eating habits measured . CONCLUSIONS Although the direction of causality requires confirmation , the results provide support for the applicability of Self-Determination Theory , and suggest that developing more autonomous motivation for eating behavior is likely to facilitate healthier food habits and lower BMI in middle-aged women",
"Assessment of habitual physical activity in epidemiologic and health education studies has been difficult . A seven-day physical activity recall interview was developed and administered in a community health survey , a r and omized clinical trial , and two worksite health promotion programs during 1979 - 1982 . These studies were conducted in several population s in California , Texas , Pennsylvania , and New Jersey . Energy expenditure estimates from the physical activity recall conformed to expected age- and sex-specific values in the cross-sectional community survey . Estimates of energy expenditure were also congruent with other questions on physical activity and job classification . In a r and omized , one-year exercise trial , the physical activity recall detected increases in energy expenditure in the treated group and was positively associated with miles run during training ( p less than 0.05 ) . Changes in energy expenditure were associated with changes in maximal oxygen uptake ( VO2max ( r = 0.33 , p less than 0.05 ) and body fatness ( r = -0.50 , p less than 0.01 ) at six months , and in high density lipoprotein-cholesterol ( r = 0.31 , p less than 0.05 ) and triglyceride ( r = -0.41 , p less than 0.01 ) at one year . The physical activity recall detected significant ( p less than 0.01 ) increases in energy expenditure in treatment groups in two worksite health promotion projects . These data suggest that the physical activity recall provides useful estimates of habitual physical activity for research in epidemiologic and health education studies",
"BACKGROUND Behavioral interventions for weight-loss have been largely unsuccessful . Exercise is the strongest predictor of maintained weight loss and much of its effects may be from associated changes in psychosocial factors . METHODS Middle-aged , formerly sedentary adults with severe obesity were r and omly selected to 6-month treatments of cognitive-behavioral exercise support paired with either st and ard nutrition education ( n = 99 ) or nutrition change supported by cognitive-behavioral means with an emphasis on self-regulation ( n = 101 ) . RESULTS Overall improvements in self-efficacy and self-regulation for both exercise and managed eating , and mood , were found , with significantly greater improvements associated with the cognitive-behavioral nutrition condition in self-regulation for eating and mood . Change scores trended toward being stronger predictors of increased exercise and fruit and vegetable intake than scores at treatment end . Multiple regression analyses indicated that significant portions of the variance in both increased volume of exercise ( R2 = 0.45 ) and fruit and vegetable intake ( R2 = 0.21 ) were explained by changes in self-regulatory skill usage , self-efficacy , and mood . CONCLUSIONS Cognitive-behavioral methods for improved eating paired with behavioral support of exercise may improve weight loss through effects on the psychosocial factors of self-regulation , self-efficacy , and overall mood more than when st and ard nutrition education is incorporated",
"BACKGROUND Physical activity is a predictor of maintained weight loss ; however , causal mechanisms are unclear . Behavioral theories suggest that associated psychologic changes may indirectly affect weight loss . OBJECTIVE We sought to test the association of a behaviorally based exercise support protocol ( The Coach Approach [ CA ] ) , with and without a group-based nutrition education program ( Cultivating Health ) , with adherence to exercise and changes in physiologic and psychologic factors , and to assess theory-based paths to weight and body-fat changes . SETTING The study took place in YMCA wellness centers . STUDY SUBJECTS Study participation was open to formerly sedentary obese women . DESIGN Study participants were r and omly assigned to the CA Only ( CA ; n = 81 ) , The CA Plus Cultivating Health ( CA/CH ; n = 128 ) , or the control ( n = 64 ) group . We contrasted dropout and attendance rates and changes in self-efficacy ( SE ) , physical self-concept ( PSC ) , total mood disturbance ( TMD ) , body areas satisfaction ( BAS ) , and select physiologic factors during a six-month period . We also analyzed proposed paths to weight loss . RESULTS The CA and CA/CH groups had significantly lower exercise dropout rates ( χ(2 ) = 44.67 , p higher attendance rates ( F = 10.02 ; p . Improvements in body fat , body mass index ( BMI ) , and waist circumference were significant for only the CA and CA/CH groups . Significant improvements in TMD , PSC , and BAS scores were found for all groups , with effect sizes greater in the groups incorporating the CA protocol . Within the five paths assessed , entry of changes in TMD and BAS scores into multiple-regression equations , along with SE and PSC scores , increased the explained variance in exercise session attendance from 5 % ( p = 0.01 ) to 16 % ( p ) . Exercise session attendance was significantly associated with changes in body fat ( r = -0.41 ; p and BMI ( r = -0.46 ; p CONCLUSION Counseling based on social cognitive and self-efficacy theory may increase exercise adherence and improve variables indirectly related to weight and body-fat reductions . Although decreases in body fat and BMI were obtained , they appeared less pronounced than psychologic improvements . Additional research on interrelations of physical activity , psychologic factors , and weight change is warranted for development of obesity treatments",
"This prospect i ve study tested whether ( a ) baseline outcome expectations regarding the benefits of a weight-loss diet , ( b ) 6-month outcome realizations regarding perceived benefits actually experienced , and /or ( c ) the interaction between them predicted 6 - 12-month weight regain among overweight/obese women r and omized to one of four popular weight-loss diets ( N=311 ) . Positive 6-month realizations regarding improvements in physical shape and appearance predicted less 6 - 12-month weight regain among Atkins diet participants only ( n=70 ) , controlling for baseline expectations , the expectations-realization interaction , and initial weight loss . Atkins participants displayed three distinct patterns of regain based on levels of 6-month realizations and initial weight loss . Experimental research should investigate whether improving realizations leads to reduced weight regain in response to this popular diet",
"We aim ed to examine moderators and mediators of behaviour change in a cognitive lifestyle program for drug-treated overweight hypertensives in Perth , Australia . We collected data at baseline , 4 months ( post-intervention ) and 1-year follow-up in a r and omized controlled trial of a program that focused on weight loss , diet , and exercise . Mediation analysis used regression models that estimate indirect effects with bootstrapped confidence limits . Outcomes examined were saturated fat intake ( % energy ) and physical activity ( hours per week ) . In total , 90/118 individuals r and omized to usual care and 102/123 to the program-completed follow-up . Sex was a moderator of response post-intervention for diet and physical activity , with a greater response among women with usual care and among men with the program . Change in self-efficacy was a mediator of dietary change post-intervention [ effect size ( ES ) -0.055 , 95 % confidence interval ( CI ) -0.125 , -0.005 ] and at follow-up ( ES 0.054 , 95 % CI -0.127 , -0.005 ) , and in physical activity post-intervention ( ES 0.059 , 95 % CI 0.003 , 0.147 ) . These findings highlight different responses of men and women to the program , and the importance of self-efficacy as a mediator . Mediators for physical activity in the longer term should be investigated in other models , with appropriate cognitive measurements , in future trials",
"BACKGROUND Declining physical activity is associated with a rising burden of global disease . Efforts to reverse this trend have not been successful . We aim ed to assess the efficacy of a facilitated behavioural intervention to increase the physical activity of sedentary individuals at familial risk of diabetes . METHODS We enrolled 365 sedentary adults who had a parental history of type 2 diabetes . They were recruited from either diabetes or family history registers at 20 general practice clinics in the UK . Eligible participants were r and omly assigned to one of two intervention groups , or to a comparison group . All participants were posted a brief advice leaflet . One intervention group was offered a 1-year behaviour-change programme , to be delivered by trained facilitators in participants ' homes , and the other the same programme by telephone . The programme was design ed to alter behavioural determinants , as defined by the theory of planned behaviour , and to teach behaviour-change strategies . The principal outcome at 1 year was daytime physical activity , which was objective ly measured as a ratio to resting energy expenditure . Analysis was by intention to treat . This study is registered as IS RCT N61323766 . FINDINGS Of 365 patients , we analysed primary endpoints for 321 ( 88 % ) for whom we had data after 1 year of follow-up . At 1 year , the physical-activity ratio of participants who received the intervention , by either delivery route , did not differ from the ratio in those who were given a brief advice leaflet . The mean difference in daytime physical-activity ratio , adjusted for baseline , was -0.04 ( 95 % CI -0.16 to 0.08 ) . The physical-activity ratio did not differ between participants who were delivered the intervention face-to-face or by telephone ( mean difference -0.05 ; 95 % CI -0.19 to 0.10 ) . INTERPRETATION A facilitated theory-based behavioural intervention was no more effective than an advice leaflet for promotion of physical activity in an at-risk group ; therefore health-care providers should remain cautious about commissioning behavioural programmes into individual preventive health-care services",
"As maintenance of lifestyle change and risk factor modification following completion of cardiac rehabilitation has been shown to be notoriously difficult , we developed a brief self-regulation lifestyle program for post-cardiac rehabilitation patients . R and omized-controlled trial . Following completion of cardiac rehabilitation 210 patients were r and omized to receive either a lifestyle maintenance program ( n = 112 ) or st and ard care ( n = 98 ) . The program was based on self-regulation principles and consisted of a motivational interview , 7 group sessions and home assignments . Risk factors and health behaviors were assessed at baseline ( end of cardiac rehabilitation ) , and 6 and 15 months thereafter . ANCOVAs showed a significant effect of the lifestyle program on exercise behavior at 15-month follow-up . Mediation analysis demonstrated that the treatment effect on exercise behavior could be explained by self-regulation skills . Chi squared tests showed that patients in the intervention group had significantly fewer uncontrolled risk factors as compared to the control group . Finally , the lifestyle intervention program was associated with a 12 % reduction in self-reported cardiac hospital admission rates . This trial indicates that a relatively brief , theory-based lifestyle program is capable of inciting and maintaining improvements in exercise adherence . It is suggested that patients may need ongoing attention and guidance , for example in the form of ( internet-based ) booster sessions , as long-term consolidation of changes is arduous",
"Effective and reliable obesity treatments are lacking because of a poor underst and ing of the health behavior change process . Community-based organizations with the capacity to train existing staff members are particularly well-positioned to implement evidence -based treatment protocol s to impact obesity-related behaviors such as unhealthy eating and lack of physical activity . The aim of this study was to assess temporal aspects of psychosocial predictors ( self-regulation , mood , and self-efficacy ) on increased fruit and vegetable intake in adults with severe obesity , while also accounting for mediation by physical activity volume . A 6-month , r and omized field investigation was conducted . Severely obese adults volunteered for behavioral support of physical activity coupled with nutrition education ( n = 73 ) or cognitive-behavioral methods for nutrition change ( n = 71 ) . Improvements in self-regulation , mood , self-efficacy , fruit and vegetable intake ( FV ) , and physical activity ( PA ) were significant , with significantly greater self-regulation at month 6 for the cognitive-behavioral group . Increase in FV was predicted by changes in the above psychosocial variables over 6 months , with mood change over 3 months also a significant predictor . Change in PA mediated the above relationships , with a reciprocal effect between changes in PA and FV . Findings have implication s for the large-scale behavioral treatment of obesity",
"Background : Although exercise is related to weight loss , minimal energy expenditures typical in deconditioned persons explain only small portions of this reduction . Thus , it has been suggested that exercise-induced changes in psychological variables associated with appropriate eating may be mediators . Methods : Adults with obesity ( N = 106 ; Mean BMI = 42.0 ; SD = 6.0 kg/m2 ) , volunteering for a cognitive-behavioral exercise support program and group nutrition information , were assessed on overall mood , self-efficacy for controlled eating , self-regulation skills usage for appropriate eating , recalled volume of physical activity , body mass index ( BMI ) , and waist circumference at baseline and at month six . Results : All within-subject changes were significant ( P volumes of physical activity were significantly related to BMI ( & bgr ; = -0.52 ) and waist circumference ( & bgr ; = −0.63 ) changes . These relationships were partially mediated by changes in self-efficacy and self-regulation scores . Mediation of mood changes did not , however , reach statistical significance . Conclusion : In severely obese persons initiating behaviorally supported exercise , weight loss may be better accounted for by changes in psychological predictors of improved eating such as self-efficacy and self-regulation than by direct energy expenditure . Implication s for weight loss theory development and clinical applications were discussed",
"OBJECTIVES Poor adherence to regular exercise is a documented challenge among people with heart disease . Identifying key determinants of exercise adherence and distinguishing between the processes driving short- and long-term adherence to regular exercise is a valuable endeavor . The purpose of the present study was to test a model of exercise behavior change , which incorporates motivational orientations and self-efficacy for exercise behavior , in the prediction of short- and long-term exercise adherence . METHOD Male and female patients ( N = 801 ) hospitalized for coronary heart disease were recruited from 3 tertiary care cardiac centers and followed for a period of 1 year after hospital discharge . A prospect i ve , longitudinal design was used to examine the roles of motivation and self-efficacy ( measured at recruitment and at 2 and 6 months after discharge ) in the prediction of exercise behavior at 6 and 12 months . Baseline measures of exercise and clinical and demographic covariates were included in the analyses . RESULTS Structural equation modeling showed that both autonomous motivation and self-efficacy were important determinants of short-term ( 6-month ) exercise behavior regulation , but that only autonomous motivation remained a significant predictor of long-term ( 12-month ) exercise behavior . Self-efficacy partially mediated the relationship between motivation for exercise and 6-month exercise behavior . CONCLUSIONS This research confirmed the roles of autonomous motivation and self-efficacy in the health behavior change process and emphasized the key function of autonomous motivation in exercise maintenance . Theoretical and cardiac rehabilitation program applications of this research are discussed",
"Despite considerable clinical interest , attempts to link perceived self-efficacy with successful weight control have had mixed success . Definitive data on prospect i ve associations between self-efficacy and weight loss are particularly sparse . This study examined relationships between self-efficacy beliefs , weight control behaviors , and weight change among individuals participating in a weight loss trial ( N = 349 , 87 % women ) . Cross-sectionally , eating and exercise self-efficacy beliefs were strongly associated with corresponding weight loss behaviors . Self-efficacy beliefs prospect ively predicted weight control behavior and weight change during active treatment but not during follow-up . Mediational models indicate that people 's weight control behaviors mediate the impact of self-efficacy on weight change"
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41170e56-06ff-11f0-808a-c43d1ab1c353
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Purpose To develop an evidence -based guideline for the management of grade s I – III neck pain and associated disorders ( NAD ) . Methods This guideline is based on recent systematic review s of high- quality studies . A multidisciplinary expert panel considered the evidence of effectiveness , safety , cost-effectiveness , societal and ethical values , and patient experiences ( obtained from qualitative research ) when formulating recommendations . Target audience includes clinicians ; target population is adults with grade s I – III NAD Recommendation 1Clinicians should rule out major structural or other pathologies as the cause of NAD . Once major pathology has been ruled out , clinicians should classify NAD as grade I , II , or III . Recommendation 2Clinicians should assess prognostic factors for delayed recovery from NAD . Recommendation 3Clinicians should educate and reassure patients about the benign and self-limited nature of the typical course of NAD grade s I – III and the importance of maintaining activity and movement . Patients with worsening symptoms and those who develop new physical or psychological symptoms should be referred to a physician for further evaluation at any time during their care . Recommendation 4For NAD grade s I – II ≤3 months duration , clinicians may consider structured patient education in combination with : range of motion exercise , multimodal care ( range of motion exercise with manipulation or mobilization ) , or muscle relaxants . In view of evidence of no effectiveness , clinicians should not offer structured patient education alone , strain-counterstrain therapy , relaxation massage , cervical collar , electroacupuncture , electrotherapy , or clinic-based heat . Recommendation 5For NAD grade s I – II > 3 months duration , clinicians may consider structured patient education in combination with : range of motion and strengthening exercises , qigong , yoga , multimodal care ( exercise with manipulation or mobilization ) , clinical massage , low-level laser therapy , or non-steroidal anti-inflammatory drugs . In view of evidence of no effectiveness , clinicians should not offer strengthening exercises alone , strain-counterstrain therapy , relaxation massage , relaxation therapy for pain or disability , electrotherapy , shortwave diathermy , clinic-based heat , electroacupuncture , or botulinum toxin injections . Recommendation 6For NAD grade III ≤3 months duration , clinicians may consider supervised strengthening exercises in addition to structured patient education . In view of evidence of no effectiveness , clinicians should not offer structured patient education alone , cervical collar , low-level laser therapy , or traction . Recommendation 7For NAD grade III > 3 months duration , clinicians should not offer a cervical collar . Patients who continue to experience neurological signs and disability more than 3 months after injury should be referred to a physician for investigation and management . Recommendation 8Clinicians should reassess the patient at every visit to determine if additional care is necessary , the condition is worsening , or the patient has recovered . Patients reporting significant recovery should be discharged
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"Abstract Whiplash‐associated disorders are common and incur considerable expense in social and economic terms . There are no known effective treatments for those people whose pain and disability persist beyond 3 months . We conducted a r and omized , assessor‐blinded , controlled trial at two centres in Australia . All participants received 3 advice sessions . In addition the experimental group participated in 12 exercise sessions over 6 weeks . Primary outcomes were pain intensity , pain bothersomeness and function measured at 6 weeks and 12 months . Exercise and advice was more effective than advice alone at 6 weeks for all primary outcomes but not at 12 months . The effect of exercise on the 0–10 pain intensity scale was −1.1 ( 95%CI −1.8 to −0.3 , p = 0.005 ) at 6 weeks and −0.2 ( 0.6 to −1.0 , p = 0.59 ) at 12 months ; on the bothersomeness scale the effect was −1.0 ( −1.9 to −0.2 , p = 0.003 ) at 6 weeks and 0.3 ( −0.6 to 1.3 , p = 0.48 ) at 12 months . The effect on function was 0.9 ( 0.3 to 1.6 , p = 0.006 ) at 6 weeks and 0.6 ( −0.1 to 1.4 , p = 0.10 ) at 12 months . High levels of baseline pain intensity were associated with greater treatment effects at 6 weeks and high levels of baseline disability were associated with greater treatment effects at 12 months . In the short‐term exercise and advice is slightly more effective than advice alone for people with persisting pain and disability following whiplash . Exercise is more effective for subjects with higher baseline pain and disability",
"Abstract Objectives Firstly , to compare the effectiveness of a brief physiotherapy intervention with “ usual ” physiotherapy for patients with neck pain . Secondly , to evaluate the effect of patients ' preferences on outcome . Design Non-inferiority r and omised controlled trial eliciting preferences independently of r and omisation . Setting Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire . Participants 268 patients ( mean age 48 years ) with subacute and chronic neck pain , who were referred by their general practitioner and r and omly assigned to a brief physiotherapy intervention ( one to three sessions ) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy , at the discretion of the physiotherapist concerned . Main outcome measures The Northwick Park neck pain question naire ( NPQ ) , a specific measure of functional disability result ing from neck pain . Also , the short form 36 ( SF-36 ) question naire , a generic , health related , quality of life measure ; and the Tampa scale for kinesophobia , a measure of fear and avoidance of movement . Results At 12 months , patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group ( mean difference 1.99 , 95 % confidence interval 0.45 to 3.52 ; P = 0.01 ) . Although the result shows a significant inferiority of the intervention , the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention ( below 1.2 points of NPQ score ) . Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy . Conclusions Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain . Patients with a preference for the brief intervention may do at least as well with this approach . Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further",
"To evaluate the effectiveness of isometric exercises as compared to general exercises in chronic non-specific neck pain . For this r and omised controlled trial total 68 patients ( 34 each group ) with chronic non-specific neck pain were recruited from Alain Poly Clinic and Institute of Physical Medicine & Rehabilitation Dow University of Health Sciences , Karachi between May , 2012 and August , 2012 . Simple r and omisation method was used to assign participants into isometric exercise group and general exercise groups . The isometric exercise group performed exercises for neck muscle groups with a rubber b and and general exercises group performed active range of movement exercises for all neck movements . Patients in both groups received 3 supervised treatment sessions per week for 12 weeks . Visual Analogue Scale ( VAS ) , North wick Park Neck Pain Question naire and goniometer were used to assess pain , disability and neck range of movements at baseline and after 12 weeks . Both interventions showed statistically significant improvements in pain , function and range of movement p = 0.001f or isometric exercise group , p = 0.04 for general exercises group and p = 0.001 for range of movement . However , mean improvements in post intervention VAS score and North wick Park Neck Pain Question naire score was better in isometric exercises group as compared to general exercise group . In conclusion , both interventions are effective in the treatment of chronic non-specific neck pain however ; isometric exercises are clinical ly more effective than general exercises ",
"Study Design . A single‐blinded , r and omized treatment study with a follow‐up period of 6 months . Objective . To study the long‐term consequences of whiplash neck sprain injuries in patients treated with two different regimes during the first 14 days after the car accident . Patients in the first group were encouraged to act as usual , i.e. , continue to engage in their normal , pre‐injury activities ; that group was compared with another group of patients who were given time off from work and who were immobilized using a soft neck collar . The end point of the comparison was the evaluation of subjective symptoms 6 months after the accident . Summary of Background Data . Few r and omized treatment studies have been performed to evaluate the clinical outcome for patients with neck sprain . Method . Patients who participated in the study were recruited from the Emergency Clinic at the University Hospital in Trondheim , Norway . The study group included 201 patients ( 47 % of the study group ) with neck sprain that result ed from a car accident . Neck and shoulder movements and subjective symptoms , which were assessed using several different measurements , were assessed during the follow‐up period . Results . There was a significant reduction of symptoms from the time of intake to 24 weeks after the treatment period in both groups . There was a significantly better outcome for the act‐as‐usual group in terms of subjective symptoms , including pain localization , pain during daily activities , neck stiffness , memory , and concentration , and in terms of visual analog scale measurements of neck pain and headache . Conclusions . The outcome was better for patients who were encouraged to continue engaging in their normal , pre‐injury activities as usual than for patients who took sick leave from work and who were immobilized during the first 14 days after the neck sprain injury",
"Background : To date , optimal strategies for the management of patients with cervical radiculopathy remain elusive . Preliminary evidence suggests that a multimodal treatment program consisting of manual therapy , exercise , and cervical traction may result in positive outcomes for patients with cervical radiculopathy . However , limited evidence exists to support the use of mechanical cervical traction in patients with cervical radiculopathy . Objective : The purpose of this study was to examine the effects of manual therapy and exercise , with or without the addition of cervical traction , on pain , function , and disability in patients with cervical radiculopathy . Design : This study was a multicenter r and omized clinical trial . Setting : The study was conducted in orthopedic physical therapy clinics . Patients : Patients diagnosed with cervical radiculopathy ( N=81 ) were r and omly assigned to 1 of 2 groups : a group that received manual therapy , exercise , and intermittent cervical traction ( MT EXTraction group ) and a group that received manual therapy , exercise , and sham intermittent cervical traction ( MTEX group ) . Intervention : Patients were treated , on average , 2 times per week for an average of 4.2 weeks . Measurements : Outcome measurements were collected at baseline and at 2 weeks and 4 weeks using the Numeric Pain Rating Scale ( NPRS ) , the Patient-Specific Functional Scale ( PSFS ) , and the Neck Disability Index ( NDI ) . Results : There were no significant differences between the groups for any of the primary or secondary outcome measures at 2 weeks or 4 weeks . The effect size between groups for each of the primary outcomes was small ( NDI=1.5 , 95 % confidence interval [CI]=−6.8 to 3.8 ; PSFS=0.29 , 95 % CI=−1.8 to 1.2 ; and NPRS=0.52 , 95 % CI=−1.8 to 1.2 ) . Limitations : The use of a nonvali date d clinical prediction rule to diagnose cervical radiculopathy and the lack of a control group without treatment were limitations of this study . Conclusions : The results suggest that the addition of mechanical cervical traction to a multimodal treatment program of manual therapy and exercise yields no significant additional benefit to pain , function , or disability in patients with cervical radiculopathy",
"Objectives The authors ' goals were to compare the effectiveness of manual therapy ( MT ; mainly spinal mobilization ) , physical therapy ( PT ; mainly exercise therapy ) , and continued care by the general practitioner ( GP ; analgesics , counseling and education ) over a period of 1 year . Methods One hundred eighty-three patients suffering for at least 2 weeks from nonspecific neck pain were r and omized to receive a 6-week treatment strategy of MT once a week , PT twice a week , or GP care once every 2 weeks . The primary outcome measures were perceived recovery , severity of physical dysfunctioning , pain intensity , and functional disability . Results The differences between groups considered over 1 year were statistically significant ( repeated measurements analyses P Neck Disability Index ( P=0.06 ) . Higher improvement scores were observed for MT for all outcomes , followed by PT and GP care . The success rate , based on perceived recovery after 13 weeks , was 72 % for MT , which was significantly higher than the success rate for continued GP care ( 42 % , P=0.001 ) but not significantly higher compared with PT treatment ( 59 % , P=0.16 ) . The difference between PT and GP approached statistical significance ( P=0.06 ) . After 1 year the success rates were 75 % , 63 % , and 56 % , respectively , and no longer significantly different . Conclusions Short-term results ( at 7 weeks ) have shown that MT speeded recovery compared with GP care and , to a lesser extent , also compared with PT . In the long-term , GP treatment and PT caught up with MT , and differences between the three treatment groups decreased and lost statistical significance at the 13-week and 52-week follow-up",
"Study Design . R and omized clinical trial . Objective . To compare the effectiveness of education and advice given by general practitioners ( GPs ) with education , advice , and active exercise therapy given by physiotherapists ( PTs ) for patients with whiplash-associated disorders . Summary of Background Data . Available evidence from systematic review s has indicated beneficial effects for active interventions in patients with whiplash-associated disorders . However , it remained unclear which kind of active treatment was most effective . Methods . Whiplash patients with symptoms or disabilities at 2 weeks after accident were recruited in primary care . Eligible patients still having symptoms or disabilities at 4 weeks were r and omly allocated to GP care or physiotherapy . GPs and PTs treated patients according to a dynamic multimodal treatment protocol primarily aim ed to increase activities and influence unfavorable psychosocial factors for recovery . We trained all health care providers about the characteristics of the whiplash problem , available evidence regarding prognosis and treatment , and protocol of the interventions . The content of the information provided to patients during treatment depended on the treatment goals set by the GPs or PTs . Also , the type of exercises chosen by the PTs depended on the treatment goals , and it was not explicitly necessary that exercise therapy was provided in all patients . Primary outcome measures included neck pain intensity , headache intensity , and work activities . Furthermore , an independent blinded assessor measured functional recovery , cervical range of motion , disability , housekeeping and social activities , fear of movement , coping , and general health status . We assessed outcomes at 8 , 12 , 26 , and 52 weeks after the accident . Results . A total of 80 patients were r and omized to either GP care ( n = 42 ) or physiotherapy ( n = 38 ) . At 12 and 52 weeks , no significant differences were found concerning the primary outcome measures . At 12 weeks , physiotherapy was significantly more effective than GP care for improving 1 of the measures of cervical range of motion ( adjusted mean difference 12.3 ° ; 95 % confidence interval [ CI ] 2.7–21.9 ) . Long-term differences between the groups favored GP care but were statistically significant only for some secondary outcome measures , including functional recovery ( adjusted relative risk 2.3 ; 95 % CI 1.0–5.0 ) , coping ( adjusted mean difference 1.7 points ; 95 % CI 0.2–3.3 ) , and physical functioning ( adjusted mean difference 8.9 points ; 95 % CI 0.6–17.2 ) . Conclusions . We found no significant differences for the primary outcome measures . Treatment by GPs and PTs were of similar effectiveness . The long-term effects of GP care seem to be better compared to physiotherapy for functional recovery , coping , and physical functioning . Physiotherapy seems to be more effective than GP care on cervical range of motion at short-term follow-up",
"CONTEXT High levels of variation and inefficiency exist in current clinical practice regarding use of cervical spine ( C-spine ) radiography in alert and stable trauma patients . OBJECTIVE To derive a clinical decision rule that is highly sensitive for detecting acute C-spine injury and will allow emergency department ( ED ) physicians to be more selective in use of radiography in alert and stable trauma patients . DESIGN Prospect i ve cohort study conducted from October 1996 to April 1999 , in which physicians evaluated patients for 20 st and ardized clinical findings prior to radiography . In some cases , a second physician performed independent interobserver assessment s. SETTING Ten EDs in large Canadian community and university hospitals . PATIENTS Convenience sample of 8924 adults ( mean age , 37 years ) who presented to the ED with blunt trauma to the head/neck , stable vital signs , and a Glasgow Coma Scale score of 15 . MAIN OUTCOME MEASURE Clinical ly important C-spine injury , evaluated by plain radiography , computed tomography , and a structured follow-up telephone interview . The clinical decision rule was derived using the kappa coefficient , logistic regression analysis , and chi(2 ) recursive partitioning techniques . RESULTS Among the study sample , 151 ( 1.7 % ) had important C-spine injury . The result ant model and final Canadian C-Spine Rule comprises 3 main questions : ( 1 ) is there any high-risk factor present that m and ates radiography ( ie , age > /=65 years , dangerous mechanism , or paresthesias in extremities ) ? ( 2 ) is there any low-risk factor present that allows safe assessment of range of motion ( ie , simple rear-end motor vehicle collision , sitting position in ED , ambulatory at any time since injury , delayed onset of neck pain , or absence of midline C-spine tenderness ) ? and ( 3 ) is the patient able to actively rotate neck 45 degrees to the left and right ? By cross-validation , this rule had 100 % sensitivity ( 95 % confidence interval [ CI ] , 98%-100 % ) and 42.5 % specificity ( 95 % CI , 40%-44 % ) for identifying 151 clinical ly important C-spine injuries . The potential radiography ordering rate would be 58.2 % . CONCLUSION We have derived the Canadian C-Spine Rule , a highly sensitive decision rule for use of C-spine radiography in alert and stable trauma patients . If prospect ively vali date d in other cohorts , this rule has the potential to significantly reduce practice variation and inefficiency in ED use of C-spine radiography",
"Objective : To compare the effectiveness of a 12-month home-based combined strength training and stretching programme against stretching alone in the treatment of chronic neck pain . Design : A r and omized follow-up study . Participants : One hundred and one patients with chronic non-specific neck pain were r and omized in two groups . Intervention : The strength training and stretching group was supported by 10 group training sessions and the stretching group was instructed to perform stretching exercises only as instructed in one group session . Main outcome measurements : Neck pain , disability , neck muscle strength and mobility of cervical spine were measured before and after the intervention . Results : No significant differences in improvement in neck pain and disability were found between the two training groups . Mean ( SD ) pain decreased from 64 ( 17 ) mm by 37 ( 95 % confidence interval ( CI ) 44 to 30 ) mm in the strength training and stretching group , and from 60 ( 17 ) mm by 32 ( 39 to 25 ) mm in the stretching group . The improvements in disability were significant in both groups ( P changes in neck strength and mobility were minor . Training adherence decreased over time from the targeted three sessions a week , ending up at 1.1 ( 0.7 ) times a week for strength training and stretching group and 1.4 ( 0.8 ) times a week for stretching group . Conclusions : No statistically significant differences in neck pain and disability were observed between the two home-based training regimens . Combined strength training and stretching or stretching only were probably as effective in achieving a long-term improvement although the training adherence was rather low most of the time",
"BACKGROUND Evidence suggests that brief physiotherapy programmes are as effective for acute whiplash-associated disorders as more comprehensive programmes ; however , whether this also holds true for chronic whiplash-associated disorders is unknown . We aim ed to estimate the effectiveness of a comprehensive exercise programme delivered by physiotherapists compared with advice in people with a chronic whiplash-associated disorder . METHODS PROMISE is a two group , pragmatic r and omised controlled trial in patients with chronic ( > 3 months and to receive either the comprehensive exercise programme ( 20 sessions ) or advice ( one session and telephone support ) . Sealed opaque envelopes were used to conceal allocation . The primary outcome was pain intensity measured on a 0 - 10 scale . Outcomes were measured at baseline , 14 weeks , 6 months , and 12 months by a masked assessor . Analysis was by intention to treat , and treatment effects were calculated with linear mixed models . The trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12609000825257 . FINDINGS 172 participants were allocated to either the comprehensive exercise programme ( n=86 ) or advice group ( n=86 ) ; 157 ( 91 % ) were followed up at 14 weeks , 145 ( 84 % ) at 6 months , and 150 ( 87 % ) at 12 months . A comprehensive exercise programme was not more effective than advice alone for pain reduction in the participants . At 14 weeks the treatment effect on a 0 - 10 pain scale was 0·0 ( 95 % CI -0·7 to 0·7 ) , at 6 months 0·2 ( -0·5 to 1·0 ) , and at 12 months -0·1 ( -0·8 to 0·6 ) . CNS hyperexcitability and symptoms of post-traumatic stress did not modify the effect of treatment . We recorded no serious adverse events . INTERPRETATION We have shown that simple advice is equally as effective as a more intense and comprehensive physiotherapy exercise programme . The need to identify effective and affordable strategies to prevent and treat acute through to chronic whiplash associated disorders is an important health priority . Future avenues of research might include improving underst and ing of the mechanisms responsible for persistent pain and disability , investigating the effectiveness and timing of drugs , and study of content and delivery of education and advice . FUNDING The National Health and Medical Research Council of Australia , Motor Accidents Authority of New South Wales , and Motor Accident Insurance Commission of Queensl and",
"We present a double-blind trial in which a pulsed infrared beam was compared with a placebo in the treatment of myofascial pain in the cervical region . The patients were su bmi tted to 12 sessions on alternate days to a total energy dose of 5 J each . At each session , the four most painful muscular trigger points and five bilateral homometameric acupuncture points were irradiated . Those in the placebo group su bmi tted to the same number of sessions following an identical procedure , the only difference being that the laser apparatus was nonoperational . Pain was monitored using the Italian version of the McGill pain question naire and the Scott-Huskisson visual analogue scale . The results show a pain attenuation in the treated group and a statistically significant difference between the two groups of patients , both at the end of therapy and at the 3-month follow-up examination",
"Study Design . R and omized control trial conducted between June 2000 and September 2002 . Objective . To determine whether a short psycho-educational video shown in the Emergency Department shortly after the injury would produce follow-up pain reductions and reduced medical utilization . Summary of Background Data . Chronic pain following a whiplash injury is one example of the massive medical/legal problem of chronic muscular pain . Approaches using local pain sources ( trigger points ) have shown promise as treatment models for this type of pain . Methods . 1 ) Setting : Emergency Departments ( ED ) and urgent care ( UC ) facilities . 2 ) Patients : 126 patients entering EDs or UCs . 3 ) Intervention : Patients assigned to 12-minute video or care as usual . 4 ) Main Outcome Measures : Short Form Musculoskelatal Function Assessment ( SMFA ) , phone question naires assessing : narcotics use , ER use , UC use , surgical consultations , etc . Results and Conclusions . Patients viewing the video had dramatically lower pain ratings at a 1-month follow ( 6.09 [ 10.6 ] vs. 21.23 [ 17.4 ] , P video group showed superior outcomes ( & khgr;2 ranged from 5 to 35 , P video patients were using narcotics at 6 month post ED visit compared with 36 % of controls . The brief psycho-educational video had a profound effect on subsequent pain and medical utilization",
"Abstract The aim of this study was to evaluate the short , medium and long – term effects of peripheral repetitive magnetic stimulation ( rMS ) on myofascial pain compared with transcutaneous electrical nerve stimulation (TENS).Fifty – three subjects with myofascial trigger points ( TPs ) at the level of the superior trapezius muscle were allocated r and omly to three groups . The first group ( n = 17 ) was treated with rMS , the second ( n = 18 ) with TENS and the third ( n = 18 ) received a placebo treatment . Each treatment consisted of ten daily 20–minute sessions . Patients were evaluated before and immediately following treatment , and at one and three months after the end of treatment . Outcome measures were : the “ neck pain and disability visual analogue scale ” ( NPDVAS ) , an algometric evaluation of pain , an evaluation of the TP characteristics , and the range of cervical bending and rotation contralateral to the affected trapezius muscle . At the end of treatment , the rMS group showed a significant improvement in the NPDVAS , algometry , TP characteristics , and cervical contralateral rotation . This improvement also persisted at one and three months post – therapy . After treatment , the TENS group showed significant improvement in the same outcome measures except for algometry . At the one month follow – up visit , this improvement had returned to non significant levels in all outcome measures with the exception of NPDVAS.No significant effect of TENS was seen at the three – month follow – up visit . The placebo group showed no significant improvement in any measure . Our results strongly suggest that at medium and longer term intervals peripheral rMS may be more effective than TENS for the treatment of myofascial pain",
"This study investigated effectiveness of manual therapy ( MT ) with transcutaneous electrical nerve stimulation ( TENS ) to reduce pain intensity in patients with mechanical neck disorder ( MND ) . A r and omized multi-centered controlled clinical trial was performed in 12 Primary Care Physiotherapy Units in Madrid Region . Ninety patients were included with diagnoses of subacute or chronic MND without neurological damage , 47 patients received MT and 43 TENS . The primary outcome was pain intensity measured in millimeters using the Visual Analogue Scale ( VAS ) . Also disability , quality of life , adverse effects and sociodemographic and prognosis variables were measured . Three evaluations were performed ( before , when the procedure finished and six months after ) . Seventy-one patients ( 79 % ) completed the follow-up measurement at six months . In more than half of the treated patients the procedure had a clinical ly relevant \" short term \" result after having ended the intervention , when either MT or TENS was used . The success rate decreased to one-third of the patients 6 months after the intervention . No differences can be found in the reduction of pain , in the decrease of disability nor in the quality of life between both therapies . Both analyzed physiotherapy techniques produce a short-term pain reduction that is clinical ly relevant",
"Study Design . R and omized clinical trial . Objective . To assess the effectiveness of manual physical therapy and exercise ( MTE ) for mechanical neck pain with or without unilateral upper extremity ( UE ) symptoms , as compared to a minimal intervention ( MIN ) approach . Summary of Background Data . Mounting evidence supports the use of manual therapy and exercise for mechanical neck pain , but no studies have directly assessed its effectiveness for UE symptoms . Methods . A total of 94 patients referred to 3 physical therapy clinics with a primary complaint of mechanical neck pain , with or without unilateral UE symptoms , were r and omized to receive MTE or a MIN approach of advice , motion exercise , and subtherapeutic ultrasound . Primary outcomes were the neck disability index , cervical and UE pain visual analog scales ( VAS ) , and patient-perceived global rating of change assessed at 3- , 6- , and 52-weeks . Secondary measures included treatment success rates and post-treatment healthcare utilization . Results . The MTE group demonstrated significantly larger reductions in short- and long-term neck disability index scores ( mean 1-year difference −5.1 , 95 % confidence intervals ( CI ) −8.1 to −2.1 ; P = 0.001 ) and short-term cervical VAS scores ( mean 6-week difference −14.2 , 95 % CI −22.7 to −5.6 ; P = 0.001 ) as compared to the MIN group . The MTE group also demonstrated significant within group reductions in short- and long-term UE VAS scores at all time periods ( mean 1-year difference −16.3 , 95 % CI −23.1 to −9.5 ; P = 0.000 ) . At 1-year , patient perceived treatment success was reported by 62 % ( 29 of 47 ) of the MTE group and 32 % ( 15 of 47 ) of the MIN group ( P = 0.004 ) . Conclusion . An impairment-based MTE program result ed in clinical ly and statistically significant short- and long-term improvements in pain , disability , and patient-perceived recovery in patients with mechanical neck pain when compared to a program comprising advice , a mobility exercise , and subtherapeutic ultrasound",
"Objective . To investigate the effect of workplace neck/shoulder strength training with and without regular supervision on neck/shoulder pain and headache among office workers . Method . A 20-week cluster r and omized controlled trial among 351 office workers was r and omized into three groups : two training groups with the same total amount of planned exercises three times per week ( 1 ) with supervision ( 3WS ) throughout the intervention period , ( 2 ) with minimal supervision ( 3MS ) only initially , and ( 3 ) a reference group ( REF ) . Main outcome is self-reported pain intensity in neck and shoulder ( scale 0–9 ) and headache ( scale 0–10 ) . Results . Intention-to-treat analyses showed a significant decrease in neck pain intensity the last 7 days in 3MS compared with REF : −0.5 ± 0.2 ( P 0.07 ) . Intensity of headache the last month decreased in both training groups : 3WS versus REF : −1.1 ± 0.2 ( P ( P 0.001 ) . Additionally , days of headache decreased 1.0 ± 0.5 in 3WS and 1.3 ± 0.5 in 3MS versus REF . There were no differences between the two training groups for any of the variables . Conclusion . Neck/shoulder training at the workplace reduced neck pain and headache among office workers independently of the extent of supervision . This finding has important practical implication s for future workplace interventions",
"Study Design . R and omized , parallel-group trial . Objective . To compare the effect of 3 early intervention strategies following whiplash injury . Summary of Background Data . Long-lasting pain and disability , known as chronic whiplash-associated disorder ( WAD ) , may develop after a forced flexion-extension trauma to the cervical spine . It is unclear whether this , in some cases disabling , condition can be prevented by early intervention . Active interventions have been recommended but have not been compared with information only . Methods . Participants were recruited from emergency units and general practitioners within 10 days after a whiplash injury and r and omized to : 1 ) immobilization of the cervical spine in a rigid collar followed by active mobilization , 2 ) advice to “ act-as-usual , ” or 3 ) an active mobilization program ( Mechanical Diagnosis and Therapy ) . Follow-up was carried out after 3 , 6 , and 12 months postinjury . Treatment effect was measured in terms of headache and neck pain intensity ( 0–10 ) , disability , and work capability . Results . A total of 458 participants were included . At the 1-year follow-up , 48 % of participants reported considerable neck pain , 53 % disability , and 14 % were still sick listed at 1 year follow-up . No significant differences were observed between the 3 interventions group . Conclusion . Immobilization , “ act-as-usual , ” and mobilization had similar effects regarding prevention of pain , disability , and work capability 1 year after a whiplash injury",
"Summary Fear of movement plays and important role in individuals with subacute whiplash‐associated disorders and it should be directly targeted in treatment . ABSTRACT Fear and avoidance of activity may play a role in fostering disability in whiplash‐associated disorders ( WAD ) . This study examined the role of fear after WAD and assessed the effectiveness of 3 treatments targeting fear . People still symptomatic from WAD grade I‐II injuries approximately 3 months previously ( n = 191 ) completed question naires ( eg , Neck Disability Index [ NDI ] ) and were r and omized to 1 of the treatments : ( 1 ) informational booklet ( IB ) describing WAD and the importance of resuming activities , ( 2 ) IB + didactic discussion s ( DD ) with clinicians reinforcing the booklet , and ( 3 ) IB + imaginal and direct exposure desensitization ( ET ) to feared activities . DD and ET participants received three 2‐hour treatment sessions . Absolute improvements in NDI were in predicted direction ( ET = 14.7 , DD = 11.9 , IB = 9.9 ) . ETs reported significantly less posttreatment pain severity compared with the IB ( Mean = 1.5 vs 2.3 , P groups . Reduction in fear was the most important predictor of improvement in NDI ( β = 0.30 , P by reductions in pain ( β = 0.20 , P = .003 ) and depression ( β = 0.18 , P = .004 ) . The mediational analysis confirmed that fear reduction significantly mediated the effect of treatment group on outcome . Results highlight the importance of fear in individuals with subacute WAD and suggest the importance of addressing fear via exposure therapy and /or educational interventions to improve function",
"Abstract Objective : To evaluate the cost effectiveness of physiotherapy , manual therapy , and care by a general practitioner for patients with neck pain . Design : Economic evaluation alongside a r and omised controlled trial . Setting : Primary care . Participants : 183 patients with neck pain for at least two weeks recruited by 42 general practitioners and r and omly allocated to manual therapy ( n=60 , spinal mobilisation ) , physiotherapy ( n=59 , mainly exercise ) , or general practitioner care ( n=64 , counselling , education , and drugs ) . Main outcome measures : Clinical outcomes were perceived recovery , intensity of pain , functional disability , and quality of life . Direct and indirect costs were measured by means of cost diaries that were kept by patients for one year . Differences in mean costs between groups , cost effectiveness , and cost utility ratios were evaluated by applying non-parametric bootstrapping techniques . Results : The manual therapy group showed a faster improvement than the physiotherapy group and the general practitioner care group up to 26 weeks , but differences were negligible by follow up at 52 weeks . The total costs of manual therapy ( € 447 ; £ 273 ; $ 402 ) were around one third of the costs of physiotherapy ( € 1297 ) and general practitioner care ( € 1379 ) . These differences were significant : P The cost effectiveness ratios and the cost utility ratios showed that manual therapy was less costly and more effective than physiotherapy or general practitioner care . Conclusions : Manual therapy ( spinal mobilisation ) is more effective and less costly for treating neck pain than physiotherapy or care by a general practitioner . What is already known on this topic The cost of treating neck pain is considerable Many conservative interventions are available , such as prescription drugs , yet their cost effectiveness has not been evaluated No r and omised trials of conservative treatment for neck pain have so far included an economic evaluation What this study adds Manual therapy is more effective and less costly than physiotherapy or care by a general practitioner for treating neck pain Patients undergoing manual therapy recovered more quickly than those undergoing the other",
"Background Back and neck pain are very common , disabling and recurrent disorders in the general population and the knowledge of long-term effect of treatments are sparse . The aim of this study was to compare the long-term effects ( up to one year ) of naprapathic manual therapy and evidence -based advice on staying active regarding non-specific back and /or neck pain . Naprapathy , a health profession mainly practice d in Sweden , Finl and , Norway and in the USA , is characterized by a combination of manual musculoskeletal manipulations , aim ing to decrease pain and disability in the neuromusculoskeletal system . Methods Subjects with non-specific pain/disability in the back and /or neck lasting for at least two weeks ( n = 409 ) , recruited at public companies in Sweden , were included in this pragmatic r and omized controlled trial . The two interventions compared were naprapathic manual therapy such as spinal manipulation/mobilization , massage and stretching , ( Index Group ) , and advice to stay active and on how to cope with pain , provided by a physician ( Control Group ) . Pain intensity , disability and health status were measured by question naires . Results 89 % completed the 26-week follow-up and 85 % the 52-week follow-up . A higher proportion in the Index Group had a clinical ly important decrease in pain ( risk difference ( RD ) = 21 % , 95 % CI : 10 - 30 ) and disability ( RD = 11 % , 95 % CI : 4 - 22 ) at 26-week , as well as at 52-week follow-ups ( pain : RD = 17 % , 95 % CI : 7 - 27 and disability : RD = 17 % , 95 % CI : 5 - 28 ) . The differences between the groups in pain and disability considered over one year were statistically significant favoring naprapathy ( p ≤ 0.005 ) . There were also significant differences in improvement in bodily pain and social function ( subscales of SF-36 health status ) favoring the Index Group . Conclusions Combined manual therapy , like naprapathy , is effective in the short and in the long term , and might be considered for patients with non-specific back and /or neck pain . Trial registration Current Controlled Trials IS RCT N56954776",
"UNLABELLED Studies regarding self-management of persistent neck pain are infrequent . OBJECTIVE to compare treatment effects of ( a ) a multi-component pain and stress self-management group intervention ( PASS ) and ( b ) individually administered physical therapy ( IAPT ) for patients with persistent musculoskeletal tension-type neck pain . METHODS Persons seeking physical therapy treatment due to persistent tension-type neck pain at nine primary health care centers in Sweden were r and omly assigned to either PASS or IAPT . Before treatment ( baseline ) and at 10- and 20-weeks the participants completed a self- assessment question naire comprising : the Self-Efficacy Scale , the Neck Disability Index , the Coping Strategies Question naire , the Hospital Anxiety and Depression Scale , the Fear-Avoidance Beliefs Question naire and questions regarding neck pain , analgesics and utilization of health care . Intention-to-treat analyses were performed using repeated measures analysis of variance between baseline , 10-week and 20-week follow-up . RESULTS One hundred and fifty six participants were included ( PASS n=77 , IAPT n=79 ) . On average participants receiving PASS attended seven treatment sessions and participants receiving IAPT 11 sessions over the 20-week follow-up period . Repeated measures ANCOVA showed significant time x group interaction effects for ability to control pain ( p self-efficacy regarding pain-interfering activities ( p=0.005 ) , disability due to neck pain ( p=0.001 ) and levels of catastrophic thinking ( p PASS had a better effect than IAPT in the treatment of persistent musculoskeletal tension-type neck pain regarding coping with pain , in terms of patients ' self-reported pain control , self-efficacy , disability and catastrophizing , over the 20-week follow-up",
"Study Design . A r and omized controlled trial with 3 and 6 months follow-up . Objective . To compare the effectiveness of acupuncture with simulated acupuncture in patients with subacute and chronic whiplash-associated disorders . Summary of Background Data . Acupuncture is widely used for the treatment of neck and other musculoskeletal pain , and there is some evidence supporting its effectiveness for short-term pain relief . The effectiveness of acupuncture in the treatment of whiplash-associated disorders is not clear . Methods . A total of 124 patients between 18 and 65 years with chronic ( 85 % ) or subacute whiplash-associated disorders ( Grade I or II ) were r and omly allocated to real or simulated electroacupuncture treatment for 12 sessions during a 6-week period . Both treatments involved skin penetration with acupuncture needles and were provided by a single university-trained acupuncturist in a University Clinic in Sydney , Australia . Primary outcome measures were pain intensity ( 10-cm visual analog scale ) , disability ( Neck Disability Index ) , and health-related quality of life ( SF-36 ) . Secondary outcomes were patient-specific activity scales , and the McGill Pain Rating Index . Results . Mean initial pain intensity for all participants was 5.6 cm . Participants receiving the real electroacupuncture treatment had significantly greater reduction in pain intensity at 3 and 6 months , 0.9 cm ( P = 0.05 ) and 1.3 cm ( P = 0.007 ) , respectively , in comparison to the sham electro-acupuncture group . After adjustment for baseline status , there was no significant reduction in disability , or improvement in health-related quality of life . There was an improvement in the activity scales of a similar size to the reduction in pain , but no difference in the McGill Index . Conclusion . Real electroacupuncture was associated with a significant reduction in pain intensity over at least 6 months . This reduction was probably not clinical ly significant . There was no improvement in disability or quality of life",
"& NA ; A clinical study tested the therapeutic efficacy of Botulinum toxin A ( BTXA ) when injected into symptomatic neck muscles after one injection session . Patients with chronic neck pain were r and omly assigned to receive either a high dose of an active treatment or an injection of the same volume of normal saline . Patients were compared for 4 months using a comprehensive set of outcome measures that included the Neck Pain and Disability Scale ( Spine 24 ( 1999 ) 1290 ) and pressure algometry ( Arch Phys Med Rehabil 67 ( 1986 ) 406 ; Pain 30 ( 1987 ) 115 ; Clin J Pain 2 ( 1987 ) 207 ) . Analyses were consistent in showing significant benefits from the injection session ; however , the effects were not specific to the group treated with BTXA . Both treatment and control groups showed a significant decline in pain and disability across time and an increased ability to withst and pressure on trigger points . The heavy incidence of adverse events in the treatment group may partly explain the absence of a treatment effect specific to BTXA . The results show that a single dose treatment without physical therapy is not effective for chronic neck pain",
"Abstract A r and omized , double‐blind , placebo‐controlled study of low‐level laser therapy ( LLLT ) in 90 subjects with chronic neck pain was conducted with the aim of determining the efficacy of 300 mW , 830 nm laser in the management of chronic neck pain . Subjects were r and omized to receive a course of 14 treatments over 7 weeks with either active or sham laser to tender areas in the neck . The primary outcome measure was change in a 10 cm Visual Analogue Scale ( VAS ) for pain . Secondary outcome measures included Short‐Form 36 Quality ‐of‐Life question naire ( SF‐36 ) , Northwick Park Neck Pain Question naire ( NPNQ ) , Neck Pain and Disability Scale ( NPAD ) , the McGill Pain Question naire ( MPQ ) and Self‐Assessed Improvement ( SAI ) in pain measured by VAS . Measurements were taken at baseline , at the end of 7 weeks ' treatment and 12 weeks from baseline . The mean VAS pain scores improved by 2.7 in the treated group and worsened by 0.3 in the control group ( difference 3.0 , 95 % CI 3.8–2.1 ) . Significant improvements were seen in the active group compared to placebo for SF‐36‐Physical Score ( SF36 PCS ) , NPNQ , NPAD , MPQVAS and SAI . The results of the SF‐36 – Mental Score ( SF36 MCS ) and other MPQ component scores ( afferent and sensory ) did not differ significantly between the two groups . Low‐level laser therapy ( LLLT ) , at the parameters used in this study , was efficacious in providing pain relief for patients with chronic neck pain over a period of 3 months",
"Study Design . R and omized parallel-group trial with 1-year follow-up . Objective . To evaluate whether education of patients communicated orally by a specially trained nurse is superior to giving patients a pamphlet after a whiplash injury . Summary of Background Data . Long-lasting pain and physical disability after whiplash injuries are related to both serious personal suffering and huge socio-economic costs . Pure educational interventions after such injuries seem generally as effective as more costly interventions , but it is unknown if the way advice is communicated is of any importance . Methods . Participants with relatively mild complaints after car collisions were recruited from emergency departments and GPs . A total of 182 participants were r and omized to either : ( 1 ) a 1 hour-educational session with a specially trained nurse , or ( 2 ) an educational pamphlet . Outcome parameters were neck pain , headache , disability , and return to work . Recovery was defined as scoring pain 0 or 1 ( 0–10 point scale ) and not being off sick at the time of the follow-ups . Results . After 3 , 6 , and 12 months 60 % , 58 % , and 66 % , respectively of the participants had recovered . Group differences were nonsignificant on all outcome parameters , even though the outcome tended to be better for the group receiving personal advice . Conclusion . Prognosis did not differ between patients who received personal education and those who got a pamphlet . However , a systematic tendency toward better outcome with personal communicated information was observed and the question how patients should be educated to reduce the risk of chronicity after whiplash is worth further investigation , since no treatment have been proven to prevent long-lasting symptoms , and all forms of advice or educational therapy are so cheap that even a modest effect justifies its use",
"Abstract Objectives : To compare the efficacy of acupuncture and conventional massage for the treatment of chronic neck pain . Design : Prospect i ve , r and omised , placebo controlled trial . Setting : Three outpatient departments in Germany . Participants : 177 patients aged 18–85 years with chronic neck pain . Interventions : Patients were r and omly allocated to five treatments over three weeks with acupuncture ( 56 ) , massage ( 60 ) , or “ sham ” laser acupuncture ( 61 ) . Main outcome measures : Primary outcome measure : maximum pain related to motion ( visual analogue scale ) irrespective of direction of movement one week after treatment . Secondary outcome measures : range of motion ( 3D ultrasound real time motion analyser ) , pain related to movement in six directions ( visual analogue scale ) , pressure pain threshold ( pressure algometer ) , changes of spontaneous pain , motion related pain , global complaints ( seven point scale ) , and quality of life ( SF-36 ) . Assessment s were performed before , during , and one week and three months after treatment . Patients ' beliefs in treatment were assessed . Results : One week after five treatments the acupuncture group showed a significantly greater improvement in motion related pain compared with massage ( difference 24.22 ( 95 % confidence interval 16.5 to 31.9 ) , P=0.0052 ) but not compared with sham laser ( 17.28 ( 10.0 to 24.6 ) , P=0.327 ) . Differences between acupuncture and massage or sham laser were greater in the subgroup who had had pain for longer than five years ( n=75 ) and in patients with myofascial pain syndrome ( n=129 ) . The acupuncture group had the best results in most secondary outcome measures . There were no differences in patients ' beliefs in treatment . Conclusions : Acupuncture is an effective short term treatment for patients with chronic neck pain , but there is only limited evidence for long term effects after five treatments . What is already known on this topic Acupuncture is a widespread complementary treatment Evidence from trials have given conflicting results on its use in the treatment of neck pain because of method ological shortcomings and because effects were compared either with alternative treatments or with different sham procedures imitating acupuncture , but not both What this study adds Compared with sham laser acupuncture and massage , needle acupuncture has beneficial effects on mobility and pain related to motion in patients with chronic neck pain Acupuncture was clearly more effective than massage , but differences were not always significant compared with sham laser acupuncture Acupuncture was the best treatment for patients with the myofascial syndrome and those who had had pain for longer than five",
"Abstract Objective To determine the effectiveness of dynamic muscle training and relaxation training for chronic neck pain . Design R and omised controlled trial . Setting Five occupational healthcare centres , Tampere , Finl and . Participants 393 female office workers ( mean age 45 years ) with chronic non-specific neck pain r and omly assigned to 12 weeks of dynamic muscle training ( n = 135 ) or relaxation training ( n = 128 ) , plus one week of reinforcement training six months after baseline ; or ordinary activity ( control group ; n = 130 ) . Main outcome measure Change in intensity of neck pain at three , six , and 12 months . Results No significant difference was found in neck pain between the groups at follow up . However , the range of motion for cervical rotation and lateral flexion increased more in the training groups than in the control group . Conclusions Dynamic muscle training and relaxation training do not lead to better improvements in neck pain compared with ordinary activity",
"Ketorolac tromethamine injected intramuscularly ( IM ) has been shown to be an effective analgesic in treating patients with acute musculoskeletal pain in the emergency department ( ED ) . The authors compare the efficacy of a single dose of IM ketorolac to osteopathic manipulative treatment ( OMT ) as delivered in the ED for the management of acute neck pain . A r and omized clinical trial was conducted in three EDs . A convenience sample of 58 patients with acute neck pain of less than three weeks ' duration were enrolled . Subjective measures of pain intensity on an 11-point numerical rating scale were gathered from patients immediately before treatment and one hour afterward . Subjects received either OMT or 30 mg , IM ketorolac . Subjects ' perceived pain relief was also recorded at one hour after treatment on a subjective 5-point pain relief scale . Twenty-nine patients received IM ketorolac , and 29 patients received OMT . Although both groups showed a significant reduction in pain intensity , 1.7+/-1.6 ( P OMT reported a significantly greater decrease in pain intensity ( P=.02 [ 95 % CI , 0.2 - 1.9 ] ) . When comparing pain relief at one hour posttreatment , there was no significant difference between the OMT and ketorolac study groups ( P=.10 ) . The authors found that , at one hour posttreatment , OMT is as efficacious as IM ketorolac in providing pain relief and significantly better in reducing pain intensity . The authors conclude that OMT is a reasonable alternative to parenteral nonsteroidal anti-inflammatory medication for patients with acute neck pain in the ED setting",
"A r and omized clinical trial was conducted to evaluate the efficacy of three commonly employed forms of traction in the treatment of cervical spine disorders . One hundred consenting men and women with disorders of the cervical spine were r and omly assigned to one of four treatment groups , static traction , intermittent traction , manual traction , or no traction . All patients , regardless of group assignment , were seen twice weekly . The four groups were shown to be similar with regard to age , sex , diagnosis , chronicity , and prescores on the seven outcome measures . Although the entire cohort of neck patients , regardless of group assignment , improved significantly on all the outcome variables over the 6-week period , patients receiving intermittent traction performed significantly better than those assigned to the no traction group in terms of pain ( P = 0.03 ) , forward flexion ( P = 0.01 ) , right rotation ( P = 0.004 ) and left rotation ( P = 0.05 )",
"BACKGROUND AND OBJECTIVES A prospect i ve , double-blind , r and omized , and controlled trial was conducted in patients with chronic myofascial pain syndrome ( MPS ) in the neck to evaluate the effects of infrared low level 904 nm Gallium-Arsenide ( Ga-As ) laser therapy ( LLLT ) on clinical and quality of life ( QoL ) . STUDY DESIGN / PATIENTS AND METHODS The study group consisted of 60 MPS patients . Patients were r and omly assigned to two treatment groups : Group I ( actual laser ; 30 patients ) and Group II ( placebo laser ; 30 patients ) . LLLT continued daily for 2 weeks except weekends . Follow-up measures were evaluated at baseline , 2 , 3 , and 12 weeks . All patients were evaluated with respect to pain at rest , pain at movement , number of trigger points ( TP ) , the Neck Pain and Disability Visual Analog Scale ( NPAD ) , Beck depression Inventory ( BDI ) , and the Nottingham Health Profile ( NHP ) . RESULTS In active laser group , statistically significant improvements were detected in all outcome measures compared with baseline ( P pain score at rest at the 1 week later of the end of treatment . The score for self-assessed improvement of pain was significantly different between the active and placebo laser groups ( 63 vs. 19 % ) ( P LLLT is effective in pain relief and in the improvement of functional ability and QoL in patients with MPS",
"The efficacy of low-level laser therapy ( LLLT ) in myofascial pain syndrome ( MPS ) seems controversial . A prospect i ve , double-blind , r and omized controlled trial was conducted in patients with chronic MPS in the neck to evaluate the effects of low-level 830-nm gallium arsenide aluminum ( Ga – As – Al ) laser therapy . The study group consisted of 64 MPS patients . The patients were r and omly assigned into two groups . In group 1 ( n = 32 ) , Ga – As – Al laser treatment was applied over three trigger points bilaterally for 2 min over each point once a day for 15 days during a period of 3 weeks . In group 2 ( n = 32 ) , the same treatment protocol was given , but the laser instrument was switched off during applications . All patients in both groups performed daily isometric exercise and stretching exercises for cervical region . Parameters were measured at baseline and after 4 weeks . All patients were evaluated with respect to pain ( at rest , movement , and night ) and assessed by visual analog scale , measurement of active range of motion using an inclinometer and a goniometer , and the neck disability index . In both groups , statistically significant improvements were detected in all outcome measures compared with baseline ( p no significant differences were obtained between the two groups ( p > 0.05 ) . In conclusion , although the laser therapy has no superiority over placebo groups in this study , we can not exclude the possibility of effectivity with another treatment regimen including different laser wavelengths and dosages ( different intensity and density and /or treatment interval )",
"BACKGROUND CONTEXT Neck pain , common among the elderly population , has considerable implication s on health and quality of life . Evidence supports the use of spinal manipulative therapy ( SMT ) and exercise to treat neck pain ; however , no studies to date have evaluated the effectiveness of these therapies specifically in seniors . PURPOSE To assess the relative effectiveness of SMT and supervised rehabilitative exercise , both in combination with and compared to home exercise ( HE ) alone for neck pain in individuals ages 65 years or older . STUDY DESIGN / SETTING R and omized clinical trial . PATIENT SAMPLE Individuals 65 years of age or older with a primary complaint of mechanical neck pain , rated ≥3 ( 0 - 10 ) for 12 weeks or longer in duration . OUTCOME MEASURES Patient self-report outcomes were collected at baseline and 4 , 12 , 26 , and 52 weeks after r and omization . The primary outcome was pain , measured by an 11-box numerical rating scale . Secondary outcomes included disability ( Neck Disability Index ) , general health status ( Medical Outcomes Study Short Form-36 ) , satisfaction ( 7-point scale ) , improvement ( 9-point scale ) , and medication use ( days per week ) . METHODS This study was funded by the US Department of Health and Human Services , Health Re sources and Services Administration . Linear mixed model analyses were used for comparisons at individual time points and for short- and long-term analyses . Blinded evaluations of objective outcomes were performed at baseline and 12 weeks . Adverse event data were collected at each treatment visit . RESULTS A total of 241 participants were r and omized , with 95 % reporting primary outcome data at all time points . After 12 weeks of treatment , the SMT with home exercise group demonstrated a 10 % greater decrease in pain compared with the HE-alone group , and 5 % change over supervised plus home exercise . A decrease in pain favoring supervised plus HE over HE alone did not reach statistical significance . Compared with the HE group , both combination groups reported greater improvement at week 12 and more satisfaction at all time points . Multivariate longitudinal analysis incorporating primary and secondary patient-rated outcomes showed that the SMT with HE group was superior to the HE-alone group in both the short- and long-term . No serious adverse events were observed as a result of the study treatments . CONCLUSIONS SMT with HE result ed in greater pain reduction after 12 weeks of treatment compared with both supervised plus HE and HE alone . Supervised exercise sessions added little benefit to the HE-alone program",
"BACKGROUND In March 2011 , the Institute of Medicine ( IOM ) issued a new set of st and ards for clinical practice guidelines intended to enhance the quality of guidelines being produced . To our knowledge , no systematic review of adherence to such st and ards has been undertaken since one published over a decade ago . METHODS Two review ers independently screened 130 guidelines selected at r and om from the National Guideline Clearinghouse ( NGC ) website for compliance with 18 of 25 IOM st and ards . RESULTS The overall median number ( percentage ) of IOM st and ards satisfied ( out of 18 ) was 8 ( 44.4 % ) , with an interquartile range of 6.5 ( 36.1 % ) to 9.5 ( 52.8 % ) . Fewer than half of the guidelines surveyed met more than 50 % of the IOM st and ards . Barely a third of the guidelines produced by subspecialty societies satisfied more than 50 % of the IOM st and ards surveyed . Information on conflicts of interest ( COIs ) was given in fewer than half of the guidelines surveyed . Of those guidelines including such information , COIs were present in over two-thirds of committee chairpersons ( 71.4 % ) and 90.5 % of co-chairpersons . Except for US government agency – produced guidelines , criteria used to select committee members and the selection process were rarely described . Committees developing guidelines rarely included an information scientist or a patient or patient representative . Non-English literature , unpublished data , and /or abstract s were rarely considered in developing guidelines ; differences of opinion among committee members generally were not aired in guidelines ; and benefits of recommendations were enumerated more often than potential harms . Guidelines published from 2006 through 2011 varied little with regard to average number of IOM st and ards satisfied . CONCLUSION Analysis of a r and om sample of clinical practice guidelines archived on the NGC website as of June 2011 demonstrated poor compliance with IOM st and ards , with little if any improvement over the past 2 decades",
"Objectives To compare naprapathic manual therapy with evidence -based care for back or neck pain regarding pain , disability , and perceived recovery . Naprapathy that is common in the Nordic countries and in some states in the United States is characterized by manual manipulations with a focus on soft and connective tissues , aim ing to decrease pain and disability in the musculoskeletal system . Methods Four hundred and nine patients with pain and disability in the back or neck lasting for at least 2 weeks , recruited at 2 large public companies in Sweden in 2005 , were included in this r and omized controlled trial . The 2 interventions were naprapathy , including spinal manipulation/mobilization , massage , and stretching ( Index Group ) and support and advice to stay active and how to cope with pain , according to the best scientific evidence available , provided by a physician ( Control Group ) . Pain , disability , and perceived recovery were measured by question naires at baseline and after 3 , 7 , and 12 weeks . Results At 7-week and 12-week follow-ups , statistically significant differences between the groups were found in all outcomes favoring the Index Group . At 12-week follow-up , a higher proportion in the naprapathy group had improved regarding pain [ risk difference (RD)=27 % , 95 % confidence interval ( CI ) : 17 - 37 ] , disability ( RD=18 % , 95 % CI : 7 - 28 ) , and perceived recovery ( RD=44 % , 95 % CI : 35 - 53 ) . Separate analysis of neck pain and back pain patients showed similar results . Discussion This trial suggests that combined manual therapy , like naprapathy , might be an alternative to consider for back and neck pain patients",
"Objective To evaluate the effectiveness of treatment with collar or physiotherapy compared with a wait and see policy in recent onset cervical radiculopathy . Design R and omised controlled trial . Setting Neurology outpatient clinics in three Dutch hospitals . Participants 205 patients with symptoms and signs of cervical radiculopathy of less than one month ’s duration Interventions Treatment with a semi-hard collar and taking rest for three to six weeks ; 12 twice weekly sessions of physiotherapy and home exercises for six weeks ; or continuation of daily activities as much as possible without specific treatment ( control group ) . Main outcome measures Time course of changes in pain scores for arm and neck pain on a 100 mm visual analogue scale and in the neck disability index during the first six weeks . Results In the wait and see group , arm pain diminished by 3 mm/week on the visual analogue scale ( β=−3.1 mm , 95 % confidence interval −4.0 to −2.2 mm ) and by 19 mm in total over six weeks . Patients who were treated with cervical collar or physiotherapy achieved additional pain reduction ( collar : β=−1.9 mm , −3.3 to −0.5 mm ; physiotherapy : β=−1.9 , −3.3 to −0.8 ) , result ing in an extra pain reduction compared with the control group of 12 mm after six weeks . In the wait and see group , neck pain did not decrease significantly in the first six weeks ( β=−0.9 mm , −2.0 to 0.3 ) . Treatment with the collar result ed in a weekly reduction on the visual analogue scale of 2.8 mm ( −4.2 to −1.3 ) , amounting to 17 mm in six weeks , whereas physiotherapy gave a weekly reduction of 2.4 mm ( −3.9 to −0.8 ) result ing in a decrease of 14 mm after six weeks . Compared with a wait and see policy , the neck disability index showed a significant change with the use of the collar and rest ( β=−0.9 mm , −1.6 to −0.1 ) and a non-significant effect with physiotherapy and home exercises . Conclusion A semi-hard cervical collar and rest for three to six weeks or physiotherapy accompanied by home exercises for six weeks reduced neck and arm pain substantially compared with a wait and see policy in the early phase of cervical radiculopathy . Trial registration Clinical trials NCT00129714",
"Objectives Little is known about the effectiveness of therapeutic massage , one of the most popular complementary medical treatments for neck pain . A r and omized controlled trial was conducted to evaluate whether therapeutic massage is more beneficial than a self-care book for patients with chronic neck pain . Methods Sixty-four such patients were r and omized to receive up to 10 massages over 10 weeks or a self-care book . Follow-up telephone interviews after 4 , 10 , and 26 weeks assessed outcomes including dysfunction and symptoms . Log-binomial regression was used to assess whether there were differences in the percentages of participants with clinical ly meaningful improvements in dysfunction and symptoms ( ie , > 5-point improvement on the Neck Disability Index ; > 30 % improvement from baseline on the symptom bothersomeness scale ) at each time point . Results At 10 weeks , more participants r and omized to massage experienced clinical ly significant improvement on the Neck Disability Index [ 39 % vs. 14 % of book group ; relative risk (RR)=2.7 ; 95 % confidence interval ( CI ) , 0.99 - 7.5 ] and on the symptom bothersomeness scale ( 55 % vs. 25 % of book group ; RR=2.2 ; 95 % CI , 1.04 - 4.2 ) . After 26 weeks , massage group members tended to be more likely to report improved function ( RR=1.8 ; 95 % CI , 0.97 - 3.5 ) , but not symptom bothersomeness ( RR=1.1 ; 95 % CI , 0.6 - 2.0 ) . Mean differences between groups were strongest at 4 weeks and not evident by 26 weeks . No serious adverse experiences were reported . Conclusions This study suggests that massage is safe and may have clinical benefits for treating chronic neck pain at least in the short term . A larger trial is warranted to confirm these results",
"Abstract Patients with chronic whiplash associated disorders present with varied sensory , motor and psychological features . In this first instance it was question ed whether a multimodal program of physical therapies was an appropriate management to be broadly prescribed for these patients when it was known that some would have sensory features suggestive of a notable pain syndrome . A r and omised controlled trial was conducted with 71 participants with persistent neck pain following a motor vehicle crash to explore this question . Participants were r and omly allocated to receive either a multimodal physiotherapy program ( MPT ) or a self‐management program ( SMP ) ( advice and exercise ) . In the r and omisation process , participants were stratified according to the presence or not of widespread mechanical or cold hyperalgesia . The intervention period was 10 weeks and outcomes were assessed immediately following treatment . Even with the presence of sensory hypersensitivity in 72.5 % of subjects , both groups reported some relief of neck pain and disability ( Neck Disability Index ) and it was superior in the group receiving multimodal physiotherapy ( p = 0.04 ) . Post‐hoc observations however suggested that relief was marginal in the subgroup with both widespread mechanical and cold hyperalgesia . Further research is required to test the validity of this sub‐group observation and to test the effect of the intervention in the long term",
"UNLABELLED The aim of this study was to evaluate the effectiveness of qigong compared with exercise therapy and no treatment . Elderly patients with chronic neck pain ( > 6 months ) were r and omly assigned to qigong or exercise therapy ( each 24 sessions over a period of 3 months ) or to a waiting list control . Patients completed st and ardized question naires at baseline and after 3 and 6 months . The main outcome measure was average neck pain on the visual analogue scale after 3 months . Secondary outcomes were neck pain and disability ( NPAD ) and quality of life ( SF-36 ) . One hundred seventeen patients ( age , 76 + /- 8 years , 95 % women ) were included in the intention-to-treat analysis . The average duration of neck pain was 19.0 + /- 14.9 years . After 3 months , no significant differences were observed between the qigong group and the waiting list control group ( visual analogue scale mean difference , -11 mm [ CI , -24.0 ; 2.1 ] , P = .099 ) or between the qigong group and the exercise therapy group ( -2.5 mm [ - 15.4 ; 10.3 ] , P = .699 ) . Results for the NPAD were similar ( qigong vs waiting list -6.7 ( -15.4 ; 2.1 ) , P = .135 ; qigong vs exercise therapy 2.3 ( -6.2 ; 10.8 ) ; P = .600 ) . We found no significant effect after 3 months of qigong or exercise therapy compared with no treatment . Further studies should include outcomes more suitable to elderly patients , longer treatment , and patients with less chronic pain . PERSPECTIVE In a r and omized controlled study , we evaluated whether a treatment of 24 qigong sessions over a period of 3 months is ( 1 ) superior to no treatment and ( 2 ) superior to the same amount of exercise therapy in elderly patients ( age , 76 + /- 8 years , 95 % women ) with long-term chronic neck pain ( 19.0 + /- 14.9 years ) . After 3 and 6 months , we found no significant differences for pain , neck pain , disability , and quality of life among the 3 groups",
"& NA ; Regular physical exercise is a cornerstone in rehabilitation programs , but adherence to comprehensive exercise remains low . This study determined the effectiveness of small daily amounts of progressive resistance training for relieving neck/shoulder pain in healthy adults with frequent symptoms ; 174 women and 24 men working at least 30 h per week and with frequent neck/shoulder pain were r and omly assigned to resistance training with elastic tubing for 2 or 12 minutes per day 5 times per week , or weekly information on general health ( control group ) . Primary outcomes were changes in intensity of neck/shoulder pain ( scale 0 to 10 ) , examiner‐verified tenderness of the neck/shoulder muscles ( total tenderness score of 0 to 32 ) , and isometric muscle strength at 10 weeks . Compared with the control group , neck/shoulder pain and tenderness , respectively , decreased 1.4 points ( 95 % confidence interval −2.0 to −0.7 , p group , muscle strength increased 2.0 Nm ( 95 % confidence interval 0.5 to 3.5 Nm , p = 0.01 ) in the 2‐minute group and 1.7 Nm ( 95 % confidence interval 0.2 to 3.3 Nm , p = 0.02 ) in the 12‐minute group . In conclusion , as little as 2 minutes of daily progressive resistance training for 10 weeks results in clinical ly relevant reductions of pain and tenderness in healthy adults with frequent neck/shoulder symptoms . Trial registration : www.is rct n.org/IS RCT N60264809 . In generally healthy adults with frequent neck/shoulder muscle pain , as little as 2 minutes of daily progressive resistance training reduces pain and tenderness",
"Study Design . Population ‐based , cross‐sectional mailed survey . Objective . To determine the lifetime , period , and point prevalence of neck pain and its related disability among Saskatchewan adults and investigate the presence and strength of nonresponse bias . Summary of Background Data . In Europe , the life‐time and point prevalence of neck pain is almost as high as the prevalence of low back pain . Similarly , chronic neck pain is highly prevalent and a common source of disability in the working‐age population . However , no studies specifically have documented the prevalence of neck pain and its related disability in North America . Methods . The Saskatchewan Health and Back Pain Survey was mailed to 2184 r and omly selected Saskatchewan adults aged 20‐69 years . Fifty‐five percent of the study population participated . The presence of nonresponse bias was investigated through logistic regression and wave analysis . The Chronic Pain Question naire was used to classify the severity of chronic neck pain . Results . The age‐st and ardized lifetime prevalence of neck pain is 66.7 % ( 95 % confidence interval , 63.8‐69.5 ) , and the point prevalence is 22.2 % ( 95 % confidence interval , 19.7‐24.7 ) . The age‐st and ardized 6‐month prevalence of low‐intensity and low‐disability neck pain is 39.7 % ( 95 % confidence interval , 36.7‐42.7 ) , whereas it is 10.1 % ( 95 % confidence interval , 8.2‐11.9 ) for high‐intensity and low‐disability neck pain and 4.6 % ( 95 % confidence interval , 3.3‐5.8 ) for significantly disabling neck pain . The prevalence of low‐intensity and low‐disability neck pain decreases with age . More women experience high‐disability neck pain than men . Wave analysis suggests that the point prevalence and 6‐month prevalence of high‐intensity and low‐disability neck pain are overestimated in this survey . Conclusion . This cross‐sectional study shows that neck pain is highly prevalent in Saskatchewan and that it significantly disables 4.6 % ( 95 % confidence interval , 3.3‐5.8 ) of the adult population",
"BACKGROUND CONTEXT Although the use of deep heat therapy is widespread , there is scant literature available on its effectiveness in treating back or neck pain . PURPOSE The purpose of this study was to determine the efficacy of microwave diathermy to treat nonspecific chronic neck pain . DESIGN The study was design ed as a double-blind , r and omized controlled trial . PATIENT SAMPLE The patient sample consisted of 149 patients with nonspecific chronic neck pain in a hospital of the And alusian Public Health Care System , Spain OUTCOME MEASURES The study outcome measures are as follows : at baseline , pain intensity ( using a visual analogue scale ) , disability ( Neck Disability Index ) , and health-related quality of life ( 36-item short form health survey [ SF-36 ] ) ; at 3 weeks , baseline measures and patients ' perceived overall outcome and satisfaction with the treatment ; and at 6 months , 3-week measures , therapeutic co- interventions , and adherence to exercises . METHODS Patients were allocated r and omly to three groups . The first group received continuous microwave diathermy , the second group was administered pulsed microwaves , and the third group ( the control group ) received unplugged microwaves . All three groups received the same general treatment : range of motion , isometric exercises , and transcutaneous electrical nerve stimulation . RESULTS The three groups had reduced pain and disability , and improvement was seen in some dimensions of the SF-36 . However , there were no differences found in any of the parameters measured among the three therapeutic groups . CONCLUSIONS Microwave diathermy does not provide additional benefit to a treatment regimen of chronic neck pain that already involves other treatment approaches",
"OBJECTIVE To evaluate the effect of neck coordination exercise on sensorimotor function in women with neck pain compared with best-available treatment and sham treatment . DESIGN Observer-blinded r and omized controlled trial with short-term and 6-month follow-ups . SUBJECTS Women with chronic non-specific neck pain were r and omized to 3 groups : neck coordination exercise with a novel training device ; strength training for the neck and shoulders ; or massage . Each group had 36 participants . METHODS The intervention period was 11 weeks with 22 individually supervised sessions . Primary outcomes were postural sway measures and precision of goal -directed arm movements . Secondary outcomes were range of motion for the neck , peak speed of axial rotation , and neck pain . A repeated measures multivariate analysis of variance ( MANOVA ) was conducted separately on the primary outcomes for the short-term and 6-month evaluations and on the sensorimotor secondary outcomes for the 6-month effect . The 6-month effect on pain was analysed with a repeated measures analysis of variance ( ANOVA ) . RESULTS No significant treatment effects in favour of neck coordination exercise were found for short-term or 6-month evaluations . CONCLUSION Neck coordination exercise is no better than strength training and massage in improving sensorimotor function . Further research should investigate the use of cut-offs for sensorimotor dysfunctions prior to proprioceptive or coordinative training",
"To evaluate the role of manual therapy with exercise regime versus exercise regime alone in the management of non-specific chronic neck pain . In this 62 subjects r and omized controlled trial 31 subjects in group A received manual therapy ( manipulation ) with supervised exercise regime whilst 31 subjects in group B performed only supervised exercise regime for the period of 3 weeks . Both groups had a home exercise program consisted of strengthening exercises for neck/scapuluar stability , stretching and general range of motion exercises for neck with advice regarding posture awareness and correction for 3 months . The results suggested significant reduction in pain intensity level in both groups ; over 3 weeks and 12 weeks ' time period in relation to baseline on visual analog scale ( p=0.001 ) . Similarly , statistically significant improvements noticed in Neck Disability Index ( NDI ) ( p=0.0001 ) in both groups while looking at baseline data with reference to 12 weeks ' time period . On closer inspection , the manual therapy ( manipulation ) with exercise regime appeared as a favorable treatment preference compared with exercise regime alone",
"OBJECTIVES Cost-effectiveness and cost-utility analyses were conducted to compare advice and exercise plus manual therapy ( MT ) and advice and exercise plus pulsed shortwave diathermy ( PSWD ) with advice and exercise alone ( A&E ) in the treatment of non-specific neck disorders by experienced physiotherapists . METHODS Between July 2000 and June 2002 , 350 participants with neck disorders from 15 physiotherapy departments were r and omized to : A&E ( n = 115 ) ; MT ( n = 114 ) and PSWD ( n = 121 ) . Outcome and re source -use data were collected using physiotherapist case report forms and participant self-complete question naires . Outcome measures were the Northwick Park Neck Pain Question naire ( NPQ ) and EuroQoL EQ-5D [ used to derive quality -adjusted-life-year ( QALY ) utility scores ] . Two economic viewpoints were considered ( health care and societal ) . Cost-effectiveness acceptability curves were used to assess the probabilities of the interventions being cost-effective at different willingness-to-pay threshold values . RESULTS Mean improvement in NPQ at 6 months was 11.5 in the A&E group , 10.2 in the MT group and 10.3 in the PSWD group ; mean QALY scores were 0.362 , 0.342 and 0.360 , respectively . Mean health care costs were pound sterling105 , pound sterling119 and pound sterling123 in the A&E , MT and PSWD groups , respectively . Mean societal costs were pound sterling373 , pound sterling303 and pound sterling 338 in each group , respectively . Depending on the viewpoint and the outcome measure , A&E or MT were most likely to be the cost-effective interventions . PSWD was consistently the least cost-effective intervention . CONCLUSIONS The cost-effective intervention is likely to be A&E or MT , depending on the economic perspective and preferred outcome , but not PSWD",
"BACKGROUND Regular paracetamol is the recommended first-line analgesic for acute low-back pain ; however , no high- quality evidence supports this recommendation . We aim ed to assess the efficacy of paracetamol taken regularly or as-needed to improve time to recovery from pain , compared with placebo , in patients with low-back pain . METHODS We did a multicentre , double-dummy , r and omised , placebo controlled trial across 235 primary care centres in Sydney , Australia , from Nov 11 , 2009 , to March 5 , 2013 . We r and omly allocated patients with acute low-back pain in a 1:1:1 ratio to receive up to 4 weeks of regular doses of paracetamol ( three times per day ; equivalent to 3990 mg paracetamol per day ) , as-needed doses of paracetamol ( taken when needed for pain relief ; maximum 4000 mg paracetamol per day ) , or placebo . R and omisation was done according to a central ised r and omisation schedule prepared by a research er who was not involved in patient recruitment or data collection . Patients and staff at all sites were masked to treatment allocation . All participants received best- evidence advice and were followed up for 3 months . The primary outcome was time until recovery from low-back pain , with recovery defined as a pain score of 0 or 1 ( on a 0 - 10 pain scale ) sustained for 7 consecutive days . All data were analysed by intention to treat . This study is registered with the Australian and New Zeal and Clinical Trial Registry , number ACTN 12609000966291 . FINDINGS 550 participants were assigned to the regular group ( 550 analysed ) , 549 were assigned to the as-needed group ( 546 analysed ) , and 553 were assigned to the placebo group ( 547 analysed ) . Median time to recovery was 17 days ( 95 % CI 14 - 19 ) in the regular group , 17 days ( 15 - 20 ) in the as-needed group , and 16 days ( 14 - 20 ) in the placebo group ( regular vs placebo hazard ratio 0·99 , 95 % CI 0·87 - 1·14 ; as-needed vs placebo 1·05 , 0·92 - 1·19 ; regular vs as-needed 1·05 , 0·92 - 1·20 ) . We recorded no difference between treatment groups for time to recovery ( adjusted p=0·79 ) . Adherence to regular tablets ( median tablets consumed per participant per day of maximum 6 ; 4·0 [ IQR 1·6 - 5·7 ] in the regular group , 3·9 [ 1·5 - 5·6 ] in the as-needed group , and 4·0 [ 1·5 - 5·7 ] in the placebo group ) , and number of participants reporting adverse events ( 99 [ 18·5 % ] in the regular group , 99 [ 18·7 % ] in the as-needed group , and 98 [ 18·5 % ] in the placebo group ) were similar between groups . INTERPRETATION Our findings suggest that regular or as-needed dosing with paracetamol does not affect recovery time compared with placebo in low-back pain , and question the universal endorsement of paracetamol in this patient group . FUNDING National Health and Medical Research Council of Australia and GlaxoSmithKline Australia",
"Prospect i ve single cohort study . To evaluate the NDI by comparison with the SF36 health Survey Question naire . The NDI is a simple ten-item question naire used to assess patients with neck pain . The SF36 measures functional ability , well being and the overall health of patients . It is used as a gold st and ard in health economics to assess the health utility , gain and economic impact of medical interventions . One hundred and sixty patients with neck pain attending the spinal clinic completed self- assessment question naires . A second question naire was completed in 34 patients after a period of 1–2 weeks . The internal consistency of the NDI and SF36 was calculated using Cronbach ’s alpha . The test – retest reliability was assessed using the Bl and and Altman method . The concurrent validity of the NDI with respect to the SF-36 was assessed using Pearson correlations . Both question naires showed robust internal consistency : Cronbach ’s alpha for the NDI scale was acceptable ( 0.864 , 95 % confidence limits 0.825–0.894 ) though slightly smaller than that of the SF36 . The correlations between each item of the NDI scores and the total NDI score ranged from 0.447 to 0.659 , ( all with P The test – retest reliability of the NDI was high ( intra-class correlation 0.93 , 95 % confidence limits 0.86–0.97 ) and comparable with the best values found for SF36 . The correlations between NDI and SF36 domains ranged from −0.45 to −0.74 ( all with P < 0.001 ) . We have shown that the NDI has good reliability and validity and that it compares well with the SF36 in the spinal surgery out patient setting",
"& NA ; Although neck pain is a common source of disability , little is known about its incidence and course . We conducted a population ‐based cohort study of 1100 r and omly selected Saskatchewan adults to determine the annual incidence of neck pain and describe its course . Subjects were initially surveyed by mail in September 1995 and followed‐up 6 and 12 months later . The age and gender st and ardized annual incidence of neck pain is 14.6 % ( 95 % confidence interval : 11.3 , 17.9 ) . Each year , 0.6 % ( 95 % confidence interval : 0.0–1.1 ) of the population develops disabling neck pain . The annual rate of resolution of neck pain is 36.6 % ( 95 % confidence interval : 32.7 , 40.5 ) and another 32.7 % ( 95 % confidence interval : 25.5 , 39.9 ) report improvement . Among subjects with prevalent neck pain at baseline , 37.3 % ( 95 % confidence interval : 33.4 , 41.2 ) report persistent problems and 9.9 % ( 95 % confidence interval : 7.4 , 12.5 ) experience an aggravation during follow‐up . Finally , 22.8 % ( 95 % confidence interval : 16.4 , 29.3 ) of those with prevalent neck pain at baseline report a recurrent episode . Women are more likely than men to develop neck pain ( incidence rate ratio=1.67 , 95 % confidence interval 1.08–2.60 ) ; more likely to suffer from persistent neck problems ( incidence rate ratio=1.19 , 95 % confidence interval 1.03–1.38 ) and less likely to experience resolution ( incidence rate ratio=0.75 , 95 % confidence interval 0.63–0.88 ) . Neck pain is a disabling condition with a course marked by periods of remission and exacerbation . Contrary to prior belief , most individuals with neck pain do not experience complete resolution of their symptoms and disability",
"STUDY DESIGN R and omized clinical study . OBJECTIVES To compare the effects of trigger point ( TrP ) dry needling ( DN ) and TrP manual therapy ( MT ) on pain , function , pressure pain sensitivity , and cervical range of motion in subjects with chronic mechanical neck pain . BACKGROUND Recent evidence suggests that TrP DN could be effective in the treatment of neck pain . However , no studies have directly compared the outcomes of TrP DN and TrP MT in this population . METHODS Ninety-four patients ( mean ± SD age , 31 ± 3 years ; 66 % female ) were r and omized into a TrP DN group ( n = 47 ) or a TrP MT group ( n = 47 ) . Neck pain intensity ( 11-point numeric pain rating scale ) , cervical range of motion , and pressure pain thresholds ( PPTs ) over the spinous process of C7 were measured at baseline , postintervention , and at follow-ups of 1 week and 2 weeks after treatment . The Spanish version of the Northwick Park Neck Pain Question naire was used to measure disability/function at baseline and the 2-week follow-up . Mixed-model , repeated- measures analyses of variance ( ANOVAs ) were used to determine if a time-by-group interaction existed on the effects of the treatment on each outcome variable , with time as the within-subject variable and group as the between-subject variable . RESULTS The ANOVA revealed that participants who received TrP DN had outcomes similar to those who received TrP MT in terms of pain , function , and cervical range of motion . The 4-by-2 mixed-model ANOVA also revealed a significant time-by-group interaction ( P for PPT : patients who received TrP DN experienced a greater increase in PPT ( decreased pressure sensitivity ) than those who received TrP MT at all follow-up periods ( between-group differences : posttreatment , 59.0 kPa ; 95 % confidence interval [ CI ] : 40.0 , 69.2 ; 1-week follow-up , 69.2 kPa ; 95 % CI : 49.5 , 79.1 ; 2-week follow-up , 78.9 kPa ; 95 % CI : 49.5 , 89.0 ) . CONCLUSION The results of this clinical trial suggest that 2 sessions of TrP DN and TrP MT result ed in similar outcomes in terms of pain , disability , and cervical range of motion . Those in the TrP DN group experienced greater improvements in PPT over the cervical spine . Future trials are needed to examine the effects of TrP DN and TrP MT over long-term follow-up periods . LEVEL OF EVIDENCE Therapy , level 1b",
"Abstract And ersen , CH , And ersen , LL , Pedersen , MT , Mortensen , P , Karstad , K , Mortensen , OS , Zebis , MK , and Sjøgaard , G. Dose-response of strengthening exercise for treatment of severe neck pain in women . J Strength Cond Res 27(12 ) : 3322–3328 , 2013—Specific strength training is shown to relieve neck pain in office workers . The purpose of this study is to evaluate the effectiveness of specific strength training in women with severe neck pain and to analyze the dose – response relationship between training adherence and pain reduction . One hundred eighteen untrained women with severe neck pain ( > 30 mm VAS pain ) were included from a larger study , in which the subjects were r and omized to 20-week specific strength training for the neck/shoulders or to a control group . In the intention-to-treat analysis , the training group experienced greater pain relief than the control group ( p decreased pain by 35 mm VAS ( 95 % confidence interval : −26 to −44 ) from baseline to follow-up corresponding to a 70 % reduction . In the dose – response analyses , participants with medium and high training adherence showed better pain relief than the control group and those with low adherence ( p decrease from baseline in the medium and high adherence groups was 37 mm VAS ( 28–46 mm ) and 33 mm VAS ( 24–43 mm ) , respectively . Specific strength training reduces pain intensity in women with severe neck pain , and 1–2 training sessions per week for 20 weeks ( ∼30 training sessions ) seems sufficient for optimal pain relief ",
"UNLABELLED Chronic neck pain is a common medical complaint partly mediated by psychosocial distress and having a high socioeconomic impact . There is preliminary evidence that stress reduction by meditation might be beneficial in chronic pain syndromes . We aim ed to evaluate the effectiveness of an 8-week meditation program ( jyoti meditation ) in patients with chronic neck pain by means of a r and omized clinical trial . Eighty-nine patients ( aged 49.7 ± 10.5 years , 73 female ) with chronic neck pain who scored > 40 mm on a 100-mm visual analog scale and had concomitant increased perceived stress were r and omized to an 8-week meditation program ( jyoti meditation ) with weekly 90-minute classes ( n = 45 ) or to a home-based exercise program ( n = 44 ) with a wait list offer for meditation . Both groups were instructed to practice at home . Outcomes were assessed at baseline and after 8 weeks . Primary outcome measure was change of mean pain at rest ( visual analog scale score ) from baseline to week 8 . Secondary outcomes included pain at motion , functional disability , pain-related bothersomeness , perceived stress , quality of life , and psychological outcomes . Patients had neck pain for a mean of 11 years . Eighteen patients in the meditation group and 16 patients in the exercise group were lost to follow-up . Meditation training significantly reduced pain when compared to the exercise group after 8 weeks ( reduction of 45.5 ± 23.3 mm to 21.6 ± 17.2 mm in the meditation group , and 43.8 ± 22.0 mm to 37.7 ± 21.5 mm in the exercise group ; mean difference : 13.2 mm [ 95 % confidence interval : 2.1 , 24.4 ; P = .02 ] ) . Pain-related bothersomeness decreased more in the meditation group ( group difference 11.0 mm [ 95 % confidence interval : 1.0 , 21.0 ; P = .03 ] ) . No significant treatment effects were found for pain at motion , psychological scores , and quality of life , although the meditation group showed nonsignificant greater improvements compared to the exercise group . In conclusion , meditation may support chronic pain patients in pain reduction and pain coping . Further well- design ed studies including more active control comparisons and longer-term follow-up are warranted . PERSPECTIVE This article presents the results of a r and omized controlled trial on the clinical effects of an 8-week meditation program or self-care exercise in patients with chronic neck pain . Meditation reduced pain at rest but not disability and might be a useful treatment option for pain management of chronic neck pain",
"OBJECTIVE To determine whether manual therapy or pulsed shortwave diathermy , in addition to advice and exercise , provide better clinical outcome at 6 months than advice and exercise alone in primary care patients with nonspecific neck disorders . METHODS This was a multicenter , 3-arm r and omized controlled trial in 15 physical therapy departments . Of the 735 screened patients , 350 were recruited to the study ( mean age 51 years ) from July 2000 to June 2002 . Participants were r and omized to advice and exercise plus manual therapy , advice and exercise plus pulsed shortwave , or advice and exercise alone . Assessment s were undertaken at baseline , 6 weeks , and 6 months . The primary outcome was the Northwick Park Neck Pain Question naire . Analysis was by intention to treat . RESULTS Of the participants , 115 were allocated to advice and exercise , 114 to advice and exercise plus manual therapy , and 121 to advice and exercise plus pulsed shortwave ; 98 % received the allocated treatment . There was 93 % followup at 6 months . The mean + /- SD fall in Northwick Park score at 6 months was 11.5 + /- 15.7 for advice and exercise alone , 10.2 + /- 14.1 for advice and exercise plus manual therapy , and 10.3 + /- 15.0 for advice and exercise plus pulsed shortwave . There were no statistically significant differences in mean changes between groups . CONCLUSION The addition of pulsed shortwave or manual therapy to advice and exercise did not provide any additional benefits in the physical therapy treatment of neck disorders",
"Summary This r and omised trial showed that multiprofessional stratified management had no effect beyond usual care in reducing transition rates to chronicity in patients with acute whiplash . ABSTRACT Acute whiplash is a heterogeneous disorder that becomes persistent in 40 % to 60 % of cases . Estimates of recovery have not changed in recent decades . This r and omized , single‐blind , controlled trial tested whether multidisciplinary individualized treatments for patients with acute whiplash ( could reduce the incidence of chronicity at 6 mo by 50 % compared to usual care . Participants ( n = 101 ) were recruited from accident and emergency centres and the community . It was hypothesized that better recovery rates were achievable if the heterogeneity was recognised and patients received individualised interventions . Patients r and omized to pragmatic intervention ( n = 49 ) could receive pharmaceutical management ( ranging from simple medications to opioid analgesia ) , multimodal physiotherapy and psychology for post‐traumatic stress according to their presentations . The treatment period was 10 wks with follow‐up at 11 weeks and 6 and 12‐months . The primary outcome was neck pain and disability ( Neck Disability Index ( NDI ) ) . Analysis revealed no significant differences in frequency of recovery ( NDI ≤8 % ) between pragmatic and usual care groups at 6 months ( OR 95 % , CI = 0.55 , 0.23–1.29 ) , P = 0.163 ) or 12 mo ( OR 95 % , CI = 0.65 , 0.28–1.47 , P = 0.297 ) . There was no improvement in current nonrecovery rates at 6 mo ( 63.6 % , pragmatic care ; 48.8 % , usual care ) , indicating no advantage of the early multiprofessional intervention . Baseline levels of pain and disability had a significant bearing on recovery both at 6 and 12 mo in both groups , suggesting that future research focus on finding early effective pain management , particularly for the subgroup of patients with initial high levels of pain and disability , towards improving recovery rates",
"Study Design . Concealed allocation , multicenter , single-blind , r and omized controlled clinical trial . Objective . To assess the efficacy of an educational video in the tertiary prevention of persistent WAD symptoms following rear-end motor vehicle collisions ( MVCs ) . Summary of Background Data . Whiplash-associated disorders ( WAD ) are an important and costly health problem . There is a lack of high quality evidence surrounding efficacy of treatments for WAD . Existing research supports active interventions and early return to regular activities . Methods . Consecutive patients presenting to four tertiary care emergency departments following rear-end MVCs were eligible . Following informed consent , patients were allocated , using central r and omization , to receive an educational video plus usual care or usual care alone . The video provided reassurance , and advice about posture , return to regular activities , exercises , and pain-relief methods . Data were collected by telephone using st and ardized question naires . The primary outcome was presence of Persistent WAD Symptoms at 24 weeks postinjury , based on the frequency and severity of neck , shoulder , or upper back pain . The absolute difference in proportion of patients with persistent WAD symptoms and rate ratios were calculated . Changes in pain scores were compared using the Mann-Whitney U test . Results . The intervention ( n = 206 ) and control ( n = 199 ) groups were similar at baseline ( mean age 38.4 years ; 64 % female ) . Overall , the proportion of subjects with Persistent WAD Symptoms decreased from 89.1 % at baseline to 33.6 % at 24 weeks after injury . At 24 weeks , the proportion of subjects with persistent WAD symptoms in the intervention group was 7.9 % ( 95 % CI , −2.0 , 17.8 ) lower than the control group . The median improvement in pain score at 24 weeks was 3 for the intervention group and 2 for the control group ( P = 0.016 ) . Conclusion . The presence of persistent WAD symptoms following simple rear-end MVCs was high in this sample . The video group demonstrated a trend toward less severe WAD symptoms . We recommend evaluating other educational interventions that could reduce WAD symptoms",
"OBJECTIVES This study compared the relative effectiveness of cervical spine manipulation and mobilization for neck pain . METHODS Neck-pain patients were r and omized to the following conditions : manipulation with or without heat , manipulation with or without electrical muscle stimulation , mobilization with or without heat , and mobilization with or without electrical muscle stimulation . RESULTS Of 960 eligible patients , 336 enrolled in the study . Mean reductions in pain and disability were similar in the manipulation and mobilization groups through 6 months . CONCLUSIONS Cervical spine manipulation and mobilization yield comparable clinical outcomes",
"This prospect i ve , r and omised study compares the efficacy of surgery , physiotherapy and cervical collar with respect to pain , motor weakness and sensory loss in 81 patients with long-lasting cervical radiculopathy corresponding to a nerve root that was significantly compressed by spondylotic encroachment , with or without an additional bulging disk , as verified by MRI or CT-myelography . Pain intensity was registered on a visual analogue scale ( VAS ) , muscle strength was measured by a h and -held dynamometer , Vigorometer and pinchometer . Sensory loss and paraesthesia were recorded . The measurements were performed before treatment ( control 1 ) , 4 months after the start of treatment ( control 2 ) and after a further 12 months ( control 3 ) . A healthy control group was used for comparison and to test the reliability of the muscle-strength measurements . The study found that before start of treatment the groups were uniform with respect to pain , motor weakness and sensory loss . At control 2 the surgery group reported less pain , less sensory loss and had better muscle strength , measured as the ratio of the affected side to the non-affected side , compared to the two conservative treatment groups . After a further year ( control 3 ) , there were no differences in pain intensity , sensory loss or paraesthesia between the groups . An improvement in muscle strengths , measured as the ratio of the affected to the non-affected side , was seen in the surgery group compared to the physiotherapy group in wrist extension , elbow extension , shoulder abduction and internal rotation , but there were no differences in the ratios between the collar group and the other treatment groups . With respect to absolute muscle strength of the affected sides , there were no differences at control 1 . At control 2 , the surgery group performed somewhat better than the two other groups but at control 3 there were no differences between the groups . We conclude that pain intensity , muscle weakness and sensory loss can be expected to improve within a few months after surgery , while slow improvement with conservative treatments and recurrent symptoms in the surgery group make the 1-year results about equal",
"Evidence supports exercise-based interventions for the management of neck pain , however there is little evidence of its superiority over usual physiotherapy . This study investigated the effectiveness of a group neck and upper limb exercise programme ( GET ) compared with usual physiotherapy ( UP ) for patients with non-specific neck pain . A total of 151 adult patients were r and omised to either GET or UP . The primary measure was the Northwick Park Neck pain Question naire ( NPQ ) score at six weeks , six months and 12 months . Mixed modelling identified no difference in neck pain and function between patients receiving GET and those receiving UP at any follow-up time point . Both interventions result ed in modest significant and clinical ly important improvements on the NPQ score with a change score of around 9 % between baseline and 12 months . Both GET and UP are appropriate clinical interventions for patients with non-specific neck pain , however preferences for treatment and targeted strategies to address barriers to adherence may need to be considered in order to maximise the effectiveness of these approaches",
"In a double-blind , cross-over study of 90 patients with degenerative disease of the hip , knee , cervical or lumbar spine , and capsulitis of the shoulder the analgesic drug benorylate ( either alone or in combination with chlormezanone , a muscle relaxant anxiolytic drug ) favourably modified pain , stiffness , quality of sleep and ability to work . Chlormezanone significantly reduced the number of breaks in sleep . There was no significant difference in the number of patients reporting side-effects on each of the four treatments , but drowsiness occurred significantly more in the chlormezanone weeks . There appeared to be no advantage in adding chlormezanone in patients suffering from osteoarthritis of the hip or knee , lumbar spondylosis or capsulitis of the shoulder , but there was significant improvement in both pain relief and quality of sleep in those patients with neck pain",
"Abstract : Pain is a major symptom in cervical osteoarthritis ( COA ) . Low-power laser ( LPL ) therapy has been cl aim ed to reduce pain in musculoskeletal pathologies , but there have been concerns about this point . The aim of this study was to evaluate the analgesic efficacy of LPL therapy and related functional changes in COA . Sixty patients between 20 and 65 years of age with clinical ly and radiologically diagnosed COA were included in the study . They were r and omised into two equal groups according to the therapies applied , either with LPL or placebo laser . Patients in each group were investigated blindly in terms of pain and pain-related physical findings , such as increased paravertebral muscle spasm , loss of lordosis and range of neck motion restriction before and after therapy . Functional improvements were also evaluated . Pain , paravertebral muscle spasm , lordosis angle , the range of neck motion and function were observed to improve significantly in the LPL group , but no improvement was found in the placebo group . LPL seems to be successful in relieving pain and improving function in osteoarthritic diseases",
"Study Design . Population -based , incidence cohort . Objectives . To evaluate a government policy of funding community and hospital-based fitness training and multidisciplinary rehabilitation for whiplash . Summary of Background Data . Although insurance benefits commonly include rehabilitation for whiplash , its effectiveness is unknown . Methods . All Saskatchewan adults treated for whiplash ( n = 6,021 ) over a 2-year period were followed up at 6 weeks , 3 , 6 , 9 , and 12 months . Recovery was defined by self-report of improvement . Recovery times were compared between those attending fitness training at health clubs ( n = 833 ) , multidisciplinary outpatient rehabilitation ( n = 468 ) , and multidisciplinary inpatient rehabilitation ( n = 135 ) to those receiving usual insured individual care . Results . Recovery was 32 % slower in those receiving fitness training within 69 days of injury ( P = 0.001 ) and 19 % slower when received within 119 days of injury ( P = 0.041 ) . Recovery was 50 % slower in those receiving outpatient rehabilitation within 119 days of injury ( P = 0.001 ) . Attending inpatient rehabilitation did not influence recovery rates during the follow up ( P = 0.131 ) . Multivariable adjustment for important prognostic factors did not change these results . Conclusions . We found no evidence to support the effectiveness of a population -based program of fitness training and multidisciplinary rehabilitation for whiplash . Rehabilitation programs should be tested in r and omized trials before being recommended to injured population",
"Abstract Currently , large levels of practice variability exist regarding the clinical deactivation of trigger points . Manual physical therapy has been identified as a potential means of resolving active trigger points ; however , to date the ideal treatment approach has yet to be eluci date d. The purpose of this clinical trial was to compare the effects of two manual treatment regimens on individuals with upper trapezius trigger points . Sixty patients , 19–38 years of age with non-specific neck pain and upper trapezius trigger points , were r and omized into one of two , 4 week physical therapy programs . One group received muscle energy techniques while the second group received an integrated neuromuscular inhibition technique ( INIT ) consisting of muscle energy techniques , ischemic compression , and strain – counterstrain ( SCS ) . Outcomes including a visual analog pain scale ( VAS ) , the neck disability index ( NDI ) , and lateral cervical flexion range of motion ( ROM ) were collected at baseline , 2 and 4 weeks after the initiation of therapy . Results revealed large pre – post-effect sizes within the INIT group ( Cohen 's d = 0.97 , 0.94 and 0.97 ) . Additionally , significantly greater improvements in pain and neck disability and lateral cervical flexion ROM were detected in favor of the INIT group ( 0.29–0.57 , 0.57–1.12 and 0.29–0.57 ) at a 95 % CI respectively . The findings of this study indicate the potential benefit of an integrated approach in deactivating upper trapezius trigger points . Further research should be performed to investigate the long-term benefits of the current treatment approach",
"PURPOSE This trial was design ed to evaluate the optimal dose of massage for individuals with chronic neck pain . METHODS We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population , and r and omized them to 5 groups receiving various doses of massage ( a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1 , 2 , or 3 times weekly ) or to a single control group ( a 4-week period on a wait list ) . We assessed neck-related dysfunction with the Neck Disability Index ( range , 0–50 points ) and pain intensity with a numerical rating scale ( range , 0–10 points ) at baseline and 5 weeks . We used log-linear regression to assess the likelihood of clinical ly meaningful improvement in neck-related dysfunction ( ≥5 points on Neck Disability Index ) or pain intensity ( ≥30 % improvement ) by treatment group . RESULTS After adjustment for baseline age , outcome measures , and imbalanced covariates , 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinical ly meaningful improvement in neck dysfunction or pain , regardless of the frequency of treatments . In contrast , 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction ( relative risk = 3.41 and 4.98 , P = .04 and .005 , respectively ) and pain intensity ( relative risk = 2.30 and 2.73 ; P = .007 and .001 , respectively ) . CONCLUSIONS After 4 weeks of treatment , we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain . Clinicians recommending massage and research ers study ing this therapy should ensure that patients receive a likely effective dose of treatment",
"Study Design . A r and omized clinical trial . Objective . To compare the effectiveness of a behavioral grade d activity program with manual therapy in patients with subacute ( 4–12 weeks ) nonspecific neck pain . Summary of Background Data . Neck pain is a common complaint , for which many conservative therapies are available in primary care . There is strong evidence for manual therapy in combination with exercises . Psychosocial factors are also believed to play a role in chronic pain . The evidence of the effectiveness of a program focused on these factors is still unknown . Methods . A r and omized clinical trial was conducted , involving 146 patients with subacute nonspecific neck pain . The BGA program can be described as a time-contingent increase in activities from baseline toward predetermined goals . Manual therapy consists of specific spinal mobilization techniques and exercises . Primary outcomes were global perceived effect , the Numerical Rating Scale for pain and the Neck Disability Index . Secondary outcomes were the Tampa Scale for Kinesiophobia , the 4 Dimensional Symptom Question naire , and the Pain Coping and Cognition List . Measurements were carried out at baseline and 6 , 13 , 26 , and 52 weeks after r and omization . Data are analyzed according to the intention-to-treat principle , using multilevel analysis . Results . The success rates at 52 weeks , based on the GPE were 89.4 % for the BGA program and 86.5 % for MT . This difference was not statistically significant . For pain and disability , a difference was found in favor of the BGA program ; mean difference for pain = 0.99 ( 95 % CI 0.15–1.83 ) and mean difference for NDI = 2.42 ( 95 % CI 0.52–4.32 ) . All other differences between the interventions in the primary and secondary outcomes were not statistically significant . Conclusion . Based on this trial it can be concluded that there are only marginal , but not clinical ly relevant , differences between a BGA program and MT",
"OBJECTIVE Strain-counterstrain is an osteopathic technique which is widely used for treating mobility restrictions in the neck . We aim ed to investigate whether a single strain-counterstrain intervention is more effective than a sham intervention in improving restricted cervical range of motion in patients with neck pain . METHODS 61 adult patients with neck pain and restricted cervical mobility were r and omly allocated to receive either a single strain-counterstrain intervention or a sham treatment . After outcome measurement all patients received full individualized osteopathic treatment . Mobility of the cervical spine was measured by a blinded observer using the Cervical Range of Motion ( CROM ) tool . In addition , patients rated pain intensity and assessed the treatment effect . The main outcome measure was the sum of changes in mobility restriction ( in % ) after treatment compared to normal mobility . RESULTS All patients completed the study . Mobility restriction decreased by 2.0 % ( SD 6.9 % ) in the group receiving strain-counterstrain treatment and 0.6 % ( SD 5.7 % ) in the group receiving sham treatment ( mean difference 1.5 % , 95 % confidence interval -1.7 to 4.8 % ; p=0.35 ) . There were no significant differences between groups for secondary outcomes . After receiving the full osteopathic treatment the group initially receiving strain-counterstrain improved by another 4.2 % ( 7.0 % ; p=0.003 ) and the group initially receiving sham by another 5.6 % ( SD 6.8 % ; p Strain-counterstrain as a single intervention did not have immediate effects on mobility and pain over a sham treatment . Future studies should probably focus on the investigation of full osteopathic treatment",
"Long 's manipulation ( LM ) is a representative Chinese manipulation approach incorporating both spinal manipulation and traditional Chinese massage ( TCM ) techniques . This r and omized controlled trial ( RCT ) aim ed to compare the immediate and short-term relative effectiveness of LM to TCM on patients with chronic neck pain . Patients were r and omly assigned to either LM group or TCM group . LM group was treated with Long 's manipulation , while the TCM group received TCM therapy . Patients attended 8 sessions of treatment ( one session every three days ) . Outcome measures included neck disability ( Northwick Park Neck Pain Question naire ; NPQ ) , pain intensity ( Numeric Pain Rating Scale ; NPRS ) , patient perceived satisfaction of care ( PPS ) ( 11-point scale ) , craniovertebral angle ( CV angle ) and cervical range of motion ( ROM ) . A blinded assessor performed assessment at baseline , immediate after treatment and 3 months post treatment . LM group achieved significantly greater improvement than TCM group in pain intensity ( p ( p = 0.049 ) and satisfaction ( p improvements in CV angle and most of cervical ROM between groups ( p = 0.169 ∼ 0.888 ) with an exception of flexion at 3-month follow-up ( p = 0.005 ) . This study shows that LM could produce better effects than TCM in relieving pain and improving disability in the management of patients with chronic mechanical neck pain",
"Abstract Purpose To evaluate the effectiveness of non-steroidal anti-inflammatory drugs ( NSAIDs ) for the management of neck pain and associated disorders ( NAD ) , whiplash-associated disorders , and non-specific low back pain ( LBP ) with or without radiculopathy . Methods We systematic ally search ed six data bases from 2000 to 2014 . R and om pairs of independent review ers critically appraised eligible systematic review s using the Scottish Intercollegiate Guidelines Network criteria . We included systematic review s with a low risk of bias in our best evidence synthesis . Results We screened 706 citations and 14 systematic review s were eligible for critical appraisal . Eight systematic review s had a low risk of bias . For recent-onset NAD , evidence suggests that intramuscular NSAIDs lead to similar outcomes as combined manipulation and soft tissue therapy . For NAD ( duration not specified ) , oral NSAIDs may be more effective than placebo . For recent-onset LBP , evidence suggests that : ( 1 ) oral NSAIDs lead to similar outcomes to placebo or a muscle relaxant ; and ( 2 ) oral NSAIDs with bed rest lead to similar outcomes as placebo with bed rest . For persistent LBP , evidence suggests that : ( 1 ) oral NSAIDs are more effective than placebo ; and ( 2 ) oral NSAIDs may be more effective than acetaminophen . For recent-onset LBP with radiculopathy , there is inconsistent evidence on the effectiveness of oral NSAIDs versus placebo . Finally , different oral NSAIDs lead to similar outcomes for neck and LBP with or without radiculopathy . Conclusions For NAD , oral NSAIDs may be more effective than placebo . Oral NSAIDs are more effective than placebo for persistent LBP , but not for recent-onset LBP . Different oral NSAIDs lead to similar outcomes for neck pain and LBP",
"OBJECTIVES To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury ; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs ; and to gain participants ' perspective on experiencing whiplash injury , NHS treatment , and recovery within the context of the Managing Injuries of the Neck Trial ( MINT ) . DESIGN Two linked , pragmatic , r and omised controlled trials . In Step 1 , emergency departments ( EDs ) were cluster r and omised to usual care advice ( UCA ) or The Whiplash Book advice (WBA)/active management advice . In Step 2 , participants were individually r and omised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions . An economic evaluation and qualitative study were run in parallel with the trial . SETTING Twelve NHS trusts in Engl and comprising 15 EDs . PARTICIPANTS People who attended EDs with an acute whiplash injury of whiplash-associated disorder grade s I-III were eligible for Step 1 . People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2 . INTERVENTIONS In Step 1 , the control intervention was UCA and the experimental intervention was a psycho-educational intervention ( WBA/active management advice ) . In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments . MAIN OUTCOME The primary outcome was the Neck Disability Index ( NDI ) , which measures severity and frequency of pain and symptoms , and a range of activities including self-care , driving , reading , sleeping and recreation . Secondary outcomes included the mental and physical health-related quality -of-life ( HRQoL ) subscales of the Short Form question naire-12 items ( SF-12 ) and the number of work days lost . RESULTS A total of 3851 patients were recruited to Step 1 of the trial . 1598 patients attending EDs were r and omised to UCA , and 2253 were r and omised to WBA/active management . Outcome data were obtained at 12 months for 70 % and 80 % of participants at Step 1 and Step 2 , respectively . The majority of people recovered from the injury . Eighteen per cent of the Step 1 cohort had late whiplash syndrome . There was no statistically or clinical ly significant difference observed in any of the outcomes for participants attending EDs r and omised to UCA or active management advice [ difference in NDI 0.5 , 95 % confidence interval ( CI ) -1.8 to 2.8 ] . In Step 2 the physiotherapy package result ed in improvements in neck disability at 4 months compared with a single advice session , but these effects were small at the population level ( difference in NDI -3.2 , 95 % CI -5.8 to -0.7 ) . The physiotherapy package was accompanied by a significant reduction in the number of work days lost at 4-month follow-up ( difference -40.2 , 95 % CI -44.3 to -35.8 ) . CONCLUSIONS MINT suggests that enhanced psycho-educational interventions in EDs are no more effective than UCA in reducing the burden of acute whiplash injuries . A physiotherapy package provided to people who have persisting symptoms within the first 6 weeks of injury produced additional short-term benefits in neck disability compared with a single physiotherapy advice session . However , from a health-care perspective , the physiotherapy package was not cost-effective at current levels of willingness to pay . Both experimental treatments were associated with increased cost with no discernible gain in health-related quality of life . However , an important benefit of the physiotherapy package was a reduction in work days lost ; consequently , the intervention may prove cost-effective at the societal level . TRIAL REGISTRATION Current Controlled Trials IS RCT N33302125 . FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 16 , No. 49 . See the HTA programme website for further project information",
"BACKGROUND Mechanical neck pain is a common condition that affects an estimated 70 % of persons at some point in their lives . Little research exists to guide the choice of therapy for acute and subacute neck pain . OBJECTIVE To determine the relative efficacy of spinal manipulation therapy ( SMT ) , medication , and home exercise with advice ( HEA ) for acute and subacute neck pain in both the short and long term . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00029770 ) SETTING 1 university research center and 1 pain management clinic in Minnesota . PARTICIPANTS 272 persons aged 18 to 65 years who had nonspecific neck pain for 2 to 12 weeks . INTERVENTION 12 weeks of SMT , medication , or HEA . MEASUREMENTS The primary outcome was participant-rated pain , measured at 2 , 4 , 8 , 12 , 26 , and 52 weeks after r and omization . Secondary measures were self-reported disability , global improvement , medication use , satisfaction , general health status ( Short Form-36 Health Survey physical and mental health scales ) , and adverse events . Blinded evaluation of neck motion was performed at 4 and 12 weeks . RESULTS For pain , SMT had a statistically significant advantage over medication after 8 , 12 , 26 , and 52 weeks ( P ≤ 0.010 ) , and HEA was superior to medication at 26 weeks ( P = 0.02 ) . No important differences in pain were found between SMT and HEA at any time point . Results for most of the secondary outcomes were similar to those of the primary outcome . LIMITATIONS Participants and providers could not be blinded . No specific criteria for defining clinical ly important group differences were prespecified or available from the literature . CONCLUSION For participants with acute and subacute neck pain , SMT was more effective than medication in both the short and long term . However , a few instructional sessions of HEA result ed in similar outcomes at most time points . PRIMARY FUNDING SOURCE National Center for Complementary and Alternative Medicine , National Institutes of Health",
"INTRODUCTION The costs associated with patients discharged with isolated clinician-elicited persistent midline tenderness and negative computed tomography ( CT ) findings have not been reported . Our aim was to determine the association of acute and post-acute patient and injury characteristics with health re source costs in such patients following road trauma . METHODS In a prospect i ve cohort study , road trauma patients presenting with isolated persistent midline cervical tenderness and negative CT , who underwent additional acute imaging with MRI , were recruited . Patients were review ed in the outpatient spine clinic following discharge , and were followed up at 6 and 12 months post-trauma . Multivariate linear regression was used to assess the association of injury mechanism , clinical assessment , socioeconomic factors and outcome findings with health re source costs generated in the acute hospital and post-acute periods . RESULTS There were 64 patients recruited , of whom 24 ( 38 % ) had cervical spine injury detected on MRI . Of these , 2 patients were managed operatively , 6 were treated in cervical collars and 16 had the cervical spine cleared and were discharged . At 12 months , there were 25 patients ( 44 % ) with residual neck pain , and 22 ( 39 % ) with neck-related disability . The mean total cost was AUD $ 10,153 ( SD=10,791 ) and the median was $ 4015 ( IQR : 3044 - 6709 ) . Transient neurologic deficit , which fully resolved early in the emergency department , was independently associated with higher marginal mean acute costs ( represented in the analysis by the β coefficient ) by $ 3521 ( 95 % CI : 50 - 6880 ) . Low education st and ard ( β coefficient : $ 5988 , 95 % CI : 822 - 13,317 ) , neck pain at 6 months ( β coefficient : $ 4017 , 95 % CI : 426 - 9254 ) and history of transient neurologic deficit ( β coefficient : $ 8471 , 95 % CI : 1766 - 18,334 ) were associated with increased post-acute costs . CONCLUSION In a homogeneous group of road trauma patients with non fracture-related persistent midline cervical tenderness , health re source costs varied considerably . As long term morbidity is common in this population , a history of resolved neurologic deficit may require greater intervention to mitigate costs . Additionally , adequate communication between acute and community care providers is essential in order to expedite the recovery process through early return to normal daily activities",
"Study Design . A r and omized comparative study with single-blind outcome assessment s. Objectives . To compare the efficacy of a multimodal treatment emphasizing proprioceptive training ( ACTIVE ) with activated home exercises ( HOME ) and recommendation of exercise ( CONTROL ) in patients with nonspecific chronic neck pain . Summary of Background Data . The efficacy of active exercises and passive physiotherapy for neck trouble has been somewhat disappointing in the previous few studies . Methods . Seventy-six patients ( 22 men , 54 women ) with chronic , nonspecific neck pain participated . Sixty-two participated the 1-year follow-up . Subjective pain and disability , cervical ranges of motion , and pressure pain threshold in the shoulder region were measured at baseline , at 3 months , and at 12 months . The ACTIVE treatment consisted of 24 sessions of proprioceptive exercises , relaxation , and behavioral support . The HOME regimen included a neck lecture and two sessions of practical training for home exercises and instructions for maintaining a diary of progress . The CONTROL treatment included a lecture regarding care of the neck with a recommendation to exercise . Results . The average self-experienced total benefit was highest in the ACTIVE group , and the HOME group rated over the CONTROL group ( P reduction of neck symptoms and improvements in general health and self-experienced working ability ( P measures of mobility and pressure pain threshold were minor . Conclusions . Regarding self-experienced benefit , the multimodal treatment was more efficacious than activated home exercises that were clearly more efficacious than just advising . No major differences were noted in objective measurements of cervical function between the groups , but the content validity of these assessment s in chronic neck trouble can be question ed",
"Study Design . R and omized controlled trial . Objective . To evaluate whether qigong is more effective than no treatment and not inferior to exercise therapy . Summary of Background Data . Lifetime prevalence of chronic neck pain is close to 50 % . Qigong is often used by patients , although , the evidence is still unclear . Methods . Patients ( aged 20–60 years ) with chronic neck pain ( visual analog scale , VAS ≥40 mm ) were r and omized to 1 ) qigong or 2 ) exercise therapy ( 18 sessions over 6 months ) or 3 ) waiting list ( no treatment ) . At baseline and after 3 and 6 months , patients completed st and ardized question naires assessing neck pain ( VAS ) , neck pain and disability , and quality of life ( Short Form SF-36 question naire , SF-36 ) . The primary endpoint was average pain in the last 7 days on VAS at 6-month follow-up . Statistical analysis included generalized estimation equation models adjusted for baseline values and patient expectation . Results . A total of 123 patients ( aged 46 ± 11 years , 88 % women ) suffering from chronic neck pain for 3.2 ( SD ± 1.6 ) years were included . After 6 months , a significant difference was seen between the qigong and waiting list control groups ( VAS mean difference : −14 mm [ 95 % CI = −23.1 to −5.4 ] , P = 0.002 ) . Mean improvements in the exercise group were comparable to those in the qigong group ( difference between groups −0.7 mm [ CI = −9.1 to 7.7 ] ) but failed to show statistical significance ( P = 0.092 ) . Neck pain and disability , and SF-36 results also yielded superiority of qigong over no treatment and similar results in the qigong and exercise therapy groups . Conclusion . Qigong was more effective than no treatment in patients with chronic neck pain . Further studies could be design ed without waiting list control and should use a larger sample to clarify the value of qigong compared to exercise therapy",
"The Scottish Intercollegiate Guidelines Network ( SIGN ) develops evidence based clinical guidelines for the NHS in Scotl and . The key elements of the methodology are ( a ) that guidelines are developed by multidisciplinary groups ; ( b ) they are based on a systematic review of the scientific evidence ; and ( c ) recommendations are explicitly linked to the supporting evidence and grade d according to the strength of that evidence . Until recently , the system for grading guideline recommendations was based on the work of the US Agency for Healthcare Research and Quality ( formerly the Agency for Health Care Policy and Research ) . 1 2 However , experience over more than five years of guideline development led to a growing awareness of this system 's weaknesses . Firstly , the grading system was design ed largely for application to questions of effectiveness , where r and omised controlled trials are accepted as the most robust study design with the least risk of bias in the results . However , in many areas of medical practice r and omised trials may not be practical or ethical to undertake ; and for many questions other types of study design may provide the best evidence . Secondly , guideline development groups often fail to take adequate account of the method ological quality of individual studies and the overall picture presented by a body of evidence rather than individual studies or they fail to apply sufficient judgment to the overall strength of the evidence base and its applicability to the target population of the guideline . Thirdly , guideline users are often not clear about the implication s of the grading system . They misinterpret the grade of recommendation as relating to its importance , rather than to the strength of the supporting evidence , and may therefore fail to give due weight to low grade recommendations . # # # # Summary points A revised system of determining levels of evidence and grade s",
"Purpose : To evaluate whether long-term neck and upper body exercises conducted in economical community-based outpatient clinic and home-based setting s could improve health-related quality of life (HRQoL)for individuals affected by chronic neck pain . The effect of baseline HRQoL and neck pain values on training adherence was also studied . Methods : Subjects ( n = 101 , 91 women/10 men , mean age 41.0 ± 9.5 years ) with chronic non-specific neck pain were r and omized to a combined strength-training and stretching-exercise group ( CSSG , n = 49 ) or to a stretching exercise group ( SG , n = 52 ) . HRQoL was assessed at baseline and after 12 months using the R AND -36 question naire . Comparisons between groups were performed using bootstrap-type analysis of covariance . The impact of HRQoL and neck pain values on training adherence , determined using participants ’ exercise logs , was studied using generalized estimating equations . Results : CSSG showed significant improvements in five and SG in four of eight of the HRQoL dimensions . There were no significant differences between the groups . Adherence to long-term training was only slightly affected by baseline-assessed HRQoL and neck pain values . Conclusions : The two training protocol s were feasible and equally effective in improving HRQoL. Baseline HRQoL and pain values had only a minor effect on training adherence . Implication s for Rehabilitation Long-term strength training and stretching are effective in improving HRQoL in people with chronic neck pain . Baseline HRQoL and neck pain values have little effect on training adherence",
"OBJECTIVE To assess the efficacy of soft cervical collars in the early management of whiplash-injury-related pain . METHODS A controlled , clinical trial was conducted in an urban ED . Adults with neck pain following automobile crashes indicated their initial degrees of pain on a visual analog scale . Patients with cervical spine fractures or subluxation , focal neurologic deficits , or other major distracting injuries were excluded . Patients were assigned to receive a soft cervical collar or no collar based on their medical record numbers . Pain at > or = 6 weeks postinjury was coded as none , better , same , or worse , and analyzed as 3 dichotomous outcomes : recovered ( pain = none ) ; improved ( pain = none or better ) ; and deteriorated ( pain = worse ) . RESULTS Of 250 patients enrolled , 196 ( 78 % ) were available for follow-up . Of these patients , 104 ( 53 % ) were assigned to the soft cervical collar group , and 92 ( 47 % ) to the control group . These groups were similar in age , gender , seat position in the car , seat belt use , and initial pain score . Pain persisted at > or = 6 weeks in 122 ( 62 % ) patients . The groups showed no difference in follow-up pain category ( p = 0.59 ) . There was no significant difference between the 2 groups in complete recovery ( p = 0.34 ) , improvement ( p = 0.34 ) , or deterioration ( p = 0.60 ) . The study had a power of 80 % to detect an absolute difference of at least 20 % in recovery , 17 % in improvement , and 7 % in deterioration ( 2-tailed , alpha = 0.05 ) . CONCLUSIONS Most patients with whiplash injuries have persistent pain for at least 6 weeks . Soft cervical collars do not influence the duration or degree of persistent pain",
"Low back pain is the fifth most common reason for all physician visits in the United States ( 1 , 2 ) . Approximately one quarter of U.S. adults reported having low back pain lasting at least 1 whole day in the past 3 months ( 2 ) , and 7.6 % reported at least 1 episode of severe acute low back pain ( see Glossary ) within a 1-year period ( 3 ) . Low back pain is also very costly : Total incremental direct health care costs attributable to low back pain in the U.S. were estimated at $ 26.3 billion in 1998 ( 4 ) . In addition , indirect costs related to days lost from work are substantial , with approximately 2 % of the U.S. work force compensated for back injuries each year ( 5 ) . Many patients have self-limited episodes of acute low back pain and do not seek medical care ( 3 ) . Among those who do seek medical care , pain , disability , and return to work typically improve rapidly in the first month ( 6 ) . However , up to one third of patients report persistent back pain of at least moderate intensity 1 year after an acute episode , and 1 in 5 report substantial limitations in activity ( 7 ) . Approximately 5 % of the people with back pain disability account for 75 % of the costs associated with low back pain ( 8) . Many options are available for evaluation and management of low back pain . However , there has been little consensus , either within or between specialties , on appropriate clinical evaluation ( 9 ) and management ( 10 ) of low back pain . Numerous studies show unexplained , large variations in use of diagnostic tests and treatments ( 11 , 12 ) . Despite wide variations in practice , patients seem to experience broadly similar outcomes , although costs of care can differ substantially among and within specialties ( 13 , 14 ) . The purpose of this guideline is to present the available evidence for evaluation and management of acute and chronic low back pain ( see Glossary ) in primary care setting s. The target audience for this guideline is all clinicians caring for patients with low ( lumbar ) back pain of any duration , either with or without leg pain . The target patient population is adults with acute and chronic low back pain not associated with major trauma . Children or adolescents with low back pain ; pregnant women ; and patients with low back pain from sources outside the back ( nonspinal low back pain ) , fibromyalgia or other myofascial pain syndromes , and thoracic or cervical back pain are not included . These recommendations are based on a systematic evidence review summarized in 2 background papers by Chou and colleagues in this issue ( 15 , 16 ) from an evidence report by the American Pain Society ( 17 ) . The evidence report ( 17 ) discusses the evidence for the evaluation , and the 2 background papers ( 15 , 16 ) summarize the evidence for management . Methods The literature search for this guideline included studies from MEDLINE ( 1966 through November 2006 ) , the Cochrane Data base of Systematic Review s , the Cochrane Central Register of Controlled Trials , and EMBASE . The literature search included all English- language articles reporting on r and omized , controlled trials of nonpregnant adults ( age > 18 years ) with low back pain ( alone or with leg pain ) of any duration that evaluated a target medication and reported at least 1 of the following outcomes : back-specific function , generic health status , pain , work disability , or patient satisfaction . The American College of Physicians ( ACP ) and the American Pain Society ( APS ) convened a multidisciplinary panel of experts to develop the key questions and scope used to guide the evidence report , review its results , and formulate recommendations . The background papers by Chou and colleagues ( 15 , 16 ) provide details about the methods used for the systematic evidence review . This guideline grade s its recommendations by using the ACP 's clinical practice guidelines grading system , adapted from the classification developed by the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) work group ( Appendix Table 1 ) ( 18 ) . The evidence in this guideline was first evaluated by the ACP/APS panel by using a system adopted from the U.S. Preventive Services Task Force for grading strength of evidence , estimating magnitude of benefits , and assigning summary ratings ( Appendix Tables 2 , 3 , and 4 ) ( 19 ) . The evidence was independently review ed by the ACP 's Clinical Efficacy Assessment Subcommittee . The ratings for individual low back pain interventions discussed in this guideline are summarized in Appendix Table 5 for acute low back pain ( 4 weeks ' duration ) . This guideline considered interventions to have proven benefits only when they were supported by at least fair- quality evidence and were associated with at least moderate benefits ( or small benefits but no significant harms , costs , or burdens ) . Figures 1 and 2 present an accompanying algorithm . Appendix Table 1 . The American College of Physicians Clinical Practice Guidelines Grading System Appendix Table 2 . Methods for Grading the Strength of the Overall Evidence for an Intervention Appendix Table 3 . Definitions for Estimating Magnitude of Effects Appendix Table 4 . Recommendations and Summary Ratings Appendix Table 5 . Level of Evidence and Summary Grade s for Noninvasive Interventions in Patients with Acute Low Back Pain Appendix Table 6 . Level of Evidence and Summary Grade s for Noninvasive Interventions in Patients with Chronic or Subacute Low Back Pain Figure 1 . Initial evaluation of low back pain ( LBP Figure 2 . Management of low back pain ( LBP Recommendations : Evaluation of Low Back Pain Recommendation 1 : Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories : nonspecific low back pain , back pain potentially associated with radiculopathy or spinal stenosis , or back pain potentially associated with another specific spinal cause . The history should include assessment of psychosocial risk factors , which predict risk for chronic disabling back pain ( strong recommendation , moderate- quality evidence ) . More than 85 % of patients who present to primary care have low back pain that can not reliably be attributed to a specific disease or spinal abnormality ( nonspecific low back pain [ see Glossary ] ) ( 20 ) . Attempts to identify specific anatomical sources of low back pain in such patients have not been vali date d in rigorous studies , and classification schemes frequently conflict with one another ( 21 ) . Moreover , no evidence suggests that labeling most patients with low back pain by using specific anatomical diagnoses improves outcomes . In a minority of patients presenting for initial evaluation in a primary care setting , low back pain is caused by a specific disorder , such as cancer ( approximately 0.7 % of cases ) , compression fracture ( 4 % ) , or spinal infection ( 0.01 % ) ( 22 ) . Estimates for prevalence of ankylosing spondylitis in primary care patients range from 0.3 % ( 22 ) to 5 % ( 23 ) . Spinal stenosis ( see Glossary ) and symptomatic herniated disc ( see Glossary ) are present in about 3 % and 4 % of patients , respectively . The cauda equina syndrome ( see Glossary ) is most commonly associated with massive midline disc herniation but is rare , with an estimated prevalence of 0.04 % among patients with low back pain ( 24 ) . A practical approach to assessment is to do a focused history and physical examination to determine the likelihood of specific underlying conditions and measure the presence and level of neurologic involvement ( 24 , 25 ) . Such an approach facilitates classification of patients into 1 of 3 broad categories : nonspecific low back pain , back pain potentially associated with radiculopathy ( see Glossary ) or spinal stenosis ( suggested by the presence of sciatica [ see Glossary ] or pseudoclaudication ) , and back pain potentially associated with another specific spinal cause . The latter category includes the small proportion of patients with serious or progressive neurologic deficits or underlying conditions requiring prompt evaluation ( such as tumor , infection , or the cauda equina syndrome ) , as well as patients with other conditions that may respond to specific treatments ( such as ankylosing spondylitis or vertebral compression fracture ) . Diagnostic triage into 1 of these 3 categories helps guide subsequent decision making . Clinicians should inquire about the location of pain , frequency of symptoms , and duration of pain , as well as any history of previous symptoms , treatment , and response to treatment . The possibility of low back pain due to problems outside the back , such as pancreatitis , nephrolithiasis , or aortic aneurysm , or systemic illnesses , such as endocarditis or viral syndromes , should be considered . All patients should be evaluated for the presence of rapidly progressive or severe neurologic deficits , including motor deficits at more than 1 level , fecal incontinence , and bladder dysfunction . The most frequent finding in the cauda equina syndrome is urinary retention ( 90 % sensitivity ) ( 24 ) . In patients without urinary retention , the probability of the cauda equina syndrome is approximately 1 in 10000 . Clinicians should also ask about risk factors for cancer and infection . In a large , prospect i ve study from a primary care setting , a history of cancer ( positive likelihood ratio , 14.7 ) , unexplained weight loss ( positive likelihood ratio , 2.7 ) , failure to improve after 1 month ( positive likelihood ratio , 3.0 ) , and age older than 50 years ( positive likelihood ratio , 2.7 ) were each associated with a higher likelihood for cancer ( 26 ) . The posttest probability of cancer in patients presenting with back pain increases from approximately 0.7 % to 9 % in patients with a history of cancer ( not including nonmelanoma skin cancer ) . In patients with any 1 of the other 3 risk factors , the likelihood of cancer only increases to approximately 1.2 % ( 26 ) . Features predicting the presence of vertebral infection have not been well studied",
"In a controlled , cross-over study the effect of low level laser therapy ( LLLT ) was evaluated . During a five weeks period forty-seven female laboratory technicians received six laser and six placebo treatments to tender points in the neck and shoulder girdle . Subjects rated the placebo treatment significantly more beneficial than LLLT ( p = .04 ) . There was no reduction in consumption of analgesics associated with either laser or placebo treatment . The results indicate no beneficial effect of LLLT for myofascial pain",
"UNLABELLED Yoga has been found effective in the treatment of chronic low back pain . We aim ed to evaluate the effectiveness of Iyengar yoga in chronic neck pain by means of a r and omized clinical trial . Seventy-seven patients ( aged 47.9 ± 7.9 , 67 female ) with chronic neck pain who scored > 40 mm on a 100-mm visual analog scale ( VAS ) were r and omized to a 9-week Iyengar yoga program with weekly 90-minute classes ( n = 38 ) or to a self-care/exercise program ( n = 38 ) . Patients were examined at baseline and after 4 and 10 weeks . The primary outcome measure was change of mean pain at rest ( VAS ) from baseline to week 10 . Secondary outcomes included pain at motion , functional disability , quality of life ( QOL ) , and psychological outcomes . Twelve patients in the yoga group and 11 patients in the self-care/exercise group were lost to follow-up , with higher study nonadherence in the self-care group ( 5 versus 10 patients ) . Mean pain at rest was reduced from 44.3 ± 20.1 to 13.0 ± 11.6 at week 10 by yoga and from 41.9 ± 21.9 to 34.4 ± 21.1 by self-care/exercise ( group difference : -20.1 , 95 % confidence interval : -30.0 , -10.1 ; P was reduced from 53.4 ± 18.5 to 22.4 ± 18.7 at week 10 by yoga and from 49.4 ± 22.8 to 39.9 ± 21.5 by self-care/exercise ( group difference : -18.7 , 95 % confidence interval : -29.3 , -8.1 ; P . Significant treatment effects of yoga were also found for pain-related apprehension , disability , QOL , and psychological outcomes . Sensitivity analyses suggested minimal influence of dropout rates . Both programs were well tolerated . In this preliminary trial , yoga appears to be an effective treatment in chronic neck pain with possible additional effects on psychological well-being and QOL . The effectiveness of yoga in chronic neck pain should be further tested by comparative effectiveness studies with longer observation periods . PERSPECTIVE This article presents the results of a r and omized controlled trial on the clinical effects of a 9-week yoga program or self-care exercise in patients with chronic neck pain . Yoga led to superior pain relief and functional improvements and might be a useful treatment option for chronic neck pain",
"Background A clinical prediction rule ( CPR ) purported to identify patients with neck pain who are likely to respond to thoracic spine thrust manipulation has recently been developed , but has yet to be vali date d. Objective The purpose of this study was to examine the validity of this CPR . Design This was a multi-center r and omized clinical trial . Methods One hundred forty patients with a primary report of neck pain were r and omly assigned to receive either 5 sessions of stretching and strengthening exercise ( exercise-only group ) or 2 sessions of thoracic spine manipulation and cervical range of motion exercise followed by 3 sessions of stretching and strengthening exercise ( manipulation + exercise group ) . Data on disability and pain were collected at baseline , 1 week , 4 weeks , and 6 months . The primary aim ( treatment group × time × status on the prediction rule ) was examined using a linear mixed model with repeated measures . Time , treatment group , and status on the rule , as well as all possible 2-way and 3-way interactions , were modeled as fixed effects , with disability ( and pain ) as the dependent variable . Effect sizes were calculated for both pain and disability at each follow-up period . Results There was no 3-way interaction for either disability or pain . A 2-way ( group × time ) interaction existed for both disability and pain . Pair-wise comparisons of disability demonstrated that significant differences existed at each follow-up period between the manipulation + exercise group and the exercise-only group . The patients who received manipulation exhibited lower pain scores at the 1-week follow-up period . The effect sizes were moderate for disability at each follow-up period and were moderate for pain at the 1-week follow-up . Limitations Different exercise approaches may have result ed in a different outcome . Conclusions The results of the current study did not support the validity of the previously developed CPR . However , the results demonstrated that patients with mechanical neck pain who received thoracic spine manipulation and exercise exhibited significantly greater improvements in disability at both the short- and long-term follow-up periods and in pain at the 1-week follow-up compared with patients who received exercise only",
"IMPORTANCE Low back pain ( LBP ) is responsible for more than 2.5 million visits to US emergency departments ( EDs ) annually . These patients are usually treated with nonsteroidal anti-inflammatory drugs , acetaminophen , opioids , or skeletal muscle relaxants , often in combination . OBJECTIVE To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients r and omized to a 10-day course of ( 1 ) naproxen + placebo ; ( 2 ) naproxen + cyclobenzaprine ; or ( 3 ) naproxen + oxycodone/acetaminophen . DESIGN , SETTING , AND PARTICIPANTS This r and omized , double-blind , 3-group study was conducted at one urban ED in the Bronx , New York City . Patients who presented with nontraumatic , nonradicular LBP of 2 weeks ' duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Rol and -Morris Disability Question naire ( RMDQ ) . The RMDQ is a 24-item question naire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment . Beginning in April 2012 , a total of 2588 patients were approached for enrollment . Of the 323 deemed eligible for participation , 107 were r and omized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen . Follow-up was completed in December 2014 . INTERVENTIONS All participants were given 20 tablets of naproxen , 500 mg , to be taken twice a day . They were r and omized to receive either 60 tablets of placebo ; cyclobenzaprine , 5 mg ; or oxycodone , 5 mg/acetaminophen , 325 mg . Participants were instructed to take 1 or 2 of these tablets every 8 hours , as needed for LBP . They also received a st and ardized 10-minute LBP educational session prior to discharge . MAIN OUTCOMES AND MEASURES The primary outcome was improvement in RMDQ between ED discharge and 1 week later . RESULTS Demographic characteristics were comparable among the 3 groups . At baseline , median RMDQ score in the placebo group was 20 ( interquartile range [IQR],17 - 21 ) , in the cyclobenzaprine group 19 ( IQR,17 - 21 ) , and in the oxycodone/acetaminophen group 20 ( IQR,17 - 22 ) . At 1-week follow-up , the mean RMDQ improvement was 9.8 in the placebo group , 10.1 in the cyclobenzaprine group , and 11.1 in the oxycodone/acetaminophen group . Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 ( 98.3 % CI , -2.6 to 3.2 ; P = .77 ) , for oxycodone/acetaminophen vs placebo , 1.3 ( 98.3 % CI , -1.5 to 4.1 ; P = .28 ) , and for oxycodone/acetaminophen vs cyclobenzaprine , 0.9 ( 98.3 % CI , -2.1 to 3.9 ; P = .45 ) . CONCLUSIONS AND RELEVANCE Among patients with acute , nontraumatic , nonradicular LBP presenting to the ED , adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up . These findings do not support use of these additional medications in this setting . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01587274",
"Context Neck pain is common among primary care patients . Evidence on the effectiveness of therapies for neck pain is limited . A previous r and omized , controlled trial suggested benefits from manual therapy and physical therapy . Contribution This r and omized , controlled trial of manual therapy , physical therapy , and continued care by a doctor confirms the superiority of manual therapy and physical therapy over continued care . At 7 weeks , 68.3 % of patients in the manual therapy group reported resolved or much improved pain , compared with 50.8 % of patients in the physical therapy group and 35.9 % of patients in the continued care group . Clinical Implication s Primary care physicians should consider manual therapy when treating patients with neck pain . The Editors Neck pain is a common problem in the general population , with point prevalences between 10 % and 15 % ( 1 - 3 ) . It is most common at approximately 50 years of age and is more common in women than in men ( 1 , 2 , 4 - 6 ) . Neck pain can be severely disabling and costly , and little is known about its clinical course ( 7 - 9 ) . Limited range of motion and a subjective feeling of stiffness may accompany neck pain , which is often precipitated or aggravated by neck movements or sustained neck postures . Headache , brachialgia , dizziness , and other signs and symptoms may also be present in combination with neck pain ( 10 , 11 ) . Although history taking and diagnostic examination can suggest a potential cause , in most cases the pathologic basis for neck pain is unclear and the pain is labeled nonspecific . Conservative treatment methods that are frequently used in general practice include analgesics , rest , or referral to a physical therapist or manual therapist ( 12 , 13 ) . Physical therapy may include passive treatment , such as massage , interferential current , or heat applications , and active treatment , such as exercise therapies . Physical therapists can specialize in passive manual ( or h and s-on ) techniques , including mobilization or manipulation ( high-velocity thrust techniques ) , also referred to as manual therapy ( 14 - 19 ) . According to the International Federation of Orthopedic Manipulative Therapies , Orthopedic manipulative ( manual ) therapy is a specialization within physical therapy and provides comprehensive conservative management for pain and other symptoms of neuro-musculo-articular dysfunction in the spine and extremities ( unpublished data ) . Today , many different manual therapy approaches are applied by various health professionals , including medical doctors , physical therapists , massage therapists , manual therapists , chiropractors , and osteopathic doctors . Review s of trials involving manual therapy or physical therapy show that most interventions in these categories are characterized by a combination of passive and active components ( 20 - 23 ) . Although a combination of manual therapy or physical therapy that includes exercises appears to be effective for neck pain , these therapies have not been studied in sufficient detail to draw firm conclusions , and the method ologic quality of most trials on neck pain is rather low ( 20 - 23 ) . Koes and colleagues ( 24 , 25 ) performed a r and omized trial on back and neck pain and found promising results for manual therapy and physical therapy in subgroup analyses of patients with neck pain . In our r and omized , controlled trial , we compared the effectiveness of manual therapy , physical therapy , and continued care by a general practitioner in patients with nonspecific neck pain . Methods Patients Patients with nonspecific neck pain whose clinical presentation did not warrant referral for further diagnostic screening were referred to one of four research centers by 42 general practitioners for study selection . We excluded patients whose history , signs , and symptoms suggested a potential nonbenign cause ( including previous surgery of the neck ) or evidence of a specific pathologic condition , such as malignancy , neurologic disease , fracture , herniated disc , or systemic rheumatic disease . Two research assistants who were experienced physical therapists and were blinded to treatment allocation performed physical examinations at baseline and follow-up . They used st and ardized inclusion and exclusion criteria and performed a short neurologic examination ( Appendix Table 1 ) and range-of-motion assessment . The eligibility criteria were age between 18 and 70 years , pain or stiffness in the neck for at least 2 weeks , neck symptoms reproducible during physical examination , willingness to adhere to treatment and measurement regimens , no physical therapy or manual therapy for neck pain during the previous 6 months , no involvement in litigation , and written informed consent . Patients with concurrent headaches , nonradicular pain in the upper extremities , and low back pain were not excluded , but neck pain had to be the main symptom for all patients . R and om Assignment and Data Collection All patient data were collected before r and omization . Patients were assigned to a treatment group on the basis of block r and omization after prestratification for symptom severity ( severity scores age ( and , mainly for practical reasons , research center ( four local centers ) . R and omized permuted blocks of six patients were generated for each stratum by using a computer-generated r and om-sequence table . A research er who was not involved in the project prepared opaque , sequentially numbered sealed envelopes that contained folded cards indicating one of the three interventions . Interventions The intervention period lasted 6 weeks . Patients were allowed to perform exercises at home and to continue medication prescribed at baseline or use over-the-counter analgesics . Other co- interventions were discouraged but were registered if they occurred . Within the boundaries of the protocol , treatment could be reassessed and adapted to the patient 's condition . The specific treatment characteristics were registered at each visit . A maximum number of visits was set for each intervention group ; however , the patients did not have to complete this maximum number if symptoms had resolved . Manual Therapy Our approach to manual therapy was eclectic and incorporated several techniques used in western Europe , North America , and Australia , including those described by Cyriax , Kaltenborn , Maitl and , and Mennel ( 15 , 16 , 19 ) . In our trial , manual therapy ( defined as the use of passive movements to help restore normal spinal function ) included h and s-on muscular mobilization techniques ( aim ed at improving soft tissue function ) , specific articular mobilization techniques ( to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine ) , and coordination or stabilization techniques ( to improve postural control , coordination , and movement patterns by using the stabilizing cervical musculature ) ( 26 ) . Joint mobilization is a form of manual therapy that involves low-velocity passive movements within or at the limit of joint range of motion ( 27 ) . Manual therapists must undergo extensive training to be able to skillfully perform mobilization techniques ( 15 , 19 ) . Spinal manipulations ( low-amplitude , high-velocity thrust techniques ) were not included in this protocol . Forty-five minute treatment sessions were scheduled once per week , for a maximum of six treatments . Six experienced manual therapists acknowledged by the Netherl and s Manual Therapy Association performed the treatment . Physical Therapy The physical therapists used a combination of several treatment options , but active exercise therapies were the cornerstone of their strategy . Active exercise therapy involves participation by the patient and includes active exercises ( to improve strength or range of motion ) , postural exercises , stretching , relaxation exercises , and functional exercises . Manual traction or stretching , massage , or physical therapy methods , such as interferential current or heat applications , could precede the exercise therapy . Specific manual mobilization techniques were not included in this protocol . Thirty-minute treatment sessions were scheduled twice per week for a maximum of 12 treatments . The treatment was performed by five experienced physical therapists . We prevented cross-contamination with manual therapy by choosing physical therapists who were not manual therapy specialists . Continued Care by a General Practitioner Each patient in this group received st and ardized care from his or her general practitioner , including advice on prognosis , advice on psychosocial issues , advice on self-care ( heat application , home exercises ) , advice on ergonomics ( for example , size of pillow , work position ) , and encouragement to await further recovery . The treatment protocol was similar to the practice guidelines for low back pain issued by the Dutch College of General Practitioners ( 28 ) . Patients received an educational booklet containing ergonomic advice and exercises ( 29 ) . Medication , including paracetamol or nonsteroidal anti-inflammatory drugs , was prescribed on a time-contingent basis if necessary . Ten-minute follow-up visits , scheduled every 2 weeks , were optional , and referral during the intervention period was discouraged . Outcome Measures Data were collected at the research center after 3 and 7 weeks . At 7 weeks , treatment results were expected to be maximal . The patients were repeatedly asked not to reveal any information about their treatment allocation to the research assistants . The success of blinding was evaluated at 7 weeks . Primary outcome measures focused on perceived recovery , pain , and functional disability . Patients rated perceived recovery on a 6-point ordinal transition scale , ranging from much worse to completely recovered . Success was defined a priori as completely recovered or much improved ( 30 ) . In addition , on the basis of the systematic assessment of spinal mobility , palpation , and pain reported by"
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Rationale Pharmacotherapy is frequently considered in the treatment of disruptive behavior disorders ( DBDs ) in children and adolescents . There are , however , no systematic review s of this literature . Objectives The aim of this work is to determine whether medication is effective in treating pediatric disruptive behavior disorders and related problems of impulse control , as well as to examine differences in the treatment response and tolerability of different medication classes and agents . Material s and methods R and omized controlled trials of the pharmacotherapy of DBDs in children and adolescents were review ed , and a meta- analysis of 14 trials ( 823 participants ) was conducted . Results There is some evidence of the effectiveness of medication in treating DBDs , with positive outcomes for lithium and risperidone in particular . Pharmacotherapy also demonstrated some efficacy in reducing symptoms of aggression . Medication was relatively well-tolerated , as indicated by equivalent dropout rates in medication and comparison groups . Conclusions There are relatively few controlled trials of the pharmacotherapy of disruptive behavior disorders or other impulse control disorders , despite the importance of research in this area . Given the potential adverse effects of agents such as lithium and risperidone , a careful risk – benefit analysis is needed for each patient
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"The efficacy and safety of haloperidol , lithium carbonate , and placebo were critically assessed in 61 treatment-resistant , hospitalized children aged 5.2 to 12.9 years with diagnoses of conduct disorder , aggressive type . In this double-blind and well-controlled study , the optimal dosages of haloperidol ranged from 1.0 to 6.0 mg/day and those of lithium carbonate from 500 to 2,000 mg/day . For the assessment of behavioral changes and untoward effects , various rating scales were used in different setting s. Both haloperidol and lithium carbonate were found to be significantly superior to placebo in decreasing behavioral symptoms . Although both medications were clinical ly effective , haloperidol was associated more often with untoward effects than was lithium carbonate",
"OBJECTIVE To examine the relationship between attention deficit disorder with hyperactivity in childhood and criminality in adolescence and adulthood in 89 hyperactive and 87 normal control subjects . METHOD In this prospect i ve study , adolescent follow-up intervals ranged from 13 to 21 years and adult follow-up ranged from 18 to 23 years . The official arrest records for all subjects were obtained . RESULTS Hyperactive subjects had significantly higher juvenile ( 46 % versus 11 % ) and adult ( 21 % versus 1 % ) arrest rates . Juvenile and adult incarceration rates were also significantly higher . Childhood conduct problems predicted later criminality , and serious antisocial behavior in adolescence predicted adult criminality . CONCLUSIONS Hyperactive children are at risk for both juvenile and adult criminality . The risk for becoming an adult offender is associated with conduct problems in childhood and serious antisocial behavior ( repeat offending ) in adolescence . Hyperactive children who do not have conduct problems are not at increased risk for later criminality",
"BACKGROUND Stimulants are not considered appropriate for the treatment of children with conduct disorders ( CDs ) . The postulated differences in stimulant effect between children with attention deficit hyperactivity disorder ( ADHD ) and CD led to the hypothesis that methylpheni date hydrochloride , which is effective in ADHD , would not significantly improve symptoms of CD . METHODS We r and omly assigned 84 children with CD , between the ages of 6 and 15 years , to receive methylpheni date hydrochloride ( up to 60 mg/d ) or placebo for 5 weeks . Behavior was evaluated by parent , teacher , and clinician reports and by direct classroom observations . Two thirds of the children also met criteria for ADHD . RESULTS Contrary to prediction , ratings of antisocial behaviors specific to CD were significantly reduced by methylpheni date treatment . The magnitude of methylpheni date effect indicated meaningful clinical benefit . Partialling out severity of ADHD did not alter the significant superiority of methylpheni date on CD ratings specifically ( P Methylpheni date has short-term positive effects on children and adolescents with CD . Key aspects of antisocial adjustment appear to be treatment responsive . This effect was independent of severity of the children 's initial ADHD symptoms",
"THE CONCEPT of minimal brain dysfunction ( MBD ) was developed to account for a variety of obscure behavioral abnormalities often considered purely functional in nature . 1 - 4 In a recent review of the subject Pincus and Glaser 2 describe the motor , perceptual , and behavioral characteristics that comprise the MBD syndrome . They state that MBD is a \" behavioral diagnosis . \" The children afflicted show \" inappropriate activity , \" \" disordered attention span , \" \" poorly controlled behavior , \" \" impulsiveness with destructive elements , \" \" hyperkinesis , \" \" outbursts of aggression , temper tantrums , sexual displays . \" There may be motor , perceptual , reading , and writing impairment , as well as poor ability at copying complex Gestalten . 5 - 7 There is often a history of delayed developmental milestones as well as organic cerebral trauma due to complications of pregnancy , traumatic birth , head trauma , or intracerebral infection after birth . Abnormal behavior such as violent aggressiveness or lack of attention at school may thus be seen as due , in part , to",
"BACKGROUND Prior research indicates that conduct disorder ( CD ) is associated with a range of co-morbid mental disorders . However , the actual prevalence , subtypes and patterns of co-morbidity of DSM-IV-defined CD in the general US population remains unknown . METHOD Retrospective assessment of CD and other DSM-IV disorders was conducted using fully structured diagnostic interviews among a nationally representative sample of respondents ( n=3199 ) in the National Comorbidity Survey Replication ( NCS-R ) . RESULTS The estimated lifetime prevalence of CD in the US is 9.5 % ( 12.0 % among males and 7.1 % among females ) , with a median age-of-onset of 11.6 ( 0.2 ) years . Latent class analysis ( LCA ) identified five CD subtypes characterized by rule violations , deceit/theft , aggression , severe covert behaviors , and pervasive CD symptoms . A dose-response relationship was revealed between CD subtype severity and risk of subsequent disorders . Results also indicated that CD typically precedes mood and substance use disorders , but most often occurs after impulse control and anxiety disorders . Although both active and remitted CD is associated with increased risk of the subsequent first onset of other mental disorders , remitted CD is associated with significantly lower risk of subsequent disorders . CONCLUSIONS CD is prevalent and heterogeneous in the US population , and more severe subtypes and the presence of active CD are associated with higher risk of co-morbid disorders . Future prospect i ve studies using general population sample s will further inform the nature and course of this disorder",
"This article describes an open study of lithium carbonate in conduct-disordered children . The objective of the study was to investigate the effectiveness of lithium in reducing aggression and the usefulness of the Overt Aggression Scale ( OAS ) , as a measure of treatment effect . The subjects , 8 children , ages 9.2 to 16.9 years ( mean + /- st and ard deviation [ SD ] = 12.48 + /- 2.97 ) , were treated for 4 weeks with lithium . Optimal dosages ranged from 1200 to 1800 mg/day ( mean = 1350 + /- 227 ) with corresponding serum lithium levels ranging from 0.86 to 1.39 mEq/L ( mean = 1.05 + /- 0.17 ) . OAS results indicated that aggression decreased significantly over time . The findings from the OAS agreed with findings from a more general measure , the Global Clinical Consensus Rating , leading to the conclusion that the OAS is a promising outcome measure for treatment studies of aggression in children . Further placebo-controlled studies of lithium carbonate in reducing aggressive behavior in conduct-disordered children , employing a specific measure such as the OAS , are warranted",
"OBJECTIVE To assess critically the efficacy and safety of lithium and replicate earlier findings in a larger sample of aggressive children with conduct disorder and to assess the utility of the Profile of Mood States ( POMS ) in this population . METHODS Children hospitalized for treatment-refractory severe aggressiveness and explosiveness and with diagnosed conduct disorder were subjects in this double-blind , placebo-controlled clinical trial . After a 2-week placebo baseline period , children were r and omly assigned to lithium or placebo treatment for 6 weeks of placebo . The main outcome measures were the Global Clinical Judgments ( Consensus ) Scale , Children 's Psychiatric Rating Scale , Conners Teacher Question naire , Parent-Teacher Question naire , and the POMS . RESULTS Fifty children ( mean age 9.4 years ) completed this study . The mean optimal daily dose of lithium was 1,248 mg and the mean serum level was 1.12 mEq/L. Lithium was superior to placebo , although the effects on some measures were more modest than in a previous study . CONCLUSIONS Lithium appears to be an effective treatment for some severely aggressive children with conduct disorder . Although the POMS appeared to be reliable , it did not detect any response to lithium",
"One of the least documented \" known \" effects of methylpheni date in hyperactive children is the suppression of peer aggression . In this study , 11 aggressive-hyperactive children received a low ( 0.3 mg/kg ) and moderate ( 0.6 mg/kg ) dose of methylpheni date and placebo for 2 weeks each under double-blind conditions . Children were observed in public school setting s during classroom seatwork activities , lunch , and recess . Results showed that methylpheni date suppressed nonphysical aggression ( p = 0.06 ) in the classroom , and a moderate dose decreased physical aggression ( p less than 0.01 ) and verbal aggression ( p = 0.07 ) on the playground . The effect on the rate of appropriate social interaction was variable . The majority of subjects exhibited either the same or higher levels of appropriate social interaction on the 0.6 mg/kg dose compared with placebo . In the classroom , both doses of methylpheni date also result ed in reduced levels of motor movement , off-task behavior , noncompliance , and disruptiveness . Teacher ratings of hyperactivity and conduct problem symptoms revealed drug effects , whereas parallel parent instruments did not",
"OBJECTIVE To determine whether risperidone is effective in reducing symptoms of disruptive behaviors ( such as aggression , impulsivity , defiance of authority figures , and property destruction ) associated with conduct disorder , oppositional defiant disorder , and disruptive behavior disorder-not otherwise specified in children with subaverage IQs . METHOD The trial consisted of a 1-week , single-blind , placebo run-in period and was followed by a 6-week , double-blind , placebo-controlled period . One hundred ten children ( aged 5 - 12 years inclusive ) with an IQ of 36 - 84 with a disruptive behavior disorder and a score of at least 24 on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form ( NCBRF ) were enrolled . Eighty percent of subjects had comorbid attention-deficit/hyperactivity disorder ( ADHD ) . Risperidone doses ranged from 0.02 to 0.06 mg/kg per day . Subjects were rated on the NCBRF , Aberrant Behavior Checklist , Behavior Problems Inventory , Clinical Global Impressions ( CGI ) , modified California Verbal Learning Test ( CVLT ) , and a continuous performance task ( CPT ) . RESULTS The intention-to-treat analysis of risperidone-treated subjects showed a significant ( p mean scores ( from 33.4 at baseline to 17.6 at end point ; 47.3 % reduction ) versus placebo-treated subjects ( mean baseline of 32.6 to 25.8 at end point ; 20.9 % reduction ) on the Conduct Problem subscale of the NCBRF . Between-group differences in favor of risperidone were seen as early as week 1 and were significant at all post-baseline visits . Other subscales showed significant improvement with risperidone compared with placebo . CGI scale ratings of improvement showed highly significant gains for risperidone over placebo . A sub analysis demonstrated that the effect of risperidone was unaffected by diagnosis , presence/absence of ADHD , psychostimulant use , IQ status , and somnolence . Risperidone produced no changes on the cognitive variables ( CPT/modified CVLT ) . The most common side effects included somnolence , headache , appetite increase , and dyspepsia . Side effects related to extrapyramidal symptoms were reported in 7 ( 13.2 % ) and 3 ( 5.3 % ) of the subjects in the risperidone and placebo groups , respectively ( p = .245 ) . CONCLUSIONS Risperidone appears to be an adequately tolerated and effective treatment in children with subaverage IQs and severe disruptive behaviors such as aggression and destructive behavior",
"Much remains to be learned about the adolescent outcomes of clinic-referred boys whose childhood conduct problems are serious enough to meet diagnostic criteria for conduct disorder ( CD ) . Six structured diagnostic assessment s were conducted over 7 years of 73 clinic-referred 7–12-year-old boys who met criteria for CD in Wave 1 . There were substantial individual differences in the adolescent outcomes of CD , ranging from worsening to sustained recovery , with most boys showing persistent , but fluctuating levels of CD . Improvement in CD was not accounted for by treatment or incarceration , but more positive outcomes over Waves 2–7 were predicted prospect ively with substantial accuracy , using a combination of baseline predictors : less initial severity of CD , fewer symptoms of attention-deficit hyperactivity disorder , higher child verbal intelligence , greater family socioeconomic advantage , and not having antisocial biological parents",
"Treatment-emergent symptoms and behavioral changes were assessed during an 8-week double-blind study comparing molindone and thioridazine in 31 aggressive hospitalized children ( ages 6 - 11 ) . Molindone was found to be as effective as thioridazine in this sample . Adverse effects differed ( nonsignificantly ) for the two groups , with more sedation in the thioridazine-treated children . Clinical records from 6 adolescent in patients treated with molindone were review ed as a comparison group . Molindone is a relatively safe neuroleptic for child and adolescent in patients because of its short half-life and minimal prolonged tissue accumulation . Additional studies on different child population s are necessary before the proper indications for molindone usage in the pediatric group can be established",
"OBJECTIVE The authors sought to replicate open-label findings showing that specific criteria for explosive temper and mood lability identify disruptive youth who improve while receiving the anticonvulsant divalproex sodium . METHOD Twenty outpatient children and adolescents ( ages 10 - 18 ) with a disruptive behavior disorder ( oppositional defiant disorder or conduct disorder ) met the specific criteria for explosive temper and mood lability . They received 6 weeks of divalproex treatment and 6 weeks of placebo by r and om assignment . Independent evaluators blind to group assignment assessed response at the end of each phase . RESULTS At the end of phase 1 , eight of 10 subjects had responded to divalproex ; zero of 10 had responded to placebo . Of the 15 subjects who completed both phases , 12 has superior response taking divalproex . CONCLUSIONS This preliminary study replicates open-label findings showing that divalproex is an efficacious treatment for explosive temper and mood lability in disruptive children and adolescents",
"BACKGROUND Oppositional defiant disorder (ODD)is associated with a high degree of impairment in social skills , family interaction , and academic functioning . Comorbid ODD is reportedly present in 40 % to 70 % of children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) . OBJECTIVE The goal of this study was to assess the efficacy and safety of mixed amphetamine salts extended release ( MAS XR ) for the treatment of ODD in children and adolescents aged 6 to 17 years . METHODS This was a 4-week , multicenter , r and omized , double-blind , parallel-group , placebo-controlled , forced-dose-escalation study . Patients were r and omized to receive active treatment with MAS XR 10 , 20 , 30 , or 40 mg/d or placebo . The primary efficacy end point was the ODD subscale of the Swanson , Nolan , and Pelham-IV ( SNAP-IV ) parent rating . Primary safety measures included adverse events recorded at each visit and for 30 days after study drug discontinuation , and changes in vital signs , 12-lead electrocardiographic ( ECG ) findings , laboratory tests and physical examinations , and body weight . A post hoc efficacy re analysis was completed based on the results for the per- protocol population . For this analysis , patients were divided into high and low baseline severity categories according to the dichotomized baseline ODD parent or teacher score or dichotomized baseline ADHD parent or teacher score ( high defined as scores at the median or greater and low defined as scores less than the median ) . RESULTS A total of 308 children and adolescents ( age range , 6 - 17 years ; 213 males , 95 females ) were r and omized to receive active treatment with MAS XR 10 mg/d ( n = 60 ) 20 mg/d ( n = 58 ) , 30 mg/d ( n = 69 ) , or 40 mg/d ( n = 61 ) or placebo ( n = 60 ) . Of the 308 study patients , 244 ( 79.2 % ) had comorbid ADHD . A significant change from baseline in the ODD symptoms measured with the SNAP-IV parent rating subscale was found for the MAS XR 30-mg/d ( -0.52 ; P MAS XR 30-mg/d group in the intent-to-treat analysis ( -0.42 ; P MAS XR was well tolerated in these children and adolescents with ODD , and most adverse events were mild to moderate in intensity . The most frequently reported adverse events occurring in MAS XR-treated patients were anorexia/decreased appetite ( 25.3 % ) , insomnia ( 19.5 % ) , headache ( 18.5 % ) , and abdominal pain ( 10.7 % ) . Statistically , but not clinical ly , significant decreases in body weight were seen with MAS XR ( range , -1.1 to -3.5 lb ; P ) . Changes in laboratory values , ECG measurements , and physical and other vital signs were also not clinical ly significant . The post hoc re analysis was based on the per- protocol population ( n = 229 ) . An assessment of the high baseline symptom severity subgroups showed a good response to MAS XR treatment for the SNAP-IV parent and teacher rating scales ( both , P XR ( 30 and 40 mg ) were effective and well tolerated in the management of ODD in these school aged children and adolescents in the presence or absence of ADHD",
"OBJECTIVE To examine whether risperidone is superior to placebo in the treatment of youths with conduct disorder . METHOD This was a 10-week , r and omized , double-blind , placebo-controlled study with 2 parallel arms . Ten youths were r and omly assigned to receive placebo and 10 youths were r and omly assigned to receive risperidone . Patients were seen weekly throughout the trial . Medications could be increased at weekly intervals during the first 6 weeks of the study from an initial dose of 0.25 mg or 0.50 mg each morning , depending on patient weight . Patients weighing less than 50 kg had a maximum total daily dose of risperidone of 1.5 mg . Patients weighing 50 kg or greater had a maximum total daily dose of risperidone of 3.0 mg . The primary outcome measure was the Rating of Aggression Against People and /or Property Scale . RESULTS Risperidone was superior to placebo in ameliorating aggression on most measures . Risperidone was reasonably well tolerated , with none of the risperidone-treated patients developing extrapyramidal side effects . CONCLUSIONS These data provide preliminary evidence that risperidone may have efficacy in the treatment of youths with conduct disorder . Because of the small sample size and the brief length of this study , further research is necessary to confirm these findings",
"OBJECTIVE The aim of this study was to examine the safety and efficacy of risperidone , with or without concomitant psychostimulant use , in the treatment of children with conduct disorder ( CD ) or other disruptive behavior disorders [ oppositional defiant disorder ( ODD ) , disruptive behavior disorder-not otherwise specified ( DBD-NOS ) ] , and comorbid attention-deficit hyperactivity disorder ( ADHD ) . METHODS Data from two 6-week placebo-controlled trials assessing risperidone therapy in children with subaverage IQs and CD , ODD , DBD-NOS were combined , and patients with comorbid ADHD were selected for this post hoc analysis . Patients were grouped according to r and omized drug therapy ( risperidone or placebo ) , and then subgrouped according to their use of a concomitant psychostimulant . Safety outcomes included adverse events and weight change , while efficacy outcomes included changes in scores on disruptive behavior and hyperactivity-based subscales of two behavior-rating instruments ( Nisonger Child Behavior Rating Form and the Aberrant Behavior Checklist ) . RESULTS The analysis included 155 of 208 originally tested children divided into four sub-groups ( 35 - 43 patients each ) . There was no significant difference in the frequency of adverse events in patients who received risperidone alone and those who received risperidone plus a stimulant . The most common adverse events in risperidone-treated patients were somnolence , headache , dyspepsia , rhinitis , and vomiting . Within each r and omized treatment group , actual weight gain was comparable , regardless of concomitant stimulant use . Risperidone-treated patients had clinical ly and statistically significant reductions in both disruptive behavior and hyperactivity subscale scores , compared to placebo , regardless of concomitant stimulant use . The addition of risperidone to a psychostimulant result ed in significantly better control of hyperactivity ( p adverse events . CONCLUSION Risperidone was a safe and effective treatment , with or without a combined psychostimulant , for both disruptive behavior disorders and comorbid ADHD in children",
"BACKGROUND The authors ' goal was to assess the efficacy and tolerability of naltrexone in the treatment of pathologic gambling disorder . METHODS Eighty-three subjects who met criteria for DSM-IV pathologic gambling disorder were enrolled in a 1-week single-blind placebo lead-in followed by an 11-week double-blind naltrexone or placebo trial . Naltrexone was started at 25 mg/day and titrated upward until maximum symptom improvement or 250 mg/day was achieved . Gambling symptom change was assessed with the patient-rated Clinical Global Impression ( PG-CGI-PT ) , clinician-rated CGI ( PG-CGI-MD ) , and the Gambling Symptom Rating Scale ( G-SAS ) . Side effects were monitored weekly and liver function tests biweekly . RESULTS Data from 45 patients were analyzed . Using r and om regression analysis , significant improvement was noted in all three gambling symptom measures : patient-rated Clinical Global Impression , p clinician-rated CGI , p Gambling Symptom Rating Scale , p naltrexone were much or very much improved on both the PE-CEI PT and the PG-CGI-MD , compared with only 24 % of those on placebo . Elevated liver enzymes occurred in four subjects who were taking analgesics concurrently . Nausea was common during the first week of treatment . CONCLUSIONS Results suggest that naltrexone is effective in reducing the symptoms of pathologic gambling . Until further studies corroborate the present findings , our report should be interpreted cautiously",
"The effect of methylpheni date on aggression in adolescents diagnosed with both aggressive conduct disorder and attention deficit disorder with hyperactivity was assessed in nine male adolescents . After three open trials , a placebo controlled double-blind design was used . During methylpheni date treatment of the six double-blind subjects , there was a significant reduction of aggressivity ( p 's less than 0.05 ) , as measured by the Adolescent Antisocial Behavior Checklist . Conners Teacher Rating Scale Hyperactivity and Aggression scores were in the predicted directions , but the differences were not statistically significant",
"BACKGROUND Risperidone is an atypical antipsychotic drug that blocks dopamine as well as serotonin receptor systems . The present study was design ed to examine the efficacy and safety of risperidone in a 6-week double-blind , r and omized , parallel-group design in the treatment of aggression in adolescents with a primary diagnosis of DSM-IV disruptive behavior disorders and with subaverage intelligence . METHOD We r and omly assigned 38 adolescents ( 33 boys ; 10 subjects with slightly subaverage IQ , 14 with borderline IQ , and 14 with mild mental retardation ) , who were hospitalized for treatment of psychiatric disorders associated with severe aggression , to receive risperidone or placebo . The main efficacy measures were the Clinical Global Impressions-Severity of Illness scale ( CGI-S ) , the modified Overt Aggression Scale ( OAS-M ) , and the Aberrant Behavior Checklist ( ABC ) . Side effects were measured using the Extrapyramidal Symptom Rating Scale ( ESRS ) . RESULTS The mean daily dose of risperidone at the end of treatment was 2.9 mg ( range , 1.5 - 4 mg ) . Risperidone , compared with placebo , was associated with significant improvements on the CGI-S ( p at-school ABC overall and hyperactivity scales ( p CGI-S scale , the OAS-M. and the ABC . Extrapyramidal symptoms were absent or very mild during risperidone treatment . Transient tiredness was present in 11 ( 58 % ) of 19 drug-treated subjects . Other untoward effects included sialorrhea , nausea , and slight weight gain ( mean = 3.5 % of body weight in the risperidone group ) . No clinical ly relevant changes were found in laboratory parameters , electrocardiogram , heart rate , or blood pressure . CONCLUSION These results suggest that risperidone may be effective for severe aggression in adolescents with disruptive behavior disorders and subaverage intelligence , and these results are consistent with reports suggesting its effectiveness for treating severe aggression in adolescents in general",
"A pilot comparison of the safety and efficacy of methylpheni date ( MPH ) combined with clonidine , clonidine monotherapy , or MPH monotherapy in 6to 16-year-old children diagnosed with attention deficit hyperactivity disorder ( ADHD ) and comorbid aggressive oppositional defiant disorder or conduct disorder was completed . Study design was a 3-month , r and omized , blinded , group comparison with eight subjects per group . No placebo comparison was used . All three treatment groups showed significant improvements in attention deficits , impulsivity , oppositional , and conduct disordered symptoms as assessed by parent and teacher rating scales and laboratory measures . Significant differences among treatment groups were found only on a few measures . Only the clonidine monotherapy group showed significantly decreased fine motor speed . These results suggest the safety and efficacy of clonidine alone or in combination with MPH for the treatment of ADHD and aggressive oppositional and conduct disorders",
"OBJECTIVE The authors examined the efficacy of lithium carbonate for treating conduct disorder in adolescents . METHOD The subjects were 33 in patients aged 12 - 17 years . Lithium or placebo was administered in a double-blind fashion for 2 weeks . RESULTS On several measures of clinical change the groups showed no significant differences . Of the patients who completed the study , 8.3 % of those receiving placebo ( one of 12 ) versus 21.4 % ( three of 14 ) of those receiving lithium were considered responders . CONCLUSIONS Lithium does not appear beneficial for this indication",
"BACKGROUND A subgroup of children and adolescents with conduct disorder are characterized by severe and persistent aggression . Although there is no agreed on treatment for such aggression , lithium carbonate has shown promise in some studies involving children . Our study was design ed to critically assess the efficacy of lithium in the treatment of aggression in children and adolescents using a measure specific for aggression . METHODS Subjects were in patients with conduct disorder hospitalized because of severe and chronic aggression . A parallel-groups design was used in this double-blind , placebo-controlled trial with r and omization to lithium or placebo . Only those who met the aggression criterion during the 2-week placebo-baseline period were r and omized to 4 weeks of treatment . Outcome measures included Clinical Global Impressions , the Global Clinical Judgements ( Consensus ) Scale , and the Overt Aggression Scale . RESULTS Eighty-six in patients enrolled in the study ; 40 ( 33 male and 7 female ; median age , 12.5 years ) entered and completed the treatment phase . Lithium was statistically and clinical ly superior to placebo . Sixteen of 20 subjects in the lithium group were responders on the Consensus ratings vs 6 of 20 in the placebo group ( P=.004 ) . Ratings on the Overt Aggression Scale decreased significantly for the lithium group vs the placebo group ( P=.04 ) . More than half of the subjects in the lithium group experienced nausea , vomiting , and urinary frequency . CONCLUSIONS Lithium is a safe and effective short-term treatment for aggression in in patients with conduct disorder , although its use is associated with adverse effects",
"OBJECTIVE The authors compared the effects of maintenance versus withdrawal of risperidone treatment in children and adolescents with symptoms of disruptive behavior disorder . METHOD Patients with disruptive behavior disorder ( 5 - 17 years of age and a range of intellect ) who had responded to risperidone treatment over 12 weeks were r and omly assigned to 6 months of double-blind treatment with either risperidone or placebo . The primary efficacy measure was time to symptom recurrence , defined as sustained deterioration on either the Clinical Global Impression severity rating ( /2 points ) or the conduct problem subscale of the Nisonger Child Behavior Rating Form ( /7 points ) . Secondary efficacy measures included rates of discontinuation due to symptom recurrence , disruptive behavior disorder symptoms , and general function . Safety and tolerability were also assessed . Risperidone dosage was based on weight ( patients 527 patients , with 335 r and omly assigned to a double-blind maintenance condition . Time to symptom recurrence was significantly longer in patients who continued risperidone treatment than in those switched to placebo . Symptom recurrence in 25 % of patients occurred after 119 days with risperidone and 37 days with placebo . Secondary efficacy measures also favored risperidone over placebo . Weight increased over the initial 12 weeks of treatment ( mean weight z score change=0.2 , SD=2.7 , N=511 ) , after which it plateaued . CONCLUSIONS This study is the first placebo-controlled maintenance versus withdrawal trial of its kind in disruptive behavior disorder and provides evidence that patients who respond to initial treatment with risperidone would benefit from continuous treatment over the longer term",
"OBJECTIVE To compare clonidine with placebo added to ongoing psychostimulant therapy for the treatment of attention-deficit/hyperactivity disorder with comorbid oppositional defiant disorder or conduct disorder . METHOD Children 6 to 14 years of age recruited through 2000 to 2001 were r and omized to receive clonidine syrup 0.10 to 0.20 mg/day ( n = 38 ) or placebo ( n = 29 ) for 6 weeks . Primary outcome measures were the Conduct and Hyperactive Index subscales of the parent-report Conners Behavior Checklist . Side effects were monitored using physiological measures and the Barkley Side Effect Rating Scale . RESULTS Evaluable patient analysis showed that significantly more clonidine-treated children than controls were responders on the Conduct scale ( 21 of 37 versus 6 of 29 ; chi2(1 ) = 8.75 , p Hyperactive Index ( 13 of 37 versus 5 of 29 ) . Compared with placebo , clonidine was associated with a greater reduction in systolic blood pressure measured st and ing and with transient sedation and dizziness . Clonidine-treated individuals had a greater reduction in a number of unwanted effects associated with psychostimulant treatment compared with placebo . CONCLUSIONS The findings support the continued use of clonidine in combination with psychostimulant medication to reduce conduct symptoms associated with attention-deficit/hyperactivity disorder . Treatment is well tolerated and unwanted effects are transient",
"OBJECTIVE The short-term efficacy and safety of risperidone in the treatment of disruptive behaviors was examined in a well-characterized cohort of children with subaverage intelligence . METHOD In this 6-week , multicenter , double-blind , parallel-group study of 118 children ( aged 5 - 12 years ) with severely disruptive behaviors and subaverage intelligence ( IQ between 36 and 84 , inclusive ) , the subjects received 0.02 - 0.06 mg/kg per day of risperidone oral solution or placebo . The a priori primary efficacy measure was the change in score from baseline to endpoint on the conduct problem subscale of the Nisonger Child Behavior Rating Form . RESULTS The risperidone group showed significantly greater improvement than did the placebo group on the conduct problem subscale of the Nisonger Child Behavior Rating Form from week 1 through endpoint ( change in score of -15.2 and -6.2 , respectively ) . Risperidone was also associated with significantly greater improvement than placebo on all other Nisonger Child Behavior Rating Form subscales at endpoint , as well as on the Aberrant Behavior Checklist subscales for irritability , lethargy/social withdrawal , and hyperactivity ; the Behavior Problems Inventory aggressive/destructive behavior subscale ; a visual analogue scale of the most troublesome symptom ; and the Clinical Global Impression change score . The most common adverse effects reported during risperidone treatment were headache and somnolence . The extrapyramidal symptom profile of risperidone was comparable to that of placebo . Mean weight increases of 2.2 kg . and 0.9 kg occurred in the risperidone and placebo groups , respectively . CONCLUSIONS Risperidone was effective and well tolerated for the treatment of severely disruptive behaviors in children with subaverage IQ",
"BACKGROUND The administration p.r.n . ( as needed ) of sedative medications is a widespread practice in the management of acute dyscontrol of child psychiatric in patients . Its efficacy , however , has never been tested in a controlled clinical trial . METHOD Twenty-one male in patients , aged 5 - 13 years , participated in a double-blind , placebo-controlled study of the p.r.n . use of diphenhydramine , a sedative antihistaminic often used in child psychiatry wards . The patients ' DSM-III-R diagnoses were conduct disorder , attention-deficit hyperactivity , and major depression . Each patient in acute dyscontrol blindly received either oral or intramuscular doses of diphenhydramine 25 - 50 mg ( N = 9 ) or placebo ( N = 12 ) . The Conners Abbreviated 10-Item Teacher Rating Scale and the Clinical Global Impressions scale were completed before and 0.5 , 1 , and 2 hours after the dose . RESULTS Repeated measures ANOVA showed significant time effects , but no difference due to drug . The intramuscular route tended to be more effective than the oral , regardless of whether active drug or placebo was given . CONCLUSION The data indicate that if p.r.n . administrations are effective , this is a placebo effect . Likewise , intramuscular administrations are more effective because of a route effect ( \" the needle \" ) and not because of a specific pharmacologic activity",
"OBJECTIVE Adolescents with conduct disorder ( CD ) and substance use disorders ( SUD ) have higher rates of comorbid attention-deficit/hyperactivity disorder ( ADHD ) than those without CD and SUD . Comorbid ADHD may contribute to more severe SUD . Treatment of ADHD may enhance effective treatment of substance abuse and behavior problems , yet there are few data regarding pharmacological treatment of ADHD in such youths . METHOD Pilot data are presented from a 5-week , open-label bupropian trial in 13 nondepressed adolescent boys in a residential treatment program focusing on substance and behavioral treatments . All had diagnoses of ADHD , CD , and SUD . Patients ' doses were titrated to a maximum fixed daily dose of 300 mg of bupropion . The Conners Hyperactivity Index and Daydream Attention scores , along with Clinical Global Impressions Severity of Illness ( CGI-S ) ratings , were obtained at baseline and at the fifth week of treatment . RESULTS Subjects ' mean Conners Hyperactivity Index score declined from 75.5 to 65.4 ( p mean Daydream Attention score declined from 59.5 to 53.6 ( p Mean CGI-S declined from 4.9 to 3.0 ( p bupropion may be a useful treatment for ADHD in adolescents with CD and SUD ; they suggest the need for a controlled trial of bupropion in such youths",
" Thirty-eight boys , referred for psychiatric treatment because of serious problems of behaviour , underwent a double-blind , placebo-controlled , crossover trial of methylpheni date and placebo . Methylpheni date was an effective treatment over a 3-week period . A good response to methylpheni date was predicted by higher levels of inattentive and restless behaviour , impaired performance on tests of attention , clumsiness , younger age and by the absence of symptoms of overt emotional disorder . DSM-III and ICD-9 diagnoses of ' hyperactivity ' were not good predictors . The results support the validity of a construct of hyperactivity in describing childhood psychopathology , but emphasize the need for a refinement of diagnostic criteria",
"BACKGROUND AND PURPOSE Hyperkinetic conduct disorder ( HCD ) has been identified as a common psychiatric diagnosis among children and adolescents . This disorder affects many life aspects of both child and family . The aim of this study was to examine the efficacy of the selective norepinephrine reuptake inhibitor ( SNRI ) , reboxetine , in treating children with HCD and its influence on associated symptoms , such as aggressiveness , impulsivity , anxiety , and depression . METHODS Fifteen children , 5 - 14 years of age , diagnosed with HCD , participated in a 12- week , prospect i ve , open-label trial with reboxetine ( 4 - 8 mg/d ) . They were examined for changes in : ADHD symptoms , as measured by the Conners Abbreviated ( 10-item ) Teacher Rating Scale , aggression , as measured by the Yudofsky Overt Aggression Scale ( OAS ) , impulsivity , as measured by the Plutchik impulsivity scale ( IS ) , anxiety , as measured by the Revised Children 's Manifest Anxiety Scale ( RCMAS ) , and depressive mood , as measured by the Hamilton Rating Scale for Depression ( HAM-D ) . RESULTS There was a significant symptomatic improvement for HCD symptoms and associated symptoms . CONCLUSION Our findings suggest that reboxetine may be effective in the treatment of HCD and associated symptoms",
"The effects of lithium carbonate and haloperidol on cognition were examined in a placebo-controlled , double-blind study of 61 treatment-resistant , hospitalized school-aged children . They all had a DSM-III diagnosis of conduct disorder-- undersocialized , aggressive , with a profile of highly explosive and aggressive behavior . Children were assessed at the end of a two-week placebo-baseline period and again after four weeks of treatment . Drug effects on cognition were mild . Haloperidol ( mean dose , 2.95 mg/day ) caused significant decreases in Porteus Maze test quotient scores and a slowing of reaction time ( RT ) on a simple RT task . Lithium carbonate ( mean dose , 1,166 mg/day ) adversely affected qualitative scores on the Porteus Maze test . No significant treatment effects were found for the Matching Familiar Figures Test , short-term recognition memory and concept attainment tasks , or the Stroop Test",
"A controlled , double-blind , crossover trial of haloperidol in a group of 16 children with behaviour disorders is described . Selection was based on the presence of at least four of the following symptoms : overactivity , restlessness , aggressiveness , temper , attention-seeking behaviour , disobedience , destructiveness , poor concentration . Benzhexol was administered concurrently with both active and placebo tablets . Thirteen children were rated as better on haloperidol , two as better on placebo and one as showing no difference . This result is statistically significant . Side-effects were minimal . It is concluded that haloperidol merits more extensive trial in conditions of the type studied",
"We report the results of an open trial of trazodone in the treatment of severe behavioral disturbances in a sample of 22 hospitalized children previously found to be unresponsive to other treatments . Response to treatment was assessed by overall clinical criteria and improvements in individual symptom dimensions during the inpatient hospitalization . Thirteen children ( 67 % ) were found to benefit from the introduction of trazodone . Aggressive , impulsive behaviors were symptoms most frequently improved by this agent . Three of those found to be nonresponders actually worsened in symptomatology . A follow-up interview of the parents was conducted 3 - 14 months after discharge from the inpatient unit , for those children who initially responded to trazodone administration . The results of this interview suggest that the effect of trazodone was persistent for a prolonged period of time after the initial inpatient trial . Trazodone appears to be of value in the management of severe behavioral disturbances in children . The possible mechanism of action of trazodone is discussed",
"OBJECTIVE To assess critically the short-term efficacy and safety of carbamazepine in the reduction of aggressiveness in children with diagnosed conduct disorder . METHOD Subjects were children aged 5 to 12 years who were hospitalized for treatment-resistant aggressiveness and explosiveness and who had diagnosed conduct disorder . The study was double-blind and placebo-controlled , using a parallel-groups design . Following a 2-week placebo baseline period , children who met the aggression criteria were r and omly assigned to treatments for 6 weeks ; the study ended with a 1-week posttreatment placebo period . Multiple raters rated the children independently , using multiple rating scales under four conditions . The main outcome measures included the Overt Aggression Scale , the Global Clinical Judgments ( Consensus ) Scale , and the Children 's Psychiatric Rating Scale . RESULTS Twenty-two children , aged 5.33 to 11.7 years , completed the study . Carbamazepine was not superior to placebo at optimal daily doses ranging from 400 to 800 mg , mean 683 mg , at serum levels of 4.98 to 9.1 micrograms/mL. Untoward effects associated with administration of carbamazepine were common . CONCLUSIONS In this modest sample of children , the superiority of carbamazepine over placebo in reducing aggressive behavior was not demonstrated",
"OBJECTIVE In adolescents with substance use disorder ( SUD ) , comorbid attention-deficit/hyperactivity disorder ( ADHD ) is associated with greater severity of substance abuse , conduct problems , and worse treatment outcomes . Although many controlled trials have established the efficacy of psychostimulants , including pemoline , for ADHD in children and adolescents , none have been conducted in adolescents with SUD . This r and omized , placebo-controlled trial , conducted between 1996 and 2000 , evaluated the safety and efficacy of pemoline on substance abuse and conduct problems . METHOD Sixty-nine adolescents ( aged 13 - 19 ) with conduct disorder ( CD ) , SUD , and ADHD were recruited from the community and r and omly assigned to a 12-week clinical trial of pemoline ( n = 35 ) or placebo ( n = 34 ) , titrated over 4 weeks to a single morning dose of 75 to 112.5 mg as tolerated . RESULTS Pemoline had greater efficacy than placebo for ADHD as determined by significantly more Clinician 's Global Impression-Improvement ( CGI-I ) ratings of 1 ( very much improved ) or 2 ( much improved ) at the study endpoint ( n = 69 ; p ADHD severity on the parent-rated Conners Hyperactivity-Impulsivity scale in pemoline-treated study completers compared to placebo-treated completers ( pemoline , n = 17 ; placebo , n = 16 ; p Substance use did not decline in either group , and there was no difference between groups in baseline to study endpoint change in substance use or CD symptoms . Overall , pemoline was well tolerated , demonstrating a good safety profile and no elevation in liver enzyme levels . CONCLUSIONS Pemoline was efficacious for ADHD but did not have an impact on CD or substance abuse in the absence of specific treatment for SUD",
"BACKGROUND Few studies have investigated the comparative risk of neuroleptic-related dyskinesias in children and adolescents receiving typical versus newer , atypical antipsychotics . This prospect i ve study was completed to test whether clinical use of atypical antipsychotics is associated with less risk for developing neuroleptic-related dyskinesias than clinical use of typical neuroleptics in an unselected heterogeneous population of seriously emotionally disturbed youths admitted to acute residential treatment . We also tested a novel model of predictive risk for neuroleptic-related dyskinesias in children and adolescents . METHOD 102 children and adolescents receiving typical neuroleptics , atypical antipsychotics , or the combination were studied . Youths developing neuroleptic-related dyskinesias were compared with youths free of dyskinesias over a 3-month study period on demographic , diagnostic , and treatment variables . Logistic regression was utilized to develop a novel model of predictive risk . RESULTS Of neuroleptic-treated youths , 5.9 % had probable tardive dyskinesia , a rate less than the prevalence of tardive dyskinesia in chronic neuroleptic-treated adults . Use of typical neuroleptics was significantly ( p = .03 ) associated with dyskinesia compared with use of atypical antipsychotics . Four variables including IQ , initial Abnormal Involuntary Movement Scale score , type of antipsychotic , and cumulative number of risk factors accounted for 35.8 % of the variance when predicting dyskinetic status . CONCLUSION Use of atypical antipsychotics appears to be associated with less dyskinesia risk than typical neuroleptics in an unselected group of seriously emotionally disturbed children and adolescents . Results support a cumulative risk model of neuroleptic-related dyskinesia in youths",
"OBJECTIVE To assess the effect of methylpheni date on the diagnosis of oppositional-defiant disorder ( ODD ) comorbid with attention-deficit hyperactivity disorder ( ADHD ) . METHOD We conducted an open-label study in which 10 children and adolescents with a dual diagnosis of ODD and ADHD were assessed for their ODD symptoms and treated with methylpheni date . At least one month after ADHD symptoms were under control , ODD symptoms were reevaluated with the Parent form of the Children Interview for Psychiatric Syndromes ( P-ChIPS ) . RESULTS Nine of the 10 patients no longer fulfilled diagnostic criteria for ODD after they were treated with methylpheni date for ADHD . CONCLUSION Methylpheni date seems to be an effective treatment for ODD , as well as for ADHD itself . The implication s for the treatment of patients with ODD not comorbid with ADHD needs further investigation",
"OBJECTIVE Although the combination of methylpheni date ( MPH ) and behavior modification ( BMOD ) has been advocated to enhance clinical outcome for children with attention-deficit hyperactivity disorder ( ADHD ) and comorbid disruptive disorders , few group studies have been conducted . This study evaluates the separate and incremental effects of these modalities on rating scale and observational measures in multiple setting s. METHOD Sixteen of 22 children with ADHD and comorbid disruptive disorder completed a r and omized , placebo-controlled study examining the separate and incremental effects of 2 doses of MPH and BMOD during a partial hospitalization program . Of the 6 who did not complete the study , 2 children developed significant side effects . For the 16 who did complete the study , effects were examined on measures of symptom ratings , behavioral frequencies , and stimulant side effects across program activities . RESULTS Based on alpha-adjusted analyses of variance , there were several main effects of MPH and BMOD on ADHD symptoms , oppositional behavior , and positive social behavior , with certain effects unique to each intervention and setting . One incremental effect each was found for MPH ( positive mood/behavior ) and BMOD ( negative behavior ) . MPH and BMOD were associated with few side effects . Effect sizes for each intervention showed considerable variability in clinical response . CONCLUSIONS That MPH and BMOD had certain unique main and incremental effects extends findings supporting their combination and suggests that integrated studies evaluate multiple dimensions of functioning and in novel setting s ( e.g. , home , school ) . The incorporation of other intervention components in combined treatments may be warranted to enhance clinical efficacy",
"OBJECTIVE To examine ( 1 ) moderating effects of oppositional defiant disorder ( ODD ) on attention-deficit/hyperactivity disorder ( ADHD ) treatment response and ( 2 ) responses of ODD symptoms to atomoxetine . METHOD Children and adolescents ( ages 8 - 18 ) with ADHD were treated for approximately 8 weeks with placebo or atomoxetine ( fixed dosing : 0.5 , 1.2 , or 1.8 mg/kg/day , b.i.d . ) under r and omized , double-blind conditions . Among patients with lifetime diagnostic information ( n = 293 ) , 39 % were diagnosed with comorbid ODD and 61 % were not . Treatment-group differences and differences between patients with and without comorbid ODD were examined post hoc for changes on the Attention-Deficit/Hyperactivity Disorder Rating Scale IV-Parent version , investigator-administered and -scored ; Conners ' Parent Rating Scale-Revised Short Form ; Clinical Global Impressions Severity of ADHD Scale ; and the parent-rated Child Health Question naire . RESULTS Youths with ADHD and comorbid ODD showed statistically significant improvement in ADHD , ODD , and quality -of-life measures . Treatment response was similar in youths with and without ODD , except that the comorbid group showed improvement compared with placebo at 1.8 mg/kg/day but not 1.2 mg/kg/day . In contrast , youths without ODD showed improvement at 1.2 mg/kg/day and no incremental benefit at 1.8 mg/kg/day . CONCLUSIONS Atomoxetine treatment improves ADHD and ODD symptoms in youths with ADHD and ODD , although the comorbid group may require higher doses",
"A trial of haloperidol has been carried out with a group of 12 children with severe behaviour disorders in an in-patient unit . While on haloperidol the children were rated by the nurses as significantly less overactive , destructive , restless , and resentful , less aggressive with adults and less disobedient , than while on placebo . They were also rated as teasing and bullying other children less . Tests suggested that the drug had a slight , but significant , slowing effect",
"OBJECTIVE This study was design ed to assess outpatient child psychiatrists ' prescribing practice s. METHOD Of 1,422 out patients in two public , university affiliated setting s in New York and Ohio , the charts of 146 medicated and 126 nonmedicated r and omly selected patients were review ed for demographic variables , DSM-III-R diagnoses , medications prescribed , and charted prescription rationale s. RESULTS Fifteen percent of the 800 out patients seen in a 1-month period in New York , and 19 % of the 626 out patients seen in a 1-year period in Ohio were prescribed medication . Patients medicated by clinic psychiatrists were significantly more likely than nonmedicated patients to be psychotic and to have been hospitalized previously , and significantly less likely to have adjustment disorder . Using st and ards employed by drug utilization review committees , medications were prescribed appropriately in approximately 90 % of cases . Of concern , 65 % of patients given antipsychotics in New York and 67 % in Ohio were not psychotic ; the primary target symptom in such cases was aggression . CONCLUSIONS Prescribing practice s appeared to be appropriate , although the use of antipsychotic medications in nonpsychotic children is a concern for the field of child psychiatry . The strong similarity of practice s in two independent and geographically remote sites suggests the findings are generalizable to providers in other public , university affiliated setting"
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BACKGROUND Valid and reliable outcome measurements are a prerequisite for evidence -based practice . The comparative validity and reliability of outcome measurements for assessing atopic eczema ( AE ) severity is unclear . OBJECTIVE We sought to assess the validity , reliability , sensitivity to change , and ease of use of outcome measurements for AE . We also sought to give recommendations on which outcomes to use in clinical research and for clinical monitoring . METHODS We performed a systematic review and survey of clinical experts and patients . RESULTS Twenty published outcome measurements were identified . There is evidence of adequate construct validity for 3 measurements ( Severity Scoring of Atopic Dermatitis index [ SCORAD ] , Eczema Area and Severity Index [ EASI ] , and Three Item Severity Score ) , adequate internal consistency of 1 scale ( Patient-oriented Eczema Measure [ POEM ] ) , adequate interobserver reliability of 5 measurements ( Basic Clinical Scoring System ; Nottingham Eczema Severity Score ; Objective Severity Assessment of Atopic Dermatitis ; Six Area , Six Sign Atopic Dermatitis severity score ; and SCORAD ) , adequate test-retest reliability of 1 scale ( POEM ) , and adequate sensitivity to change of 3 measurements ( EASI , SCORAD , and Investigators ' Global Atopic Dermatitis Assessment ) . Most outcome measurements have adequate content validity , as assessed by patients and experts . Data on the time to perform the assessment was identified for 8 outcome measurements . Only SCORAD , EASI , and POEM have been tested sufficiently and performed adequately . CONCLUSION There are too many published outcome measures for AE . Most have not been tested properly or perform adequately when tested , and their continued use hampers scientific communication . CLINICAL IMPLICATION S Only SCORAD , EASI , and POEM currently perform adequately . These scales should be used in future studies
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"Objective . This study was design ed to compare the safety and efficacy of tacrolimus ointment 0.03 % with vehicle ointment for the treatment of mild to moderate atopic dermatitis ( AD ) in pediatric patients . Methods . A total of 317 patients ( 2–15 years of age ) with mild to moderate AD were r and omized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week , multicenter , double-blind study . Efficacy evaluations , including the Investigators ' Global Atopic Dermatitis Assessment , eczema area and severity index , percentage of total body surface area affected , and patient assessment of itch occurred at baseline , day 4 , and weeks 2 , 4 , and 6 . Cutaneous adverse events were recorded to evaluate safety . Results . At the end of study , 50.6 % ( 80 of 158 ) of the patients were treated successfully with tacrolimus ointment based on Investigators ' Global Atopic Dermatitis Assessment scores , a significant improvement compared with patients treated with vehicle ointment ( 25.8 % [ 41 of 159 ] ) . The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients ( 54.8 % ) compared with vehicle-treated patients ( 20.8 % ) . There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients ( 50.5 % reduction from baseline ) compared with vehicle-treated patients ( 16.4 % ) . Patient itch scores were significantly lower in tacrolimus-treated patients ( 2.1 ) versus vehicle-treated patients ( 3.7 ) . Overall , the incidence of cutaneous adverse events reported was similar for both treatment groups . There was no significant difference in the incidence of burning or stinging between treatment groups . Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site . Conclusion . Monotherapy with tacrolimus ointment 0.03 % is a safe and effective treatment alternative for pediatric patients with mild to moderate AD",
"Background : In the published studies on the efficacy of the topical immunomodulator pimecrolimus , different eczema scores were used , and the impact on morphological key signs of eczema was not analysed . Objective : To compare the influence of pimecrolimus cream 1 % on different st and ard eczema scores in infants with atopic dermatitis and to analyse the impact of treatment on the individual morphological key signs of eczema . Methods : Pimecrolimus cream 1 % ( n = 129 ) or double-blind vehicle control ( n = 66 ) was administered for 4 weeks . The Eczema Area and Severity Index ( EASI ) , Investigators ’ Global Assessment ( IGA ) and Scoring Atopic Dermatitis Index ( SCORAD ) were determined and were correlated with each other . Results : Following treatment with pimecrolimus , the EASI , IGA and SCORAD were significantly reduced on day 29 as compared with the vehicle group ( p EASI , IGA and SCORAD . The single parameters of the EASI were already significantly decreased by day 4 in the pimecrolimus group as compared to vehicle ( each p pimecrolimus 1 % cream leads to a rapid improvement of all morphological signs of eczema . The close correlation of different scores was shown for the first time",
"OBJECTIVE To develop a simple , valid , repeatable , and readily underst and able patient-oriented assessment measure for monitoring disease activity in children and adults with atopic eczema . DESIGN Qualitative semistructured patient interviews identified a list of symptoms of atopic eczema . These symptoms were quantitatively analyzed in a larger patient population to identify which symptoms were important to patients and amenable to monitoring as part of a scoring system . SETTING The outpatient Department of Dermatology at the Queen 's Medical Centre , University Hospital , Nottingham , Engl and , and 5 local general practice s. PATIENTS Four hundred thirty-five patients with atopic eczema . RESULTS Seven symptoms were incorporated into the final patient-oriented eczema measure using a simple 5-point scale of frequency of occurrence during the previous week , with a maximum total score of 28 . Validity testing against the Dermatology Life Quality Index , Children 's Dermatology Life Quality Index , and patients ' global severity assessment s showed good correlation ( r = 0.78 , r = 0.73 , and r = 0.81 , respectively ; P Internal consistency was high ( Cronbach alpha = 0.88 ) , and test-retest reliability was good , with 95 % of scores falling within 2.6 points on repeat testing ( mean score difference , 0.04 ; SD , 1.32 ) . Individual variables in the measure demonstrated sensitivity to change during a 4-week in-clinic period and an 18-week r and omized controlled clinical trial . CONCLUSION The patient-oriented eczema measure is a practical self-assessed measurement tool for monitoring aspects of atopic eczema that are important to patients in routine clinical practice or in the clinical trial setting",
"Aim : To examine the association between childhood atopic dermatitis ( AD ) severity and family impact at baseline and after an intervention by a physician specialist , using vali date d measures of both severity and family impact . Methods : Cross sectional self administered survey of parent – caregivers of 49 r and omly selected children with AD ; 35 parents were available for follow up . Family impact was measured using a modified AD Family Impact Scale completed by the parent – caregiver . The child ’s disease severity was measured using both the investigator ’s assessment via the Eczema Area and Severity Index ( EASI ) and the caregiver ’s assessment via the recently vali date d Self Assessment Eczema Area and Severity Index ( SA-EASI ) . Results : The parent – caregiver ’s assessment of severity of the child was the most significant correlate of the family impact of the child ’s AD ( p = 0.65 at baseline and p = 0.38 at follow up ) . In multivariate regression models , the parent – caregiver ’s estimate of severity remained the single strongest predictor of family impact before and after receipt of dermatologist care , as well as the difference in impact between pre and post-dermatologist care . Conclusions : There is evidence to support the ability of parent – caregivers of children with AD to accurately determine severity of their child ’s AD ; perceived severity is the driver of the family impact of this condition . Treatment of a child by a physician specialist is associated with reductions in both perceived severity , as well as family impact of this condition",
"The ETAC ( Early Treatment of the Atopic Child ) study , a multi-national double-blind placebo-controlled r and omized trials , has been in progress since 1994 . Fifty-six centers in Europe and Canada participate in this study . A total of 817 children with atopic dermatitis [ AD ] were recruited . The severity of AD was scored using the SCORAD ( objective criteria ) . Ninety-eight investigators ( mostly pediatricians ) were trained by three members of the European Task Force on Atopic Dermatitis [ ETFAD ] to st and ardize their objective SCORAD scoring ( system developed by the ETFAD ) . The experts selected photographs and prepared a training atlas . The percentages of photographs assessed by the 98 non-expert investigators below , within and above the range of evaluations by the three experts were calculated . Taking over and underscoring together , edema/papulation was the easiest intensity item to score ( 82 % within the range by the experts ) . The global symptom score , as well as lichenification , edema/papulation , oozing and excoriation registered by physicians with dermatological experience were not statistically significantly different from those by other . Erythema was statistically significantly better scored by those with dermatological experience . The results of the Euclidean Distance method showed that the item excoriations gave the largest distance . Erythema and excoriations were scored better by dermatologically experienced physicians ( t-test , p = 0.042 and p = 0.063 respectively ) , but lichenification was better scored by non-dermatologically experienced physicians ( p = 0.013 ) . The extent of surface area involved in the disease was calculated on 3 sets of photographs . Most evaluations by the 98 nonexpert investigators were within the range of the experts . Dermatologically experienced physicians scored significantly better than the others ( t-test , p = 0.006 ) . This training program is useful for st and ardizing the scoring in AD and indicates that SCORAD can be used by investigators from different disciplines",
"Objective To vali date the Eczema Area and Severity Index ( EASI ) by assessing its internal consistency , reliability and sensitivity to change and by correlating it to other efficacy parameters .",
"Both growth and the course of allergic symptoms were evaluated in 79 infants with cow 's milk protein intolerance , aged three months or younger , diagnosed by st and ard elimination/provocation and treated with a whey-hydrolysate based infant formula : Nutrilon Pept or Pepti Junior . The efficacy of both products , in terms of symptomatology and growth , was compared with each other . The products differ in fat source ( Pepti Junior 50 % of its fat as MCT , Nutrilon Pepti normal LCT fat blend ) and the presence of lactose ( Pepti Junior : lactose free ; Nutrilon Pepti : 40 % of its carbohydrate as lactose ) . The study was part of a large project that aim ed at st and ardising the approach towards cow 's milk protein intolerance in Baby Health Clinics . Nearly 50 Baby Health Clinics participated in this project . In this study , growth and symptomatology ( skin , respiratory tract , gastrointestinal tract ) were monitored during an intervention period of at least 10 weeks . Infants in both feeding groups showed normal growth , and in at least 80 % of the infants an improvement of the overall symptomatology could be seen during the intervention period . Most profound were the decreases in prevalence and severity of eczema and infantile colic . No differences in efficacy were found in this study between the two infant formulas . It was concluded that the exclusive use of either whey hydrolysate based infant formula result ed in an improvement of allergic symptoms and in normal growth in infants diagnosed by elimination/provocation for cow 's milk protein intolerance in a Primary Health Care setting",
"Summary The efficacy of cyclosporin ( S and immun ® ) given in a daily dose of 5 mg/kg for 6 weeks in severe atopic dermatitis was confirmed in this double‐blind , placebo‐controlled , short‐term study . Of the 46 patients included in the study , 23 were r and omized to receive cyclosporin and 23 to receive placebo",
"Different scoring systems have been developed to determine the severity of atopic dermatitis . The SCORAD ( SCORing Atopic Dermatitis ) , one of the best vali date d systems , is suited for clinical trials , but is too complicated and time consuming for routine clinical use . The TIS score ( Three Item Severity score ) , a simplified system , is based on the evaluation of erythema , oedema/papulation and excoriation on a scale from 0 to 3 . In order to determine the value of the TIS score we conducted a prospect i ve study in 126 children with mild to severe atopic dermatitis . Both the TIS score and the SCORAD were assessed by trained investigators . Interobserver agreement was investigated in 20 children by comparing the independently performed scores of three investigators . A positive correlation was found between the TIS score and the SCORAD ( Rank Spearman r(s)=0.86 ; p excoriation ( r(s)=0.72 ; p oedema/papulations ( r(s)=0.66 ; p Interobserver agreement which was calculated by Cohen 's kappa ( kappa ) was \" excellent \" for SCORAD ( kappa=0.82 ; p TIS score ( kappa=0.58 ; p TIS score is a rough , though reliable and simple system for scoring atopic dermatitis . It is particularly suitable in general practice , for routine clinical use and for screening purpose s in clinical trials . For research purpose s , the objective SCORAD offers a more detailed and comprehensive assessment",
" A few patients remain severely affected by atopic dermatitis into adult life despite treatment with systemic steroids , azathioprine , and photochemotherapy . 33 patients took part in a double-blind , placebo-controlled , crossover study to assess the efficacy and safety of cyclosporin ( 5 mg/kg per day ) in adults with severe refractory atopic dermatitis . Treatments were given for eight weeks each with one group ( n = 16 ) receiving placebo followed by cyclosporin and another ( n = 17 ) receiving cyclosporin and then placebo . Disease activity , extent of disease , sleep and itch , topical steroid use , and adverse events were assessed every two weeks . Both extent and activity of dermatitis were significantly improved ( p less than 0.001 ) as were subjective measures of disease . 20 patients receiving cyclosporin reported adverse events compared with 8 taking placebo , although no patient required withdrawal from the study . Cyclosporin therapy led to an increase in the mean serum urea , creatinine , and bilirubin concentrations , although only the rise in bilirubin was significant ( p = 0.001 ) . Our results confirm that cyclosporin is a safe and effective short-term treatment for severe , refractory atopic dermatitis",
"MAS063D ( Atopiclair is a hydrolipidic cream that has been developed for the management of atopic dermatitis ( AD ) . The putative active ingredients of MAS063D are hyaluronic acid , telmesteine , Vitis vinifera , glycyrrhetinic acid . A five-week study in 30 adult patients with mild to moderate AD showed that MAS063D offered significant benefits over a vehicle-only control . MAS063D improved the total body area affected ( 17.2 % -- > 13.2 % , p itch score ( 2.7 -- > 1.3 on a 10-point scale , p = 0.001 ) and EASI score ( 28.3 -- > 24.3 , p = 0.024 ) after 22 days treatment compared to baseline . The patients ' opinion of MAS063D ( patient 's view of itch control , and view of study substance ) was rated by participating patients as significantly better than control ( p = 0.008 , p = 0.042 respectively ) . Based on these preliminary results in a small scale study , it is suggested that MAS063D is a possible new treatment option for improving signs and symptoms in adults with mild to moderate AD",
"The severity , morbidity and financial costs of atopic eczema ( AE ) were assessed during a 1‐year prospect i ve study of a cohort of 85 people aged 14–63 years ( mean 36 years ) with the disease . A dermatologist examined each participant using the Six Area Six Sign Atopic Dermatitis severity scoring system to classify severity . Participants completed a Dermatology Life Quality Index ( DLQI ) , a Nottingham Eczema Severity Score ( NESS ) and an ongoing diary of health‐care consultations and treatment costs . Follow up by mail to each participant was conducted every 2 months and participants completed a NESS , a DLQI and a diary of costs incurred . The DLQI data revealed that 36 % spent over 10 min per day applying treatments , 28 % indicated that AE influenced the clothes they wore , 21 % felt embarrassed by their skin and 15 % reported problems with treatments . There appeared to be a relationship between increased morbidity and increased severity . The average annual out‐of‐pocket cost for products used for treatment was A$ 425 , ranging from A$ 13.50 to over A$ 2000 per individual . The average out‐of‐pocket cost for medical consultations was A$ 120 , ranging from zero to over A$ 800 per individual . Although there were concerns about the reproducibility of the severity and morbidity measures , the data showed that AE can have substantial effects both financially and from a personal perspective for those affected",
"Atopic eczema begins primarily in infancy or early childhood , and sleep loss due to night-time pruritus can have a considerable impact on patients ' and parents ' quality of life ( QoL ) . In this study , infants ( n = 196 ) with mild to severe atopic eczema were r and omized 2:1 , double-blind , to receive either pimecrolimus cream 1 % ( Elidel , Novartis Pharma , Nürnberg , Germany ) or the corresponding vehicle bid for 4 wk , followed by a 12 wk , open-label phase and a 4 wk , treatment-free , follow-up period . The parents ' QoL was measured at baseline and at the end of the double-blind phase , using the question naire ' QoL in Parents of Children with Atopic Dermatitis ' ( PQoL-AD ) , thus data presented here refer to the initial 4-wk treatment phase only . After 4 wk of double-blind treatment , an increase in the mean percentage change from baseline in eczema area and severity index of 71.5 % was observed with pimecrolimus , compared with 19.4 % with vehicle . The increase in efficacy was paralleled by the following mean percentage changes from baseline in the five domains of the question naire in pimecrolimus and vehicle , respectively : psychosomatic well-being : 14.6 % vs. 6.2 % ; effects on social life : 6.7 % vs. 2.3 % ; confidence in medical treatment : 10.0 % vs. 3.7 % ; emotional coping : 16.1 % vs. 6.5 % ; acceptance of disease : 19.6 % vs. 7.0 % . Analysis ( ancova ) of the dependent variable difference from baseline and the covariate baseline value revealed values of p atopic eczema in infants achieved by treatment with pimecrolimus have a significant beneficial effect on the QoL of parents",
"Treatment of atopic dermatitis with essential fatty acids remains controversial . A double-blind , placebo-controlled , parallel-group study was done to investigate the response of patients with atopic dermatitis to essential fatty acid supplements . Patients with atopic dermatitis were r and omised to receive evening primrose oil , evening primrose oil and fish oil , or placebo for 16 weeks . Disease activity was monitored by clinical severity scores recorded by the investigator , topical steroid requirement , and symptom scores recorded by subjects . Of 123 subjects recruited , 102 completed the treatment period . No improvement with active treatment was demonstrated . Our study , which avoided the method ological and analytical problems of previous studies , found no effect of essential fatty acid supplementation in atopic dermatitis",
"To evaluate the correlation with the clinical activity of atopic dermatitis ( AD ) we investigated prospect ively cellular and serological parameters such as eosinophils , eosinophil cationic protein ( ECP ) , soluble IL-2 receptor ( sIL-2R ) , soluble CD23 ( sCD23 ) and lactate dehydrogenase ( LDH ) in peripheral blood of 37 AD patients on admission to and discharge from the Department of Dermatology at the University Hospital in Zurich . On admission the actual clinical skin condition as measured by the skin intensity score ( SIS ) was significantly correlated with eosinophils ( p less than 0.005 ) , ECP ( p less than 0.05 ) and sIL-2R ( p less than 0.001 ) . During the observation period a significant improvement in the clinical status as measured by the SIS was observed in all AD patients ( p less than 0.001 ) . A significant decrease in sIL-2R ( p less than 0.005 ) , which was most pronounced in the group of AD patients receiving systemic steroids , together with a decrease in eosinophils and ECP but not in sCD23 and LDH could be demonstrated between admission and discharge . In addition , a slight but significant increase in peripheral blood lymphocytes ( p less than 0.005 ) and monocytes ( p less than 0.01 ) was noted . Comparing the ' extrinsic ' ( n = 32 ) and the ' intrinsic ' ( n = 5 ) types of AD no significant differences with regard to the above mentioned parameters were found . Our data indicate that cellular and serological parameters such as eosinophils , ECP and sIL-2R reflect the clinical activity of AD and may therefore give further insights into the pathogenesis of this disease"
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INTRODUCTION Root canal treatment ( RCT ) success criteria inform us of the path to bony healing and of prognostic factors , but tell little about how the patient perceives , feels , or values RCT . Patients choose , undergo , and pay for RCT , they live with the result , and inform their community . The purpose of this narrative review was to appraise patient-centered outcomes of initial non-surgical RCT and nonsurgical retreatment , in adults . MATERIAL S AND METHODS Patient-centered RCT outcome themes were identified in the extant literature : quality of life , satisfaction , anxiety , fear , pain , tooth survival and cost . Narrative review was applied because the disparate themes and data were unsuited to systematic review or meta- analysis . RESULTS Application of the Oral Health Impact Profile ( OHIP ) demonstrated that disease of pulpal origin affects quality of life with moderate severity , primarily through physical pain and psychological discomfort , and that RCT results in broad improvement of quality of life . Satisfaction with RCT is extremely high , but cost is the primary reason for dissatisfaction . Anxiety and fear affect RCT patients , profoundly influencing their behaviors , including treatment avoidance , and their pain experience . Fear of pain is " fair " to " very much " prior to RCT . Pain is widely feared , disliked , and remembered ; however , disease of pulpal origin generally produces moderate , but not severe pain . RCT causes a dramatic decrease in pain prevalence and severity over the week following treatment . Survival rates of teeth after RCT are very high ; complication rates are low . Cost is a barrier to RCT , but initial costs , lifetime costs , cost effectiveness , cost utility , and cost benefit all compare extremely well to the alternatives involving replacement using implants or fixed prostheses . CONCLUSION Dentists must strive to reduce anxiety , fear , experienced and remembered pain , and to accurately inform and educate their patients with respect to technical , practical and psychosocial aspects of RCT
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"INTRODUCTION Up-to- date studies comparing endodontic treatment versus implant-supported prosthesis have shown similar clinical outcome and survival rates . However , no data are available comparing both treatment modalities based on the patient 's perception of quality of life . This study was design ed to qualitatively describe and compare the quality of life of patients with restored , single endodontically treated teeth versus patients with single implant-supported fixed prostheses . METHODS Forty-eight patients agreed to participate in the study ( n = 24 from each treatment modality ) . Of those , 37 actually participated in the study : 17 were endodontically treated and 20 had an implant-supported prosthesis . Patients in each of the two groups were r and omly selected from the Graduate Endodontics and Graduate Periodontics Departments , respectively . Six focus group discussion s ( n = 3 per treatment group ) were held and audio-recorded for subsequent thematic analysis . Data were analyzed to identify common themes within each category and compared to assess any differences in quality of life between the two treatments . Additionally , a quality of life survey , the shortened version of the Oral Health Impact Profile ( OHIP-14 ) , was given before the discussion group and the responses analyzed . RESULTS The results obtained from this study show similar overall OHIP scores and show a high rate of satisfaction with both treatment modalities . Content analysis of the discussion groups revealed several themes and subthemes . The major themes were importance of overall health , financial implication s of the treatments , perception of the treatments and its outcomes , time since treatment , and follow-up dental visits . CONCLUSIONS The results help identify patients ' perception and concerns with each treatment modality and assist the clinician and patient in the selection of an optimal treatment for their given situation . In addition to the prognosis and outcomes , clinicians should consider patients ' perceptions and preferences as well as the influence each therapy may have on their quality of life , both short- and long-term . Overall , all the participants in this study were pleased with the treatment received and expressed a clear message to save their natural dentition whenever possible",
"AIM This longitudinal , prospect i ve study ( 1 ) investigated the prevalence of post-obturation pain after root canal treatment and ( 2 ) evaluated the influence of factors affecting the pain experience . METHODOLOGY Twenty practitioners , comprising general dental practitioners , MSc graduates and Endodontists , participated in this study . The patient sample ( n = 415 ) was derived from consecutive patients attending the practitioners ' surgeries for root canal treatment on a single tooth . Demographic , medical history , preoperative and intra-operative data as well as pain experience on day 1 and day 2 after root canal obturation were recorded . Intensity of pain experienced was recorded on a visual analogue scale ( VAS ) of 0 - 5 . The data were analysed using logistic regression models . RESULTS The prevalence of post-obturation pain within 48 h after treatment was 40.2 % ( n = 167 ) but less than 12 % of patients experienced severe pain ( VAS 4 or 5 ) on either day 1 or day 2 . The factors that significantly influenced post-obturation pain experience were : gender ( OR = 0.434 , P size of periapical lesion ( OR = 0.493 , P = 0.004 ) , history of post-preparation pain ( OR = 4.110 , P = generalized swelling ( OR = 3.435 , P = 0.005 ) and number of treatment visits ( OR = 2.604 , P < 0.001 ) . CONCLUSIONS The prevalence of post-obturation pain was high ( 40.2 % ) . The important prognostic determinants of post-obturation pain were female , molar tooth , size of periapical lesion smaller than 3 mm , history of post-preparation pain or generalized swelling and single-visit treatment",
"AIM To assess previous patient experience of endodontic treatment and to quantify their satisfaction with the endodontic treatment provided in a dental school clinic . DESIGN Self-completed question naire . SETTING Hacettepe University , Faculty of Dentistry , Department of Endodontics , Ankara , Turkey . PARTICIPANTS 200 r and omly selected , scheduled non-emergency patients in good health and older than 11 years who were to be treated by undergraduate , graduate students and academics . MAIN OUTCOME MEASURES Patient satisfaction and attitudes to root canal therapy . RESULTS 96 per cent of patients , regardless their level of education , age and sex , reported that they expected RCT would save their teeth . 15 per cent of the patients were in favour of extraction versus RCT before the therapy , but this reduced to only 2.5 per cent post treatment . 82 per cent of patients reported that they were satisfied with their treatment and the clinic . CONCLUSIONS Increasing public knowledge of and interest in endodontic treatment indicates that the need for an increase in teaching of the subject and associated re sources will be required",
"Aim . To evaluate the incidence and severity of postendodontic treatment pain ( PEP ) subsequent to root canal treatment ( RCT ) in vital and necrotic pulps and after retreatment . Methodology . A prospect i ve study . Participants were all patients ( n = 274 ) who underwent RCT in teeth with vital pulp , necrotic pulp , or vital pulp that had been treated for symptomatic irreversible pulpitis or who received root canal retreatment , by one clinician , during an eight-month period . Exclusion criteria were swelling , purulence , and antibiotic use during initial treatment . A structured question naire accessed age , gender , tooth location , and pulpal diagnosis . Within 24 h of treatment , patients were asked to grade their pain at 6 and 18 hours posttreatment , using a 1–5 point scale . Results . RCT of teeth with vital pulp induced a significantly higher incidence and severity of PEP ( 63.8 % ; 2.46 ± 1.4 , resp . ) than RCT of teeth with necrotic pulp ( 38.5 % ; 1.78 ± 1.2 , resp . ) or of retreated teeth ( 48.8 % ; 1.89 ± 1.1 , resp . ) . No statistical relation was found between type of pain ( spontaneous or stimulated ) and pulp condition . Conclusion . RCT of teeth with vital pulp induced a significantly higher incidence and intensity of PEP compared to teeth with necrotic pulp or retreated teeth",
"To determine whether a relatively large dose of oral dexamethasone given for a short period of time would be effective in reducing endodontic interappointment pain , the current double-blind , placebo-controlled study was undertaken . After the visit for instrumentation , 40 patients with asymptomatic teeth having vital-inflamed pulps were r and omly given either dexamethasone ( 3 tablets of 4 mg each ) or a dextrose placebo identical in appearance ( same dosage schedule ) . The outcome showed that the oral administration of dexamethasone result ed in a statistically significant reduction in endodontic interappointment pain at all three time periods evaluated , that is , at 8 hours , 24 hours , and 48 hours ( p less than 0.01 ) . It appears from the results of this study that this dosage schedule of oral dexamethasone is sufficient to significantly reduce endodontic interappointment pain for teeth with asymptomatic vital-inflamed pulps . Further studies are needed for teeth with other endodontic pulpal-periapical conditions and for symptomatic teeth",
"AIM To investigate the probability of and factors influencing tooth survival following primary ( 1 ° RCT x ) or secondary ( 2 ° RCT x ) root canal treatment . METHODOLOGY This prospect i ve study involved annual follow-up of 2 ( 100 % ) to 4 years ( 50 % ) of 1 ° RCT x ( 759 teeth , 572 patients ) and 2 ° RCT x ( 858 teeth , 642 patients ) carried out by Endodontic postgraduate students . Pre- , intra- and post-operative data were collected prospect ively from consented patients . Information about extraction of the root filled tooth was sought from the patient , the referring dentist or derived from the patient 's records and included the timing and reasons for extraction . Tooth survival was estimated and prognostic factors were investigated using Cox regression . Clustering effects within patients were adjusted in all models using robust st and ard error . RESULTS The 4-year cumulative tooth survival following 1 ° RCT x [ 95.4 % ( 93.6 % , 96.8 % ) ] or 2 ° RCT x [ 95.3 % ( 93.6 % , 96.5 % ) ] was similar . Thirteen prognostic factors were identified . Significant patient factors included history of diabetes and systemic steroid therapy . Significant pre-operative factors included narrow but deep periodontal probing depth ; pain ; discharging sinus ; and iatrogenic perforation ( for 2 ° RCT x cases only ) . Significant intra-operative factors included iatrogenic perforation ; patency at apical terminus ; and extrusion of root fillings . Significant post-operative restorative factors included presence of cast restoration versus temporary restoration ; presence of cast post and core ; proximal contacts with both mesial and distal adjacent teeth ; and terminal location of the tooth . The presence of pre-operative pain had a profound effect on tooth loss within the first 22 months after treatment [ hazard ratio ( HR ) = 3.1 ; P = 0.001 ] with a lesser effect beyond 22 months ( HR = 2.4 ; P = 0.01 ) . Patency at the apical terminus reduced tooth loss ( HR = 0.3 ; P on tooth survival beyond 22 months . Extrusion of gutta-percha root filling did not have any effect on tooth survival ( HR = 1.1 ; P = 0.2 ) within the first 22 months but significantly increased the hazard of tooth loss beyond 22 months ( HR = 3.0 ; P = 0.003 ) . CONCLUSIONS The 4-year tooth survival following primary or secondary root canal treatment was 95 % , with thirteen prognostic factors common to both",
"Since single-tooth implant restorations were introduced 12 years ago ( Jemt 1986 ) , there has been continuous development both in the technical design and the aesthetic outcome of the treatment . In order to ensure high quality in single-tooth implant treatments a clinical follow-up study was carried out on patients treated with modifications to the original regimen . In this study 69 consecutive patients were provided with 80 single-tooth implant restorations . The patients were followed for 3 years . There was continuous development of the prosthetic design during the time of the study , allowing us to analyse possible prognostic differences for the different prosthetic treatments . This study confirms earlier reports which describe the single-tooth implant treatment as a safe method with few surgical complications and minimal marginal bone loss . Only 1 implant was lost during the follow-up period and the average marginal bone loss was 0.48 mm over the 3-year follow-up period . Crowns veneered with acrylic and with gold casted directly to the abutments , screwed onto the implants , led to recurring prosthetic complications and gave an appearance of rapid ageing . The first generation of crowns made following the Cera-One design , sometimes produced a gap between the crown and the abutment associated with significant marginal bone loss during the first year . Few surgical or prosthetic complications were noted with cemented all-ceramic constructions , although the number of these crowns in this study was limited",
"The purpose of this prospect i ve , r and omized , double-blind , placebo-controlled study was to determine the effect of prophylactic amoxicillin on the occurrence of endodontic flare-up in asymptomatic , necrotic teeth . Seventy patients participated and had a clinical diagnosis of an asymptomatic , necrotic tooth with associated periapical radiolucency . One hour before endodontic treatment , patients r and omly received either 3 g of amoxicillin or 3 g of a placebo control in a double-blind manner . After endodontic treatment , each patient received : ibuprofen ; acetaminophen with codeine ( 30 mg ) ; and a 5 1/2-day diary to record pain , swelling , percussion pain , and number and type of pain medication taken . The results demonstrated 10 % of the 70 patients had a flare-up characterized by moderate-to-severe postoperative pain or swelling that began approximately 30 h after endodontic treatment and persisted for an average of 74 h. Of the seven patients who had flare-ups , 4 were in the amoxicillin group and 3 were not . Prophylactic amoxicillin did not significantly ( p = 0.80 ) influence the endodontic flare-up . We concluded that a prophylactic dose of amoxicillin before endodontic treatment of asymptomatic , necrotic teeth had no effect on the endodontic flare-up",
"BACKGROUND More knowledge about the relationship between blood-injury-injection phobia ( BIIP ) and dental anxiety ( DA ) may give new clinical ly relevant information in the assessment and management of children with DA . OBJECTIVE The aims of this study were to explore the relationships between BIIP and DA , and to explore to what extent the two subtypes of BIIP in combination with DA are related to self-reported probability of avoiding dental treatment if a dental injection is needed . METHODS The subjects were a r and om sample of 1385 18-year-olds attending high schools in a county of Norway , and the data were collected by use of question naires completed in classrooms . The survey instruments applied were Dental Fear Survey , Injection Phobia Scale-Anxiety , and Mutilation Question naire . RESULTS About 11 % of the subjects with DA and subtypes of BIIP , respectively , reported high probability of avoiding dental treatment in a situation where a dental injection was possibly needed . In multiple regression analysis , only DA contributed to self-reports of high probability of avoiding dental treatment . CONCLUSION The results indicate that among adolescents , BIIP is relatively often connected with DA . Clinical implication s are discussed",
"AIM ( i ) To assess the impact of primary root canal treatment on the perceived quality of life amongst a cohort of Jordanian patients , ( ii ) to assess this cohort 's satisfaction of their primary root canal treatment , and ( iii ) to evaluate the association of the level of training and experience of clinicians with these two parameters . METHODOLOGY A systematic r and om sample of 302 subjects was selected from patients who attended undergraduate , graduate and specialty clinics of Jordan University of Science and Technology . Participants were interviewed before and two weeks after completion of root canal treatment . The study instrument included the Oral Health Impact Profile question naire ( Dugas et al. 2002 ) and seven semantic differential scales . Data analyses included descriptive statistics and nonparametric analyses . RESULTS More than 90 % of subjects reported improvements in the sense of taste , pain , eating , altering food temperature , self-consciousness , waking up during sleep , interruption of meals , difficulty to relax and difficulty to sleep after root canal treatment . There was no significant difference in terms of improvement amongst patients treated by specialists , graduate students or undergraduate students . The overall semantic differential score of intraoperative pain , pleasantness , chewing ability and general satisfaction was about 8 . Satisfaction of root canal treatment by specialists was higher in terms of time involved , intraoperative pain , pleasantness and general satisfaction than those treatments by undergraduate students . Patients treated by specialist were least satisfied with the treatment cost compared to those patients treated by graduate or undergraduate students . CONCLUSIONS The impact of root canal treatment on the quality of life was apparent . Satisfaction with root canal treatment approximates 8 on the semantic differential scale with preference for specialists over dental students",
"Dental fear is related to poorer oral health outcomes , and this might be explained by the less frequent dental visiting of many fearful people . The objectives of this study were to investigate differences between dentally fearful people who regularly attend the dentist and fearful people who infrequently visit the dentist . A r and om sample of 1,082 Australians ≥ 15 yr of age completed a mailed question naire ( response rate = 71.6 % ) , and 191 dentate , high-fear adults ( ≥ 18 yr of age ) were selected for further analysis . Dental avoidance was recorded if a person was currently avoiding or delaying dental care and if he/she had not been to a dentist in the previous 2 yr . Among the selected dentally fearful adults , dental avoidance was predicted by smoking status , toothbrushing frequency , coping strategy use , perceptions of dental visits as uncontrollable and unpredictable , and by anxiety relating to numbness , not knowing what the dentist is going to do , and cost . In a multivariate logistic regression model , smoking , toothbrushing , coping , and anxiety about numbness and cost remained as statistically significant predictors , with the model accounting for 30 % of the variance . While several variables were associated with dental avoidance among fearful adults , the nature and causal directions of these associations remain to be established",
"The effects of a brain wave synchronizer ( BWS ) on endodontic ( root canal ) anxiety was evaluated in the clinical practice s of the senior author . The experimental groups were : ( 1 ) a verbal method ( routine calming words by dentist ) plus BWS ( N = 10 ) and ( 2 ) verbal method plus BWS and alpha relaxation tape ( N = 10 ) . The control group was verbal method alone ( N = 10 ) . All three groups were evaluated during a complete endodontic treatment by the use of galvanic skin resistance ( GSR ) , pulse rate ( PR ) , physical responses , and pre- and post-treatment question naires . Recordings were made during the following periods : ( 1 ) start ; ( 2 ) local anesthetic injection ; ( 3 ) rubber dam application ; ( 4 ) drilling ; ( 5 ) x-ray taking ; ( 6 ) instrumentation ; ( 7 ) obturation ; and ( 8) conclusion . Results showed that the experimental groups were significantly better than the control group in the reduction of endodontic anxiety . The findings reinforced the belief that local anesthetic injection is the most anxiety producing aspect of endodontic treatment",
"AIM To provide subjects with positive information about endodontic treatment ( ET ) to reduce fear of pain associated with ET . METHODOLOGY A large sample ( n = 437 ) was r and omly allocated to read one of five informative paragraphs and afterwards asked to complete two question naires ( dental anxiety and fear of dental pain ) . The paragraphs consisted of dental information obtained from patient brochures . One ( experimental ) paragraph consisted of positive information about pain during ET . Analysis of variance followed by post hoc analysis was used to detect differences in mean score . RESULTS Subjects who were given the positive information regarding ET indicated they were less fearful of pain associated with ET . CONCLUSIONS The clinical implication of this experiment is that patients should be accurately informed about pain associated with ET . In this way , the patient may be more at ease before and during treatment , decrease avoidance behaviour and make decisions regarding treatment choice , based on common sense rather than fearful expectations",
"AIM To determine the pain experienced by patients during root canal treatment and to correlate with age and gender , pulpal diagnosis , previous periapical status , dental characteristics and length of treatment . METHODOLOGY One hundred and seventy-six patients ( 68 men and 108 women ) , with ages ranged from 6 to 83 years , were r and omly recruited . Patients completed a 10-cm visual analogue scale ( VAS ) that ranked the level of pain experienced during root canal treatment . RESULTS The mean pain level during root canal treatment was 1.2 + /- 0.8 in a VAS between 0 and 10 . Fifty-four per cent of patients did not experience pain . There were no significant differences in relation to gender or age groups . M and ibular teeth had a significantly ( P pain in comparison with maxillary teeth . Pain was absent in 63 % of anterior teeth compared with 44 % in posterior ones ( P pain absence ( P Root canal treatment was significantly ( P painful in teeth with irreversible pulpitis and acute apical periodontitis compared to the group with necrotic pulps and chronic apical periodontitis ( P = 0.049 ) . CONCLUSIONS Root canal treatment in teeth with irreversible pulpitis and acute apical periodontitis was more painful . Age , tooth type and length of the treatment were factors associated with increased risk for pain experienced during the procedure . Knowledge of pain levels endured by patients will allow dentists to decide when to use supplemental local anaesthesia",
"OBJECTIVES The purpose of this r and omised investigator-blind controlled trial is to examine the effects of music on the state anxiety and physiological indices among patients undergoing root canal treatment . DESIGN R and omised controlled trial . METHODS Purposive sampling was used to recruit 44 adult subjects . The subjects were r and omly assigned to the treatment and the control group . There were 22 subjects in each group . Subjects in the music group listened to selected sedative music using headphones throughout the root canal treatment procedure . The control group subjects worn headphones but without the music . Using a repeated measures design with a single pretest and five posttests , the subjects ' heart rate , blood pressure and finger temperature were measured before the study and every 10 minutes until the end of the root canal treatment procedure . Anxiety was measured before the study and at the end of the treatment procedure . RESULTS The results revealed that there were no significant differences between the two groups for baseline data and procedure-related characteristics , except for gender . However , the subjects in the music group showed a significant increase in finger temperature and a decrease in anxiety score over time compared with the control group . The effect size for state anxiety and finger temperature was 0.34 and 0.14 respectively . RELEVANCE TO CLINICAL PRACTICE The findings provide evidence for nurses and dentists that the use of soothing music for anxiety reduction in patients undergoing root canal treatment procedures is supported by research findings"
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41170f46-06ff-11f0-808a-c43d1ab1c353
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Objective The aim of this meta- analysis of r and omized placebo-controlled trials was to examine whether ursodeoxycholic acid treatment is an effective lipid-lowering agent . Methods PubMed - Medline , SCOPUS , Web of Science and Google Scholar data bases were search ed in order to find r and omized controlled trials evaluating the effect of ursodeoxycholic acid on lipid profile . A r and om-effect model and the generic inverse variance weighting method were used for quantitative data synthesis . Sensitivity analysis was conducted using the leave-one-out method . A r and om-effects meta-regression model was performed to explore the association between potential confounders and the estimated effect size on plasma lipid concentrations . Results Meta- analysis of 20 treatment arms revealed a significant reduction of total cholesterol following ursodeoxycholic acid treatment ( WMD : − 13.85 mg/dL , 95 % CI : -21.45 , − 6.25 , p ) . Nonetheless , LDL-C ( WMD : -6.66 mg/dL , 95 % CI : -13.99 , 0.67 , p = 0.075 ) , triglycerides ( WMD : − 1.42 mg/dL , 95 % CI : -7.51 , 4.67 , p = 0.648 ) and HDL-C ( WMD : -0.18 mg/dL , 95 % CI : -5.23 , 4.87 , p = 0.944 ) were not found to be significantly altered by ursodeoxycholic acid administration . In the subgroup of patients with primary biliary cirrhosis , ursodeoxycholic acid reduced total cholesterol ( WMD : − 29.86 mg/dL , 95 % CI : -47.39 , − 12.33 , p = 0.001 ) and LDL-C ( WMD : -37.27 mg/dL , 95 % CI : -54.16 , − 20.38 , p affecting TG and HDL-C. Conclusion This meta- analysis suggests that ursodeoxycholic acid therapy might be associated with significant total cholesterol lowering particularly in patients with primary biliary cirrhosis
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"UNLABELLED In uncontrolled clinical studies , ursodeoxycholic acid ( UDCA ) had a beneficial effect on nonalcoholic steatohepatitis ( NASH ) . However , a large controlled trial using UDCA ( 13 - 15 mg/kg/day ) was unable to confirm these results . Accordingly , a r and omized , placebo-controlled study was initiated with a high dose of UDCA ( 23 - 28 mg/kg/day ) . The allocation of patients and the evaluation of liver histology were performed according to a modified Brunt score and the nonalcoholic fatty liver disease activity score ( NAS ) . With the modified Brunt score , 185 patients with histologically proven NASH were r and omized [ intention to treat ( ITT ) ] , and 147 were treated per protocol ( PP ) . With the NAS , 137 patients were confirmed to have NASH , 48 had borderline NASH , and 1 did not have NASH . The treatment time was 18 months . At entry , the treatment groups were comparable . A second biopsy sample was obtained from 139 of 185 patients ( NAS : 107/137 ) . The primary criterion for evaluation was a change in the liver histology ; the secondary criteria were single histological variables and liver biochemistry . Significant differences in the overall histology could not be detected between the two treatment groups with the modified Brunt score ( P = 0.881 ) or NAS ( P = 0.355 ) . Only lobular inflammation improved significantly ( P for the modified Brunt score = 0.011 , P for NAS = 0.005 ) . In subgroup analyses , significant improvements in lobular inflammation were also observed in males , younger patients up to 50 years of age , slightly overweight patients , and patients with hypertension and an increased histology score . The fibrosis score did not change ( P for ITT = 0.133 , P for PP = 0.140 ) . With the exception of gamma-glutamyl transferase , UDCA did not improve laboratory data . CONCLUSION High-dose UDCA failed to improve the overall histology in patients with NASH in comparison with placebo",
"Based on uncontrolled observations , we have proposed ursodeoxycholic acid ( UDCA ) as a novel therapeutic approach in primary biliary cirrhosis ( PBC ) . To confirm and extend our original findings , we have design ed a double-blind multicentre r and omized clinical trial . An interim analysis was planned at 6 months , involving all subjects included in the trial , with a final analysis at 2 years . The UDCA-PBC trial began in June 1987 and will be completed in March 1990 . Seventy patients were r and omized to receive UDCA and 68 a placebo . The two groups were well matched with respect to age , sex , duration and prevalence of symptoms and histologic severity ( 50 % of the UDCA group had stage III-IV disease vs. 37 % of the placebo group ) . During the first 6 months of follow-up , six patients withdrew from the trial . At 6 months , the proportion of patients with jaundice was significantly lower ( p less than 0.01 ) in UDCA recipients than in the placebo group . There was a similar decrease in the proportion of patients with pruritus and fatigue in both groups . The following laboratory test values were significantly lower in UDCA recipients than in the placebo group after 6 months of therapy : serum bilirubin , alkaline phosphatase , alanine aminotransferase ( ALAT ) , aspartate aminotransferase ( ASAT ) , gamma-glutamyltranspeptidase activities ( p less than 0.001 ) , cholesterol ( p less than 0.003 ) and IgM levels ( p less than 0.03 ) . The results of this interim analysis confirm and extend the biochemical data provided by our previous pilot study . However the final analysis of the trial is necessary for a definitive assessment of the safety and efficacy of UDCA therapy in PBC",
"The administration of ursodeoxycholic acid , a hydrophilic bile acid not hepatotoxic to humans , has been suggested for treatment of primary biliary cirrhosis to improve cholestasis and reduce hepatocellular damage . Efficacy of treatment has been studied mainly in patients with asymptomatic or early-stage disease . In January 1988 , to establish the efficacy and safety of ursodeoxycholic acid in a population with more severe disease , we started a multicenter , double-blind , placebo-controlled trial in patients with symptomatic disease , that is , with pruritus or serum bilirubin exceeding 2 mg/dl . Forty-four patients were assigned to ursodeoxycholic acid , 500 mg daily ( corresponding to about 8.7 mg/kg body weight in these patients ) , and 44 to a placebo . As planned at the beginning of the study , a preliminary analysis was performed when all patients had been followed for at least 6 months ( 33 patients up to 12 months ) . Pruritus , self-evaluated by the patients , and cholestyramine consumption , as recorded in a diary , decreased significantly ( p serum bilirubin decreased significantly ( p ursodeoxycholic acid group compared to placebo . After 6 months the following were also significantly better in the ursodeoxycholic acid than in the placebo group : a composite weighted biochemical index taking into account the changes in serum bilirubin , alkaline phosphatase , gamma-GT and AST ( p serum prealbumin ( p IgG ( p IgM ( p < 0.01 ) levels . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Background and purpose Nonalcoholic fatty liver disease ( NAFLD ) is one of the causes of a fatty liver , occurring when fat is deposited ( steatosis ) in the liver not due to excessive alcohol use . It is related to insulin resistance and the metabolic syndrome . The purpose of the present study was to evaluate the impact of combination therapy with alpha-lipoic acid ( ALA ) and ursodeoxycholic acid ( UDCA ) on NAFLD . Methods Alpha-lipoic acid 400 mg/day plus UDCA 300 mg/day ( ALAUDCA ) was investigated in patients over a period of 12 months using a r and omized , placebo (PLA)-controlled study with four parallel groups . Serum concentration of gamma-glutamyl transpeptidase ( GGT ) , alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , albumin and platelets ( PLT ) were measured at the beginning and at the end of the treatment . Moreover , the AST/ALT ratio and the NAFLD fibrosis score were examined . Results A total of 120 patients were r and omly assigned to the four groups . ALA and UDCA were safe and well tolerated in the oral daily administration only . AST , ALT , GGT ( p ALAUDCA and other three groups . Besides , NAFLD fibrosis score underlined a significant reduction ( p ALAUDCA group , while AST/ALT ratio presented a moderate decline ( p > 0.05 ) . Conclusion ALAUDCA therapy reduced AST , ALT , GGT values and improved NAFLD fibrosis score and AST/ALT ratio , especially in patients who were on a hypocaloric diet . These findings will be useful in patient selection in future clinical trials with ALAUDCA in long-term studies",
"OBJECTIVE Nonalcoholic fatty liver disease is an increasingly recognized condition that may progress to end-stage liver disease . We investigated the effects of weight reduction and ursodeoxycholic acid administration in patients with this disease . RESEARCH METHODS AND PROCEDURES A double-blind , placebo-controlled trial . Twenty-seven women with a body mass index of > 30 kg/m2 and willing to participate in the diet plan for six weeks were studied were assigned to one of two treatment groups ( ursodeoxycholic acid , n = 14 : placebo n = 13 ) . Both groups received a normal diet ( 1,200 kcal/d ) plus 1200 mg/d of ursodeoxycholic acid or placebo . Hepatic steatosis , was assessed by abdominal ultrasound . Fasting glucose , cholesterol , triglycerides , and aminotransferases levels were determined before and after treatment . RESULTS Body mass index decreases significantly from 34.2 + /- 4.2 kg/m2 and 33.3 + /- 1.6 kg/m2 to 31.8 + /- 4.5 kg/m2 and 30.6 + /- 2.6 kg/m2 in the ursodeoxycholic acid and placebo groups , p hepatic steatosis index decreased from 2.3 + /- 0.7 to 1.0 + /- 0.6 and 2.2 + /- 0.7 to 1.1 + /- 0.7 in the ursodeoxycholic acid and placebo groups , p Serum AST decreased significantly from 41.2 + /- 5.6 to 34.5 + /- 3.4 in the ursodeoxycholic acid group , p Serum ALT decreased from 62.9 + /- 6.5 to 44.0 + /- 3.5 in the ursodeoxycholic acid group , p < 0.001 , and from 63.5 + /- 4.5 to 44.0 + /- 3.5 in the placebo group . We did not find any differences in all variables studied between groups . CONCLUSIONS The present study shows beneficial effect of weight reduction , producing improvements in biochemical and imaging markers of liver disease",
"BACKGROUND / AIM The aim of this study was to assess the efficacy of ursodeoxycholic acid ( UDCA ) for primary biliary cirrhosis in a r and omized , double-blind placebo-controlled trial . METHODS Consecutive patients ( n=192 ) were r and omized to receive 14 - 16 mg UDCA/kg/day or placebo . Patients underwent a complete history , physical examination , liver chemistries , immunological determinations and liver biopsy at entry and at the end of the trial , which lasted for at least 2 years . Patients were seen every 3 months and the median follow-up was 3.4 years ( range 0.3 to 6.1 years ) . RESULTS Patients receiving UDCA ( 99 ) or placebo ( 93 ) were comparable with regard to age , sex , biochemical parameters and liver histology . UDCA treatment was associated with decreases in alkaline phosphatase , gammaglutamyl transferase , alanine aminotransferase , and cholesterol levels , effects which were conspicuous after 3 months of treatment and remained similar during the follow-up . During the study 31 patients ( 10 receiving UDCA and 21 placebo ) discontinued the trial because of noncompliance ( n=11 ) , voluntary withdrawal ( n=19 ) or adverse effects ( n=1 ) . Treatment failure ( death or liver transplantation ) was observed in 17 patients receiving UDCA and in 11 patients receiving placebo . Times to death or liver transplantation and to clinical complications were not significantly different in patients receiving UDCA or placebo . Histological analysis indicates that UDCA improved portal inflammation and prevented histological stage progression . By contrast , histological stage as well as ductular proliferation and ductopenia progressed in patients receiving placebo . CONCLUSIONS Although UDCA treatment did not significantly affect time to death or liver transplantation and to clinical complications , the effects on both cholestasis and liver histology suggest that UDCA is safe and may be useful for preventing the progression of primary biliary cirrhosis",
"44 patients with radiolucent gallstones in gallbladders visible on cholecystography were r and omly alloted to three treatment groups : ursodeoxycholic acid ( 600 mg/day ) , ursodeoxycholic acid ( 150 mg/day ) , a placebo . At the end of six months ' treatment , cholecystograms of all the patients were interpreted by radiologists who were not aware of the treatment . Dissolution of gallstones occurred in 8 ( 26 % ) of the 31 patients treated with ursodeoxycholic acid , but not in the placebo group . Ursodeoxycholic acid had no hepatotoxicity , as assessed by st and ard liver-function tests . These results indicate that ursodeoxycholic acid , the 7beta epimer of chenodeoxycholic acid , is effective in the dissolution of cholesterol gallstones",
"A r and omized placebo-controlled 2-year study was performed in 69 patients with primary biliary cirrhosis ( PBC ) on serum lipids during ursodeoxycholic acid ( URSO ) and colchicine treatments . In addition to serum bilirubin and alkaline phosphatase ( AFOS ) , two variables considered to reflect liver function , serum lipoproteins , cholesterol precursors ( squalene , delta 8-cholestenol , lathosterol and desmosterol ) , markers of cholesterol synthesis , cholestanol and plant sterols ( campesterol and sitosterol ) , markers of liver function and cholesterol absorption , were studied before and during the treatments . Serum bilirubin was inconsistently improved by URSO , whereas improvement of AFOS values was better by URSO than colchicine , especially in patients with initially more advanced PBC . Serum total cholesterol was reduced by both drugs , very low-density lipoprotein ( VLDL ) and high-density lipoprotein ( HDL ) cholesterol by URSO . Cholesterol precursor sterols were increased by both URSO and colchicine mainly in patients with initially less severe PBC . On the other h and , the cholestanol values were markedly increased initially , and the values were related to bilirubin during the 2-year period , were further increased in the placebo group , and reduced in the URSO and colchicine groups , so that the improvement was highest in the URSO-treated patients with the severe form of PBC . The increase of the serum plant sterols , particularly that of sitosterol , was retarded by the two drugs so that the campesterol/sitosterol ratio , which was related to serum bilirubin , was increased especially in the cases with initially more advanced PBC . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE To study the effects of ursodeoxycholic acid ( UDCA ) on lipid levels in patients with primary biliary cirrhosis ( PBC ) . DESIGN A r and omized , placebo-controlled prospect i ve trial of UDCA was conducted in 177 well-characterized patients with PBC . MATERIAL AND METHODS The two treatment groups ( placebo and UDCA ) were matched at entry with respect to age , sex , histologic stage of PBC , biochemical values , and serum lipid levels . Serum cholesterol , high-density lipoprotein cholesterol , and triglyceride levels were measured at entry , 1 year , and 2 years . RESULTS The decrease in total cholesterol level at 1 and 2 years in the UDCA-treated group was significant in comparison with that in the placebo group . Serum high-density lipoprotein cholesterol and triglyceride levels , however , were unchanged . No severe side effects from UDCA were noted . The changes in serum cholesterol levels at 2 years were directly and strongly correlated with changes in serum bilirubin concentrations ( r = 0.70 ; P initial serum cholesterol levels ( r = -0.86 ; P UDCA could be related to amelioration of the underlying liver disease or to a direct effect of the drug on the metabolism of cholesterol in patients with hypercholesterolemia",
"BACKGROUND / AIMS Ursodeoxycholic acid ( UDCA ) and colchicine have beneficial effects in primary biliary cirrhosis ( PBC ) . The efficacy of colchicine and UDCA in PBC was compared in a 2-year placebo-controlled study ( n = 90 ) . METHODS Clinical events , laboratory test results , and liver histology were recorded at the beginning and end of the trial . RESULTS There were significantly fewer dropouts for hepatic reasons with UDCA than with placebo . Pruritus was reduced by both active drugs . Colchicine improved liver function test results only modestly , whereas UDCA significantly decreased the serum activities of aminotransferases , alkaline phosphatase , and gamma-glutamyltransferase compared with colchicine and placebo . Serum total bilirubin levels were decreased only by UDCA . Both colchicine and UDCA reduced serum cholesterol levels , and UDCA also reduced high-density lipoprotein cholesterol levels . Furthermore , UDCA reduced the serum levels of immunoglobulin ( Ig ) M and IgG , and colchicine reduced IgG levels compared with placebo . The elevated serum level of aminoterminal propeptide of type III procollagen remained unchanged by colchicine or UDCA , whereas the serum level of carboxyterminal propeptide of type I procollagen was significantly decreased by UDCA . UDCA significantly decreased ductular proliferation compared with colchicine or placebo . CONCLUSIONS These data suggest that UDCA frequently is superior to colchicine and especially to placebo in the treatment of PBC",
"A double-blind controlled trial was carried out to compare the effects of chenodeoxycholic acid ( CDCA ) , ursodeoxycholic acid ( UDCA ) , and placebo on cholesterol and triglyceride levels in patients with endogenous hypertriglyceridemias . The dose of both bile acids was four 150-mg capsules day . Total serum cholesterol levels did not show appreciable changes with any of the treatments . HDL cholesterol was significantly increased after CDCA but not after UDCA or placebo . CDCA feeding was associated with a significant decrease in serum triglyceride levels , whereas the other treatments failed to show an effect . It is concluded that UDCA does not affect serum lipid levels , whereas CDCA lowers serum triglycerides and may be useful in the treatment of endogenous hypertriglyceridemia",
"To test the effectiveness of ursodeoxycholic acid as a gallstone dissolving agent , doses of 250 mg/day and 1000 mg/day were administered for 1 year to two groups of 10 and 11 subjects each . Success was defined as a reduction in stone size and number of 50 % or more . Both groups of subjects were similar when comparing age , height , weight , gallstone size , and number although more men were enrolled in the high-dose treatment group . After 1 yr of high-dose ursodeoxycholic acid , successful treatment occurred in 70 % of subjects associated with a rise in biliary ursodeoxycholic acid ( 1.7 to 51 % ) and a decline in the proportions of cholic acid ( 36 to 16 % ) , deoxycholic acid ( 19 to 10 % ) , chenodeoxycholic acid ( 41 to 23 % ) , and lithocholic acid ( 1.9 to 0.4 % ) . The mean cholesterol saturation index decreased from 1.5 to 0.7 and was accompanied by a 3.0-fold reduction in the activity of HMG CoA reductase ( 81 to 29 units ) in 2 subjects . With low-dose ursodeoxycholic acid , successful treatment occurred in 30 % of subjects accompanied by a rise in biliary ursodeoxycholic acid to 29 % of total bile acids ; and a decline in deoxycholic acid ( 33 to 25 % ) , chenodeoxycholic acid ( 46 to 22 % ) , and lithocholic acid ( 4.0 to 2.4 % ) , while cholic acid ( 22 % ) did not change . The mean cholesterol saturation index fell from 1.9 to 1.2 . No untoward effects ( diarrhea or elevated serum transaminase levels ) were noted in either group . These results confirm that both high and low doses of ursodeoxycholic acid dissol ve gallstones in humans and were not associated with uncomfortable side effects . However , high doses of ursodeoxycholic acid were more effective and produced a greater reduction in the cholesterol saturation index , presumably by reducing hepatic cholesterol synthesis . Thus , the smallest effective dose of ursodeoxycholic acid probably lies between 250 mg and 1000 mg/day",
"In a double-blind controlled study of ursodeoxycholic acid ( 400 and 800 mg/day ) and chenodeoxycholic acid ( 375 and 750 mg/day ) , in comparison with placebo , ursodeoxycholic acid was significantly more effective than chenodeoxycholic acid in dissolving gallstones after 12 mo of treatment . Although there continued to be better dissolution during ursodeoxycholic acid treatment ( dissolution complete in 30 % and partial in another 30 % of the patients ) than during chenodeoxycholic acid treatment ( dissolution complete in 7 % and partial in 40 % ) at 24 mo , this difference between the treatment groups was no longer statistically significant . The incidence of floating stones was significantly higher in the patients who dissolved their stones than in those who did not ( p less than 0.001 ) . The three failures of dissolution of floating stones during bile acid treatment were associated with chenodeoxycholic acid therapy -- two of them with the 750-mg and the third with the 375-mg doses . Gallstone dissolution with ursodeoxycholic acid occurred in spite of a rise in biliary cholesterol saturation , which was consistent with a nonmicellar mechanism of cholelitholysis . Furthermore , more than threefold serum elevations of L-alanine aminotransferase were observed only during chenodeoxycholic acid therapy . They occurred in 2 patients treated with 375 and 750 mg/day , respectively . The enzyme levels normalized after discontinuation of chenodeoxycholic acid and have remained normal for 13 and 8 mo , respectively , after the institution of treatment with 800 mg/day of ursodeoxycholic acid . There was no correlation between the liver tests and biliary levels of lithocholic acid . Of all the symptoms studied , only constipation showed changes that approached statistical significance ( p = 0.0681 ) . There was a significant improvement of constipation in the combined chenodeoxycholic acid groups when they were compared with the combined ursodeoxycholic acid groups . The total bile acid pool exp and ed significantly in both the chenodeoxycholic acid and in the 800-mg ursodeoxycholic acid treatment groups . The marked increases of biliary ursodeoxycholic acid and chenodeoxycholic acid , respectively , indicated compliance with the treatment in all but 1 bile acid-treated patient . Neither serum triglycerides nor serum cholesterol showed significant changes in any of the treatment groups . The study shows that ursodeoxycholic acid dissolves gallstones faster and with fewer side effects than chenodeoxycholic acid . The results of the study are also consistent with the view that ursodeoxycholic acid is cholelitholytic at a lower dose than is chenodeoxycholic acid",
"Ratios of cholestanol , campesterol , and sitosterol to cholesterol in serum are known to reflect cholesterol absorption efficiency . Here , a possible link between these ratios and biliary secretion rates of cholesterol was investigated . Biliary lipid secretion rates and serum sterols were determined in 13 patients with gallstones . Seven were treated with ursodeoxycholic acid ( UDCA ) ( 1,000 mg/d ) . Serum cholesterol and non-cholesterol sterols were also measured in a cross over study in 20 healthy volunteers , who received either placebo or UDCA ( 750 mg/d ) . Biliary cholesterol secretion was significantly lower , whereas the non-cholesterol sterols and their ratio to cholesterol were higher in patients with gallstones treated with UDCA . A highly significant negative linear correlation between the ratios of non-cholesterol sterols to cholesterol and biliary cholesterol secretion was observed . In volunteers , administration of UDCA for 4 weeks was followed by a significant increase in non-cholesterol sterols and their ratios . Even 4 weeks after discontinuing UDCA administration , campesterol and sitosterol were still significantly higher than pretreatment levels , which was also true for the campesterol-cholesterol ratio after 8 weeks . The results suggest that the ratios of cholestanol , campesterol , and sitosterol to cholesterol can be used as indicators of changes in biliary cholesterol secretion rates",
"We have previously shown in a 2-yr controlled trial that hypercholesterolemia , frequent in primary biliary cirrhosis , is lowered by ursodeoxycholic acid ( 13 to 15 mg daily ) . To further investigate this effect , we analyzed the influence of long-term ursodeoxycholic acid administration on serum lipids , lipoproteins and bile acids . The study involved a subgroup of 33 noncirrhotic patients ( 17 received ursodeoxycholic acid and 16 received a placebo ) analyzed at inclusion and after 2 yr . The total serum cholesterol concentration was markedly reduced in the ursodeoxycholic acid-treated patients in comparison with the controls ( mean + /- S.E.M. = 7.49 + /- 0.42 mmol/L and 7.07 + /- 0.23 mmol/L at entry and 4.44 + /- 0.40 mmol/L and 6.89 + /- 0.27 mmol/L at 2 yr in the ursodeoxycholic acid and placebo groups , respectively ; p low-density-lipoprotein cholesterol , but very low density-lipoprotein cholesterol levels also fell significantly . High-density-lipoprotein cholesterol levels remained stable in both groups , but the high-density-lipoprotein2/high-density-lipoprotein3 cholesterol ratio fell significantly during ursodeoxycholic acid treatment . No significant change occurred in total triglyceride or total phospholipid levels . In the treated group , the proportion of ursodeoxycholic acid increased ( up to 60 % of total circulating bile acids ) , whereas that of cholic and chenodeoxycholic acids fell significantly . In conclusion , the cholesterol-lowering effect of ursodeoxycholic acid could be related to an improvement of cholestasis , modifications in cholesterol metabolism or both . Changes in endogenous bile acid composition induced by ursodeoxycholic acid might be the common denominator of these two mechanisms",
"BACKGROUND AND AIMS Despite hypercholesterolemia has been recognized to increase cardiovascular risk in human immunodeficiency virus (HIV)-infected patients , cholesterol-lowering therapy is underused in this population , due to fear of drug-drug interactions with antiretroviral therapy ( ART ) . We investigated the effects of a nutraceutical combination ( NC ) on lipid profile , proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , sub clinical inflammation and arterial stiffness in ART-treated HIV-infected patients . METHODS This was a prospect i ve r and omized open-label trial with a cross-over design including 30 stable HIV-infected patients on ART with low-density lipoprotein cholesterol ( LDL-C ) > 115 mg/dL , not taking lipid-lowering treatment . After a 3-week lipid stabilization period , the effects associated with 3 months of an oral NC containing red yeast rice and berberine vs. no active treatment ( noNC ) were assessed for plasma total cholesterol ( TC ) , LDL-C , high-density lipoprotein cholesterol ( HDL-C ) , triglyceride ( TG ) , lipoprotein(a ) , PCSK9 , high-sensitivity C-reactive protein ( hs-CRP ) levels and aortic pulse wave velocity ( aPWV ) . RESULTS At baseline , significant correlations between PCSK9 levels , age ( rho = -0.51 , p=0.004 ) , waist circumference ( rho = 0.36 , p=0.005 ) and CD4 + cell count ( rho = -0.40 , p=0.027 ) were observed . NC treatment effects corrected for noNC were significant for TC ( -14 % , p LDL-C ( -19 % , p PCSK9 ( -12 % , p=0.02 ) , hs-CRP ( -14 % , p=0.03 ) and aPWV ( -6 % , p=0.005 ) . No significant effects were observed for HDL-C , TG and lipoprotein(a ) . NC treatment was safe and no significant alterations in muscle , liver and immunovirological parameters were observed . No carry over effect was recorded . CONCLUSIONS The tested NC significantly reduced plasma cholesterol and PCSK9 levels , attenuated sub clinical inflammation and improved arterial stiffness in stable HIV-infected patients on ART"
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41170f82-06ff-11f0-808a-c43d1ab1c353
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This study aim ed to systematic ally review r and omized clinical trials ( RCTs ) to clarify the effects of pro-/synbiotic supplementation on anthropometric and biochemical measurements in women with polycystic ovary syndrome ( PCOS ) . PubMed , Scopus , ISI Web of Science , Cochrane Library , and Google Scholar were search ed through September 2018 . Eight RCTs ( nine treatment arms ) were included . Pro-/synbiotic supplementation significantly reduced fasting blood sugar ( −2.52 mg/dl , 95 % confidence interval ( CI ) : −4.10 to −0.95 ) , insulin ( −2.27 µIU/mL , 95 % CI : −3.40 to −1.14 ) , homeostasis model assessment for insulin resistance index ( −0.69 , 95 % CI : −0.98 to −0.40 ) , C-reactive protein ( −1.69 Hedges ’ , 95 % CI : −3.00 to −0.38 ) , and total testosterone ( −0.12 ng/mL , 95 % CI : −0.17 to −0.08 ) in women with PCOS . However , changes in the mean difference of weight and body mass index did not reach a statistically significant level . The findings suggest that pro-/synbiotic supplementation may improve glucose homeostasis parameters , hormonal , and inflammatory indices in women with PCOS
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"Background To our knowledge , no reports are available indicating the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with polycystic ovary syndrome ( PCOS ) . This research was done to assess the effects of synbiotic supplementation on hormonal status , biomarkers of inflammation and oxidative stress in subjects with PCOS . Methods This r and omized double-blind , placebo-controlled trial was conducted on 60 subjects diagnosed with PCOS according to the Rotterdam criteria . Subjects were r and omly assigned into two groups to take either synbiotic ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Endocrine , inflammation and oxidative stress biomarkers were quantified at baseline and after the 12-week intervention . Results After the 12-week intervention , compared with the placebo , synbiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( changes from baseline in synbiotic group : + 19.8 ± 47.3 vs. in placebo group : + 0.5 ± 5.4 nmol/L , p = 0.01 ) , plasma nitric oxide ( NO ) ( changes from baseline in synbiotic group : + 5.5 ± 4.8 vs. in placebo group : + 0.3 ± 9.1 μmol/L , p = 0.006 ) , and decreased modified Ferriman Gallwey ( mF-G ) scores ( changes from baseline in synbiotic group : − 1.3 ± 2.5 vs. in placebo group : − 0.1 ± 0.5 , p = 0.01 ) and serum high-sensitivity C-reactive protein ( hs-CRP ) ( changes from baseline in synbiotic group : − 950.0 ± 2246.6 vs. in placebo group : + 335.3 ± 2466.9 ng/mL , p = 0.02 ) . We did not observe any significant effect of synbiotic supplementation on other hormonal status and biomarkers of oxidative stress . Conclusions Overall , synbiotic supplementation for 12 weeks in PCOS women had beneficial effects on SHBG , mFG scores , hs-CRP and NO levels , but did not affect other hormonal status and biomarkers of oxidative stress . Trial registration This study was retrospectively registered in the Iranian website ( www.i rct .ir ) for registration of clinical trials ( I RCT 201509115623N53 ) , on 2015–09 - 27",
"BACKGROUND To the best of our knowledge , data on effects of probiotic administration on hormonal profiles , biomarkers of inflammation and oxidative stress in women with polycystic ovary syndrome ( PCOS ) are scarce . This investigation was conducted to assess the effects of probiotic supplementation on hormonal profiles , biomarkers of inflammation and oxidative stress in women with PCOS . METHODS This r and omized , double-blind , placebo-controlled trial was conducted on 60 women with PCOS , aged 18 - 40 years old . Subjects were r and omly assigned into 2 groups to receive either probiotics or placebo ( n = 30 each group ) for 12 weeks . Metabolic profiles were quantified at baseline and after a 12-week intervention . RESULTS After the 12-week intervention , compared with placebo , probiotic supplementation significantly increased serum sex hormone-binding globulin ( SHBG ) ( + 25.9 ± 32.5 vs. + 0.5 ± 15.6 nmol/L , P and plasma total antioxidant capacity ( TAC ) ( + 8.8 ± 120.5 vs. -98.3 ± 246.4 mmol/L , P = 0.04 ) , and significantly decreased serum total testosterone ( -0.2 ± 0.7 vs. + 0.2 ± 0.6 ng/mL , P = 0.03 ) , modified Ferriman-Gallwey ( mF-G ) scores ( -1.7 ± 1.5 vs. -0.2 ± 1.0 , P hs-CRP ) ( -1150.0 ± 1295.2 vs. + 202.5 ± 1426.3 ng/mL , P concentrations ( -0.2 ± 0.6 vs. + 0.9 ± 1.3 µmol/L , P profiles . CONCLUSION Overall , probiotic supplementation of PCOS women for 12 weeks had beneficial effects on total testosterone , SHBG , mFG scores , hs-CRP , TAC and MDA levels but did not affect other metabolic profiles ",
"Abstract The aim of the current study was to assess the effects of probiotic supplementation on weight loss , glycaemia and lipid profiles in women with polycystic ovary syndrome ( PCOS ) . In a r and omized , double-blind , placebo-controlled trial , 60 women with PCOS were r and omized to receive probiotic capsule ( n = 30 ) or placebo ( n = 30 ) for 12 weeks . Consumption of probiotic supplements result ed in a significant reduction in weight ( −0.5 ± 0.4 vs. + 0.1 ± 1.0 kg , p = 0.004 ) and BMI ( −0.2 ± 0.2 vs. + 0.03 ± 0.4 kg/m2 , p = 0.004 ) compared with the placebo . In addition , compared with the placebo , probiotic administration was associated with a significant decrease in fasting plasma glucose ( −2.4 ± 8.4 vs. + 2.1 ± 7.0 mg/dL , p = 0.02 ) , serum insulin concentrations ( −2.0 ± 5.8 vs. + 1.6 ± 5.0 μIU/mL , p = 0.01 ) , homoeostasis model of assessment -insulin resistance ( −0.5 ± 1.4 vs. + 0.3 ± 1.1 , p = 0.01 ) , homoeostatic model assessment -beta cell function ( −7.5 ± 22.3 vs. + 6.3 ± 21.7 , p = 0.01 ) , serum triglycerides ( −13.3 ± 51.3 vs. + 13.6 ± 37.1 mg/dL , p= 0.02 ) and a significant increase in quantitative insulin sensitivity check index ( QUICKI ) ( + 0.006 ± 0.01 vs. −0.005 ± 0.02 , p = 0.01 ) . When we adjusted the analysis for baseline values of biochemical parameters , age and baseline BMI , except for QUICKI ( p = 0.08 ) , other findings did not alter . We found that probiotic supplementation among PCOS women for 12 weeks had favourable effects on weight loss , markers of insulin resistance , triglycerides and VLDL-cholesterol concentrations ",
"Background : Polycystic ovary syndrome ( PCOS ) is a polygenic endocrine disorder in women of reproductive age that lead to infertility . The aim of this study was to investigate the effects of probiotic on pancreatic β-cell function and C-reactive protein ( CRP ) in PCOS patients . Methods : This r and omized double-blind placebo-controlled clinical trial was conducted among 72 women aged 15–40 years old diagnosed with PCOS . Participants were r and omly assigned to two groups receiving : ( 1 ) Probiotic supplements ( n = 36 ) , ( 2 ) placebo ( n = 36 ) for 8-week . Fasting blood sample s were taken at baseline and after 8-week of intervention . Results : Probiotic supplementation , compare with placebo , reduced fasting blood sugar ( −4.15 ± 2.87 vs. 2.57 ± 5.66 mg/dL , respectively P = 0.7 ) , serum insulin levels in crude model ( −0.49 ± 0.67 vs. 0.34 ± 0.82 μIU/mL , respectively , P = 0.09 ) , homeostasis model of assessment -insulin resistance score ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) nonsignificantly . Serum insulin levels after adjustment with covariates reduced significantly in probiotic group ( P = 0.02 ) . We did not found any significant differences in mean changes of CRP between groups ( −0.25 ± 0.18 vs. −0.05 ± 0.18 , respectively , P = 0.14 ) . Conclusions : A 8-week multispecies probiotics supplementation had nonsignificantly beneficial effect on pancreatic β-cell function and CRP in PCOS patients . After adjustment for some covariates , serum insulin changes were significantly different between groups",
"BACKGROUND AND AIMS Polycystic Ovarian Syndrome is a common reproductive , endocrine , and metabolic disease in women . Pomegranate juice , known as a rich source of phytochemicals with high antioxidant activity , enriched with probiotic may improve PCOS . METHODS AND RESULTS A r and omized , controlled , triple-blinded , parallel trial study was performed in PCOS patients ( n = 92 ) . Three treatment groups ( 23 patients each ) received 2 L of synbiotic pomegranate juice ( SPJ ) , pomegranate juice ( PJ ) , and synbiotic beverage ( SB ) weekly . The control group ( 23 patients ) received 2 L of placebo beverage weekly . Primary outcome was any change in insulin resistance and secondary outcomes were fasting blood sugar ( FBS ) , insulin sensitivity , testosterone , luteinizing hormone ( LH ) , follicle stimulating hormone ( FSH ) , body mass index ( BMI ) , waist and hip circumference , from baseline to the end of the trial . At the end of the study , 86 patients were analyzed . There was significant change in insulin resistance in the SPJ and SB groups . Insulin sensitivity increased significantly in the SPJ and SB groups . Insulin also changed significantly in the SPJ and SB groups . BMI , weight and waist circumference decreased significantly in the SPJ and SB groups . Testosterone level also decreased significantly in the SPJ and SB groups . There was no significant change in FPG , LH and FSH in any of the groups . CONCLUSION SPJ in the form of a new beverage can improve insulin resistance , insulin , testosterone level , BMI , weight and waist circumference in PCOS . This trial was registered in Iranian Registry of Clinical Trials , with number : 25272"
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41170fbe-06ff-11f0-808a-c43d1ab1c353
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CONTEXT About 5 % of the US population is morbidly obese . This disease remains largely refractory to diet and drug therapy , but generally responds well to bariatric surgery . OBJECTIVE To determine the impact of bariatric surgery on weight loss , operative mortality outcome , and 4 obesity comorbidities ( diabetes , hyperlipidemia , hypertension , and obstructive sleep apnea ) . DATA SOURCES AND STUDY SELECTION Electronic literature search of MEDLINE , Current Contents , and the Cochrane Library data bases plus manual reference checks of all articles on bariatric surgery published in the English language between 1990 and 2003 . Two levels of screening were used on 2738 citations . DATA EXTRACTION A total of 136 fully extracted studies , which included 91 overlapping patient population s ( kin studies ) , were included for a total of 22,094 patients . Nineteen percent of the patients were men and 72.6 % were women , with a mean age of 39 years ( range , 16 - 64 years ) . Sex was not reported for 1537 patients ( 8 % ) . The baseline mean body mass index for 16 944 patients was 46.9 ( range , 32.3 - 68.8 ) . DATA SYNTHESIS A r and om effects model was used in the meta- analysis . The mean ( 95 % confidence interval ) percentage of excess weight loss was 61.2 % ( 58.1%-64.4 % ) for all patients ; 47.5 % ( 40.7%-54.2 % ) for patients who underwent gastric b and ing ; 61.6 % ( 56.7%-66.5 % ) , gastric bypass ; 68.2 % ( 61.5%-74.8 % ) , gastroplasty ; and 70.1 % ( 66.3%-73.9 % ) , biliopancreatic diversion or duodenal switch . Operative mortality ( Diabetes was completely resolved in 76.8 % of patients and resolved or improved in 86.0 % . Hyperlipidemia improved in 70 % or more of patients . Hypertension was resolved in 61.7 % of patients and resolved or improved in 78.5 % . Obstructive sleep apnea was resolved in 85.7 % of patients and was resolved or improved in 83.6 % of patients . CONCLUSIONS Effective weight loss was achieved in morbidly obese patients after undergoing bariatric surgery . A substantial majority of patients with diabetes , hyperlipidemia , hypertension , and obstructive sleep apnea experienced complete resolution or improvement
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"OBJECTIVE To examine the effect of a large , long st and ing and intentional weight reduction on the incidence of diabetes , hypertension and lipid disturbances in severely obese individuals as compared to weight-stable obese controls . RESEARCH METHODS AND PROCEDURES The ongoing prospect i ve SOS ( Swedish Obese Subjects ) intervention consists of a surgically treated group and a matched control group obtaining conventional obesity treatment . This report is based on 845 surgically treated patients and 845 controls ( BMI 41.0+/-4.6 kg/m2 ( mean+/-st and ard deviation [ S ] ) ) followed for 2 years . RESULTS Surgically treated patients lost 28+/-15 kg and controls 0.5+/-8.9 kg ( p incidence of hypertension , diabetes , hyperinsulinemia , and lipid disturbances was compared in the two treatment groups . Adjusted odds ratios ( 95 % CI ) for the surgically treated group versus controls were 0.38 ( 0.22 , 0.65 ) for hypertension , 0.02 ( 0.00 , 0.16 ) for diabetes , 0.10 ( 0.03 , 0.28 ) for hyperinsulinemia , 0 . 10 ( 0.04 , 0.25 ) for hypertriglyceridemia , 0.28 ( 0.16 , 0.49 ) for low HDL-cholesterol and 1.24 ( 0.84 , 1.8 ) for hypercholesterolemia . Compared to controls , the 2-year recovery rates from hypertension , diabetes , hypo-HDL , and hypertriglyceridemia were significantly higher in the surgically treated group . DISCUSSION Intentional weight loss in the obese causes a marked reduction in the 2-year incidence of hypertension , diabetes and some lipid disturbances . The results suggest that severe obesity can and should be treated",
"Although 40 % of US women indicate they are currently trying to lose weight , the association between intentional weight loss and longevity is unknown . The authors analyzed prospect i ve data from 43,457 overweight , never-smoking US white women aged 40 - 64 years who in 1959 - 1960 completed a question naire that included questions on weight change direction , amount , time interval , and intentionality . Vital status was determined in 1972 . Proportional hazards regression was used to estimate mortality rate ratios for women who intentionally lost weight compared with women who had no change in weight . Women who died within the first 3 years of follow-up were excluded . Analyses were stratified by preexisting illness and adjusted for age , beginning body mass index , alcohol intake , education , physical activity , and health conditions . In women with obesity-related health conditions ( n = 15,069 ) , intentional weight loss of any amount was associated with a 20 % reduction in all-cause mortality , primarily due to a 40 - 50 % reduction in mortality from obesity-related cancers ; diabetes-associated mortality was also reduced by 30 - 40 % in those who intentionally lost weight . In women with no preexisting illness ( n = 28,388 ) , intentional weight loss of > or = 20 lb ( > or = 9.1 kg ) that occurred within the previous year was associated with about a 25 % reduction in all-cause , cardiovascular , and cancer mortality ; however , loss of or = 1 year was generally associated with small to modest increases in mortality . The association between intentional weight loss and longevity in middle-aged overweight women appears to depend on their health status . Intentional weight loss among women with obesity-related conditions is generally associated with decreased premature mortality , whereas among women with no preexisting illness , the association is equivocal",
"OBJECTIVE : To examine the effects of weight loss on health-related quality of life ( HRQL ) in subjects with severe obesity . DESIGN : Controlled clinical trial of the outcomes of surgical vs conventional weight reduction treatment . SUBJECTS : The first 487 surgical cases and their conventionally treated , matched controls were followed for two years in the Swedish Obese Subjects ( SOS ) intervention study . MEASUREMENTS : A battery of generic and study -specific self- assessment instruments or subscales was used to characterize HRQL in the severely obese ( BMI ) ≥34 kg/m2 for males and BMI ≥38 kg/m2 for females ) . Measures of general health perceptions ( general health rating index ; current health ) , mental well-being ( mood adjective check list ; pleasantness , activation and calmness ) , mood disorders ( hospital anxiety and depression scale ; anxiety and depression ) and social interaction ( sickness impact profile ) , were supplemented by obesity-specific modules on obesity-related psychosocial problems and eating behavior ( three-factor eating question naire ; restrained eating , disinhibition and perceived hunger ) . Assessment s were conducted prior to treatment and repeated after 6 , 12 and 24 months . RESULTS : Poor HRQL before intervention was dramatically improved after gastric restriction surgery , while only minor fluctuations in HRQL scores were observed in the conventionally treated controls . Peak values were observed in the surgical group at 6 or 12 months after intervention with a slight to moderate decrease at the two-year follow-up . The positive changes in HRQL after two years were related to the magnitude of weight loss , that is , the greater the weight reduction , the greater the HRQL improvements . Eating behavior improved accordingly . CONCLUSION : Quality of life in the severely obese is improved by substantial weight loss . Most patients benefit from weight reduction surgery , while HRQL in surgical patients with minor reduction in overweight is less positive . Further research is needed to determine outcome predictors of the surgical management of severe obesity and to ensure that HRQL improvements are maintained",
"The efficacy of three gastric restriction operations were compared in a prospect i ve r and omized study of 310 morbidly obese subjects . The median patient age was 34 years ( range , 18 to 62 years ) . They were predominantly female ( 13:1 ) and had a median pre-operative weight that was 198 % of their ideal weight ( range , 160 % to 318 % ) . There was an equitable dispersion of perceived risk factors between the groups under study and there were no deaths during the perioperative period . Compliance with follow-up at 3 years was 91 % . When success was defined as a loss of more than 50 % of excess weight or a current pregnancy , the success rates at 3 years were 17 % for gastrogastrostomy , 48 % for vertical gastroplasty , and 67 % for Roux-en-Y gastric bypass ( p less than 0.001 ) . Although the gastric bypass operation took longer to perform , there were similar outcome patterns for the three groups during the postoperative period . We conclude that the Roux-en-Y gastric bypass is the preferred procedure for the surgical treatment of morbid obesity",
"Objective This report documents that the gastric bypass operation provides long-term control for obesity and diabetes . Summary Background Data Obesity and diabetes , both notoriously resistant to medical therapy , continue to be two of our most common and serious diseases . Methods Over the last 14 years , 608 morbidly obese patients underwent gastric bypass , an operation that restricts caloric intake by ( 1 ) reducing the functional stomach to approximately 30 mL , ( 2 ) delaying gastric emptying with a c. 0.8 to 1.0 cm gastric outlet , and ( 3 ) excluding foregut with a 40 to 60 cm Roux-en-Y gastrojejunostomy . Even though many of the patients were seriously ill , the operation was performed with a perioperative mortality and complication rate of 1.5 % and 8.5 % , respectively . Seventeen of the 608 patients ( Gastric bypass provides durable weight control . Weights fell from a preoperative mean of 304.4 lb ( range , 198 to 615 lb ) to 192.2 lb ( range , 104 to 466 ) by 1 year and were maintained at 205.4 lb ( range , 107 to 512 lb ) at 5 years , 206.5 lb ( 130 to 388 lb ) at 10 years , and 204.7 lb ( 158 to 270 lb ) at 14 years . The operation provides long-term control of non-insulin-dependent diabetes mellitus ( NIDDM ) . In those patients with adequate follow-up , 121 of 146 patients ( 82.9 % ) with NIDDM and 150 of 152 patients ( 98.7 % ) with glucose impairment maintained normal levels of plasma glucose , glycosylated hemoglobin , and insulin . These antidiabetic effects appear to be due primarily to a reduction in caloric intake , suggesting that insulin resistance is a secondary protective effect rather than the initial lesion . In addition to the control of weight and NIDDM , gastric bypass also corrected or alleviated a number of other comorbidities of obesity , including hypertension , sleep apnea , cardiopulmonary failure , arthritis , and infertility",
"Background : We have demonstrated that obstructive sleep apnea ( OSA ) is prevalent in 60 % of patients undergoing bariatric surgery . A study was conducted to determine whether weight loss following bariatric surgery ameliorates OSA . Methods : All 100 consecutive patients with symptoms of OSA were prospect ively evaluated by polysomnography before gastric bypass . Preoperative and postoperative scores of Epworth Sleepiness Scale ( ESS ) , Respiratory Disturbance Index ( RDI ) , and other parameters of sleep quality were compared using t-test . Results : Preoperative RDI was 40±4 ( normal 5 events/hour , n=100 ) . 13 patients had no OSA , 29 had mild OSA , while the remaining 58 patients were treated preoperatively for moderate-severe OSA . At a median of 6 months follow-up , BMI and ESS scores improved ( 38±1 vs 54±1 kg/m2 , 6±1 vs 12±0.1 , P in ESS ( 3±1 vs 14±2 ) , minimum O2 saturation ( SpO2 86±2 vs 77±5 ) , sleep efficiency ( 85±2 % vs 65±5 % ) , all P between preoperative BMI , ESS score and the severity of OSA ; and no correlation between % excess body weight loss and postoperative RDI . Conclusion : Weight loss following gastric bypass results in profound improvement in OSA . The severity of apnea can not be reliably predicted by preoperative BMI and ESS ; therefore , patients with symptoms of OSA should undergo polysomnography",
"The purpose of the study was to examine the gastrointestinal hormone responses to meals in morbidly obese patients before and after Roux-en-Y gastric bypass ( GBP ; n = 9 ) or vertical b and ed gastroplasty ( VBG ; n = 7 ) . On consecutive days before and after operation , we measured changes in peripheral blood levels of glucose , insulin , enteroglucagon , serotonin , vasoactive intestinal polypeptide ( VIP ) , and cholecystokinin ( CCK ) in response to a st and ardized glucose or protein-fat meal . The percentage of excess weight lost at 6 months after operation was 66.3 % + /- 4 % and 41.8 % + /- 5 % for GBP and VBG , respectively ( p less than 0.01 ) . The 3-hour integrated glucose response to a glucose meal decreased from 145.3 + /- 33.7 to 75.8 + /- 15.7 g min/L ( p less than 0.02 ) after GBP . This was associated with a decrease in 3-hour integrated insulin response from 22.8 + /- 8.2 to 10.5 + /- 4.9 mU min/L. Vertical b and ed gastroplasty patients had lesser reductions of hyperglycemia and hyperinsulinemia . Neither the CCK , serotonin , nor VIP responses to meals were altered by either operation . The 3-hour integrated enteroglucagon response to glucose increased markedly in GBP patients after operation from 11.8 + /- 6 to 133.4 + /- 38 nmol min/mL ( p less than 0.02 ) . This increase in enteroglucagon occurred at the same time as development of dumping symptoms , which occurred exclusively in GBP patients after glucose but not protein . We conclude that ( 1 ) GBP surgery for morbid obesity results in amelioration of glucose intolerance and hyperinsulinemia , ( 2 ) CCK does not mediate an endocrine satiety effect of surgery , ( 3 ) GBP is associated with an exaggerated enteroglucagon response to glucose , and ( 4 ) enteroglucagon appears to be a marker of the dumping syndrome in GBP patients ",
"Background : Obesity is now one of our major public health problems . Effective and acceptable treatment options are needed . The Lap-B and ® system is placed laparoscopically and allows adjustment of the level of gastric restriction . Methods : A prospect i ve study of 709 severely obese patients was conducted over a 6-year period at a university-based multidisciplinary referral center . After extensive preoperative evaluation , patients with a body mass index > 35 were treated by LapB and ® placement . Close follow-up with progressive adjustment of gastric restriction continued permanently . Medical co-morbidities were monitored as part of comprehensive prospect i ve data collection . Results : There have been no deaths perioperatively or during follow-up . Significant perioperative adverse events occurred in 1.2 % only . Reoperation has been needed for prolapse ( slippage ) in 12.5 % , erosion of the b and into the stomach in 2.8 % and for tubing breaks in 3.6 % . A steady progression of weight loss has occurred through the duration of the study with 52 ± 19 % EWL at 24 months ( n=333 ) , 53±22 % EWL at 36 months ( n=264 ) , 52 ± 24 % EWL at 48 months ( n=108 ) , 54 ± 24 % EWL at 60 months ( n=30 ) , and 57 ± 15 % EWL at 72 months ( n=10 ) . Major improvements have occurred in diabetes , asthma , gastroesophageal reflux , dyslipidemia , sleep apnea and depression . Quality of life as measured by R and SF-36 shows highly significant improvement . Conclusions : Placement of the Lap-B and ® system provides safe and effective control of severe obesity . The effect on weight loss is durable and is associated with major improvement in health and quality of life . It has the potential to provide a broadly acceptable option for this common and serious disease",
"One of the main goals of weight reduction in morbidly obese subjects is its benefit on coronary heart disease ( CHD ) risk . A cross-sectional study was design ed to r and omly assign 79 morbidly obese subjects ( 27 men and 52 women ; age : 30 - 45 years ) either to a diet protocol ( 20 kcal per kg fat-free mass ( FFM ) ; 55 % carbohydrates , 30 % fat , and 15 % proteins ) or to malabsorptive surgery ( biliopancreatic diversion ) . Fatness parameters , measured by dual-energy X-ray absorptiometry , lipid profile , insulin , leptin , sex steroid hormones and sex hormone-binding globulin ( SHBG ) levels were compared at baseline and 1 year after the beginning of the study . The data showed that plasma SHBG levels , but not testosterone levels , correlated negatively to fasting insulin levels and positively to HDL-cholesterol in both men and women . Total leptin levels were significantly lower ( P plasma leptin correlated significantly and positively with insulin but negatively with SHBG.A step-down regression analysis showed that FFM and SHBG , but not insulin levels , were the most powerful independent variables for predicting HDL-cholesterol levels in morbidly obese patients . The negative relationship between SHBG levels and CHD risk appears to be mediated by a concomitant variation in body fatness . Finally , in obese patients , SHBG levels seem to be an indicator of total adiposity rather than an index of an altered insulin/glucose homeostasis",
"Our previous experience with vertical ( nonb and ed ) gastroplasty proved disappointing because of unsatisfactory maintenance of weight loss . Vertical b and ed gastroplasty seemed to be an attractive alternative operation because it provided an externally reinforced ( b and ed ) stoma that would not enlarge over time . In this study , our aim was to determine prospect ively the results of vertical b and ed gastroplasty used as a primary , weight-reducing procedure in patients with morbid obesity . Seventy consecutive patients with morbid obesity ( mean weight , 139 kg ) , all of whom had obesity-related complications , underwent vertical b and ed gastroplasty and prospect i ve follow-up . The hospital mortality was nil , and substantial morbidity occurred in 3 % ( two patients ) . Long-term achievement and maintenance of satisfactory weight loss , however , were variable . The median weight loss at 1 year after operation was 36.7 kg or 48 % of excess body weight . At 3 years postoperatively , however , weight loss was only 32.4 kg or 40 % of excess body weight , and only 38 % of patients had achieved and maintained a weight loss of 50 % or more of their preoperative excess body weight . Vertical b and ed gastroplasty caused major changes in eating habits , and many patients were unable to eat red meat or untoasted bread ; moreover , approximately 30 to 50 % of patients continued to vomit once or more per week . Despite theoretically attractive advantages as a weight-reduction operation , vertical b and ed gastroplasty does not seem to be the optimal procedure for most patients with morbid obesity",
"Objective To compare outcomes , quality of life ( QOL ) , and costs of laparoscopic and open gastric bypass ( GBP ) . Summary Background Data Laparoscopic GBP has been reported to be a safe and effective approach for the treatment of morbid obesity . The authors performed a prospect i ve r and omized trial to compare outcomes , QOL , and costs of laparoscopic GBP with those of open GBP . Methods From May 1999 to March 2001 , 155 patients with a body mass index ( BMI ) of 40 to 60 kg/m2 were r and omly assigned to undergo laparoscopic ( n = 79 ) or open ( n = 76 ) GBP . The two groups were similar in age , sex ratio , mean BMI , and comorbidities . Main outcome measures included operative time , estimated blood loss , length of hospital stay , operative complications , percentage of excess body weight loss , and time to return to activities of daily living and work . Changes in QOL were assessed using the SF-36 Health Survey and the bariatric analysis of reporting outcome system ( BAROS ) . Operative and hospital costs of the two operations were also compared . Results There were no deaths in either group . Mean operative time was longer for laparoscopic GBP than for open GBP , but operative blood loss was less . Two ( 2.5 % ) of the 79 patients in the laparoscopic group required conversion to laparotomy . Median length of hospital stay was shorter for laparoscopic GBP patients ( 3 vs 4 days ) . The rate of postoperative anastomotic leak was similar between groups . Wound-related complications such as infection ( 10.5 vs 1.3 % ) and incisional hernia ( 7.9 vs 0 % ) were more common after open GBP ; late anastomotic stricture was less frequent after open GBP ( 2.6 vs 11.4 % ) . Time to return to activities of daily living and work were shorter after laparoscopic GBP than after open GBP . Weight loss at 1 year was similar between groups . Preoperative SF-36 scores were similar between groups ; however , at 1 month after surgery , laparoscopic patients had better physical conditioning , social functioning , general health , and less body pain than open GBP patients . At 6 months , the BAROS outcome was classified as good or better in 97 % of laparoscopic GBP patients compared with 82 % of open GBP patients . Operative costs were higher for laparoscopic GBP patients , but hospital costs were lower . Conclusions Laparoscopic GBP is a safe and cost-effective alternative to open GBP . Despite a longer operative time , patients undergoing laparoscopic GBP benefited from less blood loss , a shorter hospital stay , and faster convalescence . Laparoscopic GBP patients had comparable weight loss at 1 year but a more rapid improvement in QOL than open GBP patients . The higher initial operative costs for laparoscopic GBP were adequately offset by the lower hospital costs",
"BACKGROUND AND METHODS The Program on the Surgical Control of the Hyperlipidemias ( POSCH ) , a r and omized clinical trial , was design ed to test whether cholesterol lowering induced by the partial ileal bypass operation would favorably affect overall mortality or mortality due to coronary heart disease . The study population consisted of 838 patients ( 417 in the control group and 421 in the surgery group ) , both men ( 90.7 percent ) and women , with an average age of 51 years , who had survived a first myocardial infa rct ion . The mean follow-up period was 9.7 years . RESULTS When compared with the control group at five years , the surgery group had a total plasma cholesterol level 23.3 percent lower ( 4.71 + /- 0.91 vs. 6.14 + /- 0.89 mmol per liter [ mean + /- SD ] ; P less than 0.0001 ) , a low-density lipoprotein cholesterol level 37.7 percent lower ( 2.68 + /- 0.78 vs. 4.30 + /- 0.89 mmol per liter ; P less than 0.0001 ) , and a high-density lipoprotein cholesterol level 4.3 percent higher ( 1.08 + /- 0.26 vs. 1.04 + /- 0.25 mmol per liter ; P = 0.02 ) . Overall mortality and mortality due to coronary heart disease were reduced , but not significantly so ( deaths overall [ control vs. surgery ] , 62 vs. 49 , P = 0.164 ; deaths due to coronary disease , 44 vs. 32 , P = 0.113 ) . The overall mortality in the surgery subgroup with an ejection fraction greater than or equal to 50 percent was 36 percent lower ( control vs. surgery , 39 vs. 24 ; P = 0.021 ) . The value for two end points combined -- death due to coronary heart disease and confirmed nonfatal myocardial infa rct ion -- was 35 percent lower in the surgery group ( 125 vs. 82 events ; P less than 0.001 ) . During follow-up , 137 control-group and 52 surgery-group patients underwent coronary-artery bypass grafting ( P less than 0.0001 ) . A comparison of base-line coronary arteriograms with those obtained at 3 , 5 , 7 , and 10 years consistently showed less disease progression in the surgery group ( P less than 0.001 ) . The most common side effect of partial ileal bypass was diarrhea ; others included occasional kidney stones , gallstones , and intestinal obstruction . CONCLUSIONS Partial ileal bypass produces sustained improvement in the blood lipid patterns of patients who have had a myocardial infa rct ion and reduces their subsequent morbidity due to coronary heart disease . The role of this procedure in the management of hypercholesterolemia remains to be determined . These results provide strong evidence supporting the beneficial effects of lipid modification in the reduction of atherosclerosis progression",
"AIM : To determine whether visceral fat reduction in connection with bariatric surgery could improve weight loss and metabolic profile of obese subjects . PATIENTS AND METHODS : In a one-center , r and omized and controlled pilot trial we assigned 50 subjects with severe obesity ( body mass index > 35 kg/m2 ) to either adjustable gastric b and ing ( AGB ) alone ( 11 men and 14 women ) , or AGB plus surgical removal of the total greater omentum ( 11 men and 14 women ) . The patients were followed at regular intervals for 2 y and examined at 0 and 24 months with respect to body composition and metabolic profile . RESULTS : No significant differences between control and omentectomized patients were observed at baseline . The removed greater omentum constituted 0.8±0.4 % ( mean±s.d . ) of total body fat . At 2 y follow-up there was an expected decrease in body weight and an improvement in metabolic profile in both groups . Although omentectomized subjects tended to lose more weight than control subjects the difference was not statistically significant and changes in waist-to-hip ratio and saggital diameter did not differ between groups . However , the improvements in oral glucose tolerance , insulin sensitivity and fasting plasma glucose and insulin were 2–3 times greater in omentectomized as compared to control subjects ( P from 0.009 to 0.04 ) , which was statistically independent of the loss in body mass index . No differences in blood lipids between the groups were recorded . No adverse effects related to omentectomy were observed . CONCLUSIONS : Omentectomy , when performed together with AGB , has significant positive and long-term effects on the glucose and insulin metabolic profiles in obese subjects",
"Background : Predicting successful outcomes after bariatric surgical procedures has been difficult , and the establishment of specific selection criteria has been a subject of ongoing research . In an effort to choose the most appropriate surgical procedure for each patient , we have established a specific set of selection criteria for each procedure based on degree of obesity , preoperative dietary habits , eating behavior , and various metabolic features . Methods : From June 1994 to December 1998 , 90 bariatric surgical procedures were performed at the authors ' institution by a single surgeon ( F.K. ) based on specific selection criteria . Vertical b and ed gastroplasty ( VBG ) was performed in 35 patients , st and ard Roux-en-Y gastric bypass ( RYGB ) in 38 patients , and distal RYGB in 17 patients . All patients were monitored postoperatively 1 , 3 , 6 , and 12 months and once per year thereafter , with an additional visit at 18 months in distal RYGB patients . Results : Early postoperative morbidity ( Long-term postoperative morbidity ( > 30 days ) included 9 incisional hernias ( 2 in the VBG group , 5 after RYGB , and 2 in the distal RYGB group ) . There were 6 cases of staple-line disruption , 4 after VBG and 2 after st and ard RYGB , 1 of which result ed in stomal ulcer . Early postoperative mortality was 0 % , and long-term mortality was 1.1 % , which was due to pulmonary embolism in 1 st and ard RYGB patient on the 65th postoperative day . Average percentage of excess weight loss ( % EWL ) was 62 % the first year , 61 % the second year , and 50 % the third year in VBG patients , and 63.6 % , 65 % , and 63.3 % , respectively , in st and ard RYGB patients . In distal RYGB patients , where the patient number was significantly smaller , the % EWL at 1 and 2 years , respectively , was 51 % and 53 % . The most significant metabolic/nutritional complication was the appearance of hypoproteinemia ( hypoalbuminemia ) in 1 distal RYGB patient 20 months after surgery , which was corrected by total parenteral nutrition and subsequent increase in dietary protein intake . Significant improvement or resolution of pre-existing comorbid conditions was observed in all patient groups . The postoperative quality of eating , as evaluated by variety of food intake and frequency of vomiting , was significantly better in RYGB patients . Conclusions : These results show that selection of the bariatric surgical procedure to be performed in each patient based on specific criteria leads to acceptable weight loss , improvement in preexisting comorbid conditions , and a high degree of patient satisfaction in most patients . On the basis of our own observations as well as those of others , our selection criteria have become more strict over time and our selection of VBG as the operation of choice increasingly infrequent",
"CONTEXT The increasing prevalence of obesity is a major public health concern , since obesity is associated with several chronic diseases . OBJECTIVE To monitor trends in state-specific data and to examine changes in the prevalence of obesity among adults . DESIGN Cross-sectional r and om-digit telephone survey ( Behavioral Risk Factor Surveillance System ) of noninstitutionalized adults aged 18 years or older conducted by the Centers for Disease Control and Prevention and state health departments from 1991 to 1998 . SETTING States that participated in the Behavioral Risk Factor Surveillance System . MAIN OUTCOME MEASURES Body mass index calculated from self-reported weight and height . RESULTS The prevalence of obesity ( defined as a body mass index > or = 30 kg/m2 ) increased from 12.0 % in 1991 to 17.9 % in 1998 . A steady increase was observed in all states ; in both sexes ; across age groups , races , educational levels ; and occurred regardless of smoking status . The greatest magnitude of increase was found in the following groups : 18- to 29-year-olds ( 7.1 % to 12.1 % ) , those with some college education ( 10.6 % to 17.8 % ) , and those of Hispanic ethnicity ( 11.6 % to 20.8 % ) . The magnitude of the increased prevalence varied by region ( ranging from 31.9 % for mid Atlantic to 67.2 % for South Atlantic , the area with the greatest increases ) and by state ( ranging from 11.3 % for Delaware to 101.8 % for Georgia , the state with the greatest increases ) . CONCLUSIONS Obesity continues to increase rapidly in the United States . To alter this trend , strategies and programs for weight maintenance as well as weight reduction must become a higher public health priority",
"OBJECTIVES To determine relationship of intra-abdominal pressure to central obesity and the comorbidity of obesity . DESIGN Non-r and omized , prospect i ve . SETTING University hospital , operating room . SUBJECTS Eighty-four anaesthetized consecutive patients prior to gastric bypass for morbid obesity and five non-obese patients before colectomy for ulcerative colitis . MAIN OUTCOME MEASURES Weight , body mass index ( BMI ) , co-morbid history , sagittal abdominal diameter , waist : hip ( W : H ) ratio and urinary bladder pressure , as an estimate of intra-abdominal pressure . RESULTS Urinary bladder pressure was greater in the obese than the non-obese ( 18 + /- 0.7 vs. 7 + /- 1.6 cm H2O , P ( hypoventilation , gastroesophageal reflux , venous stasis , stress incontinence , incisional hernia ) or possibly ( hypertension , diabetes ) due to increased abdominal pressure . W : H ratio correlated with urinary bladder pressure in men ( r = + 0.6 , P intraabdominal pressure which contributed to obesity-related comorbidity . W : H ratio was not a reliable indicator of intra-abdominal pressure for women who often have both peripheral and central obesity . Further studies are needed to evaluate the relationship between intra-abdominal pressure and Type II diabetes and hypertension",
"We present our prospect i ve comparative study on 60 patients subjected to two types of gastric restrictive procedures , i.e. Vertical B and ed Gastroplasty ( VBG ) and Laparoscopic Adjustable Gastric B and ing ( LAGB ) at King Abdul Aziz University Hospital , Jeddah , Saudi Arabia . The aim of our study was to compare weight reduction after both procedures . Thirty patients had VBG and thirty had LAGB based upon informed consents . The age , sex and preoperative weight and BMI were comparable in both groups . Excess weight loss of 87 % was achieved in the VBG group while only 50 % was noticed in the LAGB group at 6 months postoperatively",
"At the end of a long week in the office , you sink back into your chair , reflecting on some of the more memorable patients you cared for and counseled . Through gentle history taking , you discovered that urinary incontinence is the underlying cause of an elderly patient 's increasing social isolation . During a careful physical examination , you detected bruising on the torso of a woman with chronic headaches and began to explore the longst and ing abusive relationship between the woman and her alcoholic partner . You discontinued procainamide therapy in a 72-year-old man who had asymptomatic premature ventricular contractions after myocardial infa rct ion . To prevent bleeding from esophageal varices , you started -blocker therapy in a woman with long-st and ing cryptogenic cirrhosis and portal hypertension . In couples ' therapy , discussing the future quality of life of a middle-aged gay man with human immunodeficiency virus infection , you journeyed through emotionally intense dialogue about advance directives . You presented the risk factors for major and minor bleeding to a 39-year-old woman who was considering warfarin therapy because of recently diagnosed atrial fibrillation and valvular heart disease . You listened to , made diagnoses for , treated , advised , and comforted many patients . Yet there were some hiccoughs in your practice along the way . You stumbled while debating the pros and cons of breast cancer screening with a healthy 48-year-old woman who has been staying current with information on the Internet . You question ed the merits of a personalized walking program suggested to you by a motivated 66-year-old man with severe claudication . Explaining that you wanted to review the best current evidence on these issues , you resolved to address your uncertainties before these patients made their next office visits , in a week 's time . Sighing deeply , you acknowledge that you have little time to read . You subscribe to three journals , which you browse months after they arrive-either when your journal stack becomes precariously high or when your guilt is sufficiently motivational . You sometimes find the conclusions of individual articles conflicting or confusing . You know that some of the decisions and suggestions you made this week , specifically your decisions about stopping procainamide therapy and starting -blocker therapy and your advice about bleeding risks from anticoagulant therapy , were based on the best current research evidence [ 1 - 3 ] . On the other h and , your patients ' inquiries about breast cancer screening and exercise treatment for claudication highlight your need for a concise , current , rigorous synthesis of the best available evidence on each of these topics : in brief , a systematic review [ 4 , 5 ] . Incorporating Research Evidence into Clinical Decision Making The foregoing scenario is familiar to practitioners . In a typical week , we encounter patients with diverse problems ; exercise numerous clinical , interpersonal , and technical skills ; and make many decisions . The factors that affect these decisions and their outcomes are complex . For instance , each patient has unique sociodemographic characteristics , cultural circumstances , and personal preferences . Each physician has unique knowledge , experiences , and values . Moreover , practitioners and their patients make decisions within the context of a rapidly changing health care system that influences the availability , accessibility , and cost of diagnostic tests and therapies [ 6 ] . Timely , useful evidence from the biomedical literature should be an integral component of clinical decision making . If one treatment has been shown to be better than another , we need to know , so that we can recommend the treatment to the appropriate patients . The worldwide effort to develop new tests and treatments , and to determine their usefulness , has never been stronger , and our patients and their families expect us to be fonts of the knowledge that results from this effort [ 7 ] . Unfortunately , it is easy for current best research evidence to pass us by [ 8 ] . We may lack the time , motivation , and basic skills needed to find , critically appraise , and synthesize information , all of which we must do if we are to integrate the results of original studies into our practice . Fortunately , several potent methods are emerging that can greatly enhance our ability to interpret and apply research evidence ; foremost among them is the systematic review . This article begins a series in Annals that will examine systematic review s in detail and explore their many applications . Systematic review s represent the best chance that most practitioners will have to underst and and accurately apply the key signals arising from the robust and increasingly productive search for solutions to medical problems . A properly conducted systematic review faithfully summarizes the evidence from all relevant studies on the topic of interest , and it does so concisely and transparently . What Is a Systematic Review ? Systematic review s are scientific investigations in themselves , with pre-planned methods and an assembly of original studies as their subjects . They synthesize the results of multiple primary investigations by using strategies that limit bias and r and om error [ 9 , 10 ] . These strategies include a comprehensive search of all potentially relevant articles and the use of explicit , reproducible criteria in the selection of articles for review . Primary research design s and study characteristics are appraised , data are synthesized , and results are interpreted . When the results of primary studies are summarized but not statistically combined , the review may be called a qualitative systematic review . A quantitative systematic review , or meta- analysis , is a systematic review that uses statistical methods to combine the results of two or more studies . The term overview is sometimes used to denote a systematic review , whether quantitative or qualitative . Summaries of research that lack explicit descriptions of systematic methods are often called narrative review s. Review articles are one type of integrative publication ; practice guidelines , economic evaluations , and clinical decision analyses are others . These other types of integrative articles often incorporate the results of systematic review s. For example , practice guidelines are systematic ally developed statements intended to assist practitioners and patients with decisions about appropriate health care for specific clinical circumstances [ 11 ] . Evidence -based practice guidelines are based on systematic review s of the literature , appropriately adapted to local circumstances and values . Economic evaluations compare both the costs and the consequences of different courses of action ; the knowledge of consequences that are considered in these evaluations is often generated by systematic review s of primary studies . Decision analyses quantify both the likelihood and the valuation of the expected outcomes associated with competing alternatives . Differences between Systematic and Narrative Review s All review s , narrative and systematic alike , are retrospective , observational research studies and are therefore subject to systematic and r and om error . Accordingly , the quality of a review - and thus its worth-depends on the extent to which scientific review methods have been used to minimize error and bias . This is the key feature that distinguishes traditional narrative review s from systematic review s ( Table 1 ) . If a review is prepared according to the steps outlined in the right column of Table 1 , it is more likely to be systematic and to provide unbiased conclusions . If review methods approximate those found in the middle column of Table 1 , the article is more likely to be a narrative review , and the conclusions are less likely to be based on an unbiased summary of all relevant evidence . Table 1 . Differences between Narrative Review s and Systematic Review s Systematic review s are generated to answer specific , often narrow , clinical questions in depth . These questions can be formulated explicitly according to four variables : a specific population and setting ( such as elderly out patients ) , the condition of interest ( for example , hypertension ) , an exposure to a test or treatment ( such as pharmacologic management ) , and one or more specific outcomes ( such as cardiovascular and cerebrovascular events and mortality ) [ 12 ] . Thus , an example of a well-formulated , clinical ly relevant question is , Does pharmacologic treatment of hypertension in the elderly prevent strokes and myocardial infa rct ions or delay death ? If the question that is driving the review is not clear from the title , abstract , or introduction , or if no methods section is included , the paper is more likely to be a narrative review than a systematic review [ 13 ] . Most narrative review articles deal with a broad range of issues related to a given topic rather than addressing a particular issue in depth [ 9 ] . For example , a narrative review on diabetes ( such as that which might be found in a textbook chapter ) might include sections on the physiology and pathophysiology of carbohydrate , lipid , and protein metabolism ; the epidemiology of and prognosis associated with diabetes ; diagnostic and screening approaches ; and preventive , therapeutic , rehabilitative , and palliative interventions . Thus , narrative review s may be most useful for obtaining a broad perspective on a topic ; they are less often useful in furnishing quantitative answers to specific clinical questions . Narrative review s are appropriate for describing the history or development of a problem and its management . Narrative review s may better describe cutting-edge developments if research is scant or preliminary or if studies are very limited by flawed design or execution [ 13 ] . They may be particularly useful for discussing data in light of underlying theory and context . Narrative review s can draw analogies and can conceptually integrate two independent fields of research , such as"
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Atrial fibrillation ( AF ) is a major public health problem in the United States . More than 2.3 million Americans are estimated to have AF ( 1 ) . The known association between AF and substantial mortality , morbidity , and health care costs compounds the effect of this condition . Not only is the risk for death in patients with AF twice that of patients without it , but AF can result in myocardial ischemia and infa rct ion , exacerbate heart failure ( HF ) , and cause tachycardia-induced cardiomyopathy if the ventricular rate is not well-controlled ( 25 ) . The most dreaded complication of AF is thromboembolism , especially stroke ( 6 ) . In some patients , AF or therapies to manage this condition can severely depreciate quality of life ( 710 ) . Furthermore , the management of AF and its complications is responsible for nearly $ 16 billion in additional costs to the U.S. health care system per year ( 11 ) . Despite the substantial public health effect of AF , uncertainties around its management remain . In particular , the comparative safety and effectiveness of different rate- and rhythm-control therapies for patients with AF are unclear . We conducted this systematic review to evaluate the comparative safety and effectiveness of rate- versus rhythm-control strategies ; medications used for ventricular rate control ; strict versus more lenient rate-control strategies ; nonpharmacologic rate-control therapies versus medications ; electrical cardioversion and antiarrhythmic medications for restoration of sinus rhythm ; and catheter ablation , surgical ablation , and antiarrhythmic medications for maintenance of sinus rhythm . Methods We developed and followed a st and ard protocol for our review . Full details of our methods , search strategies , results , and conclusions are presented in a comparative effectiveness review commissioned by the Agency for Healthcare Research and Quality ( AHRQ ) and are available at www.effectivehealthcare.ahrq.gov ( 12 ) . Data Sources and Search es We search ed PubMed , EMBASE , and the Cochrane Data base of Systematic Review s for studies published between 1 January 2000 and 12 November 2013 . Data before 2000 have been summarized in an AHRQ report on the management of new-onset AF published in 2001 ( 1315 ) . Study Selection We identified r and omized , controlled trials ( RCTs ) published in English that were comparative assessment s of pharmacologic or nonpharmacologic rate- or rhythm-control therapies aim ed at treating adults with AF . Observational studies were also allowed for comparisons of strict versus lenient rate control or cardiac resynchronization therapy versus other rhythm-control therapies . The following outcomes were considered : restoration of sinus rhythm ( conversion ) , maintenance of sinus rhythm , recurrence of AF at 12 months , development of cardiomyopathy , death ( all-cause and cardiac ) , myocardial infa rct ion , cardiovascular hospitalizations , HF symptoms , control of AF symptoms , quality of life , functional status , stroke and other embolic events , bleeding events , and adverse effects of therapy . Data Extraction and Quality Assessment One investigator abstract ed and another confirmed data related to study setting and design , patient characteristics , details of treatment , comparators , and relevant outcomes . The quality of individual studies was evaluated using the approach described in AHRQ 's Methods Guide for Effectiveness and Comparative Effectiveness Review s ( 16 ) . Investigators also assessed factors that limited applicability of the evidence . Data Synthesis and Analysis For each treatment comparison and outcome of interest , we determined the feasibility of completing a quantitative synthesis ( meta- analysis ) based on the volume of relevant literature , conceptual homogeneity of the studies ( both in terms of study population and outcomes ) , and completeness of the reporting of results . We considered meta- analysis for outcomes that at least 3 studies reported . For our evaluation of rate- versus rhythm-control strategies , we grouped all rate-control strategies together and all rhythm-control strategies together , regardless of the specific medication or procedure . We grouped pharmacologic interventions by class , considering rate-controlling calcium-channel blockers and all -blockers each to be similar enough to be grouped together . We categorized procedures into electrical cardioversion , atrioventricular node ( AVN ) ablation , AF ablation by pulmonary vein isolation ( PVI ) ( by open surgical , minimally invasive , or transcatheter procedures ) , and different types of surgical maze procedures and explored comparisons among these categories . In addition , for the comparisons focusing on medications versus procedures , we also explored grouping all medications together and comparing them with all procedures . When a meta- analysis was appropriate , we used a r and om-effects model to synthesize the available evidence quantitatively using Comprehensive Meta- Analysis , version 2 ( Biostat , Englewood , New Jersey ) . We used a st and ardized approach to rank the overall strength of evidence ( SOE ) for each outcome ( 16 ) . Role of the Funding Source Primary funding was provided by AHRQ . Neither the technical experts nor AHRQ representatives had a role in the literature search , data analysis , interpretation of the data , or decision to su bmi t the manuscript for publication . Results We screened 10495 abstract s , evaluated 570 full-text articles , and included 200 articles representing 162 studies involving 28836 patients ( Figure 1 ) . Tables 1 to 6 of the Supplement provide details about these studies and their population s for each topic described here . Table 7 of the Supplement lists identified and potential limitations of the studies . The full AHRQ report highlights additional findings ( 12 ) . Figure 1 . Summary of evidence search and selection . AAD = antiarrhythmic drug ; CRT = cardiac resynchronization therapy ; RCT = r and omized , controlled trial . * Some studies were relevant to more than 1 topic . Supplement . Tables Rate- Versus Rhythm-Control Strategies We included 16 RCTs in this analysis : 13 compared pharmacologic rhythm-control versus rate-control strategies ( 1729 ) and 3 compared a rhythm-control strategy with PVI versus a rate-control strategy that involved AVN ablation and implantation of a pacemaker in 1 study ( 30 ) and rate-controlling medications in the other 2 ( 31 , 32 ) . Ten RCTs ( 17 , 18 , 2022 , 2428 ) provided information on outcomes of interest and were combined quantitatively ( Figure 2 ) . Of these , 5 included only patients with persistent AF ( 2022 , 25 , 28 ) , 1 included only patients with paroxysmal AF ( 17 ) , and 4 included patients with paroxysmal or persistent AF ( 18 , 24 , 26 , 27 ) . Two studies ( 17 , 22 ) compared a single-chamber pacemaker plus AVN ablation versus a dual-chamber pacemaker plus AVN ablation plus an antiarrhythmic medication ; all others compared largely unspecified rate-control with rhythm-control strategies . Figure 2 . Meta- analysis forest plots . AAD = antiarrhythmic drug ; PVI = pulmonary vein isolation . A. All-cause mortality for rate- vs. rhythm-control strategies . B. Cardiovascular mortality for rate- vs. rhythm-control strategies . C. Stroke for rate- vs. rhythm-control strategies . D. Restoration of sinus rhythm for monophasic vs. biphasic waveforms . E. Maintenance of sinus rhythm for PVI vs. AAD therapy . Figure 2 . Continued . Data from the included studies showed moderate SOE that pharmacologic rate- and rhythm-control strategies are of comparable efficacy with regard to their effect on all-cause mortality ( odds ratio [ OR ] , 1.34 [ 95 % CI , 0.89 to 2.02 ] ; Q= 21.71 ; P= 0.003 ) ( Figure 2 , A ) ( 18 , 2022 , 24 , 2628 ) , cardiac mortality ( OR , 0.96 [ CI , 0.77 to 1.20 ] ; Q= 3.55 ; P= 0.47 ) ( Figure 2 , B ) ( 18 , 21 , 22 , 24 , 25 ) , and stroke ( OR , 0.99 [ CI , 0.76 to 1.30 ] ; Q= 7.02 ; P= 0.43 ) ( Figure 2 , C ) ( 17 , 18 , 2022 , 24 , 27 , 28 ) . Although the meta- analysis for all-cause mortality showed a potential benefit , it did not reach statistical significance and 6 of the 8 studies ( 6069 patients [ 95 % ] ) had ORs that crossed 1 , result ing in a final moderate SOE . For cardiac mortality ( Figure 2 , B ) , point estimates were inconsistent and CIs were wide for 2 of the 5 studies ( 18 , 21 ) , but there was no evidence of heterogeneity ; therefore , our SOE rating was not affected . For the outcome of stroke , there was no evidence of heterogeneity , but the findings were mostly driven by 1 large , good- quality RCT ( 4060 patients ) , which was inconsistent with several of the smaller studies , reducing our confidence in the finding and in the SOE . These studies largely included older patients with mild AF symptoms . Three RCTs compared pharmacologic rate-control strategies with rhythm-control strategies using antiarrhythmic medications ( 17 , 18 , 22 ) . These RCTs showed fewer cardiovascular hospitalizations with the rhythm-control strategies ( 17 , 18 , 22 ) . Although data from 5 RCTs suggest that there is no difference between pharmacologic rate- and rhythm-control strategies in their effect on HF symptoms ( 17 , 22 , 24 , 26 , 46 ) ( Table 1 ) , a prespecified sub study of the Atrial Fibrillation and Congestive Heart Failure study showed that a higher proportion of time spent in sinus rhythm was associated with a greater improvement in New York Heart Association class ( 29 ) . Table 1 . Summary of SOE and Effect Estimates for Rate- Versus Rhythm-Control Strategies Three studies compared a rhythm-control strategy involving catheter ablation with a rate-control strategy involving rate-controlling medications ( 32 ) or AVN ablation combined with implantation of a pacemaker ( 30 ) or rate-controlling medications ( 31 ) . One study showed that catheter ablation was better than pharmacologic rate control at improving symptoms , neurohormonal status , and objective physiologic exercise capacity ( 32 ) . Another study showed that PVI isolation was superior to AVN ablation and pacemaker implantation in improving quality of life , 6-minute walk distance , and ejection fraction ( 30 ) . Another study showed that PVI result ed in long-term restoration
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"Background — Data regarding the long-term efficacy of atrial fibrillation ( AF ) ablation are still lacking . Methods and Results —Two hundred four consecutive patients symptomatic for paroxysmal or persistent/permanent AF were r and omly assigned to 2 different ablation schemes : pulmonary vein isolation ( PVI ) and PVI plus left linear lesions ( LL ) . Primary end point was to assess the maintenance of sinus rhythm ( SR ) after procedures 1 and 2 in the absence of antiarrhythmic drugs in a long-term follow-up of at least 3 years . Paroxysmal AF — With a single procedure at 12-month follow-up , 46 % of patients treated with PVI maintained SR , whereas at 3-year follow-up , 29 % were in SR ; using the “ PVI plus LL ” at the 12-month follow-up , 57 % of patients were in SR , whereas at the 3-year follow-up , 53 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 62 % with PVI and 85 % with PVI plus LL . Persistent/Permanent AF — With a single procedure at the 12-month follow-up , 27 % of patients treated with PVI were in SR , whereas at the 3-year follow-up , 19 % maintained SR ; using the PVI plus LL with a single procedure at the 12-month follow-up 45 % of patients were in SR , whereas at the 3-year follow-up , 41 % remained in SR . After a second procedure , the long-term overall success rate without antiarrhythmic drugs was 39 % with PVI and 75 % with PVI plus LL . Conclusions —A long-term follow-up of AF ablation shows that short-term results can not be considered permanent because AF recurrences are still present after the first year especially in patients who have had “ PVI ” strategy . PVI isolation plus LL is superior to the PVI strategy in maintaining SR without antiarrhythmic drugs after procedures 1 and 2 both in paroxysmal and persistent AF",
"BACKGROUND This r and omized prospect i ve study compared three ablation strategies in patients with long-st and ing persistent atrial fibrillation ( LPeAF ) . It also explored the best procedural endpoint from among the following : circumferential pulmonary vein isolation ( PVI ) + left atrial ( LA ) linear lesions ( roofline , mitral isthmus ) + complex fractionated atrial electrogram ( CFAE ) ablation , PVI + LA linear lesions + cavotricuspid isthmus ( CTI ) ablation + CFAE ablation , and PVI + CFAE ablation . METHODS AND RESULTS A total of 210 patients with LPeAF referred for catheter ablation were enrolled and r and omized into three ablation groups . The patients in group A ( n = 70 ) underwent PVI followed by LA linear and CFAE ablation ; in 93 % of patients the primary endpoint was achieved ( five patients with incomplete linear lesions ) . Of the 70 patients in group B who were subjected to PVI followed by LA linear , CFAE , and CTI ablations , in 94 % of patients the primary endpoint was achieved ( four patients with incomplete linear lesions ) . All patients in group C ( n = 70 ) successfully underwent PVI and CFAE ablation . Direct current cardioversion was performed upon PVI , CFAE elimination , and completion of linear lesions . Patients were followed-up for atrial tachyarrhythmia recurrence for at least 24 months . After a single ablation procedure , group C ( 36 % ) exhibited the lowest success compared with group A ( 54 % ) and group B ( 51 % ) ( P = 0.06 ) . At the mean follow-up of 32 ± 9 months after the final ablation procedure , 53 patients ( 76 % ) in group A , 53 ( 76 % ) in group B , and 41 ( 59 % ) in group C were in sinus rhythm without antiarrhythmic drugs ( P = 0.03 ) . CONCLUSIONS In LPeAF , linear lesions in the LA help improve outcome of ablation , additional CTI ablation does not",
"BACKGROUND Pulmonary vein ( PV ) electrical isolation is a therapeutic option in atrial fibrillation ( AF ) . New technologies may reduce the complexity of the procedure . OBJECTIVE The aim of the present study was to compare immediate results and short-term efficacy of a new circular ablation catheter ( PVAC ) with a conventional point-by-point ablation . METHODS The prospect i ve study enrolled 80 consecutive patients with paroxysmal AF or persistent AF , refractory to antiarrhythmic drugs , who were r and omized to radiofrequency ablation using duty-cycled bipolar and unipolar radiofrequency by a decapolar circular catheter ( PVAC group ) or to point-by-point ablation supported by a 3-dimensional mapping system ( 3D group ) . RESULTS Forty patients per group were included . Mean age was 58 ± 10 years , 64 % were male ; 55 % had paroxysmal AF , 45 % had persistent AF . There were no significant differences between groups . Complete electrical isolation was reached in all but 1 PV , which was not isolated in the PVAC group because of phrenic nerve capture . Procedure and fluoroscopy times were lower in the PVAC group : 171 ± 40 minutes vs. 224 ± 27 minutes , P were no major complications . During a mean follow-up of 254 ± 99 days , 72 % in the PVAC group and 68 % in the 3D group were free of AF recurrences irrespective of the initial AF type ( P = NS ) . CONCLUSION PVAC represents a safe alternative for PV isolation . It reduces both procedure and fluoroscopy time . The short- and middle-term efficacy is comparable to a conventional point-by-point antral ablation technique",
"Objective : To assess the effectiveness and safety of pharmacological conversion of persistent atrial fibrillation ( AF ) with a combined propafenone plus ibutilide regimen . Methods and results : 100 consecutive patients ( 66 men , mean ( SD ) age 65 ( 10 ) years ) with persistent AF ( mean ( SD ) duration 99 ( 92 ) days ) admitted for elective pharmacological cardioversion were r and omly assigned to treatment with either intravenous ibutilide ( 1 mg plus an additional 1 mg , if required ; n = 51 ) or oral propafenone ( 600 mg ) plus intravenous ibutilide at the same dose ( n = 49 ) . Success rates were 41.1 % ( 21 of 51 patients ) for ibutilide alone and 71.4 % ( 35 of 49 patients ) for propafenone plus ibutilide ( p = 0.0044 ) . However , cardioversion occurred earlier in the ibutilide alone group ( 55 ( 20 ) minutes ) compared with the combination group ( 81 ( 32 ) minutes , p = 0.0019 ) . A comparable increase in the QTc interval was observed in both groups but one case of sustained torsade de pointes , requiring electrical cardioversion , was observed in the propafenone plus ibutilide group . No other complications were noted during the hospitalisation period . Conclusion : Concurrent administration of propafenone plus ibutilide for pharmacological cardioversion of persistent AF is safe and more effective than ibutilide alone",
"AIMS To assess the effect of metoprolol in combination with repeated cardioversion on maintenance of sinus rhythm ( SR ) . METHODS AND RESULTS Consecutive out patients with persistent atrial fibrillation ( AF ) were r and omized to treatment with metoprolol CR or placebo in a double-blind fashion . Study treatment was started at least one week before direct current ( DC ) cardioversion . Patients were followed once a week during the first 6 weeks after cardioversion . In case of relapse during this period , a second cardioversion was performed . Total treatment time was 6 months . A total of 168 patients were r and omized to metoprolol ( n = 83 ) or placebo ( n = 85 ) . The dose of study treatment at cardioversion was 169 + /- 47 mg in the metoprolol group and 180 + /- 40 mg in the placebo group ( P = 0.12 ) . In an intention-to-treat analysis , 46 patients ( 55 % ) in the metoprolol group and 34 patients ( 40 % ) in the placebo group ( P = 0.04 ) had SR 1 week after cardioversion , and 38 patients ( 46 % ) in the metoprolol group compared with 22 patients ( 26 % ) in the placebo group had SR after 6 months ( P metoprolol CR started before cardioversion in combination with prompt second cardioversion in case of early relapse ( 1 - 6 weeks ) significantly increases the proportion of patients in SR during six months of follow-up",
"AIMS The AFFIRM and RACE studies showed that rate control is an acceptable treatment strategy for atrial fibrillation ( AF ) . We examined whether strict rate control offers benefit over more lenient rate control . METHODS AND RESULTS We compared the outcome of patients enrolled in the rate-control arms of AFFIRM and RACE , using data from patients who met a composite of overlapping inclusion and exclusion criteria . We evaluated 1091 patients , 874 from AFFIRM and 217 from RACE . In AFFIRM , the rate-control strategy aim ed for a resting heart rate composite of mortality , cardiovascular hospitalization , and myocardial infa rct ion . Mean heart rate across all follow-up visits for patients in AF was lower in AFFIRM ( 76.1 vs. 83.4 bpm ) . Event-free survival for the occurrence of the primary endpoint did not differ ( 64 % in AFFIRM vs. 66 % in RACE ) . Patients with mean heart rates during AF within the AFFIRM ( or = 100 ( hazard ratios 0.69 and 0.58 , respectively , for or = 100 bpm ) . CONCLUSION Stringency of the approach to rate control , based on the comparison of the AFFIRM and RACE studies , was not associated with an important difference in clinical events",
"Background — Catheter ablation ( CA ) and minimally invasive surgical ablation ( SA ) have become accepted therapy for antiarrhythmic drug – refractory atrial fibrillation . This study describes the first r and omized clinical trial comparing their efficacy and safety during a 12-month follow-up . Methods and Results — One hundred twenty-four patients with antiarrhythmic drug – refractory atrial fibrillation with left atrial dilatation and hypertension ( 42 patients , 33 % ) or failed prior CA ( 82 patients , 67 % ) were r and omized to CA ( 63 patients ) or SA ( 61 patients ) . CA consisted of linear antral pulmonary vein isolation and optional additional lines . SA consisted of bipolar radiofrequency isolation of the bilateral pulmonary vein , ganglionated plexi ablation , and left atrial appendage excision with optional additional lines . Follow-up at 6 and 12 months was performed by ECG and 7-day Holter recording . The primary end point , freedom from left atrial arrhythmia > 30 seconds without antiarrhythmic drugs after 12 months , was 36.5 % for CA and 65.6 % for SA ( P=0.0022 ) . There was no difference in effect for subgroups , which was consistent at both sites . The primary safety end point of significant adverse events during the 12-month follow-up was significantly higher for SA than for CA ( n=21 [ 34.4 % ] versus n=10 [ 15.9 % ] ; P=0.027 ) , driven mainly by procedural complications such as pneumothorax , major bleeding , and the need for pacemaker . In the CA group , 1 patient died at 1 month of subarachnoid hemorrhage . Conclusion — In atrial fibrillation patients with dilated left atrium and hypertension or failed prior atrial fibrillation CA , SA is superior to CA in achieving freedom from left atrial arrhythmias after 12 months of follow-up , although the procedural adverse event rate is significantly higher for SA than for CA . Clinical Trial Registration — URL : http:// clinical trials.gov . Unique identifier : NCT00662701",
"AIMS With transthoracic cardioversion of atrial fibrillation ( AF ) , biphasic are more effective than monophasic waveforms . We sought to determine the ideal energy levels for biphasic waveforms . Methods We compared biphasic truncated exponential waveforms with monophasic damped sine waveform defibrillators , in a prospect i ve , single-centre , r and omized ( 1:1 ratio ) study . The study included 154 patients receiving concomitant amiodarone ; 77 received serial biphasic ( 50 , 100 , 150 , up to 175 J ) and 77 monophasic shocks ( 100 , 200 , 300 , up to 360 J ) , as necessary . Results First-shock efficacy was similar in the two groups ( 57 vs. 55 % , P = 0.871 , respectively ) , as were serial-shocks ( 90 vs. 92 % , P = 0.780 ) . Both groups received equal numbers of shocks ( 1.8 + /- 1.1 vs. 1.7 + /- 1.0 , P = 0.921 ) . In both groups , serum creatine kinase levels showed a small but significant increase . The increase was , however , higher in the monophasic group . CONCLUSION In patients with concomitant amiodarone therapy , biphasic truncated exponential shocks , using half the energy , were as effective as monophasic damped sine shocks . The biphasic scheme was not more efficacious for cardioverting AF . In our population , a first shock of at least 100 J seemed advisable with either waveform . If necessary , escalating shocks must be performed , but ideal levels of increase per shock are still uncertain for biphasic waveforms",
"AIMS To investigate the effectiveness of additional substrate modification ( SM ) by left atrial ( LA ) linear lesions as compared with pulmonary vein isolation ( PVI ) alone in patients with persistent atrial fibrillation ( AF ) in a prospect i ve r and omized study . Percutaneous PVI has evolved as an accepted treatment for paroxysmal AF but seemed to be less effective in patients with persistent AF . The benefit of PVI alone and additional linear lesions has not been vali date d in a r and omized study so far . METHODS AND RESULTS Sixty-two patients with persistent AF ( median duration 7 , range 1 - 18 months ) were r and omly assigned to either PVI alone ( n = 30 ) or additional SM ( n = 32 ) consisting of a roof line connecting both left superior and right superior PV and LA isthmus ablation between left inferior PV and mitral annulus . Procedures including SM were performed using a three-dimensional mapping system ( EnSite NavX , St Jude Medical , St Paul , MN , USA ) . Anti-arrhythmic drugs were discontinued within 8 weeks after ablation in both groups . Follow-up included daily trans-telephonic ECG transmitted irrespective of the patient 's symptoms . PVI was successful in 98 % of all targeted veins in both groups . Additional SM did not increase fluoroscopy time ( 72.1+/-18.7 vs. 72.9+/-17.3 min , P=0.92 ) because of the use of three-dimensional navigation in the PVI+SM group . AF recurrences within the first 4 weeks following ablation were more common after PVI alone ( 77 % ) than additional SM ( 44 % , P=0.002 ) . After a follow-up time of 487 ( 429 - 570 ) days , only 20 % of patients undergoing st and alone PVI remained in sinus rhythm when compared with 69 % following PVI combined with SM ( P=0.0001 ) . Two patients assigned to PVI+SM experienced procedure-related complications ( cardiac tamponade and minor stroke ) which resolved without sequelae . CONCLUSION PVI alone is insufficient in the treatment of persistent AF . However , additional left linear lesions increase the success rate significantly . Early AF-relapses are associated with a negative outcome after PVI alone but not following additional SM",
"Background —The modification of atrial fibrillation cycle length ( AFCL ) during catheter ablation in humans has not been evaluated . Methods and Results —Seventy patients undergoing ablation of prolonged episodes of AF were r and omized to pulmonary vein ( PV ) isolation or additional ablation of the mitral isthmus . Mean AFCL was determined at a distance from the ablated area ( coronary sinus ) at the following intervals : before ablation , after 2- and 4-PV isolations , and after linear ablation . Inducibility of sustained AF ( ≥10 minutes ) was determined before and after ablation . Spontaneous sustained AF ( 715±845 minutes ) was present in 30 patients and induced in 26 ( AFCL , 186±19 ms ) . PV isolation terminated AF in 75 % , with the number of PVs requiring isolation before termination increasing with AF duration ( P = 0.018 ) . PV isolation result ed in progressive or abrupt AFCL prolongation to various extents , depending on the PV : to 214±24 ms ( P increase in AFCL ( 30±17 versus 14±11 ms ; P = 0.005 ) and the decrease in fragmentation ( 30.0±26.8 % to 10.3±14.5 % ; P prolonged AFCL , with a greater prolongation in patients with AF termination ( 44±13 versus 22±23 ms ; P = 0.08 ) . Sustained AF was noninducible in 57 % after PV isolation and in 77 % after linear ablation . At 7±3 months , 74 % with PV isolation and 83 % with linear ablation were arrhythmia free without antiarrhythmics , which was significantly associated with noninducibility ( P = 0.03 ) with a recurrence rate of 38 % and 13 % in patients with and without inducibility , respectively . Conclusions —AF ablation results in a decline in AF frequency , with a magnitude correlating with termination of AF and prevention of inducibility that is predictive of subsequent clinical outcome",
"Background —With electrogram-guided radiofrequency ablation ( RFA ) of long-lasting persistent atrial fibrillation ( AF ) , the best results have been reported when complex fractionated electrograms ( CFAEs ) in both the left ( LA ) and right ( RA ) atria were targeted . However , many studies have reported excellent outcomes from RFA of long-lasting persistent AF with the use of other ablation strategies that were limited to the LA . The incremental value of RFA of RA CFAEs is yet to be defined . Methods and Results —In 85 patients with long-lasting persistent AF ( age=59±10 years ) , RFA was directed at CFAEs in the LA and coronary sinus until AF terminated ( 19 ) or all identified LA CFAEs were eliminated . Sixty-six patients who remained in AF were r and omly assigned to cardioversion and no further RFA ( n=33 ) or to RFA of RA CFAEs ( n=33 ) . RA sites consisted of the crista terminalis ( 69 % ) , septum ( 38 % ) , superior vena cava ( 28 % ) , coronary sinus ostium ( 22 % ) , and the base of the appendage ( 31 % ) . AF terminated in 1 ( 3 % ) of 33 patients during RA RFA . At 17±6 months after a single ablation procedure , 74 % of the patients in whom AF terminated during LA RFA were in sinus rhythm . Rates of freedom from AF were similar in the patients r and omized to no RFA in the RA ( 24 % ) and those r and omized to RFA of RA CFAEs ( 30 % , P=0.8 ) . The ablation procedure was repeated in 26 patients ( 31 % ) for AF ( n=22 ) or atrial flutter ( n=4 ) . At 16±7 months after the final procedure , 89 % of the patients in whom AF terminated during LA RFA were in sinus rhythm . Among the r and omized patients , the proportion of patients who remained in sinus rhythm was similar in patients who did not undergo RFA of RA CFAEs ( 52 % ) and those who did ( 58 % , P=0.6 ) . Conclusion —After RFA of CFAEs in the LA and coronary sinus , ablation of CFAEs in the RA provides little or no increment in efficacy among patients with long-lasting persistent AF",
"Background —Atrial flutter ( AFL ) and atrial fibrillation ( AF ) frequently coexist in the same patient . Recently it has been demonstrated that the triggers for both AF and AFL may originate in the pulmonary veins ( PVs ) . We hypothesized that in patients with both AF and typical AFL , pulmonary vein – left atrial junction ( PV-LAJ ) disconnection may eliminate both arrhythmias . Methods and Results —Consecutive patients with documented symptomatic AF and typical AFL were r and omly assigned to have PV-LAJ disconnection combined with cavotricuspid isthmus ( CTI ) ablation ( group 1 , n=49 ) or PV-LAJ disconnection alone ( group 2 , n=59 ) . Within the first 8 weeks after ablation , 32 of the group 2 patients had typical AFL documented , whereas none was seen in group 1 . Twenty of these 32 converted to sinus rhythm after initiating antiarrhythmic drugs ( AADs ) . Twelve were cardioverted , and AADs were started . After 8 weeks , all AADS were stopped , and only 3 patients continued to have recurrent sustained typical AFL that was eliminated by CTI ablation . Beyond 8 weeks of follow-up , 7 patients in group 1 and 6 patients in group 2 ( 14 % and 11 % , respectively ) continued to have AF . Ten of these 13 patients underwent a repeat PV-LAJ disconnection procedure and were cured . The remaining 3 remained in normal sinus rhythm while taking AADs . Conclusions —In patients with both AFL and AF , PV-LAJ disconnection alone may be sufficient to control both arrhythmias . CTI block reduced early postablation recurrence of arrhythmias , which in the majority of patients reflects a short-term clinical problem",
"OBJECTIVE Prospect i ve r and omised study comparing patients with atrial fibrillation ( AF ) of more than 6 months duration after mitral valve surgery plus biatrial modified radiofrequency Maze procedure using Medtronic Cardioblate System ( Cardioblate group , n=24 ) vs mitral valve surgery plus intensive rhythm control strategy ( control group , n=25 ) . METHODS Patients were blinded to r and omisation . Preoperatively , at discharge , and at 3-month and 1-year follow-up , echocardiography , quality of life assessment s and ECGs were done . In both groups , sinus rhythm ( SR ) restoration was attempted by intra- and postoperative DC cardioversion and class III antiarrhythmic medication . All patients received warfarin . Amiodarone and warfarin was considered for discontinuation after 3 months in SR , 24-h Holter or event monitor excluding AF . RESULTS Both groups underwent mitral valve replacement or repair ( Cardioblate vs control : 16:8 vs 10:15 ) , had similar gender ( male : 33 % vs 56 % ) , age ( 66+/-8 years vs 68+/-9 years ) , additional aortic valve replacement ( 7 vs 6 patients ) , tricuspid annuloplasty ( 13 vs 13 patients ) , and CABG ( 10 vs 16 patients ) . There was 0 % operative mortality , 0 % postoperative cerebrovascular accidents , but 2 late deaths in the control group . At discharge , 3- and 12-month follow-up , more patients in the Cardioblate group returned to normal SR compared to control ( 29 % , 57 % and 75 % vs 20 % , 43 % and 39 % ; p=0.030 ) . Return of functional atrial contraction in patients in SR at 1 year was comparable between groups ( 63 % vs 89 % , NS ) , and more likely in non-rheumatic pathology and preoperative AF of shorter duration . The effectiveness of atrial contraction was 36+/-14 % vs 43+/-18 % of transmitral flow and there was no difference between groups . Amiodarone treatment decreased more in Cardioblate group over time ( 92 % , 55 % and 29 % vs 52 % , 52 % and 21 % ; p=0.003 ) , whereas warfarin decrease was comparable ( 100 % , 100 % and 71 % vs 100 % , 95 % and 82 % ; NS ) . CONCLUSIONS Radiofrequency Maze ablation additional to mitral valve surgery result ed in a higher SR conversion rate ( 75 % ) , despite control group treatment with intensive rhythm control strategy having a higher SR conversion rate ( 39 % ) compared to literature ( approximately 25 % ) . Maze ablation result ed in normalisation of atrial function in 63 % of patients converted to SR",
"OBJECTIVES Various modifications have been proposed to the original Cox 's Maze procedure due to concerns about the long bypass and cross clamp times . The efficacy of these procedures has been studied and reported . We conducted a r and omised prospect i ve study to compare three procedures , differing in extent , of ablation in patients in atrial fibrillation who were undergoing surgery for rheumatic valvular heart disease . These procedures utilised radiofrequency in the bipolar mode . The extent of ablation was ( 1 ) biatrial ( replication of the Cox Maze ) ( 2 ) left atrial portion of the Cox Maze and ( 3 ) pulmonary vein isolation along with a control group ( the No Maze group ) . Conversion rate to sinus rhythm was studied over a mid-term follow-up period . METHODS A total of 160 patients were studied with 40 patients in each group . Antiarrhythmic drugs were not used in the three months preceding surgery and for seven days postoperatively . The patients underwent surgery for their valve disease along with the ablative procedure as per r and omisation using radiofrequency microbipolar coagulation and cryoablation . They were followed up and were evaluated for symptomatic improvement , rhythm with ECG documentation and 2D echocardiography . RESULTS Follow-up was available for 133 patients . Mid-term results showed that sinus rhythm was restored in 62.5 % patients of Biatrial Maze group and 57.5 % in the Left Atrial Maze . In the Pulmonary Vein Isolation Maze group , 67.5 % patients converted to NSR whereas in the No Maze group only 20 % patients were in sinus rhythm ( p value for all the groups was 0.001 when compared to the No Maze group ) . The incidence of other arrhythmias was not significant and there were no other major complications . All the patients in sinus rhythm at follow-up were in NYHA functional class I-II and showed good effort tolerance . CONCLUSIONS Results achieved with the three ablative procedures are comparable . Therefore lesser procedures viz . Left Atrial Maze and the Pulmonary Vein Isolation Maze procedures must be studied further with the additional use of antiarrhythmic drugs",
"Objective To compare the rate-lowering effect of diltiazem and two amiodarone regimens in critically ill patients with recent-onset atrial tachyarrhythmias . Design Prospect i ve , r and omized , controlled study . Setting Medical cardiologic intensive care unit in a university hospital . Patients Sixty critically ill patients ( Acute Physiology and Chronic Health Evaluation [ APACHE ] III score 70 ± 30 , age 67 ± 10 yrs ) . Interventions Patients with atrial fibrillation ( n = 57 ) , atrial flutter ( n = 2 ) , or atrial tachycardia ( n = 1 , and a heart rate consistently > 120 beats/min over 30 mins were r and omly assigned to one of three intravenous treatment regimens . Group 1 received diltiazem in a 25-mg bolus followed by a continuous infusion of 20 mg/hr for 24 hrs , group 2 received amiodarone in a 300-mg bolus , and group 3 received amiodarone in a 300-mg bolus followed by 45 mg/hr for 24 hrs . Measurements and Main Results The primary study end point was a > 30 % rate reduction within 4 hrs . The secondary study end point was a heart rate ( a patient was considered to have uncontrolled tachycardia if heart rate was > 120 beats/min 4 hrs after study drug ) . The primary study end point was achieved in 14/20 ( 70 % ) , 11/20 ( 55 % ) , and 15/20 ( 75 % ) of patients in groups 1 , 2 , and 3 , respectively ( & khgr;2 = 1.95 , p = .38 ) . Uncontrolled tachycardia was more frequently observed in group 2 ( 0/20 , 9/29 [ 55 % ] , and 1/20 [ 5 % ] of patients in groups 1 , 2 , and 3 , respectively ; & khgr;2 = 17 , p = .00016 ) . In patients achieving tachycardia control , diltiazem showed a significantly better rate reduction ( p = .0001 group 1 vs. group 3 , p = .0001 over time;p = .0001 group 1 vs. group 2 , p = .001 over time ) when compared with the amiodarone groups . Premature drug discontinuation due to hypotension was required significantly more often in group 1 ( 6/20 [ 30 % ] , 0/20 , and 1/20 [ 5 % ] for groups 1 , 2 , and 3 , respectively ; & khgr;2 = 10 , p = .01 ) . Conclusion Sufficient rate control can be achieved in critically ill patients with atrial tachyarrhythmias using either diltiazem or amiodarone . Although diltiazem allowed for significantly better 24-hr heart rate control , this effect was offset by a significantly higher incidence of hypotension requiring discontinuation of the drug . Amiodarone may be an alternative in patients with severe hemodynamic compromise",
"Background Pulmonary vein isolation alone is ineffective in maintaining sinus rhythm in up to one third of patients with paroxysmal atrial fibrillation ( AF ) . We compared pulmonary vein antral isolation plus additional limited ablation along the inferoposterior left atrium and epicardially within the adjacent coronary sinus ( PVAI + CS ) to pulmonary vein antral isolation ( PVAI ) alone in patients with paroxysmal AF . Methods Forty-two consecutive patients with paroxysmal AF were prospect ively r and omized to PVAI vs. PVAI + CS . All patients were seen 3 , 6 , 12 , and 18 months after ablation and underwent 24-h ambulatory Holter monitoring . Results Following a single procedure , 17 out of 22 patients ( 77 % ) remained arrhythmia free off antiarrhythmic medication after PVAI at 18 months vs. 10 out of 20 ( 50 % ) after PVAI + CS ( p recurrent paroxysmal AF , and two had atrial tachycardia , whereas after PVAI + CS , three patients had recurrent paroxysmal AF , and seven had atrial tachycardia . All patients in the PVAI + CS group with atrial tachycardia who underwent a second procedure were found to have peri-mitral macro-reentry as the underlying mechanism . Eighty-one percent of patients remained arrhythmia free off medication after 1.09 procedures in the PVAI group vs. 80 % after 1.35 procedures in the PVAI + CS group ( p recurrence rate of paroxysmal atrial fibrillation and was associated with an increased rate of peri-mitral macro-reentrant atrial tachycardia",
"BACKGROUND Atrial fibrillation ( AF ) is a very common cardiac arrhythmia , and is associated with an increased mortality in patients with hypertension . Whether the best therapeutic approach for these patients is to restore sinus rhythm ( SR ) or to adequately control the ventricular rate is still controversial . The aim of this study is to compare both strategies in patients with hypertension . METHODS AND RESULTS Two hundred and twenty-one patients with hypertension and AF of duration > 48 h were r and omly assigned to either the rhythm ( n=155 ) or rate ( n=66 ) control group . Exercise capacity was improved in the rhythm control group in the 1st year of the study ( p embolic event rate and the total mortality between the 2 groups at the end of the study ( p = NS ) . CONCLUSIONS Although restoring and maintaining SR had a beneficial effect on exercise capacity in patients with hypertension and AF , no significant difference was found in terms of the total mortality and the embolic event rates . Thus , rate control is an acceptable primary strategy in patients with AF and hypertension",
"OBJECTIVES This study examined the relative merits of digoxin , carvedilol , and their combination for the management of patients with atrial fibrillation ( AF ) and heart failure ( HF ) . BACKGROUND In patients with AF and HF , both digoxin and beta-blockers reduce the ventricular rate , and both may improve symptoms , but only beta-blockers have been shown to improve prognosis . If combined therapy is not superior to beta-blockers alone , treatment of patients with HF and AF could be simplified by stopping digoxin . METHODS We enrolled 47 patients ( 29 males ; mean age 68 years ) with persistent AF and HF ( mean left ventricular ejection fraction [ LVEF ] 24 % ) in a r and omized , double-blinded , placebo-controlled study . In the first phase of the study , digoxin was compared with the combination of digoxin and carvedilol ( four months ) . In the second phase , digoxin was withdrawn in a double-blinded manner in the carvedilol-treated arm , thus allowing a comparison between digoxin and carvedilol ( six months ) . Investigations were undertaken at baseline and at the end of each phase . RESULTS Compared with digoxin alone , combination therapy lowered the ventricular rate on 24-h ambulatory electrocardiographic monitoring ( p LVEF ( p symptom score ( p digoxin alone and carvedilol alone in any variable . The mean ventricular rate rose and LVEF fell when patients switched from combination therapy to carvedilol alone . Six-minute walk distance was not significantly influenced by any therapy . CONCLUSIONS The combination of carvedilol and digoxin appears generally superior to either carvedilol or digoxin alone in the management of AF in patients with HF",
"BACKGROUND There are no reports describing the technique , electrophysiological evaluation , and clinical consequences of complete linear block at roofline joining the superior pulmonary veins ( PVs ) in patients with paroxysmal atrial fibrillation ( AF ) . METHODS AND RESULTS Ninety patients with drug-refractory paroxysmal AF undergoing radiofrequency ablation were prospect ively r and omized into 2 ablation strategies : ( 1 ) PV isolation ( n=45 ) or ( 2 ) PV isolation in combination with linear ablation joining the 2 superior PVs ( roofline ; n=45 ) . In both groups , the cavotricuspid isthmus , fragmented peri-PV-ostial electrograms , and spontaneous non-PV foci were ablated . Roofline ablation was performed at the most cranial part of the left atrium ( LA ) with complete conduction block demonstrated during LA appendage pacing by the online mapping of continuous double potential and an activation detour propagating around the PVs to activate caudocranially the posterior wall of the LA . The effect of ablation at the LA roof was evaluated by the change in fibrillatory cycle length , termination and noninducibility of AF , and clinical outcome . PV isolation was achieved in all patients with no significant differences in the radiofrequency duration , fluoroscopy , or procedural time between the groups . Roofline ablation required 12+/-6 ( median 11 , range 3 to 25 ) minutes of radiofrequency energy delivery with a fluoroscopic duration of 7+/-2 minutes and was performed in 19+/-7 minutes . Complete block was confirmed in 43 patients ( 96 % ) and result ed in an activation delay that was shorter circumventing the left than the right PVs during LA appendage pacing ( 138+/-15 versus 146+/-25 ms , respectively ; P=0.01 ) . Roofline ablation result ed in a significant increase in the fibrillatory cycle length ( 198+/-38 to 217+/-44 ms ; P=0.0005 ) , termination of arrhythmia in 47 % ( 8/17 ) , and subsequent noninducibility of AF in 59 % ( 10/17 ) of the patients inducible after PV isolation . However , LA flutter , predominantly perimitral , could be induced in 10 patients ( 22 % ) after roofline ablation . At 15+/-4 months , 87 % of the roofline group and 69 % with PV isolation alone are arrhythmia free without antiarrhythmics ( P=0.04 ) . CONCLUSIONS This prospect i ve r and omized study demonstrates the feasibility of achieving complete linear block at the LA roof . Such ablation result ed in the prolongation of the fibrillatory cycle , termination of AF , and subsequent noninducibility and is associated with an improved clinical outcome compared with PV isolation alone",
"Objective : To compare the efficacy of cardioversion in patients with atrial fibrillation between monophasic damped sine waveform and rectilinear biphasic waveform shocks at a high initial energy level and with a conventional paddle position . Design : Prospect i ve r and omised study . Patients and setting : 227 patients admitted for cardioversion of atrial fibrillation to a tertiary referral centre . Results : 70 % of 109 patients treated with an initial 200 J monophasic shock were cardioverted to sinus rhythm , compared with 80 % of 118 patients treated with an initial 120 J biphasic shock ( NS ) . After the second shock ( 360 J monophasic or 200 J biphasic ) , 90 % of the patients were in sinus rhythm in both groups . The mean cumulative energy used for successful cardioversion was 306 J for monophasic shocks and 159 J for biphasic shocks ( p monophasic waveform shocks in a 200–360 J sequence has the same efficacy ( 90 % ) as a protocol using rectilinear biphasic waveform shocks in a 120–200 J sequence . This equal efficacy is achieved with a significantly lower mean delivered energy level using the rectilinear biphasic shock waveform . The potential advantage of lower energy delivery for cardioversion of atrial fibrillation needs further study",
"Background — Pulmonary vein ( PV ) isolation is a promising new treatment for atrial fibrillation ( AF ) . We hypothesized that isolation of large areas around both ipsilateral PVs with verification of conduction block is more effective than the isolation of each individual PV . Methods and Results — A total of 110 patients , 67 with paroxysmal AF and 43 with persistent AF , were r and omly assigned to undergo either isolation of each individual PV or isolation of large areas around both ipsilateral PVs . The isolation of each individual PV was an electrophysiologically guided , ostial segmental ablation with a 64-pole basket catheter or a 20-pole circular mapping catheter ( group I ) . Isolation of large areas was performed around the 2 ipsilateral veins with a nonfluoroscopic navigation system and a circular 20-pole mapping catheter for verification of conduction block ( group II ) . In both groups , an irrigated-tip ablation catheter ( 25 to 35 W ) was used to achieve complete isolation . Procedure and ablation times were longer in group II , whereas fluoroscopic time was significantly shorter ( P≤0.001 ) . After a follow-up period of 15±4 months , 27 patients in group I ( 49 % ) and 37 patients in group II ( 67 % ) remained free of symptoms of AF and had no AF or atrial flutter during repetitive Holter monitoring without antiarrhythmic drug treatment after a single procedure ( P≤0.05 ) . Conclusions — The rate of success was significantly higher and fluoroscopy times were significantly lower in the group with large isolation areas around both ipsilateral PVs than in those who underwent individual PV isolation",
"OBJECTIVES This study sought to assess the impact of rhythm- versus rate-control treatment strategies and of underlying rhythm on quality of life and functional capacity in patients with atrial fibrillation ( AF ) and congestive heart failure ( CHF ) . BACKGROUND Although intention-to-treat and efficacy analyses have demonstrated similar cardiovascular outcomes in patients with AF and CHF r and omized to rhythm or rate control , effects on quality of life remain to be determined . METHODS The AF-CHF ( Atrial Fibrillation and Congestive Heart Failure ) trial r and omized 1,376 patients to rhythm- or rate-control strategies . For this pre-specified sub study , Medical Outcomes Short Form-36 question naires were administered at baseline and 4 months . Six-min walk tests were conducted at baseline , 3 weeks , 4 months , and 1 year . RESULTS Quality of life improved across all domains to a similar extent with rhythm and rate control . However , a higher proportion of time spent in sinus rhythm was associated with a modestly greater improvement in quality of life scores . Six-min walk distance ( p = 0.2328 ) and New York Heart Association functional class ( p = 0.1712 ) improved to a similar degree with rhythm and rate control . A higher proportion of time spent in sinus rhythm was associated with a greater improvement in New York Heart Association functional class ( p 6-min walk distance ( p = 0.1308 ) . CONCLUSIONS Improvements in quality of life and functional capacity were similar in patients with AF and CHF r and omized to rhythm- versus rate-control strategies . By contrast , sinus rhythm was associated with beneficial effects on New York Heart Association functional class and modest gains in quality of life . ( Atrial Fibrillation and Congestive Heart Failure [ AF-CHF ] ; NCT88597077 )",
"Rate control of atrial fibrillation ( AF ) is a main treatment modality . However , data are scarce on the relative efficacy of calcium channel blockers and β blockers or between drugs within each class . The purpose of the present study was to compare the effect of 4 rate-reducing , once-daily drug regimens on the ventricular heart rate and arrhythmia-related symptoms in patients with permanent AF . We included 60 patients ( mean age 71 ± 9 years , 18 women ) with permanent AF in an investigator-blind cross-over study . Diltiazem 360 mg/day , verapamil 240 mg/day , metoprolol 100 mg/day , and carvedilol 25 mg/day were administered for 3 weeks in a r and omized sequence . The 24-hour heart rate was measured using Holter monitoring , and arrhythmia-related symptoms were assessed using the Symptom Checklist question naire before r and omization and on the last day of each treatment period . The 24-hour mean heart rate was 96 ± 12 beats/min at baseline ( no treatment ) , 75 ± 10 beats/min with diltiazem , 81 ± 11 beats/min with verapamil , 82 ± 11 beats/min with metoprolol , and 84 ± 11 beats/min with carvedilol . All drugs reduced the heart rate compared to baseline ( p ) . The 24-hour heart rate was significantly lower with diltiazem than with any other drug tested ( p , diltiazem significantly reduced both the frequency ( p 0.001 ) and the severity ( p = 0.005 ) of symptoms . In contrast , verapamil reduced symptom frequency only ( p = 0.012 ) . In conclusion , diltiazem 360 mg/day was the most effective drug regimen for reducing the heart rate in patients with permanent AF . Arrhythmia-related symptoms were reduced by treatment with the calcium channel blockers diltiazem and verapamil , but not by the β blockers",
"AIMS The efficacy of epicardial left atrial ( LA ) cryoablation in eliminating atrial fibrillation ( AF ) in patients undergoing mitral valve surgery ( MVS ) is unknown . We hypothesized that MVS combined with LA cryoablation is superior to MVS alone . METHODS AND RESULTS Sixty-nine patients with permanent AF , included at four centres , underwent MVS with or without epicardial LA cryoablation . The primary endpoint was regained sinus rhythm . Risk factors for failed AF cryoablation were eluci date d. Sixty-five out of 69 patients reached the primary endpoint . At 6 and 12 months follow-up , 73.3 % of patients who underwent cryoablation had regained sinus rhythm at both follow-ups , compared with 45.7 and 42.9 % of patients , respectively , who underwent MVS alone ( group differences , at 6 months P = 0.024 , after 12 months P = 0.013 ) . The in-hospital complication rate was 11.4 % in the MVS group and 26.5 % in the cryoablation group ( P = 0.110 ) . Risk factors for failed elimination of AF by cryoablation were duration of permanent AF ( P = 0.012 ) and presence of coronary artery disease ( P = 0.047 ) , according to multiple logistic regression analysis . CONCLUSION This first prospect i ve r and omized study showed that combining MVS with epicardial LA cryoablation is significantly better in eliminating pre-operative permanent AF than MVS alone",
"AIMS It is well established in transthoracic ventricular defibrillation that biphasic truncated waveform shocks are associated with superior defibrillation efficacy when compared with damped sine wave monophasic waveform shocks . The aim of this study was to explore whether biphasic waveform shocks were superior to monophasic waveform shocks for external cardioversion of atrial fibrillation ( AF ) . METHODS AND RESULTS Fifty-seven patients in whom cardioversion of AF was indicated were r and omized in this prospect i ve study , to transthoracic cardioversion with either monophasic damped sine waveform shocks or biphasic impedance compensating waveform shocks . In the group r and omized to monophasic waveform shocks ( 27 patients ) , a first shock of 150 J was delivered , followed ( if necessary ) by a 360 J shock . In the biphasic waveform group ( 30 patients ) , the first shock had an energy of 150 J and ( if necessary ) a second 150 J was delivered . All shocks were delivered in the anterolateral chest pad position . Sinus rhythm was restored in 16 patients ( 51 % ) with the first monophasic shock and in 27 patients ( 86 % ) with the first biphasic shock . The difference was statistically significant ( P=0.02 ) . After the second shock , sinus rhythm was obtained in a total of 24 patients ( 88 % ) with monophasic shocks and in 28 patients ( 93 % ) with biphasic shocks . No complication was observed in either group and cardiac enzymes ( CK , CKmb , troponin I , myoglobin ) did not show any significant changes . CONCLUSION This study suggests that at the same energy level of 150 J , biphasic impedance compensating waveform shocks are superior to monophasic damped sine waveform shocks cardioversion of atrial fibrillation",
"OBJECTIVE The aim of this study was to compare , in patients with permanent atrial fibrillation ( AF ) , the efficacy and safety of left atrial ablation with that of a biatrial procedure and to assess the risk factors for late failure of sinus rhythm restoration . METHODS Between January 2004 and January 2007 , 299 consecutive patients underwent the radiofrequency ablation procedure for AF associated with concomitant cardiac surgery . According to a prospect i ve , open , and r and omized trial , 149 patients underwent left atrial plus cavotricuspid isthmus ablation ( left atrial group ) , while 150 patients underwent biatrial ablation ( biatrial group ) . The postoperative and mid-term follow-up results were compared between the two groups . Both univariate and multivariate analyses were used to assess the risk factors for late recurrence of AF . RESULTS There were seven in-hospital deaths ( 2.3 % ) , including two in the left atrial group ( 1.3 % ) and five in the biatrial group ( 3.3 % ) , and there were no differences in the incidence of the mortality and complications during the postoperative and follow-up periods between the groups . At discharge , sinus rhythm was maintained in 77.1 % of the patients , including 78.2 % of those in the left atrial group and 75.9 % in the biatrial group ( p=0.68 ) . Follow-up was completed in 97 % of the patients , with a mean time of 28+/-5 months . At the latest follow-up , two deaths occurred in the biatrial group . Sinus rhythm was documented in 237 ( 85.0 % ) out of all the patients , including 85.2 % ( 121/142 ) in the left atrial group and 84.1 % ( 116/138 ) in the biatrial group patients ( p=0.87 ) . Using a multivariate analysis , a left atrial diameter of > /=80 mm ( p=0.02 ) was an independent predictor for a late recurrence of AF . CONCLUSIONS Both the left atrial combined with cavotricuspid isthmus ablation and biatrial maze procedure is safe and effective in treating patients with AF , with an acceptable sinus conversion rate , mortality and morbidity . A left atrial dimension of > /=80 mm was a significant predictor for a late recurrence of AF",
"OBJECTIVES This study sought to assess the safety and effectiveness of a novel cryoballoon ablation technology design ed to achieve single-delivery pulmonary vein ( PV ) isolation . BACKGROUND St and ard radiofrequency ablation is effective in eliminating atrial fibrillation ( AF ) but requires multiple lesion delivery at the risk of significant complications . METHODS Patients with documented symptomatic paroxysmal AF and previously failed therapy with ≥ 1 membrane active antiarrhythmic drug underwent 2:1 r and omization to either cryoballoon ablation ( n = 163 ) or drug therapy ( n = 82 ) . A 90-day blanking period allowed for optimization of antiarrhythmic drug therapy and reablation if necessary . Effectiveness of the cryoablation procedure versus drug therapy was determined at 12 months . RESULTS Patients had highly symptomatic AF ( 78 % paroxysmal , 22 % early persistent ) and experienced failure of at least one antiarrhythmic drug . Cryoablation produced acute isolation of three or more PVs in 98.2 % and all four PVs in 97.6 % of patients . PVs isolation was achieved with the balloon catheter alone in 83 % . At 12 months , treatment success was 69.9 % ( 114 of 163 ) of cryoblation patients compared with 7.3 % of antiarrhythmic drug patients ( absolute difference , 62.6 % [ p recurrent , symptomatic AF , constituting drug treatment failure . There were 7 of the result ing 228 cryoablated patients ( 3.1 % ) with a > 75 % reduction in PV area during 12 months of follow-up . Twenty-nine of 259 procedures ( 11.2 % ) were associated with phrenic nerve palsy as determined by radiographic screening ; 25 of these had resolved by 12 months . Cryoablation patients had significantly improved symptoms at 12 months . CONCLUSIONS The STOP AF trial demonstrated that cryoballoon ablation is a safe and effective alternative to antiarrhythmic medication for the treatment of patients with symptomatic paroxysmal AF , for whom at least one antiarrhythmic drug has failed , with risks within accepted st and ards for ablation therapy . ( A Clinical Study of the A rct ic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [ Stop AF ] ; NCT00523978 )",
"CONTEXT Treatment with antiarrhythmic drugs and anticoagulation is considered first-line therapy in patients with symptomatic atrial fibrillation ( AF ) . Pulmonary vein isolation ( PVI ) with radiofrequency ablation may cure AF , obviating the need for antiarrhythmic drugs and anticoagulation . OBJECTIVE To determine whether PVI is feasible as first-line therapy for treating patients with symptomatic AF . DESIGN , SETTING , AND PARTICIPANTS A multicenter prospect i ve r and omized study conducted from December 31 , 2001 , to July 1 , 2002 , of 70 patients aged 18 to 75 years who experienced monthly symptomatic AF episodes for at least 3 months and had not been treated with antiarrhythmic drugs . INTERVENTION Patients were r and omized to receive either PVI using radiofrequency ablation ( n=33 ) or antiarrhythmic drug treatment ( n=37 ) , with a 1-year follow-up . MAIN OUTCOME MEASURES Recurrence of AF , hospitalization , and quality of life assessment . RESULTS Two patients in the antiarrhythmic drug treatment group and 1 patient in the PVI group were lost to follow-up . At the end of 1-year follow-up , 22 ( 63 % ) of 35 patients who received antiarrhythmic drugs had at least 1 recurrence of symptomatic AF compared with 4 ( 13 % ) of 32 patients who received PVI ( P Hospitalization during 1-year follow-up occurred in 19 ( 54 % ) of 35 patients in the antiarrhythmic drug group compared with 3 ( 9 % ) of 32 in the PVI group ( P antiarrhythmic drug group , the mean ( SD ) number of AF episodes decreased from 12 ( 7 ) to 6 ( 4 ) , after initiating therapy ( P = .01 ) . At 6-month follow-up , the improvement in quality of life of patients in the PVI group was significantly better than the improvement in the antiarrhythmic drug group in 5 subclasses of the Short-Form 36 health survey . There were no thromboembolic events in either group . Asymptomatic mild or moderate pulmonary vein stenosis was documented in 2 ( 6 % ) of 32 patients in the PVI group . CONCLUSION Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF . Larger studies are needed to confirm its safety and efficacy",
"Background : Patients with rheumatic heart disease with atrial fibrillation incur significant morbidity and mortality . Which approach , ventricular rate control or maintenance of sinus rhythm , in this setting might be superior is not known . The role of amiodarone in this patient population for maintaining sinus rhythm has not been evaluated . Methods and Results : We prospect ively studied 144 patients with chronic rheumatic atrial fibrillation in a double-blind protocol in which rhythm control ( group I ) , comprising 48 patients each with amiodarone ( group Ia ) and placebo ( group Ib ) , were compared with each other and with patients in a ventricular rate control group ( group II ) in which the effects by diltiazem were determined ( n = 48 , open-label ) . Direct current cardioversion was attempted in group I. The mean age of the study population was 38.6 ± 10.3 years , left atrial size , 4.7 ±0.6 cm ; atrial fibrillation duration , 6.1 ± 5.4 years ; and 72.9 % had valvular interventions performed . At 1 year , 45 patients with sinus rhythm in group I compared with 48 in group II demonstrated an increase in exercise time ( 2.6 ± 1.9 vs. 0.6 ± 2.5 min , P = .001 ) , improvement in New York Heart Association class of 1 or more ( P = .002 ) , and improvement in the quality -of-life score of one or greater ( P = 0.01 ) with no difference in hospitalizations , systemic bleeds , or thromboembolism . Five patients died in group II ; none died in group I ( P = .02 ) . In group I , 73 of 87 ( 83.9 % ) patients converted to sinus rhythm and 45 of 86 ( 52.3 % ) patients maintained the rhythm at 1 year . Conversion rates were 38 of 43 ( 88.4 % ) with amiodarone versus 34 of 44 ( 77.3 % ) with placebo ( P = .49 ) ; the corresponding rate for maintaining sinus rhythm was 29 of 42 ( 69.1 % ) versus 16 of 44 ( 36.4 % ) ( P = .008 ) . A larger number of electrical cardioversions were required in the placebo group ( 2.1 vs. 1.4 , P = .011 ) . Conclusions : Maintenance of sinus rhythm is superior to ventricular rate control in patients with rheumatic atrial fibrillation with respect to effects on exercise capacity , quality of life , morbidity , and possibly mortality . Sinus rhythm could be restored in most patients , and amiodarone was superior to placebo in the restoration and maintenance of sinus rhythm",
"BACKGROUND Pulmonary veins ( PVs ) have been shown to represent the most frequent sites of ectopic beats initiating paroxysmal atrial fibrillation ( AF ) . However , additional non-PV triggers , arising from different areas , have been reported as well . One of the most common non-PV sites described is the superior vena cava . AIMS The purpose of the study was to investigate the impact result ing from the systematic isolation of the superior vena cava ( SVCI ) in addition to pulmonary vein antrum isolation ( PVAI ) on the outcome of paroxysmal , persistent , and permanent AF ablation . METHODS A total of 320 consecutive patients who had been referred to our center in order to undergo a first attempt of AF ablation were r and omized into 2 groups . Group I ( 160 patients ) underwent PVAI only ; Group II ( 160 patients ) underwent PVAI and SVCI . RESULTS AF was paroxysmal in 134 ( 46 % ) , persistent in 75 ( 23 % ) , and permanent in 111 ( 31 % ) of said patients . SVCI was performed on 134 of the 160 patients ( 84 % ) in Group II . SVC isolation was not performed on the remaining 26 patients either because of phrenic nerve capture or the lack of SVC potentials . Comparison of the outcome data between the 2 groups , after a follow-up of 12 months , revealed a significant difference in total procedural success solely with patients manifesting paroxysmal atrial fibrillation ( 56/73 [ 77 % ] Group I vs. 55/61 [ 90 % ] Group II ; P = 0.04 ; OR 2.78 ) . CONCLUSIONS In our study , the strategy of the empiric SVCI in addition to PVAI has improved the outcome of AF ablation solely in patients manifesting paroxysmal AF",
"BACKGROUND Left atrial ( LA ) circumferential ablation has been reported to eliminate atrial fibrillation ( AF ) . Whether an ablation without encirclement of the pulmonary veins ( PVs ) is as effective as LA circumferential ablation is not clear . OBJECTIVES The purpose of this study was to compare the efficacy of LA circumferential ablation and nonencircling linear ablation in patients with chronic AF . METHODS Eighty patients with chronic AF were r and omized to undergo LA circumferential ablation ( n = 40 ) or nonencircling linear ablation ( n = 40 ) . In LA circumferential ablation , the PVs were encircled , with additional lines made in the mitral isthmus and posterior wall or roof . In nonencircling linear ablation , 4 + /- 1 ablation lines were created through areas of complex electrograms , with lines in the roof ( 38 ) , anterior wall ( 36 ) , septum ( 40 ) , mitral isthmus ( 32 ) , and posterior annulus ( 6 ) . The endpoint of LA circumferential ablation and nonencircling linear ablation was voltage abatement . RESULTS LA flutter occurred in 15 % after LA circumferential ablation and in 18 % after nonencircling linear ablation ( P = .8 ) . A repeat ablation procedure was performed for recurrent AF in 7 and 11 patients or for atrial flutter in 6 and 4 patients after LA circumferential ablation and nonencircling linear ablation , respectively ( P = .8 ) . At 9 + /- 4 months , the prevalence of AF was 28 % in the LA circumferential ablation and 25 % in the nonencircling linear ablation group ( P = .8 ) . Sixty-eight percent and 60 % of patients were in sinus rhythm and free of AF and atrial flutter in the absence of antiarrhythmic drug therapy after LA circumferential ablation and nonencircling linear ablation , respectively ( P = .5 ) . There were no complications . CONCLUSION Nonencircling linear ablation and LA circumferential ablation are equally efficacious in eliminating chronic AF . However , the advantage of nonencircling linear ablation is that it eliminates the need for ablation along the posterior wall of the LA . Therefore , nonencircling linear ablation may avoid the small but real risk of atrioesophageal fistula formation associated with LA circumferential ablation",
"BACKGROUND This prospect i ve multicenter r and omized study aim ed to compare the efficacy of 3 common ablation methods used for longst and ing permanent atrial fibrillation ( AF ) . METHODS A total of 144 patients with longst and ing permanent AF ( median duration 28 months ) were r and omly assigned to circumferential pulmonary vein ablation ( CPVA , group 1 , n = 47 ) , to pulmonary vein antrum isolation ( PVAI , group 2 , n = 48 ) or to a hybrid strategy combining ablation of complex fractionated or rapid atrial electrograms ( CFAE ) in both atria followed by a pulmonary vein antrum isolation ( CFAE + PVAI , group 3 , n = 49 ) . RESULTS Scarring in the left atrium and structural heart disease/hypertension were present in most patients ( 65 % ) . After a mean follow-up of 16 months , 11 % of patients in group 1 , 40 % of patients in group 2 and 61 % of patients in group 3 were in sinus rhythm after one procedure and with no antiarrhythmic drugs ( P Sinus rhythm maintenance would increase respectively to 28 % ( group 1 ) , 83 % ( group 2 ) , and 94 % ( group 3 ) after 2 procedures and with antiarrhythmic drugs ( AADs , P conversion to sinus rhythm or organization into an atrial tachyarrhythmia , in 13 % of patients ( group 1 ) , 44 % ( group 2 ) , and 74 % ( group 3 ) respectively . CFAE alone , performed as the first step of the ablation in group 3 , organized AF in only 1 patient . CONCLUSION In this study , the hybrid AF ablation strategy including antrum isolation and CFAE ablation had the highest likelihood of maintaining sinus rhythm in patients with longst and ing permanent AF . Electrical isolation of the PVs , although inadequate if performed alone , is relevant to achieve long-term sinus rhythm maintenance after ablation . Bi-atrial CFAE ablation had a minimal impact on AF termination during ablation",
"STUDY OBJECTIVES To compare the efficacy and safety of amiodarone and propafenone when used for the prevention of atrial fibrillation ( AF ) and maintenance of normal sinus rhythm in patients with refractory AF . DESIGN Prospect i ve , r and omized , single-blind trial . SETTING Tertiary cardiac referral center . PATIENTS One hundred forty-six consecutive patients ( 72 men ; mean age , 63 + /- 10 years [ + /- SD ] ) with recurrent symptomatic AF . INTERVENTIONS We studied 146 patients after restoration of sinus rhythm ; patients were r and omized to amiodarone , 200 mg/d , or propafenone , 450 mg/d . Follow-up clinical evaluations were conducted at the first , second , fourth , and sixth months , and at 3-month intervals thereafter . The proportion of patients relapsing to AF and /or experiencing side effects was calculated for each group using the Kaplan-Meier method . End point of the study was recurrence of AF or occurrence of side effects necessitating discontinuation of medication . MEASUREMENTS AND RESULTS Of 146 patients , 72 received amiodarone and 74 received propafenone . The two groups were clinical ly similar . Of the 72 patients receiving amiodarone , AF developed in 25 patients , after an average of 9.8 months , compared to 33 of the 74 patients receiving propafenone after an average of 3.8 months . Twelve patients receiving amiodarone and 2 patients receiving propafenone had side effects necessitating withdrawal of medication while still in sinus rhythm . CONCLUSIONS Amiodarone tends to be more effective than propafenone in maintaining sinus rhythm in patients with AF , but this advantage is offset by a higher incidence of side effects",
"OBJECTIVE To assess and compare the safety and efficacy of amiodarone and sotalol in the treatment of patients with recurrent symptomatic atrial fibrillation . DESIGN Prospect i ve , r and omised , single blind , placebo controlled study . SETTING Tertiary cardiac referral centre . PATIENTS 186 consecutive patients ( 97 men , 89 women ; mean ( SD ) age , 63 ( 10 ) years ) with recurrent , symptomatic atrial fibrillation . INTERVENTIONS 65 patients were r and omised to amiodarone , 61 to sotalol , and 60 to placebo . Patients receiving amiodarone were maintained at a dose of 200 mg/day after a 30 day loading phase . The sotalol dose was 160 - 480 mg daily , as tolerated . MAIN OUTCOME MEASURES Recurrence of atrial fibrillation or side effects . RESULTS In the amiodarone group , 31 of the 65 patients developed atrial fibrillation after an average of six months , while 15 ( 11 in sinus rhythm and four in atrial fibrillation ) experienced significant side effects after an average of 16 months . In the sotalol group , relapse to atrial fibrillation occurred in 47 of the 61 patients after an average of eight months ; three experienced side effects during the titration phase . In the placebo group , 53 of the 60 patients developed atrial fibrillation after an average of four months ( p amiodarone and sotalol v placebo ; p amiodarone v sotalol ) . CONCLUSIONS Both amiodarone and sotalol can be used for the maintenance of normal sinus rhythm in patients with symptomatic atrial fibrillation . Amiodarone is more effective but causes more side effects",
"This report compares the cumulative efficacy of cardioversion and skeletal muscle injury after either damped sine wave monophasic or truncated exponential biphasic transthoracic cardioversion of persistent atrial fibrillation . The trial sought to refute the None hypothesis of therapeutic equivalence between monophasic and biphasic waveforms . Results of the study reveal similar cumulative efficacy of waveforms and greater levels of skeletal muscle damage when patients are younger and male , and when monophasic waveforms are used",
"Objective To determine whether or not radiofrequency ablation ( RFA ) for persistent atrial fibrillation in patients with advanced heart failure leads to improvements in cardiac function . Setting Patients were recruited from heart failure outpatient clinics in Scotl and . Design and intervention Patients with advanced heart failure and severe left ventricular dysfunction were r and omised to RFA ( rhythm control ) or continued medical treatment ( rate control ) . Patients were followed up for a minimum of 6 months . Main outcome measure Change in left ventricular ejection fraction ( LVEF ) measured by cardiovascular MRI . Results 22 patients were r and omised to RFA and 19 to medical treatment . In the RFA group , 50 % of patients were in sinus rhythm at the end of the study ( compared with none in the medical treatment group ) . The increase in cardiovascular magnetic resonance ( CMR ) LVEF in the RFA group was 4.5±11.1 % compared with 2.8±6.7 % in the medical treatment group ( p=0.6 ) . The RFA group had a greater increase in radionuclide LVEF ( a prespecified secondary end point ) than patients in the medical treatment group ( + 8.2±12.0 % vs + 1.4±5.9 % ; p=0.032 ) . RFA did not improve N-terminal pro-B-type natriuretic peptide , 6 min walk distance or quality of life . The rate of serious complications related to RFA was 15 % . Conclusions RFA result ed in long-term restoration of sinus rhythm in only 50 % of patients . RFA did not improve CMR LVEF compared with a strategy of rate control . RFA did improve radionuclide LVEF but did not improve other secondary outcomes and was associated with a significant rate of serious complications . Clinical trials registration number NCT00292162",
"Background Various strategies have been used for atrial fibrillation ( AF ) ablation . It is unclear whether adding linear lesions to pulmonary vein ( PV ) isolation has significant advantages . Objectives We assessed the clinical benefit of adding linear lesions in patients undergoing PV isolation for AF . Methods One hundred patients ( 63 male and 37 female ; mean age of 59 ± 11 years ) with documented paroxysmal AF were included in the study . Patients were r and omized into two groups . The first group underwent PV isolation alone . The second group underwent PV isolation and had two linear lesions created ; one line between the superior PVs , and a second line from the left inferior PV to the mitral valve annulus . Patients ’ clinical progress after the ablation was evaluated and compared at 1 , 3 , and 9 months after their respective ablation procedures . Results The linear lesions group maintained sinus rhythm and had fewer symptoms than the lone PV isolation group ( 86 vs. 58 % , respectively ) ( p to regain sinus rhythm ( 90 vs. 82 % , respectively ) ( p = NS ) , there was no statistical difference between the groups regarding the use of antiarrhythmics , the need for electrical cardioversion , and subjective improvement . Conclusion The addition of linear lesions to PV isolation more effectively achieved sinus rhythm initially and fewer patients required additional management to maintain their rhythm when compared to patients who underwent lone PV isolation . However , at 9 months , the overall results were similar in both groups",
"Background — The mainstay of treatment for atrial fibrillation ( AF ) remains pharmacological ; however , catheter ablation has increasingly been used over the last decade . The relative merits of each strategy have not been extensively studied . Methods and Results — We conducted a r and omized multicenter comparison of these 2 treatment strategies in patients with paroxysmal AF resistant to at least 1 antiarrhythmic drug . The primary end point was absence of recurrent AF between months 3 and 12 , absence of recurrent AF after up to 3 ablation procedures , or changes in antiarrhythmic drugs during the first 3 months . Ablation consisted of pulmonary vein isolation in all cases , whereas additional extrapulmonary vein lesions were at the discretion of the physician . Crossover was permitted at 3 months in case of failure . Echocardiographic data , symptom score , exercise capacity , quality of life , and AF burden were evaluated at 3 , 6 , and 12 months by the supervising committee . Of 149 eligible patients , 112 ( 18 women [ 16 % ] ; age , 51.1±11.1 years ) were enrolled and r and omized to ablation ( n=53 ) or “ new ” antiarrhythmic drugs alone or in combination ( n=59 ) . Crossover from the antiarrhythmic drugs and ablation groups occurred in 37 ( 63 % ) and 5 patients ( 9 % ) , respectively ( P=0.0001 ) . At the 1-year follow-up , 13 of 55 patients ( 23 % ) and 46 of 52 patients ( 89 % ) had no recurrence of AF in the antiarrhythmic drug and ablation groups , respectively ( P were significantly higher in the ablation group . Conclusion — This r and omized multicenter study demonstrates the superiority of catheter ablation over antiarrhythmic drugs in patients with AF with regard to maintenance of sinus rhythm and improvement in symptoms , exercise capacity , and quality of life",
"This prospect i ve , r and omized , single-blinded , placebo-controlled study compared the efficacy and safety of sotalol and propafenone when used for long-term prevention of atrial fibrillation . For the long-term maintenance of normal sinus rhythm , propafenone seems to be more effective than sotalol",
"BACKGROUND Stepwise segmental pulmonary vein isolation ( SPVI ) and circumferential pulmonary vein isolation ( CPVI ) have been developed to treat patients with atrial fibrillation ( AF ) , but the preferable approach for paroxysmal AF ( PAF ) has not been established . METHODS AND RESULTS One hundred and ten patients with symptomatic PAF were r and omized into a stepwise SPVI group ( n=55 ) or CPVI group ( n=55 ) . Systemic SPVI combined with left atrial linear ablation tailored by inducibility of AF was performed in the stepwise SPVI group . Circumferential linear ablation around the left and right-sided pulmonary veins ( PVs ) guided by 3-dimensional electroanatomic mapping was performed in the CPVI group . The endpoints of ablation are non-induciblity of AF in the stepwise SPVI group and continuity of circular lesions combined with PV isolation in the CPVI group . After the initial procedures , atrial tachyarrhythmis ( ATa ) recurred within the first 3 months in 23 of the 55 patients ( 41.8 % ) who underwent stepwise SPVI and in 20 of the 55 patients ( 36.4 % ) who had CPVI ( p=0.69 ) . Repeat procedures were performed in 7 patients from the stepwise SPVI group and 5 from the CPVI group ( p=0.76 ) . During the 3 - 9 months after the last procedure , 46 patients ( 83.6 % ) from the CPVI group and 43 ( 78.2 % ) from the stepwise SPVI group did not have symptomatic ATa while not taking anti-arrhythmic drugs ( p=0.63 ) . Severe subcutaneous hematoma or PV stenosis occurred in 3 patients . CONCLUSIONS The efficacy of stepwise SPVI is comparable to that of CPVI for patients with PAF",
"Background —Although the Cox-Maze III procedure is effective for treating permanent atrial fibrillation ( AF ) , its high complexity limits its use . The Saline-Irrigated Cooled-tip Radiofrequency Ablation ( SICTRA ) System is an alternative source of energy used to ablate AF . The aim of this study was to evaluate the effectiveness of the SICTRA for the treatment of permanent AF in patients with rheumatic mitral valve ( MV ) disease . Methods and Results —Between February 2002 and April 2003 , 70 patients with permanent AF and rheumatic MV disease were r and omly assigned to undergo a modified Maze III procedure using SICTRA associated with MV surgery ( group A ) or MV surgery alone ( group B ) . Groups A and B were similar in terms of baseline characteristics . The in-hospital mortality rate was 2.3 % ( 1 death ) in group A versus 0 % ( no deaths ) in group B ( P>0.99 ) . The additional time required for the left-sided radiofrequency ablation in group A was 14.2±5.1 minutes and for right-sided ablation was 12.3±4.2 minutes . The mean postoperative follow-up periods were 13.8±3.4 and 11.5±7.3 months , respectively , in groups A and B. The overall mid-term survival rate was 95.1 % in group A and 92.8 % in group B ( P>0.99 ) . The cumulative rates of sinus rhythm were 79.4 % in group A and 26.9 % in group B ( P=0.001 ) . Doppler echocardiography documented biatrial transport function in 90.3 % of group A patients in sinus rhythm . Conclusions —The SICTRA is effective for treating permanent AF associated with rheumatic MV disease",
"Background —The study was conducted to compare relative safety and efficacy of pulmonary vein antrum isolation ( PVAI ) using intracardiac echocardiographic guidance and circumferential pulmonary vein ablation ( CPVA ) for atrial fibrillation ( AF ) using radiofrequency energy . Methods and Results —Sixty patients ( 81 % men ; 81 % paroxysmal ; age , 56±8 years ) failing 2±1 antiarrhythmic drugs were r and omly assigned to undergo CPVA ( n=30 ) or PVAI ( n=30 ) at 5 centers between December 2004 and October 2007 . CPVA patients had circular lesions placed at least 1 cm outside of the veins . Ipsilateral veins were ablated en block with the end point of disappearance of potentials within the circular lesion . Left atrial roof line and mitral isthmus line were ablated without verification of block . For patients in AF postablation or with AF induced with programmed stimulation , complex fractionated electrograms were mapped and ablated to the end point of AF termination or disappearance of complex fractionated electrograms . PVAI did not include complex fractionated electrogram ablation . Esophageal temperature was monitored and kept within 2 ° C of baseline or under 39 ° C . Success was defined as absence of atrial tachyarrhythmias ( AF/AT ) off antiarrhythmic drugs . There was no difference between CPVA and PVAI regarding to baseline variables , catheter used , duration of the procedure , or RF delivery . Fluoroscopy time was longer with PVAI ( 54±17 minutes versus 77±18 minutes , P=0.0001 ) . No significant complications occurred in either arm . PVAI was more likely to achieve control of AF/AT off antiarrhythmic drugs ( 57 % versus 27 % , P=0.02 ) at 2±1 years of follow-up . Conclusions —A single PVAI procedure is more likely to result in freedom from AF/AT off antiarrhythmic drugs than CPVA supplemented by complex fractionated electrogram ablation in select patients",
"Objective : Microwave ablation in conjunction with open heart surgery is effective in restoring sinus rhythm ( SR ) in patients with atrial fibrillation ( AF ) . In patients assigned for isolated mitral valve surgery no prospect i ve r and omized trial has reported its efficacy . Methods : 70 patients with longlasting AF where included from 5 different centres . They were r and omly assigned to mitral valve surgery and atrial microwave ablation or mitral valve surgery alone . Results : Out of 70 r and omized , 66 and 64 patients were available for evaluation at 6 and 12 months . At 12 months SR was restored and preserved in 71.0 % in the ablation group vs 36.4 % in the control group ( P=0.006 ) , corresponding figures at 6 months was 62.5 % vs 26.5 % ( P=0.003 ) . The 30-day mortality rate was 1.4 % , with one death in the ablation group vs zero deaths in the control group . At 12 months the mortality rate was 7,1 % ( Ablation n=3 vs Control n=2 ) . No significant differences existed between the groups with regard to the overall rate of serious adverse events ( SAE ) during the perioperative period or at the end of the study . 16 % of patients r and omized to ablation were on antiarrhytmic drugs compared to 6 % in the control group after 1 year ( p=0.22 ) . Conclusion : Microwave ablation of left and right atrium in conjunction with mitral valve surgery is safe and effectively restores sinus rhythm in patients with longlasting AF as compared to mitral valve surgery alone",
"BACKGROUND Current atrial fibrillation ( AF ) ablation involves isolation of all pulmonary veins ( PVs ) with or without additional linear lesions . However , whether such extensive ablation is necessary is unclear . OBJECTIVE The purpose of this study was to assess the efficacy of different ablation strategies on long-term AF control . METHODS We prospect ively r and omized patients to undergo isolation of all versus arrhythmogenic PVs ( identified by st and ardized stimulation protocol ) . PV isolation was guided by circular mapping catheter . The endpoint was entry/exit block persisting for > or = 20 minutes . Patients were evaluated at three clinic visits ( at 6 weeks , 6 months , and 1 year ) and multiple transtelephonic monitoring periods . Antiarrhythmic drugs were discontinued at 6 weeks . Primary study endpoint was long-term AF control ( freedom or > 90 % reduction in AF burden off or on previously ineffective antiarrhythmic drugs at 1 year after a single ablation procedure ) . RESULTS Over a 20-month period , 105 patients ( 76 men and 29 women , age 57 + /- 9 years ; paroxysmal AF = 77 ) were r and omized , and 103 patients completed 1-year follow-up ( 51 patients in all-PV arm , 52 patients in arrhythmogenic PV arm ) . The primary endpoint was achieved in 75 ( 73 % ) patients and was similar in patients r and omized to all-PV arm versus arrhythmogenic PV arm [ 38 ( 75 % ) patients vs 37 ( 71 % ) patients , respectively ; odds ratio 1.18 , 95 % confidence interval 0.50 , 2.83 , P = .70 ] . Secondary study endpoints , including freedom from AF off antiarrhythmic drugs , total procedure/fluoroscopy times , and occurrence of serious adverse events , were not different between the two groups . CONCLUSION In a r and omized comparison , isolation of arrhythmogenic veins was as efficacious as empiric isolation of all veins in achieving long-term AF control",
"AIMS The purpose of the study was to compare the efficacy and safety of sotalol and bisoprolol in the maintenance of sinus rhythm after electrical cardioversion of atrial fibrillation . METHODS Patients ( n=128 ) were r and omized to sotalol ( 80 mg b.i.d . ) or bisoprolol ( 5 mg x day(-1 ) ) . Patients with contraindications to beta-blockers , class III antiarrhythmic drugs or prior treatment with use of study medication for prevention of atrial fibrillation were excluded . Follow-up clinical evaluation was performed 1 day and 1 month after cardioversion and thereafter at 3-month intervals . RESULTS There were no group differences in baseline clinical characteristics . After a follow-up of 12 months , 59 % of all patients were still in sinus rhythm . The fraction remaining in sinus rhythm was calculated for the two groups by Kaplan -- Meier analysis . During follow-up , 41 % of patients on sotalol and 42 % on bisoprolol developed atrial fibrillation ( ns ) . In two patients ( 3.1 % ) on sotalol , life-threatening proarrhythmias ( torsade de pointes tachycardias ) occurred , whereas none were found in the bisoprolol group . Symptomatic bradycardias occurred in two patients on sotalol and three on bisoprolol . CONCLUSION This study demonstrates that sotalol ( 160 mg x day(-1 ) ) and bisoprolol ( 5 mg x day(-1 ) ) are equally effective in maintaining sinus rhythm . Because of the side effects of sotalol , bisoprolol seems to be advantageous for maintenance of sinus rhythm after cardioversion of atrial fibrillation",
"AIMS External electrical cardioversion is the method of choice to terminate persistent atrial fibrillation . Whether the type of shock electrode affects cardioversion success is not known . We tested whether h and -held steel electrodes improve cardioversion outcome with monophasic or biphasic shocks when compared with adhesive patch electrodes . METHODS AND RESULTS Two hundred and one consecutive patients with persistent atrial fibrillation ( 147 male , mean age 63+/-1 years , duration of atrial fibrillation 6.3+/-1 months ) were r and omly assigned to cardioversion using either a sinusoidal monophasic or a truncated exponential biphasic shock wave form . The first half of patients were cardioverted using adhesive patch electrodes , the second half using h and -held steel paddle electrodes , and all patients using an anterior-posterior electrode position . Paddle electrodes successfully cardioverted 100/104 patients ( 96 % ) and patch electrodes 85/97 patients ( 88 % , P=0.04 ) . This effect was comparable to that of biphasic shocks : biphasic shocks cardioverted 102/104 patients ( 98 % ) and monophasic shocks 83/97 patients ( 86 % , P=0.001 ) . A beneficial effect of paddle electrodes was observed for both shock wave forms . After cross-over from an ineffective monophasic to a biphasic shock , cardioversion was successful in 198/201 ( 98.5 % ) patients . Unsuccessful cardioversion after cross-over ( 3/201 patients ) only occurred with patch electrodes ( P=0.07 ) . CONCLUSION H and -held paddle electrodes increase success of external cardioversion of atrial fibrillation in this trial . This increase is of similar magnitude as the increase in cardioversion success achieved with biphasic shocks . A combination of biphasic shocks , paddle electrodes , and an anterior-posterior electrode position renders outcome of external cardioversion almost always successful ( 104/104 patients in this trial )",
"OBJECTIVES The VERDICT ( Verapamil Versus Digoxin and Acute Versus Routine Serial Cardioversion Trial ) is a prospect i ve , r and omized study to investigate whether : 1 ) acutely repeated serial electrical cardioversions ( ECVs ) after a relapse of atrial fibrillation ( AF ) ; and 2 ) prevention of intracellular calcium overload by verapamil , decrease intractability of AF . BACKGROUND Rhythm control is desirable in patients suffering from symptomatic AF . METHODS A total of 144 patients with persistent AF were included . Seventy-four ( 51 % ) patients were r and omized to the acute ( within 24 h ) and 70 ( 49 % ) patients to the routine serial ECVs , and 74 ( 51 % ) patients to verapamil and 70 ( 49 % ) patients to digoxin for rate control before ECV and continued during follow-up ( 2 x 2 factorial design ) . Class III antiarrhythmic drugs were used after a relapse of AF . Follow-up was 18 months . RESULTS At baseline , there were no significant differences between the groups , except for beta-blocker use in the verapamil versus digoxin group ( 38 % vs. 60 % , respectively , p = 0.01 ) . At follow-up , no difference in the occurrence of permanent AF between the acute and the routine cardioversion groups was observed ( 32 % [ 95 % confidence intervals ( CI ) ] 22 to 44 ) vs. 31 % [ 95 % CI 21 to 44 ] , respectively , p = NS ) , and also no difference between the verapamil- and the digoxin-r and omized patients ( 28 % [ 95 % CI 19 to 40 ] vs. 36 % [ 95 % CI 25 to 48 ] respectively , p = NS ) . Multivariate Cox regression analysis revealed that lone digoxin use was the only significant predictor of failure of rhythm control treatment ( hazard ratio 2.2 [ 95 % CI 1.1 to 4.4 ] , p = 0.02 ) . CONCLUSIONS An acute serial cardioversion strategy does not improve long-term rhythm control in comparison with a routine serial cardioversion strategy . Furthermore , verapamil has no beneficial effect in a serial cardioversion strategy",
"AIMS Activation of beta-adrenoceptors attenuates prolongation of action potential duration induced by blockade of the delayed rectifier potassium current . We examined whether acute administration of beta-blocker could enhance ibutilide ( IB ) efficacy in conversion of atrial fibrillation ( AF ) with a rapid ventricular rate . METHODS AND RESULTS Ninety patients ( aged 63 + /- 13.5 years ) with rapidly conducting AF were r and omized in to two groups . Group A ( n = 44 ) received esmolol titrated to achieve a heart rate of , while Group B ( n = 46 ) were treated with IB as monotherapy . In Group A , 29 patients ( 67 % ) converted to sinus rhythm ( SR ) compared with 21 ( 46 % ) in Group B ( P = 0.04 ) . The use of esmolol was the most important predictor for cardioversion ( P = 0.009 ) . The slower the heart rate at the time of IB initiation , the higher the likelihood for cardioversion ( P = 0.015 ) . Patients in Group A had significantly shorter corrected QT interval ( QTc ) at the time of conversion than those in Group B ( 433 vs. 501 ms , P = 0.003 ) . Two patients in Group A developed severe bradycardia , whereas three patients in Group B developed severe ventricular tachycardia ( VT ) . CONCLUSION Compared with IB monotherapy , the combination therapy of esmolol and IB appears to be more effective in conversion of rapidly conducting AF back to SR . The addition of beta-blocker reduces QTc prolongation and diminishes the risk of VT at the expense , however , of increased bradycardic events",
"OBJECTIVE Biphasic waveforms have similar or greater efficacy at cardioverting atrial and ventricular arrhythmias at lower energy levels than monophasic waveforms , and cause less ST depression following defibrillation of ventricular fibrillation . No studies have investigated this effect on ST change with atrial arrhythmias . We studied the efficacy of the Welch Allyn-MRL PIC biphasic defibrillator . METHODS One hundred and thirty-nine patients undergoing elective DC cardioversion for atrial arrhythmias were r and omised to cardioversion by monophasic ( Hewlett Packard Codemaster XL ; 100 , 200 , 300 , 360 and 360J ) or biphasic ( Welch Allyn-MRL PIC ; 70 , 100 , 150 , 200 and 300J ) defibrillator . We analysed success of cardioversion after 0 and 30min , cumulative energy , number of shocks and energy at successful cardioversion . The ST change in the recorded electrocardiogram was measured at 15s after all shocks using electronic callipers . RESULTS Immediately after cardioversion 59/68 ( 86.8 % ) of the monophasic group versus 56/60 ( 93.3 % ) of the biphasic group were in sinus rhythm . Of the monophasic group , 55/67 ( 82.1 % ) remained in sinus rhythm at 30min versus 53/58 ( 91.4 % ) of the biphasic group . These differences were not significant at 0min ( P=0.35 ) or 30min ( P=0.21 ) . The biphasic group required significantly fewer shocks ( P=0.006 ) , less cumulative energy ( P total energy for successful cardioversion ( P 102 patients with electrocardiogram recordings suitable for analysis , ST segment change was greater in the monophasic group ( P=0.037 ) . CONCLUSIONS The Welch Allyn-MRL biphasic waveform for DC cardioversion results in fewer shocks , with less cumulative energy delivered and less post shock ST change than with a Hewlett Packard Codemaster XL damped sine wave monophasic waveform",
"OBJECTIVE The aim of the study was to assess if the anterior-posterior electrode position for the conversion of atrial fibrillation using biphasic waveform shocks is more effective and needs less energy compared with the anterior-lateral position . BACKGROUND In several studies , anterior-posterior electrode position has been demonstrated to be superior to anterior-lateral position for the termination of atrial fibrillation using monophasic waveform shocks , but data regarding biphasic shocks are still emerging . PATIENTS AND METHODS Our prospect i ve , r and omized study enrolled 103 consecutive patients with atrial fibrillation who were referred for elective cardioversion . The electrode position was r and omly selected to be anterior-lateral ( n=55 ) and anterior-posterior ( n=48 ) . A step-up protocol of 100 , 150 , 200 , and 300 J biphasic truncated exponential waveform shocks was used . RESULTS . Two groups with different paddle position were compared . There was no difference in age , gender , body mass index , ejection fraction , or left atrial size between the groups . Sinus rhythm restoration failed only in one patient in each group . Energy of 100 J was sufficiently effective in most patients in both groups . CONCLUSIONS The anterior-posterior electrode position during transthoracic cardioversion using biphasic waveform shocks has no advantages compared with more comfortable and common anterior-lateral position",
"OBJECTIVES The Australian Intervention R and omized Control of Rate in Atrial Fibrillation Trial was a multicenter trial of atrioventricular junction ablation and pacing ( AVJAP ) compared with pharmacologic ventricular rate control ( medication [ MED ] ) in patients with mild to moderately symptomatic permanent atrial fibrillation ( AF ) . BACKGROUND There have been very few prospect i ve r and omized trials , undertaken in highly symptomatic patients , comparing AVJAP with pharmacologic methods of ventricular rate control for patients with permanent AF . METHODS There were 99 patients ( 70 men , mean age 68 + /- 8.6 years ) at five centers . Forty-nine patients were r and omized to AVJAP while 50 patients were r and omized to pharmacologic control . The primary end point was cardiac function measured by echocardiography and exercise tolerance . The secondary end points were ventricular rate control , evaluated by 24-h ambulatory electrocardiographic monitoring , and quality of life . Data were collected at r and omization and then at one month , six months , and 12 months post-r and omization . RESULTS At 12 months follow-up there was no significant difference in left ventricular ejection fraction ( AVJAP : 54 + /- 17 % ; MED : 61 + /- 13 % [ p = ns ] ) or exercise duration on treadmill testing ( AVJAP : 4.1 + /- 2 min ; MED : 4.6 + /- 2 min [ p = ns ] ) ; however , the peak ventricular rate was lower in the AVJAP group during exercise ( 112 + /- 17 beats/min vs. 153 + /- 36 beats/min , p quality -of-life question naire revealed that patients in the AVJAP group had fewer symptoms at six months ( p = 0.003 ) and at 12 months ( p = 0.004 ) . The observed relative risk reduction in symptoms at 12 months was 18 % . Global subjective semiquantitative measurement of quality of life using the \" ladder of life \" revealed that the AVJAP group reported a 6 % better quality of life at six months ( p = 0.011 ) . CONCLUSIONS In this trial , AVJAP for patients with mild to moderately symptomatic permanent AF did not worsen cardiac function during long-term follow-up , and quality of life was improved",
"AIM The aim of our study was to compare the efficacy and safety of ibutilide and amiodarone ( intravenously ) in converting recent-onset atrial fibrillation ( AF ) and atrial flutter ( Af ) to sinus rhythm ( SR ) . METHODS The study was prospect i ve , r and omized and included 152 ( 103 men and 49 women ) consecutive patients with AF or Af of 3 - 48 h duration . Ibutilide is a selective class III antiarrhythmic agent which when administered intravenously can terminate AF and Af . Amiodarone is also a class III antiarrhythmic agent that when given intravenously or orally has proved to be more effective than other agents in terminating AF and Af [ B.N. Singh , F.V. Mody , B. Lopez , J.S. Sarma . Antiarrhythmic agents for atrial fibrillation : focus on prolonging atrial repolarization . Am J Cardiol 1999 Nov 4 ; 84 : 161R-173R . ] . Seventy-nine patients ( 56 with AF and 23 with Af ) that consisted group A were treated with ibutilide . Seventy-three ( 52 with AF and 21 with Af ) consisted group B and were treated with intravenous infusion of amiodarone . RESULTS The conversion rate of group A ( ibutilide ) was significantly higher than the conversion rate of group B ( amiodarone ) ( 80 % vs. 57 % , p=0.0054 ) . As regards the kind of arrhythmia separately , for AF there was n't significant difference ( 77 % vs. 69 % , p = ns ) whereas for Af ibutilide was superior to amiodarone ( 87 % vs. 29 % , p=0.003 ) . The conversion rates of ibutilide did n't differ for AF and Af ( 77 % vs. 87 % , p = ns ) . CONCLUSIONS Ibutilide is more effective than amiodarone in converting recent-onset Af to SR whereas both drugs are equally effective in converting recent-onset AF to SR",
"Objective : To evaluate prospect ively the effects of pretreatment with verapamil on the maintenance of sinus rhythm after direct current ( DC ) cardioversion . Design : R and omised , active control , open label , parallel group comparison of verapamil versus digoxin . Setting s : Multicentre study in three teaching and three non-teaching hospitals in Sweden . Patients : 100 consecutive patients with atrial fibrillation ( AF ) of at least four weeks ’ duration and indications for cardioversion were assigned r and omly to two groups , one treated with verapamil ( verapamil group ) and the other with digoxin ( digoxin group ) before cardioversion . Fifty patients were assigned r and omly to each treatment arm . After dropout of four patients from the digoxin group and seven patients from the verapamil group , data obtained from 89 patients were analysed . Interventions : After r and omly assigned pretreatment with either verapamil or digoxin for four weeks , DC cardioversion was performed . If sinus rhythm was restored then verapamil treatment was discontinued . Main outcome measures : The rate of AF recurrence was assessed one , four , eight , and 12 weeks after cardioversion . Results : 6 patients in the verapamil treated group and none in the digoxin treated group reverted to sinus rhythm spontaneously ( p restored sinus rhythm in 24 of 37 ( 65 % ) patients in the verapamil group and 41 of 46 patients ( 89 % ) in the digoxin group ( p digoxin pretreated patients versus 9 % ( four of 43 ) of verapamil pretreated patients remained in sinus rhythm ( p verapamil alone does not improve maintenance of sinus rhythm after DC cardioversion in patients with AF . The rate of spontaneous cardioversion may be improved by verapamil",
"BACKGROUND Surgical pulmonary veins isolation ( PVI ) is done to restore sinus rhythm ( SR ) in patients with chronic permanent atrial fibrillation ( CPAF ) and mitral valve disease . Here we compare the efficacy of electrical block lines performed with radiofrequency ( RF ) compared with conventional surgery . METHODS R and omized trial of 22 patients with CPAF and indication for mitral valve surgery . Ten patients underwent conventional surgery ( SURG ) and 12 RF . To prove the efficacy of the blockage lines , epicardial pacemaker wires were placed in the isolated pulmonary veins region ( IPVR ) and right atria ( RA ) . RESULTS There were no differences in the baseline data among the groups . All patients remained in SR during the immediate postoperative period . Block lines were tested in patients who remained in SR during the following days ( eight in SURG and nine in RF ) . The median value of thresholds to conduct the stimulus of IPVR for the RA was 18 mA in SURG and 3 mA in RF ( P SR at hospital discharge . Eleven RF patients and one SURG required amiodarone to maintain SR ( P incidence of recurrent atrial fibrillation ( AF ) in the follow-up was 10.7/100 patients /year in the SURG group versus 73.1/100 patients /year in the RF group ( P = 0.009 ) . CONCLUSIONS PVI by SURG formed more effective block lines than RF . SR at hospital discharge was similar among the groups , but more amiodarone was used in RF . During follow-up , incidence of recurrent AF was higher in the RF group",
"AIMS To compare the effects of sotalol and metoprolol on heart rate , during isotonic ( ITE ) and isometric ( IME ) exercise and daily activities , in digitalized patients with chronic atrial fibrillation . METHODS AND RESULTS The study had a r and omized , single-blinded , crossover design . Twenty-three patients with chronic atrial fibrillation received placebo for 4 weeks , followed by a 4-week period of treatment with sotalol and metoprolol in r and om order . At the end of each period , the patients were assessed with 24-h ECG monitoring , a cardiopulmonary exercise test and a h and grip manoeuvre . Both agents produced a lower heart rate than placebo at rest and at all levels of isotonic exercise ( P oxygen uptake . Sotalol produced a lower heart rate than metoprolol only at submaximal exercise ( 116 + /- 9 bpm for sotalol vs 125 + /- 11 bpm for metoprolol , P maximum heart rate than did metoprolol ( 113 + /- 22 vs 129 + /- 18 bpm , respectively ) . Both agents produced a lower mean heart rate than placebo over 24 h ( P mean heart rate than metoprolol during the daytime ( P heart rate in digitalized patients with atrial fibrillation . Sotalol is superior to metoprolol at submaximal exercise , result ing in better rate control during daily activities",
"Background Catheter ablation ( CA ) is a highly effective therapy for the treatment of paroxysmal atrial fibrillation ( AF ) when compared with antiarrhythmic drug therapy ( ADT ) . No r and omized studies have compared the two strategies in persistent AF . The present r and omized trial aim ed to compare the effectiveness of CA vs. ADT in treating persistent AF . Methods and results Patients with persistent AF were r and omly assigned to CA or ADT ( excluding patients with long-st and ing persistent AF ) . Primary endpoint at 12-month follow-up was defined as any episode of AF or atrial flutter lasting > 24 h that occurred after a 3-month blanking period . Secondary endpoints were any atrial tachyarrhythmia lasting > 30 s , hospitalization , and electrical cardioversion . In total , 146 patients were included ( aged 55 ± 9 years , 77 % male ) . The ADT group received class Ic ( 43.8 % ) or class III drugs ( 56.3 % ) . In an intention-to-treat analysis , 69 of 98 patients ( 70.4 % ) in the CA group and 21 of 48 patients ( 43.7 % ) in the ADT group were free of the primary endpoint ( P = 0.002 ) , implying an absolute risk difference of 26.6 % ( 95 % CI 10.0–43.3 ) in favour of CA . The proportion of patients free of any recurrence ( > 30 s ) was higher in the CA group than in the ADT group ( 60.2 vs. 29.2 % ; P 0.018 ) . Conclusion Catheter ablation is superior to medical therapy for the maintenance of sinus rhythm in patients with persistent AF at 12-month follow-up . Clinical Trial Registration Information NCT00863213 ( http:// clinical trials.gov/ct2/show/NCT00863213 )",
"Background —There has been growing concern that linear ablation is associated with an increased risk of iatrogenic arrhythmias in patients undergoing ablation for atrial fibrillation ( AF ) . Therefore , we compared circumferential pulmonary vein ablation plus left atrial linear ablation ( CPVA+LALA ) with segmental pulmonary vein isolation (PVI)in patients with paroxysmal AF . Methods and Results —Sixty-six consecutive patients with paroxysmal AF were prospect ively r and omly assigned to receive PVI versus CPVA+LALA ( consisting of encircling lesions around the pulmonary veins ) , a roof line , and a mitral isthmus line with documentation of bidirectional mitral isthmus block . All patients were seen at 1 , 3 , 6 , and every 12 months after ablation , with 14-day continuous ECG monitoring every 6 months . At 16.4±6.3 months after 1 ablation procedure , 19 patients ( 58 % ) remained free of atrial arrhythmias after PVI versus 17 patients ( 51 % ) after CPVA+LALA ( P=0.62 ) . After PVI , 14 patients had recurrent paroxysmal AF , whereas after CPVA+LALA , 8 patients had recurrent AF , 6 had atypical left atrial flutter ( LAFL ) , and 2 had both AF and LAFL ( P=0.32 between PVI versus CPVA+LALA for AF but P=0.002 for LAFL ) . Twenty-eight patients ( 85 % ) remained arrhythmia-free after 1.3±0.5 PVI procedures versus 28 patients ( 85 % ) after 1.4±0.6 CPVA+LALA procedures ( P = NS ) . Fluoroscopy time was longer after CPVA+LALA versus PVI ( 91 versus 73 minutes , P=0.04 ) . Conclusions —As an initial ablation approach in patients with paroxysmal AF , more LAFL occurred after CPVA+LALA and fluoroscopy times were longer compared with segmental PVI",
"BACKGROUND We conducted a r and omized , controlled trial of circumferential pulmonary-vein ablation for the treatment of chronic atrial fibrillation . METHODS A total of 146 patients with a mean ( + /-SD ) age of 57+/-9 years who had chronic atrial fibrillation were r and omly assigned to receive amiodarone and undergo two cardioversions during the first three months alone ( the control group ) or in combination with circumferential pulmonary-vein ablation . Cardiac rhythm was assessed with daily telephonic transmissions for one year . The left atrial diameter and the severity of symptoms were assessed at 12 months . RESULTS Among the 77 patients assigned to undergo circumferential pulmonary-vein ablation , ablation was repeated because of recurrent atrial fibrillation in 26 percent of patients and atypical atrial flutter in 6 percent . An intention-to-treat analysis showed that 74 percent of patients in the ablation group and 58 percent of those in the control group were free of recurrent atrial fibrillation or flutter without antiarrhythmic-drug therapy at one year ( P=0.05 ) . Among the 69 patients in the control group , 53 ( 77 percent ) crossed over to undergo circumferential pulmonary-vein ablation for recurrent atrial fibrillation by one year and only 3 ( 4 percent ) were in sinus rhythm without antiarrhythmic-drug therapy or ablation . There were significant decreases in the left atrial diameter ( 12+/-11 percent , P symptom severity score ( 59+/-21 percent , P Sinus rhythm can be maintained long term in the majority of patients with chronic atrial fibrillation by means of circumferential pulmonary-vein ablation independently of the effects of antiarrhythmic-drug therapy , cardioversion , or both . The maintenance of sinus rhythm is associated with a significant decrease in both the severity of symptoms and the left atrial diameter",
"AIMS The aim of this prospect i ve , r and omized study was to determine the efficacy of a serial external electrical cardioversion strategy in maintaining sinus rhythm after 12 months in patients with recurrent persistent atrial fibrillation . METHODS AND RESULTS Ninety patients with persistent atrial fibrillation lasting more than 72 h but less than 1 year were r and omized in a one to one fashion to repetition of up to two electrical cardioversions in the event of relapse of atrial fibrillation detected within 1 month of the previous electrical cardioversion ( Group AGG ) , or to non-treatment of atrial fibrillation relapse ( Group CTL ) . ECGs were scheduled at 6 h , 7 days , and 1 month . Clinical examination and ECGs were repeated during the 6-month and 12-month follow-up examinations . Echocardiography was repeated during the 6-month follow-up examination . Clinical and echocardiographic characteristics were similar in the two groups . All patients were treated with antiarrhythmic drugs before electrical cardioversion and throughout follow-up . After 12 months , sinus rhythm was maintained in 53 % of Group AGG patients and in 29 % of Group CTL patients ( P left ventricular ejection fraction had recovered significantly only in Group AGG ( 56.8 + /- 9.0 % at enrollment vs 60.4 + /- 9.4 % at 6 months , P of electrical cardioversion after early atrial fibrillation recurrence is useful in maintaining sinus rhythm after 12 months",
"Aims This multicentre , r and omized trial compared three strategies of AF ablation : ablation of complex fractionated electrograms ( CFE ) alone , pulmonary vein isolation ( PVI ) alone , and combined PVI + CFE ablation , using st and ardized automated mapping software . Methods and results Patients with drug-refractory , high-burden paroxysmal ( episodes > 6 h , > 4 in 6 months ) or persistent atrial fibrillation ( AF ) were enrolled at eight centres . Patients ( n = 100 ) were r and omized to one of three arms . For CFE alone ( n = 34 ) , spontaneous/induced AF was mapped using vali date d , automated CFE software and all sites . Atrial fibrillation symptoms were confirmed by loop recording . Repeat procedures were allowed within the first 6 months . The primary endpoint was freedom from AF > 30 s at 1 year . Patients ( age 57 ± 10 years , LA size 42 ± 6 mm ) were 35 % persistent AF . In CFE , ablation terminated AF in 68 % . Only 0.4 PVs per patient were isolated as a result of CFE . In PVI , 94 % had all four PVs successfully isolated . In PVI + CFE , 94 % had all four PVs isolated , 76 % had inducible AF with additional CFE ablation , with 73 % termination of AF . There were significantly more repeat procedures in the CFE arm ( 47 % ) vs. PVI ( 31 % ) or PVI + CFE ( 15 % ) ( P = 0.01 ) . After one procedure , PVI + CFE had a significantly higher freedom from AF ( 74 % ) compared with PVI ( 48 % ) and CFE ( 29 % ) ( P = 0.004 ) . After two procedures , PVI + CFE still had the highest success ( 88 % ) compared with PVI ( 68 % ) and CFE ( 38 % ) ( P = 0.001 ) . Ninety-six percent of these patients were off anti-arrhythmics . Complications were two tamponades , no PV stenosis , and no mortality . Conclusion In high-burden paroxysmal/persistent AF , PVI + CFE has the highest freedom from AF vs. PVI or CFE alone after one or two procedures . Complex fractionated electrogram alone has the lowest one and two procedure success rates with a higher incidence of repeat procedures . Clinical Trials.gov identifier number NCT00367757",
"OBJECTIVE Radiofrequency or the use of microwave energy in combination with atrial size reduction during open heart surgery have been reported to be effective in up to 75 % in the treatment of permanent atrial fibrillation . However , no data from prospect i ve r and omized trials using microwave energy are available . METHODS Forty-three patients with permanent atrial fibrillation undergoing open-heart surgery were r and omly stratified into treatment group receiving microwave ablation and atrial size reduction ( n=24 ) or control group ( n=19 ) . Patients in either group were treated with amiodarone or sotalol for 3 months if sinus rhythm or any atrioventricular rhythm was successfully restored . Follow-up time points were at 3 , 6 and 12 month after surgery . RESULTS In the treatment group 22 out of 24 patients ( 91,7 % ) were successfully converted to sinus rhythm by using intraoperative microwave ablation therapy whereas only six out of 19 ( 31.5 % ) patients converted to sinus rhythm directly after surgery . At 12-month follow-up there were still a significantly higher percentage of patients in the treatment group free from atrial fibrillation when compared to control ( 80 vs. 33.3 % , P=0.036 ) . CONCLUSION The preliminary data from this first prospect ively r and omized trial indicate that microwave ablation combined with atrial size reduction is a safe and highly efficient treatment in permanent atrial fibrillation",
"Aims Surgical ablation procedure can restore sinus rhythm ( SR ) in patients with atrial fibrillation ( AF ) undergoing cardiac surgery . However , it is not known whether it has any impact on long-term clinical outcomes . Methods and results This multicentre study r and omized 224 patients with AF scheduled for valve and /or coronary surgery : group A ( left atrial surgical ablation , n = 117 ) vs. group B ( no ablation , n = 107 ) . The primary efficacy outcome was the SR presence ( without any AF episode ) during a 24 h electrocardiogram ( ECG ) after 1 year . The primary safety outcome was the combined endpoint of death/myocardial infa rct ion/stroke/renal failure at 30 days . A Holter-ECG after 1 year revealed SR in 60.2 % of group A patients vs. 35.5 % in group B ( P = 0.002 ) . The combined safety endpoint at 30 days occurred in 10.3 % ( group A ) vs. 14.7 % ( group B , P = 0.411 ) . All-cause 1-year mortality was 16.2 % ( A ) vs. 17.4 % ( B , P = 0.800 ) . Stroke occurred in 2.7 % ( A ) vs. 4.3 % ( B ) patients ( P = 0.319 ) . No difference ( A vs. B ) in SR was found among patients with paroxysmal ( 61.9 vs. 58.3 % ) or persistent ( 72 vs. 50 % ) AF , but ablation significantly increased SR prevalence in patients with longst and ing persistent AF ( 53.2 vs. 13.9 % , P Surgical ablation improves the likelihood of SR presence post-operatively without increasing peri-operative complications . However , the higher prevalence of SR did not translate to improved clinical outcomes at 1 year . Further follow-ups ( e.g. 5-year ) are warranted to show any potential clinical benefit which might occur later",
"Background — Data on the comparative value of the circumferential pulmonary vein and the segmental pulmonary vein ablation for interventional treatment of atrial fibrillation are limited . We hypothesized that the circumferential pulmonary vein ablation approach was superior to the segmental pulmonary vein ablation approach . Methods and Results —One hundred patients with highly symptomatic atrial fibrillation were r and omly assigned to undergo either circumferential ( n=50 ) or segmental pulmonary vein ablation ( n=50 ) . Freedom from atrial tachyarrhythmias in a 7-day Holter monitoring at 6 months was the primary end point . Secondary end points were freedom of arrhythmia-related symptoms and a composite of pericardial tamponade , thromboembolic complications , and pulmonary vein stenosis ( safety end point ) . On the basis of the results of the 7-day Holter monitoring at 6 months , 21 patients ( 42 % ) after circumferential pulmonary vein ablation and 33 patients ( 66 % ) after segmental pulmonary vein ablation ( P=0.02 ) were free of atrial tachyarrhythmia episodes . During the 6-month follow-up period , 27 patients ( 54 % ) after circumferential pulmonary vein ablation and 41 patients ( 82 % ) after segmental pulmonary vein ablation remained free of arrhythmia-related symptoms ( P safety end point ( 6 versus 7 events ; P=0.77 ) in the circumferential versus segmental pulmonary vein ablation group , respectively . Conclusions —This study demonstrates no superiority of the circumferential pulmonary vein ablation over segmental pulmonary vein ablation for treatment of atrial fibrillation in terms of efficacy and safety",
"AIMS Catheter ablation and surgical Maze procedure are effective in treating atrial fibrillation ( AF ) patients . However , there is no study that compares the effect of circumferential pulmonary vein isolation ( CPVI ) combined with substrate ablation after valvular surgery and the concomitant Maze procedure for the treatment of AF in patients with rheumatic heart disease ( RHD ) . The aim of this study was to compare the effectiveness of CPVI combined with substrate modification and surgical Maze procedure using Saline-Irrigated Cooled-tip Radiofrequency Ablation ( SICTRA ) system for the treatment of long-lasting persistent AF in patients with RHD . METHODS AND RESULTS Between January 2006 and June 2008 , 99 patients with long-lasting persistent AF and RHD were r and omly assigned to undergo valvular operation and CPVI combined with substrate modification 6 months after the surgery ( Group A , 49 patients ) or valvualr operation and concomitant Maze procedure ( Group B , 50 patients ) . The mean follow-up periods were 15 ± 5 and 20 ± 8 months in Groups A and B , respectively . After one procedure , Group B had a significantly higher freedom from artial arrhythmias compared with Group A ( 82 % in Group B vs. 55.2 % in Group A , P catheter ablation and four were treated successfully . The cumulative rates of sinus rhythm were 71 % in Group A and 88 % in Group B ( P concomitant Cox Maze procedure using SICTRA is more effective than subsequent CPVI combined with substrate modification in treating patients with long-lasting persistent AF and RHD",
"UNLABELLED This r and omized study compared the efficacy and safety of amiodarone , propafenone and sotalol in the prevention of atrial fibrillation . METHODS The population consisted of 214 consecutive patients ( mean age 64 + /- 8 years , 106 men ) with recurrent symptomatic atrial fibrillation . After restoration of sinus rhythm , patients were r and omized to amiodarone ( 200 mg/day ) , propafenone ( 450 mg/day ) or sotalol ( 320 + /- 20 mg/day ) . Follow-up evaluations were conducted at 1 , 2 , 4 and 6 months , and at 3-month intervals thereafter . The proportion of patients developing recurrent atrial fibrillation and /or experiencing unacceptable adverse effects was measured in the three groups by the Kaplan-Meier method . RESULTS Recurrent atrial fibrillation occurred in 25 of the 75 patients treated with amiodarone compared to 51 of the 75 patients treated with sotalol and 24 of the 64 patients treated with propafenone . Fourteen patients treated with amiodarone , five with sotalol , and one with propafenone experienced adverse effects while in sinus rhythm , necessitating discontinuation of treatment ( P amiodarone and propafenone vs sotalol ) . The difference between amiodarone and propafenone was statistically nonsignificant when all events were included in the analysis . However , if the analysis was limited to recurrent atrial fibrillation events , amiodarone was more effective than propafenone ( P Amiodarone and propafenone were superior to sotalol in maintaining long-term normal sinus rhythm in patients with atrial fibrillation . Amiodarone tended to be superior to propafenone , though its long-term efficacy was limited by adverse side effects",
"OBJECTIVES This study sought to determine whether ablation of complex fractionated atrial electrograms ( CFAEs ) after antral pulmonary vein isolation ( APVI ) further improves the clinical outcome of APVI in patients with long-lasting persistent atrial fibrillation ( AF ) . BACKGROUND Ablation of CFAEs has been reported to eliminate persistent AF . However , residual pulmonary vein arrhythmogenicity is a common mechanism of recurrence . METHODS In this r and omized study , 119 consecutive patients ( mean age 60 + /- 9 years ) with long-lasting persistent AF underwent APVI with an irrigated-tip radiofrequency ablation catheter . Antral pulmonary vein isolation result ed in termination of AF in 19 of 119 patients ( Group A , 16 % ) . The remaining 100 patients who still were in AF were r and omized to no further ablation and underwent cardioversion ( Group B , n = 50 ) or to ablation of CFAEs in the left atrium or coronary sinus for up to 2 additional hours of procedure duration ( Group C , n = 50 ) . RESULTS Atrial fibrillation terminated during ablation of CFAEs in 9 of 50 patients ( 18 % ) in Group C. At 10 + /- 3 months after a single ablation procedure , 18 of 50 ( 36 % ) in Group B and 17 of 50 ( 34 % ) in Group C were in sinus rhythm without antiarrhythmic drugs ( p = 0.84 ) . In Group A , 15 of 19 patients ( 79 % ) were in sinus rhythm . A repeat ablation procedure was performed in 34 of 100 r and omized patients ( for AF in 30 and atrial flutter in 4 ) . At 9 + /- 4 months after the final procedure , 34 of 50 ( 68 % ) in Group B and 30 of 50 ( 60 % ) in Group C were in sinus rhythm without antiarrhythmic drugs ( p = 0.40 ) . CONCLUSIONS Up to 2 h of additional ablation of CFAEs after APVI does not appear to improve clinical outcomes in patients with long-lasting persistent AF ",
"BACKGROUND Detailed analysis of signal-averaged P waves ( SAPW ) can provide insights into atrial electrophysiology . Abbreviated dosing of verapamil prior to cardioversion improves outcome at 1 week postcardioversion . The mechanism by which verapamil manifests benefit is uncertain . We hypothesized the SAPW would reflect any change in atrial electrophysiologic substrate afforded by verapamil when compared with controls . METHODS We investigated 23 patients attending external cardioversion of persistent atrial fibrillation ( AF ) ( 6 female ; mean age 68 years ) . Patients were r and omized to verapamil 240 mg daily in three divided doses 3 days before cardioversion and 1 week after , or usual medication . SAPW recordings were performed during sinus rhythm ( SR ) immediately after cardioversion , at 24 hours and 1 week . RESULTS The groups were comparable in terms of age , gender , left atrial size , and duration of AF . Eight of nine patients prescribed verapamil maintained SR at 1 week postcardioversion compared with 6 of 14 controls ( P = 0.027 ) . SAPW spectral analysis delivered higher energy for patients prescribed verapamil ( median ( IQ range ) ) ; 40.8 ( 33.4 - 95.1 ) versus 25.7 ( 19.0 - 38.0 ) for energy within 20 - 150 Hz , P20 ( microV(2)x s ; P = 0.03 ) . There was no difference in P-wave duration ( PWD ) or root mean square of the terminal 30 ms between the two groups . Early reinitiation occurred in patients with significantly lower P-wave energy 19.6 ( 12.9 - 24.6 ) versus 39.9 ( 24.0 - 47.0 ) ( P = 0.017 ) . CONCLUSIONS Verapamil 240 mg daily for 3 days prior to cardioversion and 1 week after reduces early recurrence of AF . The SAPW observations indicate change in atrial electrophysiologic substrate might be responsible for benefit afforded by verapamil",
"BACKGROUND The deployment of an ablation line connecting the left inferior PV to the mitral annulus ( mitral isthmus line [ MIL ] ) enhances the efficacy of pulmonary vein disconnection ( PVD ) in preventing atrial fibrillation ( AF ) recurrences . OBJECTIVES To investigate the long-term effect of the additional linear lesion in a prospect i ve r and omized study . METHODS One hundred and eighty-seven patients ( 37 females , mean age : 55 + /- 11 years ) with paroxysmal ( 126 ) or persistent ( 61 patients ) AF , were prospect ively r and omized into two groups : PVD ( group A , 92 patients ) or PVD combined with MIL ( group B , 95 patients ) , performed by means of an irrigated-tip ablation catheter . RESULTS Successful disconnection of all PVs was achieved in all patients . A bidirectional block ( BB ) along the left atrial isthmus was obtained in 72 of 95 ( 76 % ) patients in group B , most of whom required additional RF pulses from within the distal CS . A transient ischemic attack occurred in 1 patient of group A , and a cardiac tamponade occurred in 1 patient of group B. At 1 year , 53 + /- 5 % ( group A ) and 71 + /- 5 % ( group B ) remained arrhythmia free ( P = 0.01 ) ; subgroup analysis highlights a higher improvement among patients with persistent AF ( 74 + /- 9 % vs 36 + /- 9 % ; P sinus rhythm maintenance rate , particularly in patients with persistent AF , without the risk for major complications",
"AIM To compare ventricular rate responsive ( VVIR ) pacing with dual chamber rate responsive ( DDDR ) pacing and antiarrhythmic drugs for the treatment of patients with persistent atrial fibrillation after atrioventricular node ablation . METHODS One hundred two patients with persistent atrial fibrillation eligible for the atrioventricular node ablation were r and omly assigned to the therapy with either VVIR pacemaker ( n=52 ) or DDDR pacemaker and antiarrhythmic drugs ( n=50 ) . After ablation , patients in both pacing groups were assigned to take anticoagulant therapy . The primary end point was stroke or death from cardiovascular causes . RESULTS After a mean follow-up of 26.6+/-9.5 months , there was no difference in the stroke or death rates between patients with VVIR pacing ( 6 or 5.2 % per year ) and those with DDDR pacing and antiarrhythmic drugs ( 6 or 5.9 % per year , P=0.930 ) . The observed rates of death from all causes , hospitalization for heart failure , and myocardial ischemia were similar in the two patient groups . There was a significantly lower rate of development of permanent atrial fibrillation in patients with DDDR pacing and antiarrhythmic drugs , with a reduction in absolute risk by 56 % and relative risk by 64 % ( 32 % vs 88 % ; P cardiovascular death and morbidity , VVIR pacing is not inferior to DDDR pacing and antiarrhythmic drugs for the treatment of patients with persistent atrial fibrillation after atrioventricular node ablation and may be considered as an appropriate therapy for such patients",
"Objective Cardioversion of atrial fibrillation by means of a monophasic transthoracic shock is facilitated by pretreatment with ibutilide . The aim of this study was to r and omly and prospect ively compare the energy requirements of transthoracic biphasic cardioversion of atrial fibrillation with and without ibutilide pretreatment . Methods Fifty patients were enrolled and r and omized into two groups : immediate cardioversion with biphasic shock ( group 1 ) or ibutilide pretreatment followed by cardioversion with biphasic shock ( group 2 ) . In group 2 , ibutilide was administered intravenously in 10 min at a dose of 0.01 mg/kg . A pause of 10 min was observed before the patients underwent cardioversion . Results All patients of both groups were successfully cardioverted ( 100 % ) . Energy and number of shocks were significantly lower in group 2 than in group 1 ( P cardioverted at the first attempt with 50 J. The number of patients cardioverted at the first attempt with 50 J was significantly higher in group 2 than in group 1 ( P = 0.018 ) . Conclusions Although not essential for a successful outcome , pretreatment with ibutilide can lower energy requirements in transthoracic biphasic cardioversion",
"INTRODUCTION Many relapses of atrial fibrillation ( AF ) occur , especially during the first week(s ) after electrical cardioversion ( ECV ) . The aim of the present study was to compare in a r and omized design the efficacy of verapamil ( intracellular calcium lowering ) versus digoxin ( calcium increasing ) for maintenance of sinus rhythm after ECV . METHODS AND RESULTS Ninety-seven patients with persistent AF were r and omized to verapamil ( n = 49 ) or digoxin ( n = 48 ) for 1 month before and 1 month after ECV . The first month after ECV , patients recorded heart rhythm using daily transtelephonic monitoring . No additional antiarrhythmic drugs were given . Of the 97 patients , 43 patients ( 20 verapamil ) underwent ECV per protocol . Median previous AF duration was 18 and 26 days for verapamil and digoxin , respectively . There were no differences in atrial dimensions and underlying heart disease between the two groups . The success rate of ECV was 75 % versus 83 % ( P = NS ) . After 1 month , 47 % versus 53 % ( P = NS ) had recurrence of AF . Median time to recurrence was 5 days ( range 0 to 26 ) versus 8 days ( range 2 to 28 ) ( P = NS ) , respectively . CONCLUSION St and -alone intracellular calcium lowering by verapamil around ECV does not enhance cardioversion outcome",
"Objectives : To compare the clinical efficacy of intravenous diltiazem , digoxin , and amiodarone for acute ventricular rate ( VR ) control in patients with acute symptomatic atrial fibrillation ( AF ) necessitating hospitalization . Design : R and omized control trial . Setting : Acute emergency medical admission unit in a regional teaching hospital in Hong Kong . Patients : One hundred fifty adult patients with acute AF and rapid VR ( > 120 bpm ) . Interventions : Patients were r and omly assigned in 1:1:1 ratio to receive intravenous diltiazem , digoxin , or amiodarone for VR control . Measurements and Main Results : The primary end point was sustained VR control ( within 24 hours ; the secondary end points included AF symptom improvement and length of hospitalization . At 24 hours , VR control was achieved in 119 of 150 patients ( 79 % ) . The time to VR control was significantly shorter among patients in the diltiazem group ( log-rank test , p VR control being higher in the diltiazem group ( 90 % ) than the digoxin group ( 74 % ) and the amiodarone group ( 74 % ) . The median time to VR control was significantly shorter in the diltiazem group ( 3 hours , 1–21 hours ) compared with the digoxin ( 6 hours , 3–15 hours , p amiodarone groups ( 7 hours , 1–18 hours , p = 0.003 ) . Furthermore , patients in the diltiazem group persistently had the lowest mean VR after the first hour of drug administration compared with the other two groups ( p reduction in AF symptom frequency score and severity score ( p , length of hospital stay was significantly shorter in the diltiazem group ( 3.9 ± 1.6 days ) compared with digoxin ( 4.7 ± 2.1 days , p = 0.023 ) and amiodarone groups ( 4.7 ± 2.2 days , p = 0.038 ) . Conclusions : As compared with digoxin and amiodarone , intravenous diltiazem was safe and effective in achieving VR control to improve symptoms and to reduce hospital stay in patients with acute AF",
"Purpose We tested the hypothesis that electroanatomic pulmonary vein ( PV ) antra encircling for the PV isolation will improve the outcome in treatment of paroxysmal atrial fibrillation ( PAF ) , compared with segmental PV isolation . Methods Fifty-four patients underwent segmental PV isolation ( group 1 ) and 56 patients circumferential PV isolation ( group 2 ) for symptomatic PAF in a r and omized study . Results Following single ablation procedure , at the 48 ± 8 month follow-up , 30 ( 56 % ) and 32 ( 57 % ) patients in groups 1 and 2 remained free of arrhythmia ( P = 0.41 ) . After repeat ablation , 43 ( 80 % ) and 45 ( 80 % ) patients in groups 1 and 2 were free of arrhythmia without antiarrhythmic drugs ( AADs ) ; 48 ( 89 % ) and 51 ( 91 % ) patients in groups 1 and 2 did not have arrhythmia recurrences without or with AADs . Conclusion This study demonstrates no advantage in long-term arrhythmia-free clinical outcome after circumferential PV isolation in patients with frequent PAF",
"AIMS Permanent atrial fibrillation develops in many patients after ablation and pacing therapy . We compared a strategy that initially allowed patients to remain in atrial fibrillation with a strategy that initially attempted to restore and maintain sinus rhythm . METHODS AND RESULTS In this multicentre r and omized controlled trial , 68 patients affected by severely symptomatic paroxysmal atrial fibrillation were assigned , after successful atrioventricular junction ablation and pacing treatment , to antiarrhythmic drug therapy with amiodarone , propafenone , flecainide or sotalol and were compared with 69 patients assigned , after successful AV junction ablation and pacing treatment , to no antiarrhythmic drug therapy . The patients were followed-up for 12 to 24 months ( mean 16+/-4 ) . The drug arm patients had a 57 % reduction in the risk of developing permanent atrial fibrillation ( 21 % vs 37 % , P=0.02 ) . Evaluation after 12 months revealed similar quality of life scores and echocardiographic parameters in the two groups , but the drug arm patients had more episodes of heart failure and hospitalizations ( P=0.05 ) . The outcome was similar between the 40 patients who developed permanent atrial fibrillation and the 97 who did not . CONCLUSION Conventional antiarrhythmic therapy reduces the risk of development of permanent atrial fibrillation after ablation and pacing therapy . The present data do not support the concept that the development of permanent atrial fibrillation is related to an adverse outcome when a perfect control of heart rate is obtained by ablation and pacing",
"AIMS We conducted a multi-centre , prospect i ve , controlled , r and omized trial to investigate the adjunctive role of ablation therapy to antiarrhythmic drug therapy in preventing atrial fibrillation ( AF ) relapses in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy had already failed . METHODS AND RESULTS One hundred and thirty seven patients were r and omized to ablation and antiarrhythmic drug therapy ( ablation group ) or antiarrhythmic drug therapy alone ( control group ) . In the ablation group , patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation . The primary end-point of the study was the absence of any recurrence of atrial arrhythmia lasting > 30 s in the 1-year follow-up period , after 1-month blanking period . Three ( 4.4 % ) major complications were related to ablation : one patient had a stroke during left atrium ablation , another suffered transient phrenic paralysis , and the third had a pericardial effusion which required pericardiocentesis . After 12 months of follow-up , 63/69 ( 91.3 % ) control group patients had at least one AF recurrence , whereas 30/68 ( 44.1 % ) ( P atrial arrhythmia recurrence ( four patients had atrial flutter , 26 patients AF ) . CONCLUSION Ablation therapy combined with antiarrhythmic drug therapy is superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy has already failed",
"Background — The single-procedure efficacy of pulmonary vein isolation ( PVI ) is less than optimal in patients with persistent atrial fibrillation ( AF ) . Adjunctive techniques have been developed to enhance single-procedure efficacy in these patients . We conducted a study to compare 3 ablation strategies in patients with persistent AF . Methods and Results — Subjects were r and omized as follows : arm 1 , PVI + ablation of non-PV triggers identified using a stimulation protocol ( st and ard approach ) ; arm 2 , st and ard approach + empirical ablation at common non-PV AF trigger sites ( mitral annulus , fossa ovalis , eustachian ridge , crista terminalis , and superior vena cava ) ; or arm 3 , st and ard approach + ablation of left atrial complex fractionated electrogram sites . Patients were seen at 6 weeks , 6 months , and 1 year ; transtelephonic monitoring was performed at each visit . Antiarrhythmic drugs were discontinued at 3 to 6 months . The primary study end point was freedom from atrial arrhythmias off antiarrhythmic drugs at 1 year after a single-ablation procedure . A total of 156 patients ( aged 59±9 years ; 136 males ; AF duration , 47±50 months ) participated ( arm 1 , 55 patients ; arm 2 , 50 patients ; arm 3 , 51 patients ) . Procedural outcomes ( procedure , fluoroscopy , and PVI times ) were comparable between the 3 arms . More lesions were required to target non-PV trigger sites than a complex fractionated electrogram ( 33±9 versus 22±9 ; P single-procedure efficacy in patients with persistent AF . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00379301",
"Abstract Purpose : To assess the effects of amiodarone and diltiazem on atrial fibrillation ( AF ) induced atrial electrical remodeling and their clinical implication s. Methods : Persistent AF patients were r and omly assigned to three treatment groups over a period from 6 weeks before to 6 weeks after internal cardioversion : group A ( 35 patients , oral diltiazem ) , group B ( 34 patients , oral amiodarone ) and group C ( 37 patients , no antiarrhythmic drugs ) . Several electrophysiological parameters were assessed 5 min and 24 h after cardioversion . Results : Compared with controls , group B patients had significantly higher conversion rates ( 83 % vs. 100 % , p = 0.041 ) and a higher probability to maintain sinus rhythm ( p = 0.037 ) . Patients of group B had longer fibrillatory cycle length intervals than patients of group A and C ( 180 ± 18 ms vs. 161 ± 17 ms vs. 164 ± 19 ms , p = 0.001 ) and longer atrial effective refractory periods ( 211 ± 22 ms vs. 198 ± 16 ms vs. 194 ± 17 ms , p = 0.003 ) as assessed 5 min after conversion . Post-conversion density of supraventricular ectopics was significantly lower in group B compared to groups A and C ( p = 0.001 ) . Conclusions : Oral amiodarone increases conversion rates , prolongs fibrillatory cycle length and atrial effective refractory period and preserves sinus rhythm after cardioversion in persistent AF patients by suppressing the atrial ectopics that trigger AF",
"Atrial fibrillation ( AF ) is a very common cardiac arrhythmia with an increased mortality in patients with heart failure . Whether the best therapeutic approach to these patients is to restore sinus rhythm or to adequately control the ventricular rate is still controversial . The aim of this study was to compare both strategies in patients with AF and nonischemic heart failure . One hundred and fifty-four patients with AF duration greater than 48 hours and nonischemic left ventricular dysfunction were r and omized either to a rhythm ( n = 84 ) or rate ( n = 74 ) control group . The composite end points of the study were embolism , death , and exercise capacity . The average age of the patients was 61 + /- 10 years in the rhythm control group and 58 + /- 12 years in the rate control group ( P = NS ) . The average follow-up period was 35 + /- 21 months in the rhythm control group and 37 + /- 19 months in the rate control group ( P = NS ) . In the first year of the study , exercise capacity and left ventricular ejection fraction ( LVEF ) were improved in the rhythm control group compared to the exercise capacity and LVEF of the rate control group ( P embolic event rate between the two groups ( P = NS ) . The mortality rate , especially for death due to pump failure , was significantly higher in the rate control group at the end of the study ( P mortality and exercise capacity in patients with nonischemic heart failure and AF",
"INTRODUCTION Circumferential pulmonary vein antral isolation ( PVAI ) and atrial complex fractionated electrograms ( CFEs ) are both ablative techniques for the treatment of paroxysmal atrial fibrillation ( PAF ) . However , data on the comparative value of these 2 ablation strategies are very limited . METHODS AND RESULTS We r and omized 118 patients with drug-refractory PAF to receive PVAI ablation ( n = 60 ) or CFE ablation ( n = 58 ) . For CFE group , spontaneous/induced AF was mapped using vali date d , automated software to guide ablation until all CFE areas were eliminated . For PVAI group , all 4 pulmonary vein antra were electrically isolated as confirmed by circular mapping catheter . Patients with spontaneous/inducible AF after the initial ablation procedure were crossed over to the other arms . After initial ablation procedure , AF persisted/inducible in 24/59 patients ( 41 % ) , and 34/58 patients ( 59 % ) assigned to PVAI and CFE ablation , respectively ( P = 0.05 ) . Then 58 patients underwent PVAI + CFE ablation . After 22.6 ± 6.4 months , PVAI ablation group was more likely than CFE ablation group to achieve control of any AF/atrial tachycardia ( AT ) off drugs ( 43/60 , 72 % vs 33/58 , 57 % , P = 0.075 ) and lower recurrence rate of AT ( 11.9 % vs 34.5 % , P = 0.004 ) . Patients who received CFE ablation alone ( 38 % ) had significantly lower overall success rate to achieve control of AF/AT off drugs compared with patients who received PVAI ablation ( 77 % , P = 0.002 ) alone or PVAI + CFE ablation ( 69 % , P = 0.008 ) due to higher recurrence rate of AT ( 50 % vs 6 % vs 13 % , P CONCLUSIONS CFE ablation in PAF patients was associated with higher occurrence rate of postprocedure AT compared with PVAI ablation , whereby making it less likely to be a sole ablation strategy for PAF patients",
"Objective To compare the efficacy of electrical versus pharmacological cardioversion following prosthetic cardiac valve replacement in patients with permanent atrial fibrillation ( AF ) . Methods Patients with permanent AF who had undergone prosthetic cardiac valve replacement , who had a cardiothoracic ratio ≤0.5 and a left atrial diameter ≤50 mm for ≥6 months after surgery were r and omly divided to receive either electrical or pharmacological cardioversion . Patients in the electrical cardioversion group were given direct-current synchronized electrical defibrillation under general anaesthesia . Patients in the pharmacological cardioversion group were given oral combination therapy with amiodarone , captopril and simvastatin for 3 months . Results A total of 115 patients received either electrical cardioversion ( n = 59 ) or pharmacological cardioversion ( n = 56 ) ; reversion to sinus rhythm occurred in 98.3 % and 26.8 % , respectively . Recurrence rates were similar in the two groups ( 3.4 % and 6.7 % for electrical and pharmacological cardioversion , respectively ) . No deaths or severe complications were reported . Conclusion Electrical cardioversion has a favourable safety profile and appears to be a more effective method than pharmacological cardioversion for the treatment of permanent AF after cardiac valve replacement , once the heart has returned close to its normal size",
"OBJECTIVES This study compared a biphasic waveform with a conventional monophasic waveform for cardioversion of atrial fibrillation ( AF ) . BACKGROUND Biphasic shock waveforms have been demonstrated to be superior to monophasic shocks for termination of ventricular fibrillation , but data regarding biphasic shocks for conversion of AF are still emerging . METHODS In an international , multicenter , r and omized , double-blind clinical trial , we compared the effectiveness of damped sine wave monophasic versus impedance-compensated truncated exponential biphasic shocks for the cardioversion of AF . Patients received up to five shocks , as necessary for conversion : 100 J , 150 J , 200 J , a fourth shock at maximum output for the initial waveform ( 200 J biphasic , 360 J monophasic ) and a final cross-over shock at maximum output of the alternate waveform . RESULTS Analysis included 107 monophasic and 96 biphasic patients . The success rate was higher for biphasic than for monophasic shocks at each of the three shared energy levels ( 100 J : 60 % vs. 22 % , p monophasic performance at 360 J ( 91 % vs. 85 % , p = 0.29 ) . Biphasic patients required fewer shocks ( 1.7 + /- 1.0 vs. 2.8 + /- 1.2 , p total energy delivered ( 217 + /- 176 J vs. 548 + /- 331 J , p lower frequency of dermal injury ( 17 % vs. 41 % , p biphasic shock waveform has greater efficacy , requires fewer shocks and lower delivered energy , and results in less dermal injury than a monophasic shock waveform",
"Prior studies have suggested that intravenous diltiazem reduces the probability of spontaneous conversion of atrial fibrillation ( AF ) to sinus rhythm in the electrophysiology laboratory and in patients with postoperative AF . Whether diltiazem exerts the same effect in patients presenting to the emergency department ( ED ) with spontaneous AF is unclear . Fifty patients presenting to the ED with new-onset or paroxysmal AF and a rapid ventricular rate ( > 100 beats per minute ) were r and omly assigned to receive intravenous diltiazem or esmolol during the first 24 hours of presentation . Conversion to sinus rhythm occurred in 10 patients ( 42 % ) in the diltiazem group compared with 10 patients ( 39 % ) in the esmolol group ( P = 1.0 ) . Diltiazem does not decrease the likelihood of spontaneous conversion of AF to sinus rhythm in the ED setting",
"BACKGROUND Chronic right ventricular pacing has been reported to promote cardiac dyssynchrony . The PAVE trial prospect ively compared chronic biventricular pacing to right ventricular pacing in patients undergoing ablation of the AV node for management of atrial fibrillation with rapid ventricular rates . METHODS AND RESULTS One hundred and eighty-four patients requiring AV node ablation were r and omized to receive a biventricular pacing system ( n = 103 ) or a right ventricular pacing system ( n = 81 ) . The study endpoints were change in the 6-minute hallway walk test , quality of life , and left ventricular ejection fraction . Patient characteristics were similar ( 64 % male ; age : 69 + /- 10 years , ejection fraction : 0.46 + /- 0.16 ; 83 % , NYHA Class II or III ) . At 6 months postablation , patients treated with cardiac resynchronization had a significant improvement in 6-minute walk distance , ( 31 % ) above baseline ( 82.9 + /- 94.7 m ) , compared to patients receiving right ventricular pacing , ( 24 % ) above baseline ( 61.2 + /- 90.0 m ) ( P = 0.04 ) . There were no significant differences in the quality -of-life parameters . At 6 months postablation , the ejection fraction in the biventricular group ( 0.46 + /- 0.13 ) was significantly greater in comparison to patients receiving right ventricular pacing ( 0.41 + /- 0.13 , P = 0.03 ) . Patients with an ejection fraction 6-minute walk distance compared to patients with normal systolic function or Class I symptoms . CONCLUSION For patients undergoing AV node ablation for atrial fibrillation , biventricular pacing provides a significant improvement in the 6-minute hallway walk test and ejection fraction compared to right ventricular pacing . These beneficial effects of cardiac resynchronization appear to be greater in patients with impaired systolic function or with symptomatic heart failure",
"BACKGROUND The energy requirement for internal ventricular defibrillation is reduced by reversal of shock polarity . The influence of shock polarity on the efficacy of transthoracic atrial defibrillation is unknown . METHODS This prospect i ve , r and omized study enrolled 110 consecutive patients who were referred for elective cardioversion of persistent atrial fibrillation ( AF ) . The electrodes were placed in the anteroposterior position . The patients were r and omized to receive either st and ard ( anterior pad = cathode ) or reversed polarity ( anterior pad = anode ) shocks with a damped sinusoidal monophasic waveform . A step-up protocol was used to estimate the cardioversion threshold . The initial shock energy was 50 J , with subsequent increments to 100 , 200 , 300 , and 360 J in the event of cardioversion failure . RESULTS Sixty-four percent of the patient population were men , with a mean age of 66 + /- 13 years and a mean duration of AF of 242 + /- 556 days . The overall success rates of cardioversion were 84 % for st and ard polarity and 78 % for reversed polarity ( P not significant ) . Among the patients who were successfully cardioverted , the mean atrial defibrillation threshold was 198 + /- 103 J for st and ard polarity and 212 + /- 107 J for reversed polarity ( P not significant ) . CONCLUSIONS Reversal of shock polarity does not improve transthoracic cardioversion efficacy with a st and ard damped sinusoidal monophasic waveform . Alternate strategies should be considered for patients who fail external cardioversion , such as adjunctive pharmacologic treatment , use of a biphasic shock waveform , or internal cardioversion",
"CONTEXT Although left atrial radiofrequency ablation ( RFA ) is increasingly used for the treatment of chronic atrial fibrillation during mitral valve surgery , its efficacy to restore sinus rhythm and any result ing benefits have not been examined in the context of an adequately powered r and omized trial . OBJECTIVE To determine whether intraoperative RFA of the left atrium increases the long-term restoration of sinus rhythm and improves exercise capacity . DESIGN , SETTING , AND PATIENTS R and omized , double-blind trial performed in a single UK tertiary referral center with enrollment between December 2001 and November 2003 . A total of 101 patients referred for mitral valve surgery with at least 6 months ' history of uninterrupted atrial fibrillation were assessed for eligibility ; 97 were enrolled . Patients were followed up for 12 months . INTERVENTION Patients were r and omly assigned to undergo mitral valve surgery and RFA of the left atrium ( n = 49 ) or mitral valve surgery alone ( controls ; n = 48 ) . MAIN OUTCOME MEASURES The primary outcome measure was presence of sinus rhythm at 12 months ; secondary measures were patient functional status and exercise capacity ( assessed by shuttle-walk test ) , left atrial contractility , and left atrial and left ventricular dimension and function and plasma levels of B-type natriuretic peptide . RESULTS At 12 months , sinus rhythm was present in 20 ( 44.4 % ) of 45 RFA patients and in 2 ( 4.5 % ) of 44 controls ( rate ratio , 9.8 ; 95 % CI , 2.4 - 86.3 ; P sinus rhythm in the RFA group was accompanied by a greater improvement in mean ( SD ) shuttle-walk distance compared with controls ( + 94 [ 102 ] m vs + 48 [ 82 ] m ; P = .003 ) and a greater reduction in the plasma level of B-type natriuretic peptide ( -104 [ 87 ] fmol/mL vs -51 [ 82 ] fmol/mL ; P = .03 ) . Patients r and omized to receive RFA had similar rates of postoperative complications and deaths as control patients . CONCLUSIONS Radiofrequency ablation of the left atrium during mitral valve surgery for continuous atrial fibrillation significantly increases the rate of sinus rhythm restoration 1 year postoperatively , improving patient exercise capacity . On the basis of its efficacy and safety , routine use of RFA of the left atrium during mitral valve surgery may be justified . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00238706",
"Ninety patients who underwent cardioversion of persistent atrial fibrillation ( AF ) were r and omized to bisoprolol 5 to 10 mg once daily or carvedilol 12.5 to 25 mg twice daily . Using intention-to-treat analysis , 23 patients ( 46 % ) in the bisoprolol group and 17 patients ( 32 % ) in the carvedilol group relapsed into AF during the 1 year of total follow-up ( p = 0.486 ) . Patients treated with carvedilol had a 14 % ( hazard ratio 0.86 ) lower risk of relapse of AF compared with patients in the bisoprolol group , although results were statistically insignificant ( p = 0.661 ) after controlling for patient age , gender , baseline heart rate , and left atrial diameter",
"INTRODUCTION We compared the efficacy and safety of amiodarone and dronedarone in patients with persistent atrial fibrillation ( AF ) . METHODS Five hundred and four amiodarone-naïve patients were r and omized to receive dronedarone 400 mg bid ( n = 249 ) or amiodarone 600 mg qd for 28 days then 200 mg qd ( n = 255 ) for at least 6 months . Primary composite endpoint was recurrence of AF ( including unsuccessful electrical cardioversion , no spontaneous conversion and no electrical cardioversion ) or premature study discontinuation . Main safety endpoint ( MSE ) was occurrence of thyroid- , hepatic- , pulmonary- , neurologic- , skin- , eye- , or gastrointestinal-specific events , or premature study drug discontinuation following an adverse event . RESULTS Median treatment duration was 7 months . The primary composite endpoint was 75.1 and 58.8 % with dronedarone and amiodarone , respectively , at 12 months ( hazard ratio [ HR ] 1.59 ; 95 % confidence interval [ CI ] 1.28 - 1.98 ; P AF recurrence with dronedarone compared with amiodarone ( 63.5 vs 42.0 % ) . AF recurrence after successful cardioversion was 36.5 and 24.3 % with dronedarone and amiodarone , respectively . Premature drug discontinuation tended to be less frequent with dronedarone ( 10.4 vs 13.3 % ) . MSE was 39.3 and 44.5 % with dronedarone and amiodarone , respectively , at 12 months ( HR = 0.80 ; 95 % CI 0.60 - 1.07 ; P = 0.129 ) , and mainly driven by fewer thyroid , neurologic , skin , and ocular events in the dronedarone group . CONCLUSION In this short-term study , dronedarone was less effective than amiodarone in decreasing AF recurrence , but had a better safety profile , specifically with regard to thyroid and neurologic events and a lack of interaction with oral anticoagulants",
"BACKGROUND In biphasic external cardioversion ( CV ) of atrial fibrillation ( AF ) , the influence of different electrode positions on efficacy and incidence of early recurrent atrial fibrillation is not known . This study compared anteroposterior ( AP ) vs anterolateral ( AL ) electrode positioning . METHODS Consecutive patients referred for CV of persistent AF were r and omized either to an AP or an AL electrode position . Biphasic external CV was performed with st and ardized electrode positions and rising energy delivery . RESULTS Both groups ( N = 123 , mean age 66 years , 71 % male , 83 % with structural cardiovascular disease or hypertension ) did not differ concerning age , sex , body mass index , chronic antiarrhythmic therapy , duration of AF , left ventricular ejection fraction , and left atrial diameter . Cumulative success rates were comparable ( AP 94.9 % vs AL 95.2 % , P = ns ) . First-shock efficacy did not differ ( AP 78.3 % vs AL 74.6 % , P = ns ) . Early recurrent atrial fibrillation ( AF relapse Mean number of shocks was 1.3 per patient with the AP configuration and 1.4 per patient with the AL configuration ( P = ns ) . Mean cumulative energy delivery was also comparable ( AP 171 WS vs AL 198 WS , P = ns ) . CONCLUSIONS Both electrode positions are similar in biphasic external CV of AF with regard to acute success and early recurrent atrial fibrillation . Also , the number of shocks needed and energy delivery are comparable with both electrode configurations",
"INTRODUCTION Atrial fibrillation ( AF ) and diabetes mellitus type 2 ( DM2 ) often coexist ; however , a small number of patients with DM2 undergoing catheter ablation ( CA ) of AF have been included in previous studies . The aim of this study was to evaluate safety and efficacy of ablation therapy in DM2 patients with drug refractory AF . METHODS AND RESULTS From January 2005 to September 2006 , 70 patients with a diagnosis of DM2 and paroxysmal ( n = 29 ) or persistent ( n = 41 ) AF were r and omized to receive either pulmonary vein isolation or a new antiarrhythmic drug treatment ( ADT ) with a 1-year follow-up . The primary endpoint was the time to first AF recurrence . By Kaplan-Meier analysis , at the end of follow-up , 42.9 % of patients in the ADT group and 80 % of patients who received a single ablation procedure and were without medications were free of AF ( P = 0.001 ) . In the ablation group , a significant improvement in quality -of-life ( QoL ) scores as compared with ADT group was observed . Six patients in the ADT group ( 17.1 % ) developed significant adverse drug effects . Hospitalization rate during follow-up was higher in the ADT group ( P = 0.01 ) . The only complication attributable to ablation was one significant access-site hematoma . CONCLUSION In patients with DM2 , CA of AF provides significant clinical benefits over the ADT and appears to be a reasonable approach regarding feasibility , effectiveness , and low procedural risk",
"AIMS This study is the first prospect i ve r and omized trial evaluating the efficacy of an antiarrhythmic surgical procedure in patients with chronic atrial fibrillation undergoing mitral valve replacement . METHODS AND RESULTS Thirty consecutive patients with chronic atrial fibrillation undergoing mitral valve replacement were r and omized for an additional modified MAZE-operation using intra-operatively cooled-tip radiofrequency ablation ( group A ) or mitral valve replacement alone ( group B ) . Biatrial contraction was studied and functional capacity was evaluated in spiro-ergometry 6 months after surgery . Thirty-day mortality was 0 % in both groups . After 12 months , sinus rhythm was reinstituted significantly more often in patients of group A ( cumulative rate of sinus rhythm 0.800 ) compared to patients in group B ( 0.267 ) ( P Electrocardioversion showed long-term success in only 17 % of patients in group A and 0 % in group B. Maximal aerobic uptake at the 6-month spiro-ergometry revealed no significant difference ( 9.3 vs 8.5 ml x min(-1 ) kg(-1 ) , P=0.530 ) . CONCLUSIONS A modified MAZE operation using cooled-tip radiofrequency ablation can be safely combined with mitral valve surgery and is highly effective in restoring sinus rhythm . Biatrial contraction is found in 66.7 % of patients with sinus rhythm undergoing mitral valve replacement plus the MAZE operation",
"Background : Atrial fibrillation ( AF ) and heart failure ( HF ) often coexist . The aim was to investigate whether restoring sinus rhythm ( SR ) could improve cardiac function , symptoms , exercise capacity and quality of life ( QoL ) in patients with chronic heart failure . Methods : Patients with HF and persistent AF receiving guideline -recommended treatments , including anticoagulants , were eligible for the study . Patients were r and omised to either rhythm ( treated with amiodarone for at least 3 months prior to attempting biphasic external cardioversion and continued amiodarone long-term if SR was restored ) or rate control . Anticoagulants were continued throughout the study regardless of rhythm , unless contraindications developed . Both groups were treated with beta blockers and /or digoxin to reduce the heart rate to 80 bpm at rest and walking . Symptoms , walk distance ( 6-minute corridor walk test , 6MWT ) , QoL and cardiac function were assessed at baseline and 1 year . Results : 61 patients with HF and persistent AF ( median duration 14 months ( IQR 5 to 32 ) ) were r and omly assigned to a rate or rhythm control strategy . Of patients assigned to rhythm control ( n = 30 ) , 66 % were in SR at 1 year , and 90 % of those assigned to rate control ( n = 31 ) achieved the heart rate target . At 1 year , NYHA class ( p = 0.424 ) and 6MWT distance ( p = 0.342 ) were similar between groups but patients assigned to rhythm control had improved LV function ( p = 0.014 ) , NT-proBNP concentration ( p = 0.046 ) and QoL ( p = 0.019 ) compared with those assigned to rate control . Greatest improvement was seen in patients in whom SR was maintained . Conclusion : Restoring SR in patients with AF and heart failure may improve QoL and LV function when compared with a strategy of rate control",
"BACKGROUND Current guidelines for transthoracic direct-current cardioversion ( DCCV ) of atrial fibrillation ( AF ) recommend a step-up energy protocol . The aim of this study was to compare such a protocol with a protocol involving a high initial energy shock , anteroposterior paddle position and reversal of shock polarity , on cardioversion efficacy , total energy delivery , use of sedation and patient tolerability . METHODS 261 patients ( mean age 71+/-10 years , 62 % male ) referred for elective DCCV of persistent AF were enrolled . Patients were r and omised to either protocol A : ( 1 ) 200 J anteroapical , ( 2 ) 360 J anteroapical , ( 3 ) 360 J anteroposterior ; or protocol B : ( 1 ) 360 J anteroapical , ( 2 ) 360 J anteroposterior , and ( 3 ) 360 J posteroanterior . All procedures were performed under sedation with intravenous diazepam . RESULTS Protocol B improved shock success rates ( protocol A first shock success rate=42 % , protocol B=68 % , p fewer shocks to achieve sinus rhythm ( 1.3+/-0.6 ) compared with protocol A ( 1.6+/-0.7 , p cumulative energy used ( protocol A 473+/-286 J , protocol B 436+/-273 J , p=0.24 ) or sedation requirements ( protocol A diazepam 22.1+/-9.0 mg , protocol B 21.7+/-8.9 mg , p=0.75 ) . Both protocol s were equally well tolerated by patients . CONCLUSION High initial energy increased success rates and decreased the number of shocks but result ed in similar cumulative energy delivery , sedation use and patient tolerability compared with a conventional step-up protocol",
"OBJECTIVE To determine the importance of rhythm regulation or rate control in patients with permanent atrial fibrillation ( AF ) and normal left ventricular function . PATIENTS AND INTERVENTIONS Thirty six patients with a mixed fast and slow ventricular response rate to their AF were r and omised to either His bundle ablation ( HBA ) and VVIR pacemaker ( HBA group ) or VVI pacemaker and atrioventricular modifying drugs ( Med group ) . Outcomes assessed at one , three , six , and 12 months included exercise duration and quality of life . RESULTS Exercise duration significantly improved from baseline in both groups . There was no difference in outcome between the groups ( Med + 40%v HBA + 20 % , p = NS ) . The heart rate profile on exercise was similarly slowed in both groups compared to baseline . Quality of life significantly improved in both treatment arms for the modified Karolinska question naire ( KQ ) ( Med + 50%v HBA + 50 % , p = NS ) and the Nottingham health profile ( NHP ) ( Med + 40 % v HBA + 20 % , p = NS ) . However , for the individual symptom scores of each question naire more were improved in the Med group ( KQ-Med 6 improvedv HBA 4 , NHP-Med 3 vHBA 1 ) . Left ventricular function was equally preserved by both treatments during follow up . CONCLUSION In these patients control of ventricular response rate with either HBA + VVIR pacemaker or atrioventricular modifying drugs + VVI pacemaker will lead to a significant improvement in exercise duration and quality of life . Rhythm regulation by HBA did not confer additional benefit , suggesting rate control alone is necessary for the successful symptomatic treatment of these patients in permanent AF",
"PURPOSE The role of digoxin and verapamil in the control of ventricular response in rapid atrial fibrillation is well established . This study investigates how clonidine compares with these st and ard therapies in rate control for new-onset rapid atrial fibrillation . We set out to test the hypothesis that clonidine effectively reduces heart rate in patients with new-onset rapid atrial fibrillation . SUBJECTS AND METHODS Forty patients were seen in the emergency department with new-onset ( Eligible patients were r and omized to receive either clonidine , digoxin , or verapamil . Changes in heart rate and blood pressure over 6 hours , as well as frequency of conversion to sinus rhythm were recorded and analyzed . RESULTS The mean reduction in heart rate over 6 hours was 44.4 beats/min ( 95 % confidence interval [ CI ] 28.4 - 60.4 beats/min ) in the clonidine group , 52.1 beats/min ( 95 % CI 40.8 - 63.4 beats/min ) in the digoxin group , and 41.8 beats/min ( 95 % CI 22.5 - 61.0 beats/min ) in the verapamil group . Analysis of variance of the heart rate changes in the 3 groups after 6 hours was not significant ( P = .55 ) . At 6 hours , 7 of 12 clonidine patients , 8 of 15 digoxin patients , and 7 of 13 verapamil patients remained in atrial fibrillation ( P = .962 on chi(2 ) ) . CONCLUSION Clonidine controls ventricular rate in new-onset atrial fibrillation with an efficacy comparable to that of st and ard agents",
"BACKGROUND Amiodarone , given as intravenous bolus has not yet been studied in patients with atrial fibrillation and a high ventricular rate . METHODS One hundred consecutive patients with atrial fibrillation and a ventricular rate above 135 bpm were r and omized to receive either 450 mg amiodarone or 0.6 mg digoxin given as a single bolus through a peripheral venous access . If the ventricular rate exceeded 100 bpm after 30 min , another 300 mg amiodarone or 0.4 mg digoxin were added . Primary endpoints of the study were the ventricular rate and the occurrence of sinus rhythm after 30 and 60 min . Secondary endpoints were blood pressure during the first hour after drug administration , and safety regarding drug induced hypotension , and phlebitis at the infusion site . RESULTS Baseline heart rate was 144+/-19 in the amiodarone group and 145+/-15 in the digoxin group ( p=0.72 ) . Following amiodarone , heart rate was 104+/-25 after 30 min compared to 116+/-23 in the digoxin group ( p=0.02 ) and 94+/-22 versus 105+/-22 after 60 min ( p=0.03 ) . After 30 min , sinus rhythm was documented in 14 ( 28 % ) patients following amiodarone compared to 3 ( 6 % ) patients in the digoxin group ( p=0.003 ) , and after 60 min in 21 ( 42 % ) versus 9 ( 18 % ) patients ( p=0.012 ) . Asymptomatic hypotension was observed in 4 amiodarone treated patients , and superficial phlebitis in 1 patient . CONCLUSIONS Amiodarone , given as an intravenous bolus is relatively safe and more effective than digoxin for heart rate control and conversion to sinus rhythm in patients with atrial fibrillation and a rapid ventricular rate",
"STUDY OBJECTIVE A prospect i ve , r and omized controlled trial of new-onset atrial fibrillation was conducted to compare the efficacy and safety of sotalol and amiodarone ( active treatment ) with rate control by digoxin alone for successful reversion to sinus rhythm at 48 hours . METHODS We prospect ively r and omly assigned 120 patients with atrial fibrillation of less than 24 hours ' duration to treatment with sotalol , amiodarone , or digoxin using a single intravenous dose followed by 48 hours of oral treatment . Patients had ECG monitoring for 48 hours , and time of reversion , adequacy of rate control , and numbers of adverse events were compared . After 48 hours , those still in atrial fibrillation underwent cardioversion according to a st and ardized protocol . After 48 hours of therapy and attempted cardioversion , the number of patients whose rhythms had successfully reverted were compared . RESULTS There was a significant reduction in the time to reversion with both sotalol ( 13 . 0+/-2.5 hours , P amiodarone ( 18.1+/-2.9 hours , P digoxin only ( 26.9+/-3.4 hours ) . By 48 hours , the active treatment group was significantly more likely to have reverted to sinus rhythm than the rate control group ( 95 % versus 78 % , P ventricular rate control in the sotalol group at both 24 and 48 hours compared with those who received either amiodarone or digoxin . There were also fewer adverse events in the active treatment group compared with the rate control group . CONCLUSION Immediate pharmacologic therapy for new-onset atrial fibrillation with class III antiarrhythmic drugs ( sotalol or amiodarone ) improves complication-free 48-hour reversion rates compared with rate control with digoxin",
"We design ed a prospect i ve , r and omised , single-blind trial to compare the relative efficacy of antero-lateral versus antero-posterior paddle positions for DC cardioversion of persistent atrial fibrillation . A total of 59 patients were r and omised to cardioversion using st and ard gel pads placed either in the antero-lateral ( AL ) or antero-posterior ( AP ) positions . The first synchronised shock was given at 360 J ; if this was unsuccessful , a second shock of 360 J was given in the alternative position . We compared cardioversion success rate and energy requirements with each strategy . With the first 360 J DC shock , a significantly greater proportion of patients were restored to sinus rhythm from the antero-lateral position ( 18/30 ) compared to the antero-posterior position ( 10/29 ) ( P=0.048 ) . For those patients remaining in atrial fibrillation , there was no difference in the proportions cardioverted from the antero-lateral position ( 4/19 ) compared to the antero-posterior position ( 5/12 ) with the second 360 J DC shock ( P=0 . 22 ) . The total cardioversion success rate was 23/30 ( 77 % ) for antero-lateral followed by antero-posterior shocks compared to a success rate of 14/29 ( 48 % ) for antero-posterior followed by antero-lateral shocks , and this difference was significant ( P=0.024 ) . There was no significant difference in the mean energy delivered for patients r and omised to an initial antero-lateral shock ( 504 J ) , compared to patients given an initial antero-posterior shock ( 583 J ) ( P=0.1 ) . We conclude that the antero-lateral paddle position appears more effective for DC cardioversion of persistent atrial fibrillation",
"OBJECTIVE To analyze the efficacy of an IV combination of diltiazem and digoxin vs IV diltiazem alone for acute ventricular rate control in patients with atrial fibrillation . DESIGN Prospect i ve , r and omized , open-label study . PATIENTS AND METHODS Fifty-two patients with atrial fibrillation and uncontrolled ventricular rates were r and omized to receive either an IV combination of diltiazem and digoxin or IV diltiazem alone and were observed for 12 h. The successful rate control was defined as a ventricular rate beats per minute ( bpm ) persisting for 1 h or conversion to sinus rhythm . The loss of rate control was defined as an increase in the ventricular rate to > 100 bpm persistently for > 30 min or rebound to atrial fibrillation . RESULTS In both treatment arms ( n = 26 each ) , all patients achieved successful and comparable ventricular rate control at 12 h. The mean ( + /- SD ) time taken to achieve successful rate control was shorter in the combination arm ( 15 + /- 16 vs. 22 + /- 22 min ) . Six patients in the combination arm and 11 in the diltiazem-alone arm experienced episodes of loss of rate control . This loss in the combination arm was less than that in the diltiazem-alone arm ( 14 vs 39 episodes ; p = 0.05 ) . The loss of rate control per patient in the combination arm was also less than that in the diltiazem-alone arm ( 2.0 + /- 1.0 vs. 3.5 + /- 1.9 episodes per patient ; p = 0.04 ) . CONCLUSIONS This study demonstrates that in patients with atrial fibrillation who have a rapid ventricular response , the IV combination of diltiazem and digoxin results in a more efficacious ventricular rate control with fewer fluctuations than that achieved by therapy with IV diltiazem alone ",
"Aims : To compare the efficacy and safety of an escalating energy protocol with a non-escalating energy protocol using an impedance compensated biphasic defibrillator for direct current cardioversion of atrial fibrillation ( AF ) . Methods and results : This prospect i ve multicentre r and omised trial enrolled 380 patients ( 248 male , mean ( SD ) age 67 ( 10 ) years ) with AF . Patients were r and omised to either an escalating energy protocol ( protocol A : 100 J , 150 J , 200 J , 200 J ) , or a non-escalating energy protocol ( protocol B : 200 J , 200 J , 200 J ) . Cardioversion was performed using an impedance compensated biphasic waveform . First-shock success was significantly higher for those r and omised to 200 J than 100 J ( 71 % vs 48 % ; p 25 kg/m2 ( 75 % vs 44 % ; p = 0.01 ) . In patients with a normal BMI there was no significant difference in first-shock success . There was also no significant difference between subsequent shocks or overall success . The use of a non-escalating protocol ( protocol B ) result ed in fewer shocks but with a higher cumulative energy . There was no difference in duration of procedure , amount of sedation administered or post-shock erythema between the groups . Conclusion : First-shock success was significantly higher , particularly in patients with a BMI > 25 kg/m2 , when a non-escalating initial 200 J energy was selected . The overall success , duration of procedure and amount of sedation administered , however , did not differ significantly between the two protocol",
"BACKGROUND External cardioversion is a readily available treatment for persistent atrial fibrillation . Although anatomical and electrophysiological considerations suggest that an anterior-posterior electrode position should create a more homogeneous shock-field gradient throughout the atria than an anterior-lateral position , both electrode positions are equally recommended for external cardioversion in current guidelines . We undertook a r and omised trial comparing the two positions with the endpoint of successful cardioversion . METHODS 108 consecutive patients ( mean age 60 years [ SD 16 ] ) with persistent atrial fibrillation ( median duration 5 months , range 0.1 - 120 ) underwent elective external cardioversion by a st and ardised step-up protocol with increasing shock strengths ( 50 - 360 J ) . Electrode positions were r and omly assigned as anterior-lateral or anterior-posterior . If sinus rhythm was not achieved with 360 J energy , a single cross-over shock ( 360 J ) was applied with the other electrode configuration . A planned interim analysis was done after these patients had been recruited ; it was by intention to treat . FINDINGS Cardioversion was successful in a higher proportion of the anterior-posterior than the anterior-lateral group ( 50 of 52 [ 96 % ] vs 44 of 56 [ 78 % ] , difference 23.7 % ( 95 % CI 9.1 - 37.8 , p=0.009 ) . Cross-over from the anterior-lateral to the anterior-posterior electrode position was successful in eight of 12 patients , whereas cross-over in the other direction was not successful ( two patients ) . After cross-over , cardioversion was successful in 102 of 108 r and omised patients ( 94 % ) . INTERPRETATION An anterior-posterior electrode position is more effective than the anterior-lateral position for external cardioversion of persistent atrial fibrillation . These results should be considered in clinical practice , for the design of defibrillation electrode pads , and when guidelines for cardioversion of atrial fibrillation are up date",
"Background : Electrical direct‐current cardioversion ( DCCV ) has become a routine therapy for atrial fibrillation ( AF ) , although some uncertainty remains regarding the optimal energy setting",
"Background —Ablation of the pulmonary veins ( PVs ) for atrial fibrillation treatment is often combined with linear radiofrequency lesions along the left atrium ( LA ) to improve the success rate . The study was design ed to assess the contribution of LA posterior wall isolation to the outcome of circumferential pulmonary vein ablation ( CPVA ) . Methods and Results —CPVA consisted of continuous radiofrequency lesions encircling both ipsilateral PVs plus an ablation line along the mitral isthmus . Patients were then r and omized into 2 groups . In the first group , superior PVs were connected by linear lesions along the LA roof ( CPVA-1 group ) . In the second group , the LA posterior wall was isolated by adding a second line connecting the inferior aspect of the 2 inferior PVs ( CPVA-2 group ) . The study included 120 patients ( 53±11 years , 77 % male , 60 % paroxysmal atrial fibrillation , LA of 41.3±5.4 mm , 46 % with hypertension , and 22 % with structural heart disease ) . After a single ablation procedure and a mean follow-up of 10±4 months , 24 ( 40 % ) patients of the CPVA-1 group had atrial fibrillation recurrences and 3 ( 5 % ) had new-onset LA flutter . In the CPVA-2 group , recurrences were due to atrial fibrillation episodes in 23 patients ( 38 % ) and LA flutter in 4 ( 7 % ) . Freedom from arrhythmia recurrences was not statistically different in the CPVA-1 group as compared with the CPVA-2 group ( log rank P=0.943 ) . Conclusion —Isolation of the LA posterior wall did not increase the success rate of CPVA ",
"OBJECTIVES The aim of this study was to compare -- in patients with persistent and permanent atrial fibrillation (AF)--the efficacy and safety of left atrial ablation with that of a biatrial approach . BACKGROUND Left atrium-based catheter ablation of AF , although very effective in the paroxysmal form of the arrhythmia , has an insufficient efficacy in patients with persistent and permanent AF . METHODS Eighty highly symptomatic patients ( age , 58.6 + /- 8.9 years ) with persistent ( n = 43 ) and permanent AF ( n = 37 ) , refractory to antiarrhythmic drugs , were r and omized to two different ablation approaches guided by electroanatomical mapping . A procedure including circumferential pulmonary vein , mitral isthmus , and cavotricuspid isthmus ablation was performed in 41 cases ( left atrial ablation group ) . In the remaining 39 patients ( biatrial ablation group ) , the aforementioned approach was integrated by the following lesions in the right atrium : intercaval posterior line , intercaval septal line , and electrical disconnection of the superior vena cava . RESULTS During follow-up ( mean duration 14 + /- 5 months ) , AF recurred in 39 % of patients in the left atrial ablation group and in 15 % of patients in the biatrial ablation group ( p = 0.022 ) . Multivariable Cox regression analysis showed that ablation technique was an independent predictor of AF recurrence during follow-up . CONCLUSIONS In patients with persistent and permanent AF , circumferential pulmonary vein ablation , combined with linear lesions in the right atrium , is feasible , safe , and has a significantly higher success rate than left atrial and cavotricuspid ablation alone",
"OBJECTIVES We compared ablation strategy with antiarrhythmic drug therapy ( ADT ) in patients with paroxysmal atrial fibrillation ( PAF ) . BACKGROUND Atrial fibrillation ( AF ) ablation strategy is superior to ADT in patients with an initial history of PAF , but its role in patients with a long history of AF as compared with ADT remains a challenge . METHODS One hundred ninety-eight patients ( age , 56 + /- 10 years ) with PAF of 6 + /- 5 years ' duration ( mean AF episodes 3.4/month ) who had failed ADT were r and omized to AF ablation by circumferential pulmonary vein ablation ( CPVA ) or to the maximum tolerable doses of another ADT , which included flecainide , sotalol , and amiodarone . Crossover to CPVA was allowed after 3 months of ADT . RESULTS By Kaplan-Meier analysis , 86 % of patients in the CPVA group and 22 % of those in the ADT group who did not require a second ADT were free from recurrent atrial tachyarrhythmias ( AT ) ( p CPVA and ADT groups , respectively , were AT-free . Ejection fraction , hypertension , and age independently predicted AF recurrences in the ADT group . Circumferential pulmonary vein ablation was associated with fewer cardiovascular hospitalizations ( p transient ischemic attack and 1 pericardial effusion occurred in the CPVA group ; side effects of ADT were observed in 23 patients . CONCLUSIONS Circumferential pulmonary vein ablation is more successful than ADT for prevention of PAF with few complications . Atrial fibrillation ablation warrants consideration in selected patients in whom ADT had already failed and maintenance of sinus rhythm is desired . ( A Controlled R and omized Trial of CPVA Versus Antiarrhythmic Drug Therapy in for Paroxysmal AF : APAF/01 ; http:// clinical trials.gov/ct/show ; NCT00340314 )",
"OBJECTIVES The purpose of this study was to determine quality of life ( QOL ) and exercise performance ( EP ) in patients with persistent atrial fibrillation ( AF ) converted to sinus rhythm ( SR ) compared with those remaining in or reverting to AF . BACKGROUND Restoration of SR in patients with AF improving QOL and EP remains controversial . METHODS Patients with persistent AF were r and omized double-blind to amiodarone , sotalol , or placebo . Those not achieving SR at day 28 were cardioverted and classified into SR or AF groups at 8 weeks ( n = 624 ) and 1 year ( n = 556 ) . The QOL ( SF-36 ) , symptom checklist ( SCL ) , specific activity scale ( SAS ) , AF severity scale ( AFSS ) , and EP were assessed . RESULTS Favorable changes were seen in SR patients at 8 weeks in physical functioning ( p physical role limitations ( p = 0.03 ) , general health ( p = 0.002 ) , and vitality ( p general health ( p = 0.007 ) and social functioning ( p = 0.02 ) . Changes in the scores for SCL severity ( p = 0.01 ) , functional capacity ( p = 0.003 ) , and AFSS symptom burden ( p SCL severity ( p AF symptom burden ( p EP in SR versus AF was greater from baseline to 8 weeks ( p = 0.01 ) and to 1 year ( p = 0.02 ) . The EP correlated with physical functioning and functional capacity except in the AF group at 1 year . CONCLUSIONS In patients with persistent AF , restoration and maintenance of SR was associated with improvements in QOL measures and EP . There was a strong correlation between QOL measures and EP",
"BACKGROUND Residual gaps due to incomplete ablation lines are known to be the most common cause of recurrent atrial fibrillation ( AF ) after catheter ablation . We hypothesized that any residual potentials at the junction of the left atrium and pulmonary vein ( PV ) , inside the circumferential PV ablation ( CPVA ) lines , would contribute to the recurrence of AF or post-AF ablation atrial flutter ( AFL ) ; therefore , the elimination of these potentials increases AF-/AFL-free survival rates . METHODS AND RESULTS One hundred and two patients with paroxysmal AF ( PAF ) were enrolled and prospect ively r and omized to a group with ablation of residual potentials as add-on therapy to CPVA + PV electrical isolation ( PVI ) ( group 1 , n = 49 ) , or a group without ablation of the residual potentials ( group 2 , n = 53 ) . Post-CPVA residual potentials , inside the ablation lines , were identified by contact bipolar electrode mapping catheter and a detailed 3-dimensional voltage map . Twenty-three patients in group 1 and 18 patients in group 2 had post-CPVA residual potentials ( 46.9 % vs 34.0 % , P = 0.182 ) . The AF-/AFL-free survival rate during follow-up of 23.3 ± 7.9 months was not different in comparisons between the 2 groups ( P = 0.818 ) , and 79.6 % and 81.1 % of the patients in groups 1 and 2 maintained a sinus rhythm ( P = 0.845 ) , respectively . CONCLUSIONS Residual potentials inside CPVA were commonly found in the patients with PAF after CPVA + PVI . Further ablation of residual potentials did not increase the efficacy of catheter ablation in patients with PAF",
"BACKGROUND The present study aim ed to determine whether quality of life ( QOL ) in permanent atrial fibrillation ( AF ) patients would be improved by monotherapy with beta-blocker ( BB ) or calcium antagonist ( CAA ) as compared with digitalis . METHODS AND RESULTS Twenty-nine patients with permanent AF under digitalis were r and omized into BB ( bisoprolol , atenolol or metoprolol ) or CAA ( verapamil ) monotherapy treatment group . Twenty-five were men and the mean age was 67+/-8 years . After the assigned monotherapy , 12 patients received the other monotherapy in a cross-over fashion . Under each treatment , efficacy of rate control was determined by Holter electrocardiogram ( ECG ) , treadmill testing and QOL question naire ( Short Form-36 ( SF-36 ) and Quality of Life of Atrial Fibrillation ( AFQLQ ) ) , and compared with the baseline digitalis treatment . CAA significantly increased mean and minimum heart rate ( HR ) in Holter ECG as compared with digitalis , whereas BB increased only minimum HR . Exercise duration in treadmill testing was significantly prolonged by CAA treatment , although it only tended to be prolonged by BB treatment . CAA but not BB improved role function-physical score of SF-36 , and frequency and severity of symptoms of AFQLQ . CONCLUSION These results indicate that CAA is preferable to digitalis when monotherapy is selected for short-term improvement of QOL and exercise tolerance in patients with permanent AF",
"INTRODUCTION Early recurrent atrial fibrillation ( ERAF ) after external cardioversion of atrial fibrillation ( AF ) occurs in 12 % to 26 % of patients . Whether biphasic cardioversion has an impact on the incidence of ERAF after cardioversion of AF is unclear . METHODS AND RESULTS Consecutive patients ( n = 216 , mean age 66 years , 71 % male , 88 % with structural cardiovascular disease or hypertension ) underwent cardioversion with a biphasic ( Bi ) or monophasic ( Mo ) shock waveform in r and omized fashion . Energies used were 120 - 150 - 200 - 200 Ws ( Bi ) or 200 - 300 - 360 - 360 Ws ( Mo ) . The two study groups ( Bi vs Mo ) did not differ with regard to age , sex , body mass index , underlying cardiovascular disease , left atrial diameter , left ventricular ejection fraction , duration of AF fibrillation , and antiarrhythmic drug therapy . Mean delivered energy was significantly lower in the Bi group ( Bi : 186 + /- 143 Ws vs Mo : 324 + /- 227 Ws ; P ERAF ( AF relapse within 1 minute after successful cardioversion ) was 8.9 % and showed no difference between the two groups ( Bi : 8.1 % vs Mo : 9.7 % , P = NS ) . Cardioversion was successful in 95.4 % of patients . The success rate was comparable in both groups ( Bi : 94.3 % vs Mo 96.8 % ; P = NS ) . First shock efficacy did not differ between Bi and Mo ( 76.4 % vs 67.7 % ; P = NS ) . Mean number of shocks were 1.4 shocks per patient in both groups . CONCLUSION Biphasic cardioversion allows comparable success rates with significantly lower energies . However , the incidence of ERAF is not influenced by biphasic cardioversion . With the energies used , biphasic and monophasic shock waveforms are comparable with regard to first shock and cumulative shock efficacy",
"UNLABELLED Biphasic versus Monophasic Cardioversion . INTRODUCTION Cardioversion of atrial fibrillation using monophasic transthoracic shocks occasionally is ineffective . Biphasic cardioversion requires less energy than monophasic cardioversion , but its efficacy in shock-resistant atrial fibrillation is unknown . Thus , we compared the efficacy of cardioversion using biphasic versus monophasic waveform shocks in patients with atrial fibrillation previously refractory to monophasic cardioversion . METHODS AND RESULTS Fifty-six patients with prior failed monophasic cardioversion were r and omized to either a 360-J monophasic damped sinusoidal shock or biphasic truncated exponential shocks at 150 J , followed by 200 J and then 360 J , if necessary . If either waveform failed , patients were crossed over to the other waveform . The primary endpoint was defined as the proportion of patients achieving sinus rhythm following initial r and omized therapy . Stepwise multivariate logistic regression examined independent predictors of shock success , including patient age , sex , left atrial diameter , body mass index , drug therapy , and waveform . Twenty-eight patients were r and omized to the biphasic shocks and 28 to the monophasic shocks . Sinus rhythm was restored in 61 % of patients with biphasic versus 18 % with monophasic shocks ( P = 0.001 ) . Seventy-eight percent success was achieved in patients who crossed over to the biphasic shock after failing monophasic cardioversion , whereas only 33 % were successfully cardioverted with a monophasic shock after crossover from biphasic shock ( P = 0.02 ) . Overall , 69 % of patients who received a biphasic shock at any point in the protocol were cardioverted successfully , compared to 21 % with the monophasic shock ( P type of shock was the strongest predictor of shock success ( P = 0.0001 ) in multivariate logistic regression . CONCLUSION An ascending sequence of 150- , 200- , and 360-J transthoracic biphasic cardioversion shocks are successful more often than a single 360-J monophasic shock . Thus , biphasic shocks should be the recommended configuration of choice for all cardioversions",
"Chronic atrial fibrillation ( AF ) is a common arrhythmia with significant morbidity and mortality . AF has been the subject of considerable attention and intensive clinical research in recent years . Current opinion on the management of AF favors the restoration and maintenance of normal ventricular rhythm . This has several potential benefits , including the alleviation of arrhythmia-associated symptoms and hemodynamic improvements . Maintenance of frequents normalization of ventricular rhythm ( NVR ) can be achieved with antiarrhythmic drug therapy or with AV node radiofrequency ablation ( RFA ) and permanent ventricular pacing . Recent interest has focused on the use of class III antiarrhythmic agents , such as amiodarone hydrochloride . This investigation compared amiodarone to AV node RFA and permanent pacing of the His-bundle area in maintaining NVR in patients with resistant chronic AF . After 12 months of treatment with amiodarone ( 200 to 400 mg/d ) 30 % of patients remained in NVR , 30 % were in transitional phase of improvement , and 40 % showed negative effect . Only a few patients in this group developed ocular or hepatic side effects . On one year follow-up was achieved in 100 % of cases without any clinical ly significant side effects being seen . In conclusion , analysis of the results of this study suggests that low-dose amiodarone is well tolerated in the management of chronic AF in a selected patient population . The more aggressive interventional radiofrequency ablation technique is significantly more effective and more reliable in the long-term clinical treatment of drug-resistant AF",
"Objective : To compare the effectiveness of intravenous ( IV ) diltiazem and metoprolol in the management of rapid ventricular rate in atrial fibrillation ( AF ) . Methods : This prospect i ve , r and omised study was conducted in the Emergency Department of the Uludag University Medical Faculty Hospital , Bursa , Turkey . Forty AF patients with a ventricular rate ⩾120/minute and systolic blood pressure ⩾95 mm Hg were included and r and omised to receive IV diltiazem 0.25 mg/kg ( maximum 25 mg ) or metoprolol 0.15 mg/kg ( maximum 10 mg ) over 2 minutes . Blood pressures and heart rate were measured at 2 , 5 , 10 , 15 , and 20 minutes . Successful treatment was defined as fall in ventricular rate to below 100/minute or decrease in ventricular rate by 20 % or return to sinus rhythm . Results : Between January 2000 and July 2002 , 40 patients ( 18 men , 22 women ) met the inclusion criteria . Of these 20 ( 8 men , 12 women ; mean age 60.2 years , range 31–82 ) received diltiazem and 20 ( 10 men , 10 women ; mean age 64.0 years , range 31–82 ) received metoprolol . The success rate at 20 minutes for diltiazem and metoprolol was 90 % ( n = 18 ) and 80 % ( n = 16 ) , respectively . The success rate at 2 minutes was higher in the diltiazem group . The percentage decrease in ventricular rate was higher in the diltiazem group at each time interval . None of the patients had hypotension . Conclusion : Both diltiazem and metoprolol were safe and effective for the management of rapid ventricular rate in AF . However , the rate control effect began earlier and the percentage decrease in ventricular rate was higher with diltiazem than with metoprolol ",
"BACKGROUND The restoration and maintenance of sinus rhythm is a desirable goal in patients with atrial fibrillation , because the prevention of recurrences can improve cardiac function and relieve symptoms . Uncontrolled studies have suggested that amiodarone in low doses may be more effective and safer than other agents in preventing recurrence , but this agent has not been tested in a large , r and omized trial . METHODS We undertook a prospect i ve , multicenter trial to test the hypothesis that low doses of amiodarone would be more efficacious in preventing recurrent atrial fibrillation than therapy with sotalol or propafenone . We r and omly assigned patients who had had at least one episode of atrial fibrillation within the previous six months to amiodarone or to sotalol or propafenone , given in an open-label fashion . The patients in the group assigned to sotalol or propafenone underwent a second r and omization to determine whether they would receive sotalol or propafenone first ; if the first drug was unsuccessful the second agent was prescribed . Loading doses of the drugs were administered and electrical cardioversion was performed ( if necessary ) within 21 days after r and omization for all patients in both groups . The follow-up period began 21 days after r and omization . The primary end point was the length of time to a first recurrence of atrial fibrillation . RESULTS Of the 403 patients in the study , 201 were assigned to amiodarone and 202 to either sotalol ( 101 patients ) or propafenone ( 101 patients ) . After a mean of 16 months of follow-up , 71 of the patients who were assigned to amiodarone ( 35 percent ) and 127 of those who were assigned to sotalol or propafenone ( 63 percent ) had a recurrence of atrial fibrillation ( P Adverse events requiring the discontinuation of drug therapy occurred in 18 percent of the patients receiving amiodarone , as compared with 11 percent of those treated with sotalol or propafenone ( P=0.06 ) . CONCLUSIONS Amiodarone is more effective than sotalol or propafenone for the prevention of recurrences of atrial fibrillation",
"INTRODUCTION Pulmonary vein isolation ( PVI ) is an established treatment for paroxysmal atrial fibrillation ( AF ) . The ablation of complex fractionated atrial electrograms ( CFAE ) has emerged as a novel treatment approach . We sought to evaluate the additional effect of CFAE ablation to PVI in paroxysmal AF . METHODS AND RESULTS Ninety-eight patients with paroxysmal AF ( 57 + /- 10 years , 74 male ) were r and omized to the PVI ( n = 48 ) or PVI + CFAE group ( n = 50 ) . After PVI , CFAE ablation was performed in patients with inducible AF in the PVI + CFAE group . The primary endpoint was combined objective ( 7-day Holter ECG ) and subjective ( symptoms ) freedom of atrial tachyarrhythmia 3 months after ablation . Long-term follow-up ( 19 + /- 8 months ) was available in 94 of 98 patients . CFAE ablation was performed in 30 of 50 patients of the PVI + CFAE group . After 3 months , 36 of 48 patients ( 75 % ) in the PVI group and 38 of 50 patients ( 76 % ) in the PVI + CFAE group were in stable sinus rhythm ( P = NS ) . During long-term follow-up ( 19 + /- 8 months ) , 34 of 46 patients ( 74 % ) in the PVI group and 40 of 48 patients ( 83 % ) in the PVI + CFAE group were in sinus rhythm ( P = 0.08 ) . In a subgroup analysis , a significantly better long-term outcome was achieved if inducible AF after PVI had been treated by additional CFAE ablation as compared with PVI only ( sinus rhythm in 25/28 patients ; 89 % vs 22/30 patients 73 % ; P = 0.003 ) . CONCLUSION In the intention-to-treat analysis , additional CFAE ablation did not improve the success rate of PVI in patients with paroxysmal AF . However , during long-term follow-up , patients with still inducible AF after PVI seemed to profit from additional CFAE ablation",
"Background —Whether different ablation strategies affect paroxysmal atrial fibrillation ( AF ) long-term freedom from AF/atrial tachyarrhythmia is unclear . We sought to compare the effect of 3 different ablation approaches on the long-term success in patients with paroxysmal AF . Methods and Results —One hundred three consecutive patients with paroxysmal AF scheduled for ablation and presenting in the electrophysiology laboratory in AF were selected for this study . Patients were r and omized to pulmonary vein antrum isolation ( PVAI ; n=35 ) versus biatrial ablation of the complex fractionated atrial electrograms ( CFAEs ; n=34 ) versus PVAI followed by CFAEs ( n=34 ) . Patients were given event recorders and followed up at 3 , 6 , 9 , 12 , and 15 months postablation . There was no statistical significant difference between the groups in term of sex , age , AF duration , left atrial size , and ejection fraction . At 1 year follow-up , freedom from AF/atrial tachyarrhythmia was documented in 89 % of patients in the PVAI group , 91 % in the PVAI plus CFAEs group , and 23 % in the CFAEs group ( P success rate was seen between PVAI alone and PVAI associated with defragmentation . CFAEs ablation alone had the smallest impact on AF recurrences at 1-year follow-up . These results suggest that antral isolation is sufficient to treat most patients with paroxysmal AF",
"BACKGROUND Large trials have demonstrated that rate control is an acceptable alternative for rhythm control . However , optimal heart rate during atrial fibrillation ( AF ) remains unknown . Aim of this analysis was to compare outcome between rate control > or = 80 and patients with persistent atrial fibrillation . METHODS In the RAte Control versus Electrical cardioversion for persistent atrial fibrillation study , 522 patients were included , and 256 were r and omized to rate control . This post hoc analysis included patients r and omized to rate control . Patients were divided according to their mean resting heart rate during follow-up , or = 80 beat/min ( n = 139 ) . The end point , a composite of cardiovascular mortality , heart failure , thromboembolic complications , bleeding , pacemaker implantation , and severe drug side effects , was compared between both groups . RESULTS During follow-up ( 2.3 + /- 0.6 years ) , a significant difference between both groups in heart rate was observed ( 72 + /- 5 vs 90 + /- 8 beat/min ; P Rate control drugs were not significantly different between both groups . New York Heart Association class and fractional shortening remained unchanged in both groups . There were 17 ( 23 % ) end points in the low heart rate group and 24 ( 17 % ) in the higher heart rate group ( absolute difference , 5.4 [ -7.3 to 8.2 ] ; P = ns ) . Independent predictors for the primary end point were coronary artery disease , digoxin use , and interrupted anticoagulation , not high heart rate . Quality of life was comparable in both groups during follow-up . CONCLUSIONS In patients treated with a rate control strategy , no differences were observed in terms of cardiovascular morbidity , mortality , and quality of life between the observed differences in level of rate control throughout follow-up",
"OBJECTIVES We sought to assess the impact of intermittent atrial fibrillation ( AF ) on health-related quality of life ( QoL ) . BACKGROUND Intermittent AF is a common condition with little data on health-related QoL question naires to guide investigational therapies . METHODS Out patients from four centers , with documented AF ( n = 152 ) , completed vali date d QoL question naires ( Medical Outcomes Study Short Form 36 [ SF-36 ] , Specific Activity , Symptom Checklist , Illness Intrusiveness and University of Toronto AF Severity Scales ) . Comparison groups were made up of healthy individuals ( n = 47 ) and four cardiac control groups : published ( n = 78 ) and created for study ( n = 69 ) percutaneous transluminal coronary angioplasty ( PTCA ) ; published heart failure ( n = 216 ) and published postmyocardial infa rct ion ( MI ) ( n = 107 ) . RESULTS Across all domains of the SF-36 , AF patients reported substantially worse QoL than healthy controls ( 1.3 to 2.0 st and ard deviation units ) , with scores of 24 % , 23 % , 16 % and 30 % lower than healthy individuals on measures of physical and social functioning , mental and general health , respectively ( all p domains of the SF-36 and the same as heart failure controls on SF-36 psychological subscales . Patients with AF were as impaired or worse than study PTCA controls on measures of illness intrusiveness , activity limitations and symptoms . Associations between objective disease indexes and subjective QoL measures had poor correlations and accounted for Quality of life is as impaired in patients with intermittent AF as in patients with significant structural heart disease . Patients ' perception of QoL is not dependent on the objective measures of disease severity that are usually employed",
"Objectives : This r and omised trial evaluated if patients with atrial fibrillation ( AF ) and no history of atrial flutter ( AFL ) had any benefit of prophylactic cavotricuspid isthmus block ( CTIB ) in addition to circumferential pulmonary vein ablation ( CPVA ) . Methods : 149 patients with AF ( 54 % paroxysmal ) were r and omised to CPVA and CTIB ( group CTIB+ , n = 73 ) or CPVA alone ( group CTIB− , n = 76 ) . Patients were followed for 12 months with repetitive 7-day Holter monitoring after 3 , 6 and 12 months . Results : Six patients ( 4 % ) had cardiac tamponade , and one patient had a stroke . No difference was found in the cumulative AFL-free rate between the two treatment groups ( CTIB+ : 88 % vs CTIB− : 84 % , hazard ratio ( HR ) 0.80 , 95 % CI ( 0.34 to 1.90 ) , p = 0.61 ) . There was no difference in the cumulative AF-free rate between the groups ( CTIB+ : 34 % vs CTIB− : 32 % , HR 0.93 , 95 % CI ( 0.63 to 1.38 ) , p = 0.71 ) . Overall , 33 % of the patients were free of AF after a single procedure . Including re procedures , a complete or partial beneficial effect was noted in 62 % of the patients at 12 months . At 12-month follow-up , 24 ( 50 % ) patients with documented AF or AFL in the Holter recordings were asymptomatic . Conclusions : It was not possible to demonstrate any beneficial effect of CTIB in addition to CPVA with regard to AFL or AF recurrences during follow-up . Repetitive long-term Holter monitoring demonstrated a 33 % rate of freedom from AF during a 1-year follow-up . Including additional CPVA procedures , a clinical effect was noted in 62 % of the patients at 12 months . Patients with AF or AFL recurrences were often asymptomatic",
"STUDY OBJECTIVES The relative risks and benefits of strategies of rate control vs rhythm control in patients with atrial fibrillation ( AF ) remain to be fully explored . DESIGN The How to Treat Chronic Atrial Fibrillation ( HOT CAFE ) Polish trial was design ed to evaluate in a r and omized , multicenter , and prospect i ve manner the feasibility and long-term outcomes of rate control vs rhythm control strategies in patients with persistent AF . PATIENTS Our study population comprised 205 patients ( 134 men and 71 women ; mean [ + /- SD ] age , 60.8 + /- 11.2 years ) with a mean AF duration of 273.7 + /- 112.4 days . The mean observation period was 1.7 + /- 0.4 years . One hundred one patients were r and omly assigned to the rate control group and received rate-slowing therapy guided by repeated 24-h Holter monitoring . Direct current cardioversion and atrioventricular junctional ablation with pacemaker placement were alternative nonpharmacologic strategies for patients with tachycardia that was resistant to medical therapy . One hundred four patients were r and omized to sinus rhythm restoration and maintenance using serial cardioversion supported by a predefined stepwise antiarrhythmic drug regimen ( ie , disopyramide , propafenone , sotalol , and amiodarone ) . In both groups , thromboembolic prophylaxis followed current guidelines . MEASUREMENTS AND RESULTS At the end of follow-up , 63.5 % of patients in the rhythm control arm remained in sinus rhythm . No significant differences in the composite end point ( ie , all-cause mortality , number of thromboembolic events , or major bleeding ) were found between the rate control group and the rhythm control group ( odds ratio , 1.98 ; 95 % confidence interval , 0.28 to 22.3 ; p > 0.71 ) . The incidence of hospital admissions was much lower in the rate control arm ( 12 % vs 74 % , respectively ; p New York Heart Association functional class improved in both study groups , while mean exercise tolerance , as measured by the maximal treadmill workload , improved only in the rhythm control group ( 5.2 + /- 5.1 vs 7.6 + /- 3.3 metabolic equivalents , respectively ; p mean left ventricular fractional shortening ( 29 + /- 7 % vs 31 + /- 7 % , respectively ; p pulmonary embolism occurred in the rate control group despite oral anticoagulation therapy , while three patients in the rhythm control arm of the study experienced ischemic strokes ( not significant ) . CONCLUSIONS The Polish HOT CAFE study revealed no significant differences in major end points between the rate control group and the rhythm control group",
"BACKGROUND Beta blockers reduce mortality in patients who have chronic heart failure , systolic dysfunction , and are on background treatment with diuretics and angiotensin-converting enzyme inhibitors . We aim ed to compare the effects of carvedilol and metoprolol on clinical outcome . METHODS In a multicentre , double-blind , and r and omised parallel group trial , we assigned 1511 patients with chronic heart failure to treatment with carvedilol ( target dose 25 mg twice daily ) and 1518 to metoprolol ( metoprolol tartrate , target dose 50 mg twice daily ) . Patients were required to have chronic heart failure ( NYHA II-IV ) , previous admission for a cardiovascular reason , an ejection fraction of less than 0.35 , and to have been treated optimally with diuretics and angiotensin-converting enzyme inhibitors unless not tolerated . The primary endpoints were all-cause mortality and the composite endpoint of all-cause mortality or all-cause admission . Analysis was done by intention to treat . FINDINGS The mean study duration was 58 months ( SD 6 ) . The mean ejection fraction was 0.26 ( 0.07 ) and the mean age 62 years ( 11 ) . The all-cause mortality was 34 % ( 512 of 1511 ) for carvedilol and 40 % ( 600 of 1518 ) for metoprolol ( hazard ratio 0.83 [ 95 % CI 0.74 - 0.93 ] , p=0.0017 ) . The reduction of all-cause mortality was consistent across predefined subgroups . The composite endpoint of mortality or all-cause admission occurred in 1116 ( 74 % ) of 1511 on carvedilol and in 1160 ( 76 % ) of 1518 on metoprolol ( 0.94 [ 0.86 - 1.02 ] , p=0.122 ) . Incidence of side-effects and drug withdrawals did not differ by much between the two study groups . INTERPRETATION Our results suggest that carvedilol extends survival compared with metoprolol",
"OBJECTIVES This study was design ed to compare two treatment strategies in patients with atrial fibrillation(AF ) : rhythm-control ( restoration and maintenance of sinus rhythm ) and rate-control ( pharmacologic or invasive rate-control and anticoagulation ) . BACKGROUND Atrial fibrillation is the most common arrhythmia . It is unclear whether a strategy of rhythm- or rate-control is better in terms of mortality , morbidity , and quality of life . METHODS The Strategies of Treatment of Atrial Fibrillation ( STAF ) multicenter pilot trial r and omized 200 patients ( 100 per group ) with persistent AF to rhythm- or rate-control . The combined primary end point was a combination of death , cardiopulmonary resuscitation , cerebrovascular event , and systemic embolism . RESULTS After 19.6 + /- 8.9 months ( range 0 to 36 months ) there was no difference in the primary end point between rhythm-control ( 9/100 ; 5.54%/year ) and rate-control ( 10/100 ; 6.09%/year ; p = 0.99 ) . The percentage of patients in sinus rhythm in the rhythm-control group after up to four cardioversions during the follow-up period ( rate-control group ) was 23 % ( 0 % ) at 36 months . Eighteen primary end points occurred in atrial fibrillation ; only one occurred in sinus rhythm ( p = 0.049 ) . CONCLUSIONS The STAF pilot study showed no differences between the two treatment strategies in all end points except hospitalizations . These data suggest that there was no benefit in attempting rhythm-control in these patients with a high risk of arrhythmia recurrence . It remains unclear whether the results in the rhythm-control group would have been better if sinus rhythm had been maintained in a higher proportion of patients , as all but one end point occurred during AF",
"OBJECTIVE The aim of this study was to assess the feasibility and effectiveness of irrigated radiofrequency ( RF ) modified Maze procedure through a port access approach during mitral valve surgery and evaluate early and mid-term results . MATERIAL AND METHOD During a 16 months time period , 67 patients with chronic atrial fibrillation ( AF ) eligible for port access mitral valve surgery were r and omly assigned to either Group A , in which they underwent a combined procedure ( N = 33 ) or Group B , in which a valve procedure alone was performed ( N = 34 ) . Both groups were similar in terms of age , sex , valve pathology , duration of AF left atrial diameter and left ventricle function ( P > 0.05 ) . Four had undergone previous operations . RESULTS Median follow-up was 10 months for both groups , 95 % CI ( 9.18 - 10.8 ) . One patient in each group died early postoperatively ( 3 and 2.9 % ) . Two patients required reoperation for bleeding , one in each group ( 3 and 2.9 % ) . There were two conversions to right thoracotomy . In Group A , freedom from AF was 100 % at the end of the operation ( 76 % sinus , 24 % pacemaker ) Six and twelve months freedom from AF was 87.2 and 93.6 % , respectively . In Group B , freedom from AF at the end of operation was 41 % . At the end of 6 and 12 months , freedom from AF was 9.4 % ( P = 0.0001 ) . One patient in Group A required a permanent pacemaker ( 3 % ) . During follow-up , one patient in Group A died of non-cardiac causes ( 3 % ) . In Group B , there were two late deaths : one cardiac ( 2.9 % ) and one neurologic ( 2.9 % ) . There were no thromboembolic events detected in Group A during follow-up , whereas two patients in Group B suffered this complication ( 6 % , P = 0.081 ) . At 12 months , functional capacity had improved for patients in both groups ( P mitral valve surgery and irrigated RF Maze procedure was safe and efficient through a port access approach . There were no procedure related complications like esophageal or coronary artery injury . Early and mid-term results were favourable with 93.6 % of patients free of AF at 1 year in comparison to the 9.4 % of the control group . The data is not sufficient to reach any conclusions in terms of thromboembolic rates , despite favourable results for the RF Maze group . Nevertheless , in terms of feasibilty , sinus rhythm restoration and overall outcome , early results are encouraging and we advocate the use of the combined procedure through a port access approach",
"OBJECTIVES The use of antiarrhythmic drugs after ablation is a controversial issue when evaluating the efficacy of atrial fibrillation ( AF ) ablation . This study compares in a prospect i ve and r and omized fashion the impact of an antiarrhythmic drug in preventing AF recurrence after AF ablation . METHODS From February 2004 to May 2005 , 107 consecutive patients ( mean age 57 + /- 10 years , 69 men ) , with paroxysmal ( 60 % ) or persistent ( 40 % ) drug refractory AF , were r and omly assigned to ablation alone ( Group A , 53 patients ) or combined with the best antiarrhythmic therapy , preferably amiodarone ( Group B , 54 patients ) . All patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation , using a guided electro-anatomical approach . St and ard electrocardiograms ( ECG ) , and ambulatory and transtelephonic ECG monitoring were used to assess AF recurrences . Recurrences during the first month after ablation were excluded from this analysis . RESULTS At 12 months of follow-up , no significant difference was observed in the rates of AF recurrences between Group A ( 18/53 patients , 34 % ) and Group B ( 16/54 patients , 30 % ) . The percentage of patients with > /= 1 asymptomatic AF episode was higher in Group B than in Group A ( 10/16 patients , 63 % , vs 5/18 patients , 28 % , P = 0.04 ) . CONCLUSIONS Continuing antiarrhythmic drug therapy in patients who undergo catheter ablation for AF did not lower the rate of AF recurrences . Antiarrhythmic drugs increased the proportion of patients with asymptomatic AF episodes",
"To compare the safety and efficacy of anterior versus posterior approach for atrioventricular ( AV ) junction modification , 40 patients with medically refractory paroxysmal ( PAF ) or chronic atrial fibrillation ( AF ) were r and omly assigned to receive AV junction modification with an anterior or posterior approach . If the ablation session had taken more than 1 hour without success , the alternative ablation approach was attempted . Among the 18 patients assigned to receive the anterior approach , 14 ( 78 % ) had a primary success . One ( 5 % ) patient had complete AV block after ablation . Three patients crossed over to the posterior approach and had a successful outcome . Fourteen ( 64 % ) of 22 patients initially treated with the posterior approach had primary success . One ( 4 % ) patient developed complete AV block . Seven patients crossed over to the anterior approach and had a successful outcome . The primary success rate ( 14/18 vs 14/22 , P = NS ) , incidence of transient AV block ( 3/18 vs 3/22 , P = NS ) , and complete AV block ( 1/18 vs 1/22 , P = NS ) were similar between the anterior approach and posterior approach . The major differences between the two groups showed more radiofrequency pulses ( 10 + /- 4 vs 6 + /- 3 pulses , P procedure duration ( 50 + /- 24 vs 28 + /- 18 minutes , P fluoroscopy exposure time ( 28 + /- 17 vs 16 + /- 8 minutes , P posterior approach . In conclusion , this study demonstrated that ( 1 ) the two techniques had similar efficacies ; ( 2 ) if one approach was ineffective , switching to the other approach might be safe ; ( 3 ) combining these two approaches result ed in overall improvement in the success rate of this procedure , and ( 4 ) the posterior approach needed more radiofrequency pulses , longer procedural time , and longer fluoroscopy exposure time",
"INTRODUCTION Mapping techniques have not been systematic ally evaluated with respect to atypical atrial flutter ( AF ) not involving the inferior vena cava isthmus . The purpose of this study was to assess prospect ively the use of concealed entrainment ( CE ) in mapping of AF and to assess the clinical benefit of ablation of clinical ly relevant atypical AF . METHODS AND RESULTS In seven consecutive patients without prior cardiac surgery presenting with atypical AF , mapping was performed in the right and , if necessary , left atrium . At sites with CE , radiofrequency energy was delivered . In a posthoc analysis , the endocardial activation time , stimulus-flutter wave ( F ) interval , presence of split potentials and diastolic potentials , and postpacing interval were assessed , and effective sites were compared to ineffective sites . A total of 22 forms of atypical AF either could be induced or were present at the time of the study . Eleven of the 13 targeted atypical AFs ( 85 % ) were successfully ablated . The positive predictive value of CE increased from 45 % to 75 % in the presence of matching electrogram-F and stimulus-F intervals or if flutter terminated during entrainment pacing , and to 88 % in the presence of split atrial electrograms or diastolic potentials . During short-term clinical follow-up , none of the patients had recurrence of the ablated AF . However , the majority of patients required either medication for atrial fibrillation or repeated interventions for new forms of AF . CONCLUSION Mapping and ablation of atypical AF is feasible if sites with CE can be identified . However , the clinical benefit of successful ablations in patients with atypical flutter appears to be limited",
"OBJECTIVES This study evaluated the efficacy of antiarrhythmic drugs for the treatment of atrial fibrillation ( AF ) . BACKGROUND The most effective and safest antiarrhythmic drug for the treatment of AF is unknown . METHODS The Atrial Fibrillation Follow-up Investigation of Rhythm Management ( AFFIRM ) study compared two treatment strategies -- rate control and rhythm control -- in patients with AF and risk factors for stroke or death . This sub study , performed in patients r and omized to rhythm control , compared different antiarrhythmic drugs by r and omly assigning the first drug treatment to : 1 ) amiodarone , 2 ) sotalol , or 3 ) a class I drug . The primary end point was the proportion of patients alive , in sinus rhythm , with no additional cardioversions and still taking the assigned drug at one year . Comparisons were made between patients eligible for each of three drug pairs . RESULTS At one year , in 222 patients r and omized between amiodarone and class I agents , 62 % were successfully treated with amiodarone , compared with 23 % taking class I agents ( p patients r and omized between amiodarone and sotalol , 60 % versus 38 % were successfully treated , respectively ( p = 0.002 ) . In 183 patients r and omized between sotalol and class I agents , 34 % versus 23 % were successfully treated , respectively ( p = 0.488 ) , although this portion of the sub study was stopped early when amiodarone was shown to be better than class I agents . Sinus rhythm was achieved in nearly 80 % of patients at one-year follow-up with serial therapy . Adverse effects were common . CONCLUSIONS Amiodarone was more effective at one year than either sotalol or class I agents for the strategy of maintenance of sinus rhythm without cardioversion",
"Biphasic shocks are more effective than damped sine wave monophasic shocks for transthoracic cardioversion ( CV ) of atrial fibrillation ( AF ) , but the optimal protocol for CV with biphasic shocks has not been defined . We conducted a prospect i ve , r and omized study of 120 consecutive patients with persistent AF to delineate the dose-response curve for CV of AF with a biphasic truncated exponential shock waveform and to identify clinical predictors of shock efficacy . Our data suggest that the initial shock energy for CV with this waveform should be 200 J if the patient weighs /=90 kg",
"INTRODUCTION Isolation of all pulmonary veins ( PV ) is advocated for treatment of paroxysmal atrial fibrillation ( PAF ) . However , the superior PVs are responsible for most AF triggers , whereas the inferior PVs carry the higher risk for ablation-induced ostial stenosis . The aim of this study was to compare a superior PV isolation approach with isolation of all PVs for treatment of PAF . METHODS AND RESULTS Fifty-two patients with PAF were r and omized to either left superior pulmonary vein ( LSPV ) isolation followed by additional isolation of the right superior pulmonary vein ( RSPV ) in case of AF recurrence ( group A , n = 27 ) or isolation of all four PVs followed by a repeat procedure in case of recurrence ( group B , n = 25 ) . At 1-year follow-up , 11 patients ( 41 % ) in group A and 8 patients ( 32 % ) in group B had AF relapse ( P = 0.55 ) . No significant differences in AF relapse were detected between groups at 3 and 12 months ( log rank = 0.36 , P = 0.54 ) and by Cox proportional hazards model analysis ( P = 0.62 ) . Nonsignificant PV stenosis was detected in two patients from group B. Total radiofrequency energy delivery and fluoroscopy and procedure times were lower in group A : 8.9 + /- 1.4 minutes vs 25.6 + /- 3.7 minutes ( P superior PVs isolation approach confers equal success rates but with reduced radiofrequency energy delivery and fluoroscopy and procedure times compared to isolation of all PVs at the initial ablation attempt ",
"AIMS Direct current cardioversion of persistent atrial fibrillation is one of the most widely used and effective treatments for the restoration of sinus rhythm , but may be hampered by a low success rate and a high percentage of early recurrence . Pre-treatment with amiodarone or a glucose-insulin-potassium solution could improve the efficacy of electrical cardioversion by reversing the partially depolarized diastolic potential of the subsidiary pacemakers in atrial fibrillation . In a controlled r and omized study , we assessed the effectiveness of electrical cardioversion in patients with persistent atrial fibrillation after pre-treatment with amiodarone or potassium infusion and the efficacy of amiodarone in maintaining sinus rhythm after electrical cardioversion . METHODS AND RESULTS Ninety-two patients with persistent atrial fibrillation ( > 2 weeks duration ) were prospect ively r and omized into three matched groups : A ( n=31 , oral amiodarone 400 mg . day(-1)1 month before and 200 mg . day(-1)2 months after cardioversion ) , B ( n=31 , 180 mg . day(-1)oral diltiazem 1 month before and 2 months after cardioversion and 80 mmol potassium , 50 UI insulin in 500 ml 30 % glucose solution 24 h before cardioversion ) and C ( n=30 , control patients , 180 mg . day(-1)oral diltiazem 1 month before and 2 months after cardioversion ) . Before cardioversion all patients were under 4 weeks effective oral anticoagulant therapy ( warfarin ) . Before electrical cardioversion , the rate of spontaneous conversion to sinus rhythm was higher in group A ( 25 % ) than groups B ( 6 % ) or C ( 3 % ) ( P Electrical cardioversion was more successful in group A ( 88 % ) than groups B ( 56 % ) or C ( 65 % ) ( P electrical thresholds for effective cardioversion were lower in group B than the other groups ( P early recurrence of atrial fibrillation was similar in the three groups ( P = ns ) , while at 2 months the recurrence rate was lower in group A ( 32 % ) than groups B ( 56 % ) or C ( 52 % ) ( P amiodarone , compared with oral diltiazem or glucose-insulin-potassium treatments , induces a significantly high percentage of instances of spontaneous conversion , increases electrical cardioversion efficacy and reduces atrial fibrillation recurrence",
"AIM Mitral valve surgery seldom suppresses atrial fibrillation ( AF ) , present prior to surgery . Maze III surgery eliminates AF in > 80 % of cases , the reason why combining this procedure with mitral valve surgery in patients with AF seems worthwhile . We prospect ively studied the outcome of combining the Maze III procedure with mitral valve surgery . METHODS Thirty-five patients with AF and a mean age of 64 years undergoing mitral valve surgery were prospect ively r and omized according to a 2.5:1 ratio to surgery with ( n=25 ) , or without ( n=10 ) maze III and followed for at least 1 year . RESULTS At discharge and after 12 months freedom from AF was 56 % and 92 % , respectively , in the maze group , and 0 % and 20 % , respectively , in patients without maze ( group differences at discharge p=0.002 , after 12 months p=0.0007 ) . Sinus node incompetence was seen in 1 of 25 maze patients requiring pacing . No in-hospital or late death occurred ; stroke was observed in 1 patient ( without maze ) . Quality of life markedly improved after surgery , but did not differ between patients with or without maze surgery . CONCLUSIONS This first prospect i ve r and omized study shows that combining maze III with mitral valve surgery result ed in a significantly better elimination of preoperative AF than mitral valve surgery alone . As the quality of life did not differ between patients with , or without maze surgery , additional maze surgery is primarily recommended in patients in whom anticoagulation therapy can be avoided after surgery , specifically in patients with scheduled mitral valve plasty",
"INTRODUCTION Catheter ablation for paroxysmal atrial fibrillation is widely used for patients with drug-refractory paroxysms of arrhythmia . Recently , novel technologies have been introduced to the market that aim to simplify and shorten the procedure . AIM To compare the clinical outcome of pulmonary vein ( PV ) isolation using a multipolar circular ablation catheter ( PVAC group ) , with point-by-point PV isolation using an irrigated-tip ablation catheter and the CARTO mapping system ( CARTO group ; CARTO , Biosense Webster , Diamond Bar , CA , USA ) . METHODS Patients with documented PAF were r and omized to undergo PV isolation using PVAC or CARTO . Atrial fibrillation ( AF ) recurrences were documented by serial 7-day Holter monitoring . RESULTS One hundred and two patients ( mean age 58 ± 11 years , 68 men ) were included in the study . The patients had comparable baseline clinical characteristics , including left atrial dimensions and left ventricular ejection fraction , in both study arms ( PVAC : n = 51 and CARTO : n = 51 ) . Total procedural and fluoroscopic times were significantly shorter in the PVAC group ( 107 ± 31 minutes vs 208 ± 46 minutes , P respectively ) . The AF recurrence was documented in 23 % and 29 % of patients in the PVAC and CARTO groups , respectively ( P = 0.8 ) , during the mean follow-up of 200 ± 13 days . No serious complications were noted in both study groups . CONCLUSIONS Clinical success rates of PV isolation are similar when using multipolar circular PV ablation catheter and point-by-point ablation with a three-dimensional ( 3D ) navigation system in patients with PAF , and results in shorter procedural and fluoroscopic times with a comparable safety profile",
"OBJECTIVES This study sought to compare catheter ablation with rate control for persistent atrial fibrillation ( AF ) in heart failure ( HF ) . BACKGROUND The optimal therapy for AF in HF is unclear . Drug-based rhythm control has not proved clinical ly beneficial . Catheter ablation improves cardiac function in patients with HF , but impact on physiological performance has not been formally evaluated in a r and omized trial . METHODS In a r and omized , open-label , blinded-endpoint clinical trial , adults with symptomatic HF , radionuclide left ventricular ejection fraction ( EF ) ≤35 % , and persistent AF were assigned to undergo catheter ablation or rate control . Primary outcome was 12-month change in peak oxygen consumption . Secondary endpoints were quality of life , B-type natriuretic peptide , 6-min walk distance , and EF . Results were analyzed by intention-to-treat . RESULTS Fifty-two patients ( age 63 ± 9 years , EF 24 ± 8 % ) were r and omized , 26 each to ablation and rate control . At 12 months , 88 % of ablation patients maintained sinus rhythm ( single-procedure success 68 % ) . Under rate control , rate criteria were achieved in 96 % . The primary endpoint , peak oxygen consumption , significantly increased in the ablation arm compared with rate control ( difference + 3.07 ml/kg/min , 95 % confidence interval : 0.56 to 5.59 , p = 0.018 ) . The change was not evident at 3 months ( + 0.79 ml/kg/min , 95 % confidence interval : -1.01 to 2.60 , p = 0.38 ) . Ablation improved Minnesota score ( p = 0.019 ) and B-type natriuretic peptide ( p = 0.045 ) and showed nonsignificant trends toward improved 6-min walk distance ( p = 0.095 ) and EF ( p = 0.055 ) . CONCLUSIONS This first r and omized trial of ablation versus rate control to focus on objective exercise performance in AF and HF shows significant benefit from ablation , a strategy that also improves symptoms and neurohormonal status . The effects develop over 12 months , consistent with progressive amelioration of the HF syndrome . ( A R and omised Trial to Assess Catheter Ablation Versus Rate Control in the Management of Persistent Atrial Fibrillation in Chronic Heart Failure ; NCT00878384 )",
"OBJECTIVE To compare safety and efficacy of 8-mm versus cooled tip catheter in achieving electrical isolation ( EI ) of pulmonary veins ( PV ) for long-term control of atrial fibrillation ( AF ) . BACKGROUND There is paucity of studies comparing safety/efficacy of 8-mm and cooled tip catheters in patients undergoing AF ablation . METHODS AND RESULTS This was a r and omized and patient-blinded study . Subjects were followed by clinic visits ( at 6 weeks and 6 months ) and transtelephonic monitoring ( 3-week duration ) done around each visit . Primary endpoints were : ( 1 ) long-term AF control ( complete freedom and /or > 90 % reduction in AF burden on or off antiarrhythmic drugs at 6 months after a single ablation ) , and ( 2 ) occurrence of serious adverse events ( cardiac tamponade , stroke , LA-esophageal fistula , and /or death ) . Eighty-two patients ( age 56 + /- 9 years , 60 males , paroxysmal AF = 59 ) were r and omized ( 42 patients to 8-mm tip and 40 patients to cooled tip ) . EI of PVs was achieved in shorter time by the 8-mm tip as compared with cooled tip catheter ( 40 + /- 23 minutes vs 50 + /- 30 minutes ; P long-term AF control was not different between the two ( 32 patients [ 78 % ] vs 28 patients [ 70 % ] , respectively ; P = NS ) . One serious adverse event occurred in each group ( LA-esophageal fistula and stroke , respectively ) and no significant PV stenosis was observed in either . CONCLUSION EI of PVs using either 8-mm or cooled tip catheter results in long-term AF control in the majority after a single ablation procedure , with comparable efficacy and safety",
"We conducted a prospect i ve r and omized study to determine the safety and efficacy rate of 3 commonly used energy levels ( 100 , 200 , and 360 J ) for elective direct-current cardioversion of persistent atrial fibrillation . When compared with 100 and 200 J , the initial success rate with 360 J was significantly higher ( 14 % , 39 % , and 95 % , respectively ) , and patients r and omized to 360 J ultimately required less total energy and a lower number of shocks",
"OBJECTIVES The Atrial Fibrillation Follow-up Investigation of Rhythm Management ( AFFIRM ) functional status sub study aim ed to test the hypothesis that functional status is similar in rate-control and rhythm-control strategies . BACKGROUND R and omized studies , including the AFFIRM study , have failed to demonstrate survival benefits between rate-control and rhythm-control strategies for atrial fibrillation ( AF ) . However , AF may cause functional capacity or cognitive impairment that might justify maintenance of sinus rhythm . METHODS Investigators of the AFFIRM study enrolled 4,060 patients with AF who required long-term therapy and who were 65 years of age or older or who had another risk factor for stroke or death . New York Heart Association functional class ( NYHA-FC ) and Canadian Cardiovascular Society Angina Classification were assessed at initial and each follow-up visit . From 22 r and omly chosen functional status sub study sites , 245 participants underwent 6-min walk tests and Mini-Mental State Examination ( MMSE ) at initial , two-month , and yearly visits . Patients were assigned r and omly to rate-controlling drugs , allowing AF to persist , or rhythm-controlling antiarrhythmic drugs , to maintain sinus rhythm . RESULTS The NYHA-FC worsened with time in both rate-control and rhythm-control groups , with no differences between groups . Presence of AF was associated with worse NYHA-FC ( p Canadian Cardiovascular Society Angina Classification or MMSE scores . Six-minute walk distance improved over time in both study arms . On average , walk distance was 94 feet greater in the rhythm-control group ( adjusted p = 0.049 ) . CONCLUSIONS Modest improvement in 6-min walk distance was noted in the rhythm-control arm . Presence of AF was associated with worse NYHA-FC . No difference in cognitive function was detected",
"OBJECTIVES The goal of this study was to evaluate the relationship between the presence of sinus rhythm and outcomes in patients with a history of congestive heart failure ( CHF ) and atrial fibrillation ( AF ) . BACKGROUND The value of sinus rhythm maintenance in patients with AF and heart failure ( HF ) is uncertain . METHODS A total of 1,376 patients with AF , ejection fraction were r and omized to a rhythm- or rate-control strategy . Detailed efficacy analyses were used to evaluate the independent effects of treatment strategy and the presence of sinus rhythm on cardiovascular outcomes . RESULTS Overall , 445 ( 32 % ) patients died and 402 ( 29 % ) experienced worsening HF . The rhythm-control strategy was not predictive of cardiovascular mortality ( hazard ratio [ HR ] : 0.90 , 95 % confidence interval [ CI ] : 0.70 to 1.16 ; p = 0.41 ) , all-cause death ( HR : 0.86 , 95 % CI : 0.69 to 1.08 ; p = 0.19 ) , or worsening HF ( HR : 0.86 , 95 % CI : 0.68 to 1.10 ; p = 0.23 ) . In analyses devised to isolate the effect of underlying rhythm , sinus rhythm was not associated with cardiovascular mortality [ HR : 1.22 , 95 % CI : 0.80 to 1.87 ; p = 0.35 ) , total mortality [ HR : 1.11 , 95 % CI : 0.78 to 1.58 ; p = 0.57 ) , or worsening HF [ HR : 0.62 , 95 % CI : 0.37 to 1.02 ; p = 0.059 ) . CONCLUSIONS A rhythm-control strategy or the presence of sinus rhythm are not associated with better outcomes in patients with AF and CHF",
"OBJECTIVE In this study , we r and omly compared single oral doses of flecainide , amiodarone and propafenone versus placebo for the conversion of recent atrial fibrillation ( AF ) ( within 48 hours ) . METHODS This is a r and omized prospect i ve , placebo-controlled single-blind study that included 160 consecutive patients with recent AF who were r and omly assigned to single oral doses of flecainide ( 3 mg/kg of weight , n=40 ) , amiodarone ( 30 mg/kg weight , n=40 ) , propafenone ( 8.5 mg/kg of weight , n=40 ) or placebo ( n=40 ) . The primary end-point was conversion rate at 24 hours after the drug intake . The association between antiarrhythmic use and conversion rate was tested with multiple logistic regressions . RESULTS The primary end-point was achieved in 87.5 % of patients with flecainide , 85 % of patients with amiodarone , 85 % of patients with propafenone and 17.5 % of patients with placebo ( p placebo for all 3 drugs ) . Conversion rate within 3 hours after drug intake was greater with propafenone ( 57.5 % ) or flecainide ( 45 % ) compared with amiodarone ( 0 % ) or placebo ( 10 % ) . Between 6 and 24 hours , significantly more patients were converted to sinus rhythm with amiodarone than with flecainide or propafenone . The use of antiarrhythmic drugs was a significant predictor of conversion to sinus rhythm compared to placebo ( adjusted OR=19.53 , 95 % CI 3.14 - 121.55 , p serious side effect occurred . CONCLUSION In patients with recent-onset AF , oral flecainide , amiodarone or propafenone are superior to placebo in restoring sinus rhythm within the 24-hour period following the drug intake",
"OBJECTIVES The purpose of this study was to determine if there is a difference in commercially available biphasic waveforms . BACKGROUND Although the superiority of biphasic over monophasic waveforms for external cardioversion of atrial fibrillation ( AF ) is established , the relative efficacy of available biphasic waveforms is less clear . METHODS We compared the effectiveness of a biphasic truncated exponential ( BTE ) waveform and a biphasic rectilinear ( BR ) waveform for external cardioversion of AF . Patients ( N = 188 ) with AF were r and omized to receive transthoracic BR shocks ( 50 , 75 , 100 , 120 , 150 , 200 J ) or BTE shocks ( 50 , 70 , 100 , 125 , 150 , 200 , 300 , 360 J ) . Shock strength was escalated until success or maximum energy dose was achieved . If maximum shock strength failed , patients received the maximum shock of the opposite waveform . Analysis included 141 patients ( 71 BR , 70 BTE ; mean age 66.5 + /- 13.7 . Forty-seven r and omized patients were excluded because of flutter on precardioversion ECG upon blinded review ( n = 25 ) , presence of intracardiac thrombus ( n = 7 ) , or protocol deviation ( n = 15 ) . Groups were similar with regard to clinical and echocardiographic characteristics . RESULTS The success rate was similar for the two waveforms ( 93 % BR vs 97 BTE , P = .44 ) , although cumulative selected and delivered energy was less in the BTE group . Only AF duration was significantly different between successful and unsuccessful patients . No significant complications occurred . CONCLUSIONS Biphasic waveforms were very effective in transthoracic cardioversion of AF , and complication rates were low . No significant difference in efficacy was observed between BR and BTE waveforms . Impedance was not an important determinant of success for either biphasic waveform",
"AIMS Circumferential pulmonary vein isolation ( CPVI ) is an established strategy for atrial fibrillation ( AF ) ablation . Superior vena cava ( SVC ) , by harbouring the majority of non-pulmonary vein ( PV ) foci , is the most common non-PV origin for AF . However , it is unknown whether CPVI combined with SVC isolation ( SVCI ) could improve clinical results and whether SVCI is technically safe and feasible . METHODS AND RESULTS A total of 106 cases ( 58 males , average age 66.0 + /- 8.8 years ) with paroxysmal AF were included for ablation . They were allocated r and omly to two groups : CPVI group ( n = 54 ) and CPVI + SVCI group ( n = 52 ) . All cases underwent the procedure successfully . Pulmonary vein isolation was achieved in all cases . The procedural time and fluoroscopic time were comparable between the two groups . The mean ablation time for SVC was 7.8 + /- 2.7 min . Superior vena cava isolation was obtained in 50/52 cases . In the remaining two cases , SVCI was not achieved because of obviating diaphragmatic nerve injury . During a mean follow-up of 4 + /- 2 months , 12 ( 22.2 % ) cases in the CPVI group and 10 ( 19.2 % ) cases in the CPVI + SVCI group had atrial tachyarrhythmias ( ATa ) recurrence ( P = 0.70 ) . Nine of 12 cases in the CPVI group and 8/10 cases in the CPVI + SVCI group underwent reablation ( P = 0.86 ) , and PV reconnection occurred in 7/9 cases in the CPVI group and in 8/8 cases in the CPVI + SVCI group . All PV reconnection was reisolated by gaps ablation . There was no SVC reconnection in the CPVI + SVCI group . In two cases without PV reconnection from the CPVI group , SVC-originated short run of atrial tachycardia was identified and eliminated by the SVCI . At the end of 12 months of follow-up , 50 cases ( 92.6 % ) in the CPVI group and 49 ( 94.2 % ) in the CPVI + SVC group were free of ATa recurrence ( P = 0.73 ) . CONCLUSION In our series of paroxysmal AF patients , empirically adding SVCI to CPVI did not significantly reduce the AF recurrence after ablation . Superior vena cava isolation may be useful , however , in selected patients in whom the SVC is identified as a trigger for AF . However , because of the preliminary property of the study and its relatively small sample size , the impact of SVCI on clinical results should be evaluated in a large series of patients",
"UNLABELLED Antiarrhythmic agents enhance maintenance of sinus rhythm ( SR ) after direct current cardioversion ( DCC ) for atrial fibrillation but there are few comparative trials . BACKGROUND The aims of the study were ( 1 ) to establish whether patients successfully cardioverted to SR are more likely to stay in SR over 6 months if taking amiodarone or sotalol , and if so , to establish whether one agent is better than the other ; ( 2 ) to establish whether taking amiodarone or sotalol is better at achieving chemical cardioversion within the 6 weeks before DCC ; and ( 3 ) to establish whether DCC is more likely to be successful on a drug . METHODS R and omized , prospect i ve , nonblinded , controlled study of treatment with either amiodarone ( n = 27 ) , sotalol ( n = 36 ) , or no antiarrhythmic agent ( n = 31 ) . RESULTS Chemical cardioversion occurred in 7 patients in the amiodarone group ( A ) , 7 patients in the sotalol group ( S ) , but none in the no-antiarrhythmic group ( N ) . A total of 33 ( 92 % ) patients in the sotalol group , 22 ( 81 % ) patients in the amiodarone group , and 23 ( 74 % ) patients in the no-antiarrhythmic group were in SR after cardioversion . Of the original cohort of patients , 17 ( 63 % ) patients in the amiodarone group remained in SR at 6-month follow-up , compared with 14 ( 39 % ) in the sotalol group and 5 ( 16 % ) in the no-antiarrhythmic group ( A vs N , P Amiodarone and sotalol achieved chemical cardioversion before planned electrical cardioversion in 26 % and 19 % of patients , respectively . After successful cardioversion , amiodarone appears better than sotalol at maintaining SR at 6 months",
"BACKGROUND Electric conversion of atrial fibrillation is the most widely used and effective treatment for sinus rhythm restoration . However , it has a limited success rate and a high recurrence rate . HYPOTHESIS Pretreatment with calcium channel blocker may improve the efficacy by reversing the so-called \" electric remodeling \" phenomenon , also related to overload in cytosolic calcium . METHODS The efficacy of diltiazem or amiodarone pretreatment ( oral , 1 month before and 1 month after conversion ) on direct-current conversion of persistent atrial fibrillation was assessed in 120 patients , r and omly assigned to 3 matched groups : A ( n = 44 , diltiazem ) ; B ( n = 46 , amiodarone ) , and C ( n = 30 , digoxin ) . RESULTS Before electric conversion , all treatments significantly decreased mean heart rate . Spontaneous conversion to sinus rhythm was achieved in 6 % of patients of group A ( 3 of 46 ) versus 25 % of group B ( 11 of 44 ) and 3 % ( 1 of 30 ) of group C ( A/C vs B , P conversion was more successful in group B ( 91 % ) compared with group A ( 76 % ) and group C ( 67 % ) ( B vs A/C , P electric threshold for effective conversion ( P = not significant ) . At the 24-hour time point , early relapse of atrial fibrillation was similar between groups A and B ( A , 2 % ; B , 3 % ; P = not significant ) and lower than group C ( 12 % ) ( P recurrence rate was lower in group B ( 28 % ) versus groups A ( 56 % ) and C ( 78 % ) ( B vs A/C , P side effects were reported . CONCLUSIONS Although diltiazem seems to be as effective as amiodarone in reducing early atrial fibrillation recurrences , diltiazem is less effective in determining spontaneous or electric conversion , with a higher recurrence rate at 2 months . Diltiazem pretreatment could be considered as only a second choice treatment in those patients in whom amiodarone is contraindicated",
"Pretreatment with antiarrhythmic agents could improve cardioversion and recurrence rates in patients with persistent atrial fibrillation . In a prospect i ve controlled trial , 145 patients were r and omly assigned to treatment with carvedilol , amiodarone , or placebo for 4 weeks before electrical cardioversion . Although the 2 drugs had similar effects on cardioversion rates , amiodarone was superior in terms of sinus rhythm maintenance after conversion",
"BACKGROUND Both segmental ostial and circumferential extraostial pulmonary vein ( PV ) isolation have been proven effective in the treatment of atrial fibrillation ( AF ) . However , the recurrence of AF and PV conduction after the 2 ablation strategies has never been compared in a r and omized study . METHODS A total of 100 consecutive patients ( age 56 + /- 10 ; 71 men ) with symptomatic AF ( paroxysmal , 51 ; persistent , 49 ) were r and omized to segmental ostial ( n = 54 ) or circumferential extraostial ( n = 46 ) PV isolation . A circular catheter positioned at the ostium of each target PV guided the ostial PV isolation . Extraostial PV isolation was performed by encircling the paired left and right PVs , respectively , guided by an electroanatomic mapping system . RESULTS A total of 84 % of the patients had recurrent AF after the first PV isolation procedure , showing 72 % with AF and 12 % with organized left atrial tachycardia . In patients undergoing reablation , all but 2 patients had recurrence of left atrium PV conduction ( > 95 % ) . During a mean follow-up of 12 months without antiarrhythmic medication , 57 % of patients who underwent extraostial PV isolation were free of arrhythmia symptoms compared with 31 % of patients who underwent ostial PV isolation ( P success rate between the 2 ablation strategies was mainly seen in patients known with persistent AF ( 52 % and 15 % , respectively ; P = .02 ) as opposed to patients with paroxysmal AF ( 65 % and 46 % , respectively ; P = .26 ) . CONCLUSIONS Overall , the more proximal , extraostial PV isolation was found to be superior to ostial PV isolation , especially in patients known with persistent AF . A high recurrence rate of 84 % after a single complete PV isolation procedure was seen . At reablation , more than 95 % had recurrence of left atrium PV conduction regardless of the procedure used , supporting the idea that complete PV isolation seems essential to prevent arrhythmia recurrences",
"The limited efficacy and proarrhythmic risks of antiarrhythmia agents have result ed in alternative therapeutic approaches . Radiofrequency ablation has been reported to be an effective treatment of patients with atrial fibrillation . However , there is no r and omized clinical trial comparing drug and radiofrequency ablation . The authors r and omized 30 patients with chronic atrial fibrillation refractory to medication into amiodarone and radiofrequency ablation . The primary objective of this study was to compare the efficacy of amiodarone and radiofrequency ablation in the maintenance of sinus rhythm at 1 year after r and omization . Pulmonary vein isolation and linear ablation of right atrium was the technique used for radiofrequency ablation . There were no significant differences in baseline patient characteristics between the 2 groups . The results of this study showed that the probability of free from atrial fibrillation was better in the radiofrequency ablation group compared to amiodarone ( 78.6 % in the ablation group and 40 % in the amiodarone group , p = 0.018 ) . Radiofrequency ablation results in a significant reduction in symptoms relating to atrial fibrillation and a significant improvement in quality of life , whereas amiodarone had no significant effect on symptoms and quality of life . There was an ischemic stroke as a major complication related to radiofrequency ablation . Amiodarone was associated with adverse effects in 46.7 per cent of patients and needed discontinuation in 1 patient . In conclusion , radiofrequency ablation is an effective alternative treatment in patients with atrial fibrillation refractory to medication",
"BACKGROUND The Cox Maze procedure has been used to treat atrial fibrillation in patients with mitral valve disease . Recently , ectopic foci , originating in the pulmonary veins , were demonstrated in patients with atrial fibrillation , and the indication was that their arrhythmia could have a focal origin . In the light of this new evidence , a simplified surgical technique to isolate the pulmonary veins was developed to eliminate permanent atrial fibrillation in patients undergoing mitral valve surgery . This study compares three surgical procedures proposed to maintain sinus rhythm after mitral valve surgery . METHODS A prospect i ve clinical trial of 30 patients with mitral valve disease and permanent atrial fibrillation who had undergone mitral valve surgery were r and omized in accordance with the type of surgery used on each : ( 1 ) . associated en bloc isolation of pulmonary veins , ( 2 ) . the Maze procedure , or ( 3 ) . mitral valve correction alone . The preoperative clinical characteristics were similar in the three groups . RESULTS The overall postoperative complications were similar in all three groups . The cardiopulmonary bypass time and the aortic cross-clamping time were shorter in the control group , but this factor bore no relation to increased morbidity in the intervention groups . The relative risk of atrial fibrillation after surgery was 0.08 in the group undergoing isolation of pulmonary veins ( p = 0.010 ; 95 % confidence interval , 0.01 to 0.71 ) and 0.20 in the Maze group ( p = 0.044 ; 95 % confidence interval , 0.04 to 1.02 ) compared with the control group . CONCLUSIONS En bloc isolation of pulmonary veins associated with mitral valve surgery appears to be safe and just as effective as the Maze procedure in maintaining sinus rhythm in patients with permanent atrial fibrillation",
"This study was performed to evaluate , using a r and omized double-blind , placebo-controlled protocol , the long-term efficacy and safety of propafenone and sotalol in maintaining sinus rhythm after conversion of recurrent symptomatic atrial fibrillation ( AF ) . The maintenance of sinus rhythm in patients with recurrent AF has several potential benefits , the most important being a reduced risk of thromboembolic events . Three hundred patients with recurrent AF ( > or = 4 episodes in the last year ) and AF at enrollment lasting to receive either propafenone ( mean daily dose 13 + /- 1.5 mg/kg ; 102 patients ) , sotalol ( mean daily dose 3 + /- 0.4 mg/kg ; 106 patients ) , or placebo ( 92 patients ) . After 1-year follow-up , Kaplan-Meier estimates of the proportion of patients remaining in sinus rhythm were comparable between propafenone ( 63 % ) and sotalol ( 73 % ) and superior to placebo ( 35 % ; p = 0.001 vs both drugs ) . Symptomatic recurrences occurred later with propafenone and sotalol than with placebo . Nine patients ( 9 % ) in the propafenone group , 11 ( 10 % ) in the sotalol group , and 3 ( 3 % ) in the placebo group discontinued therapy due to adverse effects . Malignant nonfatal arrhythmias due to proarrhythmic effects were documented with sotalol only , and occurred ventricular rate was significantly reduced in patients taking propafenone and sotalol ( p = 0.001 for both drugs vs placebo ) . The likelihood of remaining in sinus rhythm during follow-up was higher in younger patients with smaller left atrial size and without concomitant heart disease . In patients with recurrent symptomatic AF , propafenone and sotalol are not significantly different from each other and are superior to placebo in maintaining sinus rhythm at 1 year . Recurrences occur later and tend to be less symptomatic with propafenone and sotalol compared with placebo",
"BACKGROUND R and omized studies evaluating left atrial radiofrequency ablation ( RFA ) in patients with persistent atrial fibrillation undergoing mitral valve surgery are scarce and monocentric . AIM To evaluate the efficacy of left atrial RFA concomitant with mitral valve surgery to restore and maintain sinus rhythm . METHODS The SAFIR is a multicentre , double-blinded , central ly r and omized study involving four university hospitals . Between December 2002 and September 2005 , 43 patients with mitral valve disease and long-st and ing , persistent atrial fibrillation ( duration > 6 months ) were included . We compared valvular surgery alone ( n=22 ) or with left atrial RFA ( n=21 ) . The main endpoint was sinus rhythm at 12 months without recurrence of arrhythmia during follow-up . Secondary endpoints were surgical adverse events , atrial fibrillation relapses , stroke and echocardiographic measurements after three and 12 months ' follow-up . Analyses of the efficacy criteria were performed on an intention-to-treat basis . RESULTS The primary endpoint occurred significantly more often in the RFA group than in the control group ( respectively , 12/21 patients [ 57 % ] vs 1/22 patients [ 4 % ] ; p=0.004 ) . There were more patients with sinus rhythm in the RFA group than in the control group at discharge ( 72.7 % vs 4.8 % ; p ) , 3-month follow-up ( 85.7 % vs 23.8 % ; p postoperative complications and stroke during follow-up as those in the control group . CONCLUSIONS This multicentre study suggests that left atrial RFA is effective and safe in patients with chronic atrial fibrillation and mitral valve disease",
"BACKGROUND Amiodarone and sotalol are commonly used for the maintenance of sinus rhythm , but the efficacy of these agents administered as high-dose infusions for rapid conversion of atrial fibrillation is unknown . Use in this context would facilitate drug initiation in patients in whom ongoing prophylactic therapy is indicated . METHODS We assessed the efficacy and safety of rapid high-dose intravenous infusions of amiodarone and sotalol for heart rate control and rapid reversion to sinus rhythm in patients who came to the emergency department with recent-onset symptomatic atrial fibrillation . Patients ( n = 140 ) were r and omized to receive 1.5mg/kg of sotalol infused in 10 minutes , 10mg/kg of amiodarone in 30 minutes , or 500 microg of digoxin in 20 minutes . Electrical cardioversion was attempted for patients not converting to sinus rhythm within 12 hours . RESULTS The rapid infusion of sotalol or amiodarone result ed in more rapid rate control than digoxin . Each of the 3 trial strategies result ed in similar rates of pharmacological conversion to sinus rhythm ( amiodarone , 51 % ; sotalol , 44 % ; digoxin , 50 % ; P = not significant ) . The overall rates of cardioversion after trial drug infusion and defibrillation were high for all groups ( amiodarone , 94 % ; sotalol , 95 % , ; digoxin , 98 % ; P = not significant ) , but there was a trend toward a higher incidence of serious adverse reactions in the amiodarone group . CONCLUSION The rapid infusion of sotalol or amiodarone in patients with symptomatic recent-onset atrial fibrillation results in rapid control of ventricular rate . Even with high-dose rapid infusions , all 3 agents are associated with a poor overall reversion rate within 12 hours . Almost all patients were returned to sinus rhythm with a combination of pharmacological therapy and electrical cardioversion",
"CONTEXT Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation ( AF ) despite inconsistent efficacy and frequent adverse effects . Catheter ablation has been proposed as an alternative treatment for paroxysmal AF . OBJECTIVE To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy ( ADT ) in treating symptomatic paroxysmal AF . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve , multicenter , r and omized ( 2:1 ) , unblinded , Bayesian- design ed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before r and omization . Enrollment occurred between October 25 , 2004 , and October 11 , 2007 , with the last follow-up on January 19 , 2009 . INTERVENTION Catheter ablation ( n = 106 ) or ADT ( n = 61 ) , with assessment for effectiveness in a comparable 9-month follow-up period . MAIN OUTCOME MEASURES Time to protocol -defined treatment failure . The proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported . RESULTS At the end of the 9-month effectiveness evaluation period , 66 % of patients in the catheter ablation group remained free from protocol -defined treatment failure compared with 16 % of patients treated with ADT . The hazard ratio of catheter ablation to ADT was 0.30 ( 95 % confidence interval , 0.19 - 0.47 ; P 30-day treatment-related adverse events occurred in 5 of 57 patients ( 8.8 % ) treated with ADT and 5 of 103 patients ( 4.9 % ) treated with catheter ablation . Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months ; improvement was maintained during the course of the study . CONCLUSION Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug , the use of catheter ablation compared with ADT result ed in a longer time to treatment failure during the 9-month follow-up period . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00116428",
"AIMS Rate control of atrial fibrillation ( AF ) has become a main treatment modality , but we need more knowledge regarding the different drugs used for this purpose . In this study , we aim ed to compare the effect of four common rate-reducing drugs on exercise capacity and levels of N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) in patients with permanent AF . METHODS AND RESULTS We included 60 patients ( mean age 71 ± 9 years , 18 women ) with permanent AF and normal left ventricular function in a r and omized , cross-over , investigator-blind study . Diltiazem 360 mg , verapamil 240 mg , metoprolol 100 mg , and carvedilol 25 mg were administered o.d . for 3 weeks . At baseline and on the last day of each treatment period , the patients underwent a maximal cardiopulmonary exercise test and blood sample s were obtained at rest and at peak exercise . The exercise capacity ( peak VO2 ) was significantly lower during treatment with metoprolol and carvedilol compared with baseline ( no treatment ) or treatment with diltiazem and verapamil ( P with diltiazem and verapamil significantly reduced the NT-proBNP levels both at rest and at peak exercise , whereas treatment with metoprolol and carvedilol increased the levels ( P with diltiazem or verapamil preserved exercise capacity and reduced levels of NT-proBNP compared with baseline , whereas treatment with metoprolol or carvedilol reduced the exercise capacity and increased levels of NT-proBNP ",
"BACKGROUND Several different biphasic waveforms are used clinical ly , but few studies have compared their efficacy . The two main waveforms are the biphasic rectilinear ( BR ) and biphasic truncated exponential ( BTE ) waveforms , both of which have important differences , particularly at the extremes of transthoracic impedance . OBJECTIVE To compare the efficacy of two commonly used defibrillation waveforms in the elective cardioversion of atrial fibrillation . METHODS In a prospect i ve r and omized controlled study , sequential adult patients undergoing elective cardioversion for AF were recruited . Patients were r and omized to receive synchronized defibrillation using either a BR or BTE waveform , both using a 50J , 100J , 150J , 200J , 200J selected energy escalating protocol . Failure to cardiovert after the fifth shock was classed as failed defibrillation . The power of this study was 80 % with 5 % significance level to detect a difference of 20 % or greater between groups . Survival analysis was used to compare the total energy delivered to achieve successful cardioversion between groups . RESULTS A total of 202 patients were recruited , of which data are complete for 199 ( 100 BR ; 99 BTE ) . Median number of shocks to achieve cardioversion was 2 for the BR waveform and 3 for the BTE waveform ( P = 0.059 ) . In the BR waveform group , 95/100 ( 95.0 % ) achieved sinus rhythm . In the BTE waveform group , 90/99 ( 90.9 % ) achieved sinus rhythm and this group required on average 117.1J more energy to achieve the outcome compared to the BR waveform group ( P = 0.838 ) . CONCLUSIONS BR and BTE waveforms show similar high efficacy in the elective cardioversion of atrial fibrillation"
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41171040-06ff-11f0-808a-c43d1ab1c353
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This study systematic ally assessed the effectiveness of lifestyle interventions on glycemic indicators among adults ( ⩾18years ) without IGT or diabetes . R and omized controlled trials using physical activity ( PA ) , diet ( D ) , or their combined strategies ( PA+D ) with follow-up ⩾12months were systematic ally search ed from multiple electronic- data bases between inception and May 4 , 2016 . Outcome measures included fasting plasma glucose ( FPG ) , glycated hemoglobin ( HbA1c ) , fasting insulin ( FI ) , homeostasis model assessment -estimated insulin resistance ( HOMA-IR ) , and bodyweight . Included studies were divided into low-range ( FPG or HbA1c ⩾5.5 % ) groups according to baseline glycemic levels . Seventy-nine studies met inclusion criteria . R and om-effect models demonstrated that compared with usual care , lifestyle interventions achieved significant reductions in FPG ( -0.14mmol/L [ 95%CI , -0.19 , -0.10 ] ) , HbA1c ( -0.06 % [ -0.09 , -0.03 ] ) , FI ( % change : -15.18 % [ -20.01 , -10.35 ] ) , HOMA-IR ( % change : -22.82 % [ -29.14 , -16.51 ] ) , and bodyweight ( % change : -3.99 % [ -4.69 , -3.29 ] ) . The same effect sizes in FPG reduction ( 0.07 ) appeared among both low-range and high-range groups . Similar effects were observed among all groups regardless of lengths of follow-up . D and PA+D interventions had larger effects on glucose reduction than PA alone . Lifestyle interventions significantly improved FPG , HbA1c , FI , HOMA-IR , and bodyweight among adults without IGT or diabetes , and might reduce progression of hyperglycemia to type 2 diabetes mellitus
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"Background Colorectal cancer ( CRC ) is the third most commonly diagnosed cancer and the second highest cause of cancer death in the UK . Most cases occur in people over 50 years and CRC often co-exists with other lifestyle related disorders including obesity , type 2 diabetes mellitus ( T2DM ) and cardiovascular disease ( CVD ) . These diseases share risk factors related to the metabolic syndrome including large body size , abnormal lipids and markers of insulin resistance indicating common aetiological pathways . Methods / Design This 3 year study will be a two-arm , multicentre , r and omised controlled trial comparing the BeWEL lifestyle ( diet , physical activity and behaviour change ) programme against usual care . The pre-trial development will take 6 months and participants will be recruited over a 12 month period and undertake the intervention and follow up for 12 months ( total 24 months recruitment and intervention implementation ) with a further 6 months for data collection , analysis and interpretation . Four hundred and fifty two participants who have had a colorectal adenoma detected and removed ( through the national colorectal screening programme ) will provide 80 % power to detect a weight loss of 7 % over 12 months . Primary outcomes are changes in body weight and waist circumference . Secondary outcomes will include cardiovascular risk factors , psycho-social measures and intervention costs . Discussion The results from this study will enhance the evidence base for lifestyle change in patients at higher risk of chronic disease including obesity related cancers . International St and ard R and omised Controlled Trials No : IS RCT",
"BACKGROUND Since the Diabetes Prevention Project ( DPP ) demonstrated that lifestyle weight-loss interventions can reduce the incidence of diabetes by 58 % , several studies have translated the DPP methods to public health-friendly context s. Although these studies have demonstrated short-term effects , no study to date has examined the impact of a translated DPP intervention on blood glucose and adiposity beyond 12 months of follow-up . PURPOSE To examine the impact of a 24-month , community-based diabetes prevention program on fasting blood glucose , insulin , insulin resistance as well as body weight , waist circumference , and BMI in the second year of follow-up . DESIGN An RCT comparing a 24-month lifestyle weight-loss program ( LWL ) to an enhanced usual care condition ( UCC ) in participants with prediabetes ( fasting blood glucose=95 - 125 mg/dL ) . Data were collected in 2007 - 2011 ; analyses were conducted in 2011 - 2012 . SETTING / PARTICIPANTS 301 participants with prediabetes were r and omized ; 261 completed the study . The intervention was held in community-based sites . INTERVENTION The LWL program was led by community health workers and sought to induce 7 % weight loss at 6 months that would be maintained over time through decreased caloric intake and increased physical activity . The UCC received two visits with a registered dietitian and a monthly newsletter . MAIN OUTCOME MEASURES The main measures were fasting blood glucose , insulin , insulin resistance , body weight , waist circumference , and BMI . RESULTS Intent-to-treat analyses of between-group differences in the average of 18- and 24-month measures of outcomes ( controlling for baseline values ) revealed that the LWL participants experienced greater decreases in fasting glucose ( -4.35 mg/dL ) ; insulin ( -3.01 μU/ml ) ; insulin resistance ( -0.97 ) ; body weight ( -4.19 kg ) ; waist circumference ( -3.23 cm ) ; and BMI ( -1.40 ) , all p-values reductions in metabolic indicators and adiposity ",
"Aims /hypothesis . The World Health Organisation Consultation recommended new diagnostic criteria for diabetes mellitus including : lowering of the diagnostic fasting plasma glucose to 7.0 mmol/l and introduction of a new category : impaired fasting glycaemia . The diagnostic 2-h glucose concentrations for diabetes and for impaired glucose tolerance were unchanged . This study identifies fasting plasma glucose concentrations predicting a diabetic 2-h plasma glucose of 11.1 mmol/l or more , analyses the sensitivity and specificity of different screening strategies for diabetes and describes the cardiovascular risk profile in people with impaired fasting glycaemia . Methods . European population based studies ( n = 17 ) or large , representative sample s of employees ( n = 3 ) with both fasting and 2-h post load glucose concentrations following 75-g oral glucose tolerance tests were included ( 18 918 men and 10 190 women ) . The Icel and study ( 8881 men and 9407 women ) is presented separately as a 50-g glucose load was used . Results . The fasting plasma glucose predicting a 2-h plasma glucose of 11.1 mmol/l or more with optimal sensitivity and specificity was a ) 5.8 mmol/l in women and 6.4 mmol/l in men ; b ) independent of age ; c ) increased with obesity . Fasting plasma glucose of 7.0/7.8 mmol/l or more predicted a diabetic 2-h plasma glucose with sensitivities of 49.0/29.8 % and specificities of 98.2/99.7 % , respectively . Conclusion /interpretation . If fasting glucose is used alone , the 31 % of diabetic subjects with a non-diabetic fasting glucose but a diabetic 2-h glucose , will not be diagnosed ; impaired fasting glycaemia and impaired glucose tolerance do not identify the same people ; the risk profile of people with impaired fasting glycaemia depends on 2-h glucose concentrations . Obesity is the main confounder in the association between fasting and 2-h glucose . [ Diabetologia ( 1999 ) 42 : 647–654",
"OBJECTIVE To evaluate the effectiveness of a lifestyle intervention for male workers in the construction industry at risk of cardiovascular disease ( CVD ) . METHODS In a r and omized controlled trial performed in the Netherl and s between 2007 and 2009 , usual care was compared to 6 months of individual counseling using motivational interviewing techniques , delivered face to face and by telephone . Participants aim ed at improving energy balance-related behavior or smoking cessation . Linear regression analyses were performed to determine the effects . RESULTS Body weight had significantly decreased at 6 ( β=-1.9 , 95 % CI -2.6 ; -1.2 ) and 12 months ( β=-1.8 , 95%CI -2.8 ; -1.1 ) . The intervention effects were also significant for diastolic blood pressure at 6 months ( β=-1.7 , 95 % CI -3.3 ; -0.1 ) . Among participants who had aim ed at energy balance , the intervention had a significant favorable effect on body weight at 6 ( β=-2.1 , 95 % CI -2.9 ; -1.3 ) and 12 months ( β=-2.2 , 95 % CI -3.1 ; -1.3 ) and at HDL cholesterol ( β=0.05 , 95 % CI 0.01 ; 0.10 ) and HbA1c ( β=-0.06 , 95%CI -0.12 ; -0.001 ) at 12 months , although there was no intervention effect on these variables over time . CONCLUSION Individual-based counseling result ed in significant beneficial long-term effects on body weight . This is an important finding for occupational health , considering the rising prevalence of obesity and CVD",
"BACKGROUND Obesity exacerbates the age-related decline in physical function and causes frailty in older adults ; however , the appropriate treatment for obese older adults is controversial . METHODS In this 1-year , r and omized , controlled trial , we evaluated the independent and combined effects of weight loss and exercise in 107 adults who were 65 years of age or older and obese . Participants were r and omly assigned to a control group , a weight-management ( diet ) group , an exercise group , or a weight-management-plus-exercise ( diet-exercise ) group . The primary outcome was the change in score on the modified Physical Performance Test . Secondary outcomes included other measures of frailty , body composition , bone mineral density , specific physical functions , and quality of life . RESULTS A total of 93 participants ( 87 % ) completed the study . In the intention-to-treat analysis , the score on the Physical Performance Test , in which higher scores indicate better physical status , increased more in the diet-exercise group than in the diet group or the exercise group ( increases from baseline of 21 % vs. 12 % and 15 % , respectively ) ; the scores in all three of those groups increased more than the scores in the control group ( in which the score increased by 1 % ) ( P peak oxygen consumption improved more in the diet-exercise group than in the diet group or the exercise group ( increases of 17 % vs. 10 % and 8 % , respectively ; P score on the Functional Status Question naire , in which higher scores indicate better physical function , increased more in the diet-exercise group than in the diet group ( increase of 10 % vs. 4 % , P Body weight decreased by 10 % in the diet group and by 9 % in the diet-exercise group , but did not decrease in the exercise group or the control group ( P Lean body mass and bone mineral density at the hip decreased less in the diet-exercise group than in the diet group ( reductions of 3 % and 1 % , respectively , in the diet-exercise group vs. reductions of 5 % and 3 % , respectively , in the diet group ; P Strength , balance , and gait improved consistently in the diet-exercise group ( P musculoskeletal injuries . CONCLUSIONS These findings suggest that a combination of weight loss and exercise provides greater improvement in physical function than either intervention alone . ( Funded by the National Institutes of Health ; Clinical Trials.gov number , NCT00146107 . )",
"BACKGROUND The Diabetes Prevention Program ( DPP ) found that an intensive lifestyle intervention can reduce the development of diabetes by more than half in adults with prediabetes , but there is little information about the feasibility of offering such an intervention in community setting s. This study evaluated the delivery of a group-based DPP lifestyle intervention in partnership with the YMCA . METHODS This pilot cluster-r and omized trial was design ed to compare group-based DPP lifestyle intervention delivery by the YMCA to brief counseling alone ( control ) in adults who attended a diabetes risk-screening event at one of two semi-urban YMCA facilities and who had a BMI > or=24 kg/m2 , > or=2 diabetes risk factors , and a r and om capillary blood glucose of 110 - 199 mg/dL. Multivariate regression was used to compare between-group differences in changes in body weight , blood pressures , HbA1c , total cholesterol , and HDL-cholesterol after 6 and 12 months . RESULTS Among 92 participants , controls were more often women ( 61 % vs 50 % ) and of nonwhite race ( 29 % vs 7 % ) . After 6 months , body weight decreased by 6.0 % ( 95 % CI=4.7 , 7.3 ) in intervention participants and 2.0 % ( 95 % CI=0.6 , 3.3 ) in controls ( p total cholesterol ( -22 mg/dL vs + 6 mg/dL controls ; p YMCA sites , it was not possible to adjust for potential clustering by site . CONCLUSIONS The YMCA may be a promising channel for wide-scale dissemination of a low-cost approach to lifestyle diabetes prevention",
"Background / Objectives : Direct evidence for the effects of vegetable intake on weight loss is qualified . The study aim ed to assess the effect of higher vegetable consumption on weight loss . Subjects/ Methods : A single blind parallel controlled trial was conducted with 120 overweight adults ( mean body mass index=29.98 kg/m2 ) r and omised to two energy deficit healthy diet advice groups differing only by doubling the serving ( portion ) sizes of vegetables in the comparator group . Data were analysed as intention-to-treat using a linear mixed model . Spearmans rho bivariate was used to explore relationships between percentage energy from vegetables and weight loss . Results : After 12 months , the study sample lost 6.5±5.2 kg ( P0.05 interaction ) . Both groups increased vegetable intake and lost weight in the first 3 months , and the change in weight was significantly correlated with higher proportions of energy consumed as vegetables ( rho=–0.217 , P=0.024 ) . Fasting glucose , insulin and triglyceride levels decreased ( P and high-density lipoprotein cholesterol levels increased ( P groups . Weight loss was sustained for 12 months by both groups , but the comparator group reported greater hunger satisfaction ( P=0.005 ) . Conclusions : Advice to consume a healthy low-energy diet leads to sustained weight loss , with reductions in cardiovascular disease risk factors regardless of an emphasis on more vegetables . In the short term , consuming a higher proportion of the dietary energy as vegetables may support a greater weight loss and the dietary pattern appears sustainable",
"Background Of all workers in Dutch construction industry , 20 % has an elevated risk of cardiovascular disease ( CVD ) . A major risk factor for CVD risk is an unhealthy lifestyle . The aim of our study is to design a lifestyle intervention for construction workers with an elevated CVD risk , and to evaluate its ( cost- ) effectiveness . Methods / Design In a RCT , 692 participants will be r and omised to either the control or the intervention group . The control group will receive usual care . For the intervention group , a lifestyle intervention has been design ed based on interviews and current literature . The intervention will last 6 months and will comprise 3 face-to-face and 4 telephone contacts , consisting of individual counselling aim ed at increasing daily physical activity ( PA ) and improving dietary behaviour , and /or smoking cessation . Counselling will take place at the Occupational Health Service ( OHS ) , and will be done according to motivational interviewing ( MI ) . Additional written information about healthy lifestyle will also be provided to those in the intervention group . At baseline , after 6 and after 12 months , measurements will take place . Primary outcome variables will be the lifestyle behaviours of concern , i.e. daily PA , dietary intake , and smoking status . Secondary outcome variables will be body mass index ( BMI ) , systolic and diastolic blood pressure , total and HDL blood cholesterol , Hba1c and cardio-respiratory fitness ( CRF ) . Sickness absenteeism and cost-effectiveness will be assessed as well . Multilevel analysis will be performed to compare all outcome measures between the intervention group and the control group . Discussion By improving lifestyle , CVD risk may be lowered , yielding benefits for both employee and employer . If proven effective , this lifestyle intervention will be implemented on a larger scale within the Occupational Health Services in construction industry . Trial registration Current Controlled Trials IS RCT",
"Aims /hypothesisA diet low in saturated fatty acids and rich in wholegrains , vegetables and fruit is recommended in order to reduce the risk of obesity , cardiovascular disease and type 2 diabetes mellitus . However there is widespread interest in high-fat ( “ Atkins Diet ” ) and high-protein ( “ Zone Diet ” ) alternatives to the conventional high-carbohydrate , high-fibre approach . We report on a r and omised trial that compared these two alternative approaches with a conventional diet in overweight insulin-resistant women . Methods Ninety-six normoglycaemic , insulin-resistant women ( BMI > 27 kg/m2 ) were r and omised to one of three dietary interventions : a high-carbohydrate , high-fibre ( HC ) diet , the high-fat ( HF ) Atkins Diet , or the high-protein ( HP ) Zone Diet . The experimental approach was design ed to mimic what might be achieved in clinical practice : the recommendations involved advice concerning food choices and were not prescriptive in terms of total energy . There were supervised weight loss and weight maintenance phases ( 8 weeks each ) , but there was no contact between the research team and the participants during the final 8 weeks of the study . Outcome was assessed in terms of body composition and indicators of cardiovascular and diabetes risk . Results Body weight , waist circumference , triglycerides and insulin levels decreased with all three diets but , apart from insulin , the reductions were significantly greater in the HF and HP groups than in the HC group . These observations suggest that the popular diets reduced insulin resistance to a greater extent than the st and ard dietary advice did . When compared with the HC diet , the HF and HP diets were shown to produce significantly ( p including weight loss ( HF −2.8 kg , HF −2.7 kg ) , waist circumference ( HF −3.5 cm , HF −2.7 cm ) and triglycerides ( HF −0.30 mmol/l , HF −0.22 mmol/l ) . LDL cholesterol decreased in individuals on the HC and HP diets , but tended to fluctuate in those on the HF diet to the extent that overall levels were significantly lower in the HP group than in the HF group ( −0.28 mmol/l , 95 % CI 0.04–0.52 , p=0.02 ) . Of those on the HF diet , 25 % showed a > 10 % increase in LDL cholesterol , whereas this occurred in only 13 % of subjects on the HC diet and 3 % of those on the HP diet . Conclusions /interpretationIn routine practice a reduced-carbohydrate , higher protein diet may be the most appropriate overall approach to reducing the risk of cardiovascular disease and type 2 diabetes . To achieve similar benefits on a HC diet , it may be necessary to increase fibre-rich wholegrains , legumes , vegetables and fruits , and to reduce saturated fatty acids to a greater extent than appears to be achieved by implementing current guidelines . The HF approach appears successful for weight loss in the short term , but lipid levels should be monitored . The potential deleterious effects of the diet in the long term remain a concern",
"Purpose Translating strategies and approaches from the successful clinical ly based Diabetes Prevention Program ’s lifestyle intervention to community setting s is a key next step . This article describes a lifestyle program developed in partnership by research ers at a major university and public health professionals at a local health department . Methods The Live Well , Be Well ( LWBW ) program was design ed to meet the needs of lower income , minority , and low-literacy adults at risk for diabetes . It was adapted from interventions with demonstrated efficacy and delivered in Spanish and English by health department staff . The program consisted of a 6-month active phase and a 6-month maintenance phase and was primarily telephone based , with one in-person planning session and several group workshops . In-person and group sessions were held in convenient community-based setting s. Counselors provided education and skills training to modify diet and increase physical activity . Self-selected and attainable goal - setting and action plans were emphasized to enhance self-efficacy . LWBW is the intervention component of a r and omized trial with primary outcomes of fasting glucose , weight , and other clinical measures . Conclusions The program provides a unique translational model for implementing diabetes risk reduction programs for underserved population s. Individually tailored and non-prescriptive , it utilized existing health department infrastructure , focused on telephone counseling , used culturally appropriate , low-literacy material s , and was delivered in local , community-based facilities",
"Context : Menopausal-related weight gain and increased waist circumference have major cardiovascular health implication s for older women . The efficacy of a dietary and physical activity lifestyle intervention to prevent weight gain and elevations in cardiovascular disease ( CVD ) risk factors from the peri- to postmenopause is unknown . Objective : To report the 54-month results of a lifestyle dietary and physical activity program on weight , body composition , physical activity , diet , and other CVD risk factors . Design : Data are from a 5-year r and omized clinical trial known as the Women ’s Healthy Lifestyle Project , conducted from 1992 to 1999 . Participants : 535 healthy , premenopausal women ages 44 to 50 at study entry enrolled into the trial . Intervention : Participants were r and omly assigned to either a lifestyle intervention group receiving a 5-year behavioral dietary and physical activity program or to an assessment -only control group . The lifestyle intervention group was given modest weight loss goals ( 5–15 lb , or approximately 2.3–6.8 kg ) to prevent subsequent gain above baseline weight by the end of the trial . To achieve weight loss and lower low-density lipoprotein cholesterol levels , intervention participants followed an eating pattern consisting of 1,300 kcal/day ( 25 % total fat , 7 % saturated fat , 100 mg of dietary cholesterol ) and increased their physical activity expenditure ( 1,000–1,500 kcal/week).Main Outcome Measures : Regarding weight gain prevention , 55 % ( 136/246 ) of intervention participants were at or below baseline weight compared with 26 % ( 68/261 ) of controls after 4.5 years , χ(2 , N = 507 ) = 45.0 , p . The mean weight change in the intervention group was 0.1 kg below baseline ( SD = 5.2 kg ) compared with an average gain of 2.4 kg ( SD = 4.9 kg ) observed in the control group . Waist circumference also significantly decreased more in the intervention group compared with controls ( M = −2.9 cm , SD = 5.3 vs. M = −0.5 cm , SD = 5.6 , p physically active and reported eating fewer calories and less fat than controls . Long-term adherence to physical activity and a low-fat eating pattern was associated with better weight maintenance . Conclusions : In healthy women , weight gain and increased waist circumference during the peri- to postmenopause can be prevented with a long-term lifestyle dietary and physical activity intervention",
"The Oslo Diet and Exercise Study ( ODES ) is an unmasked r and omized 2 x 2 factorial trial of 1-year duration for each participant . During 1990 - 1991 219 participants ( 198 males and 21 females ) aged 41 - 50 were r and omized into one of four treatment groups ; no treatment ( control ) , dietary changes alone , exercise alone , or a combination of the two treatments . At inclusion , the participants had no overt heart disease , but they had increased body weight ; slightly increased blood pressure , serum triglycerides , and total cholesterol , and they had decreased HDL cholesterol . Further , they were all inactive at leisure time . The primary aim of the trial is to compare the isolated and combined effects of the four treatments on the variables fibrinogen , fibrinolytic capacity , coagulation factor VII , and platelet volume . A series of secondary hypotheses will also be tested , such as the effects on other coagulation and fibrinolytic components and activities ; lipids and lipoproteins ; fatty acids ; glucose and insulin response to a glucose load ; clinical , physiological , and anthropometric variables ; and quality of life . The dietary treatments are adapted according to each participant 's risk profile ( level of total cholesterol , HDL cholesterol , triglycerides , blood pressure , and body weight ) . Fish and fish products are recommended . Special emphasis is put on caloric restriction in those who are overweight and those with elevated blood pressure . Exercise sessions take place three times a week under the guidance of highly qualified instructors . The aim is to increase peak oxygen uptake through aerobic endurance training . Adherence to the exercise program is monitored closely",
"BACKGROUND Weight loss , through calorie restriction or increases in energy expenditure via exercise , improves glucose tolerance and insulin action . However , exercise-induced energy expenditure may further improve glucoregulation through mechanisms independent of weight loss . OBJECTIVE The objective was to assess the hypothesis that weight loss through exercise-induced energy expenditure improves glucoregulation and circulating factors involved in insulin action to a greater extent than does similar weight loss through calorie restriction . DESIGN Sedentary men and women aged 50 - 60 y with a body mass index ( kg/m(2 ) ) of 23.5 - 29.9 were r and omly assigned to 1 of 2 weight-loss interventions [ 12 mo of exercise training ( EX group ; n = 18 ) or calorie restriction ( CR group ; n = 18 ) ] or to a healthy lifestyle ( HL ) control group ( n = 10 ) . The insulin sensitivity index and areas under the curve for glucose and insulin were assessed with an oral-glucose-tolerance test . Adiponectin and tumor necrosis factor alpha concentrations were measured in fasting serum . Fat mass was measured by dual-energy X-ray absorptiometry . RESULTS Yearlong energy deficits were not significantly different between the EX and CR groups , as evidence d by body weight and fat mass changes . The insulin sensitivity index increased and the glucose and insulin areas under the curve decreased in the EX and CR groups , remained unchanged in the HL group , and did not differ significantly between the EX and CR groups . Marginally significant increases in adiponectin and decreases in the ratio of tumor necrosis factor alpha to adiponectin occurred in the EX and CR groups but not in the HL group . CONCLUSIONS Weight loss induced by exercise training or calorie restriction improves glucose tolerance and insulin action in nonobese , healthy , middle-aged men and women . However , it does not appear that exercise training-induced weight loss results in greater improvements than those that result from calorie restriction alone",
"We evaluated changes in mindful eating as a potential mechanism underlying the effects of a mindfulness-based intervention for weight loss on eating of sweet foods and fasting glucose levels . We r and omized 194 obese individuals ( M age = 47.0 ± 12.7 years ; BMI = 35.5 ± 3.6 ; 78 % women ) to a 5.5-month diet-exercise program with or without mindfulness training . The mindfulness group , relative to the active control group , evidence d increases in mindful eating and maintenance of fasting glucose from baseline to 12-month assessment . Increases in mindful eating were associated with decreased eating of sweets and fasting glucose levels among mindfulness group participants , but this association was not statistically significant among active control group participants . Twelve-month increases in mindful eating partially mediated the effect of intervention arm on changes in fasting glucose levels from baseline to 12-month assessment . Increases in mindful eating may contribute to the effects of mindfulness-based weight loss interventions on eating of sweets and fasting glucose levels",
"OBJECTIVES To determine if a widely available weight-management program ( Weight Watchers ) could achieve sufficient weight loss in persons with prediabetes compared with a Diabetes Prevention Program-based individual counseling program supported by National Diabetes Education Program material s. METHODS We conducted an individual , r and omized intervention trial in Indianapolis , Indiana , in 2013 to 2014 , in 225 persons with prediabetes . We compared the Weight Watchers weight-management program ( n = 112 ) with Your Game Plan to Prevent Type 2 Diabetes , a program developed by the National Diabetes Education Program . Outcomes were weight and metabolic markers measured at baseline , 6 months , and 12 months . RESULTS Intervention participants lost significantly more weight than controls at 6 months ( 5.5 % vs 0.8 % ) and 12 months ( 5.5 % vs 0.2 % ; both P greater improvements in hemoglobin A1c and high-density lipoprotein cholesterol level than did controls . CONCLUSIONS A large weight-management program is effective for achieving lifestyle changes associated with diabetes prevention . Such programs could significantly increase the availability of diabetes prevention programs worldwide making an immediate and significant public health impact",
"The Women on the Move through Activity and Nutrition ( WOMAN ) study was design ed to test whether a nonpharmacological intervention including qualitative and quantitative dietary changes to induce weight loss and increased physical activity levels would reduce blood triglyceride levels and number of low-density lipoprotein particles ( LDL-P ) . Such decreases in lipoproteins and other risk factors could reduce or slow progression of sub clinical cardiovascular disease ( CVD ) . Study participants were r and omized to either the intervention ( Lifestyle Change ) or assessment ( Health Education ) group . Most of the intervention ended at the 30-month visit . The last 48-month examination was completed in 9/2008 . There was very substantial weight loss and increased exercise during the first 30 months of the trial result ing in significant decreases in CV risk factors . Most of the intervention effect was lost through 48 months . Weight loss was 3.4 kg in Lifestyle Intervention and 0.2 kg in the Health Education at 48 months ( P = 0.000 ) . There were no significant changes at 48 months in lipid levels , blood pressure ( BP ) , glucose , insulin , or in the sub clinical measures of coronary calcium , carotid intima media thickness , or plaque . There was a significant decrease in long-distance corridor walk time in the Lifestyle vs. Health Education groups . Significant lifestyle changes can be achieved that result in decreases in CV risk factors . Whether such changes reduce CV outcomes is still untested in clinical trials of weight loss or exercise . Long-term maintenance of successful lifestyle changes , weight loss and reduced risk factors is the hurdle for lifestyle interventions attempting to prevent CV and other chronic diseases",
"BACKGROUND Low-carbohydrate diets are popular for weight loss , but their cardiovascular effects have not been well-studied , particularly in diverse population s. OBJECTIVE To examine the effects of a low-carbohydrate diet compared with a low-fat diet on body weight and cardiovascular risk factors . DESIGN A r and omized , parallel-group trial . ( Clinical Trials.gov : NCT00609271 ) . SETTING A large academic medical center . PARTICIPANTS 148 men and women without clinical cardiovascular disease and diabetes . INTERVENTION A low-carbohydrate ( Both groups received dietary counseling at regular intervals throughout the trial . MEASUREMENTS Data on weight , cardiovascular risk factors , and dietary composition were collected at 0 , 3 , 6 , and 12 months . RESULTS Sixty participants ( 82 % ) in the low-fat group and 59 ( 79 % ) in the low-carbohydrate group completed the intervention . At 12 months , participants on the low-carbohydrate diet had greater decreases in weight ( mean difference in change , -3.5 kg [ 95 % CI , -5.6 to -1.4 kg ] ; P = 0.002 ) , fat mass ( mean difference in change , -1.5 % [ CI , -2.6 % to -0.4 % ] ; P = 0.011 ) , ratio of total-high-density lipoprotein ( HDL ) cholesterol ( mean difference in change , -0.44 [ CI , -0.71 to -0.16 ] ; P = 0.002 ) , and triglyceride level ( mean difference in change , -0.16 mmol/L [ -14.1 mg/dL ] [ CI , -0.31 to -0.01 mmol/L { -27.4 to -0.8 mg/dL } ] ; P = 0.038 ) and greater increases in HDL cholesterol level ( mean difference in change , 0.18 mmol/L [ 7.0 mg/dL ] [ CI , 0.08 to 0.28 mmol/L { 3.0 to 11.0 mg/dL } ] ; P low-carbohydrate diet was more effective for weight loss and cardiovascular risk factor reduction than the low-fat diet . Restricting carbohydrate may be an option for persons seeking to lose weight and reduce cardiovascular risk factors . PRIMARY FUNDING SOURCE National Institutes of Health",
"Background People with Familial Hypercholesterolemia ( FH ) may benefit from lifestyle changes supporting their primary treatment of dyslipidaemia . This project evaluated the efficacy of an individualised tailored lifestyle intervention on lipids ( low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , total cholesterol ( TC ) and triglycerides ) , systolic blood pressure , glucose , body mass index ( BMI ) and waist circumference in people with FH . Methods Adults with FH ( n = 340 ) , recruited from a Dutch cascade screening program , were r and omly assigned to either a control group or an intervention group . The personalised intervention consisted of web-based tailored lifestyle advice and personal counselling . The control group received care as usual . Lipids , systolic blood pressure , glucose , BMI , and waist circumference were measured at baseline and after 12 months . Regression analyses were conducted to examine differences between both groups . Results After 12 months , no significant between-group differences of cardiovascular disease ( CVD ) risk indicators were observed . LDL-C levels had decreased in both the intervention and control group . This difference between intervention and control group was not statistically significant . Conclusions This project suggests that an individually tailored lifestyle intervention did not have an additional effect in improving CVD risk indicators among people with FH . The cumulative effect of many small improvements in all indicators on long term CVD risk remains to be assessed in future studies .Trial registration NTR1899 at",
"The objectives of this study were to 1 ) identify the independent effects of exercise ( aerobic or resistance training ) and weight loss on whole body insulin sensitivity and 2 ) determine if aerobic or resistance training would be more successful for maintaining improved whole body insulin sensitivity 1 yr following weight loss . Subjects were 97 healthy , premenopausal women , body mass index ( BMI ) 27 - 30 kg/m(2 ) . Following r and omized assignment to one of three groups , diet only , diet + aerobic , or diet + resistance training until a BMI whole body insulin sensitivity index ( S(I ) ) was determined using a frequently sample d intravenous glucose tolerance test . Results of repeated- measures ANOVA indicated a significant improvement in S(I ) following weight loss . However , there were no group or group × time interactions . At 1-yr follow up , there were no significant time or group interactions for S(I ; ) however , there was a significant group × time interaction for S(I ) . Post hoc analysis revealed that women in the aerobic training group showed a significant increased S(I ) from weight reduced to 1-yr follow up ( P S(I ) from weight reduced to 1-yr follow up were observed for diet only or diet + resistance groups . Additionally , multiple linear regression analysis revealed that change in whole body insulin sensitivity from baseline to 1-yr follow up was independently associated with the change in Vo(2max ) from baseline to 1-yr follow up ( P long-term aerobic exercise training may conserve improvements in S(I ) following weight loss and that maintaining cardiovascular fitness following weight loss may be important for maintaining improvements in S(I )",
"Background Latinos comprise the largest racial/ethnic group in the United States and have 2–3 times the prevalence of type 2 diabetes mellitus as Caucasians . Methods and design The Lawrence Latino Diabetes Prevention Project ( LLDPP ) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a ≥ 30 % probability of developing diabetes in the next 7.5 years per a predictive equation . The project was conducted in Lawrence , Massachusetts , a predominantly Caribbean-origin urban Latino community . Individuals were identified primarily from a community health center 's patient panel , screened for study eligibility , r and omized to either a usual care or a lifestyle intervention condition , and followed for one year . Like the efficacious Diabetes Prevention Program ( DPP ) , the LLDPP intervention targeted weight loss through dietary change and increased physical activity . However , unlike the DPP , the LLDPP intervention was less intensive , tailored to literacy needs and cultural preferences , and delivered in Spanish . The group format of the intervention ( 13 group sessions over 1 year ) was complemented by 3 individual home visits and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist . Study measures included demographics , Stern predictive equation components ( age , gender , ethnicity , fasting glucose , systolic blood pressure , HDL-cholesterol , body mass index , and family history of diabetes ) , glycosylated hemoglobin , dietary intake , physical activity , depressive symptoms , social support , quality of life , and medication use . Body weight was measured at baseline , 6-months , and one-year ; all other measures were assessed at baseline and one-year . All surveys were orally administered in Spanish . Results A community-academic partnership enabled the successful recruitment , intervention , and assessment of Latinos at risk of diabetes with a one-year study retention rate of 93%.Trial registration",
"CONTEXT Adiponectin and leptin are closely related to weight control and energy balance , whereas exercise affects elderly metabolic regulation and functional capacity . OBJECTIVE The objective of this study was to investigate leptin and adiponectin responses in elderly males after exercise training and detraining . DESIGN The study design was a 1-yr r and omized controlled trial . SETTING The study was performed at the Laboratory of Physical Education and Sport Science Department . PARTICIPANTS Fifty inactive men [ age , 65 - 78 yr ; body mass index ( BMI ) , 28.7 - 30.2 kg/m2 ] were recruited from a volunteer data base by word of mouth and fliers sent to medical practitioners , physiotherapists , and nursing homes in the local community . INTERVENTION(S ) Participants were r and omly assigned to a control ( n = 10 ) , low-intensity ( n = 14 ) , moderate-intensity ( n = 12 ) , or high-intensity training ( HI ; n = 14 ) group . Resistance training ( 6 months , 3 d/wk , 10 exercises/three sets ) was followed by 6 months of detraining . MAIN OUTCOME MEASURE(S ) Strength , exercise energy cost , skinfold sum , body weight , maximal oxygen consumption , resting metabolic rate ( RMR ) , and plasma leptin and adiponectin were determined at baseline and after training and detraining . RESULTS Strength , maximal oxygen consumption , RMR , and exercise energy cost increased ( P Skinfold sum and BMI were reduced by resistance training ( P Leptin was diminished ( P adiponectin increased ( P percent leptin decrease was associated ( P percent BMI decrease and the percent RMR increase , whereas the percent adiponectin increase was associated ( P BMI decrease . CONCLUSIONS Resistance training and detraining may alter leptin and adiponectin responses in an intensity-dependent manner . Leptin and adiponectin changes were strongly associated with RMR and anthropometric changes",
"OBJECTIVES This study tested a feasible method for screening for cardiovascular risk at the worksite and investigated the effects of a long-term comprehensive program of life-style intervention to prevent cardiovascular disease . METHODS Employees in the public sector filled out a self-administered question naire with questions on social , medical , and work-related factors . The respondents numbered 454 ( 80 % ) . A score sum for cardiovascular risk was calculated ( range 1 - 20 , median 7.0 ) , and the 128 subjects with a sum above 8 were invited to a health examination including blood sampling . Thereafter the subjects were invited to participate , following r and omization , in a comprehensive , 18-month , life-style intervention program to improve cardiovascular risk or in a control group . RESULTS The intervention group significantly decreased body mass index , diastolic blood pressure , heart rate , low-density lipoprotein ( LDL ) cholesterol , and smoking habits during the intervention . The initially elevated serum cortisol , as a marker of stress reaction , normalized in the intervention group . In the control group LDL cholesterol also decreased , but the glucose and triglyceride levels increased , and smoking habits were unchanged . Sick days for a given period decreased after 1 year in the intervention group but not in the control group . CONCLUSIONS Several cardiovascular risk factors can be improved and morning serum cortisol normalized during a long-term life-style intervention program with a r and omized design using a worksite population of middle-aged subjects . The use of a 2-step screening program , with an initial question naire followed by a health check of subjects with elevated risk , is feasible for worksite setting",
"OBJECTIVE The aim of this study was to assess the effectiveness of a new dietary education ( NDE ) program in reducing plasma glucose ( PG ) levels in Japanese male workers at high risk for type 2 diabetes through a r and omized controlled trial . RESEARCH DESIGN AND METHODS We r and omly assigned 173 high-risk men ( mean age , 55 years ) to either the NDE or the control ( conventional dietary education ) group . Each subject in the NDE group received two individualized interventions especially aim ed at reducing total energy intake at dinner by modifying dietary intake . The control group received conventional group counseling . An \" overintake/underintake fraction \" for total energy intake was used to measure the status of dietary intake . Our hypothesis was that the NDE group would have a 10 % decrease in 2-h PG 1 year after the start of the education . Outcome measures were compared with ANCOVA by adjusting for baseline values . RESULTS The NDE group had a significantly lower total energy intake at dinner and daily than the control group . The adjusted differences in changes from baseline in the absolute value of the ' overintake/underintake fraction ' were -15.3 % ( 95 % CI -24.6 to -6.0 % , P = 0.002 ) for dinner and -6.0 % ( -9.8 to -2.2 % , P = 0.002 ) for daily [ corrected ] . The NDE group had a decreased 2-h PG after 1 year , whereas that value was increased in the control group . The adjusted difference in the percent change of 2-h PG was significant ( -15.2 % , -22.0 to -8.4 % , P glucose levels in high-risk subjects for type 2 diabetes ",
"BACKGROUND The Diabetes Prevention Program ( DPP ) lifestyle intervention reduced the incidence of type 2 diabetes mellitus ( DM ) among high-risk adults by 58 % , with weight loss as the dominant predictor . However , it has not been adequately translated into primary care . METHODS We evaluated 2 adapted DPP lifestyle interventions among overweight or obese adults who were recruited from 1 primary care clinic and had pre-DM and /or metabolic syndrome . Participants were r and omized to ( 1 ) a coach-led group intervention ( n = 79 ) , ( 2 ) a self-directed DVD intervention ( n = 81 ) , or ( 3 ) usual care ( n = 81 ) . During a 3-month intensive intervention phase , the DPP-based behavioral weight-loss curriculum was delivered by lifestyle coach-led small groups or home-based DVD . During the maintenance phase , participants in both interventions received lifestyle change coaching and support remotely-through secure email within an electronic health record system and the American Heart Association Heart360 website for weight and physical activity goal setting and self-monitoring . The primary outcome was change in body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) from baseline to 15 months . RESULTS At baseline , participants had a mean ( SD ) age of 52.9 ( 10.6 ) years and a mean BMI of 32.0 ( 5.4 ) ; 47 % were female ; 78 % , non-Hispanic white ; and 17 % , Asian/Pacific Isl and er . At month 15 , the mean ± SE change in BMI from baseline was -2.2 ± 0.3 in the coach-led group vs -0.9 ± 0.3 in the usual care group ( P self-directed group vs usual care ( P = .02 ) . The percentages of participants who achieved the 7 % DPP-based weight-loss goal were 37.0 % ( P = .003 ) and 35.9 % ( P = .004 ) in the coach-led and self-directed groups , respectively , vs 14.4 % in the usual care group . Both interventions also achieved greater net improvements in waist circumference and fasting plasma glucose level . CONCLUSION Proven effective in a primary care setting , the 2 DPP-based lifestyle interventions are readily scalable and exportable with potential for substantial clinical and public health impact . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00842426",
"OBJECTIVE Studies suggest that high-dairy and high-fiber/low-glycemic index diets may facilitate weight loss , but data are conflicting . The effects on weight loss and body fat of a high-dairy diet and a diet high in dairy and fiber and low in glycemic index were compared with a st and ard diet . RESEARCH METHODS AND PROCEDURES Ninety obese subjects were recruited into a r and omized trial of three diets design ed to provide a calorie deficit of 500 calories/d over a 48-week period . The study compared a moderate ( not low)-calcium diet with a high-calcium diet . RESULTS Seventy-two subjects completed the study . Significant weight and fat loss occurred with all three diets . A diet with 1400 mg of calcium did not result in greater weight ( 11.8 + /- 6.1 kg ) or fat ( 9.0 + /- 6.0 kg ) loss than a diet with 800 mg of calcium ( 10.0 + /- 6.8 and 7.5 + /- 6.6 kg , respectively ) . A diet with 1400 mg of calcium , increased fiber content , and fewer high-glycemic index foods did not result in greater weight ( 10.6 + /- 6.8 kg ) or fat ( 8.5 + /- 7.8 kg ) loss than the st and ard diet with 800 mg of calcium . Lipid profile , high-sensitivity C-reactive protein , leptin , fasting glucose , and insulin improved significantly , but there were no significant differences between the experimental diets and the control diet . DISCUSSION We found no evidence that diets higher than 800 mg of calcium in dairy products or higher in fiber and lower in glycemic index enhance weight reduction beyond what is seen with calorie restriction alone",
"OBJECTIVE : To compare the long-term compliance and effects of two low-fat diets differing in carbohydrate to protein ratio on body composition and biomarkers of cardiovascular disease risk in obese subjects with hyperinsulinemia . DESIGN : Outpatient , parallel , clinical intervention study of two groups of subjects r and omly assigned to either a st and ard protein ( SP ; 15 % protein , 55 % carbohydrate ) or high-protein ( HP ; 30 % protein , 40 % carbohydrate ) diet , during 12 weeks of energy restriction ( ∼6.5 MJ/day ) and 4 weeks of energy balance ( ∼8.3 MJ/day ) . Subsequently , subjects were asked to maintain the same dietary pattern for the succeeding 52 weeks with minimal professional support . SUBJECTS : A total of 58 obese , nondietetic subjects with hyperinsulinemia ( 13 males/45 females , mean age 50.2 y , mean body mass index ( BMI ) 34.0 kg/m2 , mean fasting insulin 17.8 mU/l ) participated in the study . MEASUREMENTS : Body composition , blood pressure , blood lipids , fasting glucose , insulin , CRP and sICAM-1 were measured at baseline and at weeks 16 and 68 . Urinary urea/creatinine ratio was measured at baseline , week 16 and at 3 monthly intervals thereafter . RESULTS : In total , 43 subjects completed the study with similar dropouts in each group ( P=0.76 ) . At week 68 , there was net weight loss ( SP −2.9±3.6 % , HP −4.1±5.8 % ; P fat loss ( P significantly increased HDL cholesterol concentrations ( P and decreased fasting insulin , insulin resistance , sICAM-1 and CRP levels ( P ) . Protein intake was significantly greater in HP during the initial 16 weeks ( P achieved net weight loss and improvements in cardiovascular risk factors ",
"Objective : High-carbohydrate (HC)–high-fibre diets are recommended for weight loss and for treating and preventing diseases such as diabetes and cardiovascular disease . We report a r and omised trial comparing high-fat ( HF ) and high-protein ( HP ) diets with the conventional approach . Research design and methods : A total of 93 overweight insulin-resistant women received advice following r and omisation to HF , HP or HC dietary regimes , to achieve weight loss followed by weight maintenance over 12 months . Weight , body composition and measures of carbohydrate and lipid metabolism were investigated . Results : Retention rates were 93 % for HP and 75 % for HC and HF . Features of the metabolic syndrome improved in all groups during the first 6 months , to a greater extent on HF and HP than an HC . During the second 6 months the HF group had increases in waist circumference ( mean difference 4.4 cm ( 95 % CI 3.0 , 5.8 ) ) , fat mass ( 2.3 kg ( 1.5 , 3.1 ) ) , triglycerides ( 0.28 mmol/l ( 0.09 , 0.46 ) ) and 2 h glucose ( 0.70 mmol/l ( 0.22 , 1.18 ) ) . Overall there was substantial sustained improvement in waist circumference , triglycerides and insulin in the HP group and sustained but more modest changes on HC . Dietary compliance at 12 months was poor in all groups . Conclusions : HP and HC approaches appear to be appropriate options for insulin-resistant individuals . When recommending HP diets appropriate composition of dietary fat must be ensured . HC diet recommendations must include advice regarding appropriate high-fibre , low glycaemic index foods",
"CONTEXT Although commercial weight loss programs provide treatment to millions of clients , their efficacy has not been evaluated in rigorous long-term trials . OBJECTIVE To compare weight loss and health benefits achieved and maintained through self-help weight loss vs with a structured commercial program . DESIGN AND SETTING A 2-year , multicenter r and omized clinical trial with clinic visits at 12 , 26 , 52 , 78 , and 104 weeks conducted at 6 academic research centers in the United States between January 1998 and January 2001 . PARTICIPANTS Overweight and obese men ( n = 65 ) and women ( n = 358 ) ( body mass index , 27 - 40 ) aged 18 to 65 years . INTERVENTION R and om assignment to either a self-help program ( n = 212 ) consisting of two 20-minute counseling sessions with a nutritionist and provision of self-help re sources or to a commercial weight loss program ( n = 211 ) consisting of a food plan , an activity plan , and a cognitive restructuring behavior modification plan , delivered at weekly meetings . MAIN OUTCOME MEASURES Weight change was the primary outcome measure . Secondary outcomes included waist circumference , body mass index , blood pressure , serum lipids , glucose , and insulin levels . RESULTS At 2 years , 150 participants ( 71 % ) in the commercial group and 159 ( 75 % ) in the self-help group completed the study . In the intent-to-treat analysis , mean ( SD ) weight loss of participants in the commercial group was greater than in the self-help group at 1 year ( -4.3 [ 6.1 ] kg vs -1.3 [ 6.1 ] kg , respectively ; P Waist circumference ( P = .003 ) and body mass index ( P Changes in blood pressure , lipids , glucose , and insulin levels were related to changes in weight in both groups , but between-group differences in biological parameters were mainly nonsignificant by year 2 . CONCLUSION The structured commercial weight loss program provided modest weight loss but more than self-help over a 2-year period",
"Objective Swimming is often recommended in the prevention and treatment of hypertension . Few studies have investigated the effect of swimming training on blood pressure ( BP ) . Our objective was to evaluate 6 months of supervised moderate swimming or walking on BP in previously sedentary , normotensive , older women . Design Women aged 50–70 years ( n = 116 ) were r and omly assigned to a supervised 6-month swimming or walking programme . They were further r and omized to receive usual care or a behavioural intervention package . Methods Exercise comprised 3 sessions/week with a warm-up , cool down , and 30-min of moderate intensity walking or swimming . BP was recorded for 20 min supine , and 5 min st and ing . Assessment s were made at 0 and 6 months . Results At baseline , mean supine BP ( ± SD ) was 115.7 ± 1.3/66.8 ± 0.7 mmHg . Swimming improved swim distance by 78.1 m ( 29.3 % ) [ 95 % confidence interval ( CI ) ; 66.7 , 89.4 ] and walk time by 0.58 min ( 3.8 % ) ( 0.41 , 0.74 ) . Walking decreased walk time by 1.0 min ( 6.5 % ) ( 0.81 , 1.19 ) . After adjustment for initial BP , age , hypertension treatment status and change in weight , swimming increased supine and st and ing systolic BP relative to walking by 4.4 mmHg ( 1.2 , 7.5 ) ( P = 0.008 ) and 6.0 mmHg ( 2.6 , 9.5 ) ( P = 0.001 ) , respectively . Supine and st and ing diastolic BP increased by 1.4 mmHg ( −0.14 , 3.0 ) ( P = 0.07 ) and 1.8 mmHg ( −0.02 , 3.5 ) ( P = 0.05 ) , respectively . Conclusion Relative to moderately paced walking , regular swimming significantly elevates BP in previously sedentary , normotensive , older women . This finding may have important implication s for exercise prescription in older subjects",
"OBJECTIVE : To compare the long-term effects of three different programs including initial 6 weeks (V)LCD diets 420 kcal/d , 530 kcal/d , 880 kcal/d ) on sustained weight loss , attrition and obesity associated conventional cardio-vascular risk factors . DESIGN : Prospect i ve , r and omized clinical 52 weeks trial . Two weeks of a booster (V)LCD period after week 26 . SETTING : University outpatient obesity clinic . SUBJECTS : Ninety-three middle-aged obese patients ( 30 men ) , initial mean BMI 38.7 kg/m2 , age 20–65 y , from the waiting list . MAIN OUTCOME MEASURES : Weight loss pattern , attrition , reported side effects , blood pressure , blood glucose and serum lipid levels . Repeated frequent measurements up to week 26 , intermittently up to final measurements at week 52 . RESULTS : One year attrition ( 30–45 % ) , sustained weight loss ( 8–15 % of initial body weight ) and changes in obesity associated risk parameters were similar in all three group . Fewer adverse events were reported in the LCD group . CONCLUSION : The results compare favorably with most previous reports of similar design . VLCD ( 420 kcal or 530 kcal/d and LCD 880 kcal/d ) were equally effective in long term treatment of obesity . The tendency to less side effects with LCD suggests that such preparations deserve further attention",
"OBJECTIVE To assess effects of a cognitively based program on health-related behaviors and cardiovascular risk factors in overweight drug-treated hypertensives . STUDY DESIGN AND SETTING In a clinical trials center , volunteers , recruited by advertisement , were r and omized to usual care ( N=118 ) or to a 4-month program ( N=123 ) incorporating weight loss ; a low-sodium diet , high in fruit , vegetables , and fish ; and increased physical activity . Diet , physical activity , weight , blood lipids , glucose , and insulin were measured at 4 and 16 months . RESULTS Ninety-eight usual care and 106 program participants completed the 4-month assessment ; 90 and 102 , respectively , completed follow-up . Using intention-to-treat analysis , relative to usual care , net changes with the program at 4 months were as follows : dietary fat ( -2.6 % energy ; P sodium ( -290mg/d ; P=0.004 ) ; energy ( -313mJ/d ; P=0.005 ) ; fish ( + 2.1 serves/wk ; P vegetables ( + 3.0 serves/wk ; P physical activity ( + 37min/wk ; P=0.004 ) ; weight ( -2.8 kg ; P waist girth ( -3.1 cm ; P total cholesterol ( -0.2mmol/L ; P=0.017 ) ; and triacylglycerols ( -0.12mmol/L ; P=0.002 ) . One year later , net changes included dietary fat ( -2.2 % energy ; P vegetables ( + 4.3 serves/wk ; P weight ( -2.5 kg ; P=0.001 ) ; waist girth ( -3.1 cm ; P high-density lipoprotein cholesterol ( + 0.03mmol/L ; P=0.031 ) . CONCLUSION Improvements in behaviors and risk factors , several maintained long term , suggest the potential for long-term benefits in hypertensives",
"Abstract About 75 % of African-Americans ( AAs ) ages 20 or older are overweight and nearly 50 % are obese , but community-based programs to reduce diabetes risk in AAs are rare . Our objective was to reduce weight and fasting plasma glucose ( FPG ) and increase physical activity ( PA ) from baseline to week-12 and to month-12 among overweight AA parishioners through a faith-based adaptation of the Diabetes Prevention Program called Fit Body and Soul ( FBAS ) . We conducted a single-blinded , cluster r and omized , community trial in 20 AA churches enrolling 604 AAs , aged 20–64 years with BMI ≥ 25 kg/m2 and without diabetes . The church ( and their parishioners ) was r and omized to FBAS or health education ( HE ) . FBAS participants had a significant difference in adjusted weight loss compared with those in HE ( 2.62 vs. 0.50 kg , p = 0.001 ) at 12-weeks and ( 2.39 vs. −0.465 kg , p = 0.005 ) at 12-months and were more likely ( 13 % ) than HE participants ( 3 % ) to achieve a 7 % weight loss ( p a 7 % weight loss ( 19 vs. 8 % , p differences in FPG and PA between arms . Of the 15.2 % of participants with baseline pre-diabetes , those in FBAS had , however , a significant decline in FPG ( 10.93 mg/dl ) at 12-weeks compared with the 4.22 mg/dl increase in HE ( p = 0.017 ) , and these differences became larger at 12-months ( FBAS , 12.38 mg/dl decrease ; HE , 4.44 mg/dl increase ) ( p = 0.021 ) . Our faith-based adaptation of the DPP led to a significant reduction in weight overall and in FPG among pre-diabetes participants . Clinical Trials.gov Identifier NCT01730196",
"OBJECTIVE : We examined three methods for calculating the area under the curve ( AUC ) following an oral glucose tolerance test ( OGTT ) in overweight adults prior to and after 9 months of exercise . METHOD : Subjects ( n=27 ) were r and omly assigned to a control ( CON , n=9 ) or intervention ( INT , n=18 ) group . INT performed supervised exercise 5 days per week , 45 min per session , at 65 % of heart rate reserve . OGTTs were administered pre- and post-training . Blood was collected during a 75 g OGTT and analyzed for glucose ( GLU ) and insulin ( INS ) concentrations . AUCs were calculated using the incremental , positive incremental , and total AUC methods and the difference scores for pre- and post-training were determined . RESULTS : No differences were observed among the methods for glucose AUC for either group . Significant differences were observed for INT insulin AUC with total AUC ( 1525±3291 µU/1/180 min ) significantly greater than incremental AUC ( 1112±3229 µU/1/180 min ) or positive incremental AUC ( 1085±3195 µU/I/180 min ) . Total insulin AUC was significantly reduced following training for INT , while incremental and positive incremental insulin AUCs showed no change . CONCLUSION : These data suggest that the method of used to calculate AUC may affect the interpretation of whether or not an intervention was effective",
"Objective To assess the effectiveness of a primary care based programme of exercise on prescription among relatively inactive women over a two year period . Design R and omised controlled trial . Setting 17 primary care practice s in Wellington , New Zeal and Participants 1089 women aged 40 - 74 not undertaking 30 minutes of moderate intensity physical activity on at least five days of the week Intervention Brief physical activity intervention led by nurse with six month follow-up visit and monthly telephone support over nine months . Main outcome measure Physical activity assessed at baseline and 12 and 24 months . Secondary outcomes were quality of life ( SF-36 ) , weight , waist circumference , blood pressure , concentrations of fasting serum lipids , glycated haemoglobin ( HbA1c ) , glucose , insulin , and physical fitness . Results Mean age was 58.9 ( SD 7 ) years . Trial retention rates were 93 % and 89 % at 12 and 24 months , respectively . At baseline , 10 % of intervention participants and 11 % of control participants were achieving 150 minutes of at least moderate intensity physical activity a week . At 12 months rates increased to 43 % and 30 % and at 24 months to 39.3 % and 32.8 % ( P SF-36 physical functioning ( P=0.03 ) and mental health ( P role physical scores were significantly lower ( P falls ( P injuries ( P=0.03 ) were recorded in the intervention group . Conclusions This programme of exercise on prescription increased physical activity and quality of life over two years , although falls and injuries also increased . This finding supports the use of exercise on prescription programmes as part of population strategies to reduce physical inactivity . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) ANZCTRN012605000490673",
"Objective Investigate the effects of 12 months of dietary weight loss and /or aerobic exercise on leukocyte telomere length in postmenopausal women . Design and Methods 439 overweight or obese women ( 50–75 y ) were r and omized to : i ) dietary weight loss ( N=118 ) ; ii ) aerobic exercise ( N=117 ) , iii ) diet + exercise ( N=117 ) , or iv ) control ( N=87 ) . The diet intervention was a group-based program with a 10 % weight loss goal . The exercise intervention was 45 mins/day , 5 days/week of moderate-to-vigorous aerobic activity . Fasting blood sample s were taken at baseline and 12 months . DNA was extracted from isolated leukocytes and telomere length was measured by quantitative-polymerase chain reaction ( qPCR ) . Mean changes were compared between groups ( intent-to-treat ) using generalized estimating equations . Results Baseline telomere length was inversely associated with age ( r=−0.12 p maximal oxygen uptake ( r=0.11 , p=0.03 ) , but not with BMI or % body fat . Change in telomere length was inversely correlated with baseline telomere length ( r=−0.47 , p significant difference in leukocyte telomere length was detected in any intervention group compared to controls , nor was the magnitude of weight loss associated with telomere length at 12 months . Conclusions Twelve-months of dietary weight loss and exercise did not change telomere length in postmenopausal women",
"Our aim was to determine whether short-term weight loss on a low-carbohydrate/low-saturated fat diet improved endothelial function compared with a conventional high-carbohydrate diet , as this diet is expected to lower both blood glucose and LDL-cholesterol . In a r and omised parallel design of two energy-restricted diets in an outpatient setting , thirty-six subjects ( BMI 33 ( sem 4 ) kg/m2 ) were r and omised to a low- or high-carbohydrate diet both low in saturated fat . Flow-mediated dilatation ( FMD ) , fasting glucose , insulin , lipids , adiponectin and adhesion molecules were measured at baseline , during weight loss and at 52 weeks . FMD did not change with either diet ( 5.2 ( sem 0.6 ) to 5.5 ( sem 0.6 ) % ) despite weight loss of 5 % and significant reductions in glucose and insulin and LDL-cholesterol and was not different after sustained weight loss of 5 % at 52 weeks . Adiponectin fell by 6 % at 12 weeks ( P = 0.1 ) with weight loss but rose by 17 % at 12 months ( P weight loss . There were no effects of diet . In contradistinction , adhesion molecules fell at 12 weeks , vascular cell adhesion molecule-1 by 14 % and intracellular adhesion molecule-1 by 13 % ( both P in HDL ( r 0.778 , P glucose ( r - 0.563 , P = 0.057 ) . In summary , weight loss does not improve FMD . Novel cardiovascular risk factors improved at 12 weeks but the improvement in adiponectin was delayed",
"Background A r and omized control trial was performed to test whether a lifestyle intervention program , carried out in a primary healthcare setting using existing re sources , can reduce the incidence of type 2 diabetes in Japanese with impaired glucose tolerance ( IGT ) . The results of 3 years ' intervention are summarized . Methods Through health checkups in communities and workplaces , 304 middle-aged IGT subjects with a mean body mass index ( BMI ) of 24.5 kg/m2 were recruited and r and omized to the intervention group or control group . The lifestyle intervention was carried out for 3 years by public health nurses using the curriculum and educational material s provided by the study group . Results After 1 year , the intervention had significantly improved body weight ( -1.5 ± 0.7 vs. -0.7 ± 2.5 kg in the control ; p = 0.023 ) and daily non-exercise leisure time energy expenditure ( 25 ± 113 vs. -3 ± 98 kcal ; p = 0.045 ) . Insulin sensitivity assessed by the Matsuda index was improved by the intervention during the 3 years . The 3-year cumulative incidence tended to be lower in the intervention group ( 14.8 % vs.8.2 % , log-rank test : p = 0.097 ) . In a sub- analysis for the subjects with a BMI > 22.5 kg/m2 , a significant reduction in the cumulative incidence was found ( p = 0.027 ) . Conclusions The present lifestyle intervention program using existing healthcare re sources is beneficial in preventing diabetes in Japanese with IGT . This has important implication s for primary healthcare-based diabetes prevention . Trial registration",
"Objective To evaluate the impact of a diet and physical activity intervention ( BeWEL ) on weight change in people with a body mass index > 25 weight (kg)/height (m)2 at increased risk of colorectal cancer and other obesity related comorbidities . Design Multicentre , parallel group , r and omised controlled trial . Setting Four Scottish National Health Service health boards . Participants 329 overweight or obese adults ( aged 50 to 74 years ) who had undergone colonoscopy after a positive faecal occult blood test result , as part of the national bowel screening programme , and had a diagnosis of adenoma confirmed by histopathology . 163 were r and omised to intervention and 166 to control . Intervention Participants were r and omised to a control group ( weight loss booklet only ) or 12 month intervention group ( three face to face visits with a lifestyle counsellor plus monthly 15 minute telephone calls ) . A goal of 7 % reduction in body weight was set and participants received a personalised energy prescription ( 2508 kJ ( 600 kcal ) below that required for weight maintenance ) and bodyweight scales . Motivational interviewing techniques explored self assessed confidence , ambivalence , and personal values concerning weight . Behavioural strategies included goal setting , identifying intentions of implementation , self monitoring of body weight , and counsellor feedback about reported diet , physical activity , and weight change . Main outcome measures The primary outcome was weight change over 12 months . Secondary outcomes included changes in waist circumference , blood pressure , fasting cardiovascular biomarkers , and glucose metabolism variables , physical activity , diet , and alcohol consumption . Results At 12 months , data on the primary outcome were available for 148 ( 91 % ) participants in the intervention group and 157 ( 95 % ) in the control group . Mean weight loss was 3.50 kg ( SD 4.91 ) ( 95 % confidence interval 2.70 to 4.30 ) in the intervention group compared with 0.78 kg ( SD 3.77 ) ( 0.19 to 1.38 ) in the control group . The group difference was 2.69 kg ( 95 % confidence interval 1.70 to 3.67 ) . Differences between groups were significant for waist circumference , body mass index , blood pressure , blood glucose level , diet , and physical activity . No reported adverse events were considered to be related to trial participation . Conclusions Significant weight loss can be achieved by a diet and physical activity intervention initiated within a national colorectal cancer screening programme , offering considerable potential for risk reduction of disease in older adults . Trial registration Current Controlled Trials IS RCT N53033856",
"OBJECTIVES In this paper , we present the results of changes in risk factors by use of hormone therapy ( HT ) at 18 months in the Women On the Move through Activity and Nutrition ( WOMAN ) r and omized trial . METHODS The trial was design ed to test the hypothesis that aggressive dietary changes and increased physical activity to reduce weight , waist circumference ( WC ) , glucose , insulin , and lipoproteins would reduce progression of sub clinical atherosclerosis , carotid intimal media thickness and plaque , coronary artery calcification , and pulse wave velocity ( PWV ) . The study focused on postmenopausal women ( n = 508 ) , mean age of 57 , who were r and omized to the Lifestyle Change ( LC ) or Health Education ( HE ) group . RESULTS At 18 months of follow-up , there was significant , 17 lb , weight loss and 10 cm WC decrease in the LC group . There were significant differences in changes in low-density lipoprotein cholesterol ( LDL-C ) , insulin , glucose , large LDL , and LDL particles between the LC and HE groups . Risk factor changes were greater for women in the LC who lost a significant amount of weight ( > or=18.8 lb ) . Participants at 18 months were subdivided into women who had stayed on HT , 125 ( 28 % ) ; stopped HT after r and omization , 145 ( 33 % ) ; and not on HT at baseline but stopped an average of 7 months prior to r and omization , 173 ( 39 % ) . Weight loss in the LC was similar for all three groups , but LDL lipoprotein response was better for women who stopped HT after r and omization or were not on HT at baseline . CONCLUSIONS The trial has been successful in increasing exercise and diet changes and reduction in weight and WC and variables related to metabolic syndrome",
"Objective : To compare the effects of counseling alone with that of additional participation in supervised training courses on exercise capacity in patients with impaired fasting glucose . Design : R and omized , controlled intervention trial using a nested cohort approach . Setting : Primary care centers in western Austria . Patients : Thirty-six patients with impaired fasting glucose ( 16 males , 20 females ; mean age , 57.5 ± 6.9 years ) . Interventions : Participants of both groups were instructed about the preventive effectiveness of changing their lifestyle , especially losing weight and increasing physical activity . One group had additionally been offered supervised , progressive , individually tailored aerobic exercise programs for 1 hour twice a week . Main Outcome Measures : Changes in the levels of exercise capacity , body mass , and fasting blood glucose . Results : The subjects with supervised exercise participated in this program for 1.8 hours ( ± 0.3 ) per week over 12 months . Supervised exercise was sufficient to maintain exercise capacity , whereas counseling alone was not ( + 4.4 % versus -6.9 % ; P = 0.01 ) . After the 12-month intervention period , body mass was reduced in the supervised exercise group ( -3.0 % ) compared with the counseling alone group ( + 1.0 % ) ( P = 0.03 ) and fasting plasma glucose levels had similarly improved by counseling for adequate lifestyle changes alone ( -8.2 % ) and in combination with supervised exercise ( -6.0 % ) . Conclusion : In contrast to counseling alone , 2 sessions of supervised training per week , besides the self-chosen physical activity and nutritional measures , are sufficient to maintain exercise capacity in patients with impaired fasting glucose",
"OBJECTIVES . To compare weight loss on a balanced hypocaloric diet to that of a Very Low Calorie Diet ( VLCD ) after two months of treatment and to further compare 26 months of weight maintenance and safety with or without VLCD assistance in obese patients . DESIGN . Prospect i ve , r and omized , controlled intervention trial , initially with two and later with three parallel groups . SETTING . Swedish University out-patient obesity clinic . SUBJECTS . Eighty-one obese patients of both gender with a BMI ≥30 kg/m2 from the waiting list participated in a structured weight reduction+weight maintenance programme . INTERVENTION . Twenty-seven patients ( group A ) were r and omized to a balanced diet of 6720 kJ/d ( 1600 kcal/d ) during the whole treatment period . The other patients ( n=54 ) were r and omized to VLCD ( Nutrilett ® ) 1764 kJ/d ( 420 kcal/d ) diet during the first two months . The VLCD treated patients were rer and omized after the initial treatment to the well balanced hypocaloric diet ( 6720 kJ/d ) with ( group C ) or without ( group B ) 1 MJ of VLCD to be taken during the evening . MAIN OUTCOME MEASURES . During the first two-month period , the mean body weight loss in the VLCD group was 18.9±7.1 kg compared to 7.2±4.8 kg in the diet treated group , with a similar relative fat loss assessed by bioimpedance of 68 % and 76 % respectively . The maintained weight loss in all groups after 28 months of treatment was 10.9±10.2 kg in the 52 % who completed the programme . Weight losses and drop-out rates were similar in all three groups . CONCLUSIONS . Twenty-four months weight maintenance and drop out rates are independent of whether the initial treatment commences with VLCD or a hypocaloric diet . One MJ nutrition powder taken freely does not affect 24 months weight maintenance on a hypocaloric ( 6.7 MJ/d ) diet",
"OBJECTIVE The main goal of the present study was to evaluate the effect of a commercially available milk containing small amounts of eicosapentaenoic acid and docosahexaenoic acid , oleic acid , and vitamins A , B6 , D , E , and folic acid compared with semi-skimmed and skimmed milk in volunteers with moderate cardiovascular risk . METHODS Two hundred ninety-seven subjects 25 to 65 y of age with moderate cardiovascular risk were r and omly allocated into three groups . In addition to their diets , one group consumed 500 mL/d of the enriched milk , another group consumed 500 mL/d of skimmed milk , and a control group consumed 500 mL/d of semi-skimmed milk . All groups consumed the dairy drinks for 1 y and blood sample s were taken at 0 and 12 mo . RESULTS Consumption of enriched milk for 1 y produced significant ( P serum folate ( 58 % ) and high-density lipoprotein cholesterol ( 4 % ) . Plasma triacylglycerols ( 10 % ) , total cholesterol ( 4 % ) , and low-density lipoprotein cholesterol ( 6 % ) were reduced significantly only in the supplemented group . Serum glucose , homocysteine , and C-reactive protein remained unchanged . In the skimmed milk and semi-skimmed milk groups , the only significant decreases were in serum folate ( 17 % and 11 % , respectively ) . CONCLUSION Daily intake of a milk enriched with fish oil , oleic acid , and vitamins improved the nutritional status and cardiovascular risk markers of volunteers , whereas skimmed milk and semi-skimmed milk did not",
"BACKGROUND Type 2 diabetes mellitus is increasingly common , primarily because of increases in the prevalence of a sedentary lifestyle and obesity . Whether type 2 diabetes can be prevented by interventions that affect the lifestyles of subjects at high risk for the disease is not known . METHODS We r and omly assigned 522 middle-aged , overweight subjects ( 172 men and 350 women ; mean age , 55 years ; mean body-mass index [ weight in kilograms divided by the square of the height in meters ] , 31 ) with impaired glucose tolerance to either the intervention group or the control group . Each subject in the intervention group received individualized counseling aim ed at reducing weight , total intake of fat , and intake of saturated fat and increasing intake of fiber and physical activity . An oral glucose-tolerance test was performed annually ; the diagnosis of diabetes was confirmed by a second test . The mean duration of follow-up was 3.2 years . RESULTS The mean ( + /-SD ) amount of weight lost between base line and the end of year 1 was 4.2+/-5.1 kg in the intervention group and 0.8+/-3.7 kg in the control group ; the net loss by the end of year 2 was 3.5+/-5.5 kg in the intervention group and 0.8+/-4.4 kg in the control group ( P cumulative incidence of diabetes after four years was 11 percent ( 95 percent confidence interval , 6 to 15 percent ) in the intervention group and 23 percent ( 95 percent confidence interval , 17 to 29 percent ) in the control group . During the trial , the risk of diabetes was reduced by 58 percent ( P the incidence of diabetes was directly associated with changes in lifestyle . CONCLUSIONS Type 2 diabetes can be prevented by changes in the lifestyles of high-risk subjects",
"INTRODUCTION Impact exercise is known to be beneficial for bones , but information regarding its effects on other health aspects is scarce . The aim of this study was to assess the effects of high-impact exercise on physical performance and glucose and lipid profiles . METHODS We performed a 12-month , population -based , r and omized controlled trial with 120 women ( 60 in the exercise group and 60 in the control group ; ages 35 - 40 yr ) . The exercise regimen comprised supervised , progressive , high-impact exercises two to three times per week and an additional home program . Physical activity was continuously recorded using an accelerometer-based method and was analyzed as the daily number of impacts within five acceleration ranges between 0.3 and 9.2 g ( g = acceleration of gravity : 9.81 m x s(-2 ) ) . The changes in physical performance and in glucose and lipid profiles were determined . RESULTS Thirty-nine women in the exercise group and 41 women in the control group completed the study . Maximal oxygen uptake ( 6.2 vs 3.1 mL x kg(-1 ) x min(-1 ) ; P = 0.008 ) and countermovement ( 2.3 vs -0.3 cm ; P static ( 1.4 vs -0.3 cm ; P = 0.004 ) jump heights increased significantly more in the exercise group than in the control group . Exercise training also decreased waist ( -1.1 vs 0.9 cm ; P = 0.048 ) and hip circumference ( -1.0 vs 1.1 cm ; P = 0.037 ) . Total cholesterol and LDL cholesterol decreased significantly more in women , with the highest number of impacts compared with the lowest quartile at intensities exceeding 1.1 g , with differences being up to -0.5 mM ( P = 0.005 ) . Additionally , poor baseline values predicted greater exercise effects . CONCLUSION The moderate-intensity exercise regimen , initially targeted at weight-bearing bones , improved cardiorespiratory fitness , speed-strength , and lipid profiles . In addition to bone health , impact exercise may be recommended for prevention of cardiovascular diseases",
"BACKGROUND Maintenance of weight loss is a core problem in the treatment of obesity . Physical activity may improve maintenance and metabolic risk factors associated with obesity . HYPOTHESES ( 1 ) A walking training program of moderate intensity , started after weight reduction by a very-low-energy diet , improves maintenance of weight loss and obesity-related metabolic disorders ; and ( 2 ) the effect of the training program is related to the prescribed amount of physical activity , ie , a higher amount ( energy expenditure ) leads to more favorable results . METHODS The participants were premenopausal women with a mean body mass index of 34.0 kg/m(2 ) . Eighty-two participants were r and omized to this study ; 74 participated in the follow-up assessment . A 12-week weight reduction by mostly a very-low-energy diet was followed by a 40-week maintenance program r and omized in 3 groups : a control group with no increase in habitual exercise and with counseling on diet and relapse prevention ; a walk-1 group , with a walking program targeted to expend 4.2 MJ/wk and diet counseling ; and a walk-2 group , with a walking program of 8 . 4 MJ/wk and diet counseling . R and om permuted blocks within strata were used , with weight loss ( in 3 classes ) as the stratifying factor . After the intervention , the subjects were followed up for 2 years . MAIN OUTCOME MEASURES Primary outcomes were body weight , fat mass , and waist circumference at the 2-year follow-up . Secondary outcomes were the levels of serum lipoproteins and lipids , plasma glucose , insulin , and blood pressure . RESULTS The mean weight loss after weight reduction was 13.1 kg . The main outcome variables remained stable during the maintenance program , but increased during the follow-up period . Compared with the end of weight reduction , weight regain at the 2-year follow-up was 3.5 kg less ( 95 % confidence interval , 0.2 - 6.8 ) and waist circumference regain 3.8 cm less ( 95 % confidence interval , 0.3 - 7.3 ) in the walk-1 group vs controls . The secondary outcomes showed a partial relapse during the maintenance program , and a further regain during the follow-up period . CONCLUSIONS Inclusion of a walking program of moderate training regimen into a weight maintenance program improved maintenance of losses in weight and waist circumference",
"Most primary care providers ( PCPs ) , constrained by time and re sources , can not provide intensive behavioral counseling for obesity . This study evaluated the effect of using medical assistants ( MAs ) as weight loss counselors . The study was a r and omized controlled trial conducted in two primary care offices at an academic medical center . Patients ( n = 50 ) had a BMI of 27 - 50 kg/m(2 ) and no contraindications to weight loss . They were r and omized to quarterly PCP visits and weight loss material s ( Control group ) or to the same approach combined with eight visits with a MA over 6 months ( Brief Counseling ) . Outcomes included change in weight and cardiovascular risk factors ( glucose , lipids , blood pressure , and waist circumference ) . Patients in the Brief Counseling and Control groups lost 4.4 + /- 0.6 kg ( 5.1 + /- 0.7 % of initial weight ) and 0.9 + /- 0.6 kg ( 1.0 + /- 0.7 % ) , respectively , at month 6 ( P cardiovascular risk factors . Brief Counseling patients regained weight between month 6 and month 12 , when MA visits were discontinued . Attrition was 10 % after 6 months and 6 % after 12 months . Brief Counseling by MAs induced significant weight loss during 6 months . Office-based obesity treatment should be tested in larger trials and should include weight loss maintenance counseling",
"Aims /hypothesisLifestyle modification helps in the primary prevention of diabetes in multiethnic American , Finnish and Chinese population s. In a prospect i ve community-based study , we tested whether the progression to diabetes could be influenced by interventions in native Asian Indians with IGT who were younger , leaner and more insulin resistant than the above population s. Methods We r and omised 531 ( 421 men 110 women ) subjects with IGT ( mean age 45.9±5.7 years , BMI 25.8±3.5 kg/m2 ) into four groups . Group 1 was the control , Group 2 was given advice on lifestyle modification ( LSM ) , Group 3 was treated with metformin ( MET ) and Group 4 was given LSM plus MET . The primary outcome measure was type 2 diabetes as diagnosed using World Health Organization criteria . Results The median follow-up period was 30 months , and the 3-year cumulative incidences of diabetes were 55.0 % , 39.3 % , 40.5 % and 39.5 % in Groups 1–4 , respectively . The relative risk reduction was 28.5 % with LSM ( 95 % CI 20.5–37.3 , p=0.018 ) , 26.4 % with MET ( 95 % CI 19.1–35.1 , p=0.029 ) and 28.2 % with LSM + MET ( 95 % CI 20.3–37.0 , p=0.022 ) , as compared with the control group . The number needed to treat to prevent one incident case of diabetes was 6.4 for LSM , 6.9 for MET and 6.5 for LSM + MET . Conclusions /interpretationProgression of IGT to diabetes is high in native Asian Indians . Both LSM and MET significantly reduced the incidence of diabetes in Asian Indians with IGT ; there was no added benefit from combining them",
"Lifestyle interventions for weight loss are the cornerstone of obesity therapy , yet their optimal design is debated . This is particularly true for postmenopausal women ; a population with a high prevalence of obesity yet toward whom fewer studies are targeted . We conducted a year-long , 4-arm r and omized trial among 439 overweight-to-obese postmenopausal sedentary women to determine the effects of a calorie-reduced , low-fat diet ( D ) , a moderate-intensity , facility-based aerobic exercise program ( E ) , or the combination of both interventions ( D+E ) , vs. a no-lifestyle-change control ( C ) on change in body weight and composition . The group-based dietary intervention had a weight-reduction goal of ≥10 % , and the exercise intervention consisted of a gradual escalation to 45-min aerobic exercise 5 day/week . Participants were predominantly non-Hispanic whites ( 85 % ) with a mean age of 58.0 ± 5.0 years , a mean BMI of 30.9 ± 4.0 kg/m(2 ) and an average of 47.8 ± 4.4 % body fat . Baseline and 12-month weight and adiposity measures were obtained by staff blinded to participants ' intervention assignment . Three hundred and ninety nine women completed the trial ( 91 % retention ) . Using an intention-to-treat analysis , average weight loss at 12 months was -8.5 % for the D group ( P decrease . BMI , waist circumference , and % body fat were also similarly reduced . Among postmenopausal women , lifestyle-change involving diet , exercise , or both combined over 1 year improves body weight and adiposity , with the greatest change arising from the combined intervention",
"The Women 's Healthy Lifestyle Project is a 5-year r and omized clinical testing whether a behavioral intervention aim ed at lifestyle changes in diet and physical activity can prevent the rise in weight and low-density lipoprotein cholesterol ( LDL-c ) observed during menopause . Cardiovascular risk factor and behavioral data from 489 participants ( intervention group n = 236 ; control group n = 253 ) who attended baseline , 6-month , and 18-month clinical assessment s were analyzed to determine how well initial improvements achieved at 6 months were maintained over the subsequent year of follow-up . Results indicated that the treatment effect persisted at 18 months for weight , body mass index , total cholesterol , LDL-c , systolic blood pressure ( SBP ) , and glucose levels . Intervention participants maintained improvements in physical activity , caloric intake , dietary cholesterol , SBP , and glucose levels between 6 and 18 months , although weight , total cholesterol , and LDL-c began to rise during this period . Eighty percent of intervention participants compared to 45 % of controls were at or under baseline weight at 18 months , suggesting that promoting modest weight loss may be an effective approach to preventing weight gain in these women",
"BACKGROUND The maintenance of weight loss may be influenced by the distribution of macronutrients in the diet and insulin sensitivity . OBJECTIVE The objective of the study was to evaluate the longterm effect of two hypocaloric diets with different protein/carbohydrate ratios in overweight and obese individuals either with insulin resistance ( IR ) or without insulin resistance ( IS ) . DESIGN Prospect i ve , r and omized , clinical intervention study . Forty patients were classified as IR/IS after a 75 g oral glucose tolerance test and then r and omized to a diet with either 40 % carbohydrate/30 % protein/30 % fat ( diet A ) or 55 % carbohydrate/15 % protein/30 % fat ( diet B ) . RESULTS After one year of follow-up there was no difference in weight loss between diets A and B in each group , but the IS group maintained weight loss better than the IR group [ -5.7 ( 3.9 ) vs. -0.6 ( 4.1 ) ; P = 0.04 ] . No differences were found in either Homeostasis Model Assessment ( HOMA ) or other metabolic glucose parameters except lower insulin at 120 minutes with diet A [ 21.40 ( 8.30 ) vs. 71.40 ( 17.11 ) ; P = 0.02 ] . CONCLUSIONS The hypocaloric diets with different protein/carbohydrate ratios produced similar changes in weight . Insulin resistance may play a negative role in maintaining weight loss",
"The relationships of age , body composition , and physical conditioning status to glucose tolerance , insulin , and lipoprotein levels were examined in 77 healthy , nonsmoking white male volunteers , aged 46 to 73 years with no evidence of coronary artery or endocrine-metabolic disease . The men had a wide range of body fat ( 13 % to 39 % ) , indexed as waist-to-hip ratio ( WHR , 0.84 to 1.08 ) , and maximal aerobic capacity ( VO2max , 17 to 48 mL/kg.min ) . Multiple regression analysis with age , VO2max , WHR , and percent body fat as independent variables demonstrated that fasting plasma insulin , triglyceride ( TG ) , and high density lipoprotein cholesterol ( HDL-C ) levels were independently related to both percent body fat and WHR . In contrast , fasting plasma glucose levels and insulin responses during oral glucose tolerance tests ( OGTT ) correlated independently with percent body fat , and glucose responses to OGTT correlated only with WHR . Although fasting plasma TG and HDL-C correlated with glucose and insulin levels , in multiple regression analyses only percent body fat and WHR were the significant independent variables . Fasting total and low density lipoprotein cholesterol values were not related to these variables . To test the effects of weight loss and exercise training on these relationships , 20 obese men of comparable age , percent body fat , WHR , and VO2max were r and omly assigned to weight loss or aerobic exercise training programs . A 12 % + /- 3 % loss in body weight ( P less than .01 , mean + /- SD ) result ed in a 19 % + /- 9 % decline in body fat ( P less than .01 ) with no change in fat free mass , WHR , or VO2max . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE There is a significant need for an obesity treatment model suitable for the primary care environment . We examined the effectiveness of a brief counselling intervention alone , in combination with orlistat , and drug-alone in a 12-month r and omized- clinical trial at a medical school obesity centre . METHODS Participants ( N = 250 ) with body mass index ( BMI ) > or=27 were r and omized . Changes in body weight , lipids , blood pressure and serum glucose were examined . Drug adherence and attendance were also evaluated . RESULTS Completers analysis was conducted on 136 participants with data at baseline , 6 and 12 months and intention-to-treat analyses ( ITT ) for the total sample . Amongst completers , participants in the drug only ( P = 0.012 ) and drug + brief counselling ( P = 0.001 ) groups lost more weight ( mean + /- SD : -3.8 + /- 5.8 kg and -4.8 + /- 4.4 kg , respectively ) than participants in the brief counselling only group at 6 months ( -1.7 + /- 3.3 kg ) , but there were no significant group differences at 12 months . ITT model results were similar to completers at 6 months and remained significant at 12 months , but the weight losses were more modest ( orlistat . For brief counselling alone , participants gained weight ( 1.7 + /- 4.2 kg ) . Cardiovascular disease ( CVD ) parameter changes were negligible . CONCLUSIONS Pharmacotherapy alone or combined with brief counselling result ed in modest weight losses that had minimal impact on cardiovascular parameters , but were greater than brief counselling alone . Whilst brief interventions and primary pharmacotherapy have been suggested as viable treatments for implementation in primary care setting s , our study suggests that such minimal interventions provide minimal benefits",
"BACKGROUND The long-term effectiveness of multicomponent worksite health promotion programs targeting cardiovascular disease risk factors remains unclear in Japan . This study was conducted to evaluate the effectiveness of such a health promotion program consisting of a main program provided over 4 days and a follow-up program provided over 1 year . METHODS The subjects of this r and omized controlled trial were male employees working for a building maintenance company in Japan . The intervention group ( n = 152 ) and the control group ( n = 150 ) consisted of employees having abnormal findings in at least one of the following items at baseline health examination : body mass index ( BMI ) , systolic ( SBP ) or diastolic blood pressure , total cholesterol , HDL cholesterol , triglycerides , and fasting blood glucose . Evaluation was conducted at 18 months after the main program . RESULTS BMI , SBP , total cholesterol , and triglycerides improved significantly in the intervention group compared with the control group ( P BMI , total cholesterol , and triglycerides improved significantly in the intervention group ( P multicomponent health promotion program provided to employees was shown to be effective in improving obesity , high blood pressure , and hyperlipidemia when evaluated 18 months after the main intervention program",
"OBJECTIVE To assess the effect of lifestyle intervention over 2 years on changes in weight , coronary heart disease ( CHD ) risk factors , and incidence of diabetes in overweight individuals with a parental history of diabetes . RESEARCH DESIGN AND METHODS Participants ( n = 154 ) , who were 30–100 % over ideal body weight , had one or both parents with diabetes , and were currently nondiabetic , were r and omly assigned to 2-year treatments focused on diet ( decreasing calories and fat intake ) , exercise ( goal of 1,500 kcal/week of moderate activity ) , or the combination of diet plus exercise or to a no-treatment control group . Subjects were reassessed at 6 months , 1 year , and 2 years . RESULTS At 6 months , the groups differed significantly on measures of eating , exercise , and fitness ; weight losses in the diet and diet-plus-exercise groups were significantly > in the exercise and control conditions . Weight losses were associated with positive changes in CHD risk factors . After 6 months , there was gradual deterioration of behavioral and physiological changes , so that at 2 years , almost no between-group differences were maintained . Differences between groups in risk of developing diabetes were of borderline significance ( P = 0.08 ) . Strongest predictors were impaired glucose tolerance at baseline , which was positively related to risk of developing diabetes , and weight loss from baseline to 2 years , which was negatively related ; in all treatment groups , a modest weight loss of 4.5 kg reduced the risk of type 2 diabetes by ∼ 30 % compared with no weight loss . CONCLUSIONS Although initially successful , the interventions studied here were not effective in producing long-term changes in behavior , weight , or physiological parameters . However , weight loss from 0 to 2 years reduced the risk of developing type 2 diabetes . Since modest weight loss significantly reduced risk of type 2 diabetes , further research is needed to determine how best to increase the percentage of subjects achieving at least a modest weight loss ",
"OBJECTIVE To examine in previously sedentary older women the effects of exercise mode and a behavioural intervention on short and long-term retention and adherence . METHODS Healthy , sedentary women aged 50 - 70 years ( N=116 ) were r and omly assigned to a supervised 6-month swimming or walking program 3 sessions a week . They were further r and omised to usual care or a behavioural intervention . The same program was further continued unsupervised for 6 months . We assessed retention , adherence , stage of exercise behaviour and changes in fitness . RESULTS One hundred women ( 86 % ) completed 6 months and 86 ( 74 % ) continued for 12 months . Retention rates were similar for both exercise modes at 6 and 12 months . Adherence to swimming or walking was similar after 6 months ( 76.3 ( 95 % CI : 69.5 , 83.1)% vs. 74.3 ( 67.7 , 80.9)% ) and 12 months ( 65.8 ( 57.9 , 73.8)% vs. 62.2 ( 54.6 , 70.0)% ) . The behavioural intervention did not enhance retention or adherence . Fitness improved for both exercise modes after 6 months and was maintained at 12 months . CONCLUSIONS Either swimming or walking programs initiated with careful supervision over 6 months result ed in similar high retention and adherence rates by highly motivated older women over 12 months . Behavioural intervention in this setting did not improve these rates further",
"OBJECTIVE Insulin resistance and hyperinsulinaemia are , in some prospect i ve studies , linked to an increased cardiovascular risk , at least in men . We tested the hypothesis that hyperinsulinaemia may be reduced by non-pharmacological methods independently of other cardiovascular risk factors . DESIGN In a non-pharmacological intervention study for 1 year three groups of subjects ( hypertensives as well as normotensives ) were selected after stratification for insulin level at baseline . Half of the hyperinsulinaemic subjects were r and omly assigned to active intervention with physical exercise and dietary regulation ( HI-A group ) , the other half were followed passively during the study period ( HI-P group ) . Normo-insulinaemics and hypo(low)-insulinaemics also underwent active intervention ( NI-A and LI-A groups , respectively ) . SETTING Primary health care in Sweden . RESULTS During the 1-year follow-up subjects in the HI-A group reduced their weight , waist : hip ratio and systolic and diastolic blood pressure , as well as their low : high-density lipoprotein (LDL : HDL)-cholesterol ratio . Glucose levels before and during an oral glucose tolerance test did not change . However , plasma insulin and plasma-C-peptide decreased both in the fasting state and after 1 and 2 h of oral glucose tolerance testing . This decrease was independent of the previously mentioned reduction in weight , waist : hip ratio , blood pressure and LDL : HDL-cholesterol ratio . No reduction in insulin levels was seen in the HI-P , NI-A or LI-A groups , but in the HI-P group there was a slight decrease in fasting plasma-C-peptide levels . In the HI-A group dietary improvements were observed during the study period , with a reduction in energy intake , fat consumption and cholesterol intake . Fibre intake was increased . No major changes were seen in the HI-P group . CONCLUSIONS We conclude that in hypertensive and normotensive subjects with hyperinsulinaemia insulin levels can be reduced by active non-pharmacological treatment for 1 year without altering glucose tolerance . This shows that insulin resistance may be lowered by non-pharmacological treatment , which may be of considerable importance , and not only for hypertensives",
"Background —The Women ’s Healthy Lifestyle Project Clinical Trial tested the hypothesis that reducing saturated fat and cholesterol consumption and preventing weight gain by decreased caloric and fat intake and increased physical activity would prevent the rise in LDL cholesterol and weight gain in women during perimenopause to postmenopause . Methods and Results —There were 275 premenopausal women r and omized into the assessment only group and 260 women into the intervention group . The mean age of participants at baseline was 47 years , and 92 % of the women were white . The mean LDL cholesterol was 115 mg/dL at baseline , and mean body mass index was 25 kg/m2 . The follow-up through 54 months was excellent . By 54 months , 35 % of the women had become postmenopausal . At the 54-month examination , there was a 3.5-mg/dL increase in LDL cholesterol in the intervention group and an 8.9-mg/dL increase in the assessment -only group ( P = 0.009 ) . Weight decreased 0.2 lb in the intervention and increased 5.2 lb in the assessment -only group ( P = 0.000 ) . Triglycerides and glucose also increased significantly more in the assessment -only group than in the intervention group . Waist circumference decreased 2.9 cm in the intervention compared with 0.5 cm in the assessment -only group ( P = 0.000 ) . Conclusions —The trial was successful in reducing the rise in LDL cholesterol during perimenopause to postmenopause but could not completely eliminate the rise in LDL cholesterol . The trial was also successful in preventing the increase in weight from premenopause to perimenopause to postmenopause . The difference in LDL cholesterol between the assessment and intervention groups was most pronounced among postmenopausal women and occurred among hormone users and nonusers",
"BACKGROUND In short-term studies , diet and exercise both improve insulin sensitivity . OBJECTIVE To determine the effects of a 48-week supervised diet and exercise program on weight and insulin sensitivity after initial weight loss and weight maintenance , and then subsequent weight regain over 96 weeks . METHODS Forty-five obese women were r and omly assigned to 1 of 3 treatment groups : ( 1 ) diet alone , ( 2 ) diet and aerobic training , and ( 3 ) diet and strength training . All subjects received the same 48-week group behavior modification program and diet ( approximately 3879 kJ/d [ approximately 925 kcal/d ] for the first 16 weeks ; approximately 6276 kJ/d [ approximately 1500 kca/d ] thereafter ) . Exercising subjects were provided 3 supervised exercise sessions per week for the first 28 weeks and 2 sessions weekly until week 48 . During weeks 48 to 96 , subjects were unsupervised . Oral glucose tolerance tests were performed at baseline and weeks 16 , 24 , 44 , and 96 . RESULTS Subjects across the 3 conditions achieved a mean weight loss of 13.8 kg by week 16 , which was associated with decreased insulin levels ( 61.8 % of baseline ) There were no significant differences among groups in changes in body mass index , which is a measure of weight in kilograms divided by the square of the height in meters , weight , glucose tolerance , or insulin levels at weeks 16 , 24 , and 44 . No additional beneficial effect of aerobic or strength exercise on insulin resistance , as reflected by serum insulin levels before and after a glucose load , was demonstrated . The 22 subjects who were studied at week 96 maintained a loss of approximately 10 % of initial weight . Insulin levels , however , had returned to pretreatment levels . CONCLUSIONS This study confirms the beneficial effect of weight reduction on hyperinsulinemia in obese individuals . Participation in supervised exercise did not result in additional improvement in weight loss or insulin sensitivity . We also observed a marked increase in insulin levels with only partial weight regain . Determining the amount of sustained weight loss necessary for continued improvement in insulin sensitivity will require further study",
"OBJECTIVE To examine changes in biomarkers of disease risk after 51 months of reduced energy intake and sustained weight loss . RESEARCH METHODS AND PROCEDURES This study was conducted as a prospect i ve , r and omized , two-arm , parallel intervention for 12 weeks followed by a prospect i ve , single-arm , 4-year trial in a university-based hospital clinic . One hundred patients were r and omly assigned to one of two dietary interventions for 3 months . Group A was prescribed an energy-restricted diet of 1200 to 1500 kcal/d , and group B was prescribed an isocaloric diet , whereby two of three meals were replaced with nutrient-fortified liquid meal replacements . After 3 months , the patients were prescribed the same caloric reduction and used once-daily replacements for the succeeding 4 years . Body weight and blood pressure were checked monthly . Biomarkers of disease risk were measured after 3 , 9 , 15 , 27 , and 51 months . RESULTS During the 3-month weight-loss period , body weight was reduced by 1.5 + /- 0.4 % and 7.8 + /- 0.5 % ( mean + /- SEM ) for groups A and B , respectively . After 4 years , 75 % of the patients were evaluated . Total mean weight loss was 3.3 + /- 0.8 % and 8.4 + /- 0.8 % for groups A and B , respectively . Both groups of patients showed significant improvement in glucose , insulin , triacylglycerol , and systolic blood pressure . Cholesterol concentrations were reduced in patients with high initial cholesterol levels and maintenance of a 7 % weight loss . DISCUSSION Providing a structured meal plan with liquid meal replacements is an effective treatment for obese subjects . Long-term maintenance of weight loss with meal replacements improves biomarkers of disease risk",
"INTRODUCTION Limited data are available supporting the notion that treatment of lifestyle risk factors may improve erectile dysfunction ( ED ) . AIM In the present study , we analyzed the effect of a program of changing in lifestyle design ed to improve erectile function in subjects with ED or at increasing risk for ED . METHODS Men were identified in our data base of subjects participating in r and omized controlled trials evaluating the effect of lifestyle changes . A total of 209 subjects were r and omly assigned to one of the two treatment groups . The 104 men r and omly assigned to the intervention program received detailed advice about how to reduce body weight , improve quality of diet , and increase physical activity . The 105 subjects in the control group were given general information about healthy food choices and general guidance on increasing their level of physical activity . MAIN OUTCOME MEASURES Changes in erectile function score ( International Index of Erectile Function-5 [ IIEF-5 ] ; items 5 , 15 , 4 , 2 , and 7 from the full-scale IIEF-15 ) and dependence of the restoration of erectile function on the changes in lifestyle that were achieved . RESULTS Erectile function score improved in the intervention group . At baseline , 35 subjects in the intervention group and 38 subjects in the control group had normal erectile function ( 34 % and 36 % , respectively ) . After 2 years , these figures were 58 subjects in the intervention group and 40 subjects in the control group , respectively ( 56 % and 38 % , P = 0.015 ) . There was a strong correlation between the success score and restoration of erectile function . CONCLUSIONS It is possible to achieve an improvement of erectile function in men at risk by means of nonpharmacological intervention aim ing at weight loss and increasing physical activity",
"BACKGROUND Guidelines established by the National Cholesterol Education Program ( NCEP ) promote exercise and weight loss for the treatment of abnormal lipoprotein levels . Little is known , however , about the effects of exercise or the NCEP diet , which is moderately low in fat and cholesterol , in persons with lipoprotein levels that place them at high risk for coronary heart disease . METHODS We studied plasma lipoprotein levels in 180 postmenopausal women , 45 through 64 years of age , and 197 men , 30 through 64 years of age , who had low high-density lipoprotein ( HDL ) cholesterol levels ( lipoprotein ( LDL ) cholesterol ( > 125 mg per deciliter but 125 mg per deciliter but The subjects were r and omly assigned to aerobic exercise , the NCEP Step 2 diet , or diet plus exercise , or to a control group , which received no intervention . RESULTS Dietary intake of fat and cholesterol decreased during the one-year study ( P body weight , in women and men in either the diet group or the diet-plus-exercise group , as compared with the controls ( P dietary intake and body weight were unchanged . Changes in HDL cholesterol and triglyceride levels and the ratio of total to HDL cholesterol did not differ significantly among the treatment groups , for subjects of either sex . The serum level of LDL cholesterol was significantly reduced among women ( a decrease of 14.5+/-22.2 mg per deciliter ) and men ( a decrease of 20.0+/-17.3 mg per deciliter ) in the diet-plus-exercise group , as compared with the control group ( women had a decrease of 2.5+/-16.6 mg per deciliter , P reduction in LDL cholesterol in men in the diet-plus-exercise group was also significant as compared with that among the men in the exercise group ( 3.6+/-18.8 mg per deciliter , P LDL cholesterol levels were not significant among the women ( a decrease of 7.3+/-18.9 mg per deciliter ) or the men ( 10.8+/-18.8 mg per deciliter ) in the diet group , as compared with the controls . CONCLUSIONS The NCEP Step 2 diet failed to lower LDL cholesterol levels in men or women with high-risk lipoprotein levels who did not engage in aerobic exercise . This finding highlights the importance of physical activity in the treatment of elevated LDL cholesterol levels",
"AIM To study the effects of a supervised exercise program on serum gamma-glutamyl transferase ( GGT ) , glycemic control and cardiovascular risk factors in pre-diabetic patients with isolated impaired fasting glucose ( IFG ) and those with IFG plus impaired glucose tolerance ( IGT ) . METHODS Out of 60 pre-diabetic patients ( 30 with isolated IFG and 30 with IFG + IGT ) 24 were r and omly assigned to the supervised exercise program ( 1 h twice a week ) and 36 only obtained counselling on the risk of diabetes and its prevention . Patients have been followed over a 12-month period . RESULTS The main findings were that patients with IFG + IGT had increased GGT levels at baseline ( 49.2±27.4 U/L ) compared to subjects with isolated IFG ( 28.1±21.9 U/L ) ( p GGT levels improved only after the supervised exercise intervention within the IFG + IGT subjects ( - 17.7±19.6 U/L ) . Similarly , baseline triglyceride levels were also higher in IFG + IGT patients ( p exercise intervention in these patients only ( p GGT is an unspecific marker of oxidative stress and both high plasma glucose and triglycerides levels may produce oxidative stress . Thus , patients with IFG + IGT seem to have higher levels of oxidative stress than those with isolated IFG . Based on the known association between GGT levels and cardiovascular risk factors , IFG + IGT patients may be at higher risk for the development of cardiovascular diseases . The specific effect of regular exercise on GGT in pre-diabetic patients may contribute to the underst and ing of the preventive effects related to exercise ",
"All types of aerobic exercise are assumed to affect cardiovascular risk similarly . There are few studies of swimming , but complex responses to water-based exercise suggest its potential for differential effects . The aim of the study was to compare the effects of swimming and walking on fitness , body weight , lipids , glucose , and insulin in older women . Sedentary women aged 50 to 70 years ( N = 116 ) , r and omly assigned to swimming or walking plus usual care or a behavioral intervention , completed 3 sessions per week of moderate-intensity exercise , supervised for 6 months then unsupervised for 6 months . After 6 months , 1.6-km walk time decreased in walkers and swimmers , with greater improvement in walkers ( 1.0 vs 0.6 minute , P = .001 ) . In swimmers , but not walkers , distance swum in 12 minutes increased ( 78.1 vs -2.2 m , P = .021 ) . Waist and hip circumferences ( 80.8 vs 83.1 cm and 101.8 vs 102.4 cm ; P = .023 and P = .042 , respectively ) and insulin area under the curve ( oral glucose tolerance test ) ( 5128 vs 5623 μU/[L 120 min ] , P with swimming . Lipids did not differ between groups . At 12 months , fitness was maintained . Relative to walking , swimming reduced body weight by ( 1.1 kg , P = .039 ) and result ed in lower total and low-density lipoprotein cholesterol ( 0.3 and 0.2 mmol/L ; P = .040 and P = .049 , respectively ) . The magnitude of the difference in the reduction of insulin area under the curve between swimming and walking was greater at 12 months ; however , the significance was attenuated ( 4677 vs 5240 μU/[L 120 min ] , P = .052 ) . Compared with walking , swimming improved body weight , body fat distribution , and insulin in the short term and , in the longer term , body weight and lipid measures . These findings suggest that the type of exercise can influence health benefits",
"The current study examined the insulin and glucose response during an oral glucose tolerance test ( OGTT ) in overweight young adults prior to and following exercise training in the Midwest Exercise Trial ( MET ) . Subjects ( N = 66 ) were r and omly assigned to non-exercise control ( CON ; 16 females , 13 males ) or exercise ( EX ; 22 females , 15 males ) groups . EX performed supervised and verified exercise on 3 to 5 days per week in 20- to 45-minute sessions at 60 % to 75 % of heart rate reserve . OGTTs and assessment s for body mass , body composition , and maximal oxygen consumption ( Vo(2 ) max ) were performed at baseline , and after 9 and 16 months of training . Blood was collected during a 75-g OGTT and analyzed for glucose and insulin concentrations with the total area under the glucose and insulin curves used in the analysis . The EX males had significant decreases from baseline to 9 months in body mass ( 94.8 + /- 12.5 to 89.2 + /- 9.8 kg ) and percent fat ( 28.3 + /- 4.8 to 24.2 + /- 3.9 ) with no further changes at 16 months . CON females had significant increases in body mass ( 78.2 + /- 6.4 to 81.1 + /- 8.1 kg ) and percent fat ( 36.6 + /- 4.2 to 37.8 + /- 4.7 ) from baseline to 16 months . Vo(2 ) max increased significantly from baseline to 9 months in the EX males ( 3.67 + /- 0.62 to 4.36 + /- 0.55 L/min ) and EX females ( 2.53 + /- 0.32 to 2.99 + /- 0.42 L/min ) . For glucose area under the curve , there were no significant differences between EX or CON across the 16 months of the study . For insulin area under the curve , there was a significant decrease for male EX from baseline to 9 months ( 12,535 + /- 6,114 to 8,390 + /- 4,231 microU/L/180 min ) . We conclude that regular exercise in healthy , previously sedentary overweight adult males leads to improvements in Vo(2 ) max and weight loss and a reduction in the insulin concentration required to dispose of a set glucose load . In females , improvement in Vo(2 ) max without weight loss does not lead to improvement in insulin sensitivity",
"A pilot trial was conducted to test adherence to specific lifestyle interventions among Pima Indians of Arizona , and to compare them for changes in risk factors for diabetes mellitus . Ninety-five obese , normoglycaemic men and women , aged 25 - 54 years , were r and omized to treatments named ' Pima Action ' ( Action ) and ' Pima Pride ' ( Pride ) , which were tested for 12 months . Action involved structured activity and nutrition interventions , and Pride included unstructured activities emphasizing Pima history and culture . Adherence to interventions , changes in self-reported activity and diet , and changes in weight , glucose concentrations , and other risk factors were assessed regularly . Thirty-five eligible subjects who had declined r and omization were also followed as an ' observational ' group and 22 members of this group were examined once at a median of 25 months for changes in weight and glucose concentration . After 12 months of intervention , members of both intervention groups reported increased levels of physical activity ( median : Action 7.3 h month(-1 ) , Pride 6.3 h month(-1 ) , p decreased starch intake ( 28 g , p = 0.008 ) . Body mass index , systolic and diastolic blood pressures , weight , 2-h glucose and 2-h insulin had all increased in Action members ( p waist circumference had decreased in Pride members ( p = 0.05 ) . Action members gained more weight than Pride members ( 2.5 kg vs 0.8 kg , p = 0.06 ) , and had a greater increase in 2-h glucose than Pride members ( 1.33 mM vs 0.03 mM , p = 0.007 ) . Members of the observational group gained an average of 1.9 kg year(-1 ) in weight and had an increase of 0.36 mM year(-1 ) in 2-h glucose . Sustaining adherence in behavioural interventions over a long term was challenging . Pimas may find a less direct , less structured , and more participative intervention more acceptable than a direct and highly structured approach",
"OBJECTIVE Individuals with impaired glucose tolerance ( IGT ) have a high risk of developing NIDDM . The purpose of this study was to determine whether diet and exercise interventions in those with IGT may delay the development of NIDDM , i.e. , reduce the incidence of NIDDM , and thereby reduce the overall incidence of diabetic complications , such as cardiovascular , renal , and retinal disease , and the excess mortality attributable to these complications . RESEARCH DESIGN AND METHODS In 1986 , 110,660 men and women from 33 health care clinics in the city of Da Qing , China , were screened for IGT and NIDDM . Of these individuals , 577 were classified ( using World Health Organization criteria ) as having IGT . Subjects were r and omized by clinic into a clinical trial , either to a control group or to one of three active treatment groups : diet only , exercise only , or diet plus exercise . Follow-up evaluation examinations were conducted at 2-year intervals over a 6-year period to identify subjects who developed NIDDM . Cox 's proportional hazard analysis was used to determine if the incidence of NIDDM varied by treatment assignment . RESULTS The cumulative incidence of diabetes at 6 years was 67.7 % ( 95 % CI , 59.8–75.2 ) in the control group compared with 43.8 % ( 95 % CI , 35.5–52.3 ) in the diet group , 41.1 % ( 95 % CI , 33.4–49.4 ) in the exercise group , and 46.0 % ( 95 % CI , 37.3–54.7 ) in the diet-plus-exercise group ( P relative decrease in rate of development of diabetes in the active treatment groups was similar when subjects were stratified as lean or overweight ( BMI baseline BMI and fasting glucose , the diet , exercise , and diet-plus-exercise interventions were associated with 31 % ( P risk of developing diabetes , respectively . CONCLUSIONS Diet and /or exercise interventions led to a significant decrease in the incidence of diabetes over a 6-year period among those with IGT",
"CONTEXT Healthy lifestyle factors are associated with maintenance of erectile function in men . OBJECTIVE To determine the effect of weight loss and increased physical activity on erectile and endothelial functions in obese men . DESIGN , SETTING , AND PATIENTS R and omized , single-blind trial of 110 obese men ( body mass index > or = 30 ) aged 35 to 55 years , without diabetes , hypertension , or hyperlipidemia , who had erectile dysfunction that was determined by having a score of 21 or less on the International Index of Erectile Function ( IIEF ) . The study was conducted from October 2000 to October 2003 at a university hospital in Italy . INTERVENTIONS The 55 men r and omly assigned to the intervention group received detailed advice about how to achieve a loss of 10 % or more in their total body weight by reducing caloric intake and increasing their level of physical activity . Men in the control group ( n = 55 ) were given general information about healthy food choices and exercise . MAIN OUTCOMES MEASURES Erectile function score , levels of cholesterol and triglycerides , circulating levels of interleukin 6 , interleukin 8 , and C-reactive protein , and endothelial function as assessed by vascular responses to l-arginine . RESULTS After 2 years , body mass index decreased more in the intervention group ( from a mean [ SD ] of 36.9 [ 2.5 ] to 31.2 [ 2.1 ] ) than in the control group ( from 36.4 [ 2.3 ] to 35.7 [ 2.5 ] ) ( P serum concentrations of interleukin 6 ( P = .03 ) , and C-reactive protein ( P = .02 ) . The mean ( SD ) level of physical activity increased more in the intervention group ( from 48 [ 10 ] to 195 [ 36 ] min/wk ; P mean ( SD ) IIEF score improved in the intervention group ( from 13.9 [ 4.0 ] to 17 [ 5 ] ; P IIEF score of 22 or higher . In multivariate analyses , changes in body mass index ( P = .02 ) , physical activity ( P = .02 ) , and C-reactive protein ( P = .03 ) were independently associated with changes in IIEF score . CONCLUSION Lifestyle changes are associated with improvement in sexual function in about one third of obese men with erectile dysfunction at baseline",
"BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin",
"AIMS To evaluate the effectiveness and feasibility of implementing a linguistically and culturally tailored Diabetes Prevention Program among Chinese immigrants with prediabetes living in New York City . METHODS A total of 60 Chinese immigrants with prediabetes were r and omized into either a Diabetes Prevention Program lifestyle intervention ( n = 30 ) consisting of 12 bi-weekly core sessions and six monthly post-core sessions or the control intervention ( n = 30 ) , consisting of quarterly mailing of diabetes prevention information . Each Diabetes Prevention Program intervention session lasted 1.5 - 2 h and covered topics such as healthy eating , physical activity , stress reduction and problem-solving skills . Outcomes such as percent change in weight , BMI , and HbA1c concentration were assessed at baseline , 6 and 12 months . A mixed-effects linear regression was applied to test the intervention effect at months 6 and 12 . Data were collected in the period 2012 - 2013 and analysed in 2014 . RESULTS The participant attrition rate was greater percent weight loss in the intervention group ( -3.5 vs. -0.1 % ; P = 0.0001 ) at 6 months , which was largely maintained at 12 months ( -3.3 vs. 0.3 % ; P = 0.0003 ) . CONCLUSIONS Participants in a Diabetes Prevention Program-based intervention achieved greater weight loss and improvements in HbA1c concentration than control participants . Evaluation of the Chinese Diabetes Prevention Program curriculum in a larger trial is warranted",
"OBJECTIVE To compare and assess the single and joint effect of diet and exercise intervention for 1 year on insulin resistance and the development leading toward the insulin resistance syndrome . RESEARCH DESIGN AND METHODS An unmasked , r and omized 2 × 2 factorial intervention trial was applied with a duration of 1 year for each participant . The trial comprised 219 men and women with diastolic blood pressure of 86–99 mmHg , HDL cholesterol 1.4 mmol/l , total cholesterol of 5.20–7.74 mmol/l , and BMI > 24 kg/m2 . Participants were r and omly allocated to diet group ( n = 35 ) , diet and exercise group ( n = 67 ) , exercise group ( n = 54 ) , and control group ( n = 43 ) . The diet included increased intake of fish and reduced total fat intake . The exercise program entailed supervised endurance exercise three times a week . Baseline cross-sectional changes and 1-year changes in insulin resistance , fasting serum levels of insulin , C-peptide , proinsulin , glucose , and lipids as well as weight , mean blood pressure , and plasminogen activator inhibitor 1 ( PAI-1 ) values were recorded . RESULTS The cross-sectional results at baseline showed significant correlations between the calculated insulin resistance and BMI ( r = 0.54 ) and correlations between the mean blood pressure ( mBP ) ( r = 0.26 ) and PAI-1 ( r = 0.40 ) . The 1-year diet intervention gave a significant decrease in the calculated insulin resistance from 4.6 to 4.2 and a positive correlation between the changes in insulin resistance and changes in BMI ( r = 0.40 ) . The diet and exercise intervention also led to significantly decreased insulin resistance ( from 5.0 to 4.0 ) . The exercise intervention did not significantly change insulin resistance . CONCLUSIONS The cross-sectional and 1-year intervention results supported each other and underscored the important connection between increased BMI and the development leading toward the insulin resistance syndrome",
"BACKGROUND We hypothesized that favorable changes in dietary patterns would lead to a reduction in body size and an improvement in metabolic status . OBJECTIVE The objective was to study changes in diet patterns relative to changes in body size , blood pressure , and circulating concentrations of lipids , glucose , insulin , adiponectin , and other cytokines in the context of a 1-y r and omized intervention study . DESIGN For 1 y , 187 men aged 45 + /- 2 y , approximately 50 % of whom met the criteria of the metabolic syndrome , were r and omly assigned to a diet protocol ( n = 45 ) , an exercise protocol ( n = 48 ) , a protocol of diet plus exercise ( n = 58 ) , or a control protocol ( n = 36 ) . A previously defined a priori diet score was created by summing tertile rankings of 35 food group variables ; a higher score generally reflected recommended dietary changes in the trial ( mean + /- SD at baseline : 31 + /- 6.5 ; range : 15 - 47 ) . RESULTS Over the study year , the diet score increased by approximately 2 + /- 5.5 in both diet groups , with a decrease of an equivalent amount in the exercise and control groups . The weight change was -3.5 + /- 0.6 kg/10-point change in diet score ( P Weight change was attenuated but remained significant after adjustment for intervention group and percentage body fat . Subjects with an increased diet score had more favorable changes in other body size variables , systolic blood pressure , and blood lipid , glucose , insulin , and adiponectin concentrations . Change in diet score was unrelated to resistin and several cytokines . CONCLUSION The change toward a more favorable diet pattern was associated with improved body size and metabolic profile",
"AIM To examine the effect of a brief theory-based health promotion intervention delivered in the community on health behaviour and diabetes-related risk factors among Danish adults at high risk of diabetes . METHODS A r and omised trial was conducted among 127 individuals aged 28 to 70 with fasting plasma glucose : 6.1 - 6.9 mmol/l and /or HbA1c : 6.0- Participants were r and omised to a control group or to receive the intervention delivered over four 2h group sessions during five weeks , and two further sessions after one and six months . Question naire data and clinical measures were collected at baseline , three months and one year after intervention . Primary outcomes ; total-fat intake 5 % ; changes in physical activity . RESULTS 85 % attended one-year follow-up . After adjusting for gender , age and education , Odds ratio ( OR ) ( 95 % CI ) intervention vs control : total-fat intake saturated-fat intake fibre intake ≥ 15 g/1000 kcal : 1.18 ( 0.48;2.92 ) , weight reduction > 5 % : 2.47 ( 0.95 ; 6.39 ) . β ( 95 % CI ) between intervention vs control in changes from baseline : IPAQ , MET min/week : -236 ( -2760 ; 2288 ) , waist circumference , cm : -2.5 ( -4.5 ; -0.5 ) ; systolic blood pressure , mmHg : -4.6 ( -8.8 ; -0.3 ) . CONCLUSION A brief theory-based health promotion intervention delivered in the community indicated effect on weight , waist circumference and systolic blood pressure at one year among Danish adults at high risk of diabetes . No effect was shown on diets or physical activity ",
"BACKGROUND AND AIM Very low carbohydrate ad libitum diets have been shown to enhance weight loss without increasing cardiometabolic risk factors but no kilojoule-controlled trials have been conducted relative to no intervention . The aim of this study was to compare the changes in weight and other cardiovascular risk factors in 3 isocaloric energy-restricted diets to no-intervention control after 1 year . METHODS AND RESULTS One hundred and thirteen subjects ( age 47 ± 10 years , BMI 32 ± 6 kg/m(2 ) with one additional cardiovascular risk factor ) were r and omly allocated to one of three isocaloric diets ( VLC-very low carbohydrate , 60 % fat , 4 % carbohydrate , n=30 ; VLF-very low fat , 10 % fat , n = 30 ; HUF-high unsaturated fat , 30 % fat , n = 30 ) with intensive support for 3 months followed by minimal support for 12 months compared to a control group ( no intervention , n = 23 ) . The estimated weight change was -3.0 ± 0.2 kg for VLC , -2.0 ± 0.1 kg for VLF , -3.7 ± 0.01 kg for HUF and 0.8 ± 0.5 kg for controls ( P=0.065 ) . After correcting for baseline values , decreases in body weight and diastolic blood pressure in the diet groups ( -2.9 ± 5.2 ) were significantly different to the increase in the control group ( 0.8 ± 5.0 ) ( P differences in cardiovascular risk factors were observed between the diet groups . CONCLUSION Significant cardiometabolic risk factor reduction was observed equally with VLC , VLF and HUF diets after 15 months , compared to an exacerbation of risk factors in the control group . At a modest level of adherence , 3 months of intensive support on these dietary patterns confer an improvement in cardiometabolic profile compared to no dietary intervention after 15 months",
"BACKGROUND TCF7L2 is the strongest locus linked to type 2 diabetes that has been identified thus far , and rs7903146 is the most significantly associated variant . Few intervention studies have shown that it has negative effects on metabolic improvement after lifestyle programs . OBJECTIVE Our objective was to assess the effects of this variant on lifestyle intervention-induced changes in glucose values and metabolic variables at 1- and 4-y follow-ups . DESIGN The rs7903146 variant was genotyped in 335 nondiabetic , dysmetabolic participants in a r and omized lifestyle intervention trial . RESULTS Subjects with the unfavorable TT genotype showed higher values of fasting glucose and lower homeostasis model assessment of beta cell function at baseline . Lifestyle modifications were successful in the amelioration of metabolic traits in all genetic subgroups after 1 y. At 4-y follow-up most of the metabolic benefits had disappeared . In a multiple regression model , values for glucose and homeostasis model assessment of beta cell function at 4 y were significantly associated with the T allele ( for glucose and homeostasis model assessment s , respectively : beta = 6.6 ; 95 % CI : 2.5 , 10.7 ; P = 0.001 ; and beta = -0.37 ; 95 % CI : -0.54 , -0.20 ; P impaired fasting glucose and diabetes incidence were inversely associated with intervention . After 4 y , the presence of a T allele was associated with impaired fasting glucose ( odds ratio : 3.04 ; 95 % CI : 1.53 , 6.04 ; P = 0.001 ) and diabetes ( odds ratio : 2.63 ; 95 % CI : 1.00 , 6.96 ; P = 0.05 ) but not with intervention . CONCLUSIONS Lifestyle modifications improved the metabolic pattern in all genetic subgroups . At the end of the trial , however , weight gain occurred , and carriers of the T allele developed first hyperglycemia and decreased insulin secretion , which suggests the need for different \" after-care \" preventive approaches tailored to each genotype 's metabolic risk",
"CONTEXT Obesity is an independent risk factor for cardiovascular disease , which may be mediated by increased secretion of proinflammatory cytokines by adipose tissue . OBJECTIVE To determine the effect of a program of changes in lifestyle design ed to obtain a sustained reduction of body weight on markers of systemic vascular inflammation and insulin resistance . DESIGN AND SETTING R and omized single-blind trial conducted from February 1999 to February 2002 at a university hospital in Italy . PATIENTS One hundred twenty premenopausal obese women ( body mass index > or = 30 ) aged 20 to 46 years without diabetes , hypertension , or hyperlipidemia . INTERVENTIONS The 60 women r and omly assigned to the intervention group received detailed advice about how to achieve a reduction of weight of 10 % or more through a low-energy Mediterranean-style diet and increased physical activity . The control group ( n = 60 ) was given general information about healthy food choices and exercise . MAIN OUTCOME MEASURES Lipid and glucose intake ; blood pressure ; homeostatic model assessment of insulin sensitivity ; and circulating levels of interleukin 6 ( IL-6 ) , interleukin 18 ( IL-18 ) , C-reactive protein ( CRP ) , and adiponectin . RESULTS After 2 years , women in the intervention group consumed more foods rich in complex carbohydrates ( 9 % corrected difference ; P energy ( -310 kcal/d ; P saturated fat ( -3.5 % ; P = .007 ) , and cholesterol intake ( -92 mg/d ; P Body mass index decreased more in the intervention group than in controls ( -4.2 ; P serum concentrations of IL-6 ( -1.1 pg/mL ; P = .009 ) , IL-18 ( -57 pg/mL ; P = .02 ) , and CRP ( -1.6 mg/L ; P = .008 ) , while adiponectin levels increased significantly ( 2.2 microg/mL ; P = .01 ) . In multivariate analyses , changes in free fatty acids ( P = .008 ) , IL-6 ( P = .02 ) , and adiponectin ( P = .007 ) levels were independently associated with changes in insulin sensitivity . CONCLUSION In this study , a multidisciplinary program aim ed to reduce body weight in obese women through lifestyle changes was associated with a reduction in markers of vascular inflammation and insulin resistance",
"OBJECTIVE To investigate the correlation between lifestyle improvements , in particular increased cardio-respiratory fitness and changes in the blood lipid profile . METHODS The participants were 217 residents of Fuji and Yamato Towns , Saga City , with mildly abnormal blood pressure , serum lipids or blood glucose detected at health check-ups in 2003 . Participants were r and omly allocated to an Intervention ( 108 subjects ) or Control group ( 109 subjects ) , matched for age and various conditions . The Intervention group was given exercise advice and prescription and dietary instructions . Cardio-respiratory fitness was evaluated using the work rate at double product breaking point . Changes of lipid parameters were compared before and after intervention , and examined the relationship with cardio-respiratory fitness . RESULTS Seventy nine subjects in each group could be followed up for 17 months without requiring pharmacotherapy . Body mass index , waist circumference , systolic blood pressure , homeostasis model assessment insulin resistance , and triglycerides were decreased in the Intervention group . Furthermore , apolipoprotein B levels were lower ( p ratio of LDL cholesterol to apolipoprotein B ( LDL/ApoB ) was higher ( p cardio-respiratory fitness , LDL/ApoB increased and apolipoprotein B decreased as the degree of improvement increased ( p<0.05 ) . CONCLUSION Improvement was seen in atherosclerotic risk factors through lifestyle modification . In particular , improved cardiorespiratory fitness was associated with qualitative and quantitative changes in LDLs",
"Background / Objectives : Short-term studies have suggested beneficial effects of a Palaeolithic-type diet ( PD ) on body weight and metabolic balance . We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women , in comparison with a diet according to the Nordic Nutrition Recommendations (NNR).Subjects/ Methods : Seventy obese postmenopausal women ( mean age 60 years , body mass index 33 kg/m2 ) were assigned to an ad libitum PD or NNR diet in a 2-year r and omized controlled trial . The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry . Results : Both groups significantly decreased total fat mass at 6 months ( −6.5 and −2.6 kg ) and 24 months ( −4.6 and −2.9 kg ) , with a more pronounced fat loss in the PD group at 6 months ( P ) . Waist circumference and sagittal diameter also decreased in both the groups , with a more pronounced decrease in the PD group at 6 months ( −11.1 vs−5.8 cm , P=0.001 and −3.7 vs−2.0 cm , P respectively ) . Triglyceride levels decreased significantly more at 6 and 24 months in the PD group than in the NNR group ( P P=0.004 ) . Nitrogen excretion did not differ between the groups . Conclusions : A PD has greater beneficial effects vs an NNR diet regarding fat mass , abdominal obesity and triglyceride levels in obese postmenopausal women ; effects not sustained for anthropometric measurements at 24 months . Adherence to protein intake was poor in the PD group . The long-term consequences of these changes remain to be studied",
"The aim of this work was to determine whether the effects of weight loss on coronary heart disease ( CHD ) risk factors are comparable in men and women and whether the long term impact of modest weight loss is as great as the initial response . Changes in CHD risk factors were examined at 6 month intervals in 159 moderately overweight subjects who were participating in an 18 month behavioral weight loss program . Men experienced greater decreases in blood pressure , triglycerides , and waist-to-hip ratio ( WHR ) and greater increases in HDL-cholesterol with weight loss than women . Most of these gender differences were removed by adjusting for baseline values and changes in BMI . After these adjustments , improvements in WHR at 18 months were shown to be greater in women than in men . Participants ( n = 39 ) who lost 4.5 kg or more from baseline to 6 months ( mean weight loss of 11.8 kg or 13 % of initial body weight ) and maintained this weight loss within + /- 2.3 kg had significant long term improvements ( through 18 months ) in triglycerides , HDL and LDL-cholesterol , WHR , systolic and diastolic blood pressure , and fasting and 2 h insulin . Changes in HDL-cholesterol , the HDL : Total cholesterol ratio , and WHR actually increased between 6 and 18 months and improvements in all other parameters were maintained over time . Men have greater improvements in CHD risk factors with weight loss than women , but this gender difference appears to derive from differences in CHD risk factors at baseline and differences in weight loss . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVES We tested the effectiveness of a community-based , literacy-sensitive , and culturally tailored lifestyle intervention on weight loss and diabetes risk reduction among low-income , Spanish-speaking Latinos at increased diabetes risk . METHODS Three hundred twelve participants from Lawrence , Massachusetts , were r and omly assigned to lifestyle intervention care ( IC ) or usual care ( UC ) between 2004 and 2007 . The intervention was implemented by trained Spanish-speaking individuals from the community . Each participant was followed for 1 year . RESULTS The participants ' mean age was 52 years ; 59 % had less than a high school education . The 1-year retention rate was 94 % . Compared with the UC group , the IC group had a modest but significant weight reduction ( -2.5 vs 0.63 lb ; P = .04 ) and a clinical ly meaningful reduction in hemoglobin A1c ( -0.10 % vs -0.04 % ; P = .009 ) . Likewise , insulin resistance improved significantly in the IC compared with the UC group . The IC group also had greater reductions in percentage of calories from total and saturated fat . CONCLUSIONS We developed an inexpensive , culturally sensitive diabetes prevention program that result ed in weight loss , improved HbA1c , and improved insulin resistance in a high-risk Latino population",
"OBJECTIVE To evaluate the impact of a low-cost nutritional intervention in changing the lifestyle of adults . DESIGN R and omised clinical trial . SETTING Primary health-care centre in São José do Rio Preto , São Paulo State , Brazil . SUBJECTS We r and omly assigned 104 adults ( 83 women and 21 men aged 30 - 65 years , body mass index 24 - 35 kg m(-2 ) , non-diabetic ) into two groups : nutrition counselling and control . Each subject in the intervention group received three individualised nutritional counselling sessions during the first 6 months aim ed at increasing intakes of fruits , vegetables and olive oil , reducing saturated fat and improving physical activity . Body composition , biochemical indicators and lifestyle were assessed at baseline and at 6 months and 1 year in both groups . RESULTS After 6 months of follow-up , body weight , waist circumference , diastolic blood pressure , fasting blood glucose , total and low-density lipoprotein cholesterol , total and saturated fat , and dietary energy and cholesterol levels showed a more significant decrease among subjects in the intervention group than in the control group ( P reduced intake of saturated fat and increased intakes of fruits , vegetables , fibre and olive oil ( P low-cost nutritional intervention programme improved serum lipids profile and weight control , and appeared to be feasible for use at a primary health-care centre in a developing country ",
"Objective To develop and evaluate the effectiveness of a community behavioural intervention to prevent weight gain and improve health related behaviours in women with young children . Design Cluster r and omised controlled trial . Setting A community setting in urban Australia . Participants 250 adult women with a mean age of 40.39 years ( SD 4.77 , range 25 - 51 ) and a mean body mass index of 27.82 kg/m2 ( SD 5.42 , range 18 - 47 ) were recruited as clusters through 12 primary ( elementary ) schools . Intervention Schools were r and omly assigned to the intervention or the control . Mothers whose schools fell in the intervention group ( n=127 ) attended four interactive group sessions that involved simple health messages , behaviour change strategies , and group discussion , and received monthly support using mobile telephone text messages for 12 months . The control group ( n=123 ) attended one non-interactive information session based on population dietary and physical activity guidelines . Main outcome measures The main outcome measures were weight change and difference in weight change between the intervention group and the control group at 12 months . Secondary outcomes were changes in serum concentrations of fasting lipids and glucose , and changes in dietary behaviours , physical activity , and self management behaviours . Results All analyses were adjusted for baseline values and the possible clustering effect . Women in the control group gained weight over the 12 month study period ( 0.83 kg , 95 % confidence interval ( CI ) 0.12 to 1.54 ) , whereas those in the intervention group lost weight ( −0.20 kg , −0.90 to 0.49 ) . The difference in weight change between the intervention group and the control group at 12 months was −1.13 kg ( −2.03 to −0.24 kg ; P for total cholesterol concentration ( −0.35 mmol/l , −0.70 to −0.001 ) , self management behaviours ( diet score 0.18 , 0.13 to 0.33 ; physical activity score 0.24 , 0.05 to 0.43 ) , and confidence to control weight ( 0.40 , 0.11 to 0.69 ) . Regular self weighing was associated with weight loss in the intervention group only ( −1.98 kg , −3.75 to −0.23 ) . Conclusions Weight gain in women with young children could be prevented using a low intensity self management intervention delivered in a community setting . Self management of health behaviours improved with the intervention . The response rate of 12 % , although comparable with that in other community studies , might limit the ability to generalise to other population s. Trial registration Australian New Zeal and Clinical Trials Registry number ACTRN12608000110381",
"OBJECTIVES We evaluated a community-based , translational lifestyle program to reduce diabetes risk in lower-socioeconomic status ( SES ) and ethnic minority adults . METHODS Through an academic-public health department partnership , community-dwelling adults at risk for diabetes were r and omly assigned to individualized lifestyle counseling delivered primarily via telephone by health department counselors or a wait-list control group . Primary outcomes ( 6 and 12 months ) were fasting glucose level , triglycerides , high- and low-density lipoprotein cholesterol , weight , waist circumference , and systolic blood pressure . Secondary outcomes included diet , physical activity , and health-related quality of life . RESULTS Of the 230 participants , study retention was 92 % . The 6-month group differences for weight and triglycerides were significant . The intervention group lost 2 pounds more than did the control group ( P=.03 ) and had decreased triglyceride levels ( difference in change , 23 mg/dL ; P=.02 ) . At 6 months , the intervention group consumed 7.7 fewer grams per day of fat ( P=.05 ) and more fruits and vegetables ( P=.02 ) than did control participants . CONCLUSIONS Despite challenges design ing effective translational interventions for lower-SES and minority communities , this program modestly improved some diabetes risk factors . Thus , individualized , telephone-based models may be a promising alternative to group-based interventions",
"OBJECTIVE Although the benefits of in-person Diabetes Prevention Program ( DPP ) classes for diabetes prevention have been demonstrated in trials , effectiveness in clinical practice is limited by low participation rates . This study explores whether text message support enhances weight loss in patients offered DPP classes . RESEARCH DESIGN AND METHODS English- and Spanish-speaking patients with prediabetes ( n = 163 ) were r and omized to the control group , which only received an invitation to DPP classes as defined by the Centers for Disease Control and Prevention , or to the text message – augmented intervention group , which also received text messages adapted from the DPP curriculum for 12 months . RESULTS Mean weight decreased 0.6 pounds ( 95 % CI −2.7 to 1.6 ) in the control group and 2.6 pounds ( 95 % CI −5.5 to 0.2 ) in the intervention group ( P value 0.05 ) . Three percent weight loss was achieved by 21.5 % of participants in the control group ( 95 % CI 12.5–30.6 ) , compared with 38.5 % in the intervention group ( 95 % CI 27.7–49.3 ) ( absolute difference 17.0 % ; P value 0.02 ) . Mean glycated hemoglobin ( HbA1c ) increased by 0.19 % or 2.1 mmol/mol ( 95 % CI −0.1 to 0.5 % ) and decreased by 0.09 % or 1.0 mmol/mol ( 95 % CI −0.2 to 0.0 % ) in the control group and intervention participants , respectively ( absolute difference 0.28 % ; P value 0.07 ) . Stratification by language demonstrated a significant treatment effect in Spanish speakers but not in English speakers . CONCLUSIONS Text message support can lead to clinical ly significant weight loss in patients with prediabetes . Further study assessing effect by primary language and in an operational setting is warranted",
"BACKGROUND The Arizona Well-Integrated Screening and Evaluation for Women Across the Nation ( WISEWOMAN ) project used provider counseling , health education , and community health workers ( CHWs ) to target chronic disease risk factors in uninsured , primarily Hispanic women over age 50 . METHODS Participants were recruited from two Tucson clinics participating in the National Breast and Cervical Cancer Early Detection Program ( NBCCEDP ) . Women were r and omly assigned into one of three intervention groups : ( 1 ) provider counseling , ( 2 ) provider counseling and health education , or ( 3 ) provider counseling , health education , and CHW support . At baseline and 12 months ( 1998 - 2000 ) , participants were measured for height , weight , waist and hip circumference , and blood pressure . Blood tests were conducted to check blood glucose , cholesterol , and triglyceride levels . At each time point , participants also completed 24-hour dietary recalls and question naires focusing on their physical activity levels . RESULTS A total of 217 women participated in baseline and 12-month follow-up . Three fourths were Hispanic . All three intervention groups showed an increase in self-reported weekly minutes of moderate-to-vigorous physical activity , with no significant differences between the groups . Significantly more women who received the comprehensive intervention of provider counseling , health education , and CHW support progressed to eating five fruits and vegetables per day , compared with participants who received only provider counseling or provider counseling plus health education . CONCLUSIONS All three interventions increased moderate-to-vigorous physical activity but not fruit and vegetable consumption . The intervention group with provider counseling , health education , and CHW support significantly increased the number of women meeting national recommendations for fruit and vegetable consumption",
"BACKGROUND A number of factors contribute to increased risk of coronary heart disease ( CHD ) among postmenopausal women , including atherogenic changes in serum cholesterol profiles , weight gain , and decreases in physical activity during the menopause . To date , no study has attempted to prevent elevations in primary CHD risk factors as women experience menopause . METHODS A sample of 535 healthy premenopausal women , ages 44 - 50 , were recruited for an ongoing 5-year r and omized prevention trial testing whether increases in low-density lipoprotein cholesterol ( LDL-C ) and body weight can be prevented during the menopause with a dietary and behavioral intervention . The aim was to reduce total dietary and saturated fat and cholesterol , prevent weight gain , and increase physical activity levels . Changes in CHD risk factors after the first 6 months of treatment were analyzed comparing 253 intervention and 267 assessment -only control participants . RESULTS The intervention group showed significant reductions in total cholesterol ( -0.34 mmol/liter ) , LDL-C ( -0.28 mmol/liter ) , triglycerides ( -0.04 mmol/liter ) , weight ( -4.8 kg ) , waist-hip ratio ( -0.008 ) , systolic blood pressure ( -3.5 mm Hg ) , diastolic blood pressure ( -2.2 mm Hg ) , serum glucose levels ( -0.06 mmol/liter ) , and HDL-C ( -0.06 mmol/liter ) and significant increases in physical activity ( + 383 kcal ) . No significant changes were observed in the control group . CONCLUSION Six-month results suggested that participants were receptive to the preventive approach to CHD risk reduction and were successful in making initial positive lifestyle changes . Follow-up data will evaluate long-term adherence to the intervention and the interaction between adherence and physiological changes during menopause",
"OBJECTIVES This study examined the health-related effects of two worksite interventions , physical exercise and reduced workhours , on women employed in dentistry . METHODS Six workplaces were r and omized to one of the following three conditions : ( i ) 2.5 hours of weekly , m and atory physical exercise of middle-to-high intensity to be performed during workhours ( N=62 ) , ( ii ) a reduction of full-time weekly workhours from 40 to 37.5 hours ( N=50 ) , and ( iii ) reference . In all , 177 women participated . Biomarkers and self-ratings in question naires were obtained before the intervention ( T ( 1 ) ) , and six ( T ( 2 ) ) and 12 months ( T ( 3 ) ) after the intervention . RESULTS The results showed increased levels of physical activity and exercise in all of the groups , the level of physical exercise being significantly greater in the physical exercise group . Repeated- measures analyses of variance using data from T ( 1 ) and T (3)for biological measures and all three time points for self-ratings produced significant interaction effects for glucose , waist-to-hip ratio , and work ability and clear trends for general symptoms and upper-extremity disorders . Posthoc analyses showed that the results of the health-related measures differed between the interventions , decreased glucose and upper-extremity disorders in the exercise group , and increased high-density lipoprotein and waist-to-hip ratio among those working reduced hours . CONCLUSIONS These results show that the two interventions had small and varied effects on biomarkers and self-reports of different aspects of health among women . It is suggested that interventions involving a modest reduction in workhours seem to be more effective if these hours are used for physical exercise",
"BACKGROUND AND AIMS Improvements in a lifestyle modification program for hypertensives were maintained 1 year later . Longer follow-up in such studies is limited ; we therefore re-assessed participants after an additional 2 years in which there was no contact with program facilitators . METHODS AND RESULTS Participants r and omised to usual care ( N=118 ) or a 4-month lifestyle program ( N=123 ) were previously assessed after 4 months and 1 year . After a further 2 years , diet , alcohol intake , physical activity , weight , waist girth , ambulatory blood pressure ( BP ) , blood lipids , glucose and insulin were measured ( usual care N=64 ; program N=76 ) . Statistically significant net changes , relative to usual care , included blood cholesterol ( -0.2 mmol/L , 95 % CI 0.1 - 0.4 ) ; physical activity ( 53 min/week , 95 % CI 15 - 91 ) ; dietary saturated fat ( -1.9 % energy , 95 % CI -0.1 to -3.8 ) ; fish ( 3.2 serves/month , 95 % CI 0.7 - 5.7 ) ; vegetables ( 9.1 serves/month , 95 % CI 3.2 - 15.1 ) ; and sweet foods ( -6.2 serves/month , 95 % CI -1.1 to -11.3 ) . Between-group changes in weight ( -0.7 kg , 95 % CI -1.8 - 0.4 ) , BP ( systolic 1.4 mmHg , 95 % CI -0.7 - 3.5)/diastolic 1.0 mmHg , 95 % CI -0.3 - 2.4 ) and Framingham risk ( usual care : men 12.1 % , women 3.7 % ; program : men 12.2 % ; women 3.5 % ) did not differ significantly . CONCLUSION Continued reinforcement with long-term follow-up is needed in lifestyle modification programs",
"BACKGROUND Lifestyle interventions among people with impaired glucose tolerance reduce the incidence of diabetes , but their effect on all-cause and cardiovascular disease mortality is unclear . We assessed the long-term effect of lifestyle intervention on long-term outcomes among adults with impaired glucose tolerance who participated in the Da Qing Diabetes Prevention Study . METHODS The study was a cluster r and omised trial in which 33 clinics in Da Qing , China-serving 577 adults with impaired glucose tolerance-were r and omised ( 1:1:1:1 ) to a control group or lifestyle intervention groups ( diet or exercise or both ) . Patients were enrolled in 1986 and the intervention phase lasted for 6 years . In 2009 , we followed up participants to assess the primary outcomes of cardiovascular mortality , all-cause mortality , and incidence of diabetes in the intention-to-treat population . FINDINGS Of the 577 patients , 439 were assigned to the intervention group and 138 were assigned to the control group ( one refused baseline examination ) . 542 ( 94 % ) of 576 participants had complete data for mortality and 568 ( 99 % ) contributed data to the analysis . 174 participants died during the 23 years of follow-up ( 121 in the intervention group vs 53 in the control group ) . Cumulative incidence of cardiovascular disease mortality was 11.9 % ( 95 % CI 8.8 - 15.0 ) in the intervention group versus 19.6 % ( 12.9 - 26.3 ) in the control group ( hazard ratio [ HR ] 0.59 , 95 % CI 0.36 - 0.96 ; p=0.033 ) . All-cause mortality was 28.1 % ( 95 % CI 23.9 - 32.4 ) versus 38.4 % ( 30.3 - 46.5 ; HR 0.71 , 95 % CI 0.51 - 0.99 ; p=0.049 ) . Incidence of diabetes was 72.6 % ( 68.4 - 76.8 ) versus 89.9 % ( 84.9 - 94.9 ; HR 0.55 , 95 % CI 0.40 - 0.76 ; p=0.001 ) . INTERPRETATION A 6-year lifestyle intervention programme for Chinese people with impaired glucose tolerance can reduce incidence of cardiovascular and all-cause mortality and diabetes . These findings emphasise the long-term clinical benefits of lifestyle intervention for patients with impaired glucose tolerance and provide further justification for adoption of lifestyle interventions as public health measures to control the consequences of diabetes . FUNDING Centers for Disease Control and Prevention , WHO , the China-Japan Friendship Hospital , Da Qing First Hospital ",
"Although the Diabetes Prevention Program ( DPP ) developed a lifestyle weight loss intervention that has been demonstrated to prevent type 2 diabetes in high-risk individuals , it has yet to be widely adopted at the community level . The Healthy Living Partnership to Prevent Diabetes study ( HELP PD ) was design ed to translate the DPP approach for use in community setting s as a cost-effective intervention led by Community Health Workers ( CHW 's ) and administered through a Diabetes Care Center ( DCC ) . Approximately 300 overweight and obese ( BMI 25 - 40 kg/m(2 ) ) individuals with prediabetes ( fasting blood glucose 95 - 124 mg/dl ) were r and omly assigned to either a lifestyle weight loss intervention ( LW ) or an enhanced usual care comparison condition ( UC ) . The goal of LW is > or=7 % weight loss achieved through increases in physical activity ( 180 min/wk ) and decreases in caloric intake ( approximately 1500 kcal/day ) . The intervention consists of CHW-led group-mediated cognitive behavioral meetings that occur weekly for 6 months and monthly thereafter for 18 months . UC consists of 2 individual meetings with a registered dietitian and a monthly newsletter . The primary outcome is change in fasting blood glucose . Secondary outcomes include cardiovascular risk factors , health-related quality of life , and social cognitive variables . Outcomes are masked and are collected every 6 months . The cost-effectiveness of the program will also be assessed . A community-based program that is administered through local DCC 's and that harnesses the experience of community members ( CHW 's ) may be a promising strategy for the widespread dissemination of interventions effective at preventing type 2 diabetes in high risk individuals",
"The authors investigated the efficacy of a lifestyle educational program , organized in small group meetings , in improving the outcome of a nonpharmacologic intervention . One hundred and eighty-eight hypertensive patients with stable blood pressure ( BP ) levels and drug therapy in the previous 6 months were r and omly divided into educational care ( EC ) and usual care ( UC ) groups . They were followed at 3-month intervals up to 2 years . In addition to the visits in an outpatient clinic , patients in the EC program participated in small group meetings in order to improve their knowledge of the disease and reinforce their motivation for treatment . At baseline , EC and UC groups were similar for age , sex , body mass index ( BMI ) , blood pressure ( BP ) levels , and pharmacologic treatment . Patients in the EC group had significantly reduced total energy , total and saturated fats , and sodium intake . Physical activity was significantly increased in the EC group as well . At the end of the 1-year follow-up , BMI ( P visceral fat ( P and BP ( P<.001 ) were significantly lower in the EC group compared with the UC group . Pharmacologic treatment during the study was similar for all classes of drugs apart from diuretics whose dose was higher in the UC group at the end of the study",
"Purpose The purpose of this study is to evaluate the effectiveness of a nutrition-based shared medical appointment ( SMA ) intervention in the treatment of prediabetes compared to the individualized counseling st and ard of care . Methods A r and omized controlled trial design comparing health outcomes in patients with prediabetes attending either an individualized counseling ( control group ) or three 90-minute nutrition SMA ( intervention group ) sessions . Demographic , anthropometric ( weight and body mass index ) , clinical ( blood pressure ) , and biochemical ( lipid profile , fasting blood sugar , glycated hemoglobin , albumin-to-creatinine ratio ) measures were obtained from all participants at baseline , at 3 months , and at 1 year . Results Ninety-four participants were r and omized into the 2 study groups with a 69 % completion rate at 1 year ( n = 34 SMA , n = 31 control ) . The average participant was Caucasian ( 64 % ) , male ( 54 % ) , 58.3 ± 9.6 years , had a BMI of 30.8 ± 4.9 kg/m2 ( obese ) , and fasting blood glucose of 109 ± 9.5 mg/dL. The SMA and control participants lost a mean of 6.6 pounds and 3.6 pound , respectively ; neither group met the 5 % modest weight loss expected . The SMA and control group experienced a mean drop in fasting blood glucose of 6 mg/dL. Conclusions As dem and s on health care providers continue to rise , finding innovative ways to manage the patient load while providing quality health care is increasingly important . SMA health outcomes were equivalent to individual counseling outcomes , while increasing the provider ’s productivity by treating 6 to 8 people with prediabetes in 90 minutes compared to 1 patient in 60 minutes"
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Bariatric surgery is currently the most effective treatment for morbid obesity . These procedures change the gastrointestinal system with the aim of reducing dietary intake . Improving diet quality is essential in maintaining nutritional health and achieving long-term benefits from the surgery . The aim of this systematic review was to examine the relationship between bariatric surgery and diet quality at least 1 year after surgery . A systematic search of five data bases was conducted . Studies were included that reported diet quality , eating pattern , or quality of eating in adult patients who had undergone laparoscopic-adjusted gastric b and ing ( LAGB ) , Roux-en-Y gastric bypass ( RYGB ) , and sleeve gastrectomy ( SG ) procedures . Data was extracted to determine the relationship between having had bariatric surgery and subsequent diet quality . A total of 34 study articles ( described in 36 articles ) met the inclusion criteria . The majority of studies were observational in nature and showed a reduction in energy intake following surgery , as well as inadequate intakes of micronutrients and protein , and an excessive intake of fats . There was evidence of nutrient imbalances , suboptimal compliance with multivitamin and mineral supplementation , and limited follow-up of patients . The current evidence base suggests that despite being effective in reducing energy intake , bariatric surgery can result in unbalanced diets , inadequate micronutrient and protein intakes , and excessive intakes of fats . In combination with suboptimal adherence to multivitamin and mineral supplementation , this may contribute to nutritional deficiencies and weight regain . There is a need for high- quality nutrition studies , to identify optimal dietary compositions following bariatric surgery
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"Background : Approximately 20 - 30 % of obese patients do not achieve successful weight outcomes after bariatric surgery . Objective : We examined whether short-term changes ( ≤0.5 y postsurgery ) in energy intake and macronutrient composition after bariatric surgery could predict 10-y weight change . Design : Participants were recruited from the Swedish Obese Subjects ( SOS ) study , which was a matched ( nonr and omized ) prospect i ve trial that compared bariatric surgery with usual care for obese patients . A total of 2010 patients who underwent bariatric surgery were included in the study . Physical examinations ( e.g. , weight ) and question naires ( e.g. , dietary question naire ) were completed before and 0.5 , 1 , 2 , 3 , 4 , 6 , 8 , and 10 y after surgery . For the main analytic strategy , a linear mixed model was implemented , which included repeated measures with a r and om intercept and an unstructured covariance matrix . Results : Short-term changes in energy intake ( P in relative proportions of energy from carbohydrates ( P fat ( P protein ( P 10-y weight change after bariatric surgery . At the 10-y follow-up , men and women with the largest reductions in energy intake had lost 7.3 % and 3.9 % more weight , respectively , compared with that of subjects with the smallest intake reductions ( P Greater weight loss was achieved in men and women who favored protein and carbohydrates over fat and in subjects who favored protein over carbohydrates than in individuals who favored the opposite changes in macronutrient composition ( P predicts long-term weight loss . Weight loss is also associated with a changing dietary macronutrient composition . This trial was registered at clinical trials.gov as NCT01479452",
"Background Patients who have undergone bariatric surgery have increased risks of developing micronutrient deficiencies . Translational research investigating the actual micronutrient intake of bariatric patients is limited . We examined the micronutrient intake of a multicentre cohort of laparoscopic adjustable gastric b and ing patients 1 year post-surgery . These data were compared to micronutrient recommendations for the general population . Methods Consecutive patients from three bariatric surgery facilities in Melbourne , Australia , were invited to participate 12 months post-operatively . A vali date d food frequency question naire was posted to 215 prospect i ve participants . Results Of the 52 participants , micronutrient intakes from food and fluids alone were below population recommendations for calcium , folate , magnesium , potassium , retinol equivalents , thiamin and vitamin E. Males did not meet the recommended intakes for zinc , and iron intakes in pre-menopausal women were insufficient . Intakes lower than recommended levels for these micronutrients suggest inadequate intake of foods from vegetable , dairy , lean meat ( or alternatives ) and wholegrains . Micronutrient intakes below recommended levels in this patient group can be further explained by their macronutrient intakes that suggested diets of poor nutrient density . Recommendations for supplementation in this group have wide variations , usually having been developed through the presence of clinical and biochemical deficiencies . Conclusions Nutritional supplementation should be more extensive in scope and dosage than is currently recommended by some professional guidelines . Further long-term studies are needed to explore both macro- and micronutrient intakes on the morbidity and mortality of this patient population",
"Background Data on gastrointestinal ( GI ) and dietary changes following bariatric surgery are scarce in the Middle Eastern region . The objective of this work was to retrospectively compare dietary intake , food preferences , and GI symptoms in subjects with extreme obesity after Roux-en-Y gastric bypass ( RYGB ) and sleeve gastrectomy ( SG ) . Methods Sixty subjects equally divided between RYGB and SG with a postoperative period of ≥6 months were recruited for a retrospective , non-r and omized , and observational study . All subjects completed three question naires ( GI symptoms , food preferences , and quantitative food frequency question naire ( FFQ ) ) and three 24-h recalls . Results At one year postoperatively , both surgical groups showed similar percentage of excess weight loss that exceeded 50 % . In addition , percentage of carbohydrate , protein , and sugar intake from total energy , frequency of daily consumption from the eight food categories and daily energy intake were comparable between surgical groups . RYGB subjects consumed significantly more fruits and juices from total energy ( P desserts . Heartburn ( P regurgitation ( P ) , nausea ( P , vomiting ( P , and constipation ( P subjects . Flatulence ( P and diarrhea ( P as dizziness ( P and fast heartbeat ( P in dietary intake and food preferences between RYGB and SG groups . There was a trend for sweet-eating in SG subjects with less dumping symptoms to suggest different mechanisms of action for each procedure , which might impact eating behavior",
"Background Data on adherence to postoperative lifestyle recommendations by bariatric patients are scarce . Thus , the aim of this study was to evaluate adherence to selected recommendations during the first year following laparoscopic sleeve gastrectomy ( LSG ) surgery . Methods A prospect i ve cohort study with 12 months of follow-up on 100 LSG patients was conducted . Data were collected at baseline and at 3 ( M3 ) , 6 ( M6 ) , and 12 ( M12 ) months post-surgery and included anthropometrics , biochemical tests , food intake , food tolerance , common surgery-related side effects , physical activity ( PA ) , supplementation , and number of follow-up meetings with a dietitian . Results Data were available for 77 patients ( 57.1 % women , mean age 43.1 ± 9.3 years and preoperative BMI 42.1 ± 4.8 kg/m2 ) . Only a minority of the patients adhered to the recommended protein intake ≥60 g/day at all time points ( ≤40.3 % ) and ≥6 meetings with a dietitian at M12 ( 41.6 % ) . Half of the patients performed ≥150 min/week of PA at all time points ( ≤50.6 % ) as recommended . PA of ≥150 min/week was associated with better lipid and glucose changes at M6 and M12 ( P ≤ 0.044 ) . Most of the patients adhered to the recommended supplementation at all time points ( ≥57.1 % ) . Adherence to supplementation at M12 was significantly associated with higher serum levels of folic acid , iron , hemoglobin , and vitamins D and B12 ( P ≤ 0.056 for all ) . Adherence to all recommendations was not significantly associated with excess weight loss ≥60 % at M12 ( P ≥ 0.195 for all ) . Conclusion Bariatric patients have medium to high adherence to the major lifestyle recommendations during the first year following LSG ; however , adherence to those recommendations was not related to better weight loss at short-term follow-up . Adherence to recommended supplementation was associated with better micronutrient status 1 year postoperatively",
"OBJECTIVE The effects of food tolerance ( if any ) on diet quality several years post-surgery remain unclear . Our study aim ed to assess food tolerance and diet quality after three bariatric procedures ; adjustable gastric b and ing ( AGB ) , sleeve gastrectomy ( SG ) and Roux-en-Y gastric bypass ( RYGBP ) , 2â??4 years post-surgery . METHODS This prospect i ve , cross-sectional study assessed weight loss , food tolerance and diet quality in 130 subjects ( 14 obese pre-surgical controls , 13 AGB , 62 SG and 41 RYGBP ) . Inclusion criteria selected patients who underwent bariatric surgery between 1 January 2007 and 31 December 2008 , at a single bariatric clinic . Non-parametric tests ( Kruksalâ??Wallis and Mannâ??Whitney ) along with Spearman 's correlation coefficient analysis were used . RESULTS Superior food tolerance was reported by the control ( 24.5 ) , SG ( 24.0 ) and RYGBP ( 22.0 ) groups , compared with the AGB group ( 15.5 ; P high-calorie extra foods ( 9.2 and 7.7 daily serves respectively ) compared with the SG ( 3.4 serves ) and RYGBP ( 4.0 serves ) groups . There were several significant correlations between food tolerance and dietary intake including breads and cereals and meat and meat alternatives . CONCLUSION The control and AGB groups consumed significantly more high-calorie extra foods , a result that was paralleled by poor weight loss and food tolerance outcomes for the AGB group . A significant positive relationship between food tolerance and diet quality was established . Poor food tolerance and thus compromised diet quality need to be considered as post-surgical complications of the AGB procedure",
"BACKGROUND Underreporting of food intake is common in obese subjects . OBJECTIVE One aim of this study was to assess to what extent underreporting by obese men is explained by underrecording ( failure to record in a food diary everything that is consumed ) or undereating . Another aim of the study was to find out whether there was an indication for selective underreporting . DESIGN Subjects were 30 obese men with a mean ( + /-SD ) body mass index ( in kg/m(2 ) ) of 34 + /- 4 . Total food intake was measured over 1 wk . Energy expenditure ( EE ) was measured with the doubly labeled water method , and water loss was estimated with deuterium-labeled water . Energy balance was checked for by measuring body weight at the start and end of the food-recording week and 1 wk after the recording week . RESULTS Mean energy intake and EE were 10.4 + /- 2.5 and 16.7 + /- 2 . 4 MJ/d , respectively ; underreporting was 37 + /- 16 % . The mean body mass loss of 1.0 + /- 1.3 kg over the recording week was significantly different ( P Water intake ( reported + metabolic water ) and water loss were significantly different from each other and indicated 12 % underrecording . The reported percentage of energy from fat was a function of the level of underreporting : percentage of energy from fat = 46 - 0.2 x percentage of underreporting ( r(2 ) = 0.28 , P = 0.003 ) . CONCLUSIONS Total underreporting by the obese men was explained by underrecording and undereating . The obese men selectively underreported fat intake",
"Background Roux-en-Y gastric bypass ( GBP ) and sleeve gastrectomy ( SG ) have increased dramatically , potentially increasing the prevalence of nutritional deficiencies . The aim of this study was to analyze the effects of food restriction during the first year after bariatric surgery ( BS ) on nutritional parameters . Methods Twenty-two and 30 obese patients undergoing GBP and SG were prospect ively followed at baseline and 3 , 6 , and 12 months after BS ( N = 14 and N = 19 at T12 ) . We evaluated food intake and nutrient adequacy ( T0 , T3 , T12 ) , as well as serum vitamin and mineral concentration ( T0 , T3 , T6 , T12 ) . Results At baseline , GBP and SG patients had similar clinical characteristics , food intake , nutrient adequacy , and serum concentration . The drastic energy and food reduction led to very low probabilities of adequacy for nutrients similar in both models ( T3 , T12 ) . Serum analysis demonstrated a continuous decrease in prealbumin during the follow-up , indicating mild protein depletion in 37 and 38 % of GBP patients and 57 and 52 % of SG patients , respectively , at T3 and T12 . Conversely , despite the low probabilities of adequacy observed at T3 and T12 , systematic multivitamin and mineral supplementation after GBP and SG prevented most nutritional deficiencies . Conclusions GBP and SG have comparable effects in terms of energy and food restriction and subsequent risk of micronutrient and protein deficiencies in the first year post BS . Such results advocate for a cautious monitoring of protein intake after GPB and SG and a systematic multivitamin and mineral supplementation in the first year after SG",
"Objective The purpose of this study was to learn whether preoperative eating habits can be used to predict outcome after vertical b and ed gastroplasty ( VBG ) and Roux-en-Y gastric bypass ( RYGB ) . Background Summary Several independent r and omized and sequential studies have reported significantly greater weight loss after RYGB in comparison with VBG . Although the mechanism responsible for weight loss after both procedures is restriction of intake rather than malabsorption , the relationships between calorie intake , food preferences , and postoperative weight loss are not well defined . Methods During the past 5 years , 138 patients were prospect ively selected for either VBG or RYGB , based on their preoperative eating habits . All patients were screened by a dietitian who determined total calorie intake and diet composition before recommending VBG or RYGB . Thirty patients were selected for VBG ; the remaining 108 patients were classified as “ sweets eaters ” or “ snackers ” and had RYGB . Detailed recall diet histories also were performed at each postoperative visit . Results Early morbidity rate was zero after VBG versus 3 % after RYGB . There were no deaths . Mean follow-up was 39 ± 11 months after VBG and 38 ± 14 months after RYGB . Mean weight loss peaked at 74 ± 23 lb at 12 months after VBG and 99 ± 24 lb at 16 months after RYGB ( p ≤ 0.001 ) . Twelve of 30 VBG patients lost > 50 % of their excess weight versus 100 of 108 RYGB patients ( p ≤ 0.0001 ) . Milk/ice cream intake was significantly greater postoperatively in patients who underwent VBG versus patients who underwent RYGB after 6 months ( p ≤ 0.003 ) , whereas solid sweets intake was significantly greater after VBG during the first 18 months postoperatively ( p ≤ 0.004 ) . Revision of VBG was performed in 6 of 30 patients ( 20 % ) for complications or poor weight loss , whereas only 2 of 108 patients who underwent RYGB required surgical revisions ( p ≤ 0.001 ) . Conclusions These data show that VBG adversely alters postoperative eating behavior toward soft , high-calorie foods , result ing in problematic postoperative weight loss . Conversely , RYGB patients had significantly greater weight loss despite inferior preoperative eating habits . The high rate",
"Background Bariatric surgery is often associated with reduced food tolerance and sometimes frequent vomiting , which influence quality of life , but are not included in the overall evaluation of these procedures , notably the BAROS . Our aim was to develop a simple question naire to evaluate food tolerance during follow-up visits . Methods A one-page question naire including questions about overall satisfaction regarding quality of alimentation , timing of eating over the day , tolerance to several types of food , and frequency of vomiting/ regurgitation was developed . A composite score was derived from this question naire , giving a score of 1 to 27.Validation was performed with a group of nonobese adults and a group of morbidly obese nonoperated patients . Patients were administered the question naire at follow-up visits since January 1999 . Data were collected prospect ively . Results It takes 1–2 minutes to fill out the question naire . Food tolerance is worse in the morbidly obese population compared with non-obese adults ( 24.2 vs 25.2 , P=0.004 ) . Following Roux-en-Y gastric bypass , food tolerance is reduced after 3 months ( 21.2 ) , but becomes comparable to that of the normal population and remains so at 1 year postoperatively . Following gastric b and ing , food tolerance is already significantly reduced after 3 months ( 22.3 ) , and worsens continuously over time ( 19.03 after 7 years ) . In the gastric b and ing population , the decision to adjust the b and is based at least partially on food tolerance , and the question naire proved helpful in that respect . Conclusion Our new question naire proved very easy to use , and helpful in day-to-day practice , especially after gastric b and ing . It was also helpful in comparing food tolerance over time after surgery , and in comparing food tolerance between procedures . Evaluation of food tolerance should be part of the overall evaluation of the results after bariatric surgery",
"BACKGROUND Obesity is among the leading causes of disease and death . Bariatric surgery is the most effective treatment of obesity . There is increasing evidence that after gastric bypass surgery , patients and animal models show a decreased preference for sweet and fatty foods . The underlying mechanism may include alterations in taste function . OBJECTIVE We hypothesize that a gastric bypass reduces the reward value of sweet and fat tastes . DESIGN In this prospect i ve case-control study , 11 obese patients who were scheduled to undergo a gastric bypass and 11 normal-weight control subjects in the fed state clicked a computer mouse to receive a sweet and fatty c and y on a progressive ratio schedule 10 wk apart ( in patients , testing took place 2 wk before and 8 wk after gastric bypass surgery ) . Subjects worked progressively harder to obtain a food reward ( reinforcer ) until they stopped clicking ( ie , the breakpoint ) , which was a measure of the reinforcer value . Breakpoints were assessed by the number of mouse clicks in the last completed ratio . The experiment was repeated in a different cohort by using vegetable pieces as the reinforcer . RESULTS Breakpoints in the test sessions of control subjects correlated highly for both reinforcers . The median breakpoint for c and ies , but not vegetables , was reduced by 50 % in the obese group after gastric bypass . Patients with the largest reduction in the breakpoint had the largest decrease in BMI . CONCLUSIONS Gastric bypass surgery result ed in the selective reduction of the reward value of a sweet and fat tastant . This application of the progressive ratio task provided an objective and reliable evaluation of taste-driven motivated behavior for food stimuli after obesity surgery",
"PURPOSE Roux-en-Y gastric bypass is a popular and successful operation for the treatment of morbid obesity . However , it greatly restricts ingestion and moderately interferes with absorption of food , thus potentially paving the way for undernutrition , especially during the first year before patients adapt to the new condition . Aim ing to document actual dietary intake during this period , a prospect i ve observational study was performed . METHODS Forty consecutive patients were investigated using a 24-hour dietary recall technique every 3 months after surgery for 1 year . Females only were accepted for greater homogeneity of the sample . All received a vitamin and mineral supplement on a daily basis as a postoperative routine . A question naire was employed regarding general , nutritional , and gastrointestinal changes as well as consumption of medications . Dietary intake was analyzed after data processing using the Virtual Nutri software package ( São Paulo , SP , Brazil ) . RESULTS The surgical response was within the expected range , with about 67 % excess weight loss at the end of the 1st year , and the same occurred with gastrointestinal symptoms and drug requirements . Daily energy intake on the 4 analyzed occasions was 529.4 + /- 47.4 , 710.9 + /- 47.6 , 833.2 + /- 72.0 , and 866.2 + /- 95,1 kcal/day ( mean + /- SEM ) ; protein intake was increased in the same proportion at 6 and 9 months , but reduced at 12 months . Thus , patients did not meet st and ard recommendations regarding calories and proteins , even at the end of the 1st year ; iron and zinc intake were also inadequate , although deficiencies were probably staved off by the prescribed supplement preparation . CONCLUSIONS 1 ) The risk for postoperative undernutrition was evidence d up to 1 year , while spontaneous improvement in food intake was slow and inefficient ; 2 ) Specific protocol s should be devised to improve nutrition and health during the postoperative phase until successful dietary adaptation is achieved",
"BACKGROUND The effect of a Roux-en-Y gastric bypass ( RYGB ) on body weight has been amply documented , but few studies have simultaneously assessed the evolution of energy and macronutrient intakes , energy expenditure , and changes in body composition over time after an RYGB . OBJECTIVE We evaluated energy and macronutrient intakes , body composition , and the basal metabolic rate ( BMR ) in obese female patients during the initial 3 y after an RYGB . METHODS Sixteen women with a mean ± SEM body mass index ( in kg/m(2 ) ) of 44.1 ± 1.6 were included in this prospect i ve observational study . The women were studied on 6 different occasions as follows : before and 1 , 3 , 6 , 12 ( n = 16 ) , and 36 ( n = 8) mo after surgery . On each occasion , food intake was evaluated from 4- or 7-d dietary records , body composition was assessed with the use of bio-impedancemetry , and energy expenditure was measured with the use of indirect calorimetry . RESULTS Body weight evolution showed the typical pattern reported after an RYGB . Total energy intake was 2072 ± 108 kcal/d at baseline and decreased to 681 ± 58 kcal/d at 1 mo after surgery ( P baseline ) . Total energy intake progressively increased to reach 1240 ± 87 kcal/d at 12 mo after surgery ( P mo after surgery ) . Protein intake was 87 ± 4 g/d at baseline and ± 2 g/d 1 mo after surgery ( P 1 mo after surgery ) . Carbohydrate and fat intakes over time showed similar patterns . Protein intake from meat and cheese were significantly reduced early at 1 mo after surgery but increased thereafter ( P decreased from 1.12 ± 0.04 kcal/min at baseline to 0.93 ± 0.03 , 0.86 ± 0.03 , and 0.85 ± 0.04 kcal/min at 3 , 12 , and 36 mo after surgery , respectively ( all P ) . CONCLUSIONS Total energy , carbohydrate , fat , and protein intakes decreased markedly during the initial 1 - 3 mo after an RYGB , whereas the BMR moderately decreased . The reduction in protein intake was particularly severe at 1 mo after surgery , and protein intake increased gradually after 3 - 6 mo after surgery . This trial was registered at clinical trials.gov as NCT01891591",
"Background Laparoscopic sleeve gastrectomy ( LSG ) results in reduced calorie intake and weight loss . Whether patients consume the same types of food before and after surgery or whether they reduce the volume and calorie density of the foods they consume remains unknown . Objectives The aim of this prospect i ve study was to evaluate the changes in daily caloric and macronutrient intake after LSG and the relation between changes of taste and food tolerance over 2 years . Methods Thirty morbidly obese patients with median body mass index ( BMI ) of 43.9 kg/m2 ( 39.5–57.3 ) were prospect ively enrolled prior to LSG . Weight , BMI , % EWL , weight loss percentage ( % WL ) , and daily intake were evaluated preoperatively at 1 , 3 , 6 , 12 , and 24 months after surgery along with a question naire evaluating food choices , quality of eating , tolerance of certain types of food , frequency of vomiting , and changes in taste . Results The median % EWL and % WL at 12 and 24 months was 65 % ( 33.9–93.6 % ) , 27.3 % ( 14.2–45.5 % ) and 71.5 % ( 39.6–101.1 % ) , 31 % ( 19.1–50.3 % ) respectively . Six months after surgery , the daily caloric intake reduced by 68 % and the reduction was maintained until 24 months . The median score of the eating question naire was 18 ( 10–27 ) at 6 months , 22 ( 16–26 ) at 12 months , and 23 ( 10–27 ) at 24 months , suggesting that the quality of nutrition improved over time . At 6 , 12 , and 24 months , 75 % of the patients reported changes in taste with reduced interest in sweets , high fat food , and alcoholic drinks . However , at 24 months , 20 % of patients reported a heightened interest in sweets compared to 12 months previously . Conclusions LSG reduced calorie intake both through volume of food and the calorie density of the food consumed . The mechanisms for the changes in food preferences may involve both unconditioned and conditioned effects . The influence of dietary counseling on learning which foods are consumed still requires further exploration",
"BACKGROUND Weight loss is associated with short-term amelioration and prevention of metabolic and cardiovascular risk , but whether these benefits persist over time is unknown . METHODS The prospect i ve , controlled Swedish Obese Subjects Study involved obese subjects who underwent gastric surgery and contemporaneously matched , conventionally treated obese control subjects . We now report follow-up data for subjects ( mean age , 48 years ; mean body-mass index , 41 ) who had been enrolled for at least 2 years ( 4047 subjects ) or 10 years ( 1703 subjects ) before the analysis ( January 1 , 2004 ) . The follow-up rate for laboratory examinations was 86.6 percent at 2 years and 74.5 percent at 10 years . RESULTS After two years , the weight had increased by 0.1 percent in the control group and had decreased by 23.4 percent in the surgery group ( P weight had increased by 1.6 percent and decreased by 16.1 percent , respectively ( P Energy intake was lower and the proportion of physically active subjects higher in the surgery group than in the control group throughout the observation period . Two- and 10-year rates of recovery from diabetes , hypertriglyceridemia , low levels of high-density lipoprotein cholesterol , hypertension , and hyperuricemia were more favorable in the surgery group than in the control group , whereas recovery from hypercholesterolemia did not differ between the groups . The surgery group had lower 2- and 10-year incidence rates of diabetes , hypertriglyceridemia , and hyperuricemia than the control group ; differences between the groups in the incidence of hypercholesterolemia and hypertension were undetectable . CONCLUSIONS As compared with conventional therapy , bariatric surgery appears to be a viable option for the treatment of severe obesity , result ing in long-term weight loss , improved lifestyle , and , except for hypercholesterolemia , amelioration in risk factors that were elevated at baseline",
"BACKGROUND Data on long-term dietary changes and nutritional deficiencies after sleeve gastrectomy ( SG ) in grade 3 obese patients are scarce . OBJECTIVE To prospect ively compare dietary changes and nutritional deficiencies in grade 3 obese patients 5 years after SG and Roux-en-y gastric bypass ( GBP ) . PARTICIPANTS / SETTING Three hundred and fifty-five patients who had SG ( n=61 ) or GBP ( n=294 ) ( May 2001-December 2006 ) at a Spanish university hospital . DESIGN Longitudinal , prospect i ve , observational study . PRIMARY OUTCOMES /STATISTICAL ANALYSES : Changes in energy , macronutrient , and micronutrient intake , and weight loss were analyzed using mixed models for repeated measurements . RESULTS At the 5-year follow-up visit , the percentage of excess weight loss ( P=0.420 ) and daily energy intake ( P=0.826 ) , as well as the proportion of energy from carbohydrates ( P=0.303 ) , protein ( P=0.600 ) , and fat ( P=0.541 ) did not differ between surgical groups . Energy intake ( P=0.004 ) , baseline weight ( P time period ( P weight loss over time . After SG or GBP , the mean daily dietary intake of calcium , magnesium , phosphorus , and iron was less than the current recommendations . Despite universal supplementation , the prevalence of nutritional deficiencies was comparable after SG or GBP , with 25-hydroxyvitamin D being the most commonly observed deficiency ( SG , 93.3 % to 100 % ; GBP , 90.9 % to 85.7 % , P = not significant ) . In an adjusted multivariate regression model , energy intake and lipid intake independently predicted plasma 25(OH)-vitamin D levels . CONCLUSIONS Data show that SG and GBP are associated with similar long-term weight loss with no differences in terms of dietary intake . Furthermore , data demonstrate that both types of surgeries carry comparable nutritional consequences",
"BACKGROUND & AIMS Roux-en-Y gastric bypass ( RYGB ) is associated with an increased risk for micronutrient deficiencies . This study aim ed to assess total ( dietary and supplement ) intake and association with iron ( including hepcidin ) , vitamin B12 , vitamin C and zinc status markers before and after Roux-en-Y gastric bypass ( RYGB ) . METHODS This prospect i ve study included patients with a planned RYGB in University Hospitals Leuven , Belgium ; who were followed until 12 months post-RYGB . Patients completed an estimated dietary record of two non-consecutive days before and 1 , 3 , 6 and 12 months post-RYGB and supplement/drug use was registered . Associations between total micronutrient intake and status markers were analyzed . RESULTS Fifty-four patients ( 21 males ; mean age : 48.0 [ 95%CI 46.6 ; 49.3 ] years ; mean preoperative BMI : 40.4 [ 95%CI 39.4 ; 41.4 ] kg/m2 ) were included . One month post-RYGB , usual dietary intake of the studied micronutrients was significantly decreased compared to pre-RYGB , but gradually increased until 12 months post-RYGB , remaining below baseline values . By including micronutrient supplement intake , 12 months post-RYGB values were higher than baseline , except for zinc . Hemoglobin , ferritin , vitamin B12 and C-reactive protein serum concentrations were significantly decreased and transferrin saturation and mean corpuscular volume were significantly increased 12 months post-RYGB . Serum hepcidin concentration was significantly decreased 6 months post-RYGB . CONCLUSIONS Medical nutritional therapy is essential following RYGB as dietary intake of iron , vitamin B12 , vitamin C , copper and zinc was markedly decreased postoperatively and some patients still had an inadequate total intake one year post-RYGB"
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Purpose of review In the past decade , food allergy has been increasingly recognized as an important public health issue . The role of maternal and infant diet in the development of food allergy has been a major focus of research throughout this period . Recently , research in this area has moved from observational studies to intervention trials , and the findings from these trials have started to influence infant feeding guidelines . In this article , we review recent studies of dietary interventions for preventing food allergy , summarize current knowledge and discuss future research directions . Recent findings The latest result from an intervention trial shows that introduction of peanut in the first year of life reduces the risk of peanut allergy in high-risk infants . A systematic review and meta- analysis of intervention trials also suggests a protective effect of egg introduction from around 4 to 6 months of age for reducing the risk of egg allergy , with most studies conducted in high-risk infants . Despite several intervention trials involving modifications to the maternal diet , the effect of maternal diet during pregnancy and lactation in preventing food allergy remains unclear . Summary Earlier introduction of allergenic foods is a promising intervention to reduce the risk of some food allergies in high-risk infants . Further work is needed to improve knowledge of how to prevent food allergy in the general population
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"The role of breastfeeding in improving allergy outcomes in early childhood is still unclear . Evidence suggests that immune mediators in human milk ( HM ) play a critical role in infant immune maturation as well as protection against atopy/allergy development . We investigated relationships between levels of immune mediators in colostrum and mature milk and infant outcomes in the first year of life . In a large prospect i ve study of 398 pregnant/lactating women in the United Kingdom , Russia and Italy , colostrum and mature human milk ( HM ) sample s were analysed for immune active molecules . Statistical analyses used models adjusting for the site of collection , colostrum collection time , parity and maternal atopic status . Preliminary univariate analysis showed detectable interleukin ( IL ) 2 and IL13 in HM to be associated with less eczema . This finding was further confirmed in multivariate analysis , with detectable HM IL13 showing protective effect OR 0.18 ( 95 % CI 0.04–0.92 ) . In contrast , a higher risk of eczema was associated with higher HM concentrations of transforming growth factor β ( TGFβ ) 2 OR 1.04 ( 95 % CI 1.01–1.06 ) per ng/mL. Parental-reported food allergy was reported less often when IL13 was detectable in colostrum OR 0.10 ( 95 % CI 0.01–0.83 ) . HM hepatocyte growth factor ( HGF ) was protective for common cold incidence at 12 months OR 0.19 ( 95 % CI 0.04–0.92 ) per ng/mL. Data from this study suggests that differences in the individual immune composition of HM may have an influence on early life infant health outcomes . Increased TGFβ2 levels in HM are associated with a higher incidence of reported eczema , with detectable IL13 in colostrum showing protective effects for food allergy and sensitization . HGF shows some protective effect on common cold incidence at one year of age . Future studies should be focused on maternal genotype , human milk microbiome and diet influence on human milk immune composition and both short- and long-term health outcomes in the infant",
"BACKGROUND Observational studies suggest that early regular ingestion of allergenic foods might reduce the risk of food allergy . OBJECTIVE We sought to determine whether early regular oral egg exposure will reduce subsequent IgE-mediated egg allergy in infants with moderate-to-severe eczema . METHODS In a double-blind , r and omized controlled trial infants were allocated to 1 teaspoon of pasteurized raw whole egg powder ( n = 49 ) or rice powder ( n = 37 ) daily from 4 to 8 months of age . Cooked egg was introduced to both groups after an observed feed at 8 months . The primary outcome was IgE-mediated egg allergy at 12 months , as defined based on the results of an observed pasteurized raw egg challenge and skin prick tests . RESULTS A high proportion ( 31 % [ 15/49 ] ) of infants r and omized to receive egg had an allergic reaction to the egg powder and did not continue powder ingestion . At 4 months of age , before any known egg ingestion , 36 % ( 24/67 ) of infants already had egg-specific IgE levels of greater than 0.35 kilounits of antibody (kUA)/L. At 12 months , a lower ( but not significant ) proportion of infants in the egg group ( 33 % ) were given a diagnosis of IgE-mediated egg allergy compared with the control group ( 51 % ; relative risk , 0.65 ; 95 % CI , 0.38 - 1.11 ; P = .11 ) . Egg-specific IgG4 levels were significantly ( P immune tolerance pathways and reduction in egg allergy incidence can be achieved by early regular oral egg exposure in infants with eczema . Caution needs to be taken when these high-risk infants are first exposed to egg because many have sensitization already by 4 months of age",
"BACKGROUND Maternal diet during pregnancy may affect childhood allergy and asthma . OBJECTIVE We sought to examine the associations between maternal intake of common childhood food allergens during early pregnancy and childhood allergy and asthma . METHODS We studied 1277 mother-child pairs from a US prebirth cohort unselected for any disease . Using food frequency question naires administered during the first and second trimesters , we assessed maternal intake of common childhood food allergens during pregnancy . In mid-childhood ( mean age , 7.9 years ) , we assessed food allergy , asthma , allergic rhinitis , and atopic dermatitis by question naire and serum-specific IgE levels . We examined the associations between maternal diet during pregnancy and childhood allergy and asthma . We also examined the cross-sectional associations between specific food allergies , asthma , and atopic conditions in mid-childhood . RESULTS Food allergy was common ( 5.6 % ) in mid-childhood , as was sensitization to at least 1 food allergen ( 28.0 % ) . Higher maternal peanut intake ( each additional z score ) during the first trimester was associated with 47 % reduced odds of peanut allergic reaction ( odds ratio [ OR ] , 0.53 ; 95 % CI , 0.30 - 0.94 ) . Higher milk intake during the first trimester was associated with reduced asthma ( OR , 0.83 ; 95 % CI , 0.69 - 0.99 ) and allergic rhinitis ( OR , 0.85 ; 95 % CI , 0.74 - 0.97 ) . Higher maternal wheat intake during the second trimester was associated with reduced atopic dermatitis ( OR , 0.64 ; 95 % CI , 0.46 - 0.90 ) . Peanut , wheat , and soy allergy were each cross-sectionally associated with increased childhood asthma , atopic dermatitis , and allergic rhinitis ( ORs , 3.6 to 8.1 ) . CONCLUSION Higher maternal intake of peanut , milk , and wheat during early pregnancy was associated with reduced odds of mid-childhood allergy and asthma",
"BACKGROUND Maternal diet during pregnancy might be one of the factors that influences fetal immune responses associated with childhood allergy . OBJECTIVE We analyzed the association between maternal diet during the last 4 wk of pregnancy and allergic sensitization and eczema in the offspring at 2 y of age . DESIGN Data from 2641 children at 2 y of age were analyzed within a German prospect i ve birth cohort study ( LISA ) . Maternal diet during the last 4 wk of pregnancy was assessed with a semiquantitative food-frequency question naire , which was administered shortly after childbirth . RESULTS High maternal intake of margarine [ adjusted odds ratio ( aOR ) : 1 . 49 ; 95 % CI : 1.08 , 2.04 ] and vegetable oils ( aOR : 1.48 ; 95 % CI : 1.14 , 1.91 ) during the last 4 wk of pregnancy was positively associated and high maternal fish intake ( aOR : 0.75 ; 95 % CI : 0.57 , 0.98 ) was inversely associated with eczema during the first 2 y in the offspring . High celery ( aOR : 1.85 ; 95 % CI : 1.18 , 2.89 ) and citrus fruit ( aOR : 1.73 ; 95 % CI : 1.18 , 2.53 ) intakes increased the risk of sensitization against food allergens . In turn , sensitization against inhalant allergens was positively related to a high maternal intake of deep-frying vegetable fat ( aOR : 1.61 ; 95 % CI : 1.02 , 2.54 ) , raw sweet pepper ( aOR : 2.16 ; 95 % CI : 1.20 , 3.90 ) , and citrus fruit ( aOR : 1.72 ; 95 % CI : 1.02 , 2.92 ) . CONCLUSIONS We suggest that the intake of allergenic foods and foods rich in n-6 polyunsaturated fatty acids during pregnancy may increase and foods rich in n-3 polyunsaturated fatty acids may decrease the risk of allergic diseases in the offspring",
"Background : Epidemiologic evidence suggests delayed introduction of egg might not protect against egg allergy in infants at risk of allergic disease . Objective : We sought to assess whether dietary introduction of egg between 4 and 6 months in infants at risk of allergy would reduce sensitization to egg . Methods : We conducted a r and omized controlled trial in infants with at least 1 first‐degree relative with allergic disease . Infants with a skin prick test ( SPT ) response to egg white ( EW ) of less than 2 mm were r and omized at age 4 months to receive whole‐egg powder or placebo ( rice powder ) until 8 months of age , with all other dietary egg excluded . Diets were liberalized at 8 months in both groups . The primary outcome was an EW SPT response of 3 mm or greater at age 12 months . Results : Three hundred nineteen infants were r and omized : 165 to egg and 154 to placebo . Fourteen infants reacted to egg within 1 week of introduction ( despite an EW SPT response Two hundred fifty‐four ( 83 % ) infants were assessed at 12 months of age . Loss to follow‐up was similar between groups . Sensitization to EW at 12 months was 20 % and 11 % in infants r and omized to placebo and egg , respectively ( odds ratio , 0.46 ; 95 % CI , 0.22–0.95 ; P = .03 , χ2 test ) . The absolute risk reduction was 9.8 % ( 95 % CI , 8.2 % to 18.9 % ) , with a number needed to treat of 11 ( 95 % CI , 6–122 ) . Levels of IgG4 to egg proteins and IgG4/IgE ratios were higher in those r and omized to egg ( P the proportion of children with probable egg allergy ( placebo , 13 ; egg , 8) . Conclusions : Introduction of whole‐egg powder into the diets of high‐risk infants reduced sensitization to EW and induced egg‐specific IgG4 levels . However , 8.5 % of infants r and omized to egg were not amenable to this primary prevention",
"Maternal nutrient intake during pregnancy and lactation potentially influences the development of allergic diseases . Cows ' milk allergy ( CMA ) is often the first manifestation of atopic diseases , but the impact of early nutritional influences on CMA has not been explored . The associations between maternal intakes of folate , folic acid and vitamin D during pregnancy and lactation were addressed in a prospect i ve , population -based birth cohort within the Finnish Type 1 Diabetes Prediction and Prevention Study . Mothers of 4921 children during pregnancy and 2940 children during lactation provided information on maternal dietary intake during the 8th month of pregnancy and the 3rd month of lactation using a detailed , vali date d FFQ . Information on diagnosed CMA in the offspring was obtained from a medical registry as well as queried from the parents . The Finnish food composition data base was used to calculate nutrient intake . Logistic regression was applied for statistical analyses . Folate intake and folic acid and vitamin D supplement use were associated with an increased risk of CMA in the offspring , whereas vitamin D intake from foods during pregnancy was associated with a decreased risk of CMA . Thus , maternal nutrient intake during pregnancy and lactation may affect the development of CMA in offspring . Supplementation with folic acid may not be beneficial in terms of CMA development , especially in children of allergic mothers . The association between dietary supplement use and CMA risk can at least partly be explained by increased health-seeking behaviour among more educated mothers who also use more dietary supplements",
"Background The influence of early exposure to allergenic foods on the subsequent development of food allergy remains uncertain . Objective We sought to determine the feasibility of the early introduction of multiple allergenic foods to exclusively breast-fed infants from 3 months of age and the effect on breastfeeding performance . Methods We performed a r and omized controlled trial . The early introduction group ( EIG ) continued breastfeeding with sequential introduction of 6 allergenic foods : cow 's milk , peanut , hard-boiled hen 's egg , sesame , whitefish ( cod ) , and wheat ; the st and ard introduction group followed the UK infant feeding recommendations of exclusive breastfeeding for around 6 months with no introduction of allergenic foods before 6 months of age . Results One thous and three hundred three infants were enrolled . By 5 months of age , the median frequency of consumption of all 6 foods was 2 to 3 times per week for every food in the EIG and no consumption for every food in the st and ard introduction group ( P non introduction of the allergenic foods in the EIG was less than 5 % for each of the 6 foods . Achievement of the stringent per- protocol consumption target for the EIG proved more difficult ( 42 % of evaluable EIG participants ) . Breastfeeding rates in both groups significantly exceeded UK government data for equivalent mothers ( P multiple allergenic foods appears achievable and did not affect breastfeeding . This has important implication s for the evaluation of food allergy prevention strategies",
"BACKGROUND The diversity in the perceived prevalence , recovery , and risk factors for cow 's milk allergy ( CMA ) necessitated a large-scale , population -based prospect i ve study . OBJECTIVE We sought to determine the prevalence , cross-reactivity with soy allergy , and risk factors for the development of CMA . METHODS In a prospect i ve study the feeding history of 13,019 infants was obtained by means of telephone interview ( 95.8 % ) or question naire ( 4.2 % ) . Infants with probable adverse reactions to milk were examined , skin prick tested , and challenged orally . RESULTS Ninety-eight percent of the cohort participated in the study . The cumulative incidence for IgE-mediated CMA was 0.5 % ( 66/13,019 patients ) . The mean age of cow 's milk protein ( CMP ) introduction was significantly different ( P days ) and those with IgE-mediated CMA ( 116.1 + /- 64.9 days ) . Only 0.05 % of the infants who were started on regular CMP formula within the first 14 days versus 1.75 % who were started on formula between the ages of 105 and 194 days had IgE-mediated CMA ( P IgE-mediated CMA among infants with exposure to CMP at the age of 15 days or more ( P Sixty-four patients with IgE-mediated CMA tolerated soy , and none had a proved allergy to soy . CONCLUSIONS IgE-mediated CMA is much less common than generally reported . Early exposure to CMP as a supplement to breast-feeding might promote tolerance . Finally , soy is a reasonable feeding alternative in patients with IgE-mediated CMA",
"Background : Hen 's egg is the most common cause of food allergy in early childhood . Objective : We investigated the efficacy and safety of early hen 's egg introduction at age 4 to 6 months to prevent hen 's egg allergy in the general population . Methods : This r and omized , placebo‐controlled trial included 4‐ to 6‐month‐old infants who were not sensitized against hen 's egg , as determined based on specific serum antibodies ( IgE ) . These infants were r and omized to receive either verum ( egg white powder ) or placebo ( rice powder ) added to the first weaning food 3 times a week under a concurrent egg‐free diet from age 4 to 6 until 12 months . The primary outcome was sensitization to hen 's egg ( increased specific serum IgE levels ) by age 12 months . Hen 's egg allergy ( secondary outcome ) was confirmed by double‐blind , placebo‐controlled food challenges . Results : Among 406 screened infants , 23 ( 5.7 % ) had hen 's egg – specific IgE before r and omization . Seventeen of 23 underwent subsequent double‐blind , placebo‐controlled food challenges , and 16 were confirmed as allergic , including 11 with anaphylactic reactions . Of the 383 nonsensitized infants ( 56.7 % male ) , 184 were r and omized to verum and 199 to placebo . At 12 months of age , 5.6 % of the children in the verum group were hen 's egg sensitized versus 2.6 % in the placebo group ( primary outcome ; relative risk , 2.20 ; 95 % CI , 0.68–7.14 ; P = .24 ) , and 2.1 % were confirmed to have hen 's egg allergy versus 0.6 % in the placebo group ( relative risk , 3.30 ; 95 % CI , 0.35–31.32 ; P = .35 ) . Conclusion : We found no evidence that consumption of hen 's egg starting at 4 to 6 months of age prevents hen 's egg sensitization or allergy . In contrast , it might result in frequent allergic reactions in the community considering that many 4‐ to 6‐month‐old infants were already allergic to hen 's egg",
"BACKGROUND Food allergy prevalence is increasing in developed countries , but these results have not yet been verified in developing countries , especially in China . Our aim was to determine whether the prevalence and characteristics of food allergy have changed over the last 10 years in Chongqing , China . METHODS Two cross-sectional studies were performed , 10 years apart ( 1999 and 2009 ) using the same diagnostic methods in the same age group ( 0 - 24 months ) of the same clinic in Chongqing , China . A total of 401 infants were r and omly selected for the present study . Food allergy was confirmed by food challenge . spss 15.0 was used to analyze the difference in prevalence . RESULTS Food allergy prevalence increased significantly from 3.5 % in 1999 to 7.7 % in 2009 ( P= 0.017 ) . The prevalence of a positive skin-prick-test response was also increased ( from 9.9 % to 18 % ; P= 0.002 ) . Egg and cow 's milk were still the most common food allergens , which cause skin and gastrointestinal symptoms in most infants . CONCLUSION This is the first study in China to indicate time trends in food allergy prevalence and characteristics . Our data show that in the 10-year period from 1999 to 2009 , the prevalence of food allergy seems to have increased in China",
"IMPORTANCE The etiology of the increasing childhood prevalence of peanut or tree nut ( P/TN ) allergy is unknown . OBJECTIVE To examine the association between peripregnancy consumption of P/TN by mothers and the risk of P/TN allergy in their offspring . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study . The 10,907 participants in the Growing Up Today Study 2 , born between January 1 , 1990 , and December 31 , 1994 , are the offspring of women who previously reported their diet during , or shortly before or after , their pregnancy with this child as part of the ongoing Nurses ' Health Study II . In 2006 , the offspring reported physician-diagnosed food allergy . Mothers were asked to confirm the diagnosis and to provide available medical records and allergy test results . Two board-certified pediatricians , including a board-certified allergist/immunologist , independently review ed each potential case and assigned a confirmation code ( eg , likely food allergy ) to each case . Unadjusted and multivariable logistic regression analyses were used to evaluate associations between peripregnancy consumption of P/TN by mothers and incident P/TN allergy in their offspring . EXPOSURE Peripregnancy consumption of P/TN . MAIN OUTCOMES AND MEASURES Physician-diagnosed P/TN allergy in offspring . RESULTS Among 8205 children , we identified 308 cases of food allergy ( any food ) , including 140 cases of P/TN allergy . The incidence of P/TN allergy in the offspring was significantly lower among children of the 8059 nonallergic mothers who consumed more P/TN in their peripregnancy diet ( ≥ 5 times vs between maternal peripregnancy P/TN consumption and risk of P/TN allergy in the offspring of 146 P/TN-allergic mothers ( P(trend ) = .12 ) . The interaction between maternal peripregnancy P/TN consumption and maternal P/TN allergy status was statistically significant ( P(interaction ) = .004 ) . CONCLUSIONS AND RELEVANCE Among mothers without P/TN allergy , higher peripregnancy consumption of P/TN was associated with lower risk of P/TN allergy in their offspring . Our study supports the hypothesis that early allergen exposure increases tolerance and lowers risk of childhood food allergy",
"BACKGROUND Early life allergen exposure may increase the risk of childhood allergy , but the protective effect of reduction in allergen exposure remains uncertain . OBJECTIVE To evaluate the effect of reduction in food and house dust mite ( HDM ) allergen exposure in infancy in preventing asthma and allergy . METHODS Infants , at higher risk because of family predisposition , were recruited prenatally and r and omized to prophylactic ( n = 58 ) and control ( n = 62 ) groups . Prophylactic group infants were either breast-fed with mother on a low allergen diet or given an extensively hydrolyzed formula . Exposure to HDM was reduced by the use of an acaricide and mattress covers . The control group followed st and ard advice . Development of allergic diseases and sensitization to common allergens ( atopy ) was assessed blindly at ages 1 , 2 , 4 , and 8 years in all 120 children . RESULTS Repeated measurement analysis , adjusted for all relevant confounding variables , confirmed a preventive effect on asthma : adjusted odds ratio ( OR ) , 0.24 ; 95 % CI , 0.09 - 0.66 ; P = .005 ; atopic dermatitis , OR , 0.23 ; CI , 0.08 - 0.64 ; P = .005 ; rhinitis , OR , 0.42 ; CI , 0.19 - 0.92 ; P = .03 ; and atopy , OR , 0.13 ; CI , 0.05 - 0.32 ; P protective effect was primarily observed in the subgroup of children with persistent disease ( symptoms at all visits ) and in those with evidence of allergic sensitization . CONCLUSION Allergic diseases can be reduced , for at least the first 8 years of life , by combined food and HDM allergen avoidance in infancy . CLINICAL IMPLICATION S Strict food and HDM allergen avoidance should be considered for prevention of allergy in high-risk infants",
"Background : The ideal age to introduce egg into the infant diet has been debated for the past 2 decades in the context of rising rates of egg allergy . Objective : We sought to determine whether regular consumption of egg protein from age 4 to 6 months reduces the risk of IgE‐mediated egg allergy in infants with hereditary risk , but without eczema . Methods : Infants aged 4 to 6 months were r and omly allocated to receive daily pasteurized raw whole egg powder ( n = 407 ) or a color‐matched rice powder ( n = 413 ) to age 10 months . All infants followed an egg‐free diet and cooked egg was introduced to both groups at age 10 months . The primary outcome was IgE‐mediated egg allergy defined by a positive pasteurized raw egg challenge and egg sensitization at age 12 months . Results : There was no difference between groups in the percentage of infants with IgE‐mediated egg allergy ( egg 7.0 % vs control 10.3 % ; adjusted relative risk , 0.75 ; 95 % CI , 0.48–1.17 ; P = .20 ) . A higher proportion of participants in the egg group stopped taking the study powder because of a confirmed allergic reaction ( 25 of 407 [ 6.1 % ] compared with 6 of 413 [ 1.5 % ] ) . Egg‐specific IgG4 levels were substantially higher in the egg group at 12 months ( median , 1.22 mgA/L vs control 0.07 mgA/L ; P the risk of egg allergy by age 1 year in infants who are at hereditary risk of allergic disease and had no eczema symptoms at study entry",
"Over the past two decades we have been debating the question of whether the age of commencement of complementary feeding affects the risk of developing food allergy . We ate up the notion that delayed introduction of more allergenic foods in early childhood , would help overcome the increasing rates of food allergy , then we promptly spat it out again despite limited evidence . Recently high- quality r and omised controlled trial evidence has given us the confidence to swallow the concept that allergenic foods , like egg and peanut , should be given to infants . We now need to recommend that when an infant is developmentally ready , a variety of nutritious foods should be introduced to ensure high diet diversity , including the ‘ more allergenic ’ foods during infancy . This article is protected by copyright . All rights reserved",
"BACKGROUND Extended breast-feeding is recommended for newborn children at risk of allergy-associated diseases , but the evidence of a protective effect on sensitization and these diseases remains elusive . OBJECTIVE The aim of this study was to investigate the effects of the duration of exclusive breast-feeding on the development of sensitization in preschool children . METHODS Information on breast-feeding was gathered by interviews involving 335 children aged 1 , 6 , and 12 months from the Copenhagen Prospect i ve Study on Asthma in Childhood2000 birth cohort born to mothers with a history of asthma . Skin prick test responses and specific IgE levels against 12 common inhalant and 10 food allergens were assessed longitudinally at ages ½ year , 1½ years , 4 years , and 6 years . Eczema , wheeze/asthma , and allergic rhinitis were diagnosed at the Copenhagen Prospect i ve Studies on Asthma in Childhood clinic at 7 years of age , strictly adhering to predefined algorithms . Associations between duration of exclusive breast-feeding and outcomes were analyzed by logistic regression . RESULTS We found no significant association between duration of exclusive breast-feeding and development of sensitization in the first 6 years of life ( odds ratio [ OR ] : ½ year , 1.10 [ 95 % CI , 0.90 - 1.36 ] ; 1½ years , 1.15 [ 95 % CI , 0.97 - 1.36 ] ; 4 years , 1.08 [ 95 % CI , 0.93 - 1.25 ] ; and 6 years , 0.96 [ 95 % CI , 0.84 - 1.10 ] ) or with current eczema , wheeze/asthma , and allergic rhinitis at age 7 years ( OR , 1.07 [ 95 % CI , 0.92 - 1.24 ] ; OR , 0.97 [ 95 % CI , 0.82 - 1.14 ] ; and OR , 1.02 [ 95 % CI , 0.84 - 1.23 ] , respectively ) . Adjusting for reverse causation by excluding children with eczema , wheeze , or a positive skin prick test response before ending exclusive breast-feeding did not alter the results . CONCLUSION Exclusive breast-feeding does not affect sensitization in early childhood or associated diseases at 7 years of age in at-risk children",
"BACKGROUND Evidence is accumulating that early consumption is more beneficial than is delayed introduction as a strategy for primary prevention of food allergy . However , allergic reactions caused by early introduction of such solid foods have been a problematic issue . We investigated whether or not early stepwise introduction of eggs to infants with eczema combined with optimal eczema treatment would prevent egg allergy at 1 year of age . METHODS In this r and omised , double-blind , placebo-controlled trial , we enrolled infants 4 - 5 months of age with eczema from two centres in Japan . Exclusion criteria were being born before 37 weeks of gestational age , experience of ingestion of hen 's eggs or egg products , history of immediate allergic reaction to hen 's eggs , history of non-immediate allergic reaction to a particular type of food , and complications of any severe disease . Infants were r and omly assigned ( block size of four ; stratified by institution and sex ) to early introduction of egg or placebo ( 1:1 ) . Participants in the egg group consumed orally 50 mg of heated egg powder per day from 6 months to 9 months of age and 250 mg per day thereafter until 12 months of age . We aggressively treated participants ' eczema at entry and maintained control without exacerbations throughout the intervention period . Participants and physicians were masked to assignment , and allocation was concealed . The primary outcome was the proportion of participants with hen 's egg allergy confirmed by open oral food challenges at 12 months of age , assessed blindly by st and ardised methods , in all r and omly allocated participants who received the intervention . This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry , number UMIN000008673 . FINDINGS Between Sept 18 , 2012 , and Feb 13 , 2015 , we r and omly allocated 147 participants ( 73 [ 50 % ] to the egg group and 74 [ 50 % ] to the placebo group ) . This trial was terminated on the basis of the results of the scheduled interim analysis of 100 participants , which showed a significant difference between the two groups ( four [ 9 % ] of 47 participants had an egg allergy in the egg group vs 18 [ 38 % ] of 47 in the placebo group ; risk ratio 0·222 [ 95 % CI 0·081 - 0·607 ] ; p=0·0012 ) . In the primary analysis population , five ( 8 % ) of 60 participants had an egg allergy in the egg group compared with 23 ( 38 % ) of 61 in the placebo group ( risk ratio 0·221 [ 0·090 - 0·543 ] ; p=0·0001 ) . The only difference in adverse events between groups was admissions to hospital ( six [ 10 % ] of 60 in the egg group vs none in the placebo group ; p=0·022 ) . 19 acute events occurred in nine ( 15 % ) participants in the egg group versus 14 events in 11 ( 18 % ) participants in the placebo group after intake of the trial powder . INTERPRETATION Introduction of heated egg in a stepwise manner along with aggressive eczema treatment is a safe and efficacious way to prevent hen 's egg allergy in high-risk infants . In this study , we developed a practical approach to overcome the second wave of the allergic epidemic caused by food allergy . FUNDING Ministry of Health , Labour and Welfare , and National Centre for Child Health and Development , Japan",
"BACKGROUND To eluci date whether maternal vitamin D supplementation during lactation improves infantile eczema and other subsequent allergic disorders , a r and omized , double-blind , placebo-controlled trial was performed . METHODS Mothers ( n = 164 ) of infants with facial eczema at 1 month check-up were r and omly assigned to receive vitamin D3 supplements ( n = 82 ; 800 IU/day ) or placebo ( n = 82 ) for 6 weeks from May 2009 to January 2011 . The primary outcome was infantile eczema quantified on Scoring Atopic Dermatitis ( SCORAD ) index at 3 month check-up , and the secondary outcomes were atopic dermatitis , food allergy , and wheeze diagnosed by doctors up to 2 years of age . RESULTS There was no significant difference in SCORAD at 3 month check-up between the two groups . Doctor-diagnosed food allergy was significantly more common up to age 2 years in the vitamin D group ( 10/39 , 25.7 % ) than in the placebo group ( 3/40 , 7.5 % ; risk ratio ( RR ) , 3.42 ; 95 % confidence interval [ CI ] : 1.02 - 11.77 ; P = 0.030 ) . Moreover , at least one secondary outcome was also significantly more common in the vitamin D group ( 17/39 , 43.6 % ) than in the placebo group ( 7/40 , 17.5 % ; RR , 2.49 ; 95%CI : 1.16 - 5.34 ; P = 0.012 ) . CONCLUSIONS Vitamin D supplementation may not decrease the severity of infantile eczema at 3 months of age , but may rather increase the risk of later food allergy up to 2 years of age . Because a large number of subjects was lost to follow up , further study is needed to confirm the findings",
"Background The prevalence of allergic diseases in infants , whose parents and siblings do not have allergy , is approximately 10 % and reaches 20–30 % in those with an allergic first-degree relative . Intestinal microbiota may modulate immunologic and inflammatory systemic responses and , thus , influence development of sensitization and allergy . Prebiotics – non-digestible oligosaccharides that stimulate growth of probiotic bacteria – have been reported to modulate immune responses and their supplementation has been proposed as a preventive intervention . Objective The World Allergy Organization ( WAO ) convened a guideline panel to develop evidence -based recommendations about the use of prebiotics in the prevention of allergy . Methods The WAO guideline panel identified the most relevant clinical questions about the use of prebiotics for the prevention of allergy . We performed a systematic review of r and omized controlled trials of prebiotics , and review ed the evidence about patient values and preferences , and re source requirements ( up to January 2015 , with an up date on July 29 , 2015 ) . We followed the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) approach to develop recommendations . Results Based on GRADE evidence to decision frameworks , the WAO guideline panel suggests using prebiotic supplementation in not-exclusively breastfed infants and not using prebiotic supplementation in exclusively breastfed infants . Both recommendations are conditional and based on very low certainty of the evidence . We found no experimental or observational study of prebiotic supplementation in pregnant women or in breastfeeding mothers . Thus , the WAO guideline panel chose not to provide a recommendation about prebiotic supplementation in pregnancy or during breastfeeding , at this time . Conclusions WAO recommendations about prebiotic supplementation for the prevention of allergy are intended to support parents , clinicians and other health care professionals in their decisions whether or not to use prebiotics for the purpose of preventing allergies in healthy , term infants",
"KE Grimshaw , J Maskell , EM Oliver . Pediatrics . 2013;132(6 ) . Available at : www.pediatrics.org/cgi/content/full/132/6/e1529 The study analyzed the significance of complementary feeding and breastfeeding in association with allergy development . This study was a nested case-control trial of 41 infants with food allergy diagnosed by age 2 years and 82 matched controls within a cohort study involving 1140 infants . The infants ’ food allergies were confirmed by using double-blind , placebo-controlled food challenges , the gold st and ard for diagnosing food allergies . Infants with food allergies were recruited from the PIFA ( Prevalence of Infant Food Allergy ) study in the United Kingdom . Parents kept prospect i ve daily food diaries and",
"Introduction Postnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy , lower respiratory tract infections and improved bone health . Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels , despite the absence of large trials proving safety or efficacy for any disease outcome . With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6–8 weeks to 12 months of age , we have started a double-blind , r and omised , placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life , VITALITY . Methods nd analysis Infants ( n=3012 ) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation , from council-led immunisation clinics throughout metropolitan Melbourne , Australia . The primary outcome is challenge-proven food allergy at 12 months of age . Secondary outcomes are food sensitisation ( positive skin prick test ) , number of lower respiratory infections ( through hospital linkage ) , moderately-severe and persistent eczema ( by history and examination ) and vitamin D deficiency ( serum vitamin D 50 nmol/L ) at age 12 months . The trial is underway and the first 130 participants have been recruited . Ethics and dissemination The VITALITY study is approved by the Royal Children 's Hospital ( RCH ) Human Research Ethics Committee ( # 34168 ) . Outcomes will be disseminated through publication and will be presented at scientific conferences . Trial registration numbers ANZCTR12614000334606 and NCT02112734 ; pre- results"
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Background An immediate loss of strength follows virtually all types of muscle injury but there is debate whether the initial strength loss is maximal or if a secondary loss of strength occurs during the first 3 days post-injury . Objective The objective of this analysis was to conduct a systematic review and meta- analysis of the research literature to determine if a secondary loss of strength occurs after an injurious initiating event . Methods Literature search es were performed using eight electronic data bases ( e.g. , PubMed , Cochrane Library ) . Search terms included skeletal muscle AND ( injur * OR damage * ) AND ( strength OR force OR torque ) . The extracted strength data were converted to a st and ard format by calculating the st and ardized mean difference , which is reported as the effect size ( ES ) along with its 95 % confidence interval ( CI ) . The calculation of ES was design ed so that a negative ES that was statistically less than zero would be interpreted as indicating a secondary loss of strength . Results A total of 223 studies with over 4000 human and animal subjects yielded data on 262 independent groups and a total of 936 separate ESs . Our overall meta- analysis yielded a small-to-medium , positive overall ES that was statistically greater than zero ( overall ES = + 0.34 , 95 % CI 0.27–0.40 ; P secondary loss of strength following an acute muscle injury , and strongly suggest that strength , on average , recovers steadily over the first 3 days post-injury
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"Background : Monophasic high voltage stimulation ( MHVS ) is widely prescribed for the treatment of inflammation associated with muscle injury . However , limited scientific evidence exists to support its purported benefits in humans . Objective : To examine the efficacy of early initiation of MHVS treatment after muscle injury . Methods : In a r and omised , cross over design , 14 men performed repetitive eccentric contractions of the elbow flexor muscles followed by either MHVS or control treatment . MHVS treatments were applied five minutes and 3 , 6 , 24 , 48 , 72 , 96 , and 120 hours after eccentric contractions . Results : MHVS result ed in a significant reduction ( p delayed onset muscle soreness 24 hours after eccentric exercise compared with controls . Elbow extension was significantly increased immediately after administration of MHVS compared with controls . No significant differences were observed between MHVS treatment and controls for maximal isometric strength , flexed arm angle , or arm volume . Conclusions : Early and frequent application of MHVS may provide transient relief from delayed onset muscle soreness and short term improvements in range of motion after injurious exercise . However , MHVS treatment may not enhance recovery after muscle injury because of lack of improvements in strength and active range of motion",
"Chapman , DW , Newton , MJ , McGuigan , MR , and Nosaka , K. Effect of slow-velocity lengthening contractions on muscle damage induced by fast-velocity lengthening contractions . J Strength Cond Res 25(1 ) : 211 - 219 , 2011-This study tested the hypothesis that the first exercise bout consisting of slow-velocity ( 30 ° ·s−1 ) maximal lengthening contractions would not affect muscle damage in a subsequent bout consisting of fast-velocity ( 210 ° ·s−1 ) lengthening contractions . Eighteen men were r and omly assigned into either a repeated bout group ( n = 10 ) or control group ( n = 8) . The repeated bout group performed 2 bouts of exercise consisting of 210 maximal lengthening contractions of the elbow flexors separated by 14 days at a velocity of 30 ° ·s−1 for the first and 210 ° ·s−1 for the second bout . The control group performed a single bout of the fast-velocity exercise . Changes in maximal isometric strength , range of motion ( ROM ) , upper-arm circumference , muscle thickness , muscle soreness , serum creatine kinase , and lactate dehydrogenase activities were measured before , immediately after , and 24 to 96 hours after exercise . The repeated bout group showed significantly ( p all criterion measures except for muscle soreness after the fast-velocity exercise compared with the control group . A significant ( p only for ROM between the slow- and fast-velocity bouts of the repeated bout group . These results suggest that slow-velocity exercise reduced muscle damage induced by fast-velocity exercise , although the reduction was not large",
"This study compared maximal ( MAX-ECC ) and submaximal ( 50%-ECC ) eccentric exercise of the elbow flexors . Untrained male students ( n = 8) performed 3 sets of 10 repetitions of MAX-ECC with one arm and 50%-ECC with the other arm , separated by 4 weeks . In MAX-ECC , the elbow joint was forcibly extended from a flexed ( 90 ° ) to a full-extended position ( 180 ° ) in 3 seconds while producing maximal force . For 50%-ECC , a dumbbell set at 50 % of the maximal isometric strength at 90 ° of the elbow joint was lowered from the flexed to the extended position in 3 seconds . Changes in indicators of muscle damage were compared between the bouts by a 2-way repeated- measures analysis of variance . Changes in isometric strength , range of motion , upper arm circumference , and plasma creatine kinase activity were significantly smaller and the recovery was significantly faster for 50%-ECC compared with MAX-ECC , although the differences in the changes immediately after exercise were small . It appeared that the magnitude of initial muscle damage was similar between the bouts ; however , secondary damage was less after 50%-ECC",
"UNLABELLED Protease supplementation has been purported to reduce the damaging effects of eccentric exercise and accelerate recovery of muscle function , possibly by regulating inflammation . PURPOSE To determine the effectiveness of protease supplementation in attenuating eccentric exercise-induced skeletal muscle damage and inflammation . METHODS After st and ard physical and hemodynamic assessment and fasting venous blood sample s , subjects performed isokinetic extension/flexion of the quadriceps group on a Biodex isokinetic dynamometer at 60 ° ·s(-1 ) , followed by VO2max testing . Subjects were r and omly assigned to consume 5.83 g daily of either a cellulose placebo ( N = 15 ; 22.27 ± 3.33 yr , 71.17 ± 2.91 inches , 179.4 ± 24.05 lb , 50.55 ± 5.66 mL·kg(-1)·min(-1 ) ) or a proteolytic supplement containing fungal proteases , bromelain , and papain ( N = 14 ; 22.85 ± 5.9 yr , 70.0 ± 2.67 inches , 173.11 ± 29.94 lb , 49.69 ± 6.15 mL·kg(-1)·min(-1 ) ) for a period of 21 d. After the supplementation period , subjects donated blood sample s before performing a 45-min downhill ( -17.5 % ) treadmill protocol at 60 % of VO2max . An additional four blood draws and three muscle function tests were performed during the next 48 h. Blood was analyzed using st and ard hematology and clinical chemistry , enzyme-linked immunosorbent assay , and bead array . Blood data were analyzed using multivariate analysis of variance ( MANOVA ) with repeated measures , whereas Biodex data were analyzed using a MANOVA on % Δ values . RESULTS Significant group differences ( T1-T3 , P = 0.033 ; T1-T4 , P = 0.043 ) and another strong trend ( T1 - 3 h , P = 0.055 ) were observed for flexion ( peak torque % Δ at 60 ° ·s(-1 ) ) indicating higher force production in the protease group . Significant group × time interactions ( P including elevations in circulating eosinophils and basophils in the protease group coinciding with lower levels of serum cyclooxygenase 2 , interleukin 6 , and interleukin 12 in this group . CONCLUSIONS Protease supplementation seems to attenuate muscle strength losses after eccentric exercise by regulating leukocyte activity and inflammation",
"PURPOSE This study investigated changes in indirect markers of muscle damage after endurance exercise of the elbow flexors and compared the changes with those after maximal eccentric actions ( Max-ECC ) of the elbow flexors . METHODS Eighteen male students rhythmically lifted ( 1 s ) and lowered ( 1 s ) a light dumbbell ( 1.1 - 1.8 kg : 9 % of MIF ) in 60 - 180 degrees of elbow joint angle for 2 h ( 2-h Ex ) . Maximal isometric force ( MIF ) , relaxed ( RANG ) and flexed elbow joint angles ( FANG ) , upper-arm circumference ( CIR ) , muscle soreness ( SOR ) , B-mode ultrasound ( US ) , and plasma creatine kinase ( CK ) activity were assessed before and immediately after , and up to 96 h after exercise . RESULTS All measures were altered significantly ( P in RANG , FANG , CIR , US , and CK ( peak : 356 + /- 121 IU.L-1 ) were significantly ( P SOR developed immediately after 2-h Ex and peaked 24 - 48 h after exercise . MIF dropped to 44.1 % of the preexercise level , which was significantly ( P MIF recovered to 79.8 % at 24 h , and 97.8 % at 96 h postexercise , which was a significantly ( P muscle damage ; however , the magnitude of the muscle damage was less severe , and the recovery was faster compared with 12 maximal eccentric muscle actions",
"OBJECTIVES The purpose of this study was to investigate the physiological and psychological effects of massage on delayed onset muscle soreness ( DOMS ) . METHODS Eighteen volunteers were r and omly assigned to either a massage or control group . DOMS was induced with six sets of eight maximal eccentric contractions of the right hamstring , which were followed 2 h later by 20 min of massage or sham massage ( control ) . Peak torque and mood were assessed at 2 , 6 , 24 , and 48 h postexercise . Range of motion ( ROM ) and intensity and unpleasantness of soreness were assessed at 6 , 24 , and 48 h postexercise . Neutrophil count was assessed at 6 and 24 h postexercise . RESULTS A two factor ANOVA ( treatment v time ) with repeated measures on the second factor showed no significant treatment differences for peak torque , ROM , neutrophils , unpleasantness of soreness , and mood ( p > 0.05 ) . The intensity of soreness , however , was significantly lower in the massage group relative to the control group at 48 h postexercise ( p Massage administered 2 h after exercise induced muscle injury did not improve hamstring function but did reduce the intensity of soreness 48 h after muscle insult",
"Background Both acute bouts of prior exercise ( preconditioning ) and antioxidant nutrients have been used in an attempt to attenuate muscle injury or oxidative stress in response to resistance exercise . However , most studies have focused on untrained participants rather than on athletes . The purpose of this work was to determine the independent and combined effects of antioxidant supplementation ( vitamin C + mixed tocopherols/tocotrienols ) and prior eccentric exercise in attenuating markers of skeletal muscle injury and oxidative stress in resistance trained men . Methods Thirty-six men were r and omly assigned to : no prior exercise + placebo ; no prior exercise + antioxidant ; prior exercise + placebo ; prior exercise + antioxidant . Markers of muscle/cell injury ( muscle performance , muscle soreness , C-reactive protein , and creatine kinase activity ) , as well as oxidative stress ( blood protein carbonyls and peroxides ) , were measured before and through 48 hours of exercise recovery . Results No group by time interactions were noted for any variable ( P > 0.05 ) . Time main effects were noted for creatine kinase activity , muscle soreness , maximal isometric force and peak velocity ( P Protein carbonyls and peroxides were relatively unaffected by exercise . Conclusion There appears to be no independent or combined effect of a prior bout of eccentric exercise or antioxidant supplementation as used here on markers of muscle injury in resistance trained men . Moreover , eccentric exercise as used in the present study results in minimal blood oxidative stress in resistance trained men . Hence , antioxidant supplementation for the purpose of minimizing blood oxidative stress in relation to eccentric exercise appears unnecessary in this population",
"PURPOSE This study investigated the effect of lengthening contraction velocity on exercise-induced muscle damage . METHODS Sixteen men were placed into two groups performing either 30 ( N = 8) or 210 ( N = 8) maximal lengthening contractions of the elbow flexors on an isokinetic dynamometer . Dominant and nondominant arms were r and omly assigned for a slow-velocity ( S : 30 degrees.s(-1 ) ) or a fast-velocity ( F : 210 degrees.s(-1 ) ) exercise separated by 14 d. Maximal voluntary strength of isometric contractions ( iMVC ) and isokinetic concentric contractions ( cMVC ) , range of motion ( ROM ) , upper-arm circumference , muscle soreness , and serum creatine kinase ( CK ) activity were measured before , immediately after , and 1 - 120 h after exercise . Changes in these measures over time were compared by a two-way repeated- measures ANOVA to examine the effect of velocity in the same number of contractions ( S30 vs F30 ; S210 vs F210 ) or the effect of contraction number at the same velocity ( S30 vs S210 ; F30 vs F210 ) . RESULTS A significant ( P interaction effect was evident only for iMVC between S30 and F30 , but it was evident for iMVC , cMVC , ROM , and CK between S210 and F210 . Changes in most of the measures were significantly ( P muscle damage after 30 contractions is minor ; however , when 210 lengthening contractions were performed , the effect of contraction velocity became conspicuous . It is concluded that fast-velocity lengthening contractions are likely to induce greater muscle damage than slow-velocity contractions ; however , muscle fatigue seems to be a confounding factor for the velocity effect",
"It has previously been shown that females incur less muscle damage than males after strenuous exercise , but limited data are available for humans . To determine possible differences between the sexes in humans , the response to high-force eccentric exercise was examined in a large sample of women ( n = 83 ) and men ( n = 82 ) . The participants performed a bout of eccentric exercise of the elbow flexors consisting of 70 maximal repetitions . Isometric strength , resting elbow angle and muscle soreness were measured before , immediately after ( except soreness ) and then daily for 7 days after exercise . There was a significant loss in strength among both groups ( 69 % for women and 63 % for men ) ( P≪0.01 ) immediately after exercise ; at 168 h post-exercise , women still had a 27 % strength loss and men had a 24 % strength loss . No significant difference in strength loss or recovery rate was found between men and women . Soreness reached peak values 32 - 48 h post-exercise ( P≪0.01 ) , with no significant difference between men and women . Range of motion decreased significantly until 3 days after exercise ( 14.6 ° or 0.255 rad loss for women ; 12.2 ° or 0.213 rad loss for men ) ( P≪0.01 ) ; at 168 h post-exercise , the women and men still showed a loss of 4.8 ° ( 0.084 rad ) and 4.0 ° ( 0.07 rad ) , respectively . There was a significant interaction of sex x time ( P≪0.01 ) ; a post-hoc test indicated that the women experienced a greater loss in range of motion at 72 h than men and this difference was maintained to 168 h post-exercise ( P≪0.01 ) . Thus , our results do not support the contention that women have a lower response to eccentric exercise than men",
"Eccentrically biased exercise results in skeletal muscle damage and stimulates adaptations in muscle , whereby indexes of damage are attenuated when the exercise is repeated . We hypothesized that changes in ultrastructural damage , inflammatory cell infiltration , and markers of proteolysis in skeletal muscle would come about as a result of repeated eccentric exercise and that gender may affect this adaptive response . Untrained male ( n = 8) and female ( n = 8) subjects performed two bouts ( bout 1 and bout 2 ) , separated by 5.5 wk , of 36 repetitions of unilateral , eccentric leg press and 100 repetitions of unilateral , eccentric knee extension exercises ( at 120 % of their concentric single repetition maximum ) , the subjects ' contralateral nonexercised leg served as a control ( rest ) . Biopsies were taken from the vastus lateralis from each leg 24 h postexercise . After bout 2 , the postexercise force deficit and the rise in serum creatine kinase ( CK ) activity were attenuated . Women had lower serum CK activity compared with men at all times ( P Muscle Z-disk streaming , quantified by using light microscopy , was elevated vs. rest only after bout 1 ( P Muscle neutrophil counts were significantly greater in women 24 h after bout 2 vs. rest and bout 1 ( P Muscle macrophages were elevated in men and women after bout 1 and bout 2 ( P Muscle protein content of the regulatory calpain subunit remained unchanged whereas ubiquitin-conjugated protein content was increased after both bouts ( P serum CK activity and , potentially , an increase in the activity of the ubiquitin proteosome proteolytic pathway",
"This study examined whether performing repeated bouts of eccentric exercise 2 and 4 days after an initial damaging bout would exacerbate muscle damage . One arm performed 3 sets of 10 eccentric actions of the elbow flexors ( ECC1 ) using a dumbbell set at 50 % of the maximal isometric force at 90 ° ( SINGLE ) . Two weeks later the same exercise was performed by the opposite arm with the exception that subsequent bouts were performed 2 ( ECC2 ) and 4 ( ECC3 ) days after ECC1 ( REPEATED ) . In the REPEATED condition , maximal isometric force ( MIF ) decreased to the same level immediately after ECC1–3 , and the decreases in range of motion ( ROM ) and increases in upper arm circumference immediately postexercise were similar among the bouts . However , no significant differences in changes in MIF , ROM , muscle soreness , and plasma creatine kinase activity were evident between the SINGLE and REPEATED conditions when excluding the changes immediately after ECC2 and ECC3 . These results suggest that ECC2 and ECC3 did not exacerbate muscle damage or affect the recovery process ",
"PURPOSE This study aim ed to evaluate the benefit of using low-intensity running or electromyostimulation ( EMS ) to hasten the recovery process from eccentric-contraction-induced injury . METHODS Before and 30 min , 24 h , 48 h , and 96 h after a one-legged downhill run , electrical stimulations were applied to the femoral nerve of healthy volunteers . Superimposed twitches were delivered during isometric maximal voluntary contraction ( MVC ) to determine the voluntary activation level ( % VA ) . For 4 d after the exercise , each subject performed either ( i ) 30 min of running at 50 % VO2max , ( ii ) 30 min of low-frequency EMS on the lower limb extensor muscles , or ( iii ) passive recovery . RESULTS Recovery time courses of the different variables did not differ significantly among the three experimental conditions . MVC decreased 30 min after the exercise and did not recover thereafter ( P Percent VA was depressed after the exercise ( P Mechanical responses to 80- and 20-Hz stimulation ( P80 and P20 , respectively ) were significantly reduced over time ( P MVC , P20 , and P80 decrements were not statistically different ( -9.6 + /- 14.5 % , -13.2 + /- 14.2 % , and -12.3 + /- 11.3 % , respectively ) at 48 h , and the P20.P80(-1 ) ratio showed complete recovery at this time . CONCLUSIONS The different recovery modes had no significant effect on the recovery time course of contractile properties . The prolonged torque loss is mainly due to peripheral alterations . Our results suggest that an alteration of the excitation-contraction coupling might be involved during the first 2 d after the eccentric exercise . From 2 to 4 d , damage to force-generating structures could account for the remaining torque deficit",
"This investigation determined whether inflammatory mediators 1 ) have diurnal variations , 2 ) respond to high-force eccentric exercise , and 3 ) associate with markers of muscle damage after high-force eccentric exercise . College-aged men and women ( n = 51 ) completed exercise ( 3 x 15 maximal eccentric elbow flexor actions using 1 arm ) and control conditions in r and om order . Blood was collected preexercise and 4 , 8 , 12 , 24 , 48 , and 96 h postexercise . Additional measures included maximal isometric force and midbiceps arm circumference ( to detect swelling ) . Serum and plasma were analyzed for soluble tumor necrosis factor receptor-1 ( sTNFR1 ) , IL-6 , C-reactive protein , cortisol , and creatine kinase ( CK ) activity . Relative to the 7:00 AM point in the control condition , diurnal decreases were measured at 12:00 PM and 4:00 PM for IL-6 and at 12:00 PM , 4:00 PM , and 8:00 PM for sTNFR1 and cortisol . sTNFR1 , IL-6 , CK , swelling , and soreness were higher in the exercise compared with the control condition . The largest of the inflammatory mediator responses was measured for IL-6 8 h postexercise in the exercise ( 3.00 + /- 3.59 pg/ml ) relative to the control condition ( 1.15 + /- 0.99 pg/ml ) . The IL-6 response ( time-matched exercise -- control concentration ) at 8 h associated ( r > 0.282 ) with muscle soreness at 24 and 96 h , and the cortisol response at 8 h associated ( r > 0.285 ) with swelling at 8 , 24 , and 96 h. Thus soreness and swelling , but not CK and strength loss , had a low association with the inflammatory response following eccentric exercise",
"This study compared the magnitude of muscle damage induced when consecutive drop jumps ( DJs ) were performed on s and vs. firm ( wood ) surfaces from a height of 0.6 m. Eight subjects performed DJs on a s and surface at a depth of 0.2 m ( S condition ) , and 8 other subjects performed DJs on a wood surface ( F condition ) . Each set consisted of 20 DJs with an interval of 10 seconds between jumps . Subjects performed 5 sets of DJs with 2 minutes between sets . Maximal isometric force , muscle soreness , and plasma cre-atine kinase ( CK ) activity were measured immediately before and immediately after the DJ exercise as well as 1 , 24 , 48 , 72 , and 96 hours after the DJ exercise . All measures changed significantly ( p measures were evident for the S condition than for the F condition . These results show that DJs on a s and surface induce less muscle damage than on a firm surface . Training on s and may improve aerobic capacity or strength with a low risk of muscle damage",
"The influence of different work-to-rest ( W : R ) ratios during fatigue induced by maximal eccentric contractions is unknown . The present study sought to exp and the underst and ing of the task-dependent nature of eccentric contractions , and the associated fatigue , during exercise and acute as well as extended recovery periods . Using a Biodex multi-joint dynamometer , the ankle dorsiflexors of eight men [ 26 ( 4 ) years ] were fatigued with 150 maximal eccentric contractions . Set structure was manipulated such that one leg performed 3 sets of 50 repetitions ( short rest protocol , SRP ) , and the other leg performed 15 sets of 10 repetitions ( long rest protocol , LRP ) . A 1-min rest interval separated each set , which result ed in 2 and 14 min of total rest for the SRP and the LRP , respectively . At fatigue , the SRP demonstrated a marginally greater loss of average peak eccentric torque than the LRP ( P isometric peak torque loss and the degree of low-frequency fatigue ( LFF ) were not recovered ( P impairment of both eccentric and isometric torque was persistent and equal for each protocol at 96 h of recovery ( P W : R ratio has a modest influence on the fatigue ( torque loss ) induced by maximal eccentric contractions , but maximal isometric torque during recovery and LFF are insensitive to changes in total rest time",
"The objective of the present study was to investigate the impact of muscle length during stretch-shortening cycles on static and dynamic muscle performance . Animals were r and omly assigned to an isometric ( control , Con , n = 12 ) , a short-muscle-length ( S-Inj , 1.22 - 2.09 rad , n = 12 ) , or a long-muscle-length ( L-Inj , 1.57 - 2.44 rad , n = 12 ) group . The dorsiflexor muscles were exposed in vivo to 7 sets of 10 stretch-shortening contractions ( conducted at 8.72 rad/s ) or 7 sets of isometric contractions of the same stimulation duration by using a custom- design ed dynamometer . Performance was characterized by multipositional isometric exertions and positive , negative , and net work before exposure , 6 h after exposure , and 48 h after exposure to contractions . Real-time muscle performance during the stretch-shortening cycles was characterized by stretch-shortening parameters and negative , positive , and net work . The S-Inj group recovery ( force difference ) was similar to the Con group force difference at 48 h , whereas the L-Inj group force difference was statistically greater at 1.39 , 1.57 , and 1.74 rad than the Con group force difference ( P Negative work ( P 0.05 ) and net work ( P S-Inj and L-Inj groups than in the Con group 48 h after exposure to contractions . Of the real-time parameters , there was a difference in cyclic force with treatment during the stretch-shortening cycles ( P < 0.0001 ) , with the L-Inj group being the most affected . Thus longer ranges of motion result in a more profound isometric force decrement 48 h after exposure to contractions and in real-time changes in eccentric forces",
"CONTEXT Numerous recovery strategies have been used in an attempt to minimize the symptoms of delayed-onset muscle soreness ( DOMS ) . Whole-body vibration ( WBV ) has been suggested as a viable warm-up for athletes . However , scientific evidence to support the protective effects of WBV training ( WBVT ) on muscle damage is lacking . OBJECTIVE To investigate the acute effect of WBVT applied before eccentric exercise in the prevention of DOMS . DESIGN R and omized controlled trial . SETTING University laboratory . PATIENTS OR OTHER PARTICIPANTS A total of 32 healthy , untrained volunteers were r and omly assigned to either the WBVT ( n = 15 ) or control ( n = 17 ) group . INTERVENTION(S ) Volunteers performed 6 sets of 10 maximal isokinetic ( 60 ° /s ) eccentric contractions of the dominant-limb knee extensors on a dynamometer . In the WBVT group , the training was applied using a vibratory platform ( 35 Hz , 5 mm peak to peak ) with 100 ° of knee flexion for 60 seconds before eccentric exercise . No vibration was applied in the control group . MAIN OUTCOME MEASURE(S ) Muscle soreness , thigh circumference , and pressure pain threshold were recorded at baseline and at 1 , 2 , 3 , 4 , 7 , and 14 days postexercise . Maximal voluntary isometric and isokinetic knee extensor strength were assessed at baseline , immediately after exercise , and at 1 , 2 , 7 , and 14 days postexercise . Serum creatine kinase was measured at baseline and at 1 , 2 , and 7 days postexercise . RESULTS The WBVT group showed a reduction in DOMS symptoms in the form of less maximal isometric and isokinetic voluntary strength loss , lower creatine kinase levels , and less pressure pain threshold and muscle soreness ( P on thigh circumference was evident ( P , WBVT may reduce DOMS via muscle function improvement . Further investigation should be undertaken to ascertain the effectiveness of WBVT in attenuating DOMS in athletes",
"PURPOSE It is known that submaximal eccentric exercise does not confer as strong a protective effect as maximal eccentric exercise . This study tested the hypothesis that four bouts of submaximal eccentric exercise would confer a similar protective effect to one bout maximal eccentric exercise . METHODS Thirty untrained men were placed into 4 x 40 % ( 40 % ) or control ( CON ) groups ( n = 15 per group ) by matching preexercise maximal voluntary isometric contraction strength ( MVC ) . The 40 % group performed 30 eccentric contractions with a load of 40 % MVC ( 40 % ECC ) every 2 wk for four times followed 2 wk later by 30 maximal eccentric exercise ( 100 % ECC ) of the elbow flexors of the nondominant arm . The CON group performed two bouts of the 100 % ECC separated by 2 wk . MVC at six angles , optimum angle ( OA ) , concentric isokinetic strength ( 30 degrees x s(-1 ) and 300 degrees x s(-1 ) ) , range of motion , upper arm circumference , plasma creatine kinase activity and myoglobin concentration , muscle soreness , and echo intensity of B-mode ultrasound images were taken before to 5 d after each exercise . RESULTS No significant differences in the changes in any measures were evident between the 100 % ECC of the 40 % group and the second 100 % ECC of the CON group . Changes in all measures except for OA and upper arm circumference after the second to the fourth 40 % ECC bouts were significantly smaller than those after the first 40 % ECC bout . The changes in the measures after any of the 40 % ECC bouts were significantly ( P submaximal eccentric exercise confers the same magnitude of protective effect as one bout of maximal eccentric exercise against the subsequent maximal eccentric exercise",
"1 . The effects of maximum voluntary eccentric muscle actions on forearm flexor strength were studied at three different elbow joint angles ( 0.87 , 1.57 and 2.79 rad ) to examine whether subsequent impairment of contractile function is muscle length-specific . 2 . A bout of 70 maximum voluntary eccentric muscle actions performed with the forearm flexors elicited delayed muscle soreness , efflux of creatine kinase into the blood , loss of elbow joint range of motion and a prolonged decline in maximum voluntary isometric contraction torque at the three elbow angles monitored ( P 30 subjects . 3 . The relative decline in maximum voluntary isometric contraction torque after eccentric exercise differed between elbow angles ( P decline in strength relative to baseline was observed at the most acute elbow angle of 0.87 rad , followed by 1.57 and 2.79 rad respectively . Superimposed electrical stimulation in a subgroup of eight subjects did not increase the torque elicited by the forearm flexors during maximum voluntary contraction tests at the most acute elbow angle ( 0.87 rad ) at any time-point after eccentric exercise , suggesting the disproportionate loss of strength at short muscle length was not due to the inhibitory effects of muscle soreness . 4 . Measures of arm circumference and ability to fully flex the elbow ( in the same subgroup of eight subjects ) suggested the greater decline in strength at the acute elbow angle was not due to the possible confounding influences of muscle swelling and /or impaired muscle shortening ability on strength measurements at short muscle length . 5 . These data suggest a shift in the forearm flexor length-tension relationship could account for the disparate decline in strength between elbow angles after eccentric exercise . The disproportionate loss of strength at short muscle length suggests that eccentric exercise evoked a subtle increase in muscle length , perhaps attributable to the cumulative effects of regions of lengthened sarcomeres and /or series elastic elements",
"The purpose of this study was to investigate the effects of high-force eccentric muscle contractions on collagen remodeling and on circulating levels of matrix metalloproteinases ( MMP ) and tissue inhibitors of metalloproteinases ( TIMP ) in humans . Nine volunteers [ 5 men and 4 women , mean age 23 ( SD 4 ) yr ] each performed a bout of 100 maximum voluntary eccentric contractions of the knee extensors . Muscle biopsies were taken before exercise and on days 4 and 22 afterward . Image analysis of stained tissue sections was used to quantify endomysial collagen staining intensity . Maximum voluntary contractile isometric force was recorded preexercise and on days 1 , 2 , 3 , 4 , 8 , 11 , and 14 postexercise . Venipuncture blood sample s were also drawn on these days for measurement of serum creatine kinase activity and concentrations of MMP-9 , TIMP-1 , TIMP-2 , and the MMP-2/TIMP-2 complex . Maximum voluntary contractile force declined by 39 + /- 23 % ( mean + /- SD ) on day 2 postexercise and recovered thereafter . Serum creatine kinase activity peaked on day 4 postexercise ( P Collagen type IV staining intensity increased significantly on day 22 postexercise to 126 + /- 29 % ( mean + /- SD ) of preexercise values ( P Serum MMP-9 levels increased on day 8 postexercise ( P serum TIMP-1 was also significantly elevated on days 1 , 2 , 3 , 4 , and 14 postexercise ( P remodeling of endomysial type IV collagen , possibly via the MMP pathway",
"BACKGROUND Submaximal eccentric exertions occur occupationally when rapidly rising tool-generated forces exceed the operator 's capacity to react against them . The purpose of this study was to investigate the effects of short duration repetitive submaximal eccentric forearm exertions at levels comparable to industrial power h and tool use on dynamic mechanical properties ( stiffness , effective mass and damping ) and on forearm edema . METHODS This study investigated changes following short term repetitive submaximal eccentric exertions comparable to occupational levels . Eight male participants exercised eccentrically for 30 min at 50 % of isometric maximum voluntary contraction forearm supination in a posture and loading similar to power h and tool use in the workplace . Dynamic mechanical properties ( stiffness , effective mass and damping ) of the upper limb were measured before , immediately following , and daily for three days after the activity . An MRI scan to assess edema was also performed for five of the participants before , on day one and day three following the activity . FINDINGS Mechanical stiffness decreased 51 % ( P effective mass decreased 43 % ( P = 0.052 ) immediately following eccentric exercise . Average isometric strength also decreased 42 % immediately following exercise ( P pain persisted for two days . The recovery of static strength however was not correlated with changes in mechanical stiffness ( r = 0.56 ) or effective mass ( r = 0.30 ) . The exercised arms had a 360 % increase ( P supinator-extensor T(2 ) relaxation time difference , a quantifiable measure of edema , one day after exercise while the non-exercised arms had no significant changes . INTERPRETATION Changes in both T(2 ) relaxation time , indicative of edema , and forearm mechanical properties , were observed following short duration submaximal repetitive exercise . If similar changes in dynamic mechanical properties of the upper extremity occur following repetitive submaximal eccentric activity in the workplace , they could negatively impact the ability of the arm to react to rapid forceful loading during repetitive industrial work activities and increase mechanical loading of the upper limb",
"We examined whether a prior bout of eccentric exercise in the elbow flexors provided protection against exercise-induced muscle damage in the contralateral arm . Fifteen males ( age 22.7 ± 2.1 years ; height 178.6 ± 6.8 cm , mass 75.8 ± 9.3 kg ) were r and omly assigned to two groups who performed two bouts of 60 eccentric contractions ( 30 ° /s ) separated by 2 weeks : ipsilateral ( n = 7 , both bouts performed in the same arm ) , contralateral ( n = 8 , one bout performed in each arm ) . Strength , muscle soreness and resting arm angle ( RAA ) were measured at baseline and at 1 , 24 and 48 h post exercise . Surface electromyography was recorded during both bouts of exercise . The degree of strength loss was attenuated ( p respectively ) . Strength loss following eccentric exercise was also attenuated ( p 2 , respectively ) . Muscle soreness ( ≈34 cf 19 mm ) and change in RAA ( ≈5 cf . 3 % ) were also lower following the second bout of eccentric exercise ( p groups . Median frequency ( MF ) was decreased by 31 % between bouts , with no difference between groups . Data support observations that the repeated bout effect transfers to the opposite ( untrained ) limb . The similar reduction in MF between bouts for the two groups provides evidence for a central ly mediated , neural adaptation",
"The purpose of this investigation was to , firstly , examine the effects of repeated applications of ice massage on the indirect markers associated with muscle damage using a within-subjects cross-over design and secondly , to examine how ice massage affects muscle function in both static and dynamic contractions following unaccustomed eccentric exercise . Twelve males performed damaging exercise on two separate occasions . The protocol consisted of three sets of 10 maximal eccentric repetitions of the elbow flexors using isokinetic dynamometry . Subjects were r and omly assigned to an ice massage group or placebo group and received treatments immediately post-exercise , 24 and 48 h post-exercise . Muscle function ( maximal isometric , slow and fast isokinetic contractions ) , creatine kinase , myoglobin , muscle soreness , limb girth and range of motion were measured pre , immediately post , 24 , 48 , 72 and 96 h post-exercise . Significant time effects were observed for all dependent variables ( P Ice massage is ineffective in reducing the indirect markers associated with exercise-induced muscle damage and enhancing recovery of muscle function in male exercisers unaccustomed to eccentric biased exercise",
"OBJECTIVE : We tested the hypothesis that altering the pre-exercise muscle temperature would influence the magnitude of muscle damage induced by eccentric exercise . SUBJECTS : Female students who had no experience in resistance training were placed into either a microwave treatment group ( n = 10 ) or an icing treatment group ( n = 10 ) . DESIGN AND SETTING : Subjects in each group performed 12 maximal eccentric actions of the forearm flexors of each arm on 2 separate occasions separated by 4 weeks . Before testing , the exercise arm was subjected to either passive warming ( microwave ) or control for the microwave treatment group or cooling ( icing ) or control for the icing treatment group . The control arm performed the same exercise protocol without treatment . Limbs were r and omized for treatment or control and order of testing . Deep muscle temperature increased by approximately 3 degrees C after the microwave treatment and decreased approximately 5 degrees C after the icing treatment . MEASUREMENTS : We evaluated changes in maximal isometric force and indirect markers of muscle damage , including range of motion , upper arm circumference , muscle soreness , and plasma creatine kinase activity , in the microwave and control and icing and control groups using a 2-way , repeated- measures analysis of variance . RESULTS : All measures changed significantly ( P muscle damage in response to eccentric exercise . Similarly , pre-exercise passive muscle warming did not prove beneficial in attenuating indicators of muscle damage . Thus , any beneficial effects of warm-up exercise can not be attributed to the effects of increased muscle temperature",
"Abstract The purpose of this study was to investigate changes in muscle hardness after eccentric exercise of the elbow flexors muscles that produce muscle shortening and swelling . To assess muscle hardness , a pressure method was used in which the force required to deform the tissue ( skin , subcutaneous tissue , muscle ) was recorded . Eleven healthy male students performed 24 maximal eccentric actions of the elbow flexor muscles with their non-dominant arms . Muscle hardness , maximal isometric force ( MIF ) , muscle soreness , plasma creatine kinase ( CK ) activity , relaxed elbow joint angle ( RANG ) , upper-arm circumference ( CIR ) and B-mode ultrasound transverse images were measured before , immediately after , and 1–5 days after exercise . A long-lasting decrease in MIF , muscle swelling shown by increases in CIR and muscle thickness , large increases in plasma CK activity , and development of muscle soreness indicated that damage occurred to the elbow flexor muscles . The RANG had decreased by approximately 20 ° at 1–3 days after exercise and showed a gradual recovery thereafter . The CIR increased gradually after exercise and peaked on day 5 post-exercise , the mean amount of increase in CIR being 18 mm . Muscle hardness measured at the relaxed elbow position did not change until 3 days after exercise , but increased significantly ( P muscle hardness measured when forcibly extending the shortened elbow joint increased significantly ( P exercise . Muscle hardness assessed by the pressure method seems to reflect changes in muscle stiffness and swelling",
"PURPOSE This study aim ed to determine the effects of 4 wk of antioxidants ( AOX ) supplementation on exercise-induced lipid peroxidation , muscle damage , and inflammation in kayakers . METHODS Subjects ( n = 20 ) were r and omly assigned to receive a placebo ( PLA ) or an AOX capsule ( AOX ; 272 mg of alpha-tocopherol , 400 mg of vitamin C , 30 mg of beta-carotene , 2 mg of lutein , 400 mug of selenium , 30 mg of zinc , and 600 mg of magnesium ) . Blood sample s were collected at rest and 15 min after a 1000-m kayak race , both before and after the supplementation period , for analysis of alpha-tocopherol , alpha-carotene , beta-carotene , lycopene , lutein plus zeaxanthin , vitamin C , uric acid , total AOX status ( TAS ) , thiobarbituric reactive acid substances ( TBARS ) and interleukin-6 ( IL-6 ) levels , and creatine kinase ( CK ) , superoxide dismutase ( SOD ) , glutathione reductase ( Gr ) , and glutathione peroxidase ( GPx ) activities . RESULTS With supplementation , plasma alpha-tocopherol ( P = 0.003 ) and beta-carotene ( P = 0.007 ) augmented significantly in the AOX group . IL-6 ( exercise , P = 0.039 ) , TBARS ( exercise , P uric acid ( exercise , P = 0.032 ) increased significantly in response to the exercise regardless of treatment group . Cortisol level raised more from pre- to postsupplementation period in the PLA group ( time x supplementation , P = 0.002 ) . Although TAS declined after exercise before intervention , it increased above preexercise values after the 4-wk period in the AOX group ( supplementation x time x exercise , P = 0.034 ) . CK increased after exercise in both groups ( exercise effect , P AOX supplementation does not offer protection against exercise-induced lipid peroxidation and inflammation and may hinder the recovery of muscle damage",
"Repeated bouts of eccentric muscle contractions were used to examine indirect indices of exercise-induced muscle damage and adaptation in human skeletal muscle . Twenty-four subjects ( 18 females , 6 males ) aged 20.0 + /- 1.4 years ( mean + /- S.D. ) performed an initial bout of either 10 ( n = 7 ) , 30 ( n = 9 ) or 50 ( n = 8) maximum voluntary eccentric contractions of the knee extensors , followed by a second bout of 50 contractions 3 weeks later using the same leg . Muscle soreness was elevated after all bouts ( P Force loss and a decline in the 20:100 Hz percutaneous electrical myostimulation force ratio were observed after all exercise bouts ( P Serum creatine kinase activity was elevated following the initial bouts of 30 and 50 repetitions ( P serum creatine kinase activity was observed in any group following the second bout of contractions ( P > 0.05 ) . We conclude that skeletal muscle adaptation can be brought about by a single bout of relatively few eccentric muscle contractions . Increasing the number of eccentric muscle repetitions did not result in an increased prophylactic effect on skeletal muscle",
"We examined whether polyphenols from dietary apple have protective effects against exercise-induced muscle strain injury . Sixteen male Wistar rats were r and omly assigned into the apple polyphenol ( APP ; N=8 ) and control ( CON ; N=8 ) groups . The APP and the CON groups were fed diets with and without 5 % APP , respectively . After a 3-wk feeding period , the gastrocnemii of the animals were subject to lengthening contractions with electrical stimulation and forced ankle dorsiflexion . Isometric torques were measured before and after the lengthening contractions and on days 1 , 2 , 3 , 5 , and 7 after the contractions . On day 7 , the animals were sacrificed and the gastrocnemii harvested . Thiobarbituric-acid-reactive substances , protein carbonyl , and mRNA of antioxidative proteins in the muscles were quantified . The APP group had significantly lower torque deficits than the CON group on days 3 , 5 , and 7 after the eccentric contractions . The thiobarbituric-acid-reactive substances and protein carbonyl levels in the case of the APP group were significantly lower than those in the case of the CON group . The APP group had significantly higher glutathione-S-transferase alpha1 mRNA levels than the CON group . Therefore , we conclude that dietary APPs have protective effects against lengthening contraction-induced muscle injury ",
"In this study , we investigated the effects of knee extensor length during eccentric exercise on indices of muscle damage and adaptation . Subjects ( n = 7 ) performed two bouts of 75 maximal voluntary eccentric muscle actions at a knee joint angular velocity of 1.57 rad s(-1 ) . One bout was performed at a short muscle length ( bout S ) with a knee joint range of motion of 2.79 to 1.40 radians ( 160 degrees to 80 degrees ) , and a second with the contralateral knee extensors at a long muscle length ( bout L ) with a range of motion of 2.01 to 0.7 radians ( 120 degrees to 40 degrees ) . The maximum voluntary contractile force ( MVC ) was measured before and 5 min after exercise , and again on days 3 , 5 , 7 , 10 and 12 , at knee angles of 160 degrees , 120 degrees and 80 degrees . Muscle soreness was measured before exercise and on each day after exercise . Serum creatine kinase activity was measured before exercise and on days 3 , 5 , 7 , 10 and 12 post-exercise . The MVC declined after each bout ( P Muscle soreness was higher relative to bout S on days 1 , 2 , 3 , 5 and 6 ( P serum creatine kinase activity was elevated after both exercise bouts ( P Functional muscle damage markers and muscle soreness suggest greater damage after bout L. Post-exercise angle-specific force decrements suggest a transient increase in muscle length after bout L but not bout",
"PURPOSE This study examined the effects of a 7-d repeated maximal isokinetic eccentric training period on the indicators of muscle damage and inflammatory response . METHODS Twenty-two college-age males were r and omly assigned to eccentric training ( ET ) ( N = 12 ) and control groups ( CON ) ( N = 10 ) . The initial exercise was 30 repetitions of maximal voluntary isokinetic eccentric contraction ( ECC1 ) on nondominant elbow flexors with Cybex 6000 at 60 degrees.s-1 angular velocity . The ET group performed the same exercise for the following 6 consecutive days ( referred to as ECC2 to ECC7 ) after ECC1 . Upper arm circumference ( CIR ) , range of motion ( ROM ) , and maximal isometric force ( MIF ) were measured before , immediately after , and every 24 h for 7 consecutive days after ECC1 . Plasma creatine kinase ( CK ) , lactate dehydrogenase ( LDH ) , glutamic oxaloacetate transaminase ( GOT ) , leukocyte counts , and serum interleukin-1beta and -6 ( IL-1beta , IL-6 ) levels were assessed before ; at 2 h ; and at 1 , 3 , 4 , 6 , and 7 d after ECC1 . Muscle soreness was measured before and for 7 consecutive days after ECC1 . RESULTS The ECC1 produced significant changes in most of the measures for both groups ( P leukocyte counts ( P > 0.05 ) . No indicators of increased damage ( P > 0.05 ) were found from ECC2 to ECC7 for the ET group . CONCLUSION Continuous intensive isokinetic eccentric training performed with damaged muscles did not exacerbate muscle damage and inflammation after ECC1 . In addition , a muscular \" adaptation effect \" may occur as early as 24 h after ECC1 , as shown by the ET group 's performance for 6 consecutive days after ECC1 ",
"Reactive oxygen species may contribute to exercise-induced skeletal muscle damage , and antioxidants may protect against such damage . This study examined the effectiveness of prophylactic supplementation with vitamins C and E on symptoms of muscle damage in a single blind , two-group study design . Twelve male volunteers were r and omly assigned to either treatment or control groups . The treatment group received 500 mg of vitamin C and 1,200 IU of alpha−tocopherol daily and the control group received glucose placebo for 37 days . After 30 days of treatment , volunteers performed 300 maximal eccentric contractions of the knee extensor muscles of one leg . Maximal voluntary isometric contraction force and electrically evoked force at a frequency of 20 Hz and 50 Hz were recorded before and after exercise , and on days 1 , 2 and 7 after exercise . Muscle soreness question naires were completed and muscle girth recorded at the same time points . Eccentric contractile torque and work during the bout declined significantly in both groups ( P . Maximal voluntary isometric contraction force and 20:50 Hz force ratio declined significantly after exercise in both groups ( P significant muscle soreness and swelling after exercise . These data suggest that prior supplementation with dietary antioxidants ameliorates muscle functional decrements subsequent to eccentric muscle contraction",
"To determine whether intermittent exposures to hyperbaric oxygen enhance recovery from delayed-onset muscle soreness of the quadriceps , we conducted a r and omized , controlled , double-blinded , prospect i ve study using 66 untrained men between the ages of 18 and 35 years . After the induction of muscle soreness , these subjects were treated in a hyperbaric chamber over a 5-day period in two phases , with four groups ( control , hyperbaric oxygen treatment , delayed treatment , and sham treatment ) in the first phase ; and three groups ( 3 days of treatment , 5 days of treatment , and sham treatment ) in the second phase . The hyperbaric exposures involved 100 % oxygen for 1 hour per day at 2.0 atm . The sham treatments involved 21 % oxygen for 1 hour per day at 1.2 atm . We monitored recovery using a leg dynamometer to test eccentric torque of the nondominant quadriceps muscle before and immediately after exercise and at 48 and 96 hours after exercise . Pain was tested daily using visual analog pain scales . In phase 1 a significant difference in recovery of eccentric torque was noted in the treatment group compared with the other groups . In phase 2 , the recovery of eccentric torque for the 5-day treatment group was significantly greater than for the sham group from immediately after exercise to 96 hours after exercise . The pain data did not differ significantly in any comparison in either phase . The results suggest that treatment with hyperbaric oxygen may enhance recovery of eccentric torque of the quadriceps muscle from delayed-onset muscle soreness",
"This study examined markers of muscle damage following a repeated bout of maximal isokinetic eccentric exercise performed prior to full recovery from a previous bout . Twenty non-resistance trained volunteers were r and omly assigned to a control ( CON , n=10 ) or experimental ( EXP , n=10 ) group . Both groups performed 36 maximal isokinetic eccentric contractions of the elbow flexors of the non-dominant arm ( ECC1 ) . The EXP group repeated the same eccentric exercise bout two days later ( ECC2 ) . Total work and peak eccentric torque were recorded during each set of ECC1 and ECC2 . Isometric torque , delayed onset muscle soreness ( DOMS ) , flexed elbow angle and plasma creatine kinase ( CK ) activity were measured prior to and immediately following ECC1 and ECC2 . at 24h intervals for 7 days following ECC1 and finally on day 11 . In both groups , all dependent variables changed significantly during the 2 days following ECC1 . A further acute post-exercise impairment in isometric torque ( 30 + /- 5 % ) and flexed elbow angle ( 20 + /- 4 % ) was observed following ECC2 ( p work and peak eccentric torque values during ECC2 ( p0.05 ) . These findings suggest that when maximal isokinetic eccentric exercise is repeated two days after experiencing of contraction-induced muscle damage , the recovery time course is not significantly altered",
"This study investigated whether a fatiguing concentric exercise performed immediately before eccentric exercise would exacerbate eccentric exercise-induced muscle damage . One arm of nine female subjects ( mean + /- s : 23.3 + /- 6.7 years ) performed 12 maximal eccentric actions of the elbow flexors ( ECC ) , and the other arm performed 100 repetitions of isokinetic concentric actions of the elbow flexors followed by the same eccentric exercise ( CON-ECC ) . The two exercise regimens ( ECC and CON-ECC ) were separated by 2 weeks and presented in a counterbalanced order . Changes in muscle soreness level , maximal isometric force generation , relaxed and flexed elbow joint angle , upper arm circumference and plasma creatine kinase activity were compared between the ECC and CON-ECC conditions . All measures changed significantly after both ECC and CON-ECC ; however , there were significant differences in the changes between the conditions . A lower level of soreness , a faster recovery of maximal isometric force generation , a smaller decrease in relaxed elbow joint angle and a smaller increase in upper arm circumference and creatine kinase activity were evident after the CON-ECC condition compared to the ECC condition . Thus , it would seem that muscle damage was attenuated by performance of previous concentric exercise . An additional experiment using a different group of subjects ( n = 5 ) showed that warm-up exercise before the eccentric exercise also attenuated eccentric exercise-induced muscle damage",
"Previous research has demonstrated that prior exercise may reduce the magnitude of muscle soreness and impaired function ( i.e. , repeated bout effect [ RBE ] ) observed during subsequent eccentric exercise . Previous investigations have predominantly used research design s that include single-joint exercise performed by untrained individuals . It is unknown how resistance trained individuals respond to novel multi-joint eccentric actions of the upper body and whether prior exercise offers protection . Thirty-one resistance trained men ( 23.4 ± 3.5 y , 177.2 ± 5.1 cm , 86.4 ± 16.5 kg , mean ± SD ) were r and omly assigned to repeated bout ( [ RB ] N = 15 ) or single bout ( [ CON ] N = 16 ) conditions . Both groups performed 100 eccentric actions of the bench press ( [ ECC ] at 70 % concentric 1 repetition maximum ) to induce muscle injury . Bilateral maximal isometric force , dynamic exercise performance ( e.g. , bench press throws ) , and muscle soreness were measured before , immediately after , and at 24 and 48 hours post-ECC . Total work , percent fatigue , and rating of perceived exertion ( ECC ) data were collected during ECC . Those assigned to RB condition exhibited less fatigue ( 9.5 vs. 22.6 % ) and lower RPE ( 14.8 vs. 17.1 ) during ECC . A significant interaction ( p experienced less soreness at 24 ( 6.5 vs. 4.9 ) and 48 ( 6.6 vs. 3.9 ) hours postexercise than the CON condition . No significant group differences ( p Although soreness , fatigue , and RPE suggest a RBE , this was not found in regards to exercise performance . It appears that in trained men , performing a strenuous high-volume eccentric exercise bout 2 weeks prior to an identical future bout offers no additional amelioration of impaired exercise performance",
"The effect of a combination of a warm-up , stretching exercises and massage on subjective scores for delayed onset muscle soreness ( DOMS ) and objective functional and biochemical measures was studied . Fifty people , r and omly divided in a treatment and a control group , performed eccentric exercise with the forearm flexors for 30 min . The treatment group additionally performed a warm-up and underwent a stretching protocol before the eccentric exercise and massage afterwards . Functional and biochemical measures were obtained before , and 1 , 24 , 48 , 72 and 96h after exercise . The median values at the five post-exercise time points differed significantly for DOMS measured when the arm was extended ( p = 0.043 ) . Significant main effects for treatment were found on the maximal force ( p = 0.026 ) , the flexion angle of the elbow ( p = 0.014 ) and the creatine kinase activity in blood ( p = 0.006 ) . No time-by-treatment interactions were found . DOMS on pressure , extension angle and myoglobin concentration in blood did not differ between the groups . This combination of a warm-up , stretching and massage reduces some negative effects of eccentric exercise , but the results are inconsistent , since some parameters were significantly affected by the treatment whereas others were not , despite the expected efficacy of a combination of treatments . The objective measures did not yield more unequivocal results than the subjective DOMS scores",
"Unaccustomed exercise ( usually of an eccentric nature ) is often followed by delayed onset muscle soreness ( DOMS ) . Previous studies have found that prior eccentric activity produces a training effect which reduces DOMS and morphological changes . The aim of this study was to examine the effects of a prior bout of maximal isokinetic eccentric exercise on DOMS , strength loss and plasma creatine kinase ( CK ) changes following a downhill run . Ten male subjects with a mean ( + /- S.D. ) age of 22.5 + /- 2.8 years , body mass of 62.67 + /- 0.05 kg and height of 176 + /- 3 cm were allocated to either a treatment group or a control group . The treatment group performed 100 maximal eccentric activations of the knee extensors in the dominant leg at 0.52 rad s-1 . Two weeks later , the downhill run was performed on a motor-driven treadmill . This consisted of five bouts of 8 min at a gradient of -10 % at a speed corresponding to 80 % of the predicted maximal heart rate . The untrained group performed the downhill run as above but without the prior isokinetic session . Tenderness measurements , plasma CK activity and concentric and eccentric isokinetic peak torque measurements of the knee extensors at 0.52 and 2.83 rad s-1 were recorded prior to , immediately following and 2 , 4 and 7 days after each protocol . The isokinetic protocol caused an increase ( P CK and tenderness and a decrease ( P concentric and eccentric torque at both speeds in the treatment group . Following the downhill run , a reduction in peak torque ( P peak torque occurred only at the faster eccentric speed . With the exception of the faster eccentric speed , the decrement in peak torque was greater in the control group in all post-exercise isokinetic strength tests . There was less tenderness ( P Peak torque also returned to pre-downhill values earlier for the trained group . Although plasma CK activity increased in both groups after downhill running , it was much lower ( P muscle damage , reduces the amount of strength loss and decreases the sensation of DOMS after downhill running",
"Surface electromyographic ( EMG ) signals were recorded from the hamstring muscles during six sets of submaximal isokinetic ( 2.6 rad s -1 ) eccentric ( 11 men , 9 women ) or concentric ( 6 men , 4 women ) contractions . The EMG per unit torque increased during eccentric ( P concentric exercise . Similarly , the median frequency increased during eccentric ( P concentric exercise . The EMG per unit torque was lower for submaximal eccentric than maximum isometric contractions ( P EMG per unit torque was lower for eccentric than concentric contractions ( P median frequency was higher for submaximal eccentric than maximum isometric contractions ( P Eccentric exercise result ed in significant isometric strength loss ( P pain ( P muscle tenderness ( P strength loss was seen 1 day after eccentric exercise , while the most severe pain and muscle tenderness occurred 2 days after eccentric exercise . A lower EMG per unit torque is consistent with the selective recruitment of a small number of motor units during eccentric exercise . A higher median frequency during eccentric contractions may be explained by selective recruitment of fast-twitch motor units . The present results are consistent with the theory that muscle damage results from excessive stress on a small number of active fibres during eccentric contractions",
"To assess the contribution of central and peripheral factors to changes in maximum voluntary force and its length dependence after eccentric muscle damage , voluntary and twitch torque were measured across a wide angular range , along with voluntary activation using twitch interpolation . Isometric torque from both maximum voluntary contractions ( MVCs ) and paired twitches to motor nerve stimulation were measured from 60 to 150 deg elbow flexion in 10 deg increments in eight subjects . Optimal angles were determined by curve fitting . Each subject then performed eccentric contractions until voluntary torque had decreased by approximately 40 % . Measurements were repeated at 2 h , 1 day and 8 days post-exercise to follow acute and longer-term changes . Before exercise , the optimal angle was in the mid-range ( 93+/-10 deg ; mean+/-s.d . ) for MVCs , and at a more extended elbow angle for the twitch ( 106+/-6 deg , P Voluntary activation was generally high ( > 94 % ) but depended on elbow angle , with activation being approximately 4 % lower at the most flexed compared to the most extended angle . Two hours after exercise , MVCs decreased 40 % , while twitch torque declined 70 % . All subjects showed a shift in optimal angle to longer muscle lengths for MVCs ( 17+/-16 deg at 2 h , 14+/-7 deg at day 1 , P torque at 90 deg , as the torque-angle relation was relatively flat around the optimum . The twitch showed a smaller shift ( approximately 4 deg ) to longer lengths which was not statistically significant . Voluntary activation was significantly impaired in the early stages after exercise ( 2 h and day 1 , P optimal angle had returned to pre-exercise values , but MVC , twitch torque and voluntary activation had not fully recovered . Eccentric exercise causes a short-term shift in the optimal angle for MVCs and produces a length-dependent impairment in voluntary activation . Therefore , it appears that both central and peripheral factors limit muscle performance following eccentric damage , with limits to voluntary drive being especially important at short lengths",
"PURPOSE This study investigated whether hyperbaric oxygen therapy ( HBOT ) improves recovery after exercise-induced muscle injury . METHODS Healthy male subjects ( N = 24 ) were r and omly assigned to either a placebo group or a HBOT group . Subjects were tested for maximal isometric strength ( preexercise ) of their right elbow flexors . Each subject then completed a high-force eccentric workout of the elbow flexor muscle group to induce delayed onset muscle soreness ( DOMS ) . On the seven successive days after this workout , the subjects were exposed to a hyperbaric environment of 2.5 ATA for 60 min , inspiring either a normoxic mixture ( P(I)O2 = 0.2 ATA ; placebo group ) or a hyperoxic gas mixture ( P(I)O2 = 2.5 ATA ; HBOT group ) . Before the eccentric workout and daily for the next 10 d , measurements were obtained regarding : maximal isometric muscle strength of the elbow flexor muscles , right upper arm circumferences , and rating of the perceived muscle soreness . RESULTS Isometric strength decreased significantly from preexercise levels of 25.1 + /- 3.8 kp to postexercise levels of 12.0 + /- 4.6 kp , for the HBOT group , and from 24.6 + /- 3.4 kp to 12.5 + /- 3.7 kp , respectively , for the placebo group . Over the 10-d recovery period , there was no difference in the rate of recovery of muscle strength between the two groups . Perceived soreness peaked at about 48 h after exercise with no difference between groups . Also , the exercise-induced increases in arm circumference were similar in the two groups . CONCLUSIONS These results indicate that HBOT is not an effective therapy for the treatment of DOMS",
"Abstract This study investigated whether performing repeated bouts of maximal voluntary isokinetic eccentric exercise ( MAX1 ) on 3 ( MAX3 ) and 6 days ( MAX6 ) after the initial bout would produce significant changes in the indirect markers of muscle damage and total work . A secondary purpose was to determine whether participants ' psychological maximal effort was equivalent to the physiological maximal effort during muscle soreness . Male university students were assigned r and omly to a control group ( n = 12 ) and a group that repeated the exercise ( EX ; n = 12 ) . The MAX1 was 3 × 10 repetitions of the nondominant elbow flexors on the Cybex 6000 system at a speed of 60 deg/s . The EX group performed the same exercise 3 days and 6 days after MAX1 . The range of motion and maximal isometric force ( MIF ) , muscle soreness index , plasma creatine kinase , and glutamic-oxaloacetate transaminase activities were measured before and every 24 hr for 9 days after MAX1 for both groups . MIF was also assessed once before and immediately after each MAX for the EX group . There were no significant changes ( p > .05 ) between the groups for all criterion measures , except for total amount of work ( p recovery process . Although individuals could perform repeated MAXs , the total work performed was significantly reduced . This has practical implication s in strength training for coaches and athletes during muscle damage",
"Jakeman , JR , Byrne , C , and Eston , RG . Efficacy of lower limb compression and combined treatment of manual massage and lower limb compression on symptoms of exercise-induced muscle damage in women . J Strength Cond Res 24(11 ) : 3157 - 3165 , 2010-Strategies to manage the symptoms of exercise-induced muscle damage ( EIMD ) are widespread , though are often based on anecdotal evidence . The aim of this study was to determine the efficacy of a combination of manual massage and compressive clothing and compressive clothing individually as recovery strategies after muscle damage . Thirty-two female volunteers completed 100 plyometric drop jumps and were r and omly assigned to a passive recovery ( n = 17 ) , combined treatment ( n = 7 ) , or compression treatment group ( n = 8) . Indices of muscle damage ( perceived soreness , creatine kinase activity , isokinetic muscle strength , squat jump , and countermovement jump performance ) were assessed immediately before and after 1 , 24 , 48 , 72 , and 96 hours of plyometric exercise . The compression treatment group wore compressive tights for 12 hours after damage and the combined treatment group received a 30-minute massage immediately after damaging exercise and wore compression stockings for the following 11.5 hours . Plyometric exercise had a significant effect on all indices of muscle damage ( p isokinetic muscle strength , squat jump performance , and countermovement jump performance and reduced the level of perceived soreness in comparison with the passive recovery group ( p sports massage to compression after muscle damage did not improve performance recovery , with recovery trends being similar in both treatment groups . The treatment combination of massage and compression significantly moderated perceived soreness at 48 and 72 hours after plyometric exercise ( p lower limb compression and a combined treatment of manual massage with lower limb compression are effective recovery strategies following EIMD . Minimal performance differences between treatments were observed , although the combination treatment may be beneficial in controlling perceived soreness ",
"This study aim ed to investigate the efficacy of lower limb compression as a recovery strategy following exercise-induced muscle damage ( EIMD ) . Seventeen female volunteers completed 10 × 10 plyometric drop jumps from a 0.6-m box to induce muscle damage . Participants were r and omly allocated to a passive recovery ( n = 9 ) or a compression treatment ( n = 8) group . Treatment group volunteers wore full leg compression stockings for 12 h immediately following damaging exercise . Passive recovery group participants had no intervention . Indirect indices of muscle damage ( muscle soreness , creatine kinase activity , knee extensor concentric strength , and vertical jump performance ) were assessed prior to and 1 , 24 , 48 , 72 , and 96 h following plyometric exercise . Plyometric exercise had a significant effect ( p ≤ 0.05 ) on all indices of muscle damage . The compression treatment reduced decrements in countermovement jump performance ( passive recovery 88.1 ± 2.8 % vs. treatment 95.2 ± 2.9 % of pre-exercise ) , squat jump performance ( 82.3 ± 1.9 % vs. 94.5 ± 2 % ) , and knee extensor strength loss ( 81.6 ± 3 % vs. 93 ± 3.2 % ) , and reduced muscle soreness ( 4.0 ± 0.23 vs. 2.4 ± 0.24 ) , but had no significant effect on creatine kinase activity . The results indicate that compression clothing is an effective recovery strategy following exercise-induced muscle damage",
"This study investigated if vitamin C supplementation before and after eccentric exercise could reduce muscle soreness ( MS ) , oxidative stress , and muscle function . Eighteen healthy men r and omly assigned to either a placebo ( P ) or vitamin C ( VC ) ( 3 g/d ) treatment group took pills for 2 wk prior and 4 d after performing 70 eccentric elbow extensions with their non-dominant arm . MS increased in both groups with significantly reduced MS for the first 24 h with VC . Range of motion was reduced equally in both groups after the exercise ( P > or = 0.05 ) . Muscle force declined equally and was unaffected by treatment . VC attenuated the creatine kinase ( CK ) increase at 48 h after exercise with similar CK after this time . Glutathione ratio ( oxidized glutathione/total glutathione ) was significantly increased at 4 and 24 h with P but VC prevented this change . These data suggest that vitamin C pretreatment can reduce MS , delay CK increase , and prevent blood glutathione oxidation with little influence on muscle function loss",
"PURPOSE Many symptoms of eccentric muscle damage can be substantially reduced if a similar eccentric bout is repeated within several weeks of the initial bout . The purpose of this study was to determine whether a nondamaging , low repetition , low volume eccentric exercise bout could also provide a protective/adaptive effect . METHODS Subjects were assigned to a control ( CON ) , eccentric exercise ( ECC ) , or low volume familiarized eccentric exercise group ( LV+ECC ) . Before the study , the LV+ECC group performed six maximal eccentric contractions during two familiarization sessions . The main eccentric bout targeted the elbow flexor muscle group and consisted of 36 maximal eccentric contractions . Muscle soreness , upper arm girth , elbow angle , creatine kinase activity , isometric torque , and concentric and eccentric torque at 0.52 and 3.14 rad.s-1 were assessed 0 , 1 , 2 , 3 , 4 , 7 , and 10 d postexercise . RESULTS No evidence of muscle damage was observed as a result of the low volume eccentric bouts . Nevertheless , with the exception of muscle soreness and concentric torque , all variables recovered more rapidly in the LV+ECC group ( P exercise can occur in the absence of significant muscle damage . Exposure to a small number of nondamaging eccentric contractions can significantly improve recovery after a subsequent damaging eccentric bout . Furthermore , this adaptation appears to be mode-specific and not applicable to concentric contractions",
"This study investigated the hypothesis that a light eccentric exercise ( ECC ) that does not induce a loss of muscle function and delayed onset muscle soreness would confer a protective effect against a more strenuous ECC . Eighteen young men were r and omly placed into two groups : 10 - 40 % ( n=9 ) and 40 % ( n=9 ) . Subjects in the 10 - 40 % group performed ECC of the elbow flexors ( six sets of five reps ) using a dumbbell set at 10 % of maximal isometric strength ( MVC ) at an elbow joint angle of 90 degrees , followed 2 days later by ECC using a dumbbell weight of 40 % MVC . Subjects in the 40 % group performed the 40 % ECC only . Changes in MVC , range of motion ( ROM ) , upper arm circumference ( CIR ) , plasma creatine kinase ( CK ) activity and muscle soreness before , immediately after , 1 - 5 and 7 days following the 40 % ECC were compared between groups by a two-way repeated measures ANOVA . No significant changes in any of the criterion measures were found immediately and 1 - 2 days after the 10 % ECC . Following the 40 % ECC , the 10 - 40 % group showed significantly ( P in MVC and ROM , and smaller increases in muscle soreness compared with the 40 % group , but no significant differences between groups were evident for CIR and plasma CK activity . These results suggest that the 10 % ECC induced some protection against a subsequent bout of 40 % ECC performed 2 days later . It appears that the light eccentric exercise preconditioned the muscles for exposure to the subsequent damaging eccentric exercise bout",
"The etiology of myofascial tenderness and pain of masticatory muscles in humans is difficult to underst and . Parafunctional oral habits such as tooth grinding or vigorous chewing are thought to be factors . The objective of this study was to determine if masticatory muscles are susceptible to weakness and injury induced by repetitive , dynamic , forced-lengthening contractions . Results would support the hypothesis that contraction-induced injuries could occur in hyperactive masticatory muscles of humans in response to parafunctional oral habits . Mice were anesthetized and r and omly assigned to three groups : non-treated controls , treated by repetitive passive jaw opening , or treated by repetitive isometric tetanic contractions with lengthening by jaw opening . In each treatment group , masticatory muscle injury was evaluated by contractile tension , plasma creatine kinase , and muscle glycogen . Contractile tension was determined at different stimulation frequencies and was significantly decreased 5 min , 4 h , and 72 h after repetitive contraction/lengthening . Plasma creatine kinase was significantly elevated at 4 but not at 72 h post-treatment in mice subjected to repetitive contraction/lengthening . Masticatory muscle glycogen was not significantly different in any groups at 4 or 72 h post-treatment . These results indicate that contraction injuries can be induced in masticatory muscle of mice by forced lengthening contractions which simulate eccentric contractions",
"While various models for exercise-induced muscle damage ( EIMD ) have been introduced , many of them use maximal voluntary contractions of the elbow flexors and knee extensors performed on isokinetic dynamometers . Few studies have used exercise protocol s that attempt to replicate submaximal eccentric muscle actions that commonly occur during daily activities . Downhill backwards walking has been used previously as an EIMD model . However , the common markers of muscle damage have not been systematic ally examined for this model . The purpose of this study was to determine the magnitude of muscle damage induced by downhill backward walking with regard to changes in commonly-used indirect markers of EIMD . Twenty subjects aged between 19 y and 42 y completed a bout of 60 min of downhill ( -15 % ) backward walking in which a single limb performed submaximal eccentric actions at a stepping rate of 30 - 35 strides per min . A repeated measures ANOVA revealed significant ( p baseline for soreness ( 24 hr- 96 hr ) , tenderness ( 24 hr - 96 hr ) , and plasma creatine kinase activity ( 0.5 hr - 96 hr ) , and significant decreases ( p maximal voluntary isometric ( approximately 25 % ) and isokinetic ( -15 % ) strength ( 0.5 hr - 96 hr ) post-walk for the exercised limb . The time course of observed changes in these markers was similar to that reported for EIMD models of the elbow flexors and knee extensors . However , the magnitude of muscle damage appeared more consistent with that demonstrated following submaximal eccentric exercise",
"This study investigated whether 10 drop jumps ( DJs ) would confer protective effect against muscle damage and soreness in a subsequent bout of 50 DJs . Sixteen men were r and omly placed into either a group performing 1 set of 10 DJs followed by 5 sets of 10 DJs ( 10–50 , n = 8) or another group performing 2 bouts of 5 sets of 10 DJs ( 50–50 , n = 8) separated by 2 weeks . The DJs were performed from a box height of 0.6 m , with a 10-second interval between jumps and a 1-minute rest between sets . Jump height , peak vertical ground reaction force , ground contact time , and heart rate during DJs were measured , and blood lactate concentration was assessed before and immediately after DJs . Changes in maximal isometric ( ISO ) and isokinetic concentric torque ( CON ) , vertical jump , muscle soreness , and plasma creatine kinase activity before , immediately after , and at 1 , 24 , 48 , and 72 hours following exercise were compared between groups for the first and second bouts and between the bouts by a 2-way repeated- measures analysis of variance . Changes in ISO , CON , vertical jump , and muscle soreness were significantly ( p 10 DJs compared with 50 DJs ; however , no signifi- ca nt differences in the measures between groups were evident following the second bout . The changes in the measures following 50 DJs in the 10–50 group were significantly ( p 10 DJs and 50 DJs conferred the same magnitude of protective effect against muscle damage by 50 DJs",
"Nine participants performed two bouts of a step exercise , during which the quadriceps muscle of one leg acted eccentrically . Before and after the exercise , isokinetic torque was measured over a range of knee angles to determine the optimum angle for torque . Immediately after the first bout of exercise , the quadriceps showed a significant ( P drop in peak torque , together with delayed soreness and swelling , confirmed that damage to muscle fibres had occurred . After the second bout of exercise , 8 days later , the shift in optimum angle was 10.4 + /- 1.0 degrees , which was significantly less than after the first bout ( P indicators of damage were also reduced . In addition , the muscle exhibited a sustained shift in optimum angle ( 3.4 + /- 0.9 degrees ) , suggesting that some adaptation had taken place after the first bout of exercise . We conclude that muscles like the quadriceps can show evidence of damage after a specific programme of eccentric exercise , followed by an adaptation response . This is despite the fact that the quadriceps routinely undergoes eccentric contractions in everyday activities",
"The purpose of this study was to examine the effectiveness of a single bout of cold-water immersion on recovery from exercise-induced muscle damage . Eighteen physically active female volunteers ( age 19.9 ( ±0.97 years ) , height 1.66 ( ±0.05 m ) , mass 63.7 ( ±10 kg ) , completed 10 sets of 10 counter-movement jumps to induce muscle damage and were r and omly allocated to a control or treatment group . The treatment group was given a single 10-min bout of lower limb cold-water immersion therapy at 10 ° C immediately following damage-inducing exercise . Indicators of muscle damage ( plasma creatine kinase activity , perceived soreness and maximal voluntary contraction of the quadriceps ) were assessed immediately prior to counter-movement jumps , and at 1 , 24 , 48 , 72 and 96 h , following the damaging exercise . Significant ( p = 0.05 ) time effects were recorded on all indicators of muscle damage , but there were no significant group or group × time interaction effects found on any of the measured variables . The results indicate that a single bout of cold-water immersion after a damaging bout of exercise has no beneficial effects on the recovery from exercise-induced muscle damage ",
"CONTEXT A dehydrated individual who performs eccentric exercise may exacerbate skeletal muscle damage , leading to structural , contractile , and enzymatic protein denaturation , in addition to the myofiber and connective damage result ing from the eccentric muscle tension . OBJECTIVE To identify the effects of dehydration on 5 physiologic characteristics of delayed-onset muscle soreness ( DOMS ) in normothermic men after an eccentric exercise perturbation . DESIGN R and omized group test-retest design . SETTING Laboratory . PATIENTS OR OTHER PARTICIPANTS Ten healthy male volunteers r and omly assigned to either a euhydration ( age = 26.2 + /- 4.9 years , height = 174.1 + /- 6.0 cm , mass = 86.5 + /- 15.3 kg ) or dehydration ( age = 25.8 + /- 2.2 years , height = 177.2 + /- 3.1 cm , mass = 84.4 + /- 3.8 kg ) group . INTERVENTION(S ) Subjects performed treadmill walking for 45 minutes in either a thermoneutral ( euhydration ) or a hot , humid ( dehydration ) environment . After a rest period to allow for return to the normothermic condition , DOMS was induced with a 45-minute downhill run . MAIN OUTCOME MEASURES We assessed 5 physiologic characteristics of DOMS before and at intervals after the eccentric exercise . The characteristics were perceived pain of the bilateral quadriceps and overall body , bilateral punctate tenderness of the superficial quadriceps muscles , bilateral knee-flexion passive range of motion , bilateral thigh circumference , and bilateral isometric quadriceps muscle strength . Thermoregulatory and cardiovascular measures were obtained to monitor participants ' heat load during exercise . RESULTS The experimental protocol produced a 0.9 % increase in body mass of the euhydration group and a significant 2.7 % decrease in body mass of the dehydration group . The downhill-running exercise perturbation induced DOMS in both the euhydrated and dehydrated participants , based on increased bilateral quadriceps and overall body perceived pain and punctate tenderness of the bilateral vastus medialis muscle . The signs and symptoms of DOMS after an eccentric exercise perturbation were not exacerbated by moderate dehydration of 2.7 % body mass after rest and return to the normothermic condition . CONCLUSIONS Significantly dehydrated participants who rested and returned to a normothermic condition did not experience increased characteristics of DOMS",
"This study investigated whether the second eccentric exercise performed 3 days after the initial bout would exacerbate muscle damage and retard the recovery . Fifty-one athletes performed 30 eccentric actions of the elbow flexors using a dumbbell weighted 100 % of the maximal isometric force ( MIF ) at the elbow joint angle of 908 ( ECC1 ) . Three days after ECC1 , all subjects except those in the control group ( n = 12 ) performed the second bout ( ECC2 ) with the same ( 100 % ) intensity ( n = 12 ) , 90 % ( n = 13 ) , or 80 % ( n = 14 ) of the ECC1 . Some subjects , especially in the 100 % group , required spotting for ECC2 but made maximal effort to complete the exercise . MIF , range of motion , upper-arm circumference , muscle soreness , muscle proteins in the blood , and ultrasound images were used to assess muscle damage . Changes in these measures for 9 days following ECC1 were compared among groups by 2-way analysis of variance ( ANOVA ) with repeated measures . All criterion measures changed significantly after ECC1 ; however , no significant differences between the groups were evident for any of the changes in the measures . These results suggest that it is possible for athletes to complete the second bout if the intensity is reduced 10–20 % from the initial bout . No significant differences between the control group and other groups indicate that the second eccentric exercise performed 3 days after the initial bout does not exacerbate muscle damage and retard the recovery regardless of the intensity of the second bout . It is concluded that the elbow flexors can perform high-intensity eccentric exercise in the early stage of recovery from the initial bout and are not damaged further by performing a subsequent bout 3 days after the first",
"The proteolytic enzyme , bromelain , reportedly has therapeutic effects in the treatment of inflammation and soft tissue injuries . We tested the hypothesis that bromelain attenuates skeletal muscle injury induced by lengthening contractions . The left extensor digitorum longus ( EDL ) muscle of anesthetized hamsters was injured using a motorized foot pedal which repeatedly flexed/extended the foot through a range of 125 degrees . The EDL muscle was electrically stimulated for 400 ms during plantarflexion . Animals were assigned r and omly to either a 0-d group ( evaluated 3-h post-injury ) or to untreated ( UT ) or bromelain-treated ( T ) groups , evaluated 3 , 7 , or 14 d post-injury . Following injury , T received 5 mg.kg-1 b.w . of bromelain , twice daily . Maximum isometric tetanic force ( Po ) was measured in vitro , then muscles were fixed , sectioned , and examined for evidence of fiber damage . The Po of injured muscles from T were higher than Po of injured muscles from UT at 3 ( 18.7 + /- 0.4 vs 16.5 + /- N.cm-2 and 14 d ( 20.5 + /- 0.6 vs 18.2 + /- 0.6 N.cm-2 ) ( P less than 0.05 ) , but not 7 d ( 19.5 + /-0.7 vs 17.7 + /- 0.8 N.cm-2 ) . The Po of UT injured muscles were significantly lower than Po of contralateral control muscles at all time periods . Po of injured muscles from T were lower than Po from control muscles at 3 and 7 d ( P less than 0.05 ) , but not 14 d. The number of intact fibers of 3-d UT injured muscles was lower than the number of intact fibers in control muscles ( P less than 0.05 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"PURPOSE The purpose of this study was to examine the role of branched-chain amino acid ( BCAA ) supplementation during recovery from intense eccentric exercise . METHODS Twenty-four non-weight-trained males were assigned to one of two groups : one group ( supplementary , SUP ) ingested BCAA beverages ( n = 12 ) ; the second group ( placebo , PLA ) ingested artificially flavored water ( n = 12 ) . Diet was controlled throughout the testing period to match habitual intake . The eccentric exercise protocol consisted of 12 x 10 repetitions of unilateral eccentric knee extension exercise at 120 % concentric one repetition maximum . On the day of the exercise , supplements were consumed 30 min before exercise , 1.5 h after exercise , between lunch and dinner , and before bed . On the following 2 d , four supplements were consumed between meals . Muscle soreness , muscle function , and putative blood markers of muscle damage were assessed before and after ( 1 , 8 , 24 , 48 , and 72 h ) exercise . RESULTS Muscle function decreased after the eccentric exercise ( P degree of force loss was unaffected by BCAA ingestion ( 51 % + /- 3 % with SUP vs -48 % + /- 7 % with PLA ) . A decrease in flexed muscle soreness was observed in SUP compared with PLA at 48 h ( 21 + /- 3 mm vs 32 + /- 3 mm , P = 0.02 ) and 72 h ( 17 + /- 3 mm vs 27 + /- 4 mm , P = 0.038 ) . Flexed muscle soreness , expressed as area under the curve , was lower in SUP than in PLA ( P = 0.024 ) . CONCLUSIONS BCAA supplementation may attenuate muscle soreness , but it does not ameliorate eccentric exercise-induced decrements in muscle function or increases in reputed blood markers of muscle damage , when consumed before exercise and for 3 d after an eccentric exercise bout",
"Background The use of sports massage is very common in the athletic community . However , only a few studies have shown any therapeutic effect of massage . Hypothesis Sports massage can improve the recovery after eccentric exercise . Study Design Prospect i ve r and omized clinical trial . Methods Sixteen subjects performed 300 maximal eccentric contractions of the quadriceps muscle bilaterally . Massage was given to 1 leg , whereas the other leg served as a control . Subjects were treated once daily for 3 days . Maximal strength was tested on a Kin-Com dynamometer , and functional tests were based on 1-leg long jumps . Pain was evaluated using a visual analog scale . Results There was a marked loss of strength and function of the quadriceps directly after exercise and on the third day after exercise . The massage treatment did not affect the level or duration of pain or the loss of strength or function following exercise . Conclusion Sports massage could not improve the recovery after eccentric exercise",
"The aims of this study were to investigate the sarcomeric accumulation and expression of heat shock proteins ( HSPs ) after two bouts of maximal eccentric exercise . Twenty-four subjects performed two bouts of 70 maximal voluntary eccentric actions using the elbow flexors in one arm . The bouts were separated by 3 wk . The changes in concentric ( 60 degrees/s ) and isometric ( 90 degrees ) force-generating capacity were monitored for 9 days after each bout , and biopsies were taken 1 and 48 h and 4 and 7 days after bout 1 and 1 and 48 h after bout 2 . The content of HSP27 , alphaB-crystallin , HSP70 , and desmin in the cytosolic and cytoskeleton/myofibrillar fractions of homogenized muscle sample s was determined by immunoassays , and the cellular and subcellular localization of the HSPs in the myofibrillar structure was analyzed by conventional and confocal immunofluorescence microscopy and quantitative electron microscopy . The force-generating capacity was reduced by approximately 50 % and did not recover completely during the 3 wk following bout 1 . After bout 2 , the subjects recovered within 4 days . The HSP levels increased in the cytosolic fraction after bout 1 , especially HSP70 ( approximately 300 % 2 - 7 days after exercise ) . Increased levels of HSP27 , alphaB-crystallin , and HSP70 were found in the cytoskeletal/myofibrillar fraction after both bouts , despite reduced damage after bout 2 . At the ultrastructural level , HSP27 and alphaB-crystallin accumulated in Z-disks , in intermediate desmin-like structures ( alphaB-crystallin ) , and in areas of myofibrillar disruption . In conclusion , HSP27 and alphaB-crystallin accumulated in myofibrillar structures , especially in the Z-disks and the intermediate structures ( desmin ) . The function of the small HSPs is possibly to stabilize and protect the myofibrillar structures during and after unaccustomed eccentric exercise . The large amount of HSP27 , alphaB-crystallin , and HSP70 in the cytoskeletal/myofibrillar fraction after a repeated bout of exercise suggests a protective role as part of the repeated-bout effect",
" Thirty-two volunteers participated in a two-period crossover study in which ibuprofen was tested against an identical placebo for its effectiveness in reducing muscle soreness and damage after two bouts of downhill running . Subjective soreness , quadriceps isometric strength and isometric endurance time at 50 percent of maximum strength , serum activities of creatine kinase , lactate dehydrogenase and aspartate transaminase and serum levels of creatinine and urea were recorded at intervals up to 72 hours after exercise . Each downhill run produced muscle soreness , and a decline in muscle strength and 50 percent endurance time , although these parameters were unaffected by ibuprofen treatment . All serum parameters measured increased after both runs , but for the three enzymes this increase was smaller after the second run . Serum creatine kinase and urea levels were higher in the ibuprofen group after both runs . These results indicate that ibuprofen is not an appropriate treatment for delayed onset muscle soreness and damage",
"The purpose of this study was to examine the effects of ibuprofen on delayed onset muscle soreness ( DOMS ) , indirect markers of muscle damage and muscular performance . Nineteen subjects ( their mean [ ± SD]age , height , and weight was 24.6 ± 3.9 years , 176.2 ± 11.1 cm , 77.3 ± 18.7 kg ) performed the eccentric leg curl exercise to induce muscle soreness in the hamstrings . Nine subjects took an ibuprofen pill of 400 mg every 8 hours within a period of 48 hours , whereas 10 subjects received a placebo r and omly ( double blind ) . White blood cells ( WBCs ) and creatine kinase ( CK ) were measured at pre-exercise , 4–6 , 24 , and 48 hours after exercise and maximal strength ( 1 repetition maximum ) . Vertical jump performance and knee flexion range of motion ( ROM ) were measured at pre-exercise , 24 and 48 hours after exercise . Muscle soreness increased ( p the ibuprofen group yielded a significantly lower value ( p hours . The WBC levels were significantly ( p 0.05 ) between the 2 groups . The CK values increased ( p placebo group at 24 and 48 hours postexercise , whereas no significant differences ( p > 0.05 ) were observed in the ibuprofen group . The CK values of the ibuprofen group were lower ( p placebo group . Maximal strength , vertical jump performance , and knee ROM decreased significantly ( p the placebo and the ibuprofen groups with no differences being observed ( p > 0.05 ) between the 2 groups . The results of this study reveal that intake of ibuprofen can decrease muscle soreness induced after eccentric exercise but can not assist in restoring muscle function",
"This study examined whether a second bout of maximal eccentric exercise performed 3 days after the first exercise bout would produce further changes in muscle damage and electromyographic activity ( EMG ) . Male students ( n=26 ) were r and omly assigned to experimental 70 ( EX70 ; n=9 ) , experimental 30 ( EX30 ; n=8 ) , and control ( CON ; n=9 ) groups . The initial exercise was 30 maximal voluntary isokinetic eccentric contractions ( MAX1 ) on non-dominant elbow flexors at 60 ° s−1 ( 1.05 rad s-1 ) . The EX70 and EX30 groups performed a second bout of 70 and 30 eccentric contractions ( MAX2 ) , respectively , 3 days after MAX1 . Upper arm circumference , range of motion , strength , integrated EMG ( IEMG ) , and mean power frequency ( MPF ) were measured before , immediately after , and once a day for 9 days after MAX1 . Plasma creatine kinase ( CK ) activity and muscle soreness were assessed before and for 9 days after MAX1 . Total work , work per contraction , IEMG , and MPF were also recorded during MAX1 and MAX2 . All indicators of muscle damage changed following MAX1 for each group ( P of additional damage ( P>0.05 ) were apparent after MAX2 for either the EX70 or EX30 groups . IEMG ( P=0.03 ) and MPF ( P=0.04 ) were lower for MAX2 compared with MAX1 for both the EX30 and EX70 groups . It is concluded that performing a second bout of eccentric exercise with damaged muscles 3 days after the initial bout does not produce further damage or retard recovery , even when the second bout of exercise is more strenuous . EMG findings were consistent with reduced activation of fast-twitch motor units during the second eccentric bout . These results may be interpreted as evidence of a neural protective mechanism",
"PURPOSE We examined the effects of short-term beta-hydroxy-beta-methylbutyrate ( HMB ) supplementation on symptoms of muscle damage following an acute bout of eccentric exercise . METHODS Non-resistance trained subjects were r and omly assigned to a HMB supplement group ( HMB , 40mg/kg bodyweight/day , n = 8) or placebo group ( CON , n = 9 ) . Supplementation commenced 6 days prior to a bout of 24 maximal isokinetic eccentric contractions of the elbow flexors and continued throughout post-testing . Muscle soreness , upper arm girth , and torque measures were assessed pre-exercise , 15 min post-exercise , and 1 , 2 , 3 , 4 , 7 , and 10 days post-exercise . RESULTS No pre-test differences between HMB and CON groups were identified , and both performed a similar amount of eccentric work during the main eccentric exercise bout ( p > .05 ) . HMB supplementation had no effect on swelling , muscle soreness , or torque following the damaging eccentric exercise bout ( p > .05 ) . CONCLUSION Compared to a placebo condition , short-term supplementation with 40mg/kg bodyweight/day of HMB had no beneficial effect on a range of symptoms associated with eccentric muscle damage . If HMB can produce an ergogenic response , a longer preexercise supplementation period may be necessary",
"There is growing evidence that reactive oxygen species ( ROS ) are involved in the muscular damage and soreness that is observed following strenuous or unaccustomed exercise . This study investigated the relationship between delayed onset muscle soreness ( DOMS ) , muscle function and ROS following downhill running using electron spin resonance ( ESR ) spectroscopy and plasma malonaldehyde ( MDA ) concentrations . Eight physically active male subjects participated in two trials consisting of 30 min of running at ~65 % V̇O2max on the flat ( FLA ) or a 15 % downhill ( DWN ) gradient . Venous blood sample s were drawn before , immediately after , and then 24 , 48 and 72 h post exercise , and at the same time DOMS and muscle function were assessed . Blood was analysed for markers of ROS , total and differential white blood cell count , and creatine kinase . Muscle function was measured on an isokinetic dynamometer , whilst DOMS was assessed using a visual analogue scale . An increase in ROS , detected via ESR spectroscopy and MDA , was observed following DWN ( P Increased DOMS and loss of muscle function were observed following DWN ( P0.05 ) . DWN result ed in a transient leukocytosis ( P DWN result ed in an increase in ROS production , the increase occurred after the peak decline in muscle function and DOMS , suggesting that there may be a disassociation in the temporal relationship between ROS , loss of muscle function and DOMS",
"This investigation evaluated the effects of oral creatine ( Cr ) supplementation on markers of exercise-induced muscle damage following high-force eccentric exercise in subjects r and omly administered Cr or placebo ( P ) in a double-blind fashion . When injected , exogenous phosphocreatine has been shown to stabilize the muscle membrane in cardiac tissue and enhance recovery of strength and power following injury . Twenty-three men aged 18–36 years ingested either 20 g of Cr or P for 5 days . Criterion measures were maximal isometric force of the elbow flexors ( MIF ) , range of motion ( ROM ) about the elbow , mid and distal arm circumference ( CIR ; to assess swelling ) , soreness with movement and palpation ( SOR ) , and blood levels of creatine kinase ( CK ) and lactate dehydrogenase ( LDH ) . Following the supplementation period , subjects performed 50 maximal eccentric contractions of the elbow flexors . Criterion measures were assessed pre-exercise , immediately postexercise , and for 5 days after exercise . Both groups experienced a significant loss of MIF and ROM ( time effect , p increase in CIR of the mid and distal biceps , SOR with movement and palpation , CK , and LDH ( time effect , p 0.05 ) . The pattern of change over the 6 days , in response to the eccentric exercise , was nearly identical between groups . These data suggest that 5 days of Cr supplementation does not reduce indirect markers of muscle damage or enhance recovery from high-force eccentric exercise",
"This study developed an electrical stimulation model for human elbow flexors to examine eccentric exercise-induced muscle damage and adaptation . Male students ( n=17 ) were r and omly placed into one of two groups ; isometric ( ES-ISO , n=8 ) and eccentric ( ES-ECC , n=9 ) . The elbow joint was fixed at 90 degrees ( 1.57 rad ) and the elbow flexors stimulated percutaneously by an electronic muscle stimulator for 5 s through two electrodes placed over the muscles for ES-ISO . In ES-ECC , the muscles were stimulated similarly to the ES-ISO , but the elbow joint was forcibly extended from an elbow flexed ( 90 degrees 1.57 rad ) to a full-extended position ( 180 degrees , 3.14 rad ) in 3 s. Maximal voluntary isometric force , range of motion , upper arm circumference , muscle thickness by ultrasonography , muscle soreness , plasma creatine kinase and aspartate aminotransferase activities were assessed before and for 4 days after exercise . ES-ECC produced significantly larger changes in all criterion measures compared with ES-ISO ( P muscle damage , but isometric contractions result ed in little or no damage . Six subjects from the ES-ECC group repeated the same eccentric exercise ( ECC2 ) 2 weeks after the first bout ( ECC1 ) , and changes in the criterion measures were compared between the bouts . Changes in all criterion measures after ECC2 were significantly smaller than ECC1 ( P effect against muscle damage in the subsequent eccentric exercise bout , which does not involve adaptations in the central nervous system",
"The study 's objective was to determine whether orally ingested caffeine could help overcome excitation-contraction-coupling failure , which has been suggested to explain part of the strength loss associated with eccentric-contraction-induced muscle injury . A sample of 13 college students ( 4 men and 9 women ) was used in a double-blind , repeated- measures experimental design . Each participant performed 2 experimental trials , 1 with each leg , with each trial lasting 4 consecutive days . On a given day , each participant was r and omly assigned to ingest a capsule containing 6 mg/kg of either caffeine or flour ( placebo ) . On the day of and the first 2 days after a bout of 50 injurious eccentric contractions done by the knee extensors , the interpolated-twitch technique was used to assess electrically evoked strength , maximal voluntary isometric contraction ( MVIC ) strength , and percent muscle activation during MVIC both before and after capsule ingestion . These variables were also measured before and after capsule ingestion the day before the eccentric-contraction bout -- when the muscle was uninjured . In injured muscle , caffeine had no effect on any variable . In uninjured muscle , caffeine also had no effect on electrically evoked strength but increased MVIC strength by 10.4 % compared with placebo ( p = .00002 ) , and this was attributed to an increase in muscle activation ( 6.2 % ; p = .01 ) . In conclusion , the data provide no evidence that caffeine ingestion can help overcome excitation-contraction-coupling failure , if it exists , in injured human muscle . The data do indicate that caffeine ingestion can increase MVIC strength and activation in uninjured muscle but not in injured muscle",
"Percutaneous electrical myostimulation ( PES ) was used to manipulate the force produced by the knee extensor muscles during eccentric exercise , thereby providing a model to investigate the role of force in muscle damage . Two eccentric exercise bouts of equal work were performed by nine subjects , using fixed voltage PES at 20 Hz ( to produce moderate muscle forces ) and 100 Hz ( to produce high muscle forces ) . Muscle contractility , serum creatine kinase activity ( CK ) and muscle soreness ( MS ) were evaluated before , and up to 14 days after exercise . Data are presented as means+/-SEM , and were analysed using repeated measures analysis of variance ( ANOVA ) , t-tests and Wilcoxon tests . Peak forces were higher during the 100 Hz bout than the 20 Hz bout for repetitions 1 ( 472+/-60 vs 237+/-23 Newtons ) , 10 ( 381+/-26 vs 233+/-26 Newtons ) , 20 ( 310+/-24 vs 218+/-24 Newtons ) , all p maximum voluntary contractile force ( MVC ) was lower ( p CK was higher ( p MS on days 2 to 6 ( p 20:100 Hz tetanic force ratio after each bout ( p0.05 , ANOVA ) . The higher rise in CK and MS after the 100 Hz bout , together with the greater deficit in MVC , suggest that in humans , muscle force is a contributing factor to muscle injury during eccentric actions",
"The purpose of this study was to determine the effects of antioxidant therapy on indirect markers of muscle damage following eccentric exercise ( EE ) . Eighteen women were r and omized to an antioxidant supplement or a placebo before a bout of EE . Plasma creatine kinase ( CK ) activity , muscle soreness ( MS ) , maximal isometric force ( MIF ) , and range of motion ( ROM ) were assessed before and through 14 d postexercise . Eccentric exercise result ed in an increase in CK activity and MS , and a drop in MIF and ROM during the days following EE , which returned to baseline values 14 d after EE in both groups . Antioxidants attenuated the CK activity and MS response to the EE , while little difference was noted between groups in MIF or ROM . These findings suggest that antioxidant supplementation was helpful in reducing the elevations in plasma CK activity and MS , with little impact on MIF and ROM loss",
"Chatzinikolaou , A , Fatouros , IG , Gourgoulis , V , Avloniti , A , Jamurtas , AZ , Nikolaidis , MG , Douroudos , I , Michailidis , Y , Beneka , A , Malliou , P , Tofas , T , Georgiadis , I , M and alidis , D , and Taxildaris , K. Time course of changes in performance and inflammatory responses after acute plyometric exercise . J Strength Cond Res 24(5 ) : 1389 - 1398 , 2010-The objectives of the present investigation were to study the inflammatory and performance responses after an acute bout of intense plyometric exercise during a prolonged recovery period . Participants were r and omly assigned to either an experimental group ( P , n = 12 ) that performed intense plyometric exercises or a control group ( C , n = 12 ) that rested . The delayed onset of muscle soreness ( DOMS ) , knee range of motion ( KROM ) , creatine kinase ( CK ) and lactate dehydrogenase ( LDH ) activities , white blood cell count , C reactive protein ( CRP ) , uric acid ( UA ) , cortisol , testosterone , IL-6 , IL-1b strength ( isometric and isokinetic ) , and countermovement ( CMJ ) and static ( SJ ) jumping performance were measured at rest , immediately postexercise and at 24 , 48 , 72 , 96 , and 120 hours of recovery . Lactate was measured at rest and postexercise . Strength remained unchanged throughout recovery , but CMJ and SJ declined ( p P induced a marked rise in DOMS , CK , and LDH ( peaked 24 - 48 hours postexercise ) and a KROM decline . An acute-phase inflammatory response consisting of leukocytosis ( postexercise and at 24 hours ) , an IL-6 , IL-1b , CRP , and cortisol elevation ( during the first 24 hours of recovery ) and a delayed increase of UA ( peaked at 48 hours ) and testosterone ( peaked at 72 hours ) was observed in P. The results of this investigation indicate that performing an acute bout of intense plyometric exercise may induce a short-term muscle damage and marked but transient inflammatory responses . Jumping performance seems to deteriorate for as long as 72 hours postexercise , whereas strength appears to remain unchanged . The acute-phase inflammatory response after a plyometric exercise protocol appears to follow the same pattern as in other exercise models . These results clearly indicate the need of sufficient recovery between successive plyometric exercise training sessions",
"There is evidence that protein hydrolysates can speed tissue repair following damage and may therefore be useful for accelerating recovery from exercise induced muscle damage . The potential for a hydrolysate ( WPI(HD ) ) of whey protein isolate ( WPI ) to speed recovery following eccentric exercise was evaluated by assessing effects on recovery of peak isometric torque ( PIT ) . In a double-blind r and omised parallel trial , 28 sedentary males had muscle soreness ( MS ) , serum creatine kinase ( CK ) activity , plasma TNFalpha , and PIT assessed at baseline and after 100 maximal eccentric contractions ( ECC ) of their knee extensors . Participants then consumed 250 ml of flavoured water ( FW ; n=11 ) , or FW containing 25 g WPI ( n=11 ) or 25 g WPI(HD ) ( n=6 ) and the assessment s were repeated 1 , 2 , 6 and 24h later . PIT decreased approximately 23 % following ECC , remained suppressed in FW and WPI , but recovered fully in WPI(HD ) by 6h ( P=0.006 , treatment x time interaction ) . MS increased following ECC ( P TNFalpha and CK did not change ( P>0.45 ) . WPI(HD ) may be a useful supplement for assisting athletes to recover from fatiguing eccentric exercise",
"1 . It is known that a period of eccentric exercise provides protection against damage to muscle from subsequent eccentric exercise . Here we ask , does concentric exercise do the opposite , make muscle more prone to damage ? 2 . The triceps surae muscle group of one leg in each of eight human subjects was subjected to 30 min of concentric exercise per day , for 5 days . At the end of the training period there was a small but significant increase in passive torque in the exercised muscle ( P eccentric exercise , angle-torque curves for muscles of both legs shifted in the direction of longer muscle lengths , suggestive of an increase in series compliance . The shift in the concentrically trained muscle was significantly greater over the first 48 h post-exercise ( P volume of the trained leg increased significantly more than the untrained leg for five subjects over 72 h post-exercise ( P Peak torque fell , passive stiffness increased and both muscles became sore , but with no significant differences between the two legs . 5 . It is concluded that a period of concentric exercise increases the susceptibility of muscle to changes associated with the damage from eccentric exercise",
"1 . The effect of muscle length on the development of muscle pain and fatigue has been studied . 2 . Eight normal young adults performed maximal eccentric contractions of the elbow flexors . The muscles of one arm were exercised at short length , and the contralateral muscle at long length . Each contraction lasted approximately 1 s , and was repeated once every 10 s for 30 min . 3 . Muscle strength and frequency-force characteristics were measured from isometric contractions before , immediately after and at 24 h intervals for the next 4 days . Muscle tenderness was assessed daily . 4 . The muscle strength was reduced by approximately 10 % by exercise at short length , and by 30 % by exercise at long length . 5 . The 20:100 ratio ( force generated by stimulation at 20 Hz/force generated at 100 Hz ) fell by 30 % after exercise at short length and had recovered after 24 h. Exercise at long length reduced this ratio by 65 % and the muscles had not fully recovered 4 days later . 6 . Muscle pain developed after both exercise regimens , but was slightly worse after that at long length . 7 . It is concluded that there is a length-dependent component in the development of pain and fatigue after eccentric exercise , which had previously been thought to be caused solely by high force generation",
"Muscle ultrastructure and contractile properties were examined before and after a single bout of resistance exercise ( 8 sets of 8 repetitions at 80 % of 1 repetition maximum ) . Eight untrained males performed the concentric ( Con ) phase of arm-curl exercise with one arm and the eccentric ( Ecc ) phase with the other arm . Needle biopsies were obtained from biceps brachii before exercise ( Base ) , immediately postexercise from each arm ( post-Con and post-Ecc ) , and 48 h postexercise from each arm ( 48 h-Con and 48 h-Ecc ) . Electron microscopy was used to quantify the presence of disrupted fibers in each sample . Analysis of variance revealed a greater ( P proportion of disrupted fibers in post-Con , post-Ecc , 48 h-Con , and 48 h-Ecc sample s compared with Base . Significantly more fibers were disrupted in post-Ecc ( 82 % ) and 48 h-Ecc ( 80 % ) sample s compared with post-Con ( 33 % ) and 48 h-Con ( 37 % ) , respectively . Voluntary and evoked strength measurements recovered to Base values within 24 h in the Con arm but remained depressed ( P myofibrillar disruption , with the greatest disruption occurring during the lowering phase",
"CONTEXT Whether muscle warming protects against exercise-induced muscle damage is unknown . OBJECTIVE To determine the effect of leg immersion in warm water before stretch-shortening exercise on the time course of indirect markers of exercise-induced muscle damage . DESIGN Crossover trial . SETTING Human kinetics laboratory . PATIENTS OR OTHER PARTICIPANTS Eleven healthy , untrained men ( age = 21.5 + /- 1.7 years ) . INTERVENTION(S ) Participants ' legs were immersed in a water bath at 44 + /- 1 degrees C for 45 minutes . MAIN OUTCOME MEASURE(S ) Creatine kinase changes in the blood , muscle soreness , prolonged ( within 72 hours ) impairment in maximal voluntary contraction force and height of drop jump , and electrically evoked muscle force at low and high stimulation frequencies at short and long muscle lengths . RESULTS Leg immersion in warm water before stretch-shortening exercise reduced most of the indirect markers of exercise-induced muscle damage , including creatine kinase activity in the blood , muscle soreness , maximal voluntary contraction force , and jump height . The values for maximal voluntary contraction force and jump height , however , were higher during prewarming than for the control condition at 48 hours after stretch-shortening exercise , but this difference was only minor at other time points . Muscle prewarming did not bring about any changes in the dynamics of low-frequency fatigue , registered at either short or long muscle length , within 72 hours of stretch-shortening exercise . CONCLUSIONS Leg immersion in warm water before stretch-shortening exercise reduced most of the indirect markers of exercise-induced muscle damage . However , the clinical application of muscle prewarming may be limited , because decreasing muscle damage did not necessarily lead to improved voluntary performance",
"Abstract We tested the hypothesis that exercise-induced muscle damage would increase the ventilatory ( [ Vdot ] E ) response to incremental/ramp cycle exercise ( lower the gas exchange threshold ) without altering the blood lactate profile , thereby dissociating the gas exchange and lactate thresholds . Ten physically active men completed maximal incremental cycle tests before ( pre ) and 48 h after ( post ) performing eccentric exercise comprising 100 squats . Pulmonary gas exchange was measured breath-by-breath and fingertip blood sample d at 1-min intervals for determination of blood lactate concentration . The gas exchange threshold occurred at a lower work rate ( pre : 136 ± 27 W ; post : 105 ± 19 W ; P oxygen uptake ( [Vdot]O2 ) ( pre : 1.58 ± 0.26 litres · min−1 ; post : 1.41 ± 0.14 litres · min−1 ; P However , the lactate threshold occurred at a similar work rate ( pre : 161 ± 19 W ; post : 158 ± 22 W ; P > 0.05 ) and [Vdot]O2 ( pre : 1.90 ± 0.20 litres · min−1 ; post : 1.88 ± 0.15 litres · min−1 ; P > 0.05 ) after eccentric exercise . These findings demonstrate that exercise-induced muscle damage dissociates the [ Vdot ] E response to incremental/ramp exercise from the blood lactate response , indicating that [ Vdot ] E may be controlled by additional or altered neurogenic stimuli following eccentric exercise . Thus , due consideration of prior eccentric exercise should be made when using the gas exchange threshold to provide a non-invasive estimation of the lactate threshold"
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A growing body of evidence suggests that the consumption of foods rich in polyphenolic compounds , particularly cocoa , may have cardioprotective effects . No review , however , has yet examined the effect of flavonoid-rich cocoa ( FRC ) on all major cardiovascular risk factors or has examined potential dose-response relationships for these effects . A systematic review and meta- analysis of r and omized , controlled trials was performed to evaluate the effect of FRC on cardiovascular risk factors and to assess a dose-response relationship . Inclusion and exclusion criteria as well as dependent and independent variables were determined a priori . Data were collected for : blood pressure , pulse , total cholesterol , HDL cholesterol , LDL cholesterol , TG , BMI , C-reactive protein , flow-mediated vascular dilation ( FMD ) , fasting glucose , fasting insulin , serum isoprostane , and insulin sensitivity/resistance indices . Twenty-four papers , with 1106 participants , met the criteria for final analysis . In response to FRC consumption , systolic blood pressure decreased by 1.63 mm Hg ( P = 0.033 ) , LDL cholesterol decreased by 0.077 mmol/L ( P = 0.038 ) , and HDL cholesterol increased by 0.046 mmol/L ( P = 0.037 ) , whereas total cholesterol , TG , and C-reactive protein remained the same . Moreover , insulin resistance decreased ( HOMA-IR : -0.94 points ; P FMD increased ( 1.53 % ; P FRC and FMD ( P = 0.004 ) , with maximum effect observed at a flavonoid dose of 500 mg/d ; a similar relationship may exist with HDL cholesterol levels ( P = 0.06 ) . FRC consumption significantly improves blood pressure , insulin resistance , lipid profiles , and FMD . These short-term benefits warrant larger long-term investigations into the cardioprotective role of FRC
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"Evidence suggests that flavonoid-containing diets reduce cardiovascular risk , but the mechanisms responsible are unclear . In the present study , we sought to determine the effect of flavanol-rich cocoa on vascular function in individuals with CAD ( coronary artery disease ) . Forty subjects ( 61+/-8 years ; 30 male ) with CAD were recruited to a 6-week r and omized double-blind placebo-controlled study . Subjects consumed either a flavanol-rich chocolate bar and cocoa beverage daily ( total flavanols , 444 mg/day ) or matching isocaloric placebos daily ( total flavanols , 19.6 mg/day ) for 6 weeks . Brachial artery FMD ( flow-mediated dilation ) and SAC ( systemic arterial compliance ) were assessed at baseline , 90 min following the first beverage and after 3 and 6 weeks of daily consumption . Soluble cellular adhesion molecules and FBF ( forearm blood flow ) responses to ACh ( acetylcholine chloride ; 3 - 30 microg/min ) and SNP ( sodium nitroprusside ; 0.3 - 3 microg/min ) infusions , forearm ischaemia and isotonic forearm exercise were assessed at baseline and after 6 weeks . FMD , SAC and FBF responses did not differ between groups at baseline . No acute or chronic changes in FMD or SAC were seen in either group . No difference in soluble cellular adhesion molecules , FBF responses to ischaemia , exercise , SNP or ACh was seen in the group receiving flavanol-rich cocoa between baseline and 6 weeks . These data suggest that over a 6-week period , flavanol-rich cocoa does not modify vascular function in patients with established CAD",
"Consumption of flavanol-rich dark chocolate ( DC ) has been shown to decrease blood pressure ( BP ) and insulin resistance in healthy subjects , suggesting similar benefits in patients with essential hypertension ( EH ) . Therefore , we tested the effect of DC on 24-hour ambulatory BP , flow-mediated dilation ( FMD ) , and oral glucose tolerance tests ( OGTTs ) in patients with EH . After a 7-day chocolate-free run-in phase , 20 never-treated , grade I patients with EH ( 10 males ; 43.7±7.8 years ) were r and omized to receive either 100 g per day DC ( containing 88 mg flavanols ) or 90 g per day flavanol-free white chocolate ( WC ) in an isocaloric manner for 15 days . After a second 7-day chocolate-free period , patients were crossed over to the other treatment . Noninvasive 24-hour ambulatory BP , FMD , OGTT , serum cholesterol , and markers of vascular inflammation were evaluated at the end of each treatment . The homeostasis model assessment of insulin resistance ( HOMA-IR ) , quantitative insulin sensitivity check index ( QUICKI ) , and insulin sensitivity index ( ISI ) were calculated from OGTT values . Ambulatory BP decreased after DC ( 24-hour systolic BP −11.9±7.7 mm Hg , P WC . DC but not WC decreased HOMA-IR ( P it improved QUICKI , ISI , and FMD . DC also decreased serum LDL cholesterol ( from 3.4±0.5 to 3.0±0.6 mmol/L ; P summary , DC decreased BP and serum LDL cholesterol , improved FMD , and ameliorated insulin sensitivity in hypertensives . These results suggest that , while balancing total calorie intake , flavanols from cocoa products may provide some cardiovascular benefit if included as part of a healthy diet for patients with EH",
"Previous studies with plant sterols ( PS ) and cocoa flavanols ( CF ) provide support for their dietary use in maintaining cardiovascular health . This double-blind , placebo-controlled , cross-over study evaluated the efficacy of daily consumption of a cocoa flavanol-containing dark chocolate bar with added PS on serum lipids , blood pressure , and other circulating cardiovascular health markers in a population with elevated serum cholesterol . We recruited 49 adults ( 32 women , 17 men ) with serum total cholesterol concentrations of 5.20 - 7.28 mmol/L and blood pressure of Following a 2-wk lead-in utilizing the AHA style diet , participants were r and omized into 2 groups and instructed to consume 2 cocoa flavanol-containing dark chocolate bars per day with ( 1.1 g sterol esters per bar ) or without PS . Each 419-kJ bar was nutrient-matched and contained approximately 180 mg CF . Participants consumed 1 bar 2 times per day for 4 wk then switched to the other bar for an additional 4 wk . Serum lipids and other cardiovascular markers were measured at baseline and after 4 and 8 wk . Blood pressure was measured every 2 wk . Regular consumption of the PS-containing chocolate bar result ed in reductions of 2.0 and 5.3 % in serum total and LDL cholesterol ( P CF also reduced systolic blood pressure at 8 wk ( -5.8 mm Hg ; P chocolate bars containing PS and CF as part of a low-fat diet may support cardiovascular health by lowering cholesterol and improving blood pressure",
"BACKGROUND Numerous studies indicate that flavanols may exert significant vascular protection because of their antioxidant properties and increased nitric oxide bioavailability . In turn , nitric oxide bioavailability deeply influences insulin-stimulated glucose uptake and vascular tone . Thus , flavanols may also exert positive metabolic and pressor effects . OBJECTIVE The objective was to compare the effects of either dark or white chocolate bars on blood pressure and glucose and insulin responses to an oral-glucose-tolerance test in healthy subjects . DESIGN After a 7-d cocoa-free run-in phase , 15 healthy subjects were r and omly assigned to receive for 15 d either 100 g dark chocolate bars , which contained approximately 500 mg polyphenols , or 90 g white chocolate bars , which presumably contained no polyphenols . Successively , subjects entered a further cocoa-free washout phase of 7 d and then were crossed over to the other condition . Oral-glucose-tolerance tests were performed at the end of each period to calculate the homeostasis model assessment of insulin resistance ( HOMA-IR ) and the quantitative insulin sensitivity check index ( QUICKI ) ; blood pressure was measured daily . RESULTS HOMA-IR was significantly lower after dark than after white chocolate ingestion ( 0.94 + /- 0.42 compared with 1.72 + /- 0.62 ; P QUICKI was significantly higher after dark than after white chocolate ingestion ( 0.398 + /- 0.039 compared with 0356 + /- 0.023 ; P = 0.001 ) . Although within normal values , systolic blood pressure was lower after dark than after white chocolate ingestion ( 107.5 + /- 8.6 compared with 113.9 + /- 8.4 mm Hg ; P Dark , but not white , chocolate decreases blood pressure and improves insulin sensitivity in healthy persons",
"Flavanols from chocolate appear to increase nitric oxide bioavailability , protect vascular endothelium , and decrease cardiovascular disease ( CVD ) risk factors . We sought to test the effect of flavanol-rich dark chocolate ( FRDC ) on endothelial function , insulin sensitivity , beta-cell function , and blood pressure ( BP ) in hypertensive patients with impaired glucose tolerance ( IGT ) . After a run-in phase , 19 hypertensives with IGT ( 11 males , 8 females ; 44.8 + /- 8.0 y ) were r and omized to receive isocalorically either FRDC or flavanol-free white chocolate ( FFWC ) at 100 g/d for 15 d. After a wash-out period , patients were switched to the other treatment . Clinical and 24-h ambulatory BP was determined by sphygmometry and oscillometry , respectively , flow-mediated dilation ( FMD ) , oral glucose tolerance test , serum cholesterol and C-reactive protein , and plasma homocysteine were evaluated after each treatment phase . FRDC but not FFWC ingestion decreased insulin resistance ( homeostasis model assessment of insulin resistance ; P insulin sensitivity ( quantitative insulin sensitivity check index , insulin sensitivity index ( ISI ) , ISI(0 ) ; P beta-cell function ( corrected insulin response CIR(120 ) ; P = 0.035 ) . Systolic ( S ) and diastolic ( D ) BP decreased ( P FRDC ( SBP , -3.82 + /- 2.40 mm Hg ; DBP , -3.92 + /- 1.98 mm Hg ; 24-h SBP , -4.52 + /- 3.94 mm Hg ; 24-h DBP , -4.17 + /- 3.29 mm Hg ) but not after FFWC . Further , FRDC increased FMD ( P total cholesterol ( -6.5 % ; P LDL cholesterol ( -7.5 % ; P in insulin sensitivity ( Delta ISI - Delta FMD : r = 0.510 , P = 0.001 ; Delta QUICKI - Delta FMD : r = 0.502 , P = 0.001 ) and beta-cell function ( Delta CIR(120 ) - Delta FMD : r = 0.400 , P = 0.012 ) were directly correlated with increases in FMD and inversely correlated with decreases in BP ( Delta ISI - Delta 24-h SBP : r = -0.368 , P = 0.022 ; Delta ISI - Delta 24-h DBP r = -0.384 , P = 0.017 ) . Thus , FRDC ameliorated insulin sensitivity and beta-cell function , decreased BP , and increased FMD in IGT hypertensive patients . These findings suggest flavanol-rich , low-energy cocoa food products may have a positive impact on CVD risk factors",
"BACKGROUND In recent years , there has been increased interest in the potential health-related benefits of antioxidant- and phytochemical-rich dark chocolate and cocoa . OBJECTIVE The objective of the study was to examine the short-term ( 6 wk ) effects of dark chocolate and cocoa on variables associated with neuropsychological functioning and cardiovascular health in healthy older adults . DESIGN A double-blind , placebo-controlled , fixed-dose , parallel-group clinical trial was used . Participants ( n = 101 ) were r and omly assigned to receive a 37-g dark chocolate bar and 8 ounces ( 237 mL ) of an artificially sweetened cocoa beverage or similar placebo products each day for 6 wk . RESULTS No significant group ( dark chocolate and cocoa or placebo)-by-trial ( baseline , midpoint , and end-of-treatment assessment s ) interactions were found for the neuropsychological , hematological , or blood pressure variables examined . In contrast , the midpoint and end-of-treatment mean pulse rate assessment s in the dark chocolate and cocoa group were significantly higher than those at baseline and significantly higher than the midpoint and end-of-treatment rates in the control group . Results of a follow-up question naire item on the treatment products that participants believed they had consumed during the trial showed that more than half of the participants in both groups correctly identified the products that they had ingested during the experiment . CONCLUSIONS This investigation failed to support the predicted beneficial effects of short-term dark chocolate and cocoa consumption on any of the neuropsychological or cardiovascular health-related variables included in this research . Consumption of dark chocolate and cocoa was , however , associated with significantly higher pulse rates at 3- and 6-wk treatment assessment",
"BACKGROUND Flavonoids are polyphenolic compounds of plant origin with antioxidant effects . Flavonoids inhibit LDL oxidation and reduce thrombotic tendency in vitro . Little is known about how cocoa powder and dark chocolate , rich sources of polyphenols , affect these cardiovascular disease risk factors . OBJECTIVE We evaluated the effects of a diet high in cocoa powder and dark chocolate ( CP-DC diet ) on LDL oxidative susceptibility , serum total antioxidant capacity , and urinary prostagl and in concentrations . DESIGN We conducted a r and omized , 2-period , crossover study in 23 healthy subjects fed 2 diets : an average American diet ( AAD ) controlled for fiber , caffeine , and theobromine and an AAD supplemented with 22 g cocoa powder and 16 g dark chocolate ( CP-DC diet ) , providing approximately 466 mg procyanidins/d . RESULTS LDL oxidation lag time was approximately 8 % greater ( P = 0.01 ) after the CP-DC diet than after the AAD . Serum total antioxidant capacity measured by oxygen radical absorbance capacity was approximately 4 % greater ( P = 0.04 ) after the CP-DC diet than after the AAD and was positively correlated with LDL oxidation lag time ( r = 0.32 , P = 0.03 ) . HDL cholesterol was 4 % greater after the CP-DC diet ( P = 0.02 ) than after the AAD ; however , LDL-HDL ratios were not significantly different . Twenty-four-hour urinary excretion of thromboxane B(2 ) and 6-keto-prostagl and in F(1)(alpha ) and the ratio of the 2 compounds were not significantly different between the 2 diets . CONCLUSION Cocoa powder and dark chocolate may favorably affect cardiovascular disease risk status by modestly reducing LDL oxidation susceptibility , increasing serum total antioxidant capacity and HDL-cholesterol concentrations , and not adversely affecting prostagl and ins",
"BACKGROUND Flavonoids may be partly responsible for some health benefits , including antiinflammatory action and a decreased tendency for the blood to clot . An acute dose of flavanols and oligomeric procyanidins from cocoa powder inhibits platelet activation and function over 6 h in humans . OBJECTIVE This study sought to evaluate whether 28 d of supplementation with cocoa flavanols and related procyanidin oligomers would modulate human platelet reactivity and primary hemostasis and reduce oxidative markers in vivo . DESIGN Thirty-two healthy subjects were assigned to consume active ( 234 mg cocoa flavanols and procyanidins/d ) or placebo ( procyanidins/d ) tablets in a blinded parallel- design ed study . Platelet function was determined by measuring platelet aggregation , ATP release , and expression of activation-dependent platelet antigens by using flow cytometry . Plasma was analyzed for oxidation markers and antioxidant status . RESULTS Plasma concentrations of epicatechin and catechin in the active group increased by 81 % and 28 % , respectively , during the intervention period . The active group had significantly lower P selectin expression and significantly lower ADP-induced aggregation and collagen-induced aggregation than did the placebo group . Plasma ascorbic acid concentrations were significantly higher in the active than in the placebo group ( P plasma oxidation markers and antioxidant status did not change in either group . CONCLUSIONS Cocoa flavanol and procyanidin supplementation for 28 d significantly increased plasma epicatechin and catechin concentrations and significantly decreased platelet function . These data support the results of acute studies that used higher doses of cocoa flavanols and procyanidins",
"BACKGROUND Epidemiologic studies have suggested that flavonoid intake plays a critical role in the prevention of coronary heart disease . Because atherosclerosis is considered a low- grade inflammatory disease , some feeding trials have analyzed the effects of cocoa ( an important source of flavonoids ) on inflammatory biomarkers , but the results have been controversial . OBJECTIVE The objective was to evaluate the effects of chronic cocoa consumption on cellular and serum biomarkers related to atherosclerosis in high-risk patients . DESIGN Forty-two high-risk volunteers ( 19 men and 23 women ; mean + /- SD age : 69.7 + /- 11.5 y ) were included in a r and omized crossover feeding trial . All subjects received 40 g cocoa powder with 500 mL skim milk/d ( C+M ) or only 500 mL skim milk/d ( M ) for 4 wk . Before and after each intervention period , cellular and serum inflammatory biomarkers related to atherosclerosis were evaluated . RESULTS Adherence to the dietary protocol was excellent . No significant changes in the expression of adhesion molecules on T lymphocyte surfaces were found between the C+M and M groups . However , in monocytes , the expression of VLA-4 , CD40 , and CD36 was significantly lower ( P = 0.005 , 0.028 , and 0.001 , respectively ) after C+M intake than after M intake . In addition , serum concentrations of the soluble endothelium-derived adhesion molecules P-selectin and intercellular adhesion molecule-1 were significantly lower ( both P = 0.007 ) after C+M intake than after M intake . CONCLUSIONS These results suggest that the intake of cocoa polyphenols may modulate inflammatory mediators in patients at high risk of cardiovascular disease . These antiinflammatory effects may contribute to the overall benefits of cocoa consumption against atherosclerosis . This trial was registered in the Current Controlled Trials at London , International St and ard R and omized Controlled Trial Number , at controlled-trials.com as IS RCT N75176807",
"Background : Dark chocolate derived from the plant ( Theobroma cacao ) is a rich source of flavonoids . Cardioprotective effects including antioxidant properties , inhibition of platelet activity , and activation of endothelial nitric oxide synthase have been ascribed to the cocoa flavonoids . Objective : To investigate the effects of flavonoid-rich dark chocolate on endothelial function , measures of oxidative stress , blood lipids , and blood pressure in healthy adult subjects . Design : The study was a r and omized , double-blind , placebo-controlled design conducted over a 2 week period in 21 healthy adult subjects . Subjects were r and omly assigned to daily intake of high-flavonoid ( 213 mg procyanidins , 46 mg epicatechin ) or low-flavonoid dark chocolate bars ( 46 g , 1.6 oz ) . Results : High-flavonoid chocolate consumption improved endothelium-dependent flow-mediated dilation ( FMD ) of the brachial artery ( mean change = 1.3 ± 0.7 % ) as compared to low-flavonoid chocolate consumption ( mean change = −0.96 ± 0.5 % ) ( p = 0.024 ) . No significant differences were noted in the resistance to LDL oxidation , total antioxidant capacity , 8-isoprostanes , blood pressure , lipid parameters , body weight or body mass index ( BMI ) between the two groups . Plasma epicatechin concentrations were markedly increased at 2 weeks in the high-flavonoid group ( 204.4 ± 18.5 nmol/L , p ≤ 0.001 ) but not in the low-flavonoid group ( 17.5 ± 9 nmol/L , p = 0.99 ) . Conclusion : Flavonoid-rich dark chocolate improves endothelial function and is associated with an increase in plasma epicatechin concentrations in healthy adults . No changes in oxidative stress measures , lipid profiles , blood pressure , body weight or BMI were seen",
"Is migration from isolated indigenous isl and communities to Panama City associated with an increase in stress ? Individuals were r and omly sample d from two Kuna communities : 325 individuals in Panama City and 133 on a Caribbean isl and . Stress was assessed through the Milcom question naire , which explores physical symptoms and symptoms relevant to mood and emotional state , and Cantril 's ladder , which examines life satisfaction . Physical symptoms were more common in the urban community ( p complaints reflecting mood were also significantly higher on the mainl and ( p systolic and diastolic blood pressure was higher in the mainl and community ( p blood pressure level and any index of stress . Despite unambiguous evidence of an increase in stress in migrants to the city , there was no indication that the stress contributed to the rise in blood pressure level . Migration to an urban setting is associated with an increase in physical symptoms and symptoms reflecting depressed mood , suggesting increased stress level . Life satisfaction is less influenced , possibly providing a measure of the degree of stress",
"Background Flavanol-rich chocolate and lycopene-rich tomato extract have attracted interest as potential alternative treatment options for hypertension , a known risk factor for cardiovascular morbidity and mortality . Treatment of prehypertension ( SBP 120–139/DBP 80–89 mmHg ) may forestall progression to hypertension . However , there has been only limited research into non-pharmacological treatment options for prehypertension . We investigated the effect of dark chocolate or tomato extract on blood pressure , and their acceptability as an ongoing treatment option in a prehypertensive population . Methods Our trial consisted of two phases : a r and omised controlled three-group-parallel trial over 12 weeks ( phase 1 ) followed by a crossover of the two active treatment arms over an additional 12-week period ( phase 2 ) . Group 1 received a 50 g daily dose of dark chocolate with 70 % cocoa containing 750 mg polyphenols , group 2 were allocated one tomato extract capsule containing 15 mg lycopene per day , and group 3 received one placebo capsule daily over 8 weeks followed by a 4-week washout period . In phase 2 the active treatment groups were crossed over to receive the alternative treatment . Median blood pressure , weight , and abdominal circumference were measured 4-weekly , and other characteristics including physical activity , general health , energy , mood , and acceptability of treatment were assessed by question naire at 0 , 8 and 20 weeks . We analysed changes over time using a linear mixed model , and one time point differences using Kruskal-Wallis , Fisher's-Exact , or t-tests . Results Thirty-six prehypertensive healthy adult volunteers completed the 6-month trial . Blood pressure changes over time within groups and between groups were not significant and independent of treatment . Weight and other characteristics did not change significantly during the trial . However , a marked difference in acceptability between the two treatment forms ( chocolate or capsule ) was revealed ( p chocolate treatment found it hard to eat 50 g of dark chocolate every day and 20 % considered it an unacceptable long-term treatment option , whereas all participants found it easy and acceptable to take a capsule each day for blood pressure . Conclusion Our study did not find a blood pressure lowering effect of dark chocolate or tomato extract in a prehypertensive population . Practicability of chocolate as a long-term treatment option may be limited . Trial registration http://www.anzctr.org.au Identifier :",
"The consumption of a diet rich in certain flavonoids , including the flavanol sub-class , has been associated with a reduced risk for vascular disease . We evaluated the effects of the regular consumption ( 14 d ) of a flavanol-containing milk chocolate ( FCMC ) or cocoa butter chocolate ( CBC ) on variables related to vascular disease risk , oxidative stress and physical activity . Twenty-eight free-living , young ( 18–20 years old ) male soccer players consumed daily 105 g of FCMC ( 168 mg of flavanols ) or CBC ( FCMC was significantly associated with a decrease in diastolic blood pressure ( -5 mm Hg ) , mean blood pressure ( -5 mm Hg ) , plasma cholesterol ( -11 % ) , LDL-cholesterol ( -15 % ) , malondialdehyde ( -12 % ) , urate ( -11 % ) and lactate dehydrogenase ( LDH ) activity ( -11 % ) , and an increase in vitamin E/cholesterol ( + 12 % ) . No relevant changes in these variables were associated with CBC consumption . No changes in the plasma levels of (-)-epicatechin were observed following analysis of fasting blood sample s. In conclusion , FCMC consumption was associated with changes in several variables often associated with cardiovascular health and oxidant stress . The presence of significant quantities of flavanols in FCMC is likely to have been one of the contributing factors to these results",
"BACKGROUND Essential hypertension is characterized by reciprocal relations between endothelial dysfunction and insulin resistance . Cocoa flavanols stimulate production of the vasodilator nitric oxide from vascular endothelium . OBJECTIVE The objective was to test the hypothesis that consumption of cocoa may simultaneously lower blood pressure , improve endothelial dysfunction , and ameliorate insulin resistance in subjects with essential hypertension . DESIGN We conducted a r and omized , placebo-controlled , double-blind , crossover trial of a flavanol-rich cocoa drink ( 150 mL twice a day , approximately 900 mg flavanols/d ) in individuals with essential hypertension ( n = 20 ) . Antihypertensive medications were discontinued before study enrollment . After a 7-d cocoa-free run-in period , cocoa or flavanol-poor placebo ( approximately 28 mg flavanols/d ) treatment for 2 wk was followed by a 1-wk washout and then crossover to the other treatment arm . Blood pressure was measured thrice weekly . At baseline and after each treatment period , we assessed insulin sensitivity ( hyperinsulinemic-isoglycemic glucose clamp ) and insulin-stimulated changes in brachial artery diameter and forearm skeletal muscle capillary recruitment ( Doppler ultrasound with or without microbubble contrast ) . RESULTS Cocoa treatment for 2 wk increased insulin-stimulated changes in brachial artery diameter when compared with placebo [ median percentage increase from baseline ( 25th-75th percentile ) : 8.3 ( 4.2 - 11.3 ) compared with 5.9 ( -0.3 to 9.6 ) ; P cocoa treatment did not significantly reduce blood pressure or improve insulin resistance and had no significant effects on skeletal muscle capillary recruitment , circulating plasma concentrations of adipocytokines , or endothelial adhesion molecules . CONCLUSIONS Daily consumption of flavanol-rich cocoa for 2 wk is not sufficient to reduce blood pressure or improve insulin resistance in human subjects with essential hypertension . This trial was registered at clinical trials.gov as NCT00099476",
"CONTEXT Regular intake of cocoa-containing foods is linked to lower cardiovascular mortality in observational studies . Short-term interventions of at most 2 weeks indicate that high doses of cocoa can improve endothelial function and reduce blood pressure ( BP ) due to the action of the cocoa polyphenols , but the clinical effect of low habitual cocoa intake on BP and the underlying BP-lowering mechanisms are unclear . OBJECTIVE To determine effects of low doses of polyphenol-rich dark chocolate on BP . DESIGN , SETTING , AND PARTICIPANTS R and omized , controlled , investigator-blinded , parallel-group trial involving 44 adults aged 56 through 73 years ( 24 women , 20 men ) with untreated upper-range prehypertension or stage 1 hypertension without concomitant risk factors . The trial was conducted at a primary care clinic in Germany between January 2005 and December 2006 . INTERVENTION Participants were r and omly assigned to receive for 18 weeks either 6.3 g ( 30 kcal ) per day of dark chocolate containing 30 mg of polyphenols or matching polyphenol-free white chocolate . MAIN OUTCOME MEASURES Primary outcome measure was the change in BP after 18 weeks . Secondary outcome measures were changes in plasma markers of vasodilative nitric oxide ( S-nitrosoglutathione ) and oxidative stress ( 8-isoprostane ) , and bioavailability of cocoa polyphenols . RESULTS From baseline to 18 weeks , dark chocolate intake reduced mean ( SD ) systolic BP by -2.9 ( 1.6 ) mm Hg ( P diastolic BP by -1.9 ( 1.0 ) mm Hg ( P body weight , plasma levels of lipids , glucose , and 8-isoprostane . Hypertension prevalence declined from 86 % to 68 % . The BP decrease was accompanied by a sustained increase of S-nitrosoglutathione by 0.23 ( 0.12 ) nmol/L ( P dark chocolate dose result ed in the appearance of cocoa phenols in plasma . White chocolate intake caused no changes in BP or plasma biomarkers . CONCLUSIONS Data in this relatively small sample of otherwise healthy individuals with above-optimal BP indicate that inclusion of small amounts of polyphenol-rich dark chocolate as part of a usual diet efficiently reduced BP and improved formation of vasodilative nitric oxide . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00421499",
"BACKGROUND Cocoa beans fresh from the tree are exceptionally rich in flavanols . Unfortunately , during conventional chocolate making , this high antioxidant capacity is greatly reduced due to manufacturing processes . AIM To evaluate the photoprotective potential of chocolate consumption , comparing a conventional dark chocolate to a specially produced chocolate with preserved high flavanol ( HF ) levels . METHODS A double-blind in vivo study in 30 healthy subjects was conducted . Fifteen subjects each were r and omly assigned to either a HF or low flavanol ( LF ) chocolate group and consumed a 20 g portion of their allocated chocolate daily . The minimal erythema dose ( MED ) was assessed at baseline and after 12 weeks under st and ardized conditions . RESULTS In the HF chocolate group the mean MED more than doubled after 12 weeks of chocolate consumption , while in the LF chocolate group , the MED remained without significant change . CONCLUSIONS Our study demonstrated that regular consumption of a chocolate rich in flavanols confers significant photoprotection and can thus be effective at protecting human skin from harmful UV effects . Conventional chocolate has no such effect",
"Endothelial dysfunction characterizes many disease states including sub clinical atherosclerosis . The consumption of flavanol-rich cocoa and cocoa-based products has been shown to improve endothelial function in both compromised and otherwise normal , healthy individuals when administered either acutely or over a period of several days , or weeks . Women experience increased risk for cardiovascular disease after menopause , which can be associated with endothelial dysfunction . Whether a flavanol-rich cocoa-based product can improve endothelial function in hypercholesterolemic postmenopausal women is not known . The purpose of the present study was to determine whether chronic dietary administration of flavanol-rich cocoa improves endothelial function and markers of cardiovascular health in hypercholesterolemic postmenopausal women . Thirty-two postmenopausal hypercholesterolemic women were r and omly assigned to consume a high-flavanol cocoa beverage ( high cocoa flavanols (CF)—446 mg of total flavanols ) , or a low-flavanol cocoa beverage ( low CF—43 mg of total flavanols ) for 6 weeks in a double-blind study ( n=16 per group ) . Endothelial function was determined by brachial artery-reactive hyperemia . Plasma was analyzed for lipids ( total cholesterol , high-density lipoprotein cholesterol , low-density lipoprotein cholesterol ) , hormones ( follicle-stimulating hormone ) , total nitrate/nitrite , activation of cellular adhesion markers ( vascular cell adhesion molecule 1 , intercellular adhesion molecule 1 , E-Selectin , P-Selectin ) , and platelet function and reactivity . Changes in these plasma markers were then correlated to brachial reactivity . Brachial artery hyperemic blood flow increased significantly by 76 % ( P cocoa intervention in the high CF group , compared with 32 % in the low CF cocoa group ( P = ns vs. baseline ) . The 2.4-fold increase in hyperemic blood flow with high CF cocoa closely correlated ( r2=0.8 ) with a significant decrease ( 11 % ) in plasma levels of soluble vascular cell adhesion molecule-1 . Similar responses were not observed after chronic use of low CF . There were no significant differences between high and low CF in other biochemical markers and parameters measured . This study is the first to identify beneficial vascular effects of flavanol-rich cocoa consumption in hypercholesterolemic postmenopausal women . In addition , our results suggest that reductions in plasma soluble vascular cell adhesion molecule-1 after chronic consumption of a flavanol-rich cocoa may be mechanistically linked to improved vascular reactivity",
"OBJECTIVES Our goal was to test feasibility and efficacy of a dietary intervention based on daily intake of flavanol-containing cocoa for improving vascular function of medicated diabetic patients . BACKGROUND Even in fully medicated diabetic patients , overall prognosis is unfavorable due to deteriorated cardiovascular function . Based on epidemiological data , diets rich in flavanols are associated with a reduced cardiovascular risk . METHODS In a feasibility study with 10 diabetic patients , we assessed vascular function as flow-mediated dilation ( FMD ) of the brachial artery , plasma levels of flavanol metabolites , and tolerability after an acute , single-dose ingestion of cocoa , containing increasing concentrations of flavanols ( 75 , 371 , and 963 mg ) . In a subsequent efficacy study , changes in vascular function in 41 medicated diabetic patients were assessed after a 30-day , thrice-daily dietary intervention with either flavanol-rich cocoa ( 321 mg flavanols per dose ) or a nutrient-matched control ( 25 mg flavanols per dose ) . Both studies were undertaken in a r and omized , double-masked fashion . Primary and secondary outcome measures included changes in FMD and plasma flavanol metabolites , respectively . RESULTS A single ingestion of flavanol-containing cocoa was dose-dependently associated with significant acute increases in circulating flavanols and FMD ( at 2 h : from 3.7 + /- 0.2 % to 5.5 + /- 0.4 % , p flavanol-containing cocoa increased baseline FMD by 30 % ( p FMD upon ingestion of flavanol-containing cocoa continued to be manifest throughout the study . Treatment was well tolerated without evidence of tachyphylaxia . Endothelium-independent responses , blood pressure , heart rate , and glycemic control were unaffected . CONCLUSIONS Diets rich in flavanols reverse vascular dysfunction in diabetes , highlighting therapeutic potentials in cardiovascular disease",
"BACKGROUND Dietary intervention studies incorporating phytosterol-enriched margarine spreads have reported significant decreases in total and low-density lipoprotein ( LDL ) cholesterol in population s with both normal lipid levels and those with hypercholesterolemia . There is emerging support for more diverse and lower-fat phytosterol-enriched matrixes . Controversy exists , however , over whether phytosterol-enriched foods affect serum fat-soluble vitamins . OBJECTIVE We investigated whether a flavanol-rich cocoa snack food containing phytosterols would decrease total and LDL cholesterol levels in subjects with hypercholesterolemia and significantly affect serum fat-soluble vitamins and carotenoids . DESIGN A r and omized , double-blind parallel arm study design was used . Subjects were r and omized to one of two dietary treatments : a cocoa flavanol-enriched snack bar containing 1.5 g phytosterol ( n=32 ) , or a control product containing no phytosterols ( n=35 ) . Subjects consumed two servings per day . RESULTS Consumption of the phytosterol-enriched snack bars but not control bars for 6 weeks was associated with significant reductions in plasma total ( 4.7 % ; P LDL cholesterol ( 6 % ; P ratio of total to high-density lipoprotein cholesterol ( 7.4 % ; P high-density lipoprotein cholesterol , triglycerides , or lipid-adjusted lycopene , beta-cryptoxanthin , lutein/zeaxanthin , alpha-carotene levels , or levels of serum vitamins A or E. A significant reduction in lipid-adjusted serum beta-carotene was observed in the phytosterol but not the no-phytosterol-added group ( P novel phytosterol-enriched snack bar to effectively reduce plasma total and LDL cholesterol levels in a population with hypercholesterolemia . The data suggest that the incorporation of this snack food into a balanced diet represents a practical dietary strategy in the management of serum cholesterol levels",
"OBJECTIVES In patients with coronary artery disease ( CAD ) medically managed according to currently accepted guidelines , we tested whether a 1-month dietary intervention with flavanol-containing cocoa leads to an improvement of endothelial dysfunction and whether this is associated with an enhanced number and function of circulating angiogenic cells ( CACs ) . BACKGROUND Dietary flavanols can improve endothelial dysfunction . The CACs , also termed endothelial progenitor cells , are critical for vascular repair and maintenance of endothelial function . METHODS In a r and omized , controlled , double-masked , cross-over trial , 16 CAD patients ( 64+/-3 years of age ) received a dietary high-flavanol intervention ( HiFI [ 375 mg ] ) and a macronutrient- and micronutrient-matched low-flavanol intervention ( LoFI [ 9 mg ] ) twice daily in r and om order over 30 days . RESULTS Endothelium-dependent vasomotor function , as measured by flow-mediated vasodilation of the brachial artery , improved by 47 % in the HiFI period compared with the LoFI period . After HiFI , the number of CD34+/KDR+-CACs , as measured by flow cytometry , increased 2.2-fold as compared with after LoFI . The CAC functions , as measured by the capacity to survive , differentiate , proliferate , and to migrate were not different between the groups . The HiFI led to a decrease in systolic blood pressure ( mean change over LoFI : -4.2+/-2.7 mm Hg ) , and increase in plasma nitrite level ( mean change over LoFI : 74+/-32 nM ) . Applying a mixed-effects linear regression model , the results demonstrated a significant increase in flow-mediated vasodilation and a decrease in systolic blood pressure with increasing levels of CD34+/KDR+-CACs . CONCLUSIONS Sustained improvements in endothelial dysfunction by regular dietary intake of flavanols are associated with mobilization of functional CACs . ( Effect of Cocoa Flavanols on Vascular Function in Optimally Treated Coronary Artery Disease Patients : Interaction Between Endothelial Progenitor Cells , Reactivity of Micro- and Macrocirculation ; NCT00553774 )",
"BACKGROUND Studies of cocoa suggest an array of cardiovascular benefits ; however , the effects of daily intake of sugar-free and sugar-sweetened cocoa beverages on endothelial function ( EF ) have yet to be established . METHODS 44 adults ( BMI 25 - 35 kg/m2 ) participated in a r and omized , controlled , crossover trial . Participants were r and omly assigned to a treatment sequence : sugar-free cocoa beverage , sugar-sweetened cocoa beverage , and sugar-sweetened cocoa-free placebo . Treatments were administered daily for 6 weeks , with a 4-week washout period . RESULTS Cocoa ingestion improved EF measured as flow-mediated dilation ( FMD ) compared to placebo ( sugar-free cocoa : change , 2.4 % [ 95 % CI , 1.5 to 3.2 ] vs. -0.8 % [ 95 % CI , -1.9 to 0.3 ] ; difference , 3.2 % [ 95 % CI , 1.8 to 4.6 ] ; p : change , 1.5 % [ 95 % CI , 0.6 to 2.4 ] vs. -0.8 % [ 95 % CI , -1.9 to 0.3 ] ; difference , 2.3 % [ 95 % CI , 0.9 to 3.7 ] ; p=0.002 ) . The magnitude of improvement in FMD after consumption of sugar-free versus sugar-sweetened cocoa was greater , but not significantly . Other biomarkers of cardiac risk did not change appreciably from baseline . BMI remained stable throughout the study . CONCLUSIONS Daily cocoa ingestion improves EF independently of other biomarkers of cardiac risk , and does not cause weight gain . Sugar-free preparations may further augment endothelial function"
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4117116c-06ff-11f0-808a-c43d1ab1c353
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STUDY OBJECTIVES Sleep disruption is common in attention deficit hyperactivity disorder ( ADHD ) . Likewise , deficits in attention are a hallmark of sleep deprivation in healthy individuals . Whether ADHD and sleep deprivation modulate common , or disparate , neural systems is unknown . No study has yet utilized functional magnetic resonance imaging ( fMRI ) to investigate sleep loss in ADHD . We address this gap by performing a novel meta- analysis to compare patterns of fMRI activation during sleep deprivation and ADHD . METHODS We performed a coordinate-based activation likelihood estimate ( ALE ) meta- analysis using the GingerALE software . A systematic review of task-based fMRI studies of sleep deprivation vs. rested and also ADHD vs. healthy controls ( HC ) yielded 134 articles . fMRI coordinates were extracted for each contrast ( i.e. " ADHD vs. HC , " " TSD vs. Rested " ) and normalized to the Talairach-atlas . Separate ALE analyses were performed for ADHD and sleep deprivation . We directly compared these initial estimates to determine shared vs. distinct areas of fMRI neural activation in ADHD and sleep deprivation . RESULTS Conjunction analyses revealed overlapping hypoactivations between ADHD and sleep loss in executive function regions , notably the dorsal anterior cingulate cortex . Sleep deprivation , however , was associated with significantly exaggerated hyperactivation in the thalamus . CONCLUSIONS Our study indicates that ADHD and sleep deprivation share a common neural signature : hypoactivation of executive function neuroanatomy . In contrast , sleep loss , but not ADHD , was associated with thalamic hyperactivations , intimating a potential compensatory response in sleep loss not present in ADHD . By elucidating shared and distinct patterns of functional neuroanatomy , these data provide novel targets for future experimental investigations of sleep loss in ADHD
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"OBJECTIVES To inform the debate over whether human sleep can be chronically reduced without consequences , we conducted a dose-response chronic sleep restriction experiment in which waking neurobehavioral and sleep physiological functions were monitored and compared to those for total sleep deprivation . DESIGN The chronic sleep restriction experiment involved r and omization to one of three sleep doses ( 4 h , 6 h , or 8 h time in bed per night ) , which were maintained for 14 consecutive days . The total sleep deprivation experiment involved 3 nights without sleep ( 0 h time in bed ) . Each study also involved 3 baseline ( pre-deprivation ) days and 3 recovery days . SETTING Both experiments were conducted under st and ardized laboratory conditions with continuous behavioral , physiological and medical monitoring . PARTICIPANTS A total of n = 48 healthy adults ( ages 21 - 38 ) participated in the experiments . INTERVENTIONS Noctumal sleep periods were restricted to 8 h , 6 h or 4 h per day for 14 days , or to 0 h for 3 days . All other sleep was prohibited . RESULTS Chronic restriction of sleep periods to 4 h or 6 h per night over 14 consecutive days result ed in significant cumulative , dose-dependent deficits in cognitive performance on all tasks . Subjective sleepiness ratings showed an acute response to sleep restriction but only small further increases on subsequent days , and did not significantly differentiate the 6 h and 4 h conditions . Polysomnographic variables and delta power in the non-REM sleep EEG-a putative marker of sleep homeostasis -- displayed an acute response to sleep restriction with negligible further changes across the 14 restricted nights . Comparison of chronic sleep restriction to total sleep deprivation showed that the latter result ed in disproportionately large waking neurobehavioral and sleep delta power responses relative to how much sleep was lost . A statistical model revealed that , regardless of the mode of sleep deprivation , lapses in behavioral alertness were near-linearly related to the cumulative duration of wakefulness in excess of 15.84 h ( s.e . 0.73 h ) . CONCLUSIONS Since chronic restriction of sleep to 6 h or less per night produced cognitive performance deficits equivalent to up to 2 nights of total sleep deprivation , it appears that even relatively moderate sleep restriction can seriously impair waking neurobehavioral functions in healthy adults . Sleepiness ratings suggest that subjects were largely unaware of these increasing cognitive deficits , which may explain why the impact of chronic sleep restriction on waking cognitive functions is often assumed to be benign . Physiological sleep responses to chronic restriction did not mirror waking neurobehavioral responses , but cumulative wakefulness in excess of a 15.84 h predicted performance lapses across all four experimental conditions . This suggests that sleep debt is perhaps best understood as result ing in additional wakefulness that has a neurobiological \" cost \" which accumulates over time",
"The purpose of this study was to examine the effects of sleep deprivation on impulsive behavior . Patients with impulse control disorders often report sleep problems , and sleep deprivation even in healthy individuals impairs cognition , decision-making , and perhaps impulse control . To characterize the effects of sleep loss on specific forms of impulsive behavior , we tested the effects of overnight , monitored sleep deprivation on measures of impulsivity and cognition in healthy volunteers . Ten men and ten women completed two 24 h sessions in r and om order , in which they were either allowed to sleep normally or remained awake all night . At 8:30 am and 6:15 pm on the day after sleep or no sleep , participants were tested on the Balloon Analogue Risk Task ( BART ) , the Experiential Discounting Task , the Adjusting Amount Delay and Probability Discounting Task , and the Stop Task . Participants also completed mood question naires and the Automated Neuropsychological Assessment Matrix ( ANAM ) throughout the course of the day . Sleep deprivation did not affect most of the measures of impulsive behavior . However , on the BART , sleep deprivation decreased risk taking in women , but not men . Sleep deprivation produced expected increases in subjective fatigue , and impaired performance on measures of attention and cognitive efficiency on the ANAM . The results indicate that sleep deprivation does not specifically increase impulsive behaviors but may differentially affect risk taking in men and women",
"BACKGROUND Slow oscillations ( consolidation of declarative memory . Children with attention-deficit/hyperactivity disorder ( ADHD ) have been shown to display deficits in sleep-dependent consolidation of declarative memory supposedly due to dysfunctional slow brain rhythms during SWS . OBJECTIVE Using transcranial oscillating direct current stimulation ( toDCS ) at 0.75 Hz , we investigated whether an externally triggered increase in slow oscillations during early SWS elevates memory performance in children with ADHD . METHODS 12 children with ADHD underwent a toDCS and a sham condition in a double-blind crossover study design conducted in a sleep laboratory . Memory was tested using a 2D object-location task . In addition , 12 healthy children performed the same memory task in their home environment . RESULTS Stimulation enhanced slow oscillation power in children with ADHD and boosted memory performance to the same level as in healthy children . CONCLUSION These data indicate that increasing slow oscillation power during sleep by toDCS can alleviate declarative memory deficits in children with ADHD",
"This study examined the effects of acute sleep restriction on the daytime behavior and performance of healthy children and adolescents . 82 participants ( 8 to 15 years of age ) completed 5 nights of baseline sleep and were r and omly assigned to Optimized ( 10 hr . ) or Restricted ( 4 hr . ) sleep for an overnight lab visit . Behavior , performance , and sleepiness were assessed the following day . Sleep restriction was associated with shorter daytime sleep latency , increased subjective sleepiness , and increased sleepy and inattentive behaviors but was not associated with increased hyperactive-impulsive behavior or impaired performance on tests of response inhibition and sustained attention . Results are discussed in terms of current theories regarding effects of inadequate or disturbed sleep among children and adolescents"
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411711a8-06ff-11f0-808a-c43d1ab1c353
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Aims There are two techniques widely used to determine the rotational alignment of the components in total knee arthroplasty ( TKA ) ; gap balancing ( GB ) and measured resection ( MR ) . Which technique is the best remains controversial . We aim ed to investigate this in a systematic review and meta‐ analysis . Material s and Methods In accordance with the methods of Cochrane , data bases were search ed for all r and omised controlled trials in the literature between January 1986 and June 2015 comparing radiographic and clinical outcomes between the use of these two tecniques . Meta‐ analysis involved the use of the Revman5.3 software provided by Cochrane collaboration . Results A total of 1464 papers were initially identified , and after the application of rigourous inclusion and exclusion critera , eight were included in the study . In total they inolved 980 TKAs . The meta‐ analysis showed that GB techniques result ed in statistically significant improvements in the restoration of mechanical and rotational alignment and mean Knee Society Scores and Knee Society Function scores two years post‐operatively , but result ed in greater elevation of the position of the joint line . There is no significant difference in the other radiographic data . Conclusion This study suggests that GB may provide better radiographic and clinical outcomes than MR when used to determine mechanical rotation in TKAs
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"Two surgical strategies are possible in total knee arthroplasty ( TKA ) : a measured resection technique , in which bone l and marks are used to guide resections equal to the distal and posterior thickness of the femoral component , or a gap-balancing approach , in which equal collateral ligament tension in flexion and extension is sought before and as a guide to final bone cuts . In this study performed with computer assisted system , we compared the 2 different methods in 126 patients followed prospect ively in order to analyze the effect of both the techniques on joint-line ( JL ) maintenance , axial limb restoration and components position . The gap technique showed a statistical increase in the post-operative value when compared with the measured resection technique , ( P = 0.008 ) . When comparing the two groups regarding to the pre-operative deformity , we have found a statistical difference ( P = 0.001 ) in case of moderate pre-operative deformity ( less than 10 ° ) , and the measured resection technique showed a slight superiority in preserving a joint line more faithful to the pre-operative . We found an ideal alignment for the mechanical axis ( 180 ° ± 3 ° ) ( 95 % of cases ) . In six cases ( 5 % ) , the mean post-operative value exceeded ( varus or valgus ) the ideal value by more than 3 ° . In the frontal plane , a good alignment was observed for both femoral and tibial components without a significant difference between the two techniques . In the sagittal plane was found more alignment variability due to the different implants used and their ideal starting slope , from 7 ° to 3 ° . Finally , the surgeon can use the approach with which he has more confidence ; however , as the measured resection technique causes less reduction in the post-operative joint-line position , in case of shortening of patellar tendon or patella infera , this technique is preferable",
" In 99 patients , 107 knee replacements were revised in two centers by two surgeons using a single revision total knee arthroplasty system . A retrospective radiographic review of joint line position before and after revision total knee arthroplasty was made , and compared with the joint line position before primary knee arthroplasty . Prospect ively collected Knee Society Clinical Rating Scores were correlated with radiographic findings . The joint line position in unreplaced knee replacements averaged 16 mm , and the joint line position in knee replacements before revision surgery averaged 17 mm . The joint line was elevated by the revision total knee arthroplasty in 85 of 107 knees ( 79 % ) . After the revision total knee replacement , the joint line elevation averaged 24 mm . The Knee Society Clinical Rating Score after revision surgery averaged 131 points . If the joint line position was elevated more than 8 mm , the Knee Society Clinical Rating Score averaged 125 points , if the joint line was elevated less than 8 mm , the score averaged 141 points . Joint line elevation after revision total knee replacement is a problem . Excessive elevation may result in worse clinical outcomes . Distal femoral augments should be used more often and with greater thicknesses . St and ard implants used for revision surgery should have increased distal dimensions",
"Abstract Purpose It was our hypothesis that patient-specific instrumentation ( PSI ) can improve the accuracy of the rotational alignment in TKA based on the concept of the system and on the potential to clearly identify pre-operatively during planning the classical anatomical l and marks that serve as references to set-up the rotation both for the femur and tibia . Material s and methods In this prospect i ve comparative r and omized study , 40 patients ( 20 in each group ) operated in our institution between September 2012 and January 2013 by the 2 senior authors were included . R and omization of patients into one of the two groups was done by the Hospital Informatics Department with the use of a systematic sampling method . All patients received the same cemented high-flex mobile bearing TKA . In the PSI group , implant position was compared to the planed position using previously vali date d dedicated software . The position of the implants ( frontal and sagittal ) was compared in the 2 groups on st and ard X-rays , and the rotational position was analysed on post-operative CT-scan . Results 90 % of the patients add tibial rotation where the variations were much higher . Mean HKA was 179 ° ( 171–185 ) in the PSI group with 4 outliers ( 2 varus : 171 ° and 172 ° :184 ° and 185 ° ) and 178.3 ° with 2 outliers ( 171 ° and 176 ° ) in the control group . No difference was observed between the two groups concerning the frontal and sagittal position of the implants on the ML and AP X-rays . No significant difference of femoral rotation was observed between the two groups with a mean of 0.4 ° in the PSI group and 0.2 ° in the control group ( p : n.s ) . Mean tibial rotation was 8 ° of internal rotation in the PSI group and 15 ° of internal rotation in the st and ard group ( p : n.s ) . Conclusion Based on our results , we were unable to confirm our hypothesis as PSI can not improve rotation in TKA . More work needs to be done to more clearly define the place of PSI in TKA , to keep on improving the accuracy of the system and to better define the individual targets in TKA in terms of frontal , sagittal and rotational positioning of the implant for each patient . Level of evidence Prospect i ve comparative r and omized study , Level II",
"A total knee arthroplasty can be completed using two techniques ; measured resection or gap balancing . A prospect i ve blinded r and omized controlled trial was completed with 103 patients r and omized to measured resection ( n = 52 ) or gap balancing ( n = 51 ) . Primary outcome measure was femoral component rotation . Secondary outcome measures were joint-line change , gap symmetry and function and quality -of-life outcomes . Gap balancing result ed in a significantly raised joint-line compared to measured resection . Gap symmetry was significantly better using gap balancing . Functional outcomes and quality -of-life were not significantly different at 24 months . Using computer navigation , gap balancing significantly raises the joint-line in order to improve gap symmetry . This does not result in a clinical difference in function or quality of life at 24 months",
"Abstract Femoral component rotation from a total knee prosthesis can be determined by either a measured resection technique or a balanced gap technique . With the balanced gap implantation technique , femoral component rotation can vary freely within the restrictions produced by soft tissue structures . Because internal rotation might cause patella problems , the effect of ligament releases on femoral component rotation in a prospect i ve clinical study was studied . Femoral component rotation was measured intraoperatively with a tensor applied in flexion at 150 N in 87 knees . Great interpatient variability was found ; femoral component rotation , reference from the posterior condyles , ranged from −4 ° to 13 ° . There was no difference in femoral component rotation of knees with or without ligament releases in extension . However , knees with major medial release had less external femoral component rotation than knees with minor lateral releases . Preoperative alignment had no influence on femoral component rotation . The use of the balanced gap implantation technique theoretically will result in a balanced flexion gap , but the amount of femoral component rotation will be variable owing to patient variability and variation in ligament releases . Level of Evidence : Level II , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence",
"Background Clinical consequences of alignment errors in total knee replacement ( TKR ) have led to the rigorous evaluation of surgical alignment techniques . Rotational alignment in the transverse plane has proven particularly problematic , with errors due to component malalignment relative to bone anatomic l and marks and an overall mismatch between the femoral and tibial components ’ relative positions . Ranges of nominal rotational alignment are not well defined , especially for the tibial component and for relative rotational mismatch , and some studies advocate the use of mobile-bearing TKR to accommo date the result ing small rotation errors . However , the relationships between prosthesis rotational alignment and mobile-bearing polyethylene insert motion are poorly understood . This prospect i ve , in vivo study evaluates whether component malalignment and mismatch affect axial rotation motions during passive knee flexion after TKR . Methods Eighty patients were implanted with mobile-bearing TKR . Rotational alignment of the femoral and tibial components was measured from postoperative CT scans . All TKR were categorized into nominal or outlier groups based on defined norms for surgical rotational alignment relative to bone anatomic l and marks and relative rotational mismatch between the femoral and tibial components . Axial rotation motion of the femoral , tibial and polyethylene bearing components was measured from fluoroscopic images acquired during passive knee flexion . Results Axial rotation motion was generally accomplished in two phases , dominated by polyethylene bearing rotation on the tibial component in early to mid-flexion and then femoral component rotation on the polyethylene articular surface in later flexion . Opposite rotations of the femur-bearing and bearing-baseplate articulations were evident at flexion greater than 80 ° . Knees with outlier alignment had lower magnitudes of axial rotation and distinct transitions from external to internal rotation during mid-flexion . Knees with femoral-tibial rotational mismatch had significantly lower total axial rotation compared to knees with nominal alignment . Conclusions Maintaining relative rotational mismatch within ±5 ° during TKR provided for controlled knee axial rotation during flexion . TKR with rotational alignment outside of defined surgical norms , with either positive or negative mismatch , experienced measurable kinematic differences and presented different patterns of axial rotation motions during passive knee flexion compared to TKR with nominal mismatch . These findings support previous studies linking prosthesis rotational alignment with inferior clinical and functional outcomes .Trial Registration Clinical Trials",
"Purpose This study aim ed to compare the clinical and radiological results of navigation-assisted TKAs performed using the measured gap resection or the gap balancing technique in thirty patients who underwent bilateral primary TKAs . Methods Sixty cases of navigation-assisted TKAs [ 30 TKAs performed using the measured gap resection technique ( Group A ) and 30 TKAs performed using the gap balancing technique ( Group B ) ] were analyzed prospect ively with minimum follow-up of 2 years . The joint line positions were measured using preoperative and postoperative weight-bearing anteroposterior and lateral radiographs . Clinical results were evaluated using knee scores and functional scores . Results No significant differences in knee scores or functional scores were observed . Polyethylene thickness and flexion/extension gaps were significantly larger in Group B ( P The navigation-assisted TKA with measured gap resection technique could be a useful technique with regard to restoration of the joint line . Level of evidence II",
"Purpose The objective of this prospect i ve study was to compare the functional outcome of conventional measured resection technique and computer-assisted gap balancing technique in TKA . Methods 140 patients were r and omized into two groups . The conventional measured resection technique without computer navigation was performed in Group 1 and the computer-assisted gap balancing technique in Group 2 . Range of motion , clinical laxity assessment with KT-1000 arthrometer , postoperative radiological films and various functional knee scores were documented at 6 months and 2 years . Results At 2 years , there were significantly more patients ( five patients , 7 % ) in the Group 1 with flexion contractures of more than 5 ° ( P = 0.05 ) . There were significantly more outliers in the Group 1 ( eight patients , 11 % ) , who demonstrated anterior tibial translation > 5 mm , than Group 2 ( two patients , 3 % ) ( P = 0.041 ) . The total excursion at 20 ° was significantly higher in Group 1 at 6 months ( P = 0.012 ) and after 2 years ( P = 0.031 ) . Group 2 was able to demonstrate significantly better limb alignment with fewer outliers ( more than 3 ° varus/valgus ) than Group 1 . At 6-month follow-up , Group 2 demonstrated better outcomes in Function Score ( P = 0.040 ) and Total Oxford Score ( P = 0.031 ) . At 2-year review , Group 2 had better outcome in the Total Oxford Score ( 0.030 ) . Conclusion Computer-assisted gap balancing technique was able to achieve more precise soft tissue balance and restoration of limb alignment with better knee scores as compared to the conventional measured resection technique in total knee arthroplasty . Level of evidence",
"Purpose . To compare the 2-year outcome of total knee arthroplasty ( TKA ) using the measured resection versus the gap balancing techniques . Methods . 21 men and 31 women aged 41 to 89 ( mean , 73 ) years who underwent primary TKA by a single surgeon for osteoarthritis and had an American Society of Anesthesiologists I or II physical status were prospect ively studied . Patients were r and omised to undergo computer-assisted TKA using the measured resection technique ( n=26 ) or the gap balancing technique ( n=26 ) . At the 2-year followup , patients were assessed by a single orthopaedic registrar blinded to the type of surgery using the Knee Society score ( KSS ) , functional Knee Society score ( FKSS ) , and revised Oxford Knee score ( ROKS ) . Results . In the measured resection group , the mean KSS , FKSS , and ROKS increased from 34.3 , 48 , and 21 to 85.9 , 89.6 , and 36.5 , respectively . In the gap balancing group , the respective scores increased from 35.4 , 50 , and 22.5 to 89.1 , 92.4 , and 40.6 . Postoperative with the gap balancing technique ; the respective p values were 0.46 , 0.44 , and 0.12 . Conclusion . Improvements in the knee scores were comparable with the 2 techniques",
"Obtaining a balanced flexion gap with correct femoral component rotation is one of the prerequisites for a successful outcome after total knee replacement ( TKR ) . Different techniques for achieving this have been described . In this study we prospect ively compared gap-balancing versus measured resection in terms of reliability and accuracy for femoral component rotation in 96 primary TKRs performed in 96 patients using the Journey system . In 48 patients ( 18 men and 30 women ) with a mean age of 65 years ( 45 to 85 ) a tensor device was used to determine rotation . In the second group of 48 patients ( 14 men and 34 women ) with a mean age of 64 years ( 41 to 86 ) , an ' adapted ' measured resection technique was used , taking into account the native rotational geometry of the femur as measured on a pre-operative CT scan . Both groups systematic ally reproduced a similar external rotation of the femoral component relative to the surgical transepicondylar axis : 2.4 ° ( SD 2.5 ) in the gap-balancing group and 1.7 ° ( SD 2.1 ) in the measured resection group ( p = 0.134 ) . Both gap-balancing and adapted measured resection techniques proved equally reliable and accurate in determining femoral component rotation after TKR . There was a tendency towards more external rotation in the gap-balancing group , but this difference was not statistically significant ( p = 0.134 ) . The number of outliers for our ' adapted ' measured resection technique was much lower than reported in the literature"
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411711e4-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Previous clinical trials indicate that probiotic consumption may improve blood glucose control , however , results from r and omized trials on glycemic control have been inconsistent . OBJECTIVE To investigate the effects of probiotics on glycemic control in a systematic review and meta- analysis of r and omized controlled trials . DATA SOURCES PubMed , Embase , Cochrane Library , and Clinical trial.gov through October 2014 . DATA EXTRACTION AND SYNTHESIS Two independent review ers extracted relevant data and assessed study quality and risk of bias . Data were pooled using a r and om-effects model and expressed as mean differences ( MD ) with 95 % CI . Heterogeneity was assessed ( Cochran Q-statistic ) and quantified ( I2 ) . RESULTS Seventeen r and omized controlled trials were included , in which 17 fasting blood glucose ( n = 1105 ) , 11 fasting plasma insulin ( n = 788 ) , 8 homeostasis model assessment of insulin resistance ( n = 635 ) comparisons were reported . Probiotic consumption , compared with placebo , significantly reduced fasting glucose ( MD = -0.31 mmol/L ; 95 % CI 0.56 , 0.06 ; p = 0.02 ) , fasting plasma insulin ( MD = -1.29 μU/mL ; 95 % CI -2.17 , -0.41 ; p = 0.004 ) , and HOMA-IR ( MD = 0.48 ; 95 % CI -0.83 , -0.13 ; p = 0.007 ) . CONCLUSIONS Probiotic consumption may improve glycemic control modestly . Modification of gut microbiota by probiotic supplementation may be a method for preventing and control hyperglycemia in clinical practice
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"Balanced glucose metabolism ensures optimal fetal growth with long-term health implication s conferred on both mother and child . We examined whether supplementation of probiotics with dietary counselling affects glucose metabolism in normoglycaemic pregnant women . At the first trimester of pregnancy 256 women were r and omised to receive nutrition counselling to modify dietary intake according to current recommendations or as controls ; the dietary intervention group was further r and omised to receive probiotics ( Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb12 ; diet/probiotics ) or placebo ( diet/placebo ) in a double-blind manner , whilst the control group received placebo ( control/placebo ) . Blood glucose concentrations were lowest in the diet/probiotics group during pregnancy ( baseline-adjusted means 4.45 , 4.60 and 4.56 mmol/l in diet/probiotics , diet/placebo and control/placebo , respectively ; P = 0.025 ) and over the 12 months ' postpartum period ( baseline-adjusted means 4.87 , 5.01 and 5.02 mmol/l ; P = 0.025 ) . Better glucose tolerance in the diet/probiotics group was confirmed by a reduced risk of elevated glucose concentration compared with the control/placebo group ( OR 0.31 ( 95 % CI 0.12 , 0.78 ) ; P = 0.013 ) as well as by the lowest insulin concentration ( adjusted means 7.55 , 9.32 and 9.27 mU/l ; P = 0.032 ) and homeostasis model assessment ( adjusted means 1.49 , 1.90 and 1.88 ; P = 0.028 ) and the highest quantitative insulin sensitivity check index ( adjusted means 0.37 , 0.35 and 0.35 ; P = 0.028 ) during the last trimester of pregnancy . The effects observed extended over the 12-month postpartum period . The present study demonstrated that improved blood glucose control can be achieved by dietary counselling with probiotics even in a normoglycaemic population and thus may provide potential novel means for the prophylactic and therapeutic management of glucose disorders",
"To our knowledge , no reports are available indicating the favorable effects of synbiotic bread consumption on blood lipid profiles among patients with type 2 diabetes mellitus ( T2DM ) . This study was conducted to evaluate the effects of the daily consumption of synbiotic bread on blood lipid profiles of patients with T2DM . This r and omized double-blinded controlled clinical trial was performed with 78 diabetic patients , aged 35–70 years . After a 2-week run-in period , subjects were r and omly assigned to consume either synbiotic ( n = 26 ) , probiotic ( n = 26 ) or control bread ( n = 26 ) for 8 weeks . The synbiotic bread contained viable and heat-resistant probiotic Lactobacillus sporogenes ( 1 × 108 CFU ) and 0.07 g inulin ( HPX ) as prebiotic per 1 g. The probiotic bread contained L. sporogenes ( 1 × 108 CFU ) per 1 g. Patients were asked to consume the synbiotic , probiotic and control breads three times a day in a 40 g package for a total of 120 g/day . Biochemical measurements including blood lipid profiles were conducted before and after 8 weeks of intervention . Consumption of the synbiotic bread , compared to the probiotic and control breads , led to a significant decrease in serum TAG ( P = 0.005 ) , VLDL-C ( P = 0.005 ) , TC/HDL-C ( P = 0.002 ) and a significant increase in serum HDL-C levels ( P = 0.01 ) . No significant effect of synbiotic bread consumption on FPG , TC , LDL-C and non-HDL-C levels was seen compared to the probiotic and control breads ( P > 0.05 ) . Trial registry code : http://www.i rct .ir I RCT 201311215623N13",
"BACKGROUND The short-chain fatty acids formed in the human colon by the bacterial fermentation of fiber may have an antiinflammatory effect , may reduce insulin production , and may improve lipid metabolism . We previously showed in hypercholesterolemic patients that supplementation with the probiotic bacteria Lactobacillus plantarum 299v significantly lowers concentrations of LDL cholesterol and fibrinogen . OBJECTIVE We determined the influence of a functional food product containing L. plantarum 299v on lipid profiles , inflammatory markers , and monocyte function in heavy smokers . DESIGN Thirty-six healthy volunteers ( 18 women and 18 men ) aged 35 - 45 y participated in a controlled , r and omized , double-blind trial . The experimental group drank 400 mL/d of a rose-hip drink containing L. plantarum 299v ( 5 x 10(7 ) colony-forming units/mL ) ; the control group consumed the same volume of product without bacteria . The experiment lasted 6 wk and entailed no changes in lifestyle . RESULTS Significant decreases in systolic blood pressure ( P leptin ( P fibrinogen ( P F(2)-isoprostanes ( 37 % ) and interleukin 6 ( 42 % ) were also noted in the experimental group in comparison with baseline . Monocytes isolated from subjects treated with L. plantarum showed significantly reduced adhesion ( P L. plantarum administration leads to a reduction in cardiovascular disease risk factors and could be useful as a protective agent in the primary prevention of atherosclerosis in smokers",
"According to animal studies , intake of probiotic bacteria may improve glucose homeostasis . We hypothesised that probiotic bacteria improve insulin sensitivity by attenuating systemic inflammation . Therefore , the effects of oral supplementation with the probiotic bacterium Lactobacillus acidophilus NCFM on insulin sensitivity and the inflammatory response were investigated in subjects with normal or impaired insulin sensitivity . In a double-blinded , r and omised fashion , forty-five males with type 2 diabetes , impaired or normal glucose tolerance were enrolled and allocated to a 4-week treatment course with either L. acidophilus NCFM or placebo . L. acidophilus was detected in stool sample s by denaturating gradient gel electrophoresis and real-time PCR . Separated by the 4-week intervention period , two hyperinsulinaemic-euglycaemic clamps were performed to estimate insulin sensitivity . Furthermore , the systemic inflammatory response was evaluated by subjecting the participants to Escherichia coli lipopolysaccharide injection ( 0·3 ng/kg ) before and after the treatment course . L. acidophilus NCFM was detected in 75 % of the faecal sample s after treatment with the probiotic bacterium . Insulin sensitivity was preserved among volunteers in the L. acidophilus NCFM group , whereas it decreased in the placebo group . Both baseline inflammatory markers and the systemic inflammatory response were , however , unaffected by the intervention . In conclusion , intake of L. acidophilus NCFM for 4 weeks preserved insulin sensitivity compared with placebo , but did not affect the systemic inflammatory response ",
"Background Lactobacillus gasseri BNR17 is a type of probiotic strain isolated from human breast milk . A study was reported regarding the fact that BNR17 was an inhibitor of obesity and diabetic activities in the human body through previous animal experiments . This study was furthered to investigate the effect of BNR17 , a probiotic strain isolated from human breast milk , on obese and overweight adults . Methods Sixty-two obese volunteers aged 19 to 60 with body mass index ≥ 23 kg/m2 and fasting blood sugar ≥ 100 mg/dL participated in a placebo controlled , r and omized , and double-blind trial . For 12 weeks , 57 participants were given either placebo or BNR17 and were tested by measuring body fat , body weight , various biochemical parameters , vital signs , and computed tomography at the start of the study and at weeks 4 , 8 , and 12 . The subjects assumed usual daily activities without having to make behavioral or dietary modifications during the course of the study . Results At the 12th week , a slight reduction in body weight was noted in the BNR17 group , but there were no significant weight changes between groups . Decrease of waist and hip circumferences in the BNR17 group was more pronounced than those in the placebo group . The two groups had no special or severe adverse reactions . Conclusion Despite there being no change in behavior or diet , administration of only the supplement of BNR17 reduced weight and waist and hip circumference . However , there were no significant differences between the two groups . These findings warrant a subsequent longer-term prospect i ve clinical investigation with a large population",
"Background The consumption of foods containing probiotic and prebiotic ingredients is growing consistently every year , and in view of the limited number of studies investigating their effect in the elderly . Objective The objective of this study was to evaluate the effect of the consumption of a symbiotic shake containing Lactobacillus acidophilus , Bifidobacterium bifidum and fructooligosaccharides on glycemia and cholesterol levels in elderly people . Methods A r and omized , double-blind , placebo-controlled study was conducted on twenty volunteers ( ten for placebo group and ten for symbiotic group ) , aged 50 to 60 years . The criteria for inclusion in the study were : total cholesterol > 200 mg/dL ; triglycerides > 200 mg/dL and glycemia > 110 mg/dL. Over a total test period of 30 days , 10 individuals ( the symbiotic group ) consumed a daily dose of 200 mL of a symbiotic shake containing 108 UFC/mL Lactobacillus acidophilus , 108 UFC/mL Bifidobacterium bifidum and 2 g oligofructose , while 10 other volunteers ( the placebo group ) drank daily the same amount of a shake that did not contain any symbiotic bacteria . Blood sample s were collected 15 days prior to the start of the experiment and at 10-day intervals after the beginning of the shake intake . The st and ard lipid profile ( total cholesterol , triglycerides and HDL cholesterol ) and glycemia , or blood sugar levels , were evaluated by an enzyme colorimetric assay . Results The results of the symbiotic group showed a non-significant reduction ( P > 0.05 ) in total cholesterol and triglycerides , a significant increase ( P HDL cholesterol and a significant reduction ( P fasting glycemia . No significant changes were observed in the placebo group . Conclusion The consumption of symbiotic shake result ed in a significant increase in HDL and a significant decrease of glycemia . Trial Registration Clinical Trials.gov :",
"Abstract Throughout life , there is an aging of the immune system that causes impairment of its defense capability . Prevention or delay of this deterioration is considered crucial to maintain general health and increase longevity . We evaluated whether dietary supplementation with Lactobacillus delbrueckii subsp . bulgaricus 8481 could enhance the immune response in the elderly . This multi-center , double-blind , and placebo controlled study enrolled 61 elderly volunteers who were r and omly assigned to receive either placebo or probiotics . Each capsule of probiotics contained at least 3 × 107 L. delbrueckii subsp . bulgaricus 8481 . Individuals in the study were administered three capsules per day for 6 months . Blood sample s were obtained at baseline ( time 0 ) , end of month 3 , and month 6 . We characterized cell sub population s , measured cytokines by flow cytometry , quantified T cell receptor excision circle ( TREC ) by real-time PCR ( RT-PCR ) , and determined human β-defensin-2 ( hBD-2 ) concentrations and human cytomegalovirus ( CMV ) titers by enzyme-linked immunosorbent assay ( ELISA ) . Elderly responded to the intake of probiotic with an increase in the percentage of NK cells , an improvement in the parameters defining the immune risk profile ( IRP ) , and an increase in the T cell subsets that are less differentiated . The probiotic group also showed decreased concentrations of the pro-inflammatory cytokine IL-8 but increased antimicrobial peptide hBD-2 . These effects disappeared within 6 months of stopping the probiotic intake . Immunomodulation induced by L. delbrueckii subsp . bulgaricus 8481 could favor the maintenance of an adequate immune response , mainly by slowing the aging of the T cell sub population s and increasing the number of immature T cells which are potential responders to new antigens",
"To evaluate the effects of probiotic ( VSL#3 ) and omega-3 fatty acid on insulin sensitivity , blood lipids , and inflammation , we conducted a clinical trial in 60 overweight ( BMI > 25 ) , healthy adults , aged 40–60 years . After initial screening the subjects were r and omized into four groups with 15 per group . The four groups received , respectively , placebo , omega-3 fatty acid , probiotic VSL#3 , or both omega-3 and probiotic , for 6 weeks . Blood and fecal sample s were collected at baseline and after 6 weeks . The probiotic ( VSL#3 ) supplemented group had significant reduction in total cholesterol , triglyceride , LDL , and VLDL and had increased HDL ( P VSL#3 improved insulin sensitivity ( P decreased hsCRP , and favorably affected the composition of gut microbiota . Omega-3 had significant effect on insulin sensitivity and hsCRP but had no effect on gut microbiota . Addition of omega-3 fatty acid with VSL#3 had more pronounced effect on HDL , insulin sensitivity and hsCRP . Subjects with low HDL , insulin resistance , and high hsCRP had significantly lower total lactobacilli and bifidobacteria count and higher E. coli and bacteroides count ",
"Introduction : The role of inflammatory cytokines in diabetes and its complications has been shown in some studies . The purpose of this study was to compare the effect of probiotic and conventional yogurt on inflammatory markers in patients with type 2 diabetes . Methods : Forty-four patients with type 2 diabetes were participated in this r and omized , double-blind controlled clinical trial and assigned to two intervention and control groups . The subjects in the intervention group consumed 300 g/d probiotic yogurt and subjects in the control group consumed 300 g/d conventional yogurt for 8 weeks . Anthropometric indices , dietary intakes , and serum levels of glucose , HbA1c , IL-6 , TNF-α and hs-CRP were evaluated at the beginning and end of the intervention . Results : For anthropometric indices and dietary intakes , no significant differences were seen within and between groups post intervention ( p > 0.05 ) . The consumption of probiotic yogurt caused significant decrease in HbA1c and TNF-α levels ( p= 0.032 and p= 0.040 , respectively ) in the intervention group . Conclusion : It is suggested that probiotic yogurt may be used as an alternative prevention approach and treatment method to control diabetic complications ",
"Background / objectives : Owing to excess body weight and increased secretion of inflammatory cytokines primarily during the third trimester , pregnancy is associated with elevated insulin resistance . To our knowledge , no report is available indicating the effects of probiotic yoghurt consumption on serum insulin levels in pregnant women . This study was design ed to determine the effects of daily consumption of probiotic yoghurt on insulin resistance and serum insulin levels of Iranian pregnant women . Subjects/ methods : In this r and omized controlled clinical trial , 70 primigravida pregnant women with singleton pregnancy at their third trimester were participated . We r and omly assigned participants to consume 200 g per day of conventional ( n=33 ) or the probiotic group ( n=37 ) for 9 weeks . The probiotic yoghurt was a commercially available product prepared with the starter cultures of Streptococcus thermophilus and Lactobacillus bulgaricus , enriched with probiotic culture of two strains of lactobacilli ( Lactobacillus acidophilus LA5 ) and bifidobacteria ( Bifidobacterium animalis BB12 ) with a total of min 1 × 107 colony-forming units . Fasting blood sample s were taken at baseline and after 9-week intervention to measure fasting plasma glucose and serum insulin levels . Homeostatic model assessment of insulin resistance ( HOMA-IR ) was used to calculate insulin resistance score . Results : Although consumption of probiotic yogurt for 9 weeks did not affect serum insulin levels and HOMA-IR score , significant differences were found comparing changes in these variables between probiotic and conventional yogurts ( changes from baseline in serum insulin levels : + 1.2±1.2 vs + 5.0±1.1 μIU/ml , respectively , P=0.02 ; and in HOMA-IR score : −0.2±0.3 vs 0.7±0.2 , respectively , P=0.01 ) . Conclusions : It is concluded that in contrast to conventional yogurt , daily consumption of probiotic yogurt for 9 weeks maintains serum insulin levels and might help pregnant women prevent developing insulin resistance",
"Background Gut lactobacilli can affect the metabolic functions of healthy humans . We tested whether a 1500 kcal/d diet supplemented with cheese containing the probiotic Lactobacillus plantarum TENSIA ( Deutsche Sammlung für Mikroorganismen , DSM 21380 ) could reduce some symptoms of metabolic syndrome in Russian adults with obesity and hypertension . Methods In this 3-week , r and omized , double-blind , placebo-controlled , parallel pilot study , 25 subjects ingested probiotic cheese and 15 ingested control cheese . Fifty grams of each cheese provided 175 kcal of energy . Blood pressure ( BP ) , anthropometric characteristics , markers of liver and kidney function , metabolic indices ( plasma glucose , lipids , and cholesterol ) , and urine polyamines were measured . Counts of fecal lactobacilli and L. plantarum TENSIA were evaluated using molecular methods . The data were analyzed by t-test for independent sample s and Spearman ’s partial correlation analysis . Results The probiotic L. plantarum TENSIA was present in variable amounts ( 529.6 ± 232.5 gene copies ) in 16/25 ( 64 % ) study subjects . Body mass index ( BMI ) was significantly reduced ( p = 0.031 ) in the probiotic cheese group versus the control cheese group . The changes in BMI were closely associated with the water content of the body ( r = 0.570 , p = 0.0007 ) when adjusted for sex and age . Higher values of intestinal lactobacilli after probiotic cheese consumption were associated with higher BMI ( r = 0.383 , p = 0.0305 ) and urinary putrescine content ( r = 0.475 , p = 0.006 ) . In patients simultaneously treated with BP-lowering drugs , similar reductions of BP were observed in both groups . A positive association was detected between TENSIA colonization and the extent of change of morning diastolic BP ( r = 0.617 , p = 0.0248 ) and a trend toward lower values of morning systolic BP ( r = −0.527 , p = 0.0640 ) at the end of the study after adjusting for BMI , age , and sex . Conclusion In a pilot study of obese hypertensive patients , a hypocaloric diet supplemented with a probiotic cheese helps to reduce BMI and arterial BP values , recognized symptoms of metabolic syndrome . Trial registration Current Controlled Trials IS RCT",
"OBJECTIVE Oxidative stress plays a major role in the pathogenesis and progression of diabetes . Among various functional foods with an antioxidant effect , probiotic foods have been reported to repress oxidative stress . The objective of this clinical trial was to assess the effects of probiotic and conventional yogurt on blood glucose and antioxidant status in type 2 diabetic patients . METHODS Sixty-four patients with type 2 diabetes mellitus , 30 to 60 y old , were assigned to two groups in this r and omized , double-blind , controlled clinical trial . The patients in the intervention group consumed 300 g/d of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 and those in the control group consumed 300 g/d of conventional yogurt for 6 wk . Fasting blood sample s , 24-h dietary recalls , and anthropometric measurements were collected at the baseline and at the end of the trial . RESULTS Probiotic yogurt significantly decreased fasting blood glucose ( P hemoglobin A1c ( P erythrocyte superoxide dismutase and glutathione peroxidase activities and total antioxidant status ( P serum malondialdehyde concentration significantly decreased compared with the baseline value in both groups ( P insulin concentration and erythrocyte catalase activity within either group ( P > 0.05 ) . CONCLUSION The consumption of probiotic yogurt improved fasting blood glucose and antioxidant status in type 2 diabetic patients . These results suggest that probiotic yogurt is a promising agent for diabetes management",
"Background / Objectives : Evidence from animal and in vitro models suggest a role of probiotic bacteria in improving glycaemic control and delaying the onset of type 2 diabetes . However , the evidence from controlled trials in humans is limited . The objective was to determine if the probiotic bacteria L. acidophilus La5 and B. animalis subsp lactis Bb12 , supplemented in a whole food ( yoghurt ) or isolated ( capsules ) form , can improve biomarkers of glycaemic control . Subjects/ methods : Following a 3-week washout period , 156 overweight men and women over 55 years ( mean age : 67±8 years ; mean body mass index ( 31±4 kg/m2 ) were r and omized to a 6-week double-blinded parallel study . The four intervention groups were : ( A ) probiotic yoghurt plus probiotic capsules ; ( B ) probiotic yoghurt plus placebo capsules ; ( C ) control milk plus probiotic capsules ; and ( D ) control milk plus placebo capsules . Outcome measurements , including fasting glucose , insulin , glycated haemoglobin and Homoeostasis Model Assessment of Insulin Resistance ( HOMA-IR ) , were performed at baseline and week 6 . Results : Relative to the milk-control group , probiotic yoghurt result ed in a significantly higher HOMA-IR ( 0.32±0.15 , P=0.038 ) , but did not have a significant effect on the other three measures of glycaemic control ( P>0.05 ) . Relative to placebo capsules , probiotic capsules result ed in a significantly higher fasting glucose ( 0.15±0.07 mmol/l , P=0.037 ) , with no significant effect on the other three measures of glycaemic control ( P>0.05 ) . Further analyses did not identify other variables as contributing to these adverse findings . Conclusions : Data from this study does not support the hypothesis that L. acidophilus La5 and B. animalis subsp lactis Bb12 , either in isolated form or as part of a whole food , benefit short-term glycaemic control . Indeed , there is weak data for an adverse effect of these strains on glucose homoeostasis ",
"BACKGROUND Recent studies have reported beneficial effects of probiotics on maternal glycemia in healthy pregnant women . Obesity significantly increases risk of impaired glucose tolerance in pregnancy , but glycemic effects of probiotics in this specific obstetric group require additional investigation . OBJECTIVE The aim of the Probiotics in Pregnancy Study was to investigate the effect of a probiotic capsule on maternal fasting glucose in obese pregnant women . DESIGN In this placebo-controlled , double-blind , r and omized trial , 175 pregnant women with an early pregnancy body mass index ( BMI ; in kg/m² ) from 30.0 to 39.9 were recruited from antenatal clinics at the National Maternity Hospital , Dublin , Irel and . Exclusion criteria were BMI 39.9 , prepregnancy or gestational diabetes , age Women were r and omly assigned to receive either a daily probiotic or a placebo capsule from 24 to 28 wk of gestation in addition to routine antenatal care . The primary outcome was the change in fasting glucose between groups from preintervention to postintervention . Secondary outcomes were the incidence of gestational diabetes and neonatal anthropometric measures . RESULTS In 138 women who completed the study ( 63 women in the probiotic group ; 75 women in the placebo group ) , mean ( ±SD ) early pregnancy BMI was 33.6 ± 2.6 , which differed significantly between probiotic ( 32.9 ± 2.4 ) and placebo ( 34.1 ± 2.7 ) groups . With adjustment for BMI , the change in maternal fasting glucose did not differ significantly between treated and control groups [ -0.09 ± 0.27 compared with -0.07 ± 0.39 mmol/L ; P = 0.391 ; B = -0.05 ( 95 % CI : -0.17 , 0.07 ) ] . There were also no differences in the incidence of impaired glycemia ( 16 % in the probiotic group compared with 15 % in the placebo group ; P = 0.561 ) , birth weight ( 3.70 kg in the probiotic group compared with 3.68 kg in the placebo group ; P = 0.723 ) , or other metabolic variables or pregnancy outcomes . A secondary analysis of 110 women , excluding antibiotic users and poor compliers , also revealed no differences in maternal glucose or other outcomes between groups . CONCLUSION Probiotic treatment of 4 wk during pregnancy did not influence maternal fasting glucose , the metabolic profile , or pregnancy outcomes in obese women",
"A significant number of human clinical trials have reported no adverse effects associated with consumption of Lactobacillus reuteri ( L. reuteri ) . In the present study , the clinical safety and toxicology of oral ingestion of supplement capsules containing L. reuteri NCIMB 30242 was investigated . A r and omized group of 131 subjects received a dose of 2.9 × 10⁹ CFU L. reuteri NCIMB 30242 capsules ( n=67 ) or placebo capsules ( n=64 ) twice daily for 9 weeks . Clinical chemistry and hematological parameters of safety were analyzed . The frequency , duration and intensity of adverse events (AE)s and clinical significance of safety parameters were recorded for both groups . No clinical ly significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results . The frequency and intensity of AEs was similar in the two groups . These results demonstrate that administration of a twice daily dose of 2.9 × 10⁹ CFU was safe and well tolerated in the population evaluated over 9 weeks",
"Urogenital infections afflict an estimated one billion people each year . The size of this problem and the increased prevalence of multi-drug resistant pathogens make it imperative that alternative remedies be found . A r and omized , placebo-controlled trial of 64 healthy women given daily oral capsules of Lactobacillus rhamnosus GR-1 and Lactobacillus fermentum RC-14 for 60 days showed no adverse effects . Microscopy analysis showed restoration from asymptomatic bacterial vaginosis microflora to a normal lactobacilli colonized microflora in 37 % women during lactobacilli treatment compared to 13 % on placebo ( P=0.02 ) . Lactobacilli were detected in more women in the lactobacilli-treated group than in the placebo group at 28 day ( P=0.08 ) and 60 day ( P=0.05 ) test points . Culture findings confirmed a significant increase in vaginal lactobacilli at day 28 and 60 , a significant depletion in yeast at day 28 and a significant reduction in coliforms at day 28 , 60 and 90 for lactobacilli-treated subjects versus controls . The combination of probiotic L. rhamnosus GR-1 and L. fermentum RC-14 is not only safe for daily use in healthy women , but it can reduce colonization of the vagina by potential pathogenic bacteria and yeast"
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BACKGROUND Attention Deficit Hyperactivity Disorder ( ADHD ) is a neurodevelopmental disorder characterised by high levels of inattention , hyperactivity and impulsivity that are present before the age of seven years , seen in a range of situations , inconsistent with the child 's developmental level and causing social or academic impairment . Parent training programmes are psychosocial interventions aim ed at training parents in techniques to enable them to manage their children 's challenging behaviour . OBJECTIVES To determine whether parent training interventions are effective in reducing ADHD symptoms and associated problems in children aged between five and eigtheen years with a diagnosis of ADHD , compared to controls with no parent training intervention . SEARCH METHODS We search ed the following electronic data bases ( for all available years until September 2010 ) : CENTRAL ( 2010 , Issue 3 ) , MEDLINE ( 1950 to 10 September 2010 ) , EMBASE ( 1980 to 2010 Week 36 ) , CINAHL ( 1937 to 13 September 2010 ) , PsycINFO ( 1806 to September Week 1 2010 ) , Dissertation Abstract s International ( 14 September 2010 ) and the metaRegister of Controlled Trials ( 14 September 2010 ) . We contacted experts in the field to ask for details of unpublished or ongoing research . SELECTION CRITERIA R and omised ( including quasi-r and omised ) studies comparing parent training with no treatment , a waiting list or treatment as usual ( adjunctive or otherwise ) . We included studies if ADHD was the main focus of the trial and participants were over five years old and had a clinical diagnosis of ADHD or hyperkinetic disorder that was made by a specialist using the operationalised diagnostic criteria of the DSM-III/DSM-IV or ICD-10 . We only included trials that reported at least one child outcome . DATA COLLECTION AND ANALYSIS Four authors were involved in screening abstract s and at least 2 authors looked independently at each one . We review ed a total of 12,691 studies and assessed five as eligible for inclusion . We extracted data and assessed the risk of bias in the five included trials . Opportunities for meta- analysis were limited and most data that we have reported are based on single studies . MAIN RESULTS We found five studies including 284 participants that met the inclusion criteria , all of which compared parent training with de facto treatment as usual ( TAU ) . One study included a nondirective parent support group as a second control arm . Four studies targeted children 's behaviour problems and one assessed changes in parenting skills . Of the four studies targeting children 's behaviour , two focused on behaviour at home and two focused on behaviour at school . The two studies focusing on behaviour at home had different findings : one found no difference between parent training and treatment as usual , whilst the other reported statistically significant results for parent training versus control . The two studies of behaviour at school also had different findings : one study found no difference between groups , whilst the other reported positive results for parent training when ADHD was not comorbid with oppositional defiant disorder . In this latter study , outcomes were better for girls and for children on medication . We assessed the risk of bias in most of the studies as unclear at best and often as high . Information on r and omisation and allocation concealment did not appear in any study report . Inevitably , blinding of participants or personnel was impossible for this intervention ; likewise , blinding of outcome assessors ( who were most often the parents who had delivered the intervention ) was impossible . We were only able to conduct meta- analysis for two outcomes : child ' externalising ' behaviour ( a measure of rulebreaking , oppositional behaviour or aggression ) and child ' internalising ' behaviour ( for example , withdrawal and anxiety ) . Meta- analysis of three studies ( n = 190 ) providing data on externalising behaviour produced results that fell short of statistical significance ( SMD -0.32 ; 95 % CI -0.83 to 0.18 , I(2 ) = 60 % ) . A meta- analysis of two studies ( n = 142 ) for internalising behaviour gave significant results in the parent training groups ( SMD -0.48 ; 95 % CI -0.84 to -0.13 , I(2 ) = 9 % ) . Data from a third study likely to have contributed to this outcome were missing , and we have some concerns about selective outcome reporting bias . Individual study results for child behaviour outcomes were mixed . Positive results on an inventory of child behaviour problems were reported for one small study ( n = 24 ) with the caveat that results were only positive when parent training was delivered to individuals and not groups . In another study ( n = 62 ) , positive effects ( once results were adjusted for demographic and baseline data ) were reported for the intervention group on a social skills measure . The study ( n = 48 ) that assessed parenting skill changes compared parent training with a nondirective parent support group . Statistically significant improvements were reported for the parent training group . Two studies ( n = 142 ) provided data on parent stress indices that were suitable for combining in a meta- analysis . The results were significant for the ' child ' domain ( MD -10.52 ; 95 % CI -20.55 to -0.48 ) but not the ' parent ' domain ( MD -7.54 ; 95 % CI -24.38 to 9.30 ) . Results for this outcome from a small study ( n = 24 ) suggested a long-term benefit for mothers who received the intervention at an individual level ; in contrast , fathers benefited from short-term group treatment . A fourth study reported change data for within group measures of parental stress and found significant benefits in only one of the two active parent training group arms ( P ≤ 0.01).No study reported data for academic achievement , adverse events or parental underst and ing of ADHD . AUTHORS ' CONCLUSIONS Parent training may have a positive effect on the behaviour of children with ADHD . It may also reduce parental stress and enhance parental confidence . However , the poor method ological quality of the included studies increases the risk of bias in the results . Data concerning ADHD-specific behaviour are ambiguous . For many important outcomes , including school achievement and adverse effects , data are lacking . Evidence from this review is not strong enough to form a basis for clinical practice guidelines . Future research should ensure better reporting of the study procedures and results
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"The efficacy of group parent training was assessed in improving compliance and time on task in preschoolers with attention-deficit disorder with hyperactivity . Positive effects were obtained on measures of child compliance , but not on measures of attention . Parental compliance-management skills and overall style of interaction were also positively affected . The use of parent training for early intervention with ADDH children is discussed",
"BACKGROUND There is a pressing need for cost-effective population -based interventions to tackle early-onset antisocial behaviour . As this is determined by many factors , it would seem logical to devise interventions that address several influences while using an efficient means of delivery . The aim of this trial was to change four risk factors that predict poor outcome : ineffective parenting , conduct problems , attention deficit/hyperactivity disorder ( ADHD ) symptoms , and low reading ability . METHODS A r and omised controlled trial was carried out in eight schools in London , Engl and . Nine hundred and thirty-six ( 936 ) 6-year-old children were screened for antisocial behaviour , then parents of 112 high scorers were r and omised to parenting groups held in schools or control ; 109 were followed up a year later . The intervention lasted 28 weeks and was novel as it had components to address both child behaviour ( through the Incredible Years programme ) and child literacy ( through a new ' SPOKES ' programme to help parents read with their children ) . Fidelity of implementation was emphasised by careful training of therapists and weekly supervision . Controls received an information helpline . Assessment of conduct problems was by parent interview , parenting by direct observation and child reading by psychometric testing . RESULTS At follow-up parents allocated to the intervention used play , praise and rewards , and time out more often than controls , and harsh discipline less ; effect sizes ranged from .31 to .59 sd ( p-values .046 to .005 ) . Compared to control children , whose behaviour did n't change , intervention children 's conduct problems reduced by .52sd , ( p oppositional-defiant disorder ( ODD ) halved from 60 % to 31 % ( p = .003 ) . ADHD symptoms reduced by .44sd ( p = .002 ) , and reading age improved by six months ( .36sd , p = .027 ) . Teacher-rated behaviour did n't change . The programme cost pound2,380 ( $ 3,800 ) per child . CONCLUSIONS Effective population -based early intervention to improve the functioning of with antisocial behaviour is practically feasible by targeting multiple risk factors and emphasising implementation fidelity",
"BACKGROUND While the use of stimulant medication as a treatment for children with attention deficit hyperactivity disorder ( ADHD ) has been the most studied therapy in child psychiatry , there is debate about its use with young children . This study describes a series of cases seen in a normal clinical context , treated with one of four different treatment programmes . METHODS Sixteen pre-school children diagnosed with ADHD and their parents were r and omly assigned to receive one of four treatments : ( 1 ) 0.3 mg/kg methylpheni date , parent training programme ; ( 2 ) 0.3 mg/kg methylpheni date , parent support programme ; ( 3 ) placebo medication , parent training ; and ( 4 ) placebo medication , parent support . Changes were assessed at the individual level , using clinical observations , parent and teacher rating scales and measures of parenting and family factors . RESULTS Children were more likely to improve when the treatment involved at least one active component ( medication or parent training ) . However , there was notable variability in individual parental and child participants ' responses to all treatment conditions , indicating the importance of interactions between treatment variables and other factors . CONCLUSIONS Findings are discussed within the framework of a transactional model , and inferences are drawn about the limitations of the idea that there is a ' best treatment ' that is universally applicable",
"A significant discrepancy between intelligence and daily adaptive functioning , or adaptive disability ( AD ) , has been previously found to be a associated with significant psychological morbidity in preschool children with disruptive behavior ( DB ) . The utility of AD as a predictor of later developmental risks was examined in a 3-year longitudinal study of normal ( N = 43 ) and DB preschool children . The DB children were grouped into those with AD ( DB+AD ; N = 28 ) and those without AD ( DB-only ; N = 98 ) . All children were followed with annual evaluations to the end of second grade . Both DB groups demonstrated substantial and pervasive psychological and educational morbidity at 3-year follow-up . In comparison to DB-only children , DB+AD children had more symptoms of attention-deficit hyperactivity disorder ( ADHD ) and conduct disorder ( CD ) , more severe and pervasive behavior problems at home , more parent-rated externalizing and internalizing , and lower academic competence and more behavioral problems at school . Parents of DB+AD children also reported greater parenting stress than did parents in the other groups . A significant contribution of AD to adverse outcomes in the DB group remained on some measures even after controlling for initial severity of DB . AD also contributed significantly to CD symptoms at follow-up after controlling for initial DB severity and initial CD symptoms . The results corroborate and extend earlier findings of the utility of AD as a risk indicator above severity of DB alone . They also imply that AD in the context of normal intellectual development may arise from both the deficient self-regulation associated with ADHD and from disrupted parenting . with exposure to kindergarten moderating these adverse effects",
"Objective The present study investigated the predictive power of anxiety , IQ , severity of ADHD and parental depression on the outcome of treatment in children with ADHD . Method Fifty children with ADHD ( ages 8–12 ) were r and omized to a 10-week treatment of methylpheni date or to a treatment of methylpheni date combined with multimodal behavior therapy . Prior to treatment predictors were assessed . Outcome was assessed separately for parents and teachers on a composite measure of inattentive , hyperactive , oppositional- and conduct disorder symptoms . Results There was neither a significant difference between the two treatments at baseline nor did treatment condition predict outcome . Therefore the data were collapsed across the two treatments . A combination of anxiety and IQ predicted teacher-rated outcome , explaining 18 % of the variance . Higher anxiety and higher IQ ’s indicated better treatment outcome . There were no significant predictors of the parent-rated outcome . Conclusion This study showed a small but significant predictive effect of IQ and anxiety on treatment outcome in children with ADHD . Clinical implication sThis study supports the idea that for the treatment of ADHD children with comorbid anxiety and higher IQ respond better to the two most used treatments for ADHD",
"Currently , there are no empirically supported psychodynamic treatments for disruptive behavior in young children . Supportive Expressive Therapy -- Parent Child ( SET-PC ) is a newly developed brief psychodynamic psychotherapy that focuses on a parent 's internal representations of self and others , particularly as they manifest in problematic parent-child relationships . It is a manualized dyadic therapy that uses videotaped parent-child play sessions followed by parent-therapist discussion s. This exploratory study is the first r and omized controlled study of SETPC . SET-PC was compared with the Incredible Years Parenting Program ( IYPP ; Webster-Stratton , 2001 ) , an empirically supported group parent training intervention for child disruptive behavior . Treatment completers were 37 consecutive referrals of parent- child dyads ( children ages 30 - 72 months ) to an outpatient psychiatry clinic . SET-PC produced treatment outcomes that were equivalent to IYPP . Both treatments were associated with large effect sizes for decreases in externalizing behavior and for the positive quality of observed parent- child interactions and small effect sizes for improvements in parents ' psychological functioning . Treatment gains were maintained at 1-year follow-up regardless of treatment condition . ( PsycINFO Data base Record ( c ) 2010 APA , all rights reserved )",
"OBJECTIVE In the intent-to-treat analysis of the Multimodal Treatment Study of Children With ADHD ( MTA ) , the effects of medication management ( MedMgt ) , behavior therapy ( Beh ) , their combination ( Comb ) , and usual community care ( CC ) differed at 14 and 24 months due to superiority of treatments that used the MTA medication algorithm ( Comb+MedMgt ) over those that did not ( Beh+CC ) . This report examines 36-month outcomes , 2 years after treatment by the study ended . METHOD For primary outcome measures ( attention-deficit/hyperactivity disorder [ ADHD ] and oppositional defiant disorder [ ODD ] symptoms , social skills , reading scores , impairment , and diagnostic status ) , mixed-effects regression models and orthogonal contrasts examined 36-month outcomes . RESULTS At 3 years , 485 of the original 579 subjects ( 83.8 % ) participated in the follow-up , now at ages 10 to 13 years , ( mean 11.9 years ) . In contrast to the significant advantage of MedMgt+Comb over Beh+CC for ADHD symptoms at 14 and 24 months , treatment groups did not differ significantly on any measure at 36 months . The percentage of children taking medication > 50 % of the time changed between 14 and 36 months across the initial treatment groups : Beh significantly increased ( 14 % to 45 % ) , MedMed+Comb significantly decreased ( 91 % to 71 % ) , and CC remained constant ( 60%-62 % ) . Regardless of their treatment use changes , all of the groups showed symptom improvement over baseline . Notably , initial symptom severity , sex ( male ) , comorbidity , public assistance , and parental psychopathology ( ADHD ) did not moderate children 's 36-month treatment responses , but these factors predicted worse outcomes over 36 months , regardless of original treatment assignment . CONCLUSIONS By 36 months , the earlier advantage of having had 14 months of the medication algorithm was no longer apparent , possibly due to age-related decline in ADHD symptoms , changes in medication management intensity , starting or stopping medications altogether , or other factors not yet evaluated",
"Utilizing a double-blind , placebo design , the effects of a high ( 0.8 mg/kg ) and a low ( 0.4 mg/kg ) dose of methylpheni date alone and in combination with behavioral parent training plus child self-control instruction were evaluated with 96 attention deficit hyperactivity disorder children . No evidence of the superiority of the combined conditions relative to medication alone was found . Some limited support was found for the hypothesis that the effects of a high dose of psychostimulant medication could be achieved by combining the low dose with a behavioral intervention . The importance of the latter finding is highlighted by the fact that both the benefits and untoward effects of the psychostimulants appear to increase with the dose",
"OBJECTIVE Many children with pervasive developmental disorders ( PDDs ) have serious , functionally impairing behavioral problems . We tested whether combined treatment ( COMB ) with risperidone and parent training ( PT ) in behavior management is superior to medication alone ( MED ) in improving severe behavioral problems in children with PDDs . METHOD This 24-week , three-site , r and omized , parallel-groups clinical trial enrolled 124 children , aged 4 through 13 years , with PDDs , accompanied by frequent tantrums , self-injury , and aggression . The children were r and omized 3:2 to COMB ( n = 75 ) or MED ( n = 49 ) . The participants received risperidone monotherapy from 0.5 to 3.5 mg/day ( with switch to aripiprazole if risperidone was ineffective ) . Parents in the COMB group ( n = 75 ; 60.5 % ) received a mean of 10.9 PT sessions . The primary measure of compliance was the Home Situations Question naire ( HSQ ) score . RESULTS Primary : intent-to-treat r and om effects regression showed that COMB was superior to MED on HSQ ( p = .006 ) [ effect size at week 24 ( d ) = 0.34 ] . The HSQ score declined from 4.31 ( ± 1.67 ) to 1.23 ( ± 1.36 ) for COMB compared with 4.16 ( ± 1.47 ) to 1.68 ( ± 1.36 ) for MED . Secondary : groups did not differ on Clinical Global Impressions-Improvement scores at endpoint ; compared with MED , COMB showed significant reductions on Aberrant Behavior Checklist Irritability ( d = 0.48 ; p = .01 ) , Stereotypic Behavior ( d = 0.23 ; p = .04 ) , and Hyperactivity/Noncompliance subscales ( d = 0.55 ; p = .04 ) . Final risperidone mean dose for MED was 2.26 mg/day ( 0.071 mg/kg ) , compared with 1.98 mg/day for COMB ( 0.066 mg/kg ) ( p = .04 ) . CONCLUSIONS Medication plus PT result ed in greater reduction of serious maladaptive behavior than MED in children with PDDs , with a lower risperidone dose",
"Behavioral parent training is an efficacious treatment for attention-deficit/hyperactivity disorder ( ADHD ) . However , single-mother households are at high risk for poor outcomes during and following behavioral parent training . This study r and omly assigned cohorts of 120 single mothers of children ( ages 5–12 years ) with ADHD to a waitlist control group , a traditional behavioral parent training program , or an enhanced behavioral parent training program — the Strategies to Enhance Positive Parenting ( STEPP ) program . Intent-to-treat analysis demonstrated benefits of participating in behavioral parent training , in general , and the STEPP program more specifically at immediate posttreatment on child and parental functioning . Moreover , the STEPP program result ed in increased engagement to treatment . However , results indicated that behavioral parent training does not normalize behavior for most children and treatment gains are not maintained",
"OBJECTIVE To test that methylpheni date combined with intensive multimodal psychosocial intervention , which includes social skills training , significantly enhances social functioning in children with attention-deficit/hyperactivity disorder ( ADHD ) compared with methylpheni date alone and methylpheni date plus nonspecific psychosocial treatment ( attention control ) . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to receive ( 1 ) methylpheni date alone , ( 2 ) methylpheni date plus multimodal psychosocial treatment that included social skills training , or ( 3 ) methylpheni date plus attention control treatment . Assessment s included parent , child , and teacher ratings of social function and direct school observations in gym . RESULTS No advantage was found on any measure of social functioning for the combination treatment over methylpheni date alone or methylpheni date plus attention control . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In young children with ADHD , there is no support for clinic-based social skills training as part of a long-term psychosocial intervention to improve social behavior . Significant benefits from methylpheni date were stable over 2 years",
"Families of 54 behaviorally disturbed preschool-aged children ( 3 to 5 years ) were r and omly assigned to 1 of 3 treatment conditions : st and ard parent-child interaction therapy ( PCIT ; STD ) ; modified PCIT that used didactic videotapes , telephone consultations , and face-to-face sessions to abbreviate treatment ; and a no-treatment waitlist control group ( WL ) . Twenty-one nondisturbed preschoolers were recruited as a social validation comparison condition . Posttreatment assessment indicated significant differences in parent-reported externalizing behavior in children , and parental stress and discipline practice s from both treatment groups on most measures compared with the WL group . Clinical significance testing suggested a superior effect for the STD immediately after intervention , but by 6-month follow-up , the two groups were comparable . The findings indicate that abbreviated PCIT may be of benefit for families with young conduct problem children",
"OBJECTIVE To evaluate two different parent-based therapies for preschool attention-deficit/hyperactivity disorder ( ADHD ) in a community sample . METHOD Three-year-old children displaying a preschool equivalent of ADHD ( n = 78 ) were r and omly assigned to either a parent training ( PT ; n = 30 ) , a parent counseling and support ( PCO&S ; n = 28 ) , or a waiting-list control group ( n = 20 ) . The PT group received coaching in child management techniques . The PC&S group received nondirective support and counseling . Measures of child symptoms and mothers ' well-being were taken before and after intervention and at 15 weeks follow-up . RESULTS ADHD symptoms were reduced ( F2,74 = 11.64 ; p mothers ' sense of well-being was increased by PT relative to both other groups ( F2,74 = 10.32 ; p ly significant improvement ( chi 2 = 4.08 ; p = .048 ) . CONCLUSIONS PT is a valuable treatment for preschool ADHD . PC&S had little effect on children 's behavior . Constructive training in parenting strategies is an important element in the success of parent-based interventions . Psychostimulants are not a necessary component of effective treatment for many children with preschool ADHD",
"OBJECTIVE Atomoxetine is an investigational , nonstimulant pharmacotherapy being studied as potential treatment for attention-deficit/hyperactivity disorder ( ADHD ) . It is thought to act via blockade of the presynaptic norepinephrine transporter in the brain . We assessed the efficacy of 3 doses of atomoxetine compared with placebo in children and adolescents with ADHD . METHODS A total of 297 children and adolescents who were 8 to 18 years of age and had ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders , 4th edition , were r and omized to placebo or atomoxetine dosed on a weight-adjusted basis at 0.5 mg/kg/day , 1.2 mg/kg/day , or 1.8 mg/kg/day for an 8-week period . ADHD symptoms , affective symptoms , and social and family functioning were assessed using parent and investigator rating scales . RESULTS Approximately 71 % of children enrolled were male , approximately 67 % met criteria for mixed subtype ( both inattentive and hyperactive/impulsive symptoms ) , and the only common psychiatric comorbidity was oppositional defiant disorder ( approximately 38 % of the sample ) . At baseline , symptom severity was rated as moderate to severe for most children . At endpoint , atomoxetine 1.2 mg/kg/day and 1.8 mg/kg/day were consistently associated with superior outcomes in ADHD symptoms compared with placebo and were not different from each other . The dose of 0.5 mg/kg/day was associated with intermediate efficacy between placebo and the 2 higher doses , suggesting a grade d dose-response . Social and family functioning also were improved in the atomoxetine groups compared with placebo with statistically significant improvements in measures of children 's ability to meet psychosocial role expectations and parental impact . Discontinuations as a result of adverse events were children and adolescents aged 8 to 18 , atomoxetine was superior to placebo in reducing ADHD symptoms and in improving social and family functioning symptoms . Atomoxetine was associated with a grade d dose-response , and 1.2 mg/kg/day seems to be as effective as 1.8 mg/kg/day and is likely to be the appropriate initial target dose for most patients . Treatment with atomoxetine was safe and well tolerated",
"Annual screenings of preschool children at kindergarten registration identified 158 children having high levels of aggressive , hyperactive , impulsive , and inattentive behavior . These \" disruptive \" children were r and omly assigned to four treatment conditions lasting the kindergarten school year : no treatment , parent training only , full-day treatment classroom only , and the combination of parent training with the classroom treatment . Results showed that parent training produced no significant treatment effects , probably owing largely to poor attendance . The classroom treatment produced improvement in multiple domains : parent ratings of adaptive behavior , teacher ratings of attention , aggression , self-control , and social skills , as well as direct observations of externalizing behavior in the classroom . Neither treatment improved academic achievement skills or parent ratings of home behavior problems , nor were effects evident on any lab measures of attention , impulse control , or mother-child interactions . It is concluded that when parent training is offered at school registration to parents of disruptive children identified through a brief school registration screening , it may not be a useful approach to treating the home and community behavioral problems of such children . The kindergarten classroom intervention was far more effective in reducing the perceived behavioral problems and impaired social skills of these children . Even so , most treatment effects were specific to the school environment and did not affect achievement skills . These findings must be viewed as tentative until follow-up evaluations can be done to determine the long-term outcomes of these interventions",
"BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes",
"Two family therapies were compared using teens with attention-deficit/hyperactivity disorder . Ninety-seven families were assigned to either 18 sessions of problem-solving communication training ( PSCT ) alone or behavior management training ( BMT ) for 9 sessions followed by PSCT for 9 sessions ( BMT/PSCT ) . Both treatments demonstrated significant improvement in ratings of parent-teen conflicts at the midpoint but did not differ . By posttreatment , both produced improvement on ratings and observations but did not differ . Significantly more families dropped out of PSCT alone than out of BMT/PSCT . At most , 23 % of families showed reliable change either by midpoint or by posttreatment , with no differences between therapies . Yet 31%-70 % of families were normalized . Group-level change and normalization rates support treatment efficacy , whereas indices of reliable change are less impressive",
"Objective To evaluate the effectiveness of a parenting programme as a preventive intervention with parents of preschool children considered to be at risk of developing conduct disorder . Design Pragmatic r and omised controlled trial using a block design with allocation by area . Setting Eleven Sure Start areas in north and mid-Wales . Participants 153 parents from socially disadvantaged areas , with children aged 36 - 59 months at risk of conduct disorder defined by scoring over the clinical cut off on the Eyberg child behaviour inventory . Participants were r and omised on a 2:1 basis , 104 to intervention and 49 to remaining on the wait listing ( control ) . Twenty ( 13 % ) were lost to follow-up six months later , 18 from the intervention group . Intervention The Webster-Stratton Incredible Years basic parenting programme , a 12 week group based intervention . Main outcome measures Problem behaviour in children and parenting skills assessed by self reports from parents and by direct observation in the home . Parents ' self reported parenting competence , stress , and depression . St and ardised and well vali date d instruments were used throughout . Results At follow-up , most of the measures of parenting and problem behaviour in children showed significant improvement in the intervention group . The intention to treat analysis for the primary outcome measure , the Eyberg child behaviour inventory , showed a mean difference between groups of 4.4 points ( 95 % confidence interval 2.0 to 6.9 , P scale with an effect size of 0.89 . Conclusion This community based study showed the effectiveness of an evidence based parenting intervention delivered with fidelity by regular Sure Start staff . It has influenced policy within Wales and provides lessons for Engl and where , to date , Sure Start programmes have not been effective . Trial registration IS RCT",
"An adaptation of the Coping With Depression Course ( CWDC ) was evaluated in mothers of children with attention-deficit/hyperactivity disorder ( ADHD ) , a population at risk for depression . Mothers were r and omly assigned to receive the CWDC either immediately following an intensive summer treatment program targeting their child 's behavior or after a wait-list period . Measures of maternal functioning , cognitions about child behavior , parent-child and marital relationship quality , child behavior , and ADHD-related family impairment were obtained at pretreatment , posttreatment , and 5-month follow-up . The CWDC result ed in improvements in maternal depressive symptoms , maternal self-esteem , child-related cognitions , and family impairment at posttreatment compared to a wait-list control group that were maintained at follow-up . Findings suggest that the CWDC is a promising intervention for mothers of children with ADHD , particularly those with current depressive symptomatology",
"OBJECTIVE To determine if a nurse-led or psychologist-led parent-training program was more successful than a minimal intervention in treating early childhood Oppositional Defiant Disorder ( ODD ) in pediatric primary care . METHODS Twenty-four practice s were r and omized to conditions in which parents of 117 , 3- to 6.11-year-olds with ODD received the 12-session Webster-Stratton Incredible Years program led by primary care nurses or clinical psychologists , or to a minimal intervention group in which parents received only the companion book to the treatment program . RESULTS There was improvement across posttreatment and 12-month follow-up for all groups , but no overall treatment group effects . There was a dose effect , with a reliable , clinical ly significant gain after seven sessions on the Eyberg intensity scale , and nine sessions on the Child Behavior Checklist externalizing scale . CONCLUSIONS There is little advantage to the therapist-led treatment over bibliotherapy unless parents attend a significant number of sessions",
"Few behavioral parent training ( BPT ) treatment studies for attention-deficit/hyperactivity disorder ( ADHD ) have included and measured outcomes with fathers . In this study , fathers were r and omly assigned to attend a st and ard BPT program or the Coaching Our Acting-Out Children : Heightening Essential Skills ( COACHES ) program . The COACHES program included BPT plus sports skills training for the children and parent-child interactions in the context of a soccer game . Groups did not differ at baseline , and father ratings of treatment outcome indicated improvement at posttreatment for both groups on measures of child behavior . There was no significant difference between groups on ADHD-related measures of child outcome . However , at posttreatment , fathers who participated in the COACHES program rated children as more improved , and they were significantly more engaged in the treatment process ( e.g. , greater attendance and arrival on time at sessions , more homework completion , greater consumer satisfaction ) . The implication s for these findings and father-related treatment efforts are discussed",
"Despite the early onset of attention deficit disorder with hyperactivity ( ADDH ) , there is a dearth of treatment studies with preschoolers with this disorder . Forty-six families with ADDH preschoolers were r and omly assigned to either an immediate or a delayed group parent training program aim ed at improving child compliance . Groups were balanced on demographic variables . Treatment outcome was evaluated by comparing the groups at pre- and posttreatment and 3-month follow-up on measures of parent-child interactions during free play , a compliance task , and parent-supervised activities , as well as on parent-completed Conners Hyperkinesis Index scores . Positive treatment effect was obtained on measures of compliance , parental style of interaction , and management skills . These improvements were maintained at 3-month follow-up . Evaluation of treatment effects on nontargeted child behaviors indicated no generalization",
"BACKGROUND The effectiveness of parent training ( PT ) when delivered as part of specialist tier-two services for preschool AD/HD children has been recently demonstrated . AIMS To assess the effectiveness of the same PT programme when delivered as part of routine primary care by non-specialist nurses . METHOD A sample of 89 3-year-old children with preschool AD/HD took part in a controlled trial of an eight-week ( one hour a week ) , health visitor delivered , PT package . Children , allocated r and omly to PT ( n = 59 ) and waiting list control ( WLC ; n = 30 ) groups , were compared . RESULTS PT did not reduce AD/HD symptoms . Maternal well-being decreased in both PT and WLC groups . CONCLUSIONS While PT is an effective intervention for preschool AD/HD when delivered in specialized setting s , these benefits do not appear to generalize when programme are delivered as part of routine primary care by non-specialist nurses",
"We report findings from a pilot intervention that trained parents to be “ friendship coaches ” for their children with Attention-Deficit/Hyperactivity Disorder ( ADHD ) . Parents of 62 children with ADHD ( ages 6–10 ; 68 % male ) were r and omly assigned to receive the parental friendship coaching ( PFC ) intervention , or to be in a no-treatment control group . Families of 62 children without ADHD were included as normative comparisons . PFC was administered in eight , 90-minute sessions to parents ; there was no child treatment component . Parents were taught to arrange a social context in which their children were optimally likely to develop good peer relationships . Receipt of PFC predicted improvements in children ’s social skills and friendship quality on play date s as reported by parents , and peer acceptance and rejection as reported by teachers unaware of treatment status . PFC also predicted increases in observed parental facilitation and corrective feedback , and reductions in criticism during the child ’s peer interaction , which mediated the improvements in children ’s peer relationships . However , no effects for PFC were found on the number of play date s hosted or on teacher report of child social skills . Findings lend initial support to a treatment model that targets parental behaviors to address children ’s peer problems",
"OBJECTIVE Numerous studies have examined the adolescent and young adult fate of children with attention deficit hyperactivity disorder ( ADHD ) . In marked contrast , relatively little is known about the adult outcome of these children . There have been only two controlled , prospect i ve studies of psychiatric status into adulthood . The present study was conducted to gain further underst and ing of the natural course of this common childhood condition . METHOD This was a prospect i ve follow-up of clinical ly diagnosed , white boys of average intelligence who were referred by teachers to a child psychiatric research clinic at an average age of 7.3 years . At a mean age of 24.1 years , 85 prob and s ( 82 % of the childhood cohort ) and 73 comparison subjects ( 94 % of adolescent comparison subjects ) were directly interviewed by trained clinicians who were blind to group status . RESULTS Evaluations of the prob and s and comparison subjects indicated significantly higher prevalences of antisocial personality disorder ( 12 % versus 3 % ) and nonalcohol substance abuse ( 12 % versus 4 % ) in the prob and s , whereas mood disorders ( 4 % versus 4 % ) and anxiety disorders ( 2 % versus 7 % ) were not significantly different . At adult follow-up , ADHD was rare , occurring in only 4 % of the prob and s ( no comparison subjects ) . CONCLUSIONS The results of the present study are consistent with the authors ' previously reported major findings . They strongly suggest that children with ADHD are at significantly higher risk for a specific negative course marked by antisocial and substance-related disorders",
"As part of a pilot project , four elementary schools were r and omly assigned to receive one of four interventions : ( a ) a schoolwide intervention that incorporated universal and targeted treatment , ( b ) a targeted-school intervention delivered to individual students in regular and special education classrooms , ( c ) a targeted-home intervention delivered in home and regular classroom setting s , and ( d ) a control condition that did not receive a design ated intervention . Results showed that the behavior of disruptive children in all schools improved during the course of the year , with some evidence that interventions provided complementary effects . These findings support the continued use of behavioral interventions in elementary schools and argue for interventions that combine different methods of delivering interventions",
"Objective : This pilot study tests the feasibility and preliminary efficacy of an after-school treatment program for middle schoolers with ADHD using a r and omized clinical trial design . Method : A total of 23 students with ADHD ( 25 % female , 48 % African American ) from a large public middle school were r and omly assigned to a 10-week program or to community comparison . Manualized treatment targeted educational , social , and recreational skills , homework completion , and school and home behavior . Parents participated . Results : Recruitment and r and omization targets were easily met ( 87 % completion ) . Parent and teacher satisfaction was positive . Small to medium treatment effects result ed despite greater medication use in the control group , with improvements in functioning for the program-treated youth or absence of deterioration relative to the comparison group . Conclusion : Despite testing an abbreviated version of the after-school program ( feasibility and palatability for this intervention and modest beneficial effects on behavioral and academic outcomes . ( J. of Att . Dis . 2008 ; 12(3 ) 207 - 217",
"Objective : This study examines the relationship between parents ' knowledge of attention-deficit hyperactivity disorder ( ADHD ) and opinions of treatment and their impact on enrolment in and adherence to both pharmacological and nonpharmacological interventions for children with ADHD . Method : Participants in the study were the parents of 81 children who reached diagnostic criteria for ADHD and who were referred to a treatment study of ADHD involving stimulant medication and parent groups . The mothers completed a modified version of the ADHD Knowledge and Opinion Scale ( AKOS ) prior to receiving diagnostic feedback and prior to the families ' decisions to participate in a 12-month r and omized trial ( medication [ methylpheni date or placebo ] and parent groups [ training or support ] ) . Treatment enrolment and adherence were monitored over the 12-month trial , and families who remained in the study at 12 months completed another modified AKOS . Results : A higher level of knowledge of ADHD was found to be related to more favourable opinions of parent groups but not of medication . Moreover , parents who were more knowledgeable about ADHD were more likely to enrol in both pharmacological and nonpharmacological treatments . Adherence to pharmacological and nonpharmacological treatments was not predicted by parental knowledge of ADHD or opinions of the treatment . Conclusion : Parents ' knowledge of ADHD and opinions of treatments play a significant role in enrolment in treatments for their children with ADHD . Providing information to parents regarding ADHD prior to offering treatment modalities could have a favourable impact on treatment enrolment and hence treatment adherence",
"This study examines interventions design ed to improve communication between individuals who take care of children with ADHD . A teacher rating of 6,171 elementary school children identifies 1,573 children with ADHD or with high risk for ADHD . Parent interviews and information from teachers are collected on 243 children who are r and omized into treatment and control conditions and followed for 39 months . The interventions consisted of group workshops and single one-on-one tutorials with parents , teachers , and providers about the evaluation and treatment of ADHD that stressed the need for communication between the three parties . There are few significant effects on communication that are short lived . Results suggest that the interventions are insufficient to cause significant increase in communication . Future attempts to improve parent-teacher-provider coordination should be continuing rather than single-session interventions",
"Practice guidelines for the treatment of youth with mental health problems tend to endorse integrating psychopharmacologic treatment with psychosocial interventions , such as psychotherapy and parent skills training . However , poor access to pediatric mental health specialists and inadequate training of primary care physicians in psychosocial interventions make it difficult for families to receive this st and ard of care . Large pediatric r and omized , multicenter trials , including the Multimodal Treatment Study of ADHD ( attention deficit hyperactivity disorder ) [ MTA ] and the Treatment for Adolescents with Depression Study ( TADS ) , have begun to identify specific advantages of multimodal treatment compared with psychopharmacology alone . Advantages of combined treatment include improvement of both symptoms and family functioning . More research is needed to determine effective and appropriate multimodal interventions for complex and severe pediatric mental illness . Advantages of multimodal treatment must be balanced with the treatment burden on the family system",
"OBJECTIVE Little is known about the adult outcome of attention-deficit hyperactivity disorder ( ADHD ) , a very prevalent childhood disorder that is known to affect deleteriously academic performance and other areas of child functioning . This study represents a third wave of evaluations that examine the long-term educational achievement and occupational rank of children with ADHD . METHOD This is a prospect i ve follow-up of white boys of average intelligence whose ADHD was clinical ly diagnosed according to systematic criteria at an average age of 7 years . Follow-up intervals range from 15 to 21 years ( mean , 17 years ) . At average age 24 years , 85 prob and s ( representing 82 % of the childhood cohort ) and 73 controls ( 84 % ) were directly interviewed by trained clinicians who were blind to group membership . RESULTS First , prob and s completed significantly less formal schooling than controls ( about 2 years less , on average ) . Second , prob and s had lower-ranking occupational positions than controls . Finally , these disadvantages were not accounted for by adult mental status . CONCLUSIONS The present study suggests that childhood ADHD predisposes to specific disadvantages and continues to affect important functional domains unrelated to current psychiatric diagnosis",
"OBJECTIVE To determine the behavioral , situational , and temporal effects of 4 months of methylpheni date ( MPH ) treatment for attention-deficit hyperactivity disorder ( ADHD ) . METHOD Ninety-one children with ADHD were r and omly assigned to receive either MPH ( titrated to a target dose of 0.7 mg/kg twice a day ) or a placebo . Treatment effects were investigated with measures sensitive to various behaviors ( core and associated symptoms ) , situations ( home and school ) , time periods ( morning and afternoon , after reaching the target dose , and after 4 months of treatment ) , and side effects . RESULTS MPH treatment improved symptoms of ADHD and oppositional behavior at school , both in the morning and afternoon , but not at home . Side effects ( increase in physiological and effective symptoms , lack of weight gain ) were significantly more frequent with MPH than with placebo treatment . Benefit was evident after titration , but the onset of some side effects was delayed . Side effects were reported by parents but not by teachers . CONCLUSIONS Positive effects of MPH on behavior are evident in the classroom , but with MPH given twice daily , parents do not report that MPH improves behavior at home . Greater impact on home behavior may require three times daily MPH and combined treatments",
"Two variants of a behavioral family intervention ( BFI ) program known as Triple P were compared using 87 preschoolers with co-occurring disruptive behavior and attentional/hyperactive difficulties . Families were r and omly allocated to enhanced BFI ( EBFI ) , st and ard BFI ( SBFI ) , or a waitlist ( WL ) control group . At postintervention both BFI programs were associated with significantly lower levels of parent-reported child behavior problems , lower levels of dysfunctional parenting , and greater parental competence than the WL condition . The EBFI condition was also associated with significantly less observed child negative behavior in comparison to the WL . The gains achieved at postintervention were maintained at 1-year follow-up . Contrary to predictions , the enhanced program was not shown to be superior to the st and ard program using any of the outcome measures at either postintervention or follow-up . Each of the programs produced significant reductions in children 's co-occurring disruptive behavior and attentional/hyperactive difficulties with 80 % of the children showing clinical ly reliable improvement in observed negative behavior from preintervention to follow-up",
"In this study , generalisation effects to day-care/school setting s were examined in an outpatient clinic sample of 127 children aged 4–8 years treated because of oppositional conduct problems in the home with parent training ( PT ) and parent training combined with child therapy ( CT ) ( “ Incredible Years ” ) . Before treatment all children scored above the 90th percentile on the Eyberg Child Behavior Inventory ( ECBI ) for home problems , and met criteria for a possible or a confirmed diagnosis of either an oppositional defiant ( ODD ) or a conduct ( CD ) disorder . Further , 83 % of the children showed clinical levels of conduct problems both at home and in day-care/school before treatment . Although most children improved at home , the majority still showed clinical levels of conduct problems in day-care/school setting s after treatment and 1-year later . Combined PT and CT produced the most powerful and significant generalisation effects across the treatment period , however these improvements were not maintained 1-year later for most areas . The results of the present study , therefore , underline the need to target conduct problems not only exhibited at home but also in day-care/school setting s , and to develop strategies to maintain positive generalisation effects after treatment for this age and problem-group",
"The efficacy of the Incredible Years parent training and child therapy programs was examined in a r and omized controlled study including 127 Norwegian children aged 4–8 years . Children diagnosed with oppositional defiant disorder ( ODD ) or conduct disorder ( CD ) were r and omized to parent training ( PT ) , parent training combined with child therapy ( PT + CT ) , or a waiting-list control condition ( WLC ) . Assessment s were carried out at baseline , posttreatment and at a one-year follow-up using st and ardized measures and a semi-structured interview . Both active treatment conditions reduced child conduct problems posttreatment as opposed to the WLC , while differences between the two treatment conditions were small and nonsignificant . About two thirds of the treated children functioned within normal variation after treatment , and the same proportion no longer received an ODD diagnosis at the one-year follow-up . Parental use of positive strategies increased after treatment , and the use of harsh and inconsistent discipline decreased as did mother experience of stress . The outcome of this study emphasizes the importance of offering parent training to young children with severe conduct problems exhibited at home . The findings and usefulness of the Incredible Years program in the present Norwegian replication study further support and extend positive outcomes of previous controlled trials conducted primarily in Anglo-Saxon countries",
"OBJECTIVE To assess the impact of maternal attention-deficit/hyperactivity disorder ( ADHD ) symptoms on the effectiveness of a parent training ( PT ) program for preschool ADHD . METHOD Eighty-three 3-year-old children with ADHD and their mothers selected from two community cohorts living in Hampshire , Engl and ( 1992 - 93 and 1995 - 96 , respectively ) , completed an 8-week PT program . ADHD symptoms and a number of other parent and child factors , including adult ADHD symptoms , were measured prior to the start of treatment ( week 1 : T1 ) , immediately after treatment ( week 8 : T2 ) , and at 15 weeks follow-up ( week 23 : T3 ) . RESULTS Mothers were divided into three groups on the basis of their scores ( T1 ) on the Adult AD/HD Rating Scale ( high , medium , low ) . Children of mothers in the high-ADHD group displayed no improvement after PT , whereas the levels of ADHD symptoms of the children of mothers in either the medium or low ADHD groups reduced substantially ( F(4,60 ) = 3.13 , p .30 , p ADHD symptoms limit the improvement shown by children with ADHD after a program of PT . This effect was unrelated to other aspects of maternal mental health and child functioning . The treatment of parental ADHD may be a prerequisite for the success of psychosocial interventions for childhood ADHD",
"BACKGROUND The efficacy of the Incredible Years ( IY ) Basic parent training ( PT ) programme for a community-based sample of families with pre-school children at risk of developing both conduct problems and attention deficit hyperactivity disorder ( ADHD ) was examined . METHODS Pre-school children displaying signs of both early-onset conduct problems and ADHD were r and omly allocated to either IY PT intervention , or to a waiting list ( WL ) control group . Child symptoms were assessed before and after the intervention . RESULTS Post intervention , the intervention group was associated with significantly lower levels of parent-reported inattention and hyperactive/impulsive difficulties , even after controlling for post-intervention changes in child deviance . In addition , 52 % of those in the intervention condition , compared with 21 % in the control condition , displayed clinical ly reliable improvements post intervention , giving an absolute risk reduction of 31 % and a number needed to treat of 3.23 . CONCLUSIONS Findings from this study indicate that the IY PT programme is a valuable intervention for many pre-school children displaying early signs of ADHD",
"BACKGROUND AND OBJECTIVE Publication bias and other sample size effects are issues for meta-analyses of test accuracy , as for r and omized trials . We investigate limitations of st and ard funnel plots and tests when applied to meta-analyses of test accuracy and look for improved methods . METHODS Type I and type II error rates for existing and alternative tests of sample size effects were estimated and compared in simulated meta-analyses of test accuracy . RESULTS Type I error rates for the Begg , Egger , and Macaskill tests are inflated for typical diagnostic odds ratios ( DOR ) , when disease prevalence differs from 50 % and when thresholds favor sensitivity over specificity or vice versa . Regression and correlation tests based on functions of effective sample size are valid , if occasionally conservative , tests for sample size effects . Empirical evidence suggests that they have adequate power to be useful tests . When DORs are heterogeneous , however , all tests of funnel plot asymmetry have low power . CONCLUSION Existing tests that use st and ard errors of odds ratios are likely to be seriously misleading if applied to meta-analyses of test accuracy . The effective sample size funnel plot and associated regression test of asymmetry should be used to detect publication bias and other sample size related effects",
"Oppositional , defiant , and disruptive behaviors are common in clinical sample s of children with tic disorders . In this study , we sought to evaluate the short-term efficacy of a structured parent training program in children with tic disorders accompanied by disruptive behavior . Children with tic disorders and at least a moderate level of disruptive behavior were r and omly assigned to a 10-session structured parent management training program or to continue treatment as usual . Twenty-four children ( 18 boys and 6 girls ) between the ages of 6 and 12 years ( mean 8.9 ± 2.0 years ) were enrolled ; 23 subjects completed the study . At baseline , subjects showed moderate to severe levels of oppositional and defiant behavior . Twenty subjects ( 83 % ) were on stable medication . The parent-rated Disruptive Behavior Rating Scale score decreased by 51 % in the parent management training group compared with a decrease of 19 % in the treatment as usual group ( P the Clinical Global Impression , a rater masked to treatment assignment classified 7 of 11 subjects who completed parent management training as much improved or very much improved compared with 2 of 12 subjects in the treatment as usual group ( Fisher exact test , P that parent management training is helpful for short-term improvement in disruptive behavior problems in children with tic disorders . Larger r and omized clinical trials are needed . ( J Child Neurol 2006;21:650—656 ; DOI 10.2310/ 7010.2006.00159 )",
"OBJECTIVE To investigate the effectiveness of behavioral parent training ( BPT ) as adjunct to routine clinical care ( RCC ) . METHOD After a first phase of RCC , 94 children with attention-deficit/hyperactivity disorder ( ADHD ) ages 4 - 12 , all referred to a Dutch outpatient mental health clinic , were r and omly assigned to 5 months of BPT plus concurrent RCC ( n = 47 ) or to 5 months of RCC ( n = 47 ) alone . BPT consisted of 12 sessions in group format ; RCC included family support and pharmacotherapy when appropriate . Exclusionary criteria were minimized , and children with and without medication could participate . Parent-reported behavioral problems , ADHD symptoms , internalizing problems , and parenting stress were assessed before and after treatment . Follow-up assessment of the BPT + RCC group was completed 25 weeks post-BPT intervention . Repeated- measures analyses of variance were carried out on an intention-to-treat basis . RESULTS Both groups showed improvements over time on all measures . BPT + RCC was superior to RCC alone in reducing behavioral ( p = .017 ) and internalizing ( p = .042 ) problems . No outcome differences were found in ADHD symptoms ( p = .161 ) and parenting stress ( p = .643 ) . These results were equal for children with and without medication . Children allocated to RCC alone received more polypharmaceutical treatment . CONCLUSIONS Adjunctive BPT enhances the effectiveness of routine treatment of children with ADHD , particularly in decreasing behavioral and internalizing problems , but not in reducing ADHD symptoms or parenting stress . Furthermore , adjunctive BPT may limit the prescription of polypharmaceutical treatment",
"OBJECTIVE Intent-to-treat analyses of the Multimodal Treatment Study of ADHD ( MTA ) revealed group differences on attention-deficit/hyperactivity disorder symptoms ratings , with better outcome in groups of participants who were assigned the medication algorithm-medication alone ( MedMgt ) and combined (Comb)--than in those who were not-behavior modification ( Beh ) alone and community comparison ( CC ) . However , the effect size was reduced by 50 % from the end of treatment to the first follow-up . The convergence of outcomes suggests differential changes by treatment group beween 14 and 24 months , which this report explores , both for benefits of treatment and for side effects on growth . METHODS We documented reported medication use at 14- and 24-month assessment s and formed 4 naturalistic subgroups ( Med/Med , Med/NoMed , NoMed/Med , and NoMed/NoMed ) . Then we performed exploratory mediator analyses to evaluate effects of changes in medication use on 14- to 24-month change scores of effectiveness ( symptom ratings ) and growth ( height and weight measures ) . RESULTS The r and omly assigned groups with the greatest improvement at the end of the treatment phase ( Comb and MedMgt ) deteriorated during the follow-up phase , but the other 2 groups ( Beh and CC ) did not . There were no significant differences in the 14- to 24-month growth rates among the r and omly assigned groups , in contrast to significant growth suppression in the Comb and MedMgt at the end of the treatment phase . Changes in medication use mediated the 14- to 24-month change in attention-deficit/hyperactivity disorder symptom ratings : the subgroup that reported stopping medication ( Med/NoMed ) showed the largest deterioration , the subgroup that consistently reported ( Med/Med ) or never reported ( NoMed/NoMed ) medication use showed modest deterioration , and the subgroup that reported starting medication ( NoMed/Med ) showed improvement . Changes in medication use also mediated growth effects : the subgroup that consistently reported medication use ( Med/Med ) showed reduced height gain compared with the subgroup that never reported medication use ( NoMed/NoMed ) , which actually grew faster than predicted by population norms . CONCLUSION In the MTA follow-up , exploratory naturalistic analyses suggest that consistent use of stimulant medication was associated with maintenance of effectiveness but continued mild growth suppression",
" Twenty-four parents of oppositional preschoolers were r and omly assigned to either a selfdirected behavioral family intervention condition ( SD ) or to a waitlist control group ( WL ) . The self-directed parent training program , based on self-regulation principles , consisted of a written information package and weekly telephone consultations for 10 weeks . At posttest , in comparison to the WL group , children in the SD group had lower levels of behavior problems on parent report measures of child behavior . At posttreatment , parents in the SD condition reported increased levels of parenting competence and lower levels of dysfunctional parenting practice s as compared to parents in the WL condition . In addition , mothers reported lower levels of anxiety , depression , and stress as compared to mothers in the WL condition at posttreatment . Using mother 's reports , gains in child behavior and parenting practice s achieved at posttreatment were maintained at 4-month follow-up",
"Objective : To review and provide details about the primary and secondary findings from the Multimodal Treatment study of ADHD ( MTA ) published during the past decade as three sets of articles . Method : In the second of a two part article , we provide additional background and detail required by the complexity of the MTA to address confusion and controversy about the findings outlined in part I ( the Executive Summary ) . Results : We present details about the gold st and ard used to produce scientific evidence , the r and omized clinical trial ( RCT ) , which we applied to evaluate the long-term effects of two well-established unimodal treatments , Medication Management ( MedMGT ) and behavior therapy ( Beh ) , the multimodal combination ( Comb ) , and treatment “ as usual ” in the community ( CC ) . For each of the first three assessment points defined by RCT methods and included in intent-to-treat analyses , we discuss our definition of evidence from the MTA , interpretation of the serial presentations of findings at each assessment point with a different definition of long-term varying from weeks to years , and qualification of the interim conclusions about long-term effects of treatments for ADHD based on many exploratory analyses described in additional published articles . Conclusions : Using a question and answer format , we discuss the possible clinical relevance of the MTA and present some practical suggestions based on current knowledge and uncertainties facing families , clinicians , and investigators regarding the long-term use of stimulant medication and behavioral therapy in the treatment of children with ADHD . ( J. of Att . Dis . 2008 ; 12(1 ) 15 - 43",
"An experimental research study was done to determine whether an educational intervention about attention deficit hyperactivity disorder ( ADHD ) would improve a mother 's knowledge about ADHD and her feelings of competence as a parent . 20 low socioeconomic status mothers who had a male child between the ages of 5 and 11 diagnosed with ADHD and placed on methylpheni date were r and omly selected for the study . An experimental group of 10 mothers was given a 5-week educational intervention on ADHD ; the remaining 10 mothers served as a control group . Differences between the experimental and non-experimental mothers in knowledge and opinions about ADHD and parental sense of competency were measured . Scores improved in parental satisfaction and parental sense of competency in mothers who participated in the educational intervention . The research findings support the idea that nurses can assist a family in learning and dealing with their child 's ADHD , a chronic condition",
"Three variants of a behavioral family intervention ( BFI ) program known as Triple P were compared using 305 preschoolers at high risk of developing conduct problems . Families were r and omly assigned to enhanced BFI ( EBFI ) , st and ard BFI ( SBFI ) , self-directed BFI ( SDBFI ) , or wait list ( WL ) . At postintervention , the 2 practitioner-assisted conditions were associated with lower levels of parent-reported disruptive child behavior , lower levels of dysfunctional parenting , greater parental competence , and higher consumer satisfaction than the SDBFI and WL conditions . Overall , children in EBFI showed greater reliable improvement than children in SBFI , SDBFI , and WL . By 1-year follow-up , children in all 3 conditions achieved similar levels of clinical ly reliable change in observed disruptive behavior . However , the EBFI and SBFI conditions showed greater reliable improvement on parent-observed disruptive child behavior",
"Parents of gifted children identify a need for tailored parenting support , and gifted children have unique requirements and vulnerabilities . The aim of this study was to assess the efficacy of a tailored behavioural parenting intervention , for enhancing the parenting skills of parents of gifted children and to assess the effect of these changes on the behavioural and emotional adjustment of their gifted child . A r and omised controlled trial of tailored Group Triple P - Positive Parenting Program was conducted with 75 parents of children identified as gifted . Results indicated significant intervention effects for the number and frequency of parent reported child behaviour problems , as well as hyperactivity in the intervention group , relative to a waitlist control . Parents also reported significant improvements in their own parenting style , including less permissiveness , harshness , and verbosity when disciplining their child . No intervention effects were evident for teacher reports , except for a trend in relation to hyperactivity . This study demonstrated that a tailored behavioural parenting intervention is effective and acceptable for parents of gifted children , and thus has clinical implication s for the delivery of parenting interventions for this population",
"The Collaborative Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder ( ADHD ) , the MTA , is the first multisite , cooperative agreement treatment study of children , and the largest psychiatric/psychological treatment trial ever conducted by the National Institute of Mental Health . It examines the effectiveness of Medication vs. Psychosocial treatment vs. their combination for treatment of ADHD and compares these experimental arms to each other and to routine community care . In a parallel group design , 579 ( male and female ) ADHD children , aged 7–9 years , 11 months , were r and omly assigned to one of the four experimental arms , and then received 14 months of prescribed treatment ( or community care ) with periodic re assessment s. After delineating the theoretical and empirical rationale s for Psychosocial treatment of ADHD , we describe the MTA 's Psychosocial Treatment strategy applied to all children in two of the four experimental arms ( Psychosocial treatment alone ; Combined treatment ) . Psychosocial treatment consisted of three major components : a Parent Training component , a two-part School Intervention component , and a child treatment component anchored in an intensive Summer Treatment Program . Components were selected based on evidence of treatment efficacy and because they address comprehensive symptom targets , setting s , comorbidities , and functional domains . We delineate key conceptual and logistical issues faced by clinical research ers in design and implementation of Psychosocial research with examples of how these issues were addressed in the MTA study",
"Methylpheni date HCl ( Ritalin ) is usually given for the treatment of hyperactivity or attention deficit disorder ( ADD ) at 30 minutes to one hour before meals . This schedule is based on the assumption that , when taken with meals , its absorption or metabolism is altered . However , no behavioral or pharmacologic data exist to support this recommendation . Eleven patients with attention deficit disorder were tested to evaluate this hypothesis using a double-blind crossover design ( methylpheni date with or before breakfast ) with a placebo control condition . Parents ' ratings , performance on a paired-associate learning test , and cortical auditory-evoked potentials were measured . All of these measurements showed clear differences between the placebo condition and conditions when medication was given . However , none of the measurements showed a significant difference between the conditions when methylpheni date was given with breakfast and the condition when methylpheni date was given 30 minutes before breakfast",
"Abstract Objective : To see whether a behaviourally based group parenting programme , delivered in regular clinical practice , is an effective treatment for antisocial behaviour in children . Design : Controlled trial with permuted block design with allocation by date of referral . Setting : Four local child and adolescent mental health services . Participants : 141 children aged 3 - 8 years referred with antisocial behaviour and allocated to parenting groups ( 90 ) or waiting list control ( 51 ) . Intervention : Webster-Stratton basic videotape programme administered to parents of six to eight children over 13 - 16 weeks . This programme emphasises engagement with parental emotions , rehearsal of behavioural strategies , and parental underst and ing of its scientific rationale . Main outcome measures : Semistructured parent interview and question naires about antisocial behaviour in children administered 5 - 7 months after entering trial ; direct observation of parent-child interaction . Results : Referred children were highly antisocial ( above the 97th centile on interview measure ) . Children in the intervention group showed a large reduction in antisocial behaviour ; those in the waiting list group did not change ( effect size between groups 1.06 SD ( 95 % confidence interval 0.71 to 1.41 ) , P proportion of praise to ineffective comm and s they gave their children threefold , while control parents reduced it by a third ( effect size between groups 0.76 ( 0.16 to 1.36 ) , P=0.018 ) . If the 31 children lost to follow up were included in an intention to treat analysis the effect size on antisocial behaviour was reduced by 16 % . Conclusions : Parenting groups effectively reduce serious antisocial behaviour in children in real life conditions . Follow up is needed to see if the children 's poor prognosis is improved and criminality prevented . What is already known on this topic Children who persistently display a high level of antisocial behaviour are at high risk of social rejection , juvenile delinquency , and long term unemployment ; the cost to society is high While some behaviourally based parenting programmes have been shown to be effective in university centre trials with volunteers or specially selected cases , most trials of psychological treatments for children in real life setting s have shown no effect What this study adds An evidence based intervention is available for use in regular clinical practice that effectively reduces antisocial behaviour in referred children The intervention works well with children at risk of criminality from a combination of highly antisocial behaviour , multiple psychopathology , and social",
"This article describes the development and the clinic-based evaluation of the Parents Plus Children ’s Programme ( PPCP ) , a group-based video-modelling-assisted programme for parents of children aged 6 to 11 referred to a Child Mental Health Service with significant behavioural problems both with and without associated developmental difficulties . In evaluating the programme , a sequential block design was used to assign 74 parents of children referred to the service to the PPCP group ( n = 42 ) or the Treatment as Usual ( TAU ) Comparison Group ( n = 32 ) . Assessment took place before and immediately following the 8-week intervention for both groups and at 5-month follow-up for the PPCP Group . Compared to the TAU Group postprogramme , the PPCP Group displayed significant reductions in total difficulties and conduct problems as measured by the Strengths and Difficulties Question naire , decreased parental stress , increased parental confidence and significant improvements in parent-defined problems and goals . These positive changes were maintained at 5-month follow-up for the PPCP group , in addition to further significant improvements in peer problems and prosocial behaviour . The analysis also suggests that the programme is more effective for parents of children with behavioural problems only , than for those with associated developmental difficulties . The strengths and limitations of the study are discussed , as well as the difficulties of conducting practice -based research"
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INTRODUCTION The aim of this project was to systematic ally review UK evidence on the effectiveness of long-term ( ≥12 months ) weight management services ( WMSs ) for weight loss and weight maintenance for adults ( ≥16 years ) with severe obesity ( body mass index ≥35 kg m-2 ) , who would generally be eligible for Tier 3 services . METHODS Four data sources were search ed from 1999 to October 2018 . RESULTS Our search es identified 20 studies , mostly noncomparative studies : 10 primary care interventions , nine in secondary care specialist weight management clinics and one commercial setting intervention . A programme including a phase of low energy formula diet ( 810 - 833 kcal day-1 ) showed the largest mean ( SD ) weight change at 12 months of -12.4 ( 11.4 ) kg for complete cases , with 25.3 % dropout . Limitations or differences in evaluation and reporting ( particularly for denominators ) , unclear dropout rates , and differences between participant groups in terms of comorbidities and psychological characteristics , made comparisons between WMSs and inferences challenging . CONCLUSIONS There is a persistent and clear need for guidance on long-term weight data collection and reporting methods to allow comparisons across studies and services for participants with severe obesity . Data could also include quality of life , clinical outcomes , adverse events , costs and economic outcomes . A r and omised trial comparison of National Health Service Tier 3 services with commercial WMSs would be of value
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"BACKGROUND Behavioural counselling with intensive follow-up for obesity is effective , but in re source -constrained primary care setting s briefer approaches are needed . OBJECTIVES To estimate the clinical effectiveness and cost-effectiveness of an internet-based behavioural intervention with regular face-to-face or remote support in primary care , compared with brief advice . DESIGN Individually r and omised three-arm parallel trial with health economic evaluation and nested qualitative interviews . SETTING Primary care general practice s in the UK . PARTICIPANTS Patients with a body mass index of ≥ 30 kg/m2 ( or ≥ 28 kg/m2 with risk factors ) identified from general practice records , recruited by postal invitation . INTERVENTIONS Positive Online Weight Reduction ( POWeR+ ) is a 24-session , web-based weight management intervention completed over 6 months . Following online registration , the website r and omly allocated participants using computer-generated r and om numbers to ( 1 ) the control intervention ( n = 279 ) , which had previously been demonstrated to be clinical ly effective ( brief web-based information that minimised pressure to cut down foods , instead encouraging swaps to healthier choices and increasing fruit and vegetables , plus 6-monthly nurse weighing ) ; ( 2 ) POWeR+F ( n = 269 ) , POWeR+ supplemented by face-to-face nurse support ( up to seven contacts ) ; or ( 3 ) POWeR+R ( n = 270 ) , POWeR+ supplemented by remote nurse support ( up to five e-mails or brief telephone calls ) . MAIN OUTCOME MEASURES The primary outcome was a modelled estimate of average weight reduction over 12 months , assessed blind to group where possible , using multiple imputation for missing data . The secondary outcome was the number of participants maintaining a 5 % weight reduction at 12 months . RESULTS A total of 818 eligible individuals were r and omised using computer-generated r and om numbers . Weight change , averaged over 12 months , was documented in 666 out of 818 participants ( 81 % ; control , n = 227 ; POWeR+F , n = 221 ; POWeR+R , n = 218 ) . The control group maintained nearly 3 kg of weight loss per person ( mean weight per person : baseline , 104.4 kg ; 6 months , 101.9 kg ; 12 months , 101.7 kg ) . Compared with the control group , the estimated additional weight reduction with POWeR+F was 1.5 kg [ 95 % confidence interval ( CI ) 0.6 to 2.4 kg ; p = 0.001 ] and with POWeR+R was 1.3 kg ( 95 % CI 0.34 to 2.2 kg ; p = 0.007 ) . By 12 months the mean weight loss was not statistically significantly different between groups , but 20.8 % of control participants , 29.2 % of POWeR+F participants ( risk ratio 1.56 , 95 % CI 0.96 to 2.51 ; p = 0.070 ) and 32.4 % of POWeR+R participants ( risk ratio 1.82 , 95 % CI 1.31 to 2.74 ; p = 0.004 ) maintained a clinical ly significant 5 % weight reduction . The POWeR+R group had fewer individuals who reported doing another activity to help lose weight [ control , 47.1 % ( 64/136 ) ; POWeR+F , 37.2 % ( 51/137 ) ; POWeR+R , 26.7 % ( 40/150 ) ] . The incremental cost to the health service per kilogram weight lost , compared with the control group , was £ 18 ( 95 % CI -£129 to £ 195 ) for POWeR+F and -£25 ( 95 % CI -£268 to £ 157 ) for POWeR+R. The probability of being cost-effective at a threshold of £ 100 per kilogram was 88 % and 98 % for POWeR+F and POWeR+R , respectively . POWeR+R was dominant compared with the control group . No harms were reported and participants using POWeR+ felt more enabled in managing their weight . The qualitative studies documented that POWeR+ was viewed positively by patients and that health-care professionals generally enjoyed supporting patients using POWeR+ . STUDY LIMITATIONS Maintenance of weight loss after 1 year is unknown . FUTURE WORK Identifying strategies for longer-term engagement , impact in community setting s and increasing physical activity . CONCLUSION Clinical ly valuable weight loss ( > 5 % ) is maintained in 20 % of individuals using novel written material s with brief follow-up . A web-based behavioural programme and brief support results in greater mean weight loss and 10 % more participants maintain valuable weight loss ; it achieves greater enablement and fewer participants undertaking other weight-loss activities ; and it is likely to be cost-effective . TRIAL REGISTRATION Current Controlled Trials IS RCT N21244703 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 21 , No. 4 . See the NIHR Journals Library website for further project information",
"OBJECTIVE : To evaluate a modified cognitive – behavioural treatment ( M-CBT ) for weight management which addresses both the psychosocial costs and the physiological health risks of obesity , without a focus on weight loss . DESIGN : R and omized controlled trial comparing M-CBT with st and ard cognitive – behavioural therapy (S-CBT).SUBJECTS : Sixty-three overweight women with body mass index ( BMI ) ≥28 kg/m2 , mean age=47.5 and mean BMI = 35.4 . MEASURES : Weight , waist and hip circumference , blood lipids , blood glucose , blood pressure , psychological well-being , depression , self esteem , stress , binge eating , eating style , body image , nutrient intake , aerobic fitness , activity levels , patient satisfaction with treatment . RESULTS : Both M-CBT and S-CBT achieved improvements in a broad range of physical , psychological and behavioural variables . Weight loss in the S-CBT group was greater than in the M-CBT group immediately after treatment , but both groups lost weight . Participants in the M-CBT group continued to lose weight up to the 1 y follow-up . M-CBT was evaluated positively by participants . CONCLUSIONS : Both M-CBT and S-CBT programmes were successful at inducing modest weight loss , as well as improving emotional well-being , reducing distress , increasing activity and fitness , improving dietary quality and reducing cardio-vascular disease risk factors . The improvements were maintained or continued at 1 y follow-up . These results suggest that treatment based on the new weight-control paradigm which emphasizes sustained lifestyle change without emphasis on dieting , can produce modest benefits to health and well-being ",
"Objective To assess the effectiveness of a range of weight management programmes in terms of weight loss . Design Eight arm r and omised controlled trial . Setting Primary care trust in Birmingham , Engl and . Participants 740 obese or overweight men and women with a comorbid disorder identified from general practice records . Interventions Weight loss programmes of 12 weeks ’ duration : Weight Watchers ; Slimming World ; Rosemary Conley ; group based , dietetics led programme ; general practice one to one counselling ; pharmacy led one to one counselling ; choice of any of the six programmes . The comparator group was provided with 12 vouchers enabling free entrance to a local leisure ( fitness ) centre . Main outcome measures The primary outcome was weight loss at programme end ( 12 weeks ) . Secondary outcomes were weight loss at one year , self reported physical activity , and percentage weight loss at programme end and one year . Results Follow-up data were available for 658 ( 88.9 % ) participants at programme end and 522 ( 70.5 % ) at one year . All programmes achieved significant weight loss from baseline to programme end ( range 1.37 kg ( general practice ) to 4.43 kg ( Weight Watchers ) ) , and all except general practice and pharmacy provision result ed in significant weight loss at one year . At one year , only the Weight Watchers group had significantly greater weight loss than did the comparator group ( 2.5 ( 95 % confidence interval 0.8 to 4.2 ) kg greater loss , ) . The commercial programmes achieved significantly greater weight loss than did the primary care programmes at programme end ( mean difference 2.3 ( 1.3 to 3.4 ) kg ) . The primary care programmes were the most costly to provide . Participants allocated to the choice arm did not have better outcomes than those r and omly allocated to a programme . Conclusions Commercially provided weight management services are more effective and cheaper than primary care based services led by specially trained staff , which are ineffective . Trial registration Current Controlled Trials IS RCT N25072883",
"Objectives There is limited evidence on the effectiveness of weight management programmes provided within routine healthcare and inconsistent use of outcome measures . Our aim was to evaluate a large National Health Service ( NHS ) weight management service and report absolute and proportional weight losses over 12 months . Design Prospect i ve observational study . Setting Glasgow and Clyde Weight Management Service ( GCWMS ) , which provides care for residents of NHS Greater Glasgow and Clyde area ( population 1.2 million ) . Participants All patients who began GCWMS between 1 October 2008 and 30 September 2009 . Interventions Structured educational lifestyle programme employing cognitive behavioural therapy , 600 kcal deficit diet , physical activity advice , lower calorie diet and pharmacotherapy . Primary and secondary outcomes measures Baseline observation carried forward ( BOCF ) , last observation carried forward ( LOCF ) and changes in programme completers reported using outcomes of absolute 5 kg and 5 % weight losses and mean weight changes at a variety of time points . Results 6505 referrals were made to GCWMS , 5637 were eligible , 3460 opted in and 1916 ( 34 % ) attended a first session . 78 patients were excluded from our analysis on 1838 patients . 72.9 % of patients were women , mean age of all patients at baseline was 49.1 years , 43.3 % lived in highly socioeconomically deprived areas and mean weights and body mass indices at baseline were 118.1 kg and 43.3 kg/m2 , respectively . 26 % lost ≥5 kg by the end of phase 1 , 30 % by the end of phase 2 and 28 % by the end of phase 3 ( all LOCF ) . Weight loss was more successful among men , particularly those ≤29 years old . Conclusions Routine NHS weight management services may achieve moderate weight losses through a comprehensive evidence -based dietary , activity and behavioural approach including psychological care . Weight losses should be reported using a range of outcome measures so that the effectiveness of different services can be compared",
"Summary Background Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity , but little evidence on optimal intervention duration is available . We aim ed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals . Methods In this non-blinded , parallel-group , r and omised controlled trial , we recruited participants who were aged 18 years or older and had body-mass index ( BMI ) of 28 kg/m2 or higher from 23 primary care practice s in Engl and . Participants were r and omly assigned ( 2:5:5 ) to brief advice and self-help material s , a weight-management programme ( Weight Watchers ) for 12 weeks , or the same weight-management programme for 52 weeks . We followed-up participants over 2 years . The primary outcome was weight at 1 year of follow-up , analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight . In a hierarchical closed-testing procedure , we compared combined behavioural programme arms with brief intervention , then compared the 12-week programme and 52-week programme . We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation . This study is registered with Current Controlled Trials , number IS RCT N82857232 . Findings Between Oct 18 , 2012 , and Feb 10 , 2014 , we enrolled 1269 participants . 1267 eligible participants were r and omly assigned to the brief intervention ( n=211 ) , the 12-week programme ( n=528 ) , and the 52-week programme ( n=528 ) . Two participants in the 12-week programme had been found to be ineligible shortly after r and omisation and were excluded from the analysis . 823 ( 65 % ) of 1267 participants completed an assessment at 1 year and 856 ( 68 % ) participants at 2 years . All eligible participants were included in the analyses . At 1 year , mean weight changes in the groups were −3·26 kg ( brief intervention ) , −4·75 kg ( 12-week programme ) , and −6·76 kg ( 52-week programme ) . Participants in the behavioural programme lost more weight than those in the brief intervention ( adjusted difference −2·71 kg , 95 % CI −3·86 to −1·55 ; p ) . The 52-week programme was more effective than the 12-week programme ( −2·14 kg , −3·05 to −1·22 ; p years . No adverse events related to the intervention were reported . Over 2 years , the incremental cost-effectiveness ratio ( ICER ; compared with brief intervention ) was £ 159 per kg lost for the 52-week programme and £ 91 per kg for the 12-week programme . Modelled over 25 years after baseline , the ICER for the 12-week programme was dominant compared with the brief intervention . The ICER for the 52-week programme was cost-effective compared with the brief intervention ( £ 2394 per quality -adjusted life-year [ QALY ] ) and the 12-week programme ( £ 3804 per QALY ) . Interpretation For adults with overweight or obesity , referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help material s. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and , although it costs more , modelling suggests that the 52-week programme is cost-effective in the longer term . Funding National Prevention Research Initiative , Weight Watchers International ( as part of an UK Medical Research Council Industrial Collaboration Award )",
"AIM This paper is a report of an exploratory study to evaluate the effectiveness and acceptability of a specialist health visitor-led weight management clinic in primary care . BACKGROUND Tackling obesity is a global health priority . Whilst there is evidence to support a role for primary healthcare professionals in its management , provision in Engl and varies widely . Using design ated ' obesity specialists ' is an approach warranting further investigation . METHOD In 2003 - 2004 , patients with a body mass index of 30 or more received a specialist health visitor-led intervention based on the Jan Felgens ' I2E2 ' model . Clinical outcome data and self-reported dietary consumption data were collected at weeks 1 , 13 , 27 and 52 . Quantitative and qualitative data on patient acceptability of the clinic were collected at week 26 . FINDINGS Eighty-nine patients attended the clinic . Mean body weight and body mass index and systolic and diastolic blood pressure decreased over time by statistically significant amounts . There was a non-significant decrease in fasting blood sugar over time , but approximately one in 10 patients with undiagnosed diabetes were identified . No statistically significant change was evident for cholesterol levels . Mean self-reported weekly consumption of cakes , desserts and snacks decreased and that of fruit and vegetables increased , each by statistically significant amounts . Participants found the clinic highly acceptable and identified the specialist health visitor as fundamental to its success . CONCLUSION A partnership approach to weight management through which patients are empowered to make sustainable lifestyle changes now needs to be tested in a multi-centre r and omized controlled trial",
"BACKGROUND With the current obesity epidemic , the search for effective weight loss approaches is required . In the present study , changes in weight , body composition and cardiovascular ( CV ) risk in response to a low-fat , reduced-energy diet ( LFRE ) , a low-carbohydrate/high-protein diet ( LCHP ) , or a commercially available very low-calorie diet ( LighterLife ; LL ) were assessed . METHODS One hundred and twenty obese patients ( body mass index ≥35 kg/m² ) underwent a screening period of 3 months on the LFRE . Those who lost > 5 % of their body weight were maintained on this approach for an additional 3 months , whereas those who lost > 10 % at this time were maintained for 1 year . Patients failing to achieve these targets were r and omly allocated to either the LCHP ( n = 38 ) or LL ( n = 34 ) for a period of 9 months . RESULTS Significantly greater weight loss was seen for patients on the LL than the LCHP at 3 ( mean ( ± SD ) -11.6 ± 12.9 vs -2.8 ± 4.5 kg , respectively ; P greater improvement in total cholesterol , low-density lipoprotein-cholesterol , fasting glucose , and diastolic blood pressure was seen at 3 months in patients on the LL compared with the LCHP ( P exception of fasting glucose . The attrition rate was elevated in the LCHP group , but did not differ significantly from the LL group . CONCLUSION Greater weight loss and improved CV risk were achieved with the LL , which mostly reflects the patient support provided for each dietary treatment",
"BACKGROUND An increasing number of people require help to manage their weight . The NHS recommends weight loss advice by general practitioners and /or a referral to a practice nurse . Although this is helpful for some , more effective approaches that can be disseminated economically on a large scale are needed . OBJECTIVE To assess whether or not a task-based weight management programme [ Weight Action Programme ( WAP ) ] has better long-term effects than a ' best practice ' intervention provided in primary care by practice nurses . DESIGN R and omised controlled trial with cost-effectiveness analysis . SETTING General practice s in east London , UK . PARTICIPANTS Three hundred and thirty adults with a body mass index ( BMI ) of ≥ 30 kg/m2 or a BMI of ≥ 28 kg/m2 plus comorbidities were recruited from local general practice s and via media publicity . Those who had a BMI of > 45 kg/m2 , had lost > 5 % of their body weight in the previous 6 months , were currently pregnant or taking psychiatric medications were excluded . Participants were r and omised ( 2 : 1 ) to the WAP or nurse arms . INTERVENTIONS The WAP intervention was delivered in eight weekly group sessions that combined dietary and physical activity , advice and self-monitoring in a group-oriented intervention . The initial course was followed by 10 monthly group maintenance sessions open to all participants in this study arm . The practice nurse intervention ( best usual care ) consisted of four one-to-one sessions delivered over 8 weeks , and included st and ard advice on diet and physical activity based on NHS ' Change4Life ' material s and motivational support . MAIN OUTCOME MEASURES The primary outcome measure was weight change at 12 months . Secondary outcome measures included change in BMI , waist circumference and blood pressure , and proportion of participants losing at least 5 % and 10 % of baseline body weight . Staff collecting measurements at the 6- and 12-month follow-ups were blinded to treatment allocation . The primary outcome measure was analysed according to the intention-to-treat principle , and included all participants with at least one recorded outcome at either 1 , 2 , 6 or 12 months . The analysis employed a mixed-effects linear regression model , adjusted for baseline weight , age , sex , ethnicity , smoking status and general practice . The European Quality of Life-5 Dimensions-5 Levels question naire was completed and used to estimate quality -adjusted life-years ( QALYs ) within the cost-effectiveness analysis . RESULTS There were 330 participants ( WAP arm , n = 221 ; nurse arm , n = 109 ; 72 % women ) . A total of 291 ( 88 % ) participants ( WAP arm , n = 194 ; nurse arm , n = 97 ) were included in the main analysis for the primary outcome . Weight loss at 12 months was greater in the WAP arm than in the nurse intervention arm [ -4.2 kg vs. -2.3 kg ; difference -1.9 kg , 95 % confidence interval ( CI ) -3.7 to -0.1 kg ; p = 0.04 ] . Participants in the WAP arm were more likely than participants in the nurse arm to have lost at least 5 % of their baseline body weight at 12 months ( 41 % vs. 27 % ; odds ratio 14.61 , 95 % CI 2.32 to 91.96 ; p = 0.004 ) . The incremental cost-effectiveness ratio for WAP over and above the nurse arm is £ 7742 per QALY . CONCLUSIONS A WAP delivered in general practice better promotes weight loss over 12 months than a best usual practice nurse-led weight loss programme . LIMITATIONS The trial recruited mostly women . Research is needed into factors that would make weight loss programmes more attractive to men . TRIAL REGISTRATION Current Controlled Trials IS RCT N45820471 . FUNDING This project was funded by the National Institute for Health Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol . 20 , No. 79 . See the NIHR Journals Library website for further project information",
"Abstract Objective To test the effectiveness and safety of a total diet replacement ( TDR ) programme for routine treatment of obesity in a primary care setting . Design Pragmatic , two arm , parallel group , open label , individually r and omised controlled trial . Setting 10 primary care practice s in Oxfordshire , UK . Participants 278 adults who were obese and seeking support to lose weight : 138 were assigned to the TDR programme and 140 to usual care . 73 % of participants were re-measured at 12 months . Interventions The TDR programme comprised weekly behavioural support for 12 weeks and monthly support for three months , with formula food products providing 810 kcal/day ( 3389 kJ/day ) as the sole food during the first eight weeks followed by re introduction of food . Usual care comprised behavioural support for weight loss from a practice nurse and a diet programme with modest energy restriction . Main outcome measures The primary outcome was weight change at 12 months analysed as intention to treat with mixed effects models . Secondary outcomes included biomarkers of cardiovascular and metabolic risk . Adverse events were recorded . Results Participants in the TDR group lost more weight ( −10.7 kg ) than those in the usual care group ( −3.1 kg ) : adjusted mean difference −7.2 kg ( 95 % confidence interval −9.4 to −4.9 kg ) . 45 % of participants in the TDR group and 15 % in the usual care group experienced weight losses of 10 % or more . The TDR group showed greater improvements in biomarkers of cardiovascular and metabolic risk than the usual care group . 11 % of participants in the TDR group and 12 % in the usual care group experienced adverse events of moderate or greater severity . Conclusions Compared with regular weight loss support from a practice nurse , a programme of weekly behavioural support and total diet replacement providing 810 kcal/day seems to be tolerable , and leads to substantially greater weight loss and greater improvements in the risk of cardiometabolic disease . Trial registration International St and ard R and omised Controlled Trials No IS RCT N75092026",
"BACKGROUND Weight management including formula total diet replacement ( TDR ) is emerging as an effective intervention for severe and complex obesity , particularly with respect to type 2 diabetes ( T2DM ) . However , no prospect i ve audit and service evaluation of such programmes have been reported . METHODS Following initial feasibility piloting , the Counterweight-Plus programme was commissioned across a variety of healthcare providers . The programme includes : Screening , TDR ( formula low energy diet ) , food re introduction and weight loss maintenance , all delivered by staff with 8 h of training , in-service mentoring , ongoing specialist support and access to medical consultant expertise . Anonymised data are returned central ly for clinical evaluation . RESULTS Up to December 2016 , 288 patients commenced the programme . Mean ( SD ) baseline characteristics were : age 47.5 ( 12.7 ) years , weight 128.0 ( 32.0 ) kg , body mass index 45.7 ( 10.1 ) kg m-2 , n = 76 ( 26.5 % ) were male and n = 99 ( 34.5 % ) had T2DM . On an intention-to-treat ( ITT ) basis , a loss of ≥15 kg at 12 months was achieved by 48 patients , representing 22.1 % of all who started and 40 % of those who maintained engagement . For complete cases , mean ( 95 % confidence interval ) weight loss was 13.3 ( 12.1 - 14.4 ) kg at 3 months , 16.0 ( 14.4 - 17.6 ) kg at 6 months and 14.2 ( 12.1 - 16.3 ) kg at 12 months ( all P respectively . Mean loss at 12 months by ITT analyses was : single imputation -10.5 ( 9.5 ) kg , last observation carried forward -10.9 ( 11.6 ) kg and baseline observation carried forward -7.9 ( 11.1 ) kg . The presence of diabetes had no significant impact on weight change outcomes . CONCLUSIONS This nonsurgical approach is effective for many individuals with severe and complex obesity , representing an option before considering surgery . The results are equally effective in terms of weight loss for people with T2DM"
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41171298-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To determine the proportion of people with hip and knee osteoarthritis that meet physical activity guidelines recommended for adults and older adults . METHOD Systematic review with meta- analysis of studies measuring physical activity of participants with hip and knee osteoarthritis using an activity monitor . Physical activity levels were calculated using the mean average [ 95 % confidence interval ( CI ) ] weighted according to sample size . Meta-analyses determined the proportion of people meeting physical activity guidelines and recommendations of ( 1 ) ≥150 min per week of moderate to vigorous physical activity ( MVPA ) in bouts of ≥10 min ; ( 2 ) ≥150 min per week of MVPA in absence of bouts ; ( 3 ) ≥10,000 steps per day and ≥7000 steps per day . The Grade s of Research , Assessment , Development and Evaluation ( GRADE ) approach was used to determine the quality of the evidence . RESULTS For knee osteoarthritis , 21 studies involving 3266 participants averaged 50 min per week ( 95 % CI = 46 , 55 ) of MVPA when measured in bouts of ≥10 min , 131 min per week ( 95 % CI = 125 , 137 ) of MVPA , and 7753 daily steps ( 95 % CI = 7582 , 7924 ) . Proportion meta-analyses provided high quality evidence that 13 % ( 95 % CI = 7 , 20 ) completed ≥150 min per week of MVPA in bouts of ≥10 min , low quality evidence that 41 % ( 95 % CI = 23 , 61 ) completed ≥150 min per week of MVPA in absence of bouts , moderate quality evidence that 19 % ( 95 % CI = 8 , 33 ) completed ≥10,000 steps per day , and low quality evidence that 48 % ( 95 % CI = 31 , 65 ) completed ≥7000 steps per day . For hip osteoarthritis , 11 studies involving 325 participants averaged 160 min per week ( 95 % CI = 114 , 216 ) of MVPA when measured in bouts of ≥10 min , 189 min per week ( 95 % CI = 166 , 212 ) of MVPA , and 8174 daily steps ( 95 % CI = 7670 , 8678 ) . Proportion meta-analyses provided low quality evidence that 58 % ( 95 % CI = 18 , 92 ) completed ≥150 min per week of MVPA in absence of bouts , low quality evidence that 30 % ( 95 % CI = 13 , 50 ) completed ≥10,000 steps per day , and low quality evidence that 60 % ( 95 % CI = 47 , 73 ) completed ≥7000 steps per day . CONCLUSION A small to moderate proportion of people with knee and hip osteoarthritis met physical activity guidelines and recommended daily steps . Future research should establish the effects of increasing physical activity in this population to meet the current physical activity guidelines
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[
"OBJECTIVE To examine effects of activity strategy training ( AST ) , a structured rehabilitation program taught by occupational therapists and design ed to teach adaptive strategies for symptom control and engagement in physical activity ( PA ) . METHODS A r and omized controlled pilot trial was conducted at 4 sites ( 3 senior housing facilities and 1 senior center ) in southeastern , lower Michigan . Fifty-four older adults with hip or knee osteoarthritis ( mean + /- SD age 75.3+/-7.1 years ) participated . At each site , older adults were r and omly assigned to 1 of 2 programs : exercise plus AST ( Ex + AST ) or exercise plus health education ( Ex + Ed ) . The programs involved 8 sessions over 4 weeks with 2 followup sessions over a 6-month period , and were conducted concurrently within each site . Pain , total PA and PA intensity ( measured objective ly by actigraphy and subjectively by the Community Healthy Activities Model Program for Seniors question naire ) , arthritis self-efficacy , and physical function were assessed at baseline and posttest . RESULTS At posttest , participants who received Ex + AST had significantly higher levels of objective peak PA ( P=0.02 ) compared with participants who received Ex + Ed . Although not statistically significant , participants in Ex + AST tended to have larger pain decreases , increased total objective and subjective PA , and increased physical function . No effects were found for arthritis self-efficacy . CONCLUSION Although participants were involved in identical exercise programs , participants who received AST tended to have larger increases in PA at posttest compared with participants who received health education . Future studies will be needed to examine larger sample s and long-term effects of AST",
"OBJECTIVE We examined whether tailored activity pacing intervention was more effective at reducing pain and fatigue than general activity pacing intervention . METHOD Adults with knee or hip osteoarthritis ( N = 32 ) stratified by age and gender were r and omized to receive either tailored or general pacing intervention . Participants wore an accelerometer for 5 days that measured physical activity and allowed for repeated symptom assessment . Physical activity and symptom data were used to tailor activity pacing instruction . Outcomes at 10-week follow-up were pain ( Western Ontario and McMaster Universities Osteoarthritis Index ) and fatigue ( Brief Fatigue Inventory ) . RESULTS Compared with general intervention , the tailored group had less fatigue interference ( p = .02 ) and trended toward decreased fatigue severity ( p = .09 ) at 10-wk follow-up . No group differences were found in pain reduction . CONCLUSION Tailoring instruction on the basis of recent symptoms and physical activity may be a more effective symptom management approach than general instruction given the positive effects on fatigue",
"OBJECTIVE To examine whether there was a dose response for valgus unloader brace wear on knee pain , function , and muscle strength in participants with medial compartment knee osteoarthritis . DESIGN In this single-group study , participants with medial compartment knee osteoarthritis were followed for approximately 6 months . SETTING Recruitment was conducted in the general community , and testing was performed at a university laboratory . PARTICIPANTS A convenience sample of patients ( N=32 ) who were prescribed a valgus unloader brace agreed to participate , met the inclusion criteria , and completed the baseline data collection . Twenty-four participants ( 20 men , 4 women ) completed baseline and follow-up collection s. INTERVENTION Participants wore their valgus unloader brace as needed . MAIN OUTCOME MEASURES Knee extensor , flexor , and plantar flexor strength was tested at baseline and follow-up . Participants filled out Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and Medical Outcomes Study 36-Item Short-Form Health Survey question naires to assess pain and function . Self-selected walking velocity and stride length were objective measures of function . Brace usage ( dose ) and activity ( step count ) were recorded at least 4 days/week for the study duration . RESULTS Positive relationships existed between brace wear usage and percent change in step count ( r=.59 , P=.006 ) and percent change in hamstrings strength ( r=.37 , P=.072 ) . At follow-up , there was significant improvement in hamstrings strength ( P=.013 ) , and trends toward improvements in WOMAC pain ( P=.059 ) and WOMAC function ( P=.089 ) . CONCLUSIONS Our results indicate that greater brace use may positively affect physical activity level , but there was minimal effect of brace wear dosage on lower-limb muscle strength . Only knee flexion showed a positive relationship . Our finding of no decreased muscle strength indicates that increased brace use over a 6-month period does not result in muscle impairment",
"Background After total knee arthroplasty ( TKA ) only 75 - 89 % of patients are satisfied . Because patient satisfaction is a prime goal of all orthopaedic procedures , optimization of patient satisfaction is of major importance . Factors related to patient satisfaction after TKA have been explored , but no studies have included two potentially relevant factors , i.e. the functional capacity of daily activities and actual daily activity . This present prospect i ve study examines whether functional capacity and actual daily activity ( in addition to an extensive set of potential factors ) contribute to patient satisfaction six months after TKA . Methods A total of 44 patients were extensively examined preoperatively and six months post surgery . Functional capacity was measured with three capacity tests , focusing on walking , stair climbing , and chair rising . Actual daily activity was measured in the patient 's home situation by means of a 48-hour measurement with an Activity Monitor . To establish which factors were related to patient satisfaction six months post surgery , logistic regression analyses were used to calculate odds ratios . Results Preoperative and postoperative functional capacity and actual daily activity had no relation with patient satisfaction . Preoperatively , only self-reported mental functioning was positively related to patient satisfaction . Postoperatively , based on multivariate analysis , only fulfilled expectations regarding pain and experienced pain six months post surgery were related to patient satisfaction . Conclusions Functional capacity and actual daily activity do not contribute to patient satisfaction after TKA . Patients with a better preoperative self-reported mental functioning , and patients who experienced less pain and had fulfilled expectations regarding pain postoperatively , were more often satisfied ",
"Abstract Limitation in daily physical activity is one of the reasons for total hip arthroplasty ( THA ) or total knee arthroplasty ( TKA ) . However , studies of the effects of THA or TKA generally do not determine actual daily activity as part of physical functioning . We determined the effect of THA or TKA on patients ’ actual physical activity and body function ( pain , stiffness ) , capacity to perform tasks , and self-reported physical functioning . We also assessed whether there are differences in the effect of the surgery between patients undergoing THA or TKA and whether the improvements vary between these different outcome measures . We recruited patients with long-st and ing end-stage osteoarthritis of the hip or knee awaiting THA or TKA . Measurements were performed before surgery and 3 and 6 months after surgery . Actual physical activity improved by 0.7 % . Patients ’ body function , capacity , and self-reported physical functioning also improved . The effects of the surgery on these aspects of physical functioning were similar for THA and TKA . The effect on actual physical activity ( 8 % ) was smaller than on body function ( 80%–167 % ) , capacity ( 19%–36 % ) , and self-reported physical functioning ( 87%–112 % ) . Therefore , in contrast to the large effect on pain and stiffness , patients ’ capacity , and their self-reported physical functioning , the improvement in actual physical activity of our patients was less than expected 6 months after surgery . Level of Evidence : Level I , prospect i ve study . See the Guidelines for Authors for a complete description of levels of evidence",
"Background Prescription of resistance training ( RT ) exercises is an essential aspect of management for knee osteoarthritis ( OA ) . However , whether patients with knee OA who are r and omly assigned to receive RT simply substitute RT for other modes of physical activity remains unclear . Objective The aim of this study was to determine the effect of a structured RT intervention on overall levels of moderate- and vigorous-intensity physical activity ( MVPA ) in patients with early-onset knee OA . The study compared patients with early-onset OA who participated in an RT program , those who participated in a self-management ( SM ) program , and those who participated in both RT and SM . Because participants r and omly assigned to receive the RT intervention may simply switch activity modes , result ing in little net effect , we assessed total MVPA in addition to tracking changes in strength ( force-generating capacity ) . Design and Intervention This study was a r and omized controlled trial comparing the effectiveness of SM alone , RT alone , and combined RT+SM on MVPA in patients with early OA of the knee . Setting The study was conducted on a university campus , with patient recruitment from the local community . Participants The participants in this study were 171 patients ( 74 % women , 26 % men ) with knee OA . They had a mean age of 55.1 ( SD=7.1 ) years , a mean body mass index of 27.6 ( SD=4.2 ) kg/m2 , and radiographic status of grade II OA ( and no higher ) in at least one knee , as defined by the Kellgren and Lawrence classification . They wore an accelerometer while awake ( X̄=14.2 [ SD=2.2 ] hours ) for 5 to 7 contiguous days ( X̄=6.8 [ SD=0.5 ] days ) at baseline and at 3 and 9 months of intervention . Results The participants engaged in MVPA a mean of 26.2 ( SD=19.3 ) minutes per day at baseline . Both groups significantly increased their MVPA from baseline to 3 months ( RT group by 18 % [ effect size (d)=0.26 ] ; SM group by 22 % [ effect size (d)=0.25 ] ) , but only the RT group sustained those changes at 9 months ( RT group maintained a 10 % increase [ effect size (d)=0.15 ] ; SM group maintained a 2 % increase [ effect size (d)=0.03 ] ) . A significant group × time interaction for MVPA indicated that the RT group maintained higher MVPA levels than the SM group . Limitations . Lack of direct measures of energy expenditure and physical function was a limitation of the study . Conclusions Patients with early-onset OA of the knee can engage in an RT program without sacrificing their overall MVPA levels . These results support the value of RT for management of knee OA",
"OBJECTIVES To determine whether a home-based pedometer-driven walking program with arthritis self-management education ( Walk + ) would increase physical activity , muscle strength , and functional performance in older adults with osteoarthritis ( OA ) of the knee as opposed to arthritis self-management education alone ( EDU ) . DESIGN A r and omized two-by-three ( group-by-time ) design with participants assigned to Walk + ( n = 17 , mean age + /- st and ard deviation = 69.6 + /- 6.7 ) or EDU ( n = 17 , age = 70.8 + /- 4.7 ) . SETTING Community located in the Baltimore-Washington area . PARTICIPANTS Thirty-four community-dwelling adults , aged 60 and older with symptomatic knee OA and self-reported functional impairment . INTERVENTIONS Both groups received 12 hours of the Arthritis Self-Management program over 12 weeks and were followed for an additional 12 weeks . In addition , the Walk + group received individualized instruction in the use of a pedometer , with the goal of increasing their step count by 30 % of their baseline step count . MEASUREMENTS The outcome measures were physical activity ( daily step counts and total activity vector magnitude as measured by a pedometer and Tritrac-R3D accelerometer ) , quadriceps femoris strength ( isometric peak torque ) , and functional performance tasks ( 100-foot walk-turn-walk , timed stair climb , timed chair rise , and pain status ) . RESULTS Daily steps walked showed a significant group-by-time interaction ( P = .04 ) after controlling for age . From baseline to completion of training , a 23 % increase in daily steps occurred in the Walk + group and a 15 % decrease in the EDU group . Although steps increased in the Walk + group , total activity vector magnitude was maintained , suggesting a more efficient gait . The Walk + group became quicker than the EDU group in the normal-pace walk-turn-walk ( P = .04 ) . An isometric strength gain of 21 % postintervention was seen in the Walk + group , compared with a loss of 3.5 % in the EDU group . CONCLUSION In older adults with symptomatic knee OA , Walk + appears to increase walking , with improvements in muscle strength and walking performance . The use of a home-based pedometer-driven program to increase physical activity , strength , and function in this population warrants further research",
"OBJECTIVE To determine the effectiveness of subsensory , pulsed electrical stimulation ( PES ) in the symptomatic management of osteoarthritis ( OA ) of the knee . METHODS This was a double-blind , r and omized , placebo-controlled , repeated- measures trial in 70 participants with clinical and radiographically diagnosed OA of the knee who were r and omized to either PES or placebo . The primary outcome was change in pain score over 26 weeks measured on a 100-mm visual analog scale ( VAS ) . Other measures included pain on the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , function on the WOMAC , patient 's global assessment of disease activity ( on a 100-mm VAS ) , joint stiffness on the WOMAC , quality of life on the Medical Outcomes Study Short-Form 36 ( SF-36 ) health survey , physical activity ( using the Human Activity Profile and an accelerometer ) , and global perceived effect ( on an 11-point scale ) . RESULTS Thirty-four participants were r and omized to PES and 36 to placebo . Intent-to-treat analysis showed a statistically significant improvement in VAS pain score over 26 weeks in both groups , but no difference between groups ( mean change difference 0.9 mm [ 95 % confidence interval -11.7 , 13.4 ] ) . Similarly , there were no differences between groups for changes in WOMAC pain , function , and stiffness scores ( -5.6 [ 95 % confidence interval -14.9 , 3.6 ] , -1.9 [ 95 % confidence interval -9.7 , 5.9 ] , and 3.7 [ 95 % confidence interval -6.0 , 13.5 ] , respectively ) , SF-36 physical and mental component summary scores ( 1.7 [ 95 % confidence interval -1.5 , 4.8 ] and 1.2 [ 95 % confidence interval -2.9 , 5.4 ] , respectively ) , patient 's global assessment of disease activity ( -2.8 [ 95 % confidence interval -13.9 , 8.4 ] ) , or activity measures . Fifty-six percent of the PES-treated group achieved a clinical ly relevant 20-mm improvement in VAS pain score at 26 weeks compared with 44 % of controls ( 12 % [ 95 % confidence interval -11 % , 33 % ] ) . CONCLUSION In this sample of subjects with mild-to-moderate symptoms and moderate-to-severe radiographic OA of the knee , 26 weeks of PES was no more effective than placebo",
"The present single-centre prospect i ve follow-up study assessed the objective changes in physical activity undertaken before and after total hip arthroplasty ( THA ) using accelerometry . We enrolled 12 female patients who underwent home-based accelerometry assessment one month before and six months after the THA procedure . We assessed the daily amount of physical activity and energy expenditure related to physical activities . We also recorded the intensity of the physical activity , and pre- and post-operative clinical evaluation with the Harris Hip Score ( HHS ) . At 6 months after surgery , we found a statistically significant increase of the total energy cost of physical activity ( DA ) ( P=0.02 ) , without significant increase of activity time ( P>0.05 ) . The energy cost of moderate/vigorous activity was statistically significant increased after surgery ( P=0.008 ) . Finally , HHS improved form 53.9±15.3 pre-operatively to 78.1±12.2 post-operatively ( P=0.03 ) . In our patients , the improvement was significant only for the total energy cost of daily activity . Thus , although patients did not exhibit a more active lifestyle , as shown by the slight increase of the activity time , they significantly increased the amount of moderate or vigorous activities performed after surgery",
"OBJECTIVE To determine whether home-based neuromuscular electrical stimulation ( NMES ) applied to the quadriceps femoris ( QF ) muscle increases strength , physical activity , and physical performance in older adults with knee osteoarthritis ( OA ) . METHODS Thirty-four adults ( > 60 yrs ) with radiographically confirmed symptomatic knee OA were r and omized to NMES plus education or education only ( EDU ) . The primary outcome was isometric QF peak torque ( PTIso ) , with secondary outcomes of daily step counts , total activity vector magnitude , 100-foot walk-turn-walk , timed stair climb , chair rise , and pain . The NMES group used a portable electrical muscle stimulator 3 days a week for unilateral QF training with incremental increases in the intensity of isometric contraction to 30 - 40 % of maximum over 12 weeks . Both groups received the 12-week Arthritis Self-Management course and were followed an additional 12 weeks . RESULTS The stimulated knee-extensor showed a 9.1 % increase in 120 degrees PTIso compared to a 7 % loss in the EDU group ( time x group interaction for 120 degrees PTIso ; p = 0.04 ) . The chair rise time decreased by 11 % in the NMES group , whereas the EDU group saw a 7 % reduction ( p = 0.01 , time ; p = 0.9 , group ) . Similarly , both groups improved their walk time by approximately 7 % ( p = 0.02 , time ; p = 0.61 group ) . Severity of pain reported following intervention did not differ between groups . CONCLUSION In older adults with knee OA , a home-based NMES protocol appears to be a promising therapy for increasing QF strength in adults with knee OA without exacerbating painful symptoms"
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411712de-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Low levels of 25-OH vitamin D are associated with respiratory tract infection ( RTI ) . However , results from r and omized controlled trials are inconclusive . Therefore , we performed a systematic review and meta- analysis to assess the preventive effect of vitamin D supplementation on RTI . METHODS R and omized , controlled trials of vitamin D for prevention of RTI were used for the analysis . The risks of within-trial and publication bias were assessed . Odds ratios of RTI were pooled using a r and om-effects model . Heterogeneity was assessed using Cochran 's Q and I(2 ) . Meta-regressions and subgroup analyses were used to assess the influence of various factors on trial outcome . The pre-defined review protocol was registered at the PROSPERO international prospect i ve register of systematic review s , registration number CRD42013003530 . FINDINGS Of 1137 citations retrieved , 11 placebo-controlled studies of 5660 patients were included in the meta- analysis . Overall , vitamin D showed a protective effect against RTI ( OR , 0.64 ; 95 % CI , 0.49 to 0.84 ) . There was significant heterogeneity among studies ( Cohran 's Q p protective effect was larger in studies using once-daily dosing compared to bolus doses ( OR = 0.51 vs OR = 0.86 , p = 0.01 ) . There was some evidence that results may have been influenced by publication bias . INTERPRETATION Results indicate that vitamin D has a protective effect against RTI , and dosing once-daily seems most effective . Due to heterogeneity of included studies and possible publication bias in the field , these results should be interpreted with caution
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"BACKGROUND Low serum 25-hydroxyvitamin D ( 25-[OH]D ) levels have been associated with lower FEV(1 ) , impaired immunologic control , and increased airway inflammation . Because many patients with chronic obstructive pulmonary disease ( COPD ) have vitamin D deficiency , effects of vitamin D supplementation may extend beyond preventing osteoporosis . OBJECTIVE To explore whether supplementation with high doses of vitamin D could reduce the incidence of COPD exacerbations . DESIGN R and omized , single-center , double-blind , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00666367 ) SETTING University Hospitals Leuven , Leuven , Belgium . PATIENTS 182 patients with moderate to very severe COPD and a history of recent exacerbations . INTERVENTION 100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year . MEASUREMENTS The primary outcome was time to first exacerbation . Secondary outcomes were exacerbation rate , time to first hospitalization , time to second exacerbation , FEV(1 ) , quality of life , and death . RESULTS Mean serum 25-(OH)D levels increased significantly in the vitamin D group compared with the placebo group ( mean between-group difference , 30 ng/mL [ 95 % CI , 27 to 33 ng/mL ] ; P median time to first exacerbation did not significantly differ between the groups ( hazard ratio , 1.1 [ CI , 0.82 to 1.56 ] ; P = 0.41 ) , nor did exacerbation rates , FEV(1 ) , hospitalization , quality of life , and death . However , a post hoc analysis in 30 participants with severe vitamin D deficiency ( serum 25-[OH]D levels exacerbations in the vitamin D group ( rate ratio , 0.57 [ CI , 0.33 to 0.98 ] ; P = 0.042 ) . LIMITATION This was a single-center study with a small sample size . CONCLUSION High-dose vitamin D supplementation in a sample of patients with COPD did not reduce the incidence of exacerbations . In participants with severe vitamin D deficiency at baseline , supplementation may reduce exacerbations . PRIMARY FUNDING SOURCE Applied Biomedical Research Program , Agency for Innovation by Science and Technology ( IWT-TBM )",
"Objective To investigate whether vitamin D supplementation can decrease the mortality and morbidity of low birthweight infants in low income countries . Design R and omised controlled trial . Setting Large government hospital in New Delhi , India . Participants 2079 low birthweight infants born at term ( > 37 weeks ’ gestation ) . Main outcome measures Primary outcome was admission to hospital or death during the first six months of life . Main secondary outcome was growth . Interventions Weekly vitamin D supplements for six months at a dose of one recommended nutrient intake per day ( 35 µg/week ) . Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements . Results Between group differences were not significant for death or hospital admissions ( 92 among 1039 infants in the vitamin D group v 99 among 1040 infants in the placebo group ; adjusted rate ratio 0.93 , 95 % confidence interval 0.68 to 1.29 ; P=0.68 ) , or referral to the outpatient clinic for moderate morbidity . Vitamin D supplementation result ed in better vitamin D status as assessed by plasma calcidiol levels at six months . In adjusted analyses , vitamin D treatment significantly increased st and ard deviation ( z ) scores at six months for weight , length , and arm circumference and decreased the proportion of children with stunted growth ( length for age z score ≤2 ) or with arm circumference z scores of 2 or less . Conclusion A weekly dose of vitamin D result ed in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants . Trial registration Clinical Trials.gov NCT00415402",
"Background Low serum levels of 25-hydroxyvitamin D3 are associated with an increased risk of respiratory tract infections ( RTIs ) . Clinical trials with vitamin D3 against various infections have been carried out but data are so far not conclusive . Thus , there is a need for additional r and omised controlled trials of effects of vitamin D3 on infections . Objective To investigate if supplementation with vitamin D3 could reduce infectious symptoms and antibiotic consumption among patients with antibody deficiency or frequent RTIs . Design A double-blind r and omised controlled trial . Setting Karolinska University Hospital , Huddinge . Participants 140 patients with antibody deficiency ( selective IgA subclass deficiency , IgG subclass deficiency , common variable immune disorder ) and patients with increased susceptibility to RTIs ( > 4 bacterial RTIs/year ) but without immunological diagnosis . Intervention Vitamin D3 ( 4000 IU ) or placebo was given daily for 1 year . Primary and secondary outcome measures The primary endpoint was an infectious score based on five parameters : symptoms from respiratory tract , ears and sinuses , malaise and antibiotic consumption . Secondary endpoints were serum levels of 25-hydroxyvitamin D3 , microbiological findings and levels of antimicrobial peptides ( LL-37 , HNP1–3 ) in nasal fluid . Results The overall infectious score was significantly reduced for patients allocated to the vitamin D group ( 202 points ) compared with the placebo group ( 249 points ; adjusted relative score 0.771 , 95 % CI 0.604 to 0.985 , p=0.04 ) . Limitations A single study centre , small sample size and a selected group of patients . The sample size calculation was performed using p=0.02 as the significance level whereas the primary and secondary endpoints were analysed using the conventional p=0.05 as the significance level . Conclusions Supplementation with vitamin D3 may reduce disease burden in patients with frequent RTIs",
"OBJECTIVE : Observational studies suggest that serum levels of 25-hydroxyvitamin D ( 25[OH]D ) are inversely associated with acute respiratory infections ( ARIs ) . We hypothesized that vitamin D supplementation of children with vitamin D deficiency would lower the risk of ARIs . METHODS : By using cluster r and omization , classrooms of 744 Mongolian schoolchildren were r and omly assigned to different treatments in winter ( January – March ) . This analysis focused on a subset of 247 children who were assigned to daily ingestion of unfortified regular milk ( control ; n = 104 ) or milk fortified with 300 IU of vitamin D3 ( n = 143 ) . This comparison was double-blinded . The primary outcome was the number of parent-reported ARIs over the past 3 months . RESULTS : At baseline , the median serum 25(OH)D level was 7 ng/mL ( interquartile range : 5–10 ng/mL ) . At the end of the trial , follow-up was 99 % ( n = 244 ) , and the median 25(OH)D levels of children in the control versus vitamin D groups was significantly different ( 7 vs 19 ng/mL ; P receiving vitamin D reported significantly fewer ARIs during the study period ( mean : 0.80 vs 0.45 ; P = .047 ) , with a rate ratio of 0.52 ( 95 % confidence interval : 0.31–0.89 ) . Adjusting for age , gender , and history of wheezing , vitamin D continued to halve the risk of ARI ( rate ratio : 0.50 [ 95 % confidence interval : 0.28–0.88 ] ) . Similar results were found among children either below or above the median 25(OH)D level at baseline ( rate ratio : 0.41 vs 0.57 ; Pinteraction = .27 ) . CONCLUSIONS : Vitamin D supplementation significantly reduced the risk of ARIs in winter among Mongolian children with vitamin D deficiency",
"Aims : To investigate the effects of a 6-month supplementation with calcium and cholecalciferol on biochemical parameters and muscle strength of institutionalized elderly . Methods : This prospect i ve , double-blind , placebo-controlled , r and omized trial included Brazilian institutionalized people ≥60 years of age receiving a 6-month supplementation ( December to May ) of daily calcium plus monthly placebo ( calcium/placebo group ) or daily calcium plus oral cholecalciferol ( 150,000 IU once a month during the first 2 months , followed by 90,000 IU once a month for the last 4 months ; calcium/vitamin D group ) . Fasting blood sample s for 25(OH)D , PTH and calcium determination were collected ( n = 56 ) and muscle tests were performed ( n = 46 ) to measure the strength of hip flexors ( SHF ) and knee extensors ( SKE ) before ( baseline ) and after the 6-month intervention ( 6 months ) . Results : Due to seasonal variations , serum 25(OH)D significantly enhanced in both groups after treatment , but the calcium/vitamin D group had significantly higher 25 (OH)D levels than the calcium/placebo group ( 84 vs. 33 % , respectively ; p of hypercalcemia were observed . While the calcium/placebo group showed no improvement in SHF and SKE at 6 months ( p = 0.93 and p = 0.61 , respectively ) , SHF was increased in the calcium/vitamin D group by 16.4 % ( p = 0.0001 ) and SKE by 24.6 % ( p = 0.0007 ) . Conclusions : The suggested cholecalciferol supplementation was safe and efficient in enhancing 25(OH)D levels and lower limb muscle strength in the elderly , in the absence of any regular physical exercise practice",
"BACKGROUND To our knowledge , no rigorously design ed clinical trials have evaluated the relation between vitamin D and physician-diagnosed seasonal influenza . OBJECTIVE We investigated the effect of vitamin D supplements on the incidence of seasonal influenza A in schoolchildren . DESIGN From December 2008 through March 2009 , we conducted a r and omized , double-blind , placebo-controlled trial comparing vitamin D(3 ) supplements ( 1200 IU/d ) with placebo in schoolchildren . The primary outcome was the incidence of influenza A , diagnosed with influenza antigen testing with a nasopharyngeal swab specimen . RESULTS Influenza A occurred in 18 of 167 ( 10.8 % ) children in the vitamin D(3 ) group compared with 31 of 167 ( 18.6 % ) children in the placebo group [ relative risk ( RR ) , 0.58 ; 95 % CI : 0.34 , 0.99 ; P = 0.04 ] . The reduction in influenza A was more prominent in children who had not been taking other vitamin D supplements ( RR : 0.36 ; 95 % CI : 0.17 , 0.79 ; P = 0.006 ) and who started nursery school after age 3 y ( RR : 0.36 ; 95 % CI : 0.17 , 0.78 ; P = 0.005 ) . In children with a previous diagnosis of asthma , asthma attacks as a secondary outcome occurred in 2 children receiving vitamin D(3 ) compared with 12 children receiving placebo ( RR : 0.17 ; 95 % CI : 0.04 , 0.73 ; P = 0.006 ) . CONCLUSION This study suggests that vitamin D(3 ) supplementation during the winter may reduce the incidence of influenza A , especially in specific subgroups of schoolchildren . This trial was registered at https://center.umin.ac.jp as UMIN000001373",
"Calcidiol , the major circulating metabolite of vitamin D , supports induction of pleiotropic antimicrobial responses in vitro . Vitamin D supplementation elevates circulating calcidiol concentrations , and thus has a potential role in the prevention and treatment of infection . The immunomodulatory effects of administering vitamin D to humans with an infectious disease have not previously been reported . To characterize these effects , we conducted a detailed longitudinal study of circulating and antigen-stimulated immune responses in ninety-five patients receiving antimicrobial therapy for pulmonary tuberculosis who were r and omized to receive adjunctive high-dose vitamin D or placebo in a clinical trial , and who fulfilled criteria for per- protocol analysis . Vitamin D supplementation accelerated sputum smear conversion and enhanced treatment-induced resolution of lymphopaenia , monocytosis , hypercytokinaemia , and hyperchemokinaemia . Administration of vitamin D also suppressed antigen-stimulated proinflammatory cytokine responses , but attenuated the suppressive effect of antimicrobial therapy on antigen-stimulated secretion of IL-4 , CC chemokine lig and 5 , and IFN-α . We demonstrate a previously unappreciated role for vitamin D supplementation in accelerating resolution of inflammatory responses during tuberculosis treatment . Our findings suggest a potential role for adjunctive vitamin D supplementation in the treatment of pulmonary infections to accelerate resolution of inflammatory responses associated with increased risk of mortality",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Abstract Objective : To determine the effect of four monthly vitamin D supplementation on the rate of fractures in men and women aged 65 years and over living in the community . Design : R and omised double blind controlled trial of 100 000 IU oral vitamin D3 ( cholecalciferol ) supplementation or matching placebo every four months over five years . Setting and participants : 2686 people ( 2037 men and 649 women ) aged 65 - 85 years living in the general community , recruited from the British doctors register and a general practice register in Suffolk . Main outcome measures : Fracture incidence and total mortality by cause . Results : After five years 268 men and women had incident fractures , of whom 147 had fractures in common osteoporotic sites ( hip , wrist or forearm , or vertebrae ) . Relative risks in the vitamin D group compared with the placebo group were 0.78 ( 95 % confidence interval 0.61 to 0.99 , P=0.04 ) for any first fracture and 0.67 ( 0.48 to 0.93 , P=0.02 ) for first hip , wrist or forearm , or vertebral fracture . 471 participants died . The relative risk for total mortality in the vitamin D group compared with the placebo group was 0.88 ( 0.74 to 1.06 , P=0.18 ) . Findings were consistent in men and women and in doctors and the general practice population . Conclusion : Four monthly supplementation with 100 000 IU oral vitamin D may prevent fractures without adverse effects in men and women living in the general community . What is already known in this topic Vitamin D and calcium supplements are effective in preventing fractures in elderly women Whether isolated vitamin D supplementation prevents fractures is not clear What this paper adds Four monthly oral supplementation with 100 000 IU vitamin D reduces fractures in men and women aged over 65 living in the general community Total fracture incidence was reduced by 22 % and fractures in major osteoporotic sites by 33",
"Summary Background Vitamin D has a role in regulating immune function , and its deficiency is a suggested risk factor for childhood pneumonia . Our aim was to assess whether oral supplementation of vitamin D3 ( cholecalciferol ) will reduce the incidence and severity of pneumonia in a high-risk infant population . Methods We did a r and omised placebo-controlled trial to compare oral 100 000 IU ( 2·5 mg ) vitamin D3 with placebo given to children aged 1–11 months in Kabul , Afghanistan . R and omisation was by use of a computer-generated list . Vitamin D or placebo was given by fieldworkers once every 3 months for 18 months . Children presenting at the study hospital with signs of pneumonia had their diagnosis confirmed radiographically . Our primary outcome was the first or only episode of radiologically confirmed pneumonia . Our analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00548379 . Findings 1524 children were assigned to receive vitamin D3 and 1522 placebo . There was no significant difference between the incidence of first or only pneumonia between the vitamin D ( 0·145 per child per year , 95 % CI 0·129–0·164 ) and the placebo group ( 0.137 , 0·121–0·155 ) ; the incidence rate ratio was 1·06 ( 95 % CI 0·89–1·27 ) . From 652 children during five separate periods of testing serum calcifediol , only one child in each of two testing periods had results greater than 375 nmol/L in the intervention group — a toxic level . Interpretations Quarterly bolus doses of oral vitamin D3 supplementation to infants are not an effective intervention to reduce the incidence of pneumonia in infants in this setting . Funding Wellcome Trust and British Council",
"OBJECTIVES To determine whether ( i ) supplementation of oral 100,000 iu of vitamin D(3 ) ( cholecalciferol ) along with antibiotics will reduce the duration of illness in children with pneumonia ; ( ii ) supplementation will reduce the risk of repeat episodes . METHODS Double-blind individually r and omised placebo-controlled trial in an inner-city hospital in Kabul , of 453 children aged 1 - 36 months , diagnosed with non-severe or severe pneumonia at the outpatient clinic . Children with rickets , other concurrent severe diseases , very severe pneumonia or wheeze , were excluded . Children were given vitamin D(3 ) or placebo drops additional to routine pneumonia treatment . RESULTS Two hundred and twenty-four children received vitamin D(3 ; ) and 229 received placebo . There was no significant difference in the mean number of days to recovery between the vitamin D(3 ) ( 4.74 days ; SD 2.22 ) and placebo arms ( 4.98 days ; SD 2.89 ; P = 0.17 ) . The risk of a repeat episode of pneumonia within 90 days of supplementation was lower in the intervention ( 92/204 ; 45 % ) than the placebo group [ 122/211 ; ( 58 % ; relative risk 0.78 ; 95 % CI 0.64 , 0.94 ; P = 0.01 ] . Children in the vitamin D(3 ) group survived longer without experiencing a repeat episode ( 72 days vs. 59 days ; HR 0.71 ; 95 % CI 0.53 - 0.95 ; P = 0.02 ) . CONCLUSION A single high-dose oral vitamin D(3 ) supplementation to young children along with antibiotic treatment for pneumonia could reduce the occurrence of repeat episodes of pneumonia",
"BACKGROUND Care of elderly patients after hip fracture is not well established . METHODS We enrolled 173 patients with acute hip fracture who were 65 years or older ( 79.2 % women ; mean age , 84 years ; 77.4 % living at home ) . Using a factorial design , we r and omly allocated patients to extended physiotherapy ( PT ) ( supervised 60 min/d during acute care plus an unsupervised home program ) vs st and ard PT ( supervised 30 min/d during acute care plus no home program ; single-blinded ) , and to cholecalciferol therapy , 2000 vs 800 IU/d ( double-blinded ) . Primary outcome was rate of falls ; secondary outcome was rate of hospital readmissions during the 12-month follow-up . All analyses included 173 individuals and used multivariate Poisson regression analyses . RESULTS At baseline , 50.9 % of participants had 25-hydroxyvitamin D levels of less than 12 ng/mL and 97.7 % of less than 30 ng/mL. We documented 212 falls and 74 hospital readmissions . Because this was a factorial design trial , all analyses tested the main effect of each treatment while controlling for the other in 173 participants . Extended vs st and ard PT reduced the rate of falls by 25 % ( 95 % confidence interval [ CI ] , -44 % to -1 % ) . Cholecalciferol treatment , 2000 vs 800 IU/d , did not reduce falls ( 28 % ; 95 % CI , -4 % to 68 % ) , but reduced the rate of hospital readmissions by 39 % ( 95 % CI , -62 % to -1 % ) . CONCLUSIONS Extended PT was successful in reducing falls but not hospital readmissions , whereas cholecalciferol treatment , 2000 IU/d , was successful in reducing hospital readmission but not falls . Thus , the 2 strategies may be useful together because they address 2 different and important complications after hip fracture",
"BACKGROUND Recent studies suggest a role for vitamin D in innate immunity , including the prevention of respiratory tract infections ( RTIs ) . We hypothesize that serum 25-hydroxyvitamin D ( 25[OH]D ) levels are inversely associated with self-reported recent upper RTI ( URTI ) . METHODS We performed a secondary analysis of the Third National Health and Nutrition Examination Survey , a probability survey of the US population conducted between 1988 and 1994 . We examined the association between 25(OH)D level and recent URTI in 18 883 participants 12 years and older . The analysis adjusted for demographics and clinical factors ( season , body mass index , smoking history , asthma , and chronic obstructive pulmonary disease ) . RESULTS The median serum 25(OH)D level was 29 ng/mL ( to convert to nanomoles per liter , multiply by 2.496 ) ( interquartile range , 21 - 37 ng/mL ) , and 19 % ( 95 % confidence interval [ CI ] , 18%-20 % ) of participants reported a recent URTI . Recent URTI was reported by 24 % of participants with 25(OH)D levels less than 10 ng/mL , by 20 % with levels of 10 to less than 30 ng/mL , and by 17 % with levels of 30 ng/mL or more ( P 25(OH)D levels were independently associated with recent URTI ( compared with 25[OH]D levels of > or = 30 ng/mL : odds ratio [ OR ] , 1.36 ; 95 % CI , 1.01 - 1.84 for 25(OH)D level and URTI seemed to be stronger in individuals with asthma and chronic obstructive pulmonary disease ( OR , 5.67 and 2.26 , respectively ) . CONCLUSIONS Serum 25(OH)D levels are inversely associated with recent URTI . This association may be stronger in those with respiratory tract diseases . R and omized controlled trials are warranted to explore the effects of vitamin D supplementation on RTI",
"Background : Vitamin D deficiency has been associated with a number of diseases , including influenza . Whether or not this reflects a causal relationship is unknown . We therefore wanted to examine if supplementation with vitamin D would affect the incidence and severity of influenza-like disease . Methods : Question naires on influenza were sent to subjects participating in ongoing placebo-controlled intervention studies with vitamin D supplementation , up until the end of April 2010 . Results : Five hundred and sixty-nine subjects from 10 different clinical trials were included in the study , of whom 289 were r and omized to receive vitamin D ( 1111–6800 IU/day ) and 280 to receive placebo . Influenza-like disease during the previous fall/winter was reported in 38 subjects in the vitamin D group and 42 in the placebo group ( non-significant ) , of whom 25 and 26 subjects , respectively , fulfilled our clinical criteria for influenza . In these latter subjects , the duration of illness was significantly longer among those in the vitamin D group than among those in the placebo group ( median 7 ( range 2–60 ) days vs median 4 ( range 2–18 ) days ; p = 0.007 ) . However , this difference was not statistically significant if all 38 ( vitamin D ) and 42 ( placebo ) subjects who reported symptoms were included . Conclusion : Our results do not support the hypothesis that high doses of vitamin D supplementation will have a pronounced effect on influenza-like disease in population s not targeted for high influenza risk",
"CONTEXT Observational studies have reported an inverse association between serum 25-hydroxyvitamin D ( 25-OHD ) levels and incidence of upper respiratory tract infections ( URTIs ) . However , results of clinical trials of vitamin D supplementation have been inconclusive . OBJECTIVE To determine the effect of vitamin D supplementation on incidence and severity of URTIs in healthy adults . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial conducted among 322 healthy adults between February 2010 and November 2011 in Christchurch , New Zeal and . INTERVENTION Participants were r and omly assigned to receive an initial dose of 200,000 IU oral vitamin D3 , then 200,000 IU 1 month later , then 100,000 IU monthly ( n = 161 ) , or placebo administered in an identical dosing regimen ( n = 161 ) , for a total of 18 months . MAIN OUTCOME MEASURES The primary end point was number of URTI episodes . Secondary end points were duration of URTI episodes , severity of URTI episodes , and number of days of missed work due to URTI episodes . RESULTS The mean baseline 25-OHD level of participants was 29 ( SD , 9 ) ng/mL. Vitamin D supplementation result ed in an increase in serum 25-OHD levels that was maintained at greater than 48 ng/mL throughout the study . There were 593 URTI episodes in the vitamin D group and 611 in the placebo group , with no statistically significant differences in the number of URTIs per participant ( mean , 3.7 per person in the vitamin D group and 3.8 per person in the placebo group ; risk ratio , 0.97 ; 95 % CI , 0.85 - 1.11 ) , number of days of missed work as a result of URTIs ( mean , 0.76 days in each group ; risk ratio , 1.03 ; 95 % CI , 0.81 - 1.30 ) , duration of symptoms per episode ( mean , 12 days in each group ; risk ratio , 0.96 ; 95 % CI , 0.73 - 1.25 ) , or severity of URTI episodes . These findings remained unchanged when the analysis was repeated by season and by baseline 25-OHD levels . CONCLUSION In this trial , monthly administration of 100,000 IU of vitamin D did not reduce the incidence or severity of URTIs in healthy adults . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12609000486224",
"Vitamin D has been shown to be an important immune system regulator . Vitamin D insufficiency during winter may cause increased susceptibility to upper respiratory tract infections ( URIs ) . To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms , 162 adults were r and omized to receive 50 microg vitamin D3 ( 2000 IU ) daily or matching placebo for 12 weeks . A bi-weekly question naire was used to record the incidence and severity of URI symptoms . There was no difference in the incidence of URIs between the vitamin D and placebo groups ( 48 URIs vs. 50 URIs , respectively , P=0.57 ) . There was no difference in the duration or severity of URI symptoms between the vitamin D and placebo groups [ 5.4+/-4.8 days vs. 5.3+/-3.1 days , respectively , P=0.86 ( 95 % CI for the difference in duration -1.8 to 2.1 ) ] . The mean 25-hydroxyvitamin D level at baseline was similar in both groups ( 64.3+/-25.4 nmol/l in the vitamin D group ; 63.0+/-25.8 nmol/l in the placebo group ; n.s . ) . After 12 weeks , 25-hydroxyvitamin D levels increased significantly to 88.5+/-23.2 nmol/l in the vitamin D group , whereas there was no change in vitamin D levels in the placebo group . There was no benefit of vitamin D3 supplementation in decreasing the incidence or severity of symptomatic URIs during winter . Further studies are needed to determine the role of vitamin D in infection",
"Objective To determine the role of oral vitamin D supplementation for resolution of severe pneumonia in under-five children . Design R and omized , double blind , placebo-controlled trial . Setting In patients from a tertiary care hospital . Participants Two hundred children [ mean ( SD ) age : 13.9 ( 11.7 ) months ; boys : 120 ] between 2 months to 5 years with severe pneumonia . Pneumonia was diagnosed in the presence of fever , cough , tachypnea ( as per WHO cut-offs ) and crepitations . Children with pneumonia and chest indrawing or at least one of the danger sign ( inability to feed , lethargy , cyanosis ) were diagnosed as having severe pneumonia . The two groups were comparable for baseline characteristics including age , anthropometry , socio-demographic profile , and clinical and laboratory parameters . InterventionOral vitamin D ( 1000 IU for 1 year ) ( n=100 ) or placebo ( lactose ) ( n=100 ) once a day for 5 days , from enrolment . Both the groups received antibiotics as per the Indian Academy of Pediatrics guidelines , and supportive care ( oxygen , intravenous fluids and monitoring ) . Outcome variables Primary : time to resolution of severe pneumonia . Secondary : duration of hospitalization and time to resolution of tachypnea , chest retractions and inability to feed . Results Median duration ( SE , 95 % CI ) of resolution of severe pneumonia was similar in the two groups [ vitamin D : 72 ( 3.7 , 64.7–79.3 ) hours ; placebo : 64 ( 4.5 , 55.2–72.8 ) hours ] . Duration of hospitalization and time to resolution of tachypnea , chest retractions , and inability to feed were also comparable between the two groups . ConclusionS hort-term supplementation with oral vitamin D ( 1000–2000 IU per day for 5 days ) has no beneficial effect on resolution of severe pneumonia in under-five children . Further studies need to be conducted with higher dose of Vitamin D or longer duration of supplementation to corroborate these findings",
"CONTEXT The active metabolite of vitamin D , 1,25-dihydroxyvitamin D [ 1,25(OH)(2)D ] , is a potent modulator of immune cells in vitro . OBJECTIVE Our objective was to determine whether the sun-dependent nutrient , cholecalciferol , can alter disease-associated cellular immune abnormalities in patients with multiple sclerosis ( MS ) . DESIGN This was an open-label , 12-month , r and omized controlled trial . SETTING Patients with MS were recruited from the MS Clinic at St. Michael 's Hospital , Toronto . PATIENTS Forty-nine patients were matched ( for age , sex , disease duration , disease-modifying drug , and disability ) and enrolled ( treated n = 25 ; control n = 24 ) . Four patients were lost to follow-up ( n = 2 from each group ) . INTERVENTION Treated patients received increasing doses of cholecalciferol ( 4,000 - 40,000 IU/d ) plus calcium ( 1200 mg/d ) , followed by equilibration to a moderate , physiological intake ( 10,000 IU/d ) . Control patients did not receive supplements . MAIN OUTCOME MEASURES At enrollment and at 12 months , peripheral blood mononuclear cell ( P BMC ) proliferative responses to disease-associated , MS-relevant , and control antigens were measured , along with selected serum biochemical markers . RESULTS At 12 months , mean serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations were 83 ± 35 nmol/liter and 179 ± 76 nmol/liter in control and treated participants , respectively ( paired t , P Serum 1,25(OH)(2)D did not differ between baseline and 1 yr . In treated patients , 12-month P BMC proliferative responses to neuron antigens myelin basic protein and exon-2 were suppressed ( P = 0.002 ) . In controls , there were no significant changes in disease-associated P BMC responsiveness . There were no significant differences between groups in levels of selected biomarkers . INTERPRETATION MS-associated , abnormal T cell reactivities were suppressed in vivo by cholecalciferol at serum 25(OH)D concentrations higher than 100 nmol/liter"
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PURPOSE To provide evidence -based recommendations to oncologists and others on potentially curative therapy for patients with localized pancreatic cancer . METHODS ASCO convened a panel of medical oncology , radiation oncology , surgical oncology , palliative care , and advocacy experts and conducted a systematic review of literature from January 2002 to June 2015 . Outcomes included overall survival , disease-free survival , progression-free survival , and adverse events . RESULTS Nine r and omized controlled trials met the systematic review criteria . RECOMMENDATIONS A multiphase computed tomography scan of the abdomen and pelvis or magnetic resonance imaging should be performed for all patients to assess the anatomic relationships of the primary tumor and for the presence of intra-abdominal metastases . Baseline performance status , comorbidity profile , and goals of care should be evaluated and established . Primary surgical resection is recommended for all patients who have no metastases , appropriate performance and comorbidity profiles , and no radiographic interface between primary tumor and mesenteric vasculature . Preoperative therapy is recommended for patients who meet specific characteristics . All patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of contraindications . Adjuvant chemoradiation may be offered to patients who did not receive preoperative therapy with microscopically positive margins ( R1 ) after resection and /or who had node-positive disease after completion of 4 to 6 months of systemic adjuvant chemotherapy . Patients should have a full assessment of symptoms , psychological status , and social supports and should receive palliative care early . Patients who have completed treatment and have no evidence of disease should be monitored . Additional information is available at www.asco.org/ guidelines /PCPC and www.asco.org/ guidelines wiki
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"Background We report the results of a multi-institutional phase II trial that used preoperative full-dose gemcitabine and radiotherapy for patients with potentially resectable pancreatic carcinoma . Methods Patients were treated before surgery with three cycles of full-dose gemcitabine ( 1000 mg/m2 intravenously ) , with radiation during the second cycle ( 36 Gy in daily 2.4-Gy fractions ) . Patients underwent surgery 4 to 6 weeks after the last gemcitabine infusion . Results There were 10 men and 10 women , with a median age of 58 years ( range , 50–80 years ) . Nineteen patients ( 95 % ) completed therapy without interruption , and one experienced grade 3 gastrointestinal toxicity . The mean weight loss after therapy was 4.0 % . Of 20 patients taken to surgery , 17 ( 85 % ) underwent resections ( 16 pancreaticoduodenectomies and 1 distal pancreatectomy ) . The complication rate was 24 % , with an average length of stay of 13.5 days . There were no operative deaths . Pathologic analysis revealed clear margins in 16 ( 94 % ) of 17 and uninvolved lymph nodes in 11 ( 65 % ) of 17 specimens . One specimen contained no residual tumor , and three specimens revealed only microscopic foci of residual disease . With a median follow-up of 18 months , 7 ( 41 % ) of the 17 patients with resected disease are alive with no recurrence , 3 ( 18 % ) are alive with distant metastases , and 7 ( 41 % ) have died . Conclusions Preoperative gemcitabine/radiotherapy is well tolerated and safe when delivered in a multi-institutional setting . This protocol had a high rate of subsequent resection , with acceptable morbidity . The high rate of negative margins and uninvolved nodes suggests a significant tumor response . Preliminary survival data are encouraging . This regimen should be considered in future neoadjuvant trials for pancreatic cancer",
"The efficacy of combined radiation and fluorouracil as adjuvant therapy for pancreatic cancer is suggested by a prospect i ve r and omized study conducted by the Gastrointestinal Tumor Study Group ( GITSG ) . Twenty-two patients r and omized to no adjuvant treatment and 21 to combined therapy were analyzed . Neither life-threatening toxic reaction nor death due to toxic effect was encountered . The study was terminated prematurely because of an unacceptably low rate of accrual combined with the observation of increasingly large survival differences between the study arms . Median survival for the treatment group ( 20 months ) was significantly longer than that observed for the control group ( 11 months ) . Four patients , three in the treated and one in the control group , have survived five years or longer following surgery . The extent of the tumor and initial performance status were significantly and independently related to survival",
"PURPOSE To examine the efficacy of adjuvant chemoradiotherapy after pancreaticoduodenectomy ( PD ) for pancreatic adenocarcinoma ( PC ) in patients undergoing resection at Johns Hopkins Hospital ( JHH ; Baltimore , MD ) . PATIENTS AND METHODS Between August 30 , 1993 , and February 28 , 2005 , a total of 908 patients underwent PD for PC at JHH . A prospect i ve data base was review ed to determine which patients received fluorouracil ( FU ) -based CRT . Excluded patients had metastatic disease , died 60 or fewer days after PD , received preoperative therapy , an experimental vaccine , adjuvant chemotherapy or radiation alone . The final cohort includes 616 patients . RESULTS The median follow-up was 17.8 months ( interquartile range , 9.7 to 33.5 months ) . Overall median survival was 17.9 months ( 95 % CI , 16.3 to 19.5 months ) . Groups were similar with respect to tumor size , nodal status , and margin status , but the CRT group was younger ( P carcinomas larger than 3 cm ( P = .001 ) , grade 3 and 4 ( P margin-positive resection ( P = .001 ) , and complications after surgery ( P = .017 ) had poor long-term survival . Patients receiving CRT experienced an improved median ( 21.2 v 14.4 months ; P survival compared with no CRT . After controlling for high-risk features , CRT was still associated with improved survival ( relative risk = 0.74 ; 95 % CI , 0.62 to 0.89 ) . CONCLUSION These data suggest that adjuvant concurrent FU-based CRT significantly improves survival after PD for PC when compared with patients not receiving CRT . These data support the use of combined adjuvant CRT for PC",
"Background Despite major improvements in the perioperative outcome of pancreas surgery , the prognosis of pancreatic cancer after curative resection remains poor . Adjuvant chemotherapy increases disease-free and overall survival , but this treatment can not be offered to a significant proportion of patients due to the surgical morbidity . In contrast , almost all patients can receive (neo)adjuvant chemotherapy before surgery . This treatment is safe and effective , and has result ed in a median survival of 26.5 months in a recent phase II trial . Moreover , neoadjuvant chemotherapy improves the nutritional status of patients with pancreatic cancer . This multicenter phase III trial ( NEOPAC ) has been design ed to explore the efficacy of neoadjuvant chemotherapy . Methods / Design This is a prospect i ve r and omized phase III trial . Patients with resectable cytologically proven adenocarcinoma of the pancreatic head are eligible for this study . All patients must be at least 18 years old and must provide written informed consent . An infiltration of the superior mesenteric vein > 180 ° or major visceral arteries are considered exclusion criteria . Eligible patients will be r and omized to surgery followed by adjuvant gemcitabine ( 1000 mg/m2 ) for 6 months or neoadjuvant chemotherapy ( gemcitabine 1000 mg/m2 , oxaliplatin 100 mg/m2 ) followed by surgery and the same adjuvant treatment . Neoadjuvant chemotherapy is given four times every two weeks . The staging as well as the restaging protocol after neoadjuvant chemotherapy include computed tomography of chest and abdomen and diagnostic laparoscopy . The primary study endpoint is progression-free survival . According to the sample size calculation , 155 patients need to be r and omized to each treatment arm . Disease recurrence will be documented by scheduled computed tomography scans 9 , 12 , 15 , 21 and thereafter every 6 months until disease progression . For quality control , circumferential resection margins are marked intraoperatively , and representative histological sections will be central ly review ed by a dedicated pathologist . Discussion The NEOPAC study will determine the efficacy of neoadjuvant chemotherapy in pancreatic cancer for the first time and offers a unique potential for translational research . Furthermore , this trial will provide the unbiased overall survival of all patients undergoing surgery for resectable cancer of the pancreatic head . Trial registration clinical Trials.gov",
"Background : This multicentre r and omised phase III trial was design ed to determine whether adjuvant chemotherapy with gemcitabine improves the outcomes of patients with resected pancreatic cancer . Methods : Eligibility criteria included macroscopically curative resection of invasive ductal carcinoma of the pancreas and no earlier radiation or chemotherapy . Patients were r and omly assigned at a 1 : 1 ratio to either the gemcitabine group or the surgery-only group . Patients assigned to the gemcitabine group received gemcitabine at a dose of 1000 mg m−2 over 30 min on days 1 , 8 and 15 , every 4 weeks for 3 cycles . Results : Between April 2002 and March 2005 , 119 patients were enrolled in this study . Among them , 118 were eligible and analysable ( 58 in the gemcitabine group and 60 in the surgery-only group ) . Both groups were well balanced in terms of baseline characteristics . Although heamatological toxicity was frequently observed in the gemcitabine group , most toxicities were transient , and grade 3 or 4 non-heamatological toxicity was rare . Patients in the gemcitabine group showed significantly longer disease-free survival ( DFS ) than those in the surgery-only group ( median DFS , 11.4versus 5.0 months ; hazard ratio=0.60 ( 95 % confidence interval ( CI ) : 0.40–0.89 ) ; P=0.01 ) , although overall survival did not differ significantly between the gemcitabine and surgery-only groups ( median overall survival , 22.3 versus 18.4 months ; hazard ratio=0.77 ( 95 % CI : 0.51–1.14 ) ; P=0.19 ) . Conclusion : The current results suggest that adjuvant gemcitabine contributes to prolonged DFS in patients undergoing macroscopically curative resection of pancreatic cancer",
"PURPOSE Adjuvant chemotherapy prolongs survival in patients with pancreatic cancer , but its benefit is limited . Long-term survival times of up to 44 months after adjuvant chemoradioimmunotherapy in phase II trials motivated the present study . PATIENTS AND METHODS Between 2004 and 2007 , 132 R0/R1 resected patients received either fluorouracil ( FU ) , cisplatin , and interferon alfa-2b ( IFN α-2b ) plus radiotherapy followed by two cycles of FU ( arm A , n=64 ) or six cycles of FU monotherapy ( arm B , n=68 ) . One hundred ten patients ( arm A , n=53 ; arm B , n=57 ) received at least one dose of the study medication , and these patients composed the per- protocol ( PP ) population . Biomarkers were analyzed longitudinally for their predictive value . RESULTS Median survival for all r and omly assigned patients was 26.5 months ( 95 % CI , 21.6 to 39.5 months ) in arm A and 28.5 months ( 95 % CI , 20.4 to 38.6 months ) in arm B. The hazard ratio was 1.04 ( arm A v arm B : 95 % CI , 0.66 to 1.53 ; P=.99 ) . Median survival for the PP population was 32.1 months ( 95 % CI , 22.8 to 42.2 months ) in arm A and 28.5 months ( 95 % CI , 19.5 to 38.6 months ) in arm B ( P=.49 ) . Eighty-five percent of patients in arm A and 16 % of patients in arm B experienced grade 3 or 4 toxicity . The quality of life was temporarily negatively affected in arm A. CONCLUSION The FU , cisplatin , and IFN α-2b plus radiotherapy regimen did not improve the survival compared with FU monotherapy . Given the substantial adverse effects , this treatment can currently not be recommended . Nevertheless , the outcome in both arms represents the best survival , to our knowledge , ever reported for patients with resected pancreatic cancer in r and omized controlled trials . Future studies will demonstrate whether immune response to IFN α-2b challenge has a predictive value",
"BACKGROUND In a phase 1 - 2 trial of albumin-bound paclitaxel ( nab-paclitaxel ) plus gemcitabine , substantial clinical activity was noted in patients with advanced pancreatic cancer . We conducted a phase 3 study of the efficacy and safety of the combination versus gemcitabine monotherapy in patients with metastatic pancreatic cancer . METHODS We r and omly assigned patients with a Karnofsky performance-status score of 70 or more ( on a scale from 0 to 100 , with higher scores indicating better performance status ) to nab-paclitaxel ( 125 mg per square meter of body-surface area ) followed by gemcitabine ( 1000 mg per square meter ) on days 1 , 8 , and 15 every 4 weeks or gemcitabine monotherapy ( 1000 mg per square meter ) weekly for 7 of 8 weeks ( cycle 1 ) and then on days 1 , 8 , and 15 every 4 weeks ( cycle 2 and subsequent cycles ) . Patients received the study treatment until disease progression . The primary end point was overall survival ; secondary end points were progression-free survival and overall response rate . RESULTS A total of 861 patients were r and omly assigned to nab-paclitaxel plus gemcitabine ( 431 patients ) or gemcitabine ( 430 ) . The median overall survival was 8.5 months in the nab-paclitaxel-gemcitabine group as compared with 6.7 months in the gemcitabine group ( hazard ratio for death , 0.72 ; 95 % confidence interval [ CI ] , 0.62 to 0.83 ; P survival rate was 35 % in the nab-paclitaxel-gemcitabine group versus 22 % in the gemcitabine group at 1 year , and 9 % versus 4 % at 2 years . The median progression-free survival was 5.5 months in the nab-paclitaxel-gemcitabine group , as compared with 3.7 months in the gemcitabine group ( hazard ratio for disease progression or death , 0.69 ; 95 % CI , 0.58 to 0.82 ; P response rate according to independent review was 23 % versus 7 % in the two groups ( P adverse events of grade 3 or higher were neutropenia ( 38 % in the nab-paclitaxel-gemcitabine group vs. 27 % in the gemcitabine group ) , fatigue ( 17 % vs. 7 % ) , and neuropathy ( 17 % vs. 1 % ) . Febrile neutropenia occurred in 3 % versus 1 % of the patients in the two groups . In the nab-paclitaxel-gemcitabine group , neuropathy of grade 3 or higher improved to grade 1 or lower in a median of 29 days . CONCLUSIONS In patients with metastatic pancreatic adenocarcinoma , nab-paclitaxel plus gemcitabine significantly improved overall survival , progression-free survival , and response rate , but rates of peripheral neuropathy and myelosuppression were increased . ( Funded by Celgene ; Clinical Trials.gov number , NCT00844649 . )",
"Objective : To assess the impact of postoperative complications on the receipt of adjuvant chemotherapy . Background : R and omized trials have demonstrated that adjuvant chemotherapy is associated with improved long-term survival . However , pancreatic surgery is associated with significant morbidity and the degree to which complications limit subsequent treatment options is unknown . Methods : Patients from the American College of Surgeons National Surgical Quality Improvement Program and the National Cancer Data Base who underwent pancreatic resection for cancer were linked ( 2006–2009 ) . The associations between complications and adjuvant chemotherapy use or treatment delay ( ≥70 days from surgery ) were assessed using multivariable regression methods . Results : From 149 hospitals , 2047 patients underwent resection for stage I-III pancreatic adenocarcinoma of which 23.2 % had at least 1 serious complication . Overall adjuvant chemotherapy receipt was 57.7 % : 61.8 % among patients not experiencing any complication and 43.6 % among those who had a serious complication . Serious complications increased the likelihood of not receiving adjuvant therapy over twofold [ odds ratio ( OR ) = 2.20 , 95 % confidence interval ( CI ) : 1.73–2.80 ] . Specific complications associated with adjuvant chemotherapy omission were reintubation ( OR = 7.79 , 95 % CI : 3.59–16.87 ) , prolonged ventilation ( OR = 5.92 , 95 % CI : 3.23–10.86 ) , pneumonia ( OR = 2.83 , 95 % CI : 1.63–4.90 ) , sepsis/shock ( OR = 2.76 , 95 % CI : 2.02–3.76 ) , organ space/deep surgical site infection ( OR = 2.19 , 95 % CI : 1.53–3.13 ) , venous thromboembolism ( OR = 1.92 , 95 % CI : 1.08–3.43 ) , and urinary tract infection ( OR = 1.61 , 95 % CI : 1.02–2.54 ) . Serious complications also doubled the likelihood of delaying adjuvant treatment administration ( OR = 2.08 , 95 % CI : 1.42–3.05 ) . Sensitivity analysis in a younger , healthier patient cohort demonstrated similar associations . Conclusions : Postoperative complications are common following pancreatic surgery and are associated with adjuvant chemotherapy omission and treatment delays",
"CONTEXT The role of adjuvant therapy in resectable pancreatic cancer is still uncertain , and no recommended st and ard exists . OBJECTIVE To test the hypothesis that adjuvant chemotherapy with gemcitabine administered after complete resection of pancreatic cancer improves disease-free survival by 6 months or more . DESIGN , SETTING , AND PATIENTS Open , multicenter , r and omized controlled phase 3 trial with stratification for resection , tumor , and node status . Conducted from July 1998 to December 2004 in the outpatient setting at 88 academic and community-based oncology centers in Germany and Austria . A total of 368 patients with gross complete ( R0 or R1 ) resection of pancreatic cancer and no prior radiation or chemotherapy were enrolled into 2 groups . INTERVENTION Patients received adjuvant chemotherapy with 6 cycles of gemcitabine on days 1 , 8 , and 15 every 4 weeks ( n = 179 ) , or observation ( [ control ] n = 175 ) . MAIN OUTCOME MEASURES Primary end point was disease-free survival , and secondary end points were overall survival , toxicity , and quality of life . Survival analysis was based on all eligible patients ( intention-to-treat ) . RESULTS More than 80 % of patients had R0 resection . The median number of chemotherapy cycles in the gemcitabine group was 6 ( range , 0 - 6 ) . Grade 3 or 4 toxicities rarely occurred with no difference in quality of life ( by Spitzer index ) between groups . During median follow-up of 53 months , 133 patients ( 74 % ) in the gemcitabine group and 161 patients ( 92 % ) in the control group developed recurrent disease . Median disease-free survival was 13.4 months in the gemcitabine group ( 95 % confidence interval , 11.4 - 15.3 ) and 6.9 months in the control group ( 95 % confidence interval , 6.1 - 7.8 ; P Estimated disease-free survival at 3 and 5 years was 23.5 % and 16.5 % in the gemcitabine group , and 7.5 % and 5.5 % in the control group , respectively . Subgroup analyses showed that the effect of gemcitabine on disease-free survival was significant in patients with either R0 or R1 resection . There was no difference in overall survival between the gemcitabine group ( median , 22.1 months ; 95 % confidence interval , 18.4 - 25.8 ; estimated survival , 34 % at 3 years and 22.5 % at 5 years ) and the control group ( median , 20.2 months ; 95 % confidence interval , 17 - 23.4 ; estimated survival , 20.5 % at 3 years and 11.5 % at 5 years ; P = .06 , log-rank ) . CONCLUSIONS Postoperative gemcitabine significantly delayed the development of recurrent disease after complete resection of pancreatic cancer compared with observation alone . These results support the use of gemcitabine as adjuvant chemotherapy in resectable carcinoma of the pancreas . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N34802808",
"Purpose : Hemostatic activation is common in pancreatic cancer and may be linked to angiogenesis and venous thromboembolism . We investigated expression of tissue factor ( TF ) , the prime initiator of coagulation , in noninvasive and invasive pancreatic neoplasia . We correlated TF expression with vascular endothelial growth factor ( VEGF ) expression , microvessel density , and venous thromboembolism in resected pancreatic cancer . Experimental Design : Tissue cores from a tri-institutional retrospective series of patients were used to build tissue microarrays . TF expression was grade d semiquantitatively using immunohistochemistry in normal pancreas ( n = 10 ) , intraductal papillary mucinous neoplasms ( n = 70 ) , pancreatic intraepithelial neoplasia ( n = 40 ) , and resected or metastatic pancreatic adenocarcinomas ( n = 130 ) . Results : TF expression was observed in a majority of noninvasive and invasive pancreatic neoplasia , including 77 % of pancreatic intraepithelial neoplasias , 91 % of intraductal papillary mucinous neoplasms , and 89 % of pancreatic cancers , but not in normal pancreas . Sixty-six of 122 resected pancreatic cancers ( 54 % ) were found to have high TF expression ( defined as grade ≥2 , the median score ) . Carcinomas with high TF expression were more likely to also express VEGF ( 80 % versus 27 % with low TF expression , P higher median MVD ( 8 versus 5 per tissue core with low TF expression , P = 0.01 ) . Pancreatic cancer patients with high TF expression had a venous thromboembolism rate of 26.3 % compared with 4.5 % in patients with low TF expression ( P = 0.04 ) . Conclusions : TF expression occurs early in pancreatic neoplastic transformation and is associated with VEGF expression , increased microvessel density , and possibly clinical venous thromboembolism in pancreatic cancer . Prospect i ve studies evaluating the role of TF in pancreatic cancer outcomes are warranted",
"PURPOSE We conducted a phase II trial to assess the outcomes of patients who received preoperative gemcitabine-based chemoradiation and pancreaticoduodenectomy ( PD ) for stage I/II pancreatic adenocarcinoma . PATIENTS AND METHODS Eligible patients with pancreatic head/uncinate process adenocarcinoma and radiographically defined potentially resectable disease received chemoradiation with 7 weekly intravenous ( IV ) infusions of gemcitabine ( 400 mg/m(2 ) IV over 30 minutes ) plus radiation therapy ( 30 Gy in 10 fractions over 2 weeks ) . Patients underwent restaging 4 to 6 weeks after completion of chemoradiation and , in the absence of disease progression , were taken to surgery . RESULTS The study enrolled 86 patients . At the time of restaging , disease progression or a decline in performance status precluded 13 patients from surgery . Seventy-three ( 85 % ) of 86 patients were taken to surgery , extrapancreatic disease was found in nine , and 64 ( 74 % ) of 86 underwent a successful PD . Median overall survival ( 86 patients ) was 22.7 months with a 27 % 5-year survival . Median survival was 34 months for the 64 patients who underwent PD and 7 months for the 22 unresected patients ( P 5-year survival for those who did and did not undergo PD was 36 % and 0 % , respectively . CONCLUSION Preoperative gemcitabine-based chemoradiation followed by restaging and evaluation for surgery separated the study population into two different subsets : patients likely to benefit from PD ( n = 64 ) and those in whom surgery would be unlikely to provide clinical benefit ( n = 22 ) . Furthermore , the encouraging overall survival observed in this large trial supports the continued investigation of gemcitabine-based preoperative therapy in resectable pancreatic cancer",
"Purpose To evaluate the impact of a multidisciplinary clinic on the clinical care recommendations of patients with pancreatic cancer compared with the recommendations the patients received prior to review by the multidisciplinary tumor board . Methods The records of 203 consecutive patients referred to the Johns Hopkins pancreatic multidisciplinary clinic were prospect ively collected from November 2006 to October 2007 . Cross-sectional imaging , pathology , and medical history were evaluated by a panel of medical/radiation oncologists , surgical oncologists , pathologists , diagnostic radiologists , and geneticists . Alterations in treatment recommendations between the outside institution and the multidisciplinary clinic were recorded and compared . Results On presentation , the outside computed tomography ( CT ) report described locally advanced/unresectable disease ( 34.9 % ) , metastatic disease ( 17.7 % ) , and locally advanced disease with metastasis ( 1.1 % ) . On review of su bmi tted imaging and imaging performed at Hopkins , 38 out of 203 ( 18.7 % ) patients had a change in the status of their clinical stage . Review of the histological slides by dedicated pancreatic pathologists result ed in changes in the interpretation for 7 of 203 patients ( 3.4 % ) . Overall , 48 out of 203 ( 23.6 % ) patients had a change in their recommended management based on clinical review of their case by the multidisciplinary tumor board . Enrollment into the National Familial Pancreas Tumor Registry increased from 52 out of 106 ( 49.2 % ) patients in 2005 to 158 out of 203 ( 77.8 % ) with initiation of the multidisciplinary clinic . Conclusion The single-day pancreatic multidisciplinary clinic provided a comprehensive and coordinated evaluation of patients that led to changes in therapeutic recommendations in close to one-quarter of patients",
"PURPOSE Adjuvant chemotherapy improves patient survival rates after resection for pancreatic adenocarcinoma , but the optimal duration and time to initiate chemotherapy is unknown . PATIENTS AND METHODS Patients with pancreatic ductal adenocarcinoma treated within the international , phase III , European Study Group for Pancreatic Cancer-3 ( version 2 ) study were included if they had been r and omly assigned to chemotherapy . Overall survival analysis was performed on an intention-to-treat basis , retaining patients in their r and omized groups , and adjusting the overall treatment effect by known prognostic variables as well as the start time of chemotherapy . RESULTS There were 985 patients , of whom 486 ( 49 % ) received gemcitabine and 499 ( 51 % ) received fluorouracil ; 675 patients ( 68 % ) completed all six cycles of chemotherapy ( full course ) and 293 patients ( 30 % ) completed one to five cycles . Lymph node involvement , resection margins status , tumor differentiation , and completion of therapy were all shown by multivariable Cox regression to be independent survival factors . Overall survival favored patients who completed the full six courses of treatment versus those who did not ( hazard ratio [ HR ] , 0.516 ; 95 % CI , 0.443 to 0.601 ; P Time to starting chemotherapy did not influence overall survival rates for the full study population ( HR , 0.985 ; 95 % CI , 0.956 to 1.015 ) . Chemotherapy start time was an important survival factor only for the subgroup of patients who did not complete therapy , in favor of later treatment ( P adjuvant chemotherapy rather than early initiation was an independent prognostic factor after resection for pancreatic adenocarcinoma . There seems to be no difference in outcome if chemotherapy is delayed up to 12 weeks , thus allowing adequate time for postoperative recovery",
"Objective To assess the influence of resection margins on survival for patients with resected pancreatic cancer treated within the context of the adjuvant European Study Group for Pancreatic Cancer-1 ( ESPAC-1 ) study . Summary Background Data Pancreatic cancer is associated with a poor long-term survival rate of only 10 % to 15 % after resection . Patients with positive microscopic resection margins ( R1 ) have a worse survival , but it is not known how they fare in adjuvant studies . Methods ESPAC-1 , the largest r and omized adjuvant study of resectable pancreatic cancer ever performed , set out to look at the roles of chemoradiation and chemotherapy . R and omization was stratified prospect ively by resection margin status . Results Of 541 patients with a median follow-up of 10 months , 101 ( 19 % ) had R1 resections . Resection margin status was confirmed as an influential prognostic factor , with a median survival of 10.9 months for R1 versus 16.9 months months for patients with R0 margins . Resection margin status remained an independent factor in a Cox proportional hazards model only in the absence of tumor grade and nodal status . There was a survival benefit for chemotherapy but not chemoradiation , irrespective of R0/R1 status . The median survival was 19.7 months with chemotherapy versus 14.0 months without . For patients with R0 margins , chemotherapy produced longer survival compared with to no chemotherapy . This difference was less apparent for the smaller subgroup of R1 patients , but there was no significant heterogeneity between the R0 and R1 groups . Conclusions Resection margin-positive pancreatic tumors represent a biologically more aggressive cancer ; these patients benefit from resection and adjuvant chemotherapy but not chemoradiation . The magnitude of benefit for chemotherapy treatment is reduced for patients with R1 margins versus those with R0 margins . Patients with R1 tumors should be included in future trials of adjuvant treatments and r and omization and analysis should be stratified by this significant prognostic factor",
"BACKGROUND Cancer is a disease that particularly affects the elderly and , although surgery is the first treatment choice , many elderly cancer patients do not receive st and ard surgery because they are considered unfit for treatment due to an inaccurate estimation of operative risk . Pre-operative Assessment of Cancer in the Elderly ( PACE ) was developed in order to address the need to provide detailed information about the functional reserve of the elderly cancer patient to aid individualised management . METHODS PACE incorporates a battery of vali date d instruments including the Comprehensive Geriatric Assessment ( CGA ) , Brief Fatigue Inventory ( BFI ) , Eastern Cooperative Oncology Group Performance Status ( ECOG-PS ) , and American Society Anesthesiologists ( ASA ) grade . An international prospect i ve study was conducted with 460 consecutive elderly cancer patients ( 216 breast , 146 GIT , 71 GUT , 27 other ) receiving PACE prior to receiving elective surgery . RESULTS Three hundred and eighty four patients ( 83.4 % ) were observed to have at least one co-morbidity ; the most common being hypertension ( n=246 , 53.5 % ) . More than two thirds of the patients had good functional and mental status according to PACE . After adjusting for age , sex and type of cancer , six of the seven items of PACE were found to be significantly associated with co-morbidities ( according to the Satariano 's Index of Co-morbidities ( SIC ) ) . A multivariate analysis identified IADL , BFI and ASA to be the most important instruments in explaining SIC . DISCUSSION PACE has been effectively used to describe the functional capacity and health status in an international cohort of elderly cancer patients . The majority of PACE instruments have been found to be significantly associated with co-morbidities ( SIC ) and can distinguish between type and severity of cancer . PACE represents a useful tool in evaluating onco-geriatric fitness for surgery",
"Background R and omized trials have demonstrated a benefit associated with adjuvant therapy for pancreatic cancer , and retrospective studies have demonstrated improvements in postoperative mortality . The purpose of this study was to evaluate whether these improvements could be identified in a cohort of patients who underwent resection for pancreatic cancer at a single institution over three decades . Methods Short- ( 30 days ) , intermediate- ( 1 year ) , and long-term survival were compared between decades . Long-term survival focused on patients who survived at least 1 year to minimize the effects of perioperative mortality and patient selection . Results Between 1983 and 2009 , 1147 pancreatic resections were performed for ductal adenocarcinoma , including 123 resections in the 1980s , 399 in the 1990s , and 625 in the 2000s . The 30-day mortality rates were 4.9 % , 1.5 % ( P = 0.03 vs. 1980s ) , and 1.3 % ( P = 0.007 vs. 1980s ) . The 1-year mortality rates were 42 % , 31 % ( P overall survivals were 23.2 months , 25.6 months ( P = 0.6 vs. 1980s ) , and 24.5 months ( P = 0.2 vs. 1980s ) . In a multivariate analysis adjusted for pathologic features , the decade of resection was not a significant predictor of long-term survival ( hazard ratio = 1.1 , P = 0.3 ) . Conclusions Patients who underwent resection for pancreatic cancer between 2000 and 2009 experienced improved operative mortality and 1-year survival compared to those who underwent resection in the 1980s , while the long-term survival was similar over all three decades . These results underscore the need for early detection strategies and more effective adjuvant therapies for patients with pancreatic cancer",
"BACKGROUND Annualised figures show an up to 7-fold higher incidence of vascular thromboembolism ( VTE ) in patients with advanced pancreatic cancer ( APC ) compared to other common malignancies . Concurrent VTE has been shown to confer a worse overall prognosis in APC . METHODS One hundred and twenty three APC patients were r and omised to receive either gemcitabine 1000 mg/m(2 ) or the same with weight-adjusted dalteparin ( WAD ) for 12 weeks . Primary end-point was the reduction of all-type VTE during the study period . NCT00462852 , IS RCT N : 76464767 . FINDINGS The incidence of all-type VTE during the WAD treatment period ( risk ratio (RR)of 0.145 , 95 % confidence interval ( CI ) ( 0.035 - 0.612 ) and an 85 % risk reduction . All-type VTE throughout the whole follow-up period was reduced from 28 % to 12 % ( p = 0.039 ) , RR = 0.419 , 95 % CI ( 0.187 - 0.935 ) and a 58 % risk reduction . Lethal VTE was seen only in the control arm , 8.3 % compared to 0 % ( p = 0.057 ) , RR = 0.092 , 95 % CI ( 0.005 - 1.635 ) . INTERPRETATION Weight adjusted dalteparin used as primary prophylaxis for 12 weeks is safe and produces a highly significant reduction of all-type VTE during the prophylaxis period . The benefit is maintained after dalteparin withdrawal although decreases with time",
"Background The impact of the addition of gemcitabine to 5-fluorouracil ( 5-FU ) chemoradiation ( CRT ) on 5-year overall survival ( OS ) in resected pancreatic adenocarcinoma are presented with up date d results of a phase III trial . Methods After resection of pancreatic adenocarcinoma , patients were r and omized to pre- and post-CRT 5-FU versus pre- and post-CRT gemcitabine . 5-FU was provided continuously at 250 mg/m2/day , and gemcitabine was provided at 1000 mg/m2 weekly . Both were provided over 3 weeks before and 12 weeks after CRT . CRT was provided at 50.4 Gy with continuously provided 5-FU . The primary end point was survival for all patients and for patients with tumor of the pancreatic head . Results Four hundred fifty-one patients were eligible . Univariate analysis showed no difference in OS . Pancreatic head tumor patients ( n = 388 ) had a median survival and 5-year OS of 20.5 months and 22 % with gemcitabine versus 17.1 months and 18 % with 5-FU . On multivariate analysis , patients on the gemcitabine arm with pancreatic head tumors experienced a trend toward improved OS ( P = 0.08 ) . First site of relapse local recurrence in 28 % of patients versus distant relapse in 73 % . Conclusions The sequencing of 5-FU CRT with gemcitabine as done in this trial is not associated with a statistically significant improvement in OS . Despite local recurrence being approximately half of that reported in previous adjuvant trials , distant disease relapse still occurs in ≥70 % of patients . These findings serve as the basis for the recently activated EORTC/U.S. Intergroup RTOG 0848 phase III adjuvant trial evaluating the impact of CRT after completion of a full course of gemcitabine ",
"PURPOSE The role of adjuvant chemoradiotherapy ( CRT ) in resectable pancreatic cancer is still debated . This r and omized phase II intergroup study explores the feasibility and tolerability of a gemcitabine-based CRT regimen after R0 resection of pancreatic head cancer . PATIENTS AND METHODS Within 8 weeks after surgery , patients were r and omly assigned to receive either four cycles of gemcitabine ( control arm ) or gemcitabine for two cycles followed by weekly gemcitabine with concurrent radiation ( 50.4 Gy ; CRT arm ) . The primary objective was to exclude a 40 % rate of grade 4 hematologic or GI toxicity in the CRT arm with type I and II errors of 10 % . Secondary end points were late toxicity , disease-free survival ( DFS ) , and overall survival ( OS ) . RESULTS Between September 2004 and January 2007 , 90 patients were r and omly assigned ( 45:45 ) . Patient characteristics were similar in both arms . Treatment was completed per protocol by 86.7 % and 73.3 % ( 80 % CI , 63.1 % to 81.9 % ; 95 % CI , 58.1 % to 85.4 % ) in the control and CRT arms , respectively , and grade 4 toxicity was 0 % and 4.7 % ( two of 43 ; 80 % CI , 1.2 % to 11.9 % ) , respectively . In the CRT arm , three patients experienced grade 3-related late toxicity . Median DFS was 12 months in the CRT arm and 11 months in the control arm . Median OS was 24 months in both arms . First local recurrence was less frequent in the CRT arm ( 11 % v 24 % ) . CONCLUSION Adjuvant gemcitabine-based CRT is feasible , well-tolerated , and not deleterious ; adding this treatment to full-dose adjuvant gemcitabine after resection of pancreatic cancer should be evaluated in a phase III trial",
"IMPORTANCE The prognosis for patients with pancreatic cancer is poor , even after resection with curative intent . Gemcitabine-based chemotherapy is st and ard treatment for advanced pancreatic cancer , but its effect on survival in the adjuvant setting has not been demonstrated . OBJECTIVE To analyze whether previously reported improvement in disease-free survival with adjuvant gemcitabine therapy translates into improved overall survival . DESIGN , SETTING , AND PATIENTS CONKO-001 ( Charité Onkologie 001 ) , a multicenter , open-label , phase 3 r and omized trial to evaluate the efficacy and toxicity of gemcitabine in patients with pancreatic cancer after complete tumor resection . Patients with macroscopically completely removed pancreatic cancer entered the study between July 1998 and December 2004 in 88 hospitals in Germany and Austria . Follow-up ended in September 2012 . INTERVENTIONS After stratification for tumor stage , nodal status , and resection status , patients were r and omly assigned to either adjuvant gemcitabine treatment ( 1g/m2 d 1 , 8 , 15 , q 4 weeks ) for 6 months or to observation alone . MAIN OUTCOMES AND MEASURES The primary end point was disease-free survival . Secondary end points included treatment safety and overall survival , with overall survival defined as the time from date of r and omization to death . Patients lost to follow-up were censored on the date of their last follow-up . RESULTS A total of 368 patients were r and omized , and 354 were eligible for intention-to-treat- analysis . By September 2012 , 308 patients ( 87.0 % [ 95 % CI , 83.1%-90.1 % ] ) had relapsed and 316 patients ( 89.3 % [ 95 % CI , 85.6%-92.1 % ] ) had died . The median follow-up time was 136 months . The median disease-free survival was 13.4 ( 95 % CI , 11.6 - 15.3 ) months in the treatment group compared with 6.7 ( 95 % CI , 6.0 - 7.5 ) months in the observation group ( hazard ratio , 0.55 [ 95 % CI , 0.44 - 0.69 ] ; P prolonged overall survival compared with those r and omized to observation alone ( hazard ratio , 0.76 [ 95 % CI , 0.61 - 0.95 ] ; P = .01 ) , with 5-year overall survival of 20.7 % ( 95 % CI , 14.7%-26.6 % ) vs 10.4 % ( 95 % CI , 5.9%-15.0 % ) , respectively , and 10-year overall survival of 12.2 % ( 95 % CI , 7.3%-17.2 % ) vs 7.7 % ( 95 % CI , 3.6%-11.8 % ) . CONCLUSIONS AND RELEVANCE Among patients with macroscopic complete removal of pancreatic cancer , the use of adjuvant gemcitabine for 6 months compared with observation alone result ed in increased overall survival as well as disease-free survival . These findings provide strong support for the use of gemcitabine in this setting . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N34802808",
"BACKGROUND The effect of adjuvant treatment on survival in pancreatic cancer is unclear . We report the final results of the European Study Group for Pancreatic Cancer 1 Trial and up date the interim results . METHODS In a multicenter trial using a two-by-two factorial design , we r and omly assigned 73 patients with resected pancreatic ductal adenocarcinoma to treatment with chemoradiotherapy alone ( 20 Gy over a two-week period plus fluorouracil ) , 75 patients to chemotherapy alone ( fluorouracil ) , 72 patients to both chemoradiotherapy and chemotherapy , and 69 patients to observation . RESULTS The analysis was based on 237 deaths among the 289 patients ( 82 percent ) and a median follow-up of 47 months ( interquartile range , 33 to 62 ) . The estimated five-year survival rate was 10 percent among patients assigned to receive chemoradiotherapy and 20 percent among patients who did not receive chemoradiotherapy ( P=0.05 ) . The five-year survival rate was 21 percent among patients who received chemotherapy and 8 percent among patients who did not receive chemotherapy ( P=0.009 ) . The benefit of chemotherapy persisted after adjustment for major prognostic factors . CONCLUSIONS Adjuvant chemotherapy has a significant survival benefit in patients with resected pancreatic cancer , whereas adjuvant chemoradiotherapy has a deleterious effect on survival",
"PURPOSE We conducted a phase II trial of preoperative gemcitabine and cisplatin chemotherapy in addition to chemoradiation ( Gem-Cis-XRT ) and pancreaticoduodenectomy ( PD ) for patients with stage I/II pancreatic adenocarcinoma . PATIENTS AND METHODS Chemotherapy consisted of gemcitabine ( 750 mg/m(2 ) ) and cisplatin ( 30 mg/m(2 ) ) given every 2 weeks for four doses . Chemoradiation consisted of four weekly infusions of gemcitabine ( 400 mg/m(2 ) ) combined with radiation therapy ( 30 Gy in 10 fractions administered over 2 weeks ) delivered 5 days per week . Patients underwent restaging 4 to 6 weeks after completion of chemoradiation and , in the absence of disease progression , were taken to surgery . RESULTS The study enrolled 90 patients ; 79 patients ( 88 % ) completed chemo-chemoradiation . Sixty-two ( 78 % ) of 79 patients were taken to surgery and 52 ( 66 % ) of 79 underwent PD . The median overall survival of all 90 patients was 17.4 months . Median survival for the 79 patients who completed chemo-chemoradiation was 18.7 months , with a median survival of 31 months for the 52 patients who underwent PD and 10.5 months for the 27 patients who did not undergo surgical resection of their primary tumor ( P Gem-Cis-XRT did not improve survival beyond that achieved with preoperative gemcitabine-based chemoradiation ( Gem-XRT ) alone . The longer preoperative interval required more durable biliary decompression ( metal stents ) but was not associated with local tumor progression . The gemcitabine-based chemoradiation platform is a reasonable foundation on which to build future phase II multimodality trials for stage I/II pancreatic cancer incorporating emerging systemic therapies",
"PURPOSE Older adults are vulnerable to chemotherapy toxicity ; however , there are limited data to identify those at risk . The goals of this study are to identify risk factors for chemotherapy toxicity in older adults and develop a risk stratification schema for chemotherapy toxicity . PATIENTS AND METHODS Patients age ≥ 65 years with cancer from seven institutions completed a prechemotherapy assessment that captured sociodemographics , tumor/treatment variables , laboratory test results , and geriatric assessment variables ( function , comorbidity , cognition , psychological state , social activity/support , and nutritional status ) . Patients were followed through the chemotherapy course to capture grade 3 ( severe ) , grade 4 ( life-threatening or disabling ) , and grade 5 ( death ) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events . RESULTS In total , 500 patients with a mean age of 73 years ( range , 65 to 91 years ) with stage I to IV lung ( 29 % ) , GI ( 27 % ) , gynecologic ( 17 % ) , breast ( 11 % ) , genitourinary ( 10 % ) , or other ( 6 % ) cancer joined this prospect i ve study . Grade 3 to 5 toxicity occurred in 53 % of the patients ( 39 % grade 3 , 12 % grade 4 , 2 % grade 5 ) . A predictive model for grade 3 to 5 toxicity was developed that consisted of geriatric assessment variables , laboratory test values , and patient , tumor , and treatment characteristics . A scoring system in which the median risk score was 7 ( range , 0 to 19 ) and risk stratification schema ( risk score : percent incidence of grade 3 to 5 toxicity ) identified older adults at low ( 0 to 5 points ; 30 % ) , intermediate ( 6 to 9 points ; 52 % ) , or high risk ( 10 to 19 points ; 83 % ) of chemotherapy toxicity ( P the risk of chemotherapy toxicity in older adults . Geriatric assessment variables independently predicted the risk of toxicity ",
"A r and omized controlled trial has begun in Japan to compare orally administered S-1 with intravenous gemcitabine ( GEM ) as adjuvant chemotherapy for patients with curatively resected pancreatic cancer . Patients are enrolled within 10 weeks after pancreatectomy to be treated for six months after assignment to either S-1 ( 80 mg/m(2)/day for four weeks , repeated similarly every six weeks for a total of four courses ) or GEM ( 1000 mg/m(2 ) on days 1 , 8 and 15 , repeated similarly every four weeks for a total of six courses ) . The primary endpoint is overall survival ; secondary endpoints include relapse-free survival , incidence of adverse events and health-related quality of life . Each treatment arm includes 180 patients , providing an expected hazard ratio of 0.87 and an upper margin of 1.25 ( two-sided alpha-error , 0.05 ; power , 0.8 ) . Follow-up abdominal computed tomography is repeated every three months during the first two years , then every six months for three years",
"Background : The role for neoadjuvant systemic therapy in resectable pancreas adenocarcinoma remains undefined . Objective : We evaluated the efficacy of gemcitabine and oxaliplatin administered as preoperative therapy in patients with resectable pancreas adenocarcinoma . Methods : Eligible patients were screened using computed tomography – pancreas angiography , laparoscopy , endoscopic ultrasonography , and fine-needle aspiration cytology to identify 38 patients who received 4 cycles of neoadjuvant gemcitabine 1000 mg/m2 intravenously over 100 minutes and oxaliplatin 80 mg/m2 intravenously over 2 hours , every 2 weeks . Patients whose tumors remained resectable at restaging proceeded to operation and subsequently received 5 cycles of adjuvant gemcitabine ( 1000 mg/m2 intravenously over 30 minutes days 1 , 8 , and 15 every 4 weeks ) . The primary endpoint was 18-month overall survival and secondary endpoints included radiological , tumor marker and pathological response to neoadjuvant therapy , time to recurrence , patterns of failure , and feasibility of obtaining preoperative core biopsies . Results : Thirty-five of 38 patients ( 92 % ) completed neoadjuvant therapy . Twenty-seven patients underwent tumor resection ( resectability rate 71 % ) , of which 26 initiated adjuvant therapy for a total of 23 patients ( 60.5 % ) who completed all planned therapy . The 18-month survival was 63 % ( 24 patients alive ) . The median overall survival for all 38 patients was 27.2 months ( 95 % confidence interval : 17–NA ) and the median disease-specific survival was 30.6 months ( 95 % confidence interval : 19–NA ) . Conclusions : This study met its endpoint and provided a signal suggesting that exploration of neoadjuvant systemic therapy is worthy of further investigation in resectable pancreas adenocarcinoma . Improved patient selection and more active systemic regimens are key . Clinical trials identification : NCT00536874",
"Objective : To prospect ively evaluate the additional value of geriatric assessment ( GA ) for predicting surgical outcomes in a cohort of older patients undergoing a pancreaticoduodenectomy ( PD ) for pancreatic tumors . Background : Older patients are less often referred for possible PD . St and ard preoperative assessment s may underestimate the likelihood of significant adverse outcomes . The prospect i ve utility of vali date d GA has not been studied in this group . Methods : PD-eligible patients were enrolled in a prospect i ve outcome study . St and ard preoperative assessment s were recorded . Elements of vali date d GA were also measured , including components of Fried 's model of frailty , the Vulnerable Elders Survey ( VES-13 ) , and the Short Physical Performance Battery ( SPPB ) . All postoperative adverse events were recorded , systematic ally review ed , and grade d using the Clavien-Dindo system by a surgeon blinded to the GA results . Multivariate regression analyses were conducted . Results : Seventy-six older patients underwent a PD . Significant unrecognized vulnerability was identified at the baseline : Fried 's “ exhaustion ” ( 37.3 % ) , SPPB 3 ( 15.4 % ) . Within 30 days of PD , 46 % experienced a severe complication ( Clavien-Dindo grade ≥III ) . In regression analyses controlling for age , the body mass index , the American Society of Anesthesiologists score , and comorbidity burden , Fried 's “ exhaustion ” predicted major complications [ odds ratio ( OR ) = 4.06 ; P = 0.01 ] , longer hospital stays ( & bgr ; = 0.27 ; P = 0.02 ) , and surgical intensive care unit admissions ( OR = 4.30 ; P = 0.01 ) . Both SPPB ( OR = 0.61 ; P = 0.04 ) and older age predicted discharge to a rehabilitation facility ( OR = 1.1 ; P lower likelihood of hospital readmission ( OR = 0.94 ; P = 0.02 ) . Conclusions : Controlling for st and ard preoperative assessment s , worse scores on GA prospect ively and independently predicted important adverse outcomes . Geriatric assessment may help identify older patients at high risk for complications from PD",
"Background In treating pancreatic cancer , there is no clearly defined optimal sequence of chemotherapy , radiation therapy and surgery . Therefore , cost-effectiveness should be considered . The objective of this study was to compare cost and outcomes between a surgery-first approach versus neoadjuvant chemoradiation followed by surgery for resectable pancreatic head cancer . Methods A decision analytic model was constructed to compare the 2 approaches . Data from the National Cancer Data base , National Surgical Quality Improvement Program , and literature populated the surgery-first arm . Data from our prospect ively maintained institutional pancreatic cancer data base populated the neoadjuvant arm . Costs were estimated by Medicare payment ( 2011 U.S. dollars ) . Survival was reported in quality -adjusted life-months ( QALMs ) . Results The neoadjuvant chemoradiation arm consisted of 164 patients who completed preoperative therapy . Of these , 36 ( 22 % ) did not proceed to surgery ; 12 ( 7 % ) underwent laparotomy but had unresectable disease ; and 116 ( 71 % ) underwent definitive resection . The surgery-first approach cost $ 46,830 and yielded survival of 8.7 QALMs ; the neoadjuvant chemoradiation approach cost $ 36,583 and yielded survival of 18.8 QALMs . In the neoadjuvant arm , costs and survival times for patients not undergoing surgery , those with unresectable disease at laparotomy , and those completing surgery were $ 12,401 and 7.7 QALMs , $ 20,380 and 7.1 QALMs , and $ 45,673 and 23.4 QALMs , respectively . Conclusions Neoadjuvant chemoradiation for pancreatic cancer identifies patients with early metastases or poor performance status , who can be spared an ineffective or prohibitively morbid operation , and is associated with improved survival at significantly lower cost than a surgery-first approach . Neoadjuvant chemoradiation followed by surgery is a strategy that provides more cost-effective care than a surgery-first approach"
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41171356-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES To identify if enamel bevelling , compared to no treatment , improves the retention rates and marginal discolouration of cervical composite restorations in non-carious cervical lesions ( NCCLs ) of adult patients , through a systematic review of the literature and meta- analysis . SOURCES MEDLINE , Scopus , Web of Science , LILACS , BBO Library , Cochrane Library and SIGLE were search ed without restrictions , as well as the abstract s of the annual conference of the IADR and the trials registry . Dissertations and theses were search ed using the ProQuest Dissertations and Periódicos Capes Theses data bases . STUDY SELECTION We included r and omised clinical trials ( RCTs ) that compared the retention rates restorations in NCCLs placed with or without bevel with at least 1-year follow-up . The risk of bias tool of the Cochrane Collaboration was used for quality assessment . DATA After duplicate removal , 1356 articles were identified . After abstract screening , 14 studies remained and this number was reduced to four after examination of the full-texts . Only two were considered to have a ' low ' risk of bias . The overall risk difference was 0.0 ( 95 % CI -0.04 to 0.04 ) for the retention rate ( p=0.91 ) and 0.05 ( -0.02 to 0.13 ) for the marginal discolouration ( p=0.17 ) . CONCLUSIONS No superiority of bevelled restorations was observed in the short-term follow-up of 1-year , although this conclusion was based on only two RCTs . There is not enough evidence to support the bevelled technique over non-bevelled for NCCLs over longer periods of time . Better st and ardization and reporting of RCTs of enamel bevelling are necessary in longer-term follow-ups . CLINICAL SIGNIFICANCE The literature still lacks a body of evidence to support the benefits of enamel bevel over non-bevelled for longer-term follow-ups , and future r and omised clinical trials with low risk of bias should be conducted
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"PURPOSE To evaluate the 18-month clinical performance of a multimode adhesive ( Scotchbond Universal Adhesive , SU , 3 M ESPE , St Paul , MN , USA ) in noncarious cervical lesions ( NCCLs ) using two evaluation criteria . MATERIAL S AND METHODS Thirty-nine patients participated in this study . Two-hundred restorations were assigned to four groups : ERm , etch- and -rinse + moist dentin ; ERd , etch- and -rinse + dry dentin ; Set , selective enamel etching ; and SE , self-etch . The composite resin , Filtek Supreme Ultra ( 3 M ESPE ) , was placed incrementally . The restorations were evaluated at baseline , and at 18 months , using both the World Dental Federation ( FDI ) and the United States Public Health Service ( USPHS ) criteria . Statistical analyses were performed using Friedman repeated- measures analysis of variance by rank and McNemar test for significance in each pair ( α=0.05 ) . RESULTS Five restorations ( SE : 3 ; Set : 1 ; and ERm : 1 ) were lost after 18 months ( p>0.05 for either criteria ) . Marginal staining occurred in four and 10 % of the restorations evaluated ( p>0.05 ) , respectively , for USPHS and FDI criteria . Nine restorations were scored as bravo for marginal adaptation using the USPHS criteria and 38 % , 40 % , 36 % , and 44 % for groups ERm , ERd , Set , and SE , respectively , when the FDI criteria were applied ( p>0.05 ) . However , when semiquantitative scores ( or SQUACE ) for marginal adaptation were used , SE result ed in a significantly greater number of restorations , with more than 30 % of the total length of the interface showing marginal discrepancy ( 28 % ) in comparison with the other groups ( 8 % , 6 % , and 8 % , respectively , for ERm , ERd , and Set ) . CONCLUSIONS The clinical retention of the multimode adhesive at 18 months does not depend on the bonding strategy . The only differences between strategies were found for the parameter marginal adaptation , for which the FDI criteria were more sensitive than the USPHS criteria",
"This study tested the hypothesis that beveling and /or etching enamel does not affect the 6-month clinical performance of the self-etch adhesive Clearfil SE Bond in class V noncarious lesions . With Institutional Review Board approval , 34 patients were enrolled in this study . A total of 120 noncarious cervical lesions were selected and assigned to 4 groups : ( 1 ) Clearfil SE Bond was applied without any cavity preparation ; ( 2 ) After the enamel was beveled , Clearfil SE Bond was applied ; ( 3 ) After the enamel was etched for 15 seconds with 35 % phosphoric acid , Clearfil SE Bond was applied ; ( 4 ) After the enamel was beveled and etched with 35 % phosphoric acid for 15 seconds , Clearfil SE Bond was applied . A microfilled composite resin was used for all restorations . Six months after initial placement , 120 restorations ( a 100 % recall rate ) were re-evaluated . Retention rates at 6 months were 100 % for all groups . Sensitivity to air improved from baseline to 6 months , but the overall difference was not statistically significant . The 6-month retention rate of the self etch dentin adhesive system Clearfil SE Bond was not improved by enamel beveling or by enamel etching . For the self-etch material Clearfil SE Bond , instrumentation or etching of enamel may not be critical for its clinical performance at 6 months",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVES This r and omized controlled clinical trial evaluated the 3-year clinical performance of a hybrid ( Clearfil AP-X ; AP ) and a flowable ( Clearfil Flow FX ; FX ) resin composite in 98 non-carious cervical lesions . METHODS Twenty-two patients , 11 males and 11 females ( mean age : 61.9 years , range : 29 - 78 years ) regularly visiting the Nagasaki University Hospital , participated in the study . Each patient received both material s r and omly . All restorations ( 48 restorations for AP and 50 restorations for FX ) were placed in conjunction with an all-in-one system ( Clearfil S(3 ) Bond ) by one dentist . The restorations were blindly evaluated by two examiners at baseline , 6 months , 1 , 2 and 3 years using modified USPHS criteria . The data were statistically analyzed using the Cochran 's Q-test and Fisher 's exact test . RESULTS All the patients were examined at each recall . However , five restorations could not be evaluated at 3-year recall as two teeth had been extracted and three restorations had been lost . The only minor problem was the integrity of the enamel margin . The incidence and extent of marginal staining increased with time , but it was still superficial . Marginal staining occurred adjacent to 11 restorations for AP and 12 restorations for FX after 3 years . Neither lesion size nor depth had influence on marginal staining adjacent to each type of resin composite . There were no significant differences in the clinical performances between AP and FX for each variable . CONCLUSIONS Under the protocol used in this study , both types of resin composite in conjunction with S(3 ) Bond demonstrated an acceptable clinical performance up to 3 years",
"OBJECTIVES The objective of this r and omized controlled clinical trial was to evaluate the 8-year clinical performance of a mild 2-step self-etch adhesive in non-carious Class-V lesions with and without prior selective phosphoric acid-etching of the enamel cavity margins . METHODS A total of 100 non-carious Class-V lesions in 29 patients were restored with Clearfil AP-X ( Kuraray ) . The composite restorations were bonded following two different approaches : ( 1 ) application of Clearfil SE ( Kuraray ) following a self-etch approach ( control group ; C-SE non-etch ) , ( 2 ) selective phosphoric acid-etching of the enamel cavity margins before application of Clearfil SE ( experimental group ; C-SE etch ) . The restorations were evaluated after 6 months , 1 , 2 , 3 , 5 and 8 years of clinical service regarding their retention , marginal integrity and discoloration , caries occurrence , preservation of tooth vitality and post-operative sensitivity . RESULTS The recall rate at 8 years was 76 % . Only two restorations , one of the C-SE non-etch group and one of the C-SE etch group , were clinical ly unacceptable due to loss of retention leading to a retention rate and a clinical success rate of 97 % in both groups . Aging of the restorations was characterized by an increase in the percentage of restorations with a small but clinical ly acceptable marginal defect ( C-SE non-etch : 92 % ; C-SE etch : 84 % ) and /or a superficial marginal discoloration ( C-SE non-etch : 44 % ; C-SE etch : 28 % ) . At the enamel side , the presence of small marginal defects ( C-SE non-etch : 86 % ; C-SE etch : 65 % ) and superficial marginal discoloration ( C-SE non-etch : 11 % ; C-SE etch% ) was more frequently noticed in the control group than in the experimental group . The difference , however , was only statistically significant for the presence of superficial marginal discoloration ( McNemar , p=0.01 ) . SIGNIFICANCE After 8 years of clinical functioning , the clinical effectiveness of Clearfil SE remained excellent , with selective acid-etching of the enamel cavity margins only having some minor positive effect on marginal integrity and absence of marginal discoloration at enamel",
"This study evaluated the effect of the elastic modulus and margin configuration on the clinical performance of resin-based composite restorations in Class V non-carious defects . One hundred and five cervical non-carious defects on buccal surfaces of canines and premolars were included in this study . Defects were r and omly divided into three Groups and restored according to the following techniques : Group 1 - -no enamel bevel was placed and the defect was restored with a microfilled resin-based composite ( Durafill VS ) ; Group 2 - -the enamel margin was beveled and the defect restored as in Group 1 ; Group 3-the enamel margin was beveled and the defect was restored with a flowable resin-based composite ( Natural Flow ) . Each group comprised 35 lesions . A total-etch , one-bottle adhesive ( One-Step ) was used in all groups . Retention rate , pre- and post-operative sensitivity , marginal discoloration and secondary caries were determined over a three-year period and the data were analyzed statistically . At six months post-insertion , the restorations placed with beveled enamel margins result ed in 100 % retention regardless of the composite used compared to a 66 % retention of the non-beveled margins . At two and three years , no significant difference in retention rate was found among the three groups . Post-operative sensitivity , marginal discoloration and secondary caries were not affected by enamel beveling and restorative material . Beveled enamel margins result ed in significantly better clinical retention in the first six months only . Enamel beveling and composite viscosity appeared to not significantly affect the clinical performance of Class V non-retentive composite restorations after three years",
"PURPOSE This study tested the None hypothesis that the preparation of the enamel surface would not affect the enamel microtensile bond strengths of self-etching adhesive material s. MATERIAL S AND METHODS Ten bovine incisors were trimmed with a diamond saw to obtain a squared enamel surface with an area of 8 x 8 mm . The specimens were r and omly assigned to five adhesives : ( 1 ) ABF ( Kuraray ) , an experimental two-bottle self-etching adhesive ; ( 2 ) Clearfil SE Bond ( Kuraray ) , a two-bottle self-etching adhesive ; ( 3 ) One-Up Bond F ( Tokuyama ) , an all-in-one adhesive ; ( 4 ) Prompt L-Pop ( 3 M ESPE ) , an all-in-one adhesive ; and ( 5 ) Single Bond ( 3 M ESPE ) , a two-bottle total-etch adhesive used as positive control . For each specimen , one half was roughened with a diamond bur for 5 seconds under water spray , whereas the other half was left unprepared . The adhesives were applied as per manufacturers ' directions . A universal hybrid composite resin ( Filtek Z250 , 3 M ESPE ) was inserted in three layers of 1.5 mm each and light-cured . Specimens were sectioned in X and Y directions to obtain bonded sticks with a cross-sectional area of 0.8 + /- 0.2 mm2 . Sticks were tested in tension in an Instron at a cross-speed of 1 mm per minute . Statistical analysis was carried out with two-way analysis of variance and Duncan 's test at p microtensile bond strength than any of the other adhesives regardless of the enamel preparation ( unprepared = 31.5 MPa ; prepared = 34.9 MPa , not statistically different at p self-etching adhesives result ed in higher microtensile bond strength when enamel was roughened than when enamel was left unprepared . However , for ABF and for Clearfil SE Bond this difference was not statistically significant at p > .05 . When applied to ground enamel , mean bond strengths of Prompt L-Pop were not statistically different from those of Clearfil SE Bond and ABF . One-Up Bond F did not bond to unprepared enamel . Commercial self-etching adhesives performed better on prepared enamel than on unprepared enamel . The field-emission scanning electron microscope revealed a deep inter prisma tic etching pattern for the total-etch adhesive , whereas the self-etching systems result ed in an etching pattern ranging from absent to moderate",
"Laboratory testing of dentin adhesive systems still requires corroboration by long-term clinical trials for their ultimate clinical effectiveness to be vali date d. The objective of this clinical investigation was to evaluate , retrospectively , the clinical effectiveness of earlier-investigated dentin adhesive systems ( Scotchbond , Gluma , Clearf il New Bond , Scotchbond 2 , Tenure , and Tripton ) , and to compare their clinical results with those obtained with four modern total-etch adhesive systems ( Bayer exp . 1 and 2 , Clearfil Liner Bond System , and Scotchbond Multi- Purpose ) . In total , 1177 Class V cervical lesions in the teeth of 346 patients were restored following two cavity design s : In Group A , enamel was neither beveled nor intentionally etched , as per ADA guidelines ; in Group B , adjacent enamel was beveled and conditioned . Clinical retention rates definitely indicated the improved clinical efficacy of the newest dentin adhesives over the earlier systems . With regard to adhesion strategy , adhesive systems that removed the smear layer and concurrently demineralized the dentin surface layer performed clinical ly better than systems that modified the disorderly layer of smear debris without complete removal . Hybridization by resin interdiffusion into the exposed dentinal collagen layer , combined with attachment of resin tags into the opened dentin tubules , appeared to be essential for reliable dentin bonding but might be insufficient by itself . The additional formation of an elastic bonding area as a polymerization shrinkage absorber and the use of a microfine restorative composite apparently guaranteed an efficient clinical result . The perfect one-year retention recorded for Clearfil Liner Bond System and Scotchbond Multi- Purpose must be confirmed at later recalls",
"This double-blind clinical trial was undertaken to compare the retention rate of restorative material s with contrasting stiffness in noncarious class 5 lesions . All restorations were placed using retraction cord and cotton roll isolation to more closely mimic the general practice setting . Thirty subjects with at least two lesions were recruited to participate in the study . Each subject received one restoration using Silux Plus and one using Z100 . The assignment of material was r and omized , and the subjects were unaware of which tooth had received which material . All restorations were placed with a fourth-generation adhesive liner , Scotchbond Multi- Purpose . Evaluations were performed at baseline , 6 , and 12 months by two independent examiners unaware of the restoration 's group identity . The restorations were evaluated using criteria developed by Cvar and Ryge in a forced-consensus model . Despite the fact that the two material s have widely different elastic modulus values , after 12 months no difference between the retention rates for the two groups was found , and both groups of restorations performed very well",
"PURPOSE To test the None hypothesis that beveling and /or etching enamel would not affect the 18-month clinical performance of the self-etching adhesive Clearfil SE Bond ( CSEB ) in noncarious cervical lesions ( NCCL ) . METHODS With Institutional Review Board approval , 34 patients were enrolled in this study . A total of 120 NCCL was selected and assigned to four groups : ( 1 ) CSEB was applied without any cavity preparation ; ( 2 ) CSEB was applied after beveling enamel ; ( 3 ) CSEB was applied after etching enamel for 15 seconds with 35 % phosphoric acid ; ( 4 ) CSEB was applied after beveling and etching enamel . A microfilled composite resin was used for all restorations . RESULTS At 6 months after initial placement , 120 restorations ( a 100 % recall rate ) were evaluated . At 18 months , 87 restorations ( a 72.5 % recall rate ) were available for evaluation . A survival rate of 100 % was measured for all groups at both 6 and 18 months . Sensitivity to air decreased significantly only for Group 3 ( no bevel+acid etch ) from baseline to 18 months without statistical changes from 6 months to 18 months . None of the other parameters result ed in significant differences for any of the four groups . However , when data were pooled , both the overall marginal discoloration and the overall marginal adaptation were significantly worse at 18 months than at baseline , while sensitivity to air decreased significantly from baseline to 18 months . The 18-month survival rate of the self-etching adhesive Clearfil SE Bond was not improved by enamel bevel or by enamel etching . Both overall marginal adaptation and overall marginal discoloration were worse at 18 months than at baseline .",
"AIM : This was to assess the effect of bevelling the margins of fissures on buccal surfaces in permanent molars on marginal microleakage of fissure sealants . METHODS : The in vitro study was performed on buccal surfaces of 20 extracted permanent third molars , r and omly divided into two groups of 10 teeth . Group I : performing enameloplasty ( opening the fissures using fissurotomy bur ) , conditioning with phosphoric acid ( 37 % phosphoric acid for 20 s ) , placing bonding ( enamel bonding agent ) , and then fissure sealant . Group II : all stages were similar to Group I , except for bevelling the margins of buccal fissures ( 0.5 mm bevel ) after enameloplasty . Teeth were then thermocycled , stained with 0.5 % basic fuchsin , sectioned and examined for marginal microleakage . The Mann-Whitney test was used for statistical analysis . RESULTS : No dye penetration was seen in Group II ( with bevel ) , but there was a 60 % microleakage in Group I ( without bevel ) ( P=0.005 ) . CONCLUSIONS : In permanent molar teeth , bevelling the margins of fissures on the buccal surfaces appears to reduce the marginal microleakage of fissure sealants",
"PURPOSE This study compared the effectiveness of self-etch and total-etch adhesive systems in bonding to the beveled and nonbeveled margins of primary and permanent teeth . METHODS This in vitro , factorial- design ed study allowed evaluation of 3 factors : ( 1 ) tooth type ; ( 2 ) presence of a bevel ; and ( 3 ) adhesive type . Two preparations , each including a beveled and nonbeveled margin , were completed on buccal surfaces of 60 extracted molars ( 30 primary and 30 permanent ) . Preparations were r and omly assigned to self-etch or a total-etch adhesive system and restored with resin composite . After thermocycling , teeth were stained with silver nitrate , sectioned , and measured for microleakage . Statistical analysis used a repeated measures analysis of variance . RESULTS Beveled margins had less microleakage than nonbeveled margins for primary and permanent teeth ( P Total-etch had less microleakage than self-etch adhesives on primary ( 53 % less , P Self-etch had considerably more microleakage when enamel margins were not beveled . Comparably less microleakage , however , was found for total-etch and self-etch in restorations with beveled margins . CONCLUSIONS Total-etch adhesive and beveled margins result ed in the least microleakage . Margin beveling has a greater effect in minimizing microleakage than the type of adhesive used"
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Research into the basic effects and therapeutic applications of psychedelic drugs has grown considerably in recent years . Yet , pressing questions remain regarding the substances ' lasting effects . Although individual studies have begun monitoring sustained changes , no study to- date has synthesized this information . Therefore , this systematic review aims to fill this important gap in the literature by synthesizing results from 34 contemporary experimental studies which included classic psychedelics , human subjects , and follow-up latencies of at least two weeks . The bulk of this work was published in the last five years , with psilocybin being the most frequently administered drug . Enduring changes in personality/attitudes , depression , spirituality , anxiety , wellbeing , substance misuse , meditative practice s , and mindfulness were documented . Mystical experiences , connectedness , emotional breakthrough , and increased neural entropy were related to these long-term changes in psychological functioning . Finally , with proper screening , preparation , supervision , and integration , limited aversive side effects were noted by study participants . Future research ers should focus on including larger and more diverse sample s , lengthier longitudinal design s , stronger control conditions , and st and ardized dosages
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"A recent large population study of 130,000 adults in the United States failed to find evidence for a link between psychedelic use ( lysergic acid diethylamide , psilocybin or mescaline ) and mental health problems . Using a new data set consisting of 135,095 r and omly selected United States adults , including 19,299 psychedelic users , we examine the associations between psychedelic use and mental health . After adjusting for sociodemographics , other drug use and childhood depression , we found no significant associations between lifetime use of psychedelics and increased likelihood of past year serious psychological distress , mental health treatment , suicidal thoughts , suicidal plans and suicide attempt , depression and anxiety . We failed to find evidence that psychedelic use is an independent risk factor for mental health problems . Psychedelics are not known to harm the brain or other body organs or to cause addiction or compulsive use ; serious adverse events involving psychedelics are extremely rare . Overall , it is difficult to see how prohibition of psychedelics can be justified as a public health measure",
"Personality is known to be relatively stable throughout adulthood . Nevertheless , it has been shown that major life events with high personal significance , including experiences engendered by psychedelic drugs , can have an enduring impact on some core facets of personality . In the present , balanced‐order , placebo‐controlled study , we investigated biological predictors of post‐lysergic acid diethylamide ( LSD ) changes in personality . Nineteen healthy adults underwent resting state functional MRI scans under LSD ( 75 µg , I.V. ) and placebo ( saline I.V. ) . The Revised NEO Personality Inventory ( NEO‐PI‐R ) was completed at screening and 2 weeks after LSD/placebo . Scanning sessions consisted of three 7.5‐min eyes‐closed resting‐state scans , one of which involved music listening . A st and ardized preprocessing pipeline was used to extract measures of sample entropy , which characterizes the predictability of an fMRI time‐series . Mixed‐effects models were used to evaluate drug‐induced shifts in brain entropy and their relationship with the observed increases in the personality trait openness at the 2‐week follow‐up . Overall , LSD had a pronounced global effect on brain entropy , increasing it in both sensory and hierarchically higher networks across multiple time scales . These shifts predicted enduring increases in trait openness . Moreover , the predictive power of the entropy increases was greatest for the music‐listening scans and when “ ego‐dissolution ” was reported during the acute experience . These results shed new light on how LSD‐induced shifts in brain dynamics and concomitant subjective experience can be predictive of lasting changes in personality . Hum Brain Mapp 37:3203–3213 , 2016 . © 2016 Wiley Periodicals ,",
"Abstract A double-blind , r and omized , active placebo-controlled pilot study was conducted to examine safety and efficacy of lysergic acid diethylamide (LSD)-assisted psychotherapy in 12 patients with anxiety associated with life-threatening diseases . Treatment included drug-free psychotherapy sessions supplemented by two LSD-assisted psychotherapy sessions 2 to 3 weeks apart . The participants received either 200 & mgr;g of LSD ( n = 8) or 20 & mgr;g of LSD with an open-label crossover to 200 & mgr;g of LSD after the initial blinded treatment was unmasked ( n = 4 ) . At the 2-month follow-up , positive trends were found via the State-Trait Anxiety Inventory ( STAI ) in reductions in trait anxiety ( p = 0.033 ) with an effect size of 1.1 , and state anxiety was significantly reduced ( p = 0.021 ) with an effect size of 1.2 , with no acute or chronic adverse effects persisting beyond 1 day after treatment or treatment-related serious adverse events . STAI reductions were sustained for 12 months . These results indicate that when administered safely in a method ologically rigorous medically supervised psychotherapeutic setting , LSD can reduce anxiety , suggesting that larger controlled studies are warranted",
"HighlightsSerotonergic psychedelics act as agonists at cortical 5‐HT2A receptors.5‐HT2A receptors are expressed in fronto‐temporo‐parieto‐occipital areas .Some personality traits seem to be related to 5‐HT2A receptor expression . Acute and long‐term use of psychedelics is associated with personality changes . Personality changes induced by psychedelics may have therapeutic effects . & NA ; Serotonergic psychedelics act as agonists at cortical 5‐HT2A receptors and seem to induce personality changes . We conducted a systematic review of studies assessing the effects of these drugs on personality . Papers published from 1985–2016 were included from PubMed , LILACS , and SciELO data bases . Three hundred and sixty‐nine studies were identified , and 18 were included . Specific personality traits , such as Absorption and Self‐Transcendence , seem to influence the effects of psychedelics , and psychedelic drug users and nonusers appear to differ in some personality traits . Psychedelics administered in controlled setting s may induce personality changes , such as increased Openness and Self‐Transcendence . Increases in global brain entropy induced by acute psychedelic administration predicted changes in Openness , and Self‐Transcendence was negatively correlated with cortical thinning of the posterior cingulate cortex in long‐term religious ayahuasca users . Acute and long‐term use of psychedelics is associated with personality changes that appear to be modulated by 5‐HT2A receptors . These changes seem to induce therapeutic effects that should be further explored in r and omized controlled studies",
"Rationale Recent clinical trials are reporting marked improvements in mental health outcomes with psychedelic drug-assisted psychotherapy . Objectives Here , we report on safety and efficacy outcomes for up to 6 months in an open-label trial of psilocybin for treatment-resistant depression . Methods Twenty patients ( six females ) with ( mostly ) severe , unipolar , treatment-resistant major depression received two oral doses of psilocybin ( 10 and 25 mg , 7 days apart ) in a supportive setting . Depressive symptoms were assessed from 1 week to 6 months post-treatment , with the self-rated QIDS-SR16 as the primary outcome measure . Results Treatment was generally well tolerated . Relative to baseline , marked reductions in depressive symptoms were observed for the first 5 weeks post-treatment ( Cohen ’s d = 2.2 at week 1 and 2.3 at week 5 , both p conventional antidepressant treatment within 5 weeks of psilocybin . Reductions in depressive symptoms at 5 weeks were predicted by the quality of the acute psychedelic experience . Conclusions Although limited conclusions can be drawn about treatment efficacy from open-label trials , tolerability was good , effect sizes large and symptom improvements appeared rapidly after just two psilocybin treatment sessions and remained significant 6 months post-treatment in a treatment-resistant cohort . Psilocybin represents a promising paradigm for unresponsive depression that warrants further research in double-blind r and omised control trials",
"Psilocybin-occasioned mystical experiences have been linked to persisting effects in healthy volunteers including positive changes in behavior , attitudes , and values , and increases in the personality domain of openness . In an open-label pilot- study of psilocybin-facilitated smoking addiction treatment , 15 smokers received 2 or 3 doses of psilocybin in the context of cognitive behavioral therapy ( CBT ) for smoking cessation . Twelve of 15 participants ( 80 % ) demonstrated biologically verified smoking abstinence at 6-month follow-up . Participants who were abstinent at 6 months ( n=12 ) were compared to participants still smoking at 6 months ( n=3 ) on measures of subjective effects of psilocybin . Abstainers scored significantly higher on a measure of psilocybin-occasioned mystical experience . No significant differences in general intensity of drug effects were found between groups , suggesting that mystical-type subjective effects , rather than overall intensity of drug effects , were responsible for smoking cessation . Nine of 15 participants ( 60 % ) met criteria for \" complete \" mystical experience . Smoking cessation outcomes were significantly correlated with measures of mystical experience on session days , as well as retrospective ratings of personal meaning and spiritual significance of psilocybin sessions . These results suggest a mediating role of mystical experience in psychedelic-facilitated addiction treatment",
"Several lines of evidence suggest that classic ( 5HT2A agonist ) hallucinogens have clinical ly relevant effects in alcohol and drug addiction . Although recent studies have investigated the effects of psilocybin in various population s , there have been no studies on the efficacy of psilocybin for alcohol dependence . We conducted a single-group proof-of-concept study to quantify acute effects of psilocybin in alcohol-dependent participants and to provide preliminary outcome and safety data . Ten volunteers with DSM-IV alcohol dependence received orally administered psilocybin in one or two supervised sessions in addition to Motivational Enhancement Therapy and therapy sessions devoted to preparation for and debriefing from the psilocybin sessions . Participants ’ responses to psilocybin were qualitatively similar to those described in other population s. Abstinence did not increase significantly in the first 4 weeks of treatment ( when participants had not yet received psilocybin ) , but increased significantly following psilocybin administration ( p intensity of effects in the first psilocybin session ( at week 4 ) strongly predicted change in drinking during weeks 5–8 ( r = 0.76 to r = 0.89 ) and also predicted decreases in craving and increases in abstinence self-efficacy during week 5 . There were no significant treatment-related adverse events . These preliminary findings provide a strong rationale for controlled trials with larger sample s to investigate efficacy and mechanisms . TRIAL REGISTRATION :",
"Psilocybin can occasion mystical-type experiences with participant-attributed increases in well-being . However , little research has examined enduring changes in traits . This study administered psilocybin to participants who undertook a program of meditation/spiritual practice s. Healthy participants were r and omized to three groups ( 25 each ) : ( 1 ) very low-dose ( 1 mg/70 kg on sessions 1 and 2 ) with moderate-level ( “ st and ard ” ) support for spiritual- practice ( LD-SS ) ; ( 2 ) high-dose ( 20 and 30 mg/70 kg on sessions 1 and 2 , respectively ) with st and ard support ( HD-SS ) ; and ( 3 ) high-dose ( 20 and 30 mg/70 kg on sessions 1 and 2 , respectively ) with high support for spiritual practice ( HD-HS ) . Psilocybin was administered double-blind and instructions to participants /staff minimized expectancy confounds . Psilocybin was administered 1 and 2 months after spiritual- practice initiation . Outcomes at 6 months included rates of spiritual practice and persisting effects of psilocybin . Compared with low-dose , high-dose psilocybin produced greater acute and persisting effects . At 6 months , compared with LD-SS , both high-dose groups showed large significant positive changes on longitudinal measures of interpersonal closeness , gratitude , life meaning/ purpose , forgiveness , death transcendence , daily spiritual experiences , religious faith and coping , and community observer ratings . Determinants of enduring effects were psilocybin-occasioned mystical-type experience and rates of meditation/spiritual practice s. Psilocybin can occasion enduring trait-level increases in prosocial attitudes/behaviors and in healthy psychological functioning . Trial Registration Clinical Trials.gov Identifier",
"Rationale Although psilocybin has been used for centuries for religious purpose s , little is known scientifically about its acute and persisting effects . Objectives This double-blind study evaluated the acute and longer-term psychological effects of a high dose of psilocybin relative to a comparison compound administered under comfortable , supportive conditions . Material s and methods The participants were hallucinogen-naïve adults reporting regular participation in religious or spiritual activities . Two or three sessions were conducted at 2-month intervals . Thirty volunteers received orally administered psilocybin ( 30 mg/70 kg ) and methylpheni date hydrochloride ( 40 mg/70 kg ) in counterbalanced order . To obscure the study design , six additional volunteers received methylpheni date in the first two sessions and unblinded psilocybin in a third session . The 8-h sessions were conducted individually . Volunteers were encouraged to close their eyes and direct their attention inward . Study monitors rated volunteers ’ behavior during sessions . Volunteers completed question naires assessing drug effects and mystical experience immediately after and 2 months after sessions . Community observers rated changes in the volunteer ’s attitudes and behavior . Results Psilocybin produced a range of acute perceptual changes , subjective experiences , and labile moods including anxiety . Psilocybin also increased measures of mystical experience . At 2 months , the volunteers rated the psilocybin experience as having substantial personal meaning and spiritual significance and attributed to the experience sustained positive changes in attitudes and behavior consistent with changes rated by community observers . Conclusions When administered under supportive conditions , psilocybin occasioned experiences similar to spontaneously occurring mystical experiences . The ability to occasion such experiences prospect ively will allow rigorous scientific investigations of their causes and consequences",
"Background : Clinical ly significant anxiety and depression are common in patients with cancer , and are associated with poor psychiatric and medical outcomes . Historical and recent research suggests a role for psilocybin to treat cancer-related anxiety and depression . Methods : In this double-blind , placebo-controlled , crossover trial , 29 patients with cancer-related anxiety and depression were r and omly assigned and received treatment with single-dose psilocybin ( 0.3 mg/kg ) or niacin , both in conjunction with psychotherapy . The primary outcomes were anxiety and depression assessed between groups prior to the crossover at 7 weeks . Results : Prior to the crossover , psilocybin produced immediate , substantial , and sustained improvements in anxiety and depression and led to decreases in cancer-related demoralization and hopelessness , improved spiritual wellbeing , and increased quality of life . At the 6.5-month follow-up , psilocybin was associated with enduring anxiolytic and anti-depressant effects ( approximately 60–80 % of participants continued with clinical ly significant reductions in depression or anxiety ) , sustained benefits in existential distress and quality of life , as well as improved attitudes towards death . The psilocybin-induced mystical experience mediated the therapeutic effect of psilocybin on anxiety and depression . Conclusions : In conjunction with psychotherapy , single moderate-dose psilocybin produced rapid , robust and enduring anxiolytic and anti-depressant effects in patients with cancer-related psychological distress . Trial Registration : Clinical Trials.gov Identifier :",
"Cancer patients often develop chronic , clinical ly significant symptoms of depression and anxiety . Previous studies suggest that psilocybin may decrease depression and anxiety in cancer patients . The effects of psilocybin were studied in 51 cancer patients with life-threatening diagnoses and symptoms of depression and /or anxiety . This r and omized , double-blind , cross-over trial investigated the effects of a very low ( placebo-like ) dose ( 1 or 3 mg/70 kg ) vs. a high dose ( 22 or 30 mg/70 kg ) of psilocybin administered in counterbalanced sequence with 5 weeks between sessions and a 6-month follow-up . Instructions to participants and staff minimized expectancy effects . Participants , staff , and community observers rated participant moods , attitudes , and behaviors throughout the study . High-dose psilocybin produced large decreases in clinician- and self-rated measures of depressed mood and anxiety , along with increases in quality of life , life meaning , and optimism , and decreases in death anxiety . At 6-month follow-up , these changes were sustained , with about 80 % of participants continuing to show clinical ly significant decreases in depressed mood and anxiety . Participants attributed improvements in attitudes about life/self , mood , relationships , and spirituality to the high-dose experience , with > 80 % endorsing moderately or greater increased well-being/life satisfaction . Community observer ratings showed corresponding changes . Mystical-type psilocybin experience on session day mediated the effect of psilocybin dose on therapeutic outcomes . Trial Registration Clinical Trials.gov identifier :",
"BACKGROUND Anecdotal reports suggest that psychedelic agents may relieve symptoms of obsessive-compulsive disorder ( OCD ) . This modified double-blind study investigated the safety , tolerability , and clinical effects of psilocybin , a potent 5-HT(1A ) and 5-HT(2A/2C ) agonist , in patients with OCD . METHOD Nine subjects with DSM-IV-defined OCD and no other current major psychiatric disorder participated in up to 4 single-dose exposures to psilocybin in doses ranging from sub-hallucinogenic to frankly hallucinogenic . Low ( 100 microg/kg ) , medium ( 200 microg/kg ) , and high ( 300 microg/kg ) doses were assigned in that order , and a very low dose ( 25 microg/kg ) was inserted r and omly and in double-blind fashion at any time after the first dose . Testing days were separated by at least 1 week . Each session was conducted over an 8-hour period in a controlled environment in an outpatient clinic ; subjects were then transferred to a psychiatric inpatient unit for overnight observation . The Yale-Brown Obsessive Compulsive Scale ( YBOCS ) and a visual analog scale measuring overall obsessive-compulsive symptom severity were administered at 0 , 4 , 8 , and 24 hours post-ingestion . The Hallucinogen Rating Scale was administered at 8 hours , and vital signs were recorded at 0 , 1 , 4 , 8 , and 24 hours after ingestion . The study was conducted from November 2001 to November 2004 . RESULTS Nine subjects were administered a total of 29 psilocybin doses . One subject experienced transient hypertension without relation to anxiety or somatic symptoms , but no other significant adverse effects were observed . Marked decreases in OCD symptoms of variable degrees were observed in all subjects during 1 or more of the testing sessions ( 23%-100 % decrease in YBOCS score ) . Repeated- measures analysis of variance for all YBOCS values revealed a significant main effect of time on Wilks lambda ( F = 9.86 , df = 3,3 ; p = .046 ) , but no significant effect of dose ( F = 2.25 , df = 3,3 ; p = .261 ) or interaction of time and dose ( F = 0.923 , df = 9,45 ; p = .515 ) . Improvement generally lasted past the 24-hour timepoint . CONCLUSIONS In a controlled clinical environment , psilocybin was safely used in subjects with OCD and was associated with acute reductions in core OCD symptoms in several subjects",
"Background Anxiety and depression are two important contributors to the global burden of disease . In many developing countries , including Nepal , their prevalences are yet to be assessed . Methods A nationwide cross-sectional study was conducted among a representative sample of Nepalese adults aged 18–65 years ( N = 2100 ) , selected by multistage r and om cluster sampling and interviewed at home during unannounced visits . The vali date d question naires included the Hospital Anxiety and Depression Scale ( HADS ) , to detect cases of anxiety ( HADS-A ) , depression ( HADS-D ) and comorbid anxiety and depression ( HADS-cAD ) , the Eysenck Personality Question naire Revised Short Form-Neuroticism ( EPQRS-N ) , and the World Health Organization Quality of Life 8- question scale ( WHOQOL-8 ) . Logistic regression analyses were used to explore associations of caseness with four groups of variables : demographic , domicile , substance use , and behavioural and health . Results Age- and gender-adjusted point prevalences of HADS-A , HADS-D and HADS-cAD were 16.1 , 4.2 and 5.9 % respectively . In a multivariate model , HADS-A was positively associated with urban residence ( AOR = 1.82 ; p alcohol consumption ( AOR = 0.71 ; p = 0.041 ) . HADS-D was positively associated with marijuana use ( AOR = 3.61 ; p = 0.017 ) and negatively with quality of life ( QoL ) ( AOR = 0.86 ; p widowhood ( AOR = 2.71 ; p = 0.002 ) , urban residence ( AOR = 2.37 ; p = 0.001 ) , living at altitude ≥2000 m ( AOR = 2.32 ; p = 0.002 ) and neuroticism ( AOR = 1.26 ; p with alcohol use ( AOR = 0.56 ; p = 0.026 ) and QoL ( AOR = 0.79 ; p < 0.001 ) . Conclusion Depression and anxiety are important mental health conditions in Nepal , and major contributors to public ill health , being very highly prevalent , comorbid and associated with psychosocial burden . They are also linked to the unique topography , habitation and social structure of the country . High prevalence coupled with the disabling nature of these disorders establishes their health-care priority and their importance in national health policy",
"BACKGROUND Validation of animal models of hallucinogenic drugs ' subjective effects requires human data . Previous human studies used varied groups of subjects and assessment methods . Rating scales for hallucinogen effects emphasized psychodynamic principles or the drugs ' dysphoric properties . We describe the subjective effects of grade d doses of N , N-dimethyltryptamine ( DMT ) , an endogenous hallucinogen and drug of abuse , in a group of experienced hallucinogen users . We also present preliminary data from a new rating scale for these effects . METHODS Twelve highly motivated volunteers received two doses ( 0.04 and 0.4 mg/kg ) of intravenous ( IV ) dimethyltryptamine fumarate \" nonblind , \" before entering a double-blind , saline placebo-controlled , r and omized study using four doses of IV DMT . Subjects were carefully interviewed after resolution of drug effects , providing thorough and systematic descriptions of DMT 's effects . They also were administered a new instrument , the Hallucinogen Rating Scale ( HRS ) . The HRS was drafted from interviews obtained from an independent sample of 19 experienced DMT users , and modified during early stages of the study . RESULTS Psychological effects of IV DMT began almost immediately after administration , peaked at 90 to 120 seconds , and were almost completely resolved by 30 minutes . This time course paralleled DMT blood levels previously described . Hallucinogenic effects were seen after 0.2 and 0.4 mg/kg of dimethyltryptamine fumarate , and included a rapidly moving , brightly colored visual display of images . Auditory effects were less common . \" Loss of control , \" associated with a brief , but overwhelming \" rush , \" led to a dissociated state , where euphoria alternated or coexisted with anxiety . These effects completely replaced subjects ' previously ongoing mental experience and were more vivid and compelling than dreams or waking awareness . Lower doses , 0.1 and 0.05 mg/kg , were primarily affective and somaesthetic , while 0.1 mg/kg elicited the least desirable effects . Clustering of HRS items , using either a clinical , mental status method or principal components factor analysis provided better resolution of dose effects than did the biological variables described previously . CONCLUSIONS These clinical and preliminary quantitative data provide bases for further psychopharmacologic characterization of DMT 's properties in humans . They also may be used to compare the effects of other agents affecting relevant brain receptors in volunteer and psychiatric population",
"Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders , rigorous follow-up has not been conducted . To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment we conducted an open-label pilot study administering moderate ( 20 mg/70 kg ) and high ( 30 mg/70 kg ) doses of psilocybin within a structured 15-week smoking cessation treatment protocol . Participants were 15 psychiatrically healthy nicotine-dependent smokers ( 10 males ; mean age of 51 years ) , with a mean of six previous lifetime quit attempts , and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake . Biomarkers assessing smoking status , and self-report measures of smoking behavior demonstrated that 12 of 15 participants ( 80 % ) showed seven-day point prevalence abstinence at 6-month follow-up . The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and /or pharmacological therapies ( typically psilocybin , these findings suggest psilocybin may be a potentially efficacious adjunct to current smoking cessation treatment models . The present study illustrates a framework for future research on the efficacy and mechanisms of hallucinogen-facilitated treatment of addiction",
"BACKGROUND Lysergic acid diethylamide ( LSD ) is a potent serotonergic hallucinogen or psychedelic that modulates consciousness in a marked and novel way . This study sought to examine the acute and mid-term psychological effects of LSD in a controlled study . METHOD A total of 20 healthy volunteers participated in this within-subjects study . Participants received LSD ( 75 µg , intravenously ) on one occasion and placebo ( saline , intravenously ) on another , in a balanced order , with at least 2 weeks separating sessions . Acute subjective effects were measured using the Altered States of Consciousness question naire and the Psychotomimetic States Inventory ( PSI ) . A measure of optimism ( the Revised Life Orientation Test ) , the Revised NEO Personality Inventory , and the Peter 's Delusions Inventory were issued at baseline and 2 weeks after each session . RESULTS LSD produced robust psychological effects ; including heightened mood but also high scores on the PSI , an index of psychosis-like symptoms . Increased optimism and trait openness were observed 2 weeks after LSD ( and not placebo ) and there were no changes in delusional thinking . CONCLUSIONS The present findings reinforce the view that psychedelics elicit psychosis-like symptoms acutely yet improve psychological wellbeing in the mid to long term . It is proposed that acute alterations in mood are secondary to a more fundamental modulation in the quality of cognition , and that increased cognitive flexibility subsequent to serotonin 2A receptor ( 5-HT2AR ) stimulation promotes emotional lability during intoxication and leaves a residue of ' loosened cognition ' in the mid to long term that is conducive to improved psychological wellbeing",
"& NA ; Recent evidence indicates that psilocybin with psychological support may be effective for treating depression . Some studies have found that patients with depression show heightened amygdala responses to fearful faces and there is reliable evidence that treatment with SSRIs attenuates amygdala responses ( Ma , 2015 ) . We hypothesised that amygdala responses to emotional faces would be altered post‐treatment with psilocybin . In this open‐label study , 20 individuals diagnosed with moderate to severe , treatment‐resistant depression , underwent two separate dosing sessions with psilocybin . Psychological support was provided before , during and after these sessions and 19 completed fMRI scans one week prior to the first session and one day after the second and last . Neutral , fearful and happy faces were presented in the scanner and analyses focused on the amygdala . Group results revealed rapid and enduring improvements in depressive symptoms post psilocybin . Increased responses to fearful and happy faces were observed in the right amygdala post‐treatment , and right amygdala increases to fearful versus neutral faces were predictive of clinical improvements at 1‐week . Psilocybin with psychological support was associated with increased amygdala responses to emotional stimuli , an opposite effect to previous findings with SSRIs . This suggests fundamental differences in these treatments ' therapeutic actions , with SSRIs mitigating negative emotions and psilocybin allowing patients to confront and work through them . Based on the present results , we propose that psilocybin with psychological support is a treatment approach that potentially revives emotional responsiveness in depression , enabling patients to reconnect with their emotions . Trial registration : IS RCT N , number IS RCT N14426797 . This article is part of the Special Issue entitled ‘ Psychedelics : New Doors , Altered Perceptions ’ . HighlightsPsilocybin with psychological support was used successfully to treat depression . Amygdala responses to fearful faces were increased one day after psilocybin session . Increased amygdala responses predicted positive clinical outcomes .Psilocybin assisted therapy treats depression by reviving emotional responsiveness",
"Rationale This dose-effect study extends previous observations showing that psilocybin can occasion mystical-type experiences having persisting positive effects on attitudes , mood , and behavior . Objectives This double-blind study evaluated psilocybin ( 0 , 5 , 10 , 20 , 30 mg/70 kg , p.o . ) administered under supportive conditions . Methods Participants were 18 adults ( 17 hallucinogen-naïve ) . Five 8-h sessions were conducted individually for each participant at 1-month intervals . Participants were r and omized to receive the four active doses in either ascending or descending order ( nine participants each ) . Placebo was scheduled quasi-r and omly . During sessions , volunteers used eyeshades and were instructed to direct their attention inward . Volunteers completed question naires assessing effects immediately after and 1 month after each session , and at 14 months follow-up . Results Psilocybin produced acute perceptual and subjective effects including , at 20 and /or 30 mg/70 kg , extreme anxiety/fear ( 39 % of volunteers ) and /or mystical-type experience ( 72 % of volunteers ) . One month after sessions at the two highest doses , volunteers rated the psilocybin experience as having substantial personal and spiritual significance , and attributed to the experience sustained positive changes in attitudes , mood , and behavior , with the ascending dose sequence showing greater positive effects . At 14 months , ratings were undiminished and were consistent with changes rated by community observers . Both the acute and persisting effects of psilocybin were generally a monotonically increasing function of dose , with the lowest dose showing significant effects . Conclusions Under supportive conditions , 20 and 30 mg/70 kg psilocybin occasioned mystical-type experiences having persisting positive effects on attitudes , mood , and behavior . Implication s for therapeutic trials are discussed",
"Objective : A recently published study showed the safety and efficacy of LSD-assisted psychotherapy in patients with anxiety associated with life-threatening diseases . Participants of this study were included in a prospect i ve follow-up . Method : 12 months after finishing LSD psychotherapy , 10 participants were tested for anxiety ( STAI ) and participated in a semi-structured interview . A Qualitative Content Analysis ( QCA ) was carried out on the interviews to elaborate about LSD effects and lasting psychological changes . Results : None of the participants reported lasting adverse reactions . The significant benefits as measured with the STAI were sustained over a 12-month period . In the QCA participants consistently reported insightful , cathartic and interpersonal experiences , accompanied by a reduction in anxiety ( 77.8 % ) and a rise in quality of life ( 66.7 % ) . Evaluations of subjective experiences suggest facilitated access to emotions , confrontation of previously unknown anxieties , worries , re sources and intense emotional peak experiences à la Maslow as major psychological working mechanisms . The experiences created led to a restructuring of the person ’s emotional trust , situational underst and ing , habits and world view . Conclusions : LSD administered in a medically supervised psychotherapeutic setting can be safe and generate lasting benefits in patients with a life-threatening disease . Explanatory models for the therapeutic effects of LSD warrant further study",
"ABSTRACT Background : A recent epidemiological study suggested that 5-methoxy-N , N-dimethyltryptamine ( 5-MeO-DMT ) used for spiritual and recreational reasons is associated with subjective improvement in depression and anxiety . Further exploration of the potential psychotherapeutic effects of 5-MeO-DMT could inform future clinical trials . Objectives : We examined self-reported improvement in depression and anxiety among people who use 5-MeO-DMT in a group setting with structured procedures guiding dose and administration of 5-MeO-DMT . Such procedures also include activities for the preparation of , and support during/following sessions , which are similar to procedures used in clinical trials of hallucinogen administration . Next , we examined whether depression or anxiety were improved following use , and whether the acute subjective effects ( mystical/challenging ) or beliefs about the 5-MeO-DMT experience were associated with improvements in these conditions . Methods : Respondents ( n = 362 ; Mage = 47.7 ; Male = 55 % ; White/Caucasian = 84 % ) completed an anonymous web-based survey . Results : Of those reporting having been diagnosed with depression ( 41 % ) or anxiety ( 48 % ) , most reported these conditions were improved ( depression = 80 % ; anxiety = 79 % ) following 5-MeO-DMT use , and fewer reported they were unchanged ( depression = 17 % ; anxiety = 19 % ) or worsened ( depression = 3 % ; anxiety = 2 % ) . Improvement in depression/anxiety conditions were associated with greater intensity of mystical experiences and higher ratings of the spiritual significance and personal meaning of the 5-MeO-DMT experience . There were no associations between depression or anxiety improvement and the intensity of acute challenging physical/psychological effects during the 5-MeO-DMT experience . Conclusions : Future prospect i ve controlled clinical pharmacology studies should examine the safety and efficacy of 5-MeO-DMT administration for relieving depression and anxiety",
"Both psychedelics and meditation exert profound modulatory effects on consciousness , perception and cognition , but their combined , possibly synergistic effects on neurobiology are unknown . Accordingly , we conducted a r and omized , double-blind , placebo-controlled study with 38 participants following a single administration of the psychedelic psilocybin ( 315 μg/kg p.o . ) during a 5-day mindfulness retreat . Brain dynamics were quantified directly pre- and post-intervention by functional magnetic resonance imaging during the resting state and two meditation forms . The analysis of functional connectivity identified psilocybin-related and mental state-dependent alterations in self-referential processing regions of the default mode network ( DMN ) . Notably , decoupling of medial prefrontal and posterior cingulate cortices , which is thought to mediate sense of self , was associated with the subjective ego dissolution effect during the psilocybin-assisted mindfulness session . The extent of ego dissolution and brain connectivity predicted positive changes in psycho-social functioning of participants 4 months later . Psilocybin , combined with meditation , facilitated neurodynamic modulations in self-referential networks , subserving the process of meditation by acting along the anterior-posterior DMN connection . The study highlights the link between altered self-experience and subsequent behavioral changes . Underst and ing how interventions facilitate transformative experiences may open novel therapeutic perspectives . Insights into the biology of discrete mental states foster our underst and ing of non-ordinary forms of human self-consciousness and their concomitant brain substrate",
"Background : Meta- analysis of r and omized studies using lysergic acid diethylamide ( LSD ) for alcohol use disorder ( AUD ) showed large , significant effects for LSD efficacy compared to control conditions . Clinical studies suggest potential anti-addiction effects of LSD and mechanistically-related classic psychedelics for alcohol and other substance use disorders . Aims : To supplement clinical studies , reports of psychedelic use in naturalistic setting s can provide further data regarding potential effects of psychedelics on alcohol use . Methods : An anonymous online survey of individuals with prior AUD reporting cessation or reduction in alcohol use following psychedelic use in non- clinical setting s. Results : 343 respondents , mostly White ( 89 % ) , males ( 78 % ) , in the USA ( 60 % ) completed the survey . Participants reported seven years of problematic alcohol use on average before the psychedelic experience to which they attributed reduced alcohol consumption , with 72 % meeting retrospective criteria for severe AUD . Most reported taking a moderate or high dose of LSD ( 38 % ) or psilocybin ( 36 % ) , followed by significant reduction in alcohol consumption . After the psychedelic experience 83 % no longer met AUD criteria . Participants rated their psychedelic experience as highly meaningful and insightful , with 28 % endorsing psychedelic-associated changes in life priorities or values as facilitating reduced alcohol misuse . Greater psychedelic dose , insight , mystical-type effects , and personal meaning of experiences were associated with a greater reduction in alcohol consumption , controlling for prior alcohol consumption and related distress . Conclusions : Although results can not demonstrate causality , they suggest that naturalistic psychedelic use may lead to cessation or reduction in problematic alcohol use , supporting further investigation of psychedelic-assisted treatment for AUD",
"BACKGROUND Psilocybin is a serotonin receptor agonist that occurs naturally in some mushroom species . Recent studies have assessed the therapeutic potential of psilocybin for various conditions , including end-of-life anxiety , obsessive-compulsive disorder , and smoking and alcohol dependence , with promising preliminary results . Here , we aim ed to investigate the feasibility , safety , and efficacy of psilocybin in patients with unipolar treatment-resistant depression . METHODS In this open-label feasibility trial , 12 patients ( six men , six women ) with moderate-to-severe , unipolar , treatment-resistant major depression received two oral doses of psilocybin ( 10 mg and 25 mg , 7 days apart ) in a supportive setting . There was no control group . Psychological support was provided before , during , and after each session . The primary outcome measure for feasibility was patient-reported intensity of psilocybin 's effects . Patients were monitored for adverse reactions during the dosing sessions and subsequent clinic and remote follow-up . Depressive symptoms were assessed with st and ard assessment s from 1 week to 3 months after treatment , with the 16-item Quick Inventory of Depressive Symptoms ( QIDS ) serving as the primary efficacy outcome . This trial is registered with IS RCT N , number IS RCT N14426797 . FINDINGS Psilocybin 's acute psychedelic effects typically became detectable 30 - 60 min after dosing , peaked 2 - 3 h after dosing , and subsided to negligible levels at least 6 h after dosing . Mean self-rated intensity ( on a 0 - 1 scale ) was 0·51 ( SD 0·36 ) for the low-dose session and 0·75 ( SD 0·27 ) for the high-dose session . Psilocybin was well tolerated by all of the patients , and no serious or unexpected adverse events occurred . The adverse reactions we noted were transient anxiety during drug onset ( all patients ) , transient confusion or thought disorder ( nine patients ) , mild and transient nausea ( four patients ) , and transient headache ( four patients ) . Relative to baseline , depressive symptoms were markedly reduced 1 week ( mean QIDS difference -11·8 , 95 % CI -9·15 to -14·35 , p=0·002 , Hedges ' g=3·1 ) and 3 months ( -9·2 , 95 % CI -5·69 to -12·71 , p=0·003 , Hedges ' g=2 ) after high-dose treatment . Marked and sustained improvements in anxiety and anhedonia were also noted . INTERPRETATION This study provides preliminary support for the safety and efficacy of psilocybin for treatment-resistant depression and motivates further trials , with more rigorous design s , to better examine the therapeutic potential of this approach . FUNDING Medical Research Council",
"ABSTRACT Background : A recent open-label pilot study ( N = 15 ) found that two to three moderate to high doses ( 20 and 30 mg/70 kg ) of the serotonin 2A receptor agonist , psilocybin , in combination with cognitive behavioral therapy ( CBT ) for smoking cessation , result ed in substantially higher 6-month smoking abstinence rates than are typically observed with other medications or CBT alone . Objectives : To assess long-term effects of a psilocybin-facilitated smoking cessation program at ≥12 months after psilocybin administration . Methods : The present report describes biologically verified smoking abstinence outcomes of the previous pilot study at ≥12 months , and related data on subjective effects of psilocybin . Results : All 15 participants completed a 12-month follow-up , and 12 ( 80 % ) returned for a long-term ( ≥16 months ) follow-up , with a mean interval of 30 months ( range = 16–57 months ) between target-quit date ( i.e. , first psilocybin session ) and long-term follow-up . At 12-month follow-up , 10 participants ( 67 % ) were confirmed as smoking abstinent . At long-term follow-up , nine participants ( 60 % ) were confirmed as smoking abstinent . At 12-month follow-up 13 participants ( 86.7 % ) rated their psilocybin experiences among the five most personally meaningful and spiritually significant experiences of their lives . Conclusion : These results suggest that in the context of a structured treatment program , psilocybin holds considerable promise in promoting long-term smoking abstinence . The present study adds to recent and historical evidence suggesting high success rates when using classic psychedelics in the treatment of addiction . Further research investigating psilocybin-facilitated treatment of substance use disorders is warranted",
"Background : A recently published r and omized controlled trial compared single-dose psilocybin with single-dose niacin in conjunction with psychotherapy in participants with cancer-related psychiatric distress . Results suggested that psilocybin-assisted psychotherapy facilitated improvements in psychiatric and existential distress , quality of life , and spiritual well-being up to seven weeks prior to the crossover . At the 6.5-month follow-up , after the crossover , 60–80 % of participants continued to meet criteria for clinical ly significant antidepressant or anxiolytic responses . Methods : The present study is a long-term within-subjects follow-up analysis of self-reported symptomatology involving a subset of participants that completed the parent trial . All 16 participants who were still alive were contacted , and 15 participants agreed to participate at an average of 3.2 and 4.5 years following psilocybin administration . Results : Reductions in anxiety , depression , hopelessness , demoralization , and death anxiety were sustained at the first and second follow-ups . Within-group effect sizes were large . At the second ( 4.5 year ) follow-up approximately 60–80 % of participants met criteria for clinical ly significant antidepressant or anxiolytic responses . Participants overwhelmingly ( 71–100 % ) attributed positive life changes to the psilocybin-assisted therapy experience and rated it among the most personally meaningful and spiritually significant experiences of their lives . Conclusion : These findings suggest that psilocybin-assisted psychotherapy holds promise in promoting long-term relief from cancer-related psychiatric distress . Limited conclusions , however , can be drawn regarding the efficacy of this therapy due to the crossover design of the parent study . Nonetheless , the present study adds to the emerging literature base suggesting that psilocybin-facilitated therapy may enhance the psychological , emotional , and spiritual well-being of patients with life-threatening cancer"
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Objectives The objectives were to review systematic ally the range of assessment tools used in cats to detect the behavioural expression of pain and the evidence of their quality ; and to examine behavioural metrics ( considering both the sensory and affective domains ) used to assess pain . Methods A search of PubMed and ScienceDirect , alongside articles known to the authors , from 2000 onwards , for papers in English was performed . This was followed by a manual search of the references within the primary data sources . Only peer- review ed publications that provided information on the assessment tool used to evaluate the behavioural expression of pain in cats , in conscious animals ( not anaesthetised cats ) , were included . Results No previous systematic review s were identified . One hundred papers were included in the final assessment . Studies were primarily related to the assessment of pain in relation to surgical procedures , and no clear distinction was made concerning the onset of acute and chronic pain . Ten broad types of instrument to assess pain were identified , and generally the quality of evidence to support the use of the various instruments was poor . Only one specific instrument ( UNESP-Botucatu scale ) had published evidence of validity , reliability and sensitivity at the level of a r and omised control trial , but with a positive rather than placebo control , and limited to its use in the ovariohysterectomy situation . The metrics used within the tools appeared to focus primarily on the sensory aspect of pain , with no study clearly discriminating between the sensory and affective components of pain . Conclusions and relevance Further studies are required to provide a higher quality of evidence for methods used to assess pain in cats . Furthermore , a consistent definition for acute and chronic pain is needed . Tools need to be vali date d that can detect pain in a range of conditions and by different evaluators ( veterinary surgeons and owners ) , which consider both the sensory and emotional aspects of pain
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"OBJECTIVE To evaluate the sedative and analgesic effects of intramuscular buprenorphine with either dexmedetomidine or acepromazine , administered as premedication to cats and dogs undergoing elective surgery . STUDY DESIGN Prospect i ve , r and omized , blinded clinical study . ANIMALS Forty dogs and 48 cats . METHODS Animals were assigned to one of four groups , according to anaesthetic premedication and induction agent : buprenorphine 20 μg kg(-1 ) with either dexmedetomidine ( dex ) 250 μg m(-2 ) or acepromazine ( acp ) 0.03 mg kg(-1 ) , followed by alfaxalone ( ALF ) or propofol ( PRO ) . Meloxicam was administered preoperatively to all animals and anaesthesia was always maintained using isoflurane . Physiological measures and assessment s of pain , sedation and mechanical nociceptive threshold ( MNT ) were made before and after premedication , intraoperatively , and for up to 24 hours after premedication . Data were analyzed with one-way , two-way and mixed between-within subjects anova , Kruskall-Wallis analyses and Chi squared tests . Results were deemed significant if p ≤ 0.05 , except where multiple comparisons were performed ( p ≤ 0.005 ) . RESULTS Cats premedicated with dex were more se date d than cats premedicated with acp ( p in sedation in dogs however PRO doses were lower in dex dogs ( 1.5 ± 0.8 mg kg(-1 ) ) compared to acp dogs ( 3.3 ± 1.1 mg kg(-1 ) ) ( p respect to pain scores or MNT for cats or dogs . CONCLUSION Choice of dex or acp , when given with buprenorphine , caused minor , clinical ly detectable , differences in various characteristics of anaesthesia , but not in the level of analgesia . CLINICAL RELEVANCE A combination of buprenorphine with either acp or dex , followed by either PRO or ALF , and then isoflurane , accompanied by an NSAID , was suitable for anaesthesia in dogs and cats undergoing elective surgery . Choice of sedative agent may influence dose of anaesthetic induction agent",
"OBJECTIVE To evaluate the sedative and antinociceptive effects of combinations of dexmedetomidine and buprenorphine in cats . STUDY DESIGN Experimental r and omized study . ANIMALS Twelve purpose -bred neutered domestic short-hair cats ( 4 male and 8 female ) weighing 4.6 kg ( range 3.7 - 5.5 kg ) aged from 2 to 5 years . METHODS Six cats per group were administered buprenorphine ( B ) at 10 ( B10 ) or 20 microg kg(-1 ) ( B20 ) or dexmedetomidine ( D ) at 20 ( D20 ) or 40 microg kg(-1 ) ( D40 ) or a combination of B10/D20 . A feline thermal nociceptive threshold testing device was used to evaluate the antinociceptive effects of the drugs before and up to 24 hours after drug treatment . Sedation was scored using a 100 mm visual analogue scale ( VAS ) . RESULTS Thermal thresholds increased significantly after administration of all but D20 . Area under the curve ( AUC , hours degrees C ) for the first 6 hours ( mean + /- SD ) for B20 ( 281 + /- 17.8 ) was significantly greater than B10 ( 260 + /- 11.4 ) , D20 ( 250 + /- 7.9 ) and D40 ( 255 + /- 11.4 ) . The AUC for B10/D20 ( 273 + /- 12.2 ) was significantly greater than D20 but not the other treatments . No sedation was seen after administration of B10 or B20 and maximal sedation was seen for all animals in the D40 and B10/D20 groups and most animals in the D20 group . CONCLUSIONS D20 alone had the smallest analgesic effect ; B10 alone provided no sedation but their combination gave good sedation with analgesia comparable with B20 . CLINICAL RELEVANCE This combination could be a useful multimodal sedative/analgesic regimen in cats",
"BACKGROUND There are no vali date d systems for measuring pain from osteoarthritis in cats . HYPOTHESIS Owner subjective assessment s and an activity monitor ( AM ) can be used to detect pain in cats with osteoarthritis and to assess efficacy of treatments . ANIMALS Thirteen cats older than 10 years old , with owner-assessed decreases in activity , painful arthritic joints , and clinical ly normal blood work were included and evaluated for 3 weeks . METHODS A collar-mounted AM measured activity and a client-specific outcome measure ( CSOM ) question naire characterized the severity of impairment . Overall global quality of life was also evaluated for each treatment . In weeks 2 and 3 , meloxicam ( 0.1 mg/kg , day 1 ; 0.05 mg/kg , days 2 - 5 ) or a placebo was administered in a blinded , r and omized , cross-over manner to test the assessment systems . RESULTS The cats had a median of 4 arthritic appendicular joints . Activity counts for the week when cats ( complete data on activity ; n=9 ) were administered meloxicam were significantly higher than at baseline ( P = .02 ) but not after placebo ( P = .06 ) . Baseline activity counts were not significantly different from placebo ( P = .6 ) . The CSOM data ( n=13 ) showed that owners considered their cats to be more active on meloxicam compared with baseline ( P = .001 ) and placebo ( P placebo than at baseline ( P Global quality of life improved significantly with meloxicam ( P pain relief in cats that are arthritic . Objective activity data might allow subjective assessment systems to be vali date d for use in clinical studies",
"OBJECTIVE To evaluate the ability of various subjective and objective measurements to determine the presence and degree of postoperative pain in cats . DESIGN R and omized controlled prospect i ve clinical study . ANIMALS 18 healthy client-owned cats . PROCEDURE Cats were r and omly assigned to 3 groups of 6 : control , tenectomy , and onychectomy . Jugular catheters were placed the day prior to surgery . All surgeries were performed by the same surgeon , and all observations were made by the same blinded trained observer . One hour prior to surgery and at assigned intervals for 36 hours after surgery , heart rate , respiratory rate , and rectal temperature were measured . Scores were assigned for 3 interaction responses , including response to palpation , by use of simple descriptive scales , and to 2 pain assessment s by use of visual analogue scales . Blood was collected to measure plasma beta-endorphin and cortisol concentrations . Butorphanol was administered to all cats before surgery and to any cat subjectively assessed to be experiencing pain after surgery . RESULTS Only visual analogue scale scores and response to palpation scores differed significantly between control and surgical groups . CONCLUSIONS AND CLINICAL RELEVANCE Determination of the presence of pain in cats can be made on the basis of observation and interaction by a trained observer . Physiologic measurements , including plasma cortisol and beta-endorphin concentrations , did not differentiate between control cats and cats that underwent surgery",
"OBJECTIVE To evaluate the clinical efficacy of dexmedetomidine as a preanesthetic medication administered prior to anesthetic induction with ketamine or propofol and with or without isoflurane for maintenance of anesthesia . DESIGN R and omized , blinded , controlled clinical trial . ANIMALS 184 client-owned cats . PROCEDURES Cats requiring general anesthesia for short or long procedures were assigned to receive 1 of 4 preanesthetic and induction drug combinations ( dexmedetomidine and ketamine , placebo [ saline { 0.9 % NaCl } solution ] and ketamine , dexmedetomidine and propofol , or placebo and propofol ) . Cats undergoing long procedures received isoflurane for maintenance of anesthesia . RESULTS Administration of dexmedetomidine prior to anesthetic induction with ketamine significantly increased the intubation success rate ( 57/64 [ 89 % ] ) , compared with the success rate for the placebo ( 4/37 [ 11 % ] ) ; significantly reduced the median induction dose of propofol ( ≤ 5.1 mg/kg [ 2.32 mg/lb ] ) , compared with that for the placebo ( ≤ 10.5 mg/kg [ 4.77 mg/lb ] ) ; and significantly reduced the isoflurane concentration ( 1.5 % ) required for anesthesia maintenance , compared with that for the placebo ( 3.0 % ) . Postoperatively , fewer cats receiving dexmedetomidine required rescue analgesia , and cats had lower pain scores for at least 2 hours after surgery , compared with results for cats receiving the placebo . Heart rate was lower during the procedure and respiratory rate and rectal temperature were lower during and after the procedure for cats receiving dexmedetomidine . More cats that received dexmedetomidine had emesis and pale mucous membranes , compared with the number of cats with those signs that received placebo . CONCLUSIONS AND CLINICAL RELEVANCE Dexmedetomidine as a preanesthetic was efficacious for clinical use in cats requiring general anesthesia",
"The objective of this study was to evaluate the efficacy and tolerability of robenacoxib , a selective cyclooxygenase-2 inhibitor , for the treatment of post-operative pain and inflammation in cats . The study was a prospect i ve , multi-centre , r and omised , blinded , non-inferiority design clinical study to compare robenacoxib to meloxicam . Ninety-six cats undergoing surgery at eight centres in Japan were allocated r and omly to receive a single s.c . injection of robenacoxib ( 2 mg/kg , n=67 ) or meloxicam ( 0.3 mg/kg , n=29 ) shortly before induction of anaesthesia . Most cats underwent soft tissue surgery ( n=87 ) , mainly ovariectomy ( n=68 ) . Post-operative pain and inflammation were assessed at 3 , 8 and 22 h after recovery from anaesthesia using numerical rating scales . For the primary efficacy endpoint ( total clinician score ) , robenacoxib had significantly better efficacy than meloxicam , the relative efficacy ratio being 1.47 ( 95 % confidence interval 1.19 - 1.78 , P=0.0003 ) . For the secondary efficacy endpoints , robenacoxib was superior to meloxicam when assessed on the basis of posture , behaviour , pain on palpation and overall pain control , while meloxicam was superior with respect to wound heat . No cat in either group required rescue analgesia therapy . In tolerability assessment s , pain during injection and pain and inflammation at the injection site 22 h after recovery from anaesthesia were rated significantly less with robenacoxib compared to meloxicam . Both treatments were well tolerated on the basis of clinical observations and blood tests , with no significant differences between groups . In conclusion , single pre-operative administration of robenacoxib was well tolerated and had superior efficacy to meloxicam in reducing post-operative pain in cats",
"The objective of the study was to evaluate the efficacy and tolerability of robenacoxib , a selective cyclooxygenase-2 inhibitor , for the treatment of acute pain and inflammation associated with musculoskeletal disorders in cats . The study was a prospect i ve , multi-centre , r and omised , blinded , non-inferiority design clinical trial comparing robenacoxib to ketoprofen . A total of 68 cats presenting with pain and inflammation associated with acute musculoskeletal disorders were recruited and allocated r and omly to receive , orally once daily for 5 - 6 days , either 1.0 - 2.4 mg/kg robenacoxib ( n=47 ) or 1mg/kg ketoprofen ( n=21 ) . The primary efficacy endpoint was the total clinician score , which was the sum of clinician numerical rating scale scores for pain , inflammation and mobility . Assessment s were made at baseline , on day 2 , and day 4 or 5 . For the total clinician score , non-inferior efficacy of robenacoxib was demonstrated with a relative efficacy of 1.151 ( 95 % confidence interval 0.872 - 1.494 ) . Non-inferior efficacy of robenacoxib was also demonstrated for the secondary endpoint of the total owner score . Robenacoxib was superior ( P ketoprofen for the owner 's assessment of activity and human/animal relationship . The tolerability of both treatments was good as assessed by monitoring adverse events , clinical signs and haematology and serum biochemistry variables",
"EMLA is a lidocaine/prilocaine cream used for topical analgesia in human pediatric patients . The purpose of this study was to establish the safety of EMLA in clinical ly ill cats , to measure systemic absorption and to determine whether EMLA reduced the need for sedation for the placement of jugular catheters . Thirty-one cats were r and omized to either a placebo or EMLA cream group . Cream was applied to a 10 cm2 area over the jugular vein , with 1 h of occlusive dressing . Neither anesthetic was systemically absorbed in any cat , and no adverse clinical signs were observed . Struggling during catheter placement was less in the EMLA-treated cats compared to placebo , but did not reach significance ( P=0.06 ) . Jugular catheters were successfully placed in 60 % of EMLA-treated cats and 38 % of placebo cats ; this difference was not statistically significant and may not justify the added steps of EMLA cream administration for this purpose . However , EMLA does appear to be safe in clinical ly ill cats , and may be useful for other applications such as for skin mass removal or repeated venepuncture",
"Thermal thresholds were measured in eight cats after the intramuscular administration of morphine ( 0.2 mg/kg ) , buprenorphine ( 0.01 mg/kg ) or butorphanol ( 0.2 mg/kg ) , doses commonly used in clinical practice ; 0.9 per cent saline ( 0.3 ml ) was injected as a control . Groups of six cats were used and each cat participated in at least two treatments , according to a r and omised design . The investigator was blinded to the treatments . The thermal thresholds were measured with a testing device developed specifically for cats , and measurements were made before and five , 30 , 45 and 60 minutes and two , four , six , 12 and 24 hours after the injections . There was no significant change in thermal threshold after the injection of saline . With butorphanol , the threshold was increased only at five minutes after the injection and was decreased two hours after the injection ; with morphine it was increased from between four and six hours after the injection , and with buprenorphine it was increased from between four and 12 hours after the injection",
"Six domestic shorthair cats , aged three to four years and weighing 5·1 to 7·4 kg , were used to assess the thermal antinociceptive effect of a transdermal buprenorphine patch , design ed to supply 35 μg buprenorphine/hour , which was applied to the shaved thorax . The cats ' thermal thresholds were tested before the patch was applied and two , four , six , eight , 10 , 12 , 14 and 16 hours after it had been applied , and then every six hours until it was removed after 72 hours , and for a further 24 hours afterwards . Blood was collected at each time to measure the plasma concentration of buprenorphine . The patches did not produce a significant change in the thermal thresholds of the cats throughout the testing period . The mean ( sd ) peak plasma buprenorphine concentration was 10 ( 0·81 ) ng/ml",
"Background Available information suggests a mismatch between radiographic and orthopedic examination findings in cats with DJD . However , the extent of the discrepancy between clinical and radiographic signs of OA in companion animals has not been described in detail . This study aim ed to evaluate the relationship between orthopedic examination findings , joint goniometry , and radiographic signs of DJD in 100 cats , in a prospect i ve observational design . Cat temperament , pain response to palpation , joint crepitus , effusion and thickening were grade d. Radiographs of appendicular joints and the axial skeleton were made under sedation . Joint motion was measured by use of a plastic goniometer before and after sedation . Associations between radiographic degenerative joint disease ( DJD ) and examination findings were assessed to determine sensitivity , specificity and likelihood estimations . Results Pain response to palpation was elicited in 0 - 67 % of the joints with DJD , with a specificity ranging from 62 - 99 % ; crepitus was detected in 0 - 56 % of the joints and its specificity varied between 87 and 99 % ; for effusion , values ranged between 6 and 38 % ( specificity , 82 - 100 % ) , and thickening , 0 - 59 % ( specificity , 74 - 99 % ) . Joints with DJD tended to have a decreased range of motion . The presence of pain increased the odds of having DJD in the elbow ( right : 5.5 ; left : 4.5 ) ; the presence of pain in the lower back increased the odds of spinal DJD being present ( 2.97 for lumbar ; 4.67 for lumbo-sacral ) . Conclusions Radiographic DJD can not be diagnosed with certainty using palpation or goniometry . However , negative findings tend to predict radiographically normal joints . Palpation and goniometry may be used as a tool to help to screen cats , mostly to rule out DJD",
"OBJECTIVE To evaluate the use of a ketamine-propofol combination , with or without dexmedetomidine , in cats undergoing ovariectomy and to assess Heinz body formation following administration of these drugs . DESIGN R and omized clinical trial . ANIMALS 15 client-owned female cats . PROCEDURES Anesthesia was induced with a ketamine ( 2.0 mg/kg [ 0.91 mg/lb])-propofol ( 2.0 mg/kg ) combination with ( n = 7 ) or without ( 8) dexmedetomidine ( 0.003 mg/kg [ 0.0013 mg/lb ] ) and was maintained via continuous IV infusion of a 1:1 ketamine-propofol combination ( administration rate for each drug , 10.0 mg/kg/h [ 4.54 mg/lb/h ] ) . Cats underwent ovariectomy ; duration of infusion was 25 minutes . Physiologic variables were measured at predetermined time points . Heinz bodies were quantified via examination of blood smears . Numeric scales were used to assess quality of recovery , degree of sedation , and signs of pain after surgery . RESULTS The ketamine-propofol group had a significantly higher mean heart rate at several time points during drug infusion , a significantly shorter time from the end of infusion to extubation ( 7 vs 29 minutes ) , and significantly lower sedation scores for the first hour after surgery than did the ketamine-propofol-dexmedetomidine group . Other variables were similar between groups ; recovery was smooth , and anesthesia and postoperative analgesia were deemed adequate for all cats . The number of RBCs with Heinz bodies was not increased after surgery , compared with values immediately after anesthetic induction . CONCLUSIONS AND CLINICAL RELEVANCE Total IV anesthesia with a ketamine-propofol combination , with or without dexmedetomidine , appeared to be effective in healthy cats . These short-term infusions produced smooth recovery and adequate analgesia during the postoperative period",
"OBJECTIVE To compare the effectiveness of preoperative PO and SC administration of buprenorphine and meloxicam for prevention of postoperative pain-associated behaviors in cats undergoing ovariohysterectomy . DESIGN R and omized controlled study . ANIMALS 51 female cats ( 4 to 60 months old ; weight range , 1.41 to 4.73 kg [ 3.1 to 10.4 lb ] ) . PROCEDURE Cats received 1 of 5 treatments at the time of anesthetic induction : buprenorphine PO ( 0.01 mg/kg [ 0.0045 mg/lb ] ; n = 10 ) , buprenorphine SC ( 0.01 mg/kg ; 10 ) , meloxicam SC ( 0.3 mg/kg 10.14 mg/lb ] ; 10 ) , meloxicam PO ( 0.3 mg/kg ; 10 ) , or 0.3 mL of sterile saline ( 0.9 % NaCI ) solution SC ( control group ; 11 ) . Sedation scores and visual analog scale and interactive visual analog scale ( IVAS ) pain-associated behavior scores were assigned to each cat 2 hours before and at intervals until 20 hours after surgery . RESULTS Cats receiving meloxicam PO or SC had significantly lower IVAS scores ( 2.91 and 2.02 , respectively ) , compared with IVAS scores for cats receiving buprenorphine PO ( 755 ) . Pain-associated behavior scores for cats administered buprenorphine or meloxicam PO or SC preoperatively did not differ significantly from control group scores . Rescue analgesia was not required by any of the cats receiving meloxicam , whereas 3 of 10 cats receiving buprenorphine PO , 2 of 10 cats receiving buprenorphine SC , and 1 of 11 cats receiving the control treatment required rescue analgesia . CONCLUSIONS AND CLINICAL RELEVANCE On the basis of pain-associated behavior scores , cats receiving meloxicam PO or SC before ovariohysterectomy appeared to have less pain after surgery than those receiving buprenorphine PO preoperatively",
"OBJECTIVE To measure cutaneous electrical nociceptive thresholds in relation to known thermal and mechanical stimulation for nociceptive threshold detection in cats . STUDY DESIGN Prospect i ve , blinded , r and omized cross-over study with 1-week washout interval . ANIMALS Eight adult cats [ bodyweight 5.1 + /- 1.8 kg ( mean + SD ) ] . METHODS Mechanical nociceptive thresholds were tested using a step-wise manual inflation of a modified blood pressure bladder attached to the cat 's thoracic limb . Thermal nociceptive thresholds were measured by increasing the temperature of a probe placed on the thorax . The electrical nociceptive threshold was tested using an escalating current from a constant current generator passed between electrodes placed on the thoracic region . A positive response ( threshold ) was recorded when cats displayed any or all of the following behaviors : leg shake , head turn , avoidance , or vocalization . Four baseline readings were performed before intramuscular injection of meperidine ( 5 mg kg(-1 ) ) or an equal volume of saline . Threshold recordings with each modality were made at 15 , 30 , 45 , 60 , 90 , and 120 minutes post-injection . Data were analyzed using ANOVA and paired t-tests ( significance at p thermal , mechanical , or electrical thresholds after saline . Thermal thresholds increased at 15 - 60 minutes ( p mechanical threshold increased at 30 and 45 minutes after meperidine ( p Maximum thermal threshold was + 4.1 + /- 0.3 degrees C above baseline at 15 minutes while maximum mechanical threshold was 296 + /- 265 mmHg above baseline at 30 minutes after meperidine . Electrical thresholds following meperidine were not significantly different than baseline ( p > 0.05 ) . Thermal and electrical thresholds after meperidine were significantly higher than saline at 30 and 45 minutes ( p Mechanical thresholds were significantly higher than saline treatment at 30 minutes ( p thermal and mechanical thresholds changed after meperidine administration in cats",
"OBJECTIVE To determine the lowest efficacious dose of oral meloxicam for relieving pain in cats with a sodium urate (SU)-induced acute inflammatory synovitis . STUDY DESIGN R and omized , blinded , controlled , and four-way crossover study . ANIMALS Eight surgically neutered cats ( four males , four females ) paired according to sex . METHODS Each pair of cats was treated with 0 ( placebo ) , 0.025 , 0.05 , or 0.075 mg kg(-1 ) oral meloxicam once daily for 4 days prior to injection , into alternating stifles , of 1 mL of 20 mg mL(-1 ) SU crystals , beginning with the right stifle . Each cat received each of the four treatments , separated by at least 21 days . Analgesic efficacy was evaluated based on objective ( e.g. , pressure mat data total force , contact pressure , and contact area ) and subjective ( e.g. , scores for Analgesia Scale [ AS ] , Lameness Scale [ LS ] , and Visual Analog Scale [ VAS ] ) outcome measures for pain assessment . All outcome measures were recorded before and during 30 hours after SU injection . The pre-defined primary outcome measure was the area under the response-time curve ( AUC(0 - 30 ) hours ) of the total force of the injected limb . Data were analyzed by analysis of variance . A sequential test procedure was applied and the test sequence stopped in case of a nonsignificant result . RESULTS Meloxicam at doses of 0.05 and 0.075 mg kg(-1 ) day(-1 ) PO was significantly different from placebo for the pre-defined primary outcome measure ( i.e. , AUC(0 - 30 ) hours of total force ) . All tested meloxicam doses were lower than placebo for the subjective outcome measures ( i.e. , AUC(0 - 30 ) hours of AS , LS , and VAS ) . CONCLUSIONS AND CLINICAL RELEVANCE The lowest efficacious dose of meloxicam for relieving pain in cats with an SU-induced synovitis was 0.05 mg kg(-1 ) day(-1 ) PO according to the pre-defined primary outcome measure . However , lower doses may also be effective as seen in the subjective outcome measures",
"OBJECTIVE To compare postoperative discomfort assessed by subjective pain score and plasma cortisol concentrations in cats undergoing onychectomy that received analgesia by use of transdermal fentanyl ( TDF ) patches or an i.m . injection of butorphanol . DESIGN R and omized prospect i ve clinical trial . ANIMALS 22 client-owned cats weighing 2.2 to 5 kg ( 4.84 to 11 lb ) undergoing onychectomy . PROCEDURE Research ers were blinded to which cats received a TDF patch ( 25 microg/h ) 18 to 24 hours prior to surgery or an i.m . injection of butorphanol ( 0.2 mg/kg ( 0.09 mg/lb ] ) at the time of sedation , immediately following extubation , and at 4-hour intervals thereafter for 12 hours . Clinical variables , plasma cortisol concentration , and pain scores were evaluated and recorded 24 hours prior to surgery , at extubation , and 2 , 4 , 8 , 12 , 24 , 36 , and 48 hours after surgery . RESULTS The TDF group had a lower pain score than the butorphanol group only at 8 hours after surgery . Both groups had significantly lower mean plasma cortisol concentrations 0 , 24 , 36 , and 48 hours after surgery , compared with mean plasma cortisol concentrations prior to surgery . No significant differences in appetite or response to h and ling the feet were observed between the 2 groups . CONCLUSIONS AND CLINICAL RELEVANCE Our data did not reveal a difference in pain relief between administration of TDF and butorphanol . Plasma cortisol concentrations were not different between groups . Fentanyl appeared to provide equivalent analgesia to butorphanol in cats undergoing onychectomy . The primary advantage of using a TDF patch is that repeated injections are not required",
"OBJECTIVE To evaluate signs of postoperative pain and complications after forelimb onychectomy in cats receiving buprenorphine alone or with bupivacaine administered as a 4-point regional nerve block . DESIGN Prospect i ve , r and omized , double-blind clinical trial . ANIMALS 20 cats . PROCEDURE All cats received buprenorphine ( 0.01 mg/kg [ 0.004 mg/lb ] , IM ) preoperatively . One forelimb of each cat also received bupivacaine ( 1 mg/kg [ 0.45 mg/lb ] of a 0.75 % solution ) administered as a 4-point regional nerve block . After onychectomy , discomfort ( lameness , foot reaction , and pain ) scores were evaluated by 2 experienced observers 2 , 4 , 6 , 8 , 24 , and 168 hours postoperatively . Complication ( hemorrhage , swelling , and infection ) scores were evaluated 24 and 168 hours postoperatively . Surgeries were performed by 1 experienced veterinary surgeon . Rescue analgesia was provided if needed . RESULTS 6 cats required rescue analgesia postoperatively . There was no difference in discomfort or complication scores between control limbs and limbs in which a nerve block was administered . Additionally , there was no difference in discomfort and complication scores between cats that did or did not require rescue analgesia . CONCLUSIONS AND CLINICAL RELEVANCE Bupivacaine administered as a 4-point regional nerve block in addition to a systemic analgesic did not decrease discomfort or complication scores in cats undergoing forelimb onychectomy",
"OBJECTIVES To identify a cohort of cats with clinical osteoarthritis and to report on the clinical signs , the frequency of joints affected and the possible aetiopathogenesis within this population . METHODS Inclusion criteria for this prospect i ve study were presence of historical evidence and /or clinical signs of osteoarthritis , together with radiographic evidence of osteoarthritis . Patients showed clinical improvement within four weeks of analgesic administration and were free from other disease processes , which might explain the clinical signs and /or their response to analgesia . RESULTS Twenty-eight cases were included in the cohort . The elbow ( 45 per cent ) and the hip ( 38 per cent ) were the most frequently affected joints . Seventy-one per cent of cases had primary /idiopathic aetiology . Alterations in both the ability to jump ( 71 per cent ) and the height ( 67 per cent ) of jump ( lifestyle changes ) were the most frequent signs of disease . Sixty-one per cent of owners felt that their pet had made a marked improvement following administration of an analgesic/anti-inflammatory drug . There were statistically significant improvements in the ability to jump ( P height of jump ( P lameness ( P = 0.03 ) , stiff gait ( P = 0.04 ) and the activity level ( P = 0.02 ) when compared with the start and the end of the study period . CLINICAL SIGNIFICANCE Osteoarthritis is a clinical problem in cats , but overt lameness is not the most common clinical feature",
"OBJECTIVES The antipyretic and analgesic efficacy of vedaprofen ( at a dose of 0.5 mg/kg ) was evaluated after repeated once-daily administration ( for three or five days ) to 80 cats with upper respiratory tract disease or 302 cats undergoing ovariohysterectomy . METHODS Both clinical trials were r and omised , double blinded and placebo controlled . RESULTS In the upper respiratory tract disease trial , vedaprofen produced a significant reduction in rectal temperature when compared with cats administered antimicrobial treatment only . This antipyretic activity lasted at least four hours after administration on the first day of treatment ( day 0 ) and at least eight hours on day 1 and day 2 . Significantly more cats in the treatment group were classified as having returned to normal on day 5 , day 6 and day 7 compared with the placebo group . In the ovariohysterectomy trial , scores for behaviour ( on day 1 , day 2 and day 3 ) and appetite ( on day 1 and day 2 ) were significantly better in the vedaprofen group than in the placebo-treated cats . CLINICAL SIGNIFICANCE Vedaprofen produced a clinical ly relevant reduction in body temperature and a more rapid return to normality in cats with upper respiratory tract disease . Vedaprofen treatment also result ed in more rapid recovery , presumably through the relief of pain and inflammation , in cats that had undergone soft tissue surgery ",
"OBJECTIVE To compare carprofen to butorphanol , with regard to postsurgical analgesic effects , duration of analgesia , and adverse side effects . STUDY DESIGN Blinded , r and omized clinical study . ANIMALS Seventy-one cats , 0.5 - 5 years of age , weighing 3.24 + /- 0.61 kg , undergoing ovariohysterectomy ( OHE ) . METHODS Cats were premedicated with subcutaneous atropine ( 0.04 mg kg(-1 ) ) , acepromazine ( 0.02 mg kg(-1 ) ) , and ketamine ( 5 mg kg(-1 ) ) . Anesthesia was induced with ketamine ( 5 mg kg(-1 ) ) and diazepam ( 0.25 mg kg(-1 ) ) given intravenously , and maintained with isoflurane . There were three treatment groups : group C ( 4 mg kg(-1 ) carprofen SC at induction ) , group B ( 0.4 mg kg(-1 ) butorphanol SC at end of surgery ) , and group S ( 0.08 mL kg(-1 ) of sterile saline SC at induction and end of surgery ) . Behavioral data were collected using a composite pain scale ( CPS ) , prior to surgery ( baseline ) and 1 , 2 , 3 , 4 , 8 , 12 , 16 , 20 , and 24 hours post-surgery . Interaction scores were analyzed separately . Cats with CPS scores > 12 received rescue analgesia ( meperidine , 4 mg kg(-1 ) , intramuscular ) . RESULTS Sixty cats completed the study . The CPS scores did not differ significantly between groups C and B at any time period . CPS scores for groups B and C were significantly increased for 12 hours post-surgery , and in group S for 20 hours . Both group C and B CPS scores were significantly lower than group S in this 20-hour postoperative period , except at 4 hours ( B and C ) and at 3 and 8 hours ( B alone ) . Interaction scores for group C returned to preoperative baseline 4 hours after surgery , while both groups B and S remained increased for at least 24 hours post-surgery . Nine cats required meperidine . CONCLUSION In this study , carprofen provided better postsurgical analgesia than butorphanol . Clinical relevance Neither drug completely abolished pain , however preoperative carprofen provided better pain control compared with postoperative butorphanol in the 24-hour period following OHE surgery in cats",
"OBJECTIVES To investigate the efficacy of meloxicam or tolfenamic acid administered preoperatively and postoperatively ( five days in total ) to cats undergoing surgical fracture repair . METHODS Eighty-eight otherwise healthy cats were matched according to fracture site and then r and omly allocated to one of two groups , receiving 0·2 mg/kg meloxicam by subcutaneous injection ( group M ) or 1·5 to 3 mg/kg tolfenamic acid orally ( group T ) before anaesthesia . Analgesia was continued with 0.05 mg/kg oral meloxicam once daily or 1·5 to 3 mg/kg oral tolfenamic acid twice daily for four days postoperatively . Pain was assessed by a blinded observer using visual analogue scales and a functional limb score . The drug administrator assessed feed intake and palatability of the treatment . RESULTS Data from 66 cats were analysed . Visual analogue scale pain scores and functional limb scores decreased over time in both groups but were not significantly different between treatments . Feed intake was similar in both groups . Meloxicam was significantly more palatable than tolfenamic acid on all treatment days . CLINICAL SIGNIFICANCE Meloxicam and tolfenamic acid demonstrated comparable analgesia , without clinical ly observable side effects . Meloxicam may be associated with superior compliance in clinical practice due to the higher palatability and once daily treatment result ing in better ease of administration",
"OBJECTIVE To characterize the antinociceptive actions of several doses of butorphanol by use of a thermal threshold testing device specifically design ed for cats . ANIMALS 6 domestic shorthair cats . PROCEDURE The study was a masked , r and omized , crossover design . Thermal thresholds were measured by use of a thermal threshold-testing device specifically developed for cats . A small probe containing a heater element and temperature sensor was held with consistent contact against a shaved area of the cat 's skin with an elasticized b and . Skin temperature was recorded before each test , prior to activation of the heater . On detection of a response ( eg , the cat flinched , turned , or jumped ) , the stimulus was terminated and the threshold temperature recorded . Three baseline measurements were recorded before IV injection of 0.1 , 0.2 , 0.4 , or 0.8 mg of butorphanol/kg . Each cat received all doses in a r and omized order at least 1 week apart . The investigator was unaware of the treatment received . Thermal thresholds were measured every 15 minutes for 6 hours . RESULTS Mean+/-SD pretreatment threshold temperature for all cats was 40.8+/-2.2 degrees C. There were no dose-related differences among treatments . There was a significant increase in threshold values for all treatments from 15 to 90 minutes after injection . Mydriasis was detected in all cats after treatment with butorphanol and dysphoric behavior was frequently exhibited . CONCLUSIONS AND CLINICAL RELEVANCE Results obtained by use of a thermal stimulus indicated that the duration of antinociceptive action of butorphanol was 90 minutes and there was no dose-response relationship in cats",
" Elective ovariohysterectomy was performed on 66 cats . Surgical approach was flank ( group F ) or midline ( group M ) allocated by block r and omisation . Pre-anaesthetic medication was acepromazine ( 0.1 mg/kg ) via intramuscular injection . Anaesthesia was induced with intravenous thiopentone , and maintained with halothane in 100 % oxygen . Carprofen ( 4 mg/kg ) was administered by the subcutaneous route immediately after induction of anaesthesia . Postoperative pain and wound tenderness were assessed at 1 , 3 , 6 , 9 , 11–12 and 20–24 h after the end of surgery , and the assessment outcome marked on visual analogue scales ( VAS ) . Intervention analgesia ( if pain VAS was > 40 mm ) was pethidine 4 mg/kg via intramuscular injection . Area under the curve ( AUC ) for VAS for pain and VAS for wound tenderness for each cat were calculated . AUC for wound tenderness was significantly greater for group F ( P=0.007 ) . There was no significant difference for AUC for pain between the groups . In conclusion , wounds after flank ovariohysterectomy are significantly more tender than after midline ovariohysterectomy in the cat . This indicates that interactive methods , including wound palpation , must be used to assess postoperative pain and the findings should be appropriately weighted in the overall assessment",
"The aim of this study was to evaluate the efficacy and palatability of meloxicam 0.5mg/ml oral suspension , compared to ketoprofen tablets in cats suffering from painful acute locomotor disorders . This single blinded , positively-controlled , r and omised , multicentre trial involved 121 client owned cats . Cats received either meloxicam ( 0.5mg/ml oral suspension ) at 0.1mg/kg on day 1 followed by 0.05mg/kg q 24h on days 2 - 5 , or ketoprofen 5 mg tablets at 1.0mg/kg q 24h for 5 days . The efficacy of the two treatments was assessed subjectively by clinicians on day 6 using a clinical sum score ( CSS ) . Palatability and accuracy of dosing were also assessed . The baseline CSS was not significantly different between the groups , and after 5 days of treatment the CSS had decreased to a similar extent , reflecting a reduction in pain . There were no significant differences between the CSS of each group at day 6 . Both treatments were well tolerated . Meloxicam was significantly more palatable than ketoprofen , and allowed for more accurate dosing . Meloxicam and ketoprofen are a safe and efficacious treatment for acute locomotor disorders in cats . Meloxicam ( Metacam ) may be associated with superior compliance in clinical practice due to the higher palatability , which results in better ease of administration",
"OBJECTIVE To evaluate short-term postoperative forelimb function after scalpel and laser onychectomy in cats . DESIGN R and omized , prospect i ve study . ANIMALS 20 healthy adult cats . PROCEDURES Cats were r and omly assigned to the laser ( n = 10 ) or scalpel ( 10 ) onychectomy group . Unilateral left forelimb onychectomy was performed . In the scalpel group , a tourniquet was used during surgery and a b and age was applied after surgery . Pressure platform gait analysis was performed prior to and 1 , 2 , 3 , and 12 days after onychectomy . Peak vertical force ( PVF ) , vertical impulse , and the ratio of the PVF of the left forelimb to the sum of the remaining limbs ( PVF ratio ) were used as outcome measures . RESULTS The laser onychectomy group had significantly higher ground reaction forces on days 1 and 2 and significantly higher PVF ratio on day 12 , compared with the scalpel group . Similarly , significant differences were found in change in ground reaction forces on days 1 and 2 and the PVF ratio on day 12 , compared with day -1 . No cats required rescue analgesia during the course of the study . One cat in the laser group had signs of depression and was reluctant to walk on day 2 after surgery , had physical examination findings consistent with cardiac insufficiency , and was euthanized . CONCLUSIONS AND CLINICAL RELEVANCE Cats had improved limb function immediately after unilateral laser onychectomy , compared with onychectomy with a scalpel , tourniquet , and b and age . This improved limb function may result from decreased pain during the 48 hours following unilateral laser onychectomy",
"OBJECTIVE To compare postoperative signs of discomfort and complications associated with use of CO2 laser for onychectomy with those of the scalpel technique in cats . DESIGN Prospect i ve , r and omized , masked clinical trial . ANIMALS 20 client-owned cats . PROCEDURE Forelimb feet ( right , left ) were r and omly assigned to laser and scalpel treatment groups . Signs of discomfort ( lameness and signs of pain ) and complications ( hemorrhage , swelling , and discharge ) were assessed on days 0 , 1 , and 7 . Surgeries were performed by 1 experienced surgeon . Evaluations were performed by 2 individuals without knowledge of treatment group . Signs of discomfort and complications were scored on scales of 0 to 8 and 0 to 9 , respectively . RESULTS Onychectomy did not result in high discomfort or complication scores 1 day after surgery , regardless of technique used , although the laser-treated group had significantly lower scores for signs of discomfort and complications . Seven days after surgery , significant differences were not detected between groups for signs of discomfort or complications . CONCLUSIONS AND CLINICAL RELEVANCE The CO2 laser can be an excellent tool for onychectomy in cats , with excellent hemostasis and minimal postoperative discomfort and complications . Differences in discomfort and complications between groups treated via scalpel versus CO2 laser were not clinical ly relevant and were only observed 1 day after surgery",
"OBJECTIVE To compare three opioid agonist drugs for perioperative analgesia in cats . STUDY DESIGN Prospect i ve , blind , controlled , r and omised trial . ANIMALS Ninety client-owned cats , weighing 3.1 ( 2.1 - 4.5 ) kg , aged 14.6 ( 6.0 - 84.0 ) months , were studied . METHODS Seventy-six cats , scheduled for ovariectomy , received either 0.6 mg kg(-1 ) racemic methadone , 0.3 mg kg(-1 ) levo-methadone , 0.05 mg kg(-1 ) dextromoramide or a saline placebo IM . Behaviour and body position were assessed and scored 20 minutes later by a single ' blinded ' observer . Anaesthesia was induced with propofol and maintained with halothane . Heart rate ( HR ) , respiratory rate ( RR ) , Fe'CO2 and SpO2 were recorded during anaesthesia . Post-operatively , pain was categorised as absent , moderate or severe , on the basis of appearance , behaviour and response to palpation of the surgical wound ( pain score ) . Appearance , pain scores and physiological variables were monitored every 30 minutes , for a duration of 4 hours . Differences between time-dependent continuous variables were analysed using mixed models for repeated measurements . Differences in categorical , time-dependent variables were analysed using chi2-tests . Significance was set at p appearance after pre-anaesthetic medication . After surgery , there was no association between appearance and pain score with HR or RR . The assessment of pain depended on comparison with the placebo group , by comparing animals ' reactions to wound palpation . Sixteen of the 18 cats in the placebo group and 14 of the 19 cats in the dextromoramide group showed signs of moderate-to-severe pain after surgery . In the levo-methadone group ( n = 20 ) , one animal showed pain after 60 minutes and two after 120 minutes . One cat in the racemic methadone group ( n = 19 ) showed pain signs and behavioural changes at 60 minutes . Compared to the two methadone groups , ' rescue ' analgesia was required more often in cats treated with dextromoramide or saline . CONCLUSION AND CLINICAL RELEVANCE Dextromoramide ( 0.05 mg kg(-1 ) ) was ineffective , while racemic methadone ( 0.6 mg kg(-1 ) ) and levo-methadone ( 0.3 mg kg(-1 ) ) provided effective analgesia in cats following ovariectomy , without behavioural , respiratory or cardiovascular side effects",
"OBJECTIVE To evaluate the antinociceptive effects of epidurally administered hydromorphone in conscious , healthy cats . ANIMALS 7 healthy adult cats . PROCEDURES An epidural catheter was implanted in each cat . Thermal threshold ( TT ) was measured by increasing the temperature of a probe placed on the thorax and monitoring the cat 's response . Mechanical threshold ( MT ) was measured by manually inflating a modified blood-pressure bladder affixed to a thoracic limb and monitoring the response . After the baseline TT and MT values were determined , hydromorphone ( 0.05 mg/kg ) or an equal volume of saline ( 0.9 % NaCl ) solution was epidurally injected . The TT and MT were again measured at 15 , 30 , 45 , 60 , 120 , 180 , 240 , 300 , 360 , and 480 minutes after injection . RESULTS TT and MT did not change significantly from baseline values at any point after saline solution was administered . The MT and TT values were significantly higher than the baseline value at 15 minutes and at 120 and 180 minutes after hydromorphone administration , respectively . The MT and TT values after hydromorphone administration were also significantly different from those obtained at 30 minutes and at 15 minutes and 120 to 300 minutes , respectively , after administration of saline solution . No significant changes in skin temperature were detected after either treatment . CONCLUSIONS AND CLINICAL RELEVANCE Epidural administration of hydromorphone at a dosage of 0.05 mg/kg yielded thermal and some mechanical antinociceptive effects in cats , and no hyperthermia was detected . Additional studies of the antinociceptive effectiveness and duration of epidurally administered hydromorphone in clinical situations are required",
"OBJECTIVE To investigate the safety , sedative and analgesic properties of methadone in combination with acepromazine prior to neutering in cats . STUDY DESIGN Controlled clinical , block r and omized , prospect i ve , blinded study design ed for regulatory purpose s. ANIMALS 24 female and 21 male healthy cats . METHODS Cats received one of three opioids combined with acepromazine ( 0.05 mg kg(-1 ) ) intramuscularly ( IM ) for premedication : Group 1 : buprenorphine ( 0.02 mg kg(-1 ) ) , group 2 : methadone ( 0.5 mg kg(-1 ) ) , group 3 butorphanol ( 0.4 mg kg(-1 ) ) . Sedation was assessed 30 minutes after premedication using a visual analogue scale ( VAS ) and simple descriptive scale . Anaesthesia was induced with alfaxalone and maintained with isoflurane in oxygen . Surgical ovariohysterectomy or castration was performed . Pain was assessed using an interactive VAS ( IVAS ) and mechanical nociceptive threshold ( MNT ) with a pressure rate onset device . Methadone ( 0.5 mg kg(-1 ) IM ) and meloxicam ( 0.2 mg kg(-1 ) subcutaneously ) were provided 6 and 8 hours after premedication respectively , or together as rescue analgesia ( IVAS above 50 ) . RESULTS Sedation scores , induction agent dose , pain scores at all time points and rescue analgesia were not statistically different between groups . In methadone treated cats there was no significant variation in MNT over time , suggesting a possible anti-hyperalgesic action , whereas in the other two groups lower thresholds were recorded at various time points after surgery compared to baseline . No cats required rescue analgesia after the second dose of methadone . No perioperative adverse effects occurred . CONCLUSION AND CLINICAL RELEVANCE Methadone provided comparable sedation and analgesia to both buprenorphine and butorphanol when combined with acepromazine . Differences in analgesic efficacy between opioids might have been undetectable because of the surgical model and surgeon competency . Nevertheless , methadone is an effective analgesic in cats and its administration prior to feline neutering may be advantageous",
"OBJECTIVE To describe the dose-related thermal antinociceptive effects of intravenous ( i.v . ) hydromorphone in cats . STUDY DESIGN R and omized , blinded , crossover design . ANIMALS Seven adult cats ( 3.5 - 7.4 kg ) , two spayed females , and five neutered males . METHODS Hydromorphone ( 0.025 , 0.05 , or 0.1 mg kg(-1 ) ) was administered i.v .. Skin temperature and thermal threshold were measured before and at selected time points to 720 minutes post-administration . Statistical analysis of mean thermal threshold and skin temperatures over time for each dose and between doses was by way of a split-plot model and post hoc Bonferroni t-tests . p mean thermal threshold was identified for the 0.05 mg kg(-1 ) dose ( 5 - 80 minutes , peak thermal threshold 46.9 + /- 6.2 degrees C ) and 0.1 mg kg(-1 ) dose ( 5 - 200 minutes , peak thermal threshold 54.9 + /-0.2 degrees C ) . The thermal threshold was significantly greater after the 0.1 mg kg(-1 ) dose from 5 to 200 minutes compared to the 0.025 mg kg(-1 ) and 0.5 mg kg(-1 ) doses . The thermal threshold was significantly greater from 35 to 80 minutes for the 0.05 mg kg(-1 ) dose when compared with the 0.025 mg kg(-1 ) dose . Skin temperature was significantly increased from 35 to 140 minutes following the 0.1 mg kg(-1 ) dose . CONCLUSIONS A dose-related antinociceptive effect was demonstrated for i.v . hydromorphone in cats . CLINICAL RELEVANCE Hydromorphone at doses less than 0.1 mg kg(-1 ) has a modest antinociceptive effect and a short duration of action . At a dose of 0.1 mg kg(-1 ) i.v . , onset of analgesia is rapid with a clinical ly useful duration of effect , but is associated with a rise in skin temperature",
"A placebo-controlled , r and omized blind study was conducted in cats ( n = 60 ) after fracture repair to compare the analgesic effects as well as the side-effects of carprofen , buprenorphine and levomethadone during a 5-day treatment . Cats with severe shock symptoms or increases in blood urea nitrogen ( BUN ) and creatinine were excluded from the study . The cats were r and omly assigned to four groups ( n= 15 ) . In group 1 , carprofen was administered upon extubation at an initial dose of 4 mg/kg body weight , followed by one-third of that dose three times daily on days 2 to 5 . In group 2 , buprenorphine was administered in a single dose of 0.01 mg/kg body weight upon extubation and subsequently every 8 h. Levomethadone ( group 3 ) was applied according to the same scheme at a dosage of 0.3 mg/kg body weight each time . The placebo ( group 4 ) was given at the same time intervals as the opioids . Examinations were carried out prior to anaesthesia , between 30 min and 8 h after extubation , and on the following 4 days , 1 h after administration of the analgesics or the placebo as well as 1 h before the next administration . Pain and sedation evaluation was carried out with a visual analogue system ( VAS ) and with the aid of a numerical estimation scale ( NRS ) . Pain was also scored by measuring mechanical nociceptive threshold of traumatized tissue . Plasma glucose and cortisol concentration , heart rate , respiration rate , blood pressure and body temperature were measured . Furthermore , a complete blood count and clinical chemistry including BUN , creatinine , alanine aminotransferase ( ALT ) , glutamate dehydrogenase ( GLDH ) , arterial blood pressure ( AP ) , total protein and electrolytes of the cats were checked on the day of admission as well as on the last day of this study ( day 5 ) . Defaecation and urination as well as wound healing were monitored . On the basis of the mechanical nociceptive threshold of the traumatized tissue , concentrations of plasma glucose and cortisol and pain assessment using NRS and VAS , carprofen was found to have better anti-nociceptive efficacy when compared with the two opioid analgesics , while the analgesic effect of levomethadone was similar to that of buprenorphine . However , the carprofen group also showed comparably high median NRS and VAS pain scores in addition to occasional broad deviations from the group mean on the first post-operative treatment day . Sedative effects were detected for buprenorphine and levomethadone ; in addition , symptoms of central excitation were noted with levomethadone . There was no indication of any clinical ly relevant respiratory depressive or cardiovascular effects , nor of any undesired renal , gastrointestinal or hepatic effects of the analgesics applied . However , the somewhat insensitive examination methods did not permit sufficient evaluation of side-effects , particularly on the gastrointestinal tract and the kidneys . It was found that carprofen and buprenorphine were well-tolerated analgesics for a 5-day administration in the cat , whereas levomethadone caused central excitation in some cases in the dosage scheme used here . However , it was apparent that none of the tested analgesics induced sufficient analgesia in the post-operative phase . For this reason , suitable methods must be found to improve analgesia , particularly in the immediate post-operative phase",
"BACKGROUND Feline degenerative joint disease ( DJD ) is common and there are no approved therapies for the alleviation of the associated pain . OBJECTIVE To test a diet high in eicosapentaenoic acid ( EPA ) , and docosahexaenoic acid ( DHA ) content and supplemented with green-lipped mussel extract and glucosamine/chondroitin sulfate ( test-diet ) for its pain-relieving and activity-enhancing effects in cats with painful , mobility-impairing DJD over a 9-week period . ANIMALS Forty client-owned cats . METHODS R and omized , controlled , blinded , parallel group , prospect i ve clinical study . Cats with no detectable systemic disease , and with at least 1 appendicular joint with radiographic evidence of DJD where manipulation elicited an aversive response were included . Cats were r and omly allocated to the test-diet or control diet ( C-diet ) . Outcome measures were subjective owner and veterinarian assessment s , and objective activity monitoring ( accelerometry ) . Nonparametric statistics were used to evaluate changes within and between groups for both subjective and objective data , and locally weighted scatterplot smoothing regression analysis was used to predict activity changes . RESULTS The primary objective outcome measures indicated that activity declined significantly ( P C-diet group , significantly increased ( P EPA and DHA and supplemented with green-lipped mussel extract and glucosamine/chondroitin sulfate improved objective measures of mobility . Dietary modulation might be 1 method to use to improve mobility in cats with DJD-associated pain",
"The dose-related antinociceptive effects of intravenous ( IV ) buprenorphine were evaluated in cats . Thermal ( TT ) and mechanical threshold ( MT ) devices were used for nociceptive stimulation . After baseline threshold recordings , buprenorphine was administered IV ( 0.01 , 0.02 or 0.04 mg/kg ; B1 , B2 and B4 , respectively ) in a r and omised , blinded and cross-over study . Data were analysed by ANOVA ( P TT increased 15 , 30 , 45 min and 1 ( 5.2+/-2.7 degrees C ) , 2 , 3 and 4 h after B1 ; 15 , 30 , 45 min and 1 ( 5.1+/-3.9 degrees C ) and 2 h after B2 , and 15 , 30 , 45 min and 1 ( 5.4+/-3.3 degrees C ) , 2 , 3 , 6 and 8 h after B4 . MT increased 15 and 45 min after B2 ( 260+/-171 mmHg ) , and 30 ( 209+/-116 mmHg ) and 45 min and 1 and 2 h after B4 . At 45 min , MT values were significantly higher after B2 compared to B1 ( P MT , B2 and B4 produced more antinociception and longer duration of action than B1 , respectively . No dose response to thermal stimulation was detected",
"This study evaluated the types of items owners consider important to their cats ’ quality of life ( QoL ) . We hypothesized that items contributing to QoL in cats are predominantly items requiring mobility . The objectives of the study were to describe the types of items considered important by owners for their cats ’ QoL ; to describe the proportion of these items that involve mobility ; to evaluate what patient factors , including severity of degenerative joint disease ( DJD ) , affect this distribution ; and to evaluate whether the proportion of QoL items involving mobility chosen by owners is different in cats presenting for a DJD study compared with a r and omly selected population . A total of 830 client-generated items were evaluated . Regardless of DJD status , 40 % of items listed by owners involved mobility , while 60 % were ‘ inactive ’ items , rejecting our hypothesis . This highlights the need to assess non-active items that owners consider to constitute QoL to fully assess the impact of diseases like DJD and , therefore , the success of therapeutic interventions",
"OBJECTIVE To evaluate the analgesic effects of medetomidine ( MED ) and butorphanol ( BTO ) in cats after ovariohysterectomy . STUDY DESIGN A placebo-controlled , blinded monocenter clinical study . ANIMALS Healthy adult female client-owned cats . METHODS Sixty-four cats weighing 3.15 + /- 0.6 kg , presented to the University of Helsinki 's Small Animal Teaching Hospital for routine elective ovariohysterectomy , received MED at 15 microg/kg ( n = 18 ) , BTO at 0.1 mg/kg ( n = 23 ) , or saline ( PL ) ( n = 23 ) intramuscularly immediately after ovariohysterectomy . Level of pain perception , degree of restlessness , and extent of sedation were scored subjectively before and at 30 , 60 , 90 , and 120 minutes after test-drug administration . RESULTS BTO provided the best pain relief , followed by MED . Saline provided the least pain relief . Both MED and BTO effectively and identically prevented postoperative restlessness . MED and BTO produced an identical degree of sedation that was better than the PL . CONCLUSIONS Both MED ( at 15 microg/kg ) and BTO ( at 0.1 mg/kg ) prevent postoperative pain in cats after ovariohysterectomy . Clinical Relevance -MED and BTO are useful for preventing postoperative pain in cats",
"OBJECTIVE To compare the postoperative analgesic and sedative properties of buprenorphine and morphine in cats . STUDY DESIGN Prospect i ve , r and omized , blinded study . ANIMALS Thirty-two domestic cats undergoing surgery . METHODS Cats received pre-anaesthetic medication with acepromazine ( 0.05 mg kg-1 ) given intramuscularly and were r and omly allocated to group M and given morphine ( 0.1 mg kg-1 ) intramuscularly ( IM ) or to group B and given buprenorphine ( 0.01 mg kg-1 ) IM . Anaesthesia was induced with propofol and maintained with halothane in oxygen and nitrous oxide . Pain and sedation scores using visual analogue scales , and heart and respiratory rates , were measured immediately before , and 30 , 60 , 120 , 180 , 300 and 420 minutes after anaesthesia . RESULTS Pain scores were significantly lower at 60 , 120 and 180 minutes after anaesthesia in group B. Group B also had higher heart rates at 30 minutes . There were no other statistically significant differences between the groups . CLINICAL RELEVANCE Buprenorphine ( 0.01 mg kg-1 ) appeared to provide better postoperative analgesia than morphine ( 0.1 mg kg-1 ) and may also have a longer duration of action",
"OBJECTIVE To determine analgesic efficacy and adverse effects of preemptive administration of meloxicam or butorphanol in cats undergoing onychectomy or onychectomy and neutering . DESIGN R and omized controlled study . ANIMALS 64 female and 74 male cats that were 4 to 192 months old and weighed 1.09 to 705 kg ( 2.4 to 15.5 lb ) . PROCEDURE Cats received meloxicam ( 0.3 mg/kg [ 0.14 mg/lb ] , s.c . ) or butorphanol ( 0.4 mg/kg [ 0.18 mg/lb ] , s.c . ) 15 minutes after premedication and prior to anesthesia . A single blinded observer measured physiologic variables , assigned analgesia and lameness scores , and withdrew blood sample s for each cat at baseline and throughout the 24 hours after surgery . Rescue analgesia ( butorphanol , 0.4 mg/kg , i.v . or s.c . ) or administration of acepromazine ( 0.025 to 0.05 mg/kg [ 0.011 to 0.023 mg/lb ] , i.v . ) was allowed . RESULTS Meloxicam-treated cats were less lame and had lower pain scores . Cortisol concentration was higher at extubation and lower at 1 , 5 , and 12 hours in the meloxicam-treated cats . Fewer meloxicam-treated cats required rescue analgesia at 3 , 5 , 12 , and 24 hours after extubation . General impression scores were excellent or good in 75 % of meloxicam-treated cats and 44 % of butorphanol-treated cats . There was no treatment effect on buccal bleeding time ; PCV and BUN concentration decreased in both groups , and glucose concentration decreased in meloxicam-treated cats . CONCLUSIONS AND CLINICAL RELEVANCE Preoperative administration of meloxicam improved analgesia for 24 hours without clinical ly relevant adverse effects in cats that underwent onychectomy or onychectomy and neutering and provided safe , extended analgesia , compared with butorphanol",
"Eighty-nine cats and 38 dogs naturally infested with the ear mite Otodectes cynotis were r and omly allocated into two treatment groups . One group was treated with a product containing miconazole nitrate , polymyxin B sulphate and prednisolone acetate , the other with a combination of diethanolamine fusi date , framycetin sulphate , nystatin and prednisolone . The treatment ( five drops in each ear ) was applied twice daily for 14 days , and its efficacy was evaluated on days 7 , 14 and 21 on the basis of an otoscopic examination of the external ear canal , a microscopical examination of scrapings for the presence of ear mites and clinical signs of pruritus , pain , erythema and /or exu date . Both treatments were highly effective , and there were no significant differences between the two products , either in efficacy or in the clinical improvements observed . Apart from an allergic reaction in one cat treated with the second product , no adverse effects were observed",
"Data allowing rational use of analgesics in cats are limited . Pharmacokinetics and pharmacodynamics of fentanyl were studied in cats . Plasma fentanyl concentrations were measured using radioimmunoassay in a crossover study in six cats after 10 microg/kg ( i.v . ) or by application of fentanyl in pluronic lecithin organogel ( PLO ) to the inner ear pinna . On a separate occasion thermal thresholds were measured after i.v . fentanyl ( 10 microg/kg ) or saline . Plasma fentanyl concentrations reached 4.7 - 8.31 ng/mL 2 min after i.v . administration and were undetectable after 95 min . Fentanyl was not detected in plasma at any time after PLO use . Thermal thresholds did not change following saline administration but were increased above baseline from 5 to 110 min after i.v . fentanyl . In this model a plasma concentration of > 1.07 ng/mL was required to provide analgesia . Plasma concentrations were measured in additional cats after intranasal or oral dosing ( 2 microg/kg ) and after 30 microg/kg in PLO gel . After oral and nasal dosing , Cmax values were 0.96 and 1.48 ng/mL at 5 and 2 min , respectively . Plasma fentanyl was not detected after application of the higher dose of fentanyl in PLO",
"The analgesic efficacy of tramadol and /or vedaprofen was evaluated in cats su bmi tted for elective ovariohysterectomy , using a r and omised double blind placebo controlled design . Forty adult female cats ( 3.0±0.32 kg ; 1.8±0.7 years ) were distributed into four groups . Vedaprofen PO ( 0.5 mg/kg ) , tramadol SC ( 2 mg/kg ) , both , or placebo was administered 1 h before surgery and every 24 and 8 h , respectively , for 72 h after surgery . Pain score evaluated by interactive visual analogue and composite pain score and hyperalgesia by the von Frey filament test were recorded at 1 , 2 , 4 , 6 , 8 , 12 , 24 , 28 , 32 , 48 , 52 , 56 , 72 , 96 h and on the 7th day after surgery . Animals treated with combined vedaprofen and tramadol treatment did not need rescue analgesia , did not develop hyperalgesia , and their serum cortisol concentrations and pain scores were lower than placebo until 24 and 72 h after surgery , respectively . Combined vedaprofen and tramadol treatment provided more effective postoperative analgesia and prevented hyperalgesia than when used on their own . Multimodal technique is a superior method of treating pain after feline ovariohysterectomy . This work also provides evidence for the benefits of analgesia for up to 3 days following ovariohysterectomy",
"This study examined the effect of amantadine , an N-methyl-d-aspartate receptor antagonist , on the thermal antinociceptive effect of oxymorphone in cats . Six adult healthy cats were used . After baseline thermal threshold determinations , oxymorphone was administered intravenously to maintain plasma oxymorphone concentrations of 10 , 20 , 50 , 100 , 200 , and 400 ng/mL. In addition , amantadine , or an equivalent volume of saline , was administered intravenously to maintain a plasma amantadine concentration of 1100 ng/mL. Thermal threshold and plasma oxymorphone and amantadine concentrations were determined at each target plasma oxymorphone concentration . Effect maximum models were fitted to the oxymorphone concentration-thermal threshold data , after transformation in % maximum response . Oxymorphone increased skin temperature , thermal threshold , and thermal excursion ( i.e. , the difference between thermal threshold and skin temperature ) in a concentration-dependent manner . No significant difference was found between the amantadine and saline treatments . Mean ± SE oxymorphone EC(50 ) were 14.2 ± 1.2 and 24.2 ± 7.4 ng/mL in the amantadine and saline groups , respectively . These values were not significantly different . Large differences in oxymorphone EC(50 ) in the saline and amantadine treatment groups were observed in two cats . These results suggest that amantadine may decrease the antinociceptive dose of oxymorphone in some , but not all , cats",
"OBJECTIVES The primary objective was to determine the prevalence , spinal distribution , and association with the signalment of cats suffering from different grade s of feline spondylosis deformans ( spondylosis ) . The secondary objective was to document behavioural changes associated with spondylosis by owner observation . METHODS A cross-sectional study was performed to determine the prevalence of feline spondylosis ( group 1 ) . A prospect i ve study was performed to determine the association between radiographic abnormalities of the lumbosacral region ( L3-S1 ) and owner perceived behavioural changes based on a completed question naire ( group 2 ) . The radiographs were review ed using a grading system ( 0 - 3 ) for spondylosis . RESULTS The prevalence of spondylosis in group 1 was 39.4 % ( 158/402 ) . Cats with spondylosis were significantly older than cats without spondylosis ( p owner-reported behavioural changes , such as a decreased willingness to greet people and to being petted , increased aggressiveness , and a poor perceived quality of life ( p = 0.037 ) . CLINICAL SIGNIFICANCE This study found that feline spondylosis is common and that spondylosis of the lumbosacral region may be accompanied by behavioural changes",
"OBJECTIVE To determine the items ( question topics ) for a subjective instrument to assess degenerative joint disease (DJD)-associated chronic pain in cats and determine the instrument design most appropriate for use by cat owners . ANIMALS 100 r and omly selected client-owned cats from 6 months to 20 years old . PROCEDURES Cats were evaluated to determine degree of radiographic DJD and signs of pain throughout the skeletal system . Two groups were identified : high DJD pain and low DJD pain . Owner-answered questions about activity and signs of pain were compared between the 2 groups to define items relating to chronic DJD pain . Interviews with 45 cat owners were performed to generate items . Fifty-three cat owners who had not been involved in any other part of the study , 19 veterinarians , and 2 statisticians assessed 6 preliminary instrument design s. RESULTS 22 cats were selected for each group ; 19 important items were identified , result ing in 12 potential items for the instrument ; and 3 additional items were identified from owner interviews . Owners and veterinarians selected a 5-point descriptive instrument design over 11-point or visual analogue scale formats . CONCLUSIONS AND CLINICAL RELEVANCE Behaviors relating to activity were substantially different between healthy cats and cats with signs of DJD-associated pain . Fifteen items were identified as being potentially useful , and the preferred instrument design was identified . This information could be used to construct an owner-based question naire to assess feline DJD-associated pain . Once vali date d , such a question naire would assist in evaluating potential analgesic treatments for these patients",
"A pressure analgesiometric device was developed for unrestrained cats . Eleven cats were studied . Stimulation was via three rounded pins within a bracelet on the forearm . The pins were advanced by manual bladder inflation . Bladder pressure was measured using a strain gauge pressure transducer . The threshold was recorded at the behavioural end point . Thresholds were measured at 5 and 15min intervals for 2 - 4h , after removal/replacement of the cuff , for 120min after SC butorphanol ( 0.4mg/kg ) , and with mild skin inflammation at the testing site . Data were analysed using ANOVA . Pressure thresholds in untreated cats were around 150mmHg . The minimum interval for testing was established as 15min . Data were reproducible over 4h and beyond 24h . Thresholds in 5 cats increased ( P butorphanol with a maximum increase of 270+/-182mmHg at 10min . Thresholds decreased with inflammation . The method appears suitable for feline analgesia investigations",
"Eighty female cats presented for ovariohysterectomy were r and omly allocated to one of two treatment groups in this assessor-blinded trial . After pre-anaesthetic assessment , the cats were premedicated with acepromazine ( 0.1 mg/kg ) . Anaesthesia was induced with thiopentone and maintained with halothane in oxygen . Forty cats received carprofen ( 4 mg/kg subcutaneously ) and 40 received meloxicam ( 0.3 mg/kg subcutaneously ) after anaesthetic induction . Following routine flank ovariohysterectomy the cats were assessed using visual analogue scale scores for pain and sedation over a 20-hour study period . Blood sample s were taken before sedation and at 20 hours for serum biochemistry ( urea , creatinine , alanine aminotransferase and aspartate aminotransferase ) . There were no significant differences between the groups for pain and sedation scores . Serum biochemistry values were similar between the groups , with some differences within groups between the pre-sedation and 20-hour values . One cat in the carprofen group and two cats in the meloxicam group required rescue analgesia with intramuscular morphine ( 0.2 mg/kg )",
"The ability of two non-steroidal anti-inflammatory drugs to modify the clinical manifestations of pain associated with locomotor disease was assessed . Sixty-nine cats with acute or chronic locomotor disorders were recruited from 14 first opinion UK veterinary practice s and r and omly allocated to one of two treatment groups . Group A received meloxicam drops ( 0.3 mg/kg orally on day 1 followed by 0.1 mg/kg daily for four more consecutive days ) and group B received ketoprofen tablets ( 1.0 mg/kg orally once daily for five days ) . Each cat underwent a full clinical examination before treatment , 24 hours after initiation of treatment and 24 hours after completion of treatment . General clinical parameters ( demeanour and feed intake ) and specific locomotor parameters ( weightbearing , lameness , local inflammation and pain on palpation ) were scored using a discontinuous scale scoring system . The two groups did not differ in terms of age , weight , gender distribution or duration of clinical signs ; nor did they differ in terms of general clinical or specific locomotor scores pretreatment . Both treatment regimens result ed in a significant improvement in demeanour , feed intake and weightbearing , and a significant reduction in lameness , pain on palpation and inflammation . No significant difference was observed between the two treatment groups with respect to any of the parameters measured and both treatments were associated with minimal observed side effects . Meloxicam and ketoprofen were found to be effective analgesics and well tolerated in cats with acute or chronic locomotor disorders when administered for short-term treatment ( five days ) in such cases . However , meloxicam was assessed to be significantly more palatable than ketoprofen",
"The adequacy of postoperative analgesia was assessed in 40 cats following ovariohysterectomy . At extubation , cats were given one dose of carprofen , ketoprofen , meloxicam or tolfenamic acid . Postoperative analgesia was assessed using visual analogue scale ( VAS ) scoring for pain and sedation ; measurement of mechanical nociceptive thresholds at the wound ; recognition of the requirement for rescue intervention analgesia ; and an overall clinical assessment score at 18 hours . VAS pain scores were low throughout the trial , with no significant differences found between the groups . Postoperative mechanical nociceptive thresholds decreased significantly from baseline in all four groups , with no significant differences between the groups . One cat in each of the tolfenamic acid , ketoprofen and meloxicam groups required rescue intervention analgesia . Nine out of 10 cats in all four groups were classified as having desirable overall clinical assessment scores . In summary , all four drugs provided good postoperative analgesia , although none was able to prevent postoperative wound tenderness",
"One hundred and fifty-three cats undergoing surgery in seven veterinary practice s in Great Britain were studied . They were r and omly allocated to receive either 10–20 μg/kg buprenorphine or 0.4 mg/kg butorphanol with acepromazine before anaesthesia with propofol , Saffan or thiopentone and isoflurane or halothane . Routine monitoring was undertaken . Pain and sedation were assessed blind using a four point ( 0–3 ) simple descriptive scale ( SDS ) at 1 , 2 , 4 , 8 and 24 h. Pain and sedation data were compared using non-parametric statistical tests and continuous data using t tests or analysis of variance ( ANOVA ) . Anaesthesia and surgery were uneventful , and cardiorespiratory data were within normal limits . After surgery , overall , more cats had pain score 0 after buprenorphine and more had pain score 3 after butorphanol ( P=0.0465 ) . At individual time points , more cats had lower pain scores after buprenorphine at 2 ( P=0.040 ) and 24 ( P=0.036 ) h. At 24 h 83 % after buprenorphine and 63 % after butorphanol had pain score 0 ( P ) . Buprenorphine provided better and longer lasting postoperative analgesia than butorphanol ",
"OBJECTIVE -To determine the thermal antinociceptive effect of oral administration of tramadol hydrochloride at doses between 0.5 and 4 mg/kg in cats . ANIMALS-6 healthy adult domestic shorthair cats . PROCEDURES -Baseline ( before drug administration ; time 0 ) thermal threshold was determined by applying a thermal probe to the thorax of each cat . Tramadol ( 0.5 , 1 , 2 , 3 , or 4 mg/kg ) or a placebo was then administered orally in accordance with a Latin square design . Thermal threshold was determined by an observer who was unaware of treatment at various times until thermal threshold returned to baseline values or 6 hours had elapsed . Plasma tramadol and O-desmethyl-tramadol concentrations were measured prior to drug administration and at 1-hour intervals thereafter . Effect-concentration data were fitted to effect maximum models . RESULTS -Highest plasma tramadol and O-desmethyl-tramadol concentrations increased with increasing tramadol dose . Significant effects of dose and time on thermal threshold were detected . Thermal threshold was significantly higher than the baseline value at 80 and 120 minutes for the 0.5 mg/kg dose , at 80 and from 120 to 360 minutes for the 2 mg/kg dose , from 40 to 360 minutes for the 3 mg/kg dose , and from 60 to 360 minutes for the 4 mg/kg dose . CONCLUSIONS AND CLINICAL RELEVANCE -Tramadol induced thermal antinociception in cats . Doses of 2 to 4 mg/kg appeared necessary for induction of significant and sustained analgesic effects . Simulations predicted that 4 mg/kg every 6 hours would maintain analgesia close to the maximum effect of tramadol",
"OBJECTIVE To evaluate the efficacy of the transdermal fentanyl patch in relieving perioperative pain and stress associated with ovariohysterectomy in cats . STUDY DESIGN Prospect i ve laboratory trial . ANIMALS Twenty-four female , purpose -bred cats . METHODS Each cat was r and omly assigned to groups 1 - 3 . Group 1 received a 25-microg/h transdermal fentanyl patch only . Group 2 received the patch and anesthesia . Group 3 received anesthesia only . Patches were left in place for 72 hours . Rectal temperature , heart rate , respiratory rate , indirect blood pressure , blood glucose , serum cortisol concentration , plasma fentanyl concentration , pain score , and excitement/sedation score were monitored at prescribed intervals over an 81-hour period . Cats from groups 1 - 3 were reassigned to groups 4 and 5 . Group 4 received the patch , anesthesia , and an ovariohysterectomy . Group 5 received anesthesia and an ovariohysterectomy only . The study period and monitored parameters were the same as for groups 1 - 3 . RESULTS Serum cortisol concentrations were significantly lower in group 4 than group 5 during the surgical and early postsurgical time periods . A similar effect was noted in blood glucose concentrations during the surgical period . Rectal temperature was significantly higher in group 2 when comparing all anesthetized groups during the early postsurgical period . Pain scores were significantly higher in groups 4 and 5 than in groups 2 and 3 during the early postsurgical period . There was no significant difference in pain scores between groups 4 and 5 during this period , however . CONCLUSIONS The transdermal fentanyl patch affects biochemical markers of perioperative pain and stress associated with ovariohysterectomy in cats , attenuating rises in serum cortisol and blood glucose concentrations during the surgical and early postsurgical periods . CLINICAL RELEVANCE The transdermal fentanyl patch is effective in alleviating perioperative pain and stress associated with ovariohysterectomy in cats as evidence d by attenuated rises in cortisol and blood glucose concentrations in cats that were operated on and treated with the patch",
"OBJECTIVE To describe simultaneous pharmacokinetics ( PK ) and thermal antinociception after intravenous ( i.v . ) , intramuscular ( i.m . ) and subcutaneous ( SC ) buprenorphine in cats . STUDY DESIGN R and omized , prospect i ve , blinded , three period crossover experiment . ANIMALS Six healthy adult cats weighing 4.1±0.5 kg . METHODS Buprenorphine ( 0.02 mg kg(-1 ) ) was administered i.v . , i.m . or s.c .. Thermal threshold ( TT ) testing and blood collection were conducted simultaneously at baseline and at predetermined time points up to 24 hours after administration . Buprenorphine plasma concentrations were determined by liquid chromatography t and em mass spectrometry . TT was analyzed using anova ( p RESULTS TT increased above baseline from 15 to 480 minutes and at 30 and 60 minutes after i.v . and i.m . administration , respectively ( p increase in TT ( mean±SD ) was 9.3±4.9 ° C at 60 minutes ( i.v . ) , 4.6±2.8 ° C at 45 minutes ( i.m . ) and 1.9±1.9 ° C at 60 minutes ( s.c . ) . TT was significantly higher at 15 , 60 , 120 and 180 minutes , and at 15 , 30 , 45 , 60 and 120 minutes after i.v . administration compared to i.m . and s.c . , respectively . I.v . and i.m . buprenorphine concentration-time data decreased curvilinearly . S.c . PK could not be modeled due to erratic absorption and disposition . I.v . buprenorphine disposition was similar to published data . The PK-PD model showed an onset delay mainly attributable to slow biophase equilibration ( t(1/2 ) k(e0)=47.4 minutes ) and receptor binding ( k(on)=0.011 mL ng(-1 ) minute(-1 ) ) . Persistence of thermal antinociception was due to slow receptor dissociation ( t(1/2 ) k(off)=18.2 minutes ) . CONCLUSIONS AND CLINICAL RELEVANCE I.v . and i.m . data followed classical disposition and elimination in most cats . Plasma concentrations after i.v . administration were associated with antinociceptive effect in a PK-PD model including negative hysteresis . At the doses administered , the i.v . route should be preferred over the i.m . and s.c . routes when buprenorphine is administered to cats",
"OBJECTIVE To evaluate the efficacy and tolerability of oral administration of robenacoxib for treatment of acute pain and inflammation associated with musculoskeletal disorders in cats . ANIMALS 155 cats requiring relief of signs of pain and inflammation associated with acute musculoskeletal disorders . PROCEDURES The study was a multicenter , prospect i ve , r and omized , masked , noninferiority field trial . Cats were allocated r and omly to 1 of 3 treatment groups : group 1 ( 1.0 to 2.4 mg of robenacoxib/kg , q 24 h ) , group 2 ( 1.0 to 2.4 mg of robenacoxib/kg , q 12 h [ daily dosage , 2.0 to 4.8 mg/kg ] ) , and group 3 ( ketoprofen [ mean dosage , 1 mg/kg , q 24 h ] ) . All cats were administered tablets PO for 5 or 6 days . The primary efficacy endpoint was the investigator global assessment score , which was the sum of scores of signs of pain , inflammation , and mobility assessed in a masked manner by veterinary investigators at baseline , day 2 , and day 4 or 5 . Cat owners monitored in a nonmasked manner secondary responses by observation of cats ' activity , behavior , appetite , and interactions . Safety was assessed by monitoring adverse events , clinical signs , and hematologic and plasma biochemical variables ( before and after treatment ) . RESULTS No significant differences were detected among the 3 treatment groups for any primary or secondary efficacy endpoints or for tolerability variables . Robenacoxib tablets administered once daily were significantly more palatable than ketoprofen tablets . CONCLUSIONS AND CLINICAL RELEVANCE Robenacoxib tablets administered once daily had noninferior efficacy and tolerability , and superior palatability , compared with the active control drug , ketoprofen , for the treatment of signs of acute pain and inflammation associated with musculoskeletal disorders in cats",
"OBJECTIVE To evaluate efficacy and safety of using transdermal fentanyl patches ( TFP ) for analgesia in cats undergoing onychectomy . DESIGN R and omized controlled clinical trial . ANIMALS 45 client-owned cats weighing > or = 2.7 kg ( 5.9 lb ) undergoing onychectomy , onychectomy and ovariohysterectomy , or onychectomy and castration . PROCEDURE Cats were r and omly assigned to be treated with a TFP ( 25 micrograms/h ) or butorphanol ; TFP were applied a minimum of 4 hours before surgery ( approx 8 hours prior to extubation ) . Rectal temperature , heart rate , respiratory rate , force applied by the forelimbs , and serum fentanyl concentration were measured , and temperament , recovery , degree of sedation , severity of pain , severity of lameness , and appetite were scored before and periodically for up to 40 hours after surgery . RESULTS Cats treated with a TFP had better recovery scores at 2 of 4 evaluation times , lower sedation scores at 2 of 8 evaluation times , and lower pain scores at 6 of 8 evaluation times , compared with cats treated with butorphanol . Use of a pressure-sensitive mat to evaluate force applied by the forelimbs did not reveal any differences between groups but did reveal a significant difference between preoperative and postoperative values . Mean + /- SD serum fentanyl concentrations were 1.56 + /- 1.08 , 4.85 + /- 2.38 , 4.87 + /- 1.56 , and 4.35 + /- 2.97 ng/ml approximately 8 , 24 , 32 , and 48 hours , respectively , after TFP placement . CONCLUSIONS AND CLINICAL RELEVANCE Results suggest that use of a TFP ( 25 micrograms/h ) for postoperative analgesia in cats undergoing onychectomy with or without surgical sterilization is safe and effective",
"BACKGROUND Progress in establishing if therapies provide relief to cats with degenerative joint disease (DJD)-associated pain is hampered by a lack of vali date d owner-administered assessment methods . HYPOTHESIS That an appropriately developed subjective owner-completed instrument ( Feline Musculoskeletal Pain Index-FMPI ) to assess DJD-associated impairment would have responsiveness and criterion validity . ANIMALS Twenty-five client-owned cats with DJD-associated pain . METHODS FMPI responsiveness ( ability to detect the effect of an analgesic treatment ) and validity ( correlation with an objective measure ) were explored through a stratified , r and omized , double blinded , placebo-controlled , crossover 10-week clinical study . Meloxicam was administered to effect pain relief . A linear mixed model , backward stepwise regression , and Pearson correlations were used to assess responsiveness and criterion validity with the assumption that the NSAID would increase activity . RESULTS Positive responses of cats to placebo ( P = .0001 ) and meloxicam treatment ( P = .0004 ) were detected ; however , the instrument did not detect any difference between placebo and meloxicam ( linear mixed model ) , even for the high impairment cases . Percent meloxicam target dose administered , temperament , and total baseline FMPI score were covariates that most affected FMPI scores . Controlling for significant covariates , most positive effects were seen for placebo treatment . Positive treatment effects on activity were detected , but only for the cases design ated as most highly impaired . CONCLUSIONS AND CLINICAL IMPORTANCE Neither responsiveness nor criterion validity were detected by the inclusion criteria for cases in this study . The data suggest that further work is indicated to underst and factors affecting activity in cats to optimize inclusion criteria",
"OBJECTIVE To compare the postoperative analgesic effects of intravenous ( IV ) , intramuscular ( IM ) , subcutaneous ( SC ) or oral transmucosal ( OTM ) buprenorphine administered to cats undergoing ovariohysterectomy . STUDY DESIGN R and omized , prospect i ve and blinded clinical trial . ANIMALS 100 female cats . METHODS Cats were assigned to receive 0.01 mg kg(-1 ) of buprenorphine administered by the IV , IM , SC or OTM route ( n = 25/group ) . Buprenorphine was made up to 0.3 mL with 0.9 % saline . DIVAS ( 0 - 100 mm ) and simple descriptive scale ( SDS ) ( from 0 to 4 ) pain and sedation scores were assigned to each cat before and 1 , 2 , 3 , 4 , 6 , 8 , 12 and 24 hours after ovariohysterectomy . Buprenorphine and carprofen were administered for rescue analgesia . Data were analyzed using anova and Fisher 's exact test ( p , anesthetic time or surgery time ( p > 0.05 ) . There were no significant differences between groups for sedation scores at any time . SDS pain scores did not detect any differences between groups ( p > 0.05 ) . DIVAS pain scores after OTM administration were significantly higher than IV and IM administration at 1 hour and at 3 , 4 , 6 , 8 and 12 hours , respectively ( p DIVAS pain scores after SC administration were significantly higher than IV and IM administration at 2 hours and at 2 , 3 , 4 , 8 , 12 and 24 hours ( p buprenorphine required rescue analgesia , respectively . There was a significantly higher incidence of treatment failure in cats that received SC and OTM buprenorphine compared with cats that received IV and IM buprenorphine ( p buprenorphine provided better postoperative analgesia than SC or OTM administration of the drug and these routes of administration should be preferred when buprenorphine is administered to cats",
"Osteoarthritis is a chronic , painful condition that is now recognised as affecting a large proportion of cats . Non-steroidal anti-inflammatory drugs ( NSAIDs ) have proven efficacy in dogs and humans but there are limited published data on the use of NSAIDs in the long-term management of this condition in cats . This prospect i ve study aim ed to assess the long-term safety and palatability of oral meloxicam and its efficacy in treating osteoarthritic pain in cats when given at a dose of 0.01–0.03 mg/kg once daily . Forty cats diagnosed with osteoarthritis completed the trial with a mean treatment duration of 5.8 months . Gastrointestinal upset in 2/46 ( 4 % ) cats was the only adverse effect noted . No deleterious effect on renal function was detected in cats studied . Owners subjectively assessed treatment efficacy as good or excellent in 34/40 ( 85 % ) of cases . The results of this study showed oral meloxicam to be safe and palatable long-term treatment for osteoarthritis in cats when given with food at a dose of 0.01–0.03 mg/kg",
"In this prospect i ve , r and omized , blinded study , 68 clinical ly healthy cats that had onychectomy ( n = 20 ) , onychectomy and castration ( n = 20 ) , or onychectomy and ovariohysterectomy ( n = 28 ) were r and omly assigned to one of four postoperative analgesic treatment groups : buprenorphine ( 0.01 mg/kg body weight , intramuscularly [ IM ] ) , oxymorphone hydrochloride ( 0.05 mg/kg body weight , IM ) , ketoprofen ( 2 mg/kg body weight , IM ) , and placebo ( physiological saline ) . Sedation scores , visual analog pain scores , cumulative pain scores , serum cortisol concentration , and appetite were used to assess postoperative analgesic effect . Buprenorphine demonstrated the highest efficacy with the lowest cumulative pain scores and serum cortisol levels",
"OBJECTIVE The hypothesis was that Visual Analog Scale ( VAS ) scores would be lower , and mechanical wound thresholds ( MWT ) higher , in cats receiving tolfenamic acid compared to those receiving placebo in the postoperative period following elective ovariohysterectomy . ANIMALS Sixty-nine client-owned cats . METHODS A prospect i ve , r and omized , blinded and placebo-controlled study was performed in cats which underwent ovariohysterectomy following preoperative tolfenamic acid , meloxicam , or placebo . A second dose of the same analgesic was administered 24 hours postoperatively . Assessment s were made 1-hour before induction and 1 , 2 , 4 , 6 , 22 , and 25 hours postoperatively . Pain was assessed by a blinded observer using Numerical Rating ( NRS ) and VAS scales . The MWT were measured using a force-measuring device . Group comparison was performed by using one-way ANOVA and chi-squared test for qualitative and quantitative data , respectively , and a mixed model for repeated measurements ( p Sixty-five cats were included in the study . There were no differences between groups at baseline . There was a treatment effect on the NRS scores at 6 , 22 and 25 hours . The meloxicam group was less painful than controls at 6 and 22 hours ; both treatment groups were less painful than controls at 25 hours . There were no differences between groups in VAS for pain or sedation . The number of animals receiving rescue analgesia did not differ between groups . There was a treatment effect on MWT ; thresholds in both treatment groups were significantly higher than that observed in controls at all time points . CONCLUSIONS Preoperative tolfenamic acid or meloxicam reduced wound sensitivity following ovariohysterectomy in the cat . CLINICAL RELEVANCE Tolfenamic acid and meloxicam administered preoperatively provided a similar analgesic effect in the postoperative period lasting 24 hours . Mechanical thresholds may be a better way of evaluating postoperative analgesia provided by nonsteroidal anti-inflammatory drugs in cats",
"& NA ; Altogether 553 children ( 195 first grade rs , mean age 6.8 years , and 358 third grade rs , mean age 8.7 years ) participated in the development of a self‐report measure to assess the intensity of children 's pain . The first step was the derivation , from children 's drawings of facial expressions of pain , of 5 sets of 7 schematic faces depicting changes in severity of expressed pain from no pain to the most pain possible . With the set of faces that achieved the highest agreement in pain ordering , additional studies were conducted to determine whether the set had the properties of a scale . In one study , children rank‐ordered the faces on 2 occasions , separated by 1 week . All 7 faces were correctly ranked by 64 % ( retest 1 week later , 61 % ) of grade 1 children and by 86 % ( retest 89 % ) of grade 3 children . In a second study , the faces were presented in all possible paired combinations . All 7 faces were correctly placed by 62 % ( retest 86 % ) of the younger and by 75 % ( retest 71 % ) of the older subjects . A third study asked children to place faces along scale : a procedure allowing a check on the e quality of intervals . The fourth study checked on whether pain was acting as an underlying construct for ordering the faces in memory . We asked whether children perceived the set as a scale by asking if memory for an ordered set of faces was more accurate than for a r and om set . The final study checked , with 6‐year‐old children , the test‐retest reliability of ratings for recalled experiences of pain . Overall , the faces pain scale incorporates conventions used by children , has achieved strong agreement in the rank ordering of pain , has indications that the intervals are close to equal , and is treated by children as a scale . The test‐retest data suggest that it may prove to be a reliable index over time of self‐reported pain",
"This study aim ed to characterize osteoarthritis (OA)-related chronic pain and disability in experimental cats with naturally occurring OA . Peak vertical ground reaction force ( PVF ) , accelerometer-based motor activity ( MA ) and the von Frey anesthesiometer-induced paw withdrawal threshold were used to define OA and to test the efficacy of meloxicam . A diagnosis of OA was based on radiographic and orthopedic examinations . Cats with OA ( n=39 ) and classified as non-OA ( n=6 ) were used to assess the reliability and sensitivity of the parameters to assess OA over 3weeks while being administered placebo medication . A r and omised parallel design study was then used to investigate the effects on OA of daily oral meloxicam treatment for 4weeks at different dose rates ( 0.025mg/kg , n=10mg/kg ; 0.04mg/kg , n=10 ; 0.05mg/kg , n=9 ) , compared to cats administered a placebo ( n=10 ) . The test-retest repeatability for each tool was good ( intra-class correlation coefficient ⩾0.6 ) . The PVF and the von Frey anesthesiometer-induced paw withdrawal threshold discriminated OA ( P ) . Meloxicam did not add to the PVF improvement observed in placebo-treated cats during the treatment period ( adj-P⩽0.01 ) . The 0.025 and the 0.05mg/kg meloxicam-treated cats experienced a higher night-time ( 17:00 - 06:58h ) MA intensity during the treatment period compared to the placebo period ( adj-P=0.04 , and 0.02 , respectively ) and this effect was not observed in the placebo group . The high allodynia rate observed in the 0.04mg/kg meloxicam-treated group may explain the lower responsiveness to the drug . The von Frey anesthesiometer-induced paw withdrawal threshold demonstrated no responsiveness to meloxicam . The results from this study indicated that daily oral meloxicam administration for 4weeks provided pain relief according to night-time MA",
"The aim of this study was to compare the postoperative analgesic effects of robenacoxib and buprenorphine alone or in combination , in cats after ovariohysterectomy . Thirty healthy cats were r and omly assigned to receive buprenorphine ( 0.02 mg/kg , n=10 ; GB ) , robenacoxib ( 2mg/kg , n=10 ; GR ) or their combination at the same dosages ( n=10 ; GBR ) SC . After 30 min cats were se date d with an IM administration of medetomidine ( 0.02 mg/kg ) and ketamine ( 5mg/kg ) . General anaesthesia was induced with propofol and after intubation was maintained with isoflurane . Before premedication and at 1 , 2 , 3 , 4 , 6 , 8 , 12 and 24h after extubation , pain and sedation were assessed using a simple descriptive pain scale , ranging from 0 ( no pain/no sedation ) to 4 ( intense pain/ deep sedation ) . If the pain score was ≥ 3 , rescue analgesia was provided using buprenorphine ( 0.02 mg/kg ) administered IM . Pain score was higher in GB at 2 , 3 , 4 , 6 and 8h compared to baseline and compared to GBR at the same study times . Moreover , the pain score was also higher in GB compared to GR at 2 , 3 , 4 and 6h . Pain score was similar at all study times between GR and GBR . Sedation at 1 and 2h was higher than baseline values in all groups . Cats in GB received rescue analgesia more often than cats assigned to GR or GBR . Robenacoxib was an effective analgesic drug in cats up to 24h after ovariohysterectomy . The addition of buprenorphine did not provide any additional analgesic effects compared to robenacoxib alone",
"One hundred female cats undergoing routine ovariohysterectomy under midazolam-medetomidine-ketamine anaesthesia were included in a blinded , r and omised , prospect i ve clinical study to compare postoperative analgesia produced by four analgesic drug combinations given preoperatively ( n = 25 per group ) . A secondary aim was to assess the effects in kittens and pregnant animals . Buprenorphine 180 µg/m2 or butorphanol 6 mg/m2 were given with either carprofen 4 mg/kg ( groups BUPC and BUTC , respectively ) or meloxicam 0.3 mg/kg ( groups BUPM or BUTM , respectively ) . Medetomidine was not antagonised . A simple , descriptive scale ( SDS ; 0–4 ) , a dynamic and interactive visual analogue scale ( DIVAS ; 0–100 mm ) and mechanical nociceptive thresholds ( MT ; 2.5-mm diameter probe ) were used to evaluate postoperative pain . All pain scores were low ( DIVAS 10 N ) and there were no significant differences between the groups . It was concluded that all protocol s provided adequate analgesia and when used with midazolam-medetomidine-ketamine are effective for routine feline ovariohysterectomy"
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Surgical resection remains the best treatment option for patients with early stage of non-small cell lung cancer ( NSCLC ) . However , it may be responsible of postoperative complication and mortality , especially in patients with impaired pulmonary function . Enhanced recovery after surgery ( ERAS ) programs have been focused mainly in minimal invasive surgery approach during lung resection and respiratory rehabilitation after surgery . Preoperative exercise-based intervention ( prehabilitation ) has demonstrated reduction of morbi-mortality in other surgeries but in thoracic surgery continues to be under discussion . Cardio-pulmonary exercise test ( CPET ) is the gold st and ard technique to predict postoperative morbi-mortality . The implementation of a preoperative respiratory rehabilitation could optimize patient 's physical capacity before surgery and improve outcomes and enhance recovery . The aim of this systematic review of the literature is to identify the effectiveness and safety of prehabilitation programs in thoracic surgery , the type of exercise and its duration , and the group of patients with best benefit . Prehabilitation is a safe intervention without side effects in patients . High-intensity interval training ( HIT ) with duration of 2 to 6 weeks seems to be the best exercise programme in a prehabilitation intervention but it exists heterogeneity in terms of intensity and duration . Prehabilitation increase exercise capacity and significantly enhances pulmonary function . But the reduction of postoperative complication and mortality has not been clearly demonstrated . Different criteria selection , type of intervention and small sample size , in addition to no r and omization , could justify disparate results . It seems that not all patients can benefit from prehabilitation and it could be indicated only in patients with impaired lung function . Further r and omized clinical trials with enough patients , correct duration of HIT ( 2 to 6 weeks ) and focused in COPD patients are needed to clarify the suitability of prehabilitation . Meanwhile , safety of prehabilitation and good results of some studies support this intervention in high-risk patients
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"BACKGROUND The impact of short-term preoperative pulmonary rehabilitation on exercise capacity of patients with chronic obstructive pulmonary disease undergoing lobectomy for non-small cell lung cancer is evaluated . METHODS A prospect i ve observational study was design ed . Inclusion criteria consisted of an indication to lung resection because of a clinical stage I or II non-small cell lung cancer and a chronic obstructive disease on preoperative pulmonary function test . In such conditions , maximal oxygen consumption by a cardio-pulmonary exercise test was evaluated ; when this result ed as being pulmonary rehabilitation programme lasting 4 weeks was considered . Twelve patients fulfilled inclusion criteria , completed the preoperative rehabilitation programme and underwent a new functional evaluation prior to surgery . The postoperative record of these patients was collected . RESULTS On completion of pulmonary rehabilitation , the resting pulmonary function test and diffuse lung capacity of patients was unchanged , whereas the exercise performance was found to have significantly improved ; the mean increase in maximal oxygen consumption proved to be at 2.8 ml/kg/min ( p Eleven patients underwent lobectomy ; no postoperative mortality was noted and mean hospital stay was 17 days . Postoperative pulmonary complication was recorded in 8 patients . CONCLUSIONS Short-term preoperative pulmonary rehabilitation could improve the exercise capacity of patients with chronic obstructive pulmonary disease who are c and i date s for lung resection for non-small cell lung cancer",
"BACKGROUND Fast track programs , multimodal therapy strategies , have been introduced in many surgical fields to minimize postoperative morbidity and mortality . In terms of lung resections no r and omized controlled trials exist to evaluate such patient care programs . METHODS In a prospect i ve , r and omized controlled pilot study a conservative and fast track treatment regimen in patients undergoing lung resections was compared . Main differences between the two groups consisted in preoperative fasting ( 6h vs 2h ) and analgesia ( patient controlled analgesia vs patient controlled epidural analgesia ) . Study endpoints were pulmonary complications ( pneumonia , atelectasis , prolonged air leak ) , overall morbidity and mortality . Analysis was performed in an intention to treat . RESULTS Both study groups were similar in terms of age , sex , preoperative forced expiratory volume in one second ( FEV(1 ) ) , American Society of Anesthesiologists score and operations performed . The rate of postoperative pulmonary complications was 35 % in the conservative and 6.6 % in the fast track group ( p=0.009 ) . A subgroup of patients with reduced preoperative FEV(1 ) ( pulmonary complications in the fast track group ( 55 % vs 7 % , p=0.023 ) . Overall morbidity was not significantly different ( 46 % vs 26 % , p=0.172 ) , mortality was comparable in both groups ( 4 % vs 3 % ) . CONCLUSION We evaluated an optimized patient care program for patients undergoing lung resections in a prospect i ve r and omized pilot study . Using this fast track clinical pathway the rate of pulmonary complications could be significantly decreased as compared to a conservative treatment regimen ; our results support the implementation of an optimized perioperative treatment in lung surgery in order to reduce pulmonary complications after major lung surgery",
"Parra et al. ( Acta Physiol . Sc and 169 : 157 - 165 , 2000 ) showed that 2 wk of daily sprint interval training ( SIT ) increased citrate synthase ( CS ) maximal activity but did not change \" anaerobic \" work capacity , possibly because of chronic fatigue induced by daily training . The effect of fewer SIT sessions on muscle oxidative potential is unknown , and aside from changes in peak oxygen uptake ( Vo(2 peak ) ) , no study has examined the effect of SIT on \" aerobic \" exercise capacity . We tested the hypothesis that six sessions of SIT , performed over 2 wk with 1 - 2 days rest between sessions to promote recovery , would increase CS maximal activity and endurance capacity during cycling at approximately 80 % Vo(2 peak ) . Eight recreationally active subjects [ age = 22 + /- 1 yr ; Vo(2 peak ) = 45 + /- 3 ml.kg(-1).min(-1 ) ( mean + /- SE ) ] were studied before and 3 days after SIT . Each training session consisted of four to seven \" all-out \" 30-s Wingate tests with 4 min of recovery . After SIT , CS maximal activity increased by 38 % ( 5.5 + /- 1.0 vs. 4.0 + /- 0.7 mmol.kg protein(-1).h(-1 ) ) and resting muscle glycogen content increased by 26 % ( 614 + /- 39 vs. 489 + /- 57 mmol/kg dry wt ) ( both P cycle endurance capacity increased by 100 % after SIT ( 51 + /- 11 vs. 26 + /- 5 min ; P Vo(2 peak ) . The coefficient of variation for the cycle test was 12.0 % , and a control group ( n = 8) showed no change in performance when tested approximately 2 wk apart without SIT . We conclude that short sprint interval training ( approximately 15 min of intense exercise over 2 wk ) increased muscle oxidative potential and doubled endurance capacity during intense aerobic cycling in recreationally active individuals",
"Purpose Peak oxygen consumption ( VO2peak ) is an important predictive factor for long-term prognosis in patients with non-small cell lung cancer ( NSCLC ) . The purpose of this study was to investigate whether 8 weeks of exercise training improves exercise capacity , as assessed by VO2peak , and other related factors in patients with NSCLC receiving targeted therapy . Methods A total of 24 participants with adenocarcinoma were r and omly assigned to either the control group ( n = 11 ) or the exercise group ( n = 13 ) . Subjects in the exercise group participated in individualized , high-intensity aerobic interval training of exercise . The outcome measures assessed at baseline and after 8 weeks were as follows : VO2peak and the percentage of predicted VO2peak ( % predVO2peak ) , muscle strength and endurance of the right quadriceps , muscle oxygenation during exercise , insulin resistance as calculated by the homeostasis model , high-sensitivity C-reactive protein , and quality of life ( QoL ) question naire inventory . Results No exercise-related adverse events were reported . After exercise training , VO2peak and % predVO2peak increased by 1.6 mL kg−1 min−1 and 5.3 % ( p improvements in circulatory , respiratory , and muscular functions at peak exercise ( all p = 0.001 ) . The exercise group also had less dyspnea ( p = 0.01 ) and favorably lower fatigue ( p = 0.05 ) than baseline . Conclusions Patients with NSCLC receiving targeted therapy have quite a low exercise capacity , even with a relatively high QoL. Exercise training appears to improve exercise capacity and alleviate some cancer-related symptoms",
"OBJECTIVE The purpose of this study was to investigate the impact of pulmonary rehabilitation on surgical morbidity and lung function in lung cancer patients with chronic obstructive pulmonary disease ( COPD ) . METHODS Prospect ively , 22 lung cancer patients with COPD who underwent lobectomy between 2000 and 2003 were enrolled for this study as a rehabilitation group ( Rehab . Group ) . The criteria of COPD were preoperative forced expiratory volume in 1 second (FEV1)/forced vital capacity ( FVC ) Preoperatively patients performed aggressive pulmonary exercise for two weeks and received chest physiotherapy postoperatively . As a historical control , 60 patients with lung cancer who fulfilled the same criteria but did not receive rehabilitation between 1995 and 1999 ( control group ) were entered in this study . RESULTS Patient background s were all equivalent between the two groups . However , FEV1 and FEV1/FVC were significantly lower in the Rehab . Group ( p Prolonged oxygen supplement and tracheostomy tended to be more frequent in the control group . The ratio of actual postoperative to predicted postoperative FEV1 was significantly better in the Rehab . Group ( p = 0.047 ) . Furthermore , postoperative hospital stay was significantly longer in the control group ( p = 0.0003 ) . CONCLUSION Despite lower FEV1 and FEV1/FVC in the Rehab . Group , postoperative pulmonary complications and long hospital stay could be effectively prevented and FEV1 was well preserved by rehabilitation and physiotherapy",
"To determine whether high-intensity interval training ( HIT ) would increase respiratory muscle strength and expiratory flow rates more than endurance training ( ET ) , 15 physically active , healthy subjects ( untrained ) were r and omly assigned to an ET group ( n = 7 ) or a HIT group ( n = 8) . All subjects performed an incremental test to exhaustion ( VO2max ) on a cycle ergometer before and after training . St and ard pulmonary function tests , maximum inspiratory pressure ( PImax ) , maximum expiratory pressure ( PEmax ) , and maximal flow volume loops were performed pre training and after each week of training . HIT subjects performed a 4-week training program , 3 days a week , on a cycle ergometer at 90 % of their VO2max final workload , while the ET subjects performed exercise at 60–70 % VO2max . The HIT group performed five 1-min bouts with 3-min recovery periods and the ET group cycled for 45 min continuously . A five-mile time trial ( TT ) was performed prior to , after 2 weeks , and after completion of training . Both groups showed improvements ( P ( ~8–10 % ) and TT ( HIT 6.5 ± 1.3 % , ET 4.4 ± 1.8 % ) following training with no difference ( P > 0.05 ) between groups . Both groups increased ( P training ( ET ~ 25 % , HIT ~ 43 % ) with values significantly higher for HIT than ET . There was no change ( P > 0.05 ) in expiratory flow rates with training in either group . These data suggest that both whole-body exercise training and HIT are effective in increasing inspiratory muscle strength with HIT offering a time-efficient alternative to ET in improving aerobic capacity and performance",
"Complete surgical resection is the most effective curative treatment for lung cancer . However , many patients with lung cancer also have severe COPD which increases their risk of postoperative complications and their likelihood of being considered \" inoperable . \" Preoperative pulmonary rehabilitation ( PR ) has been proposed as an intervention to decrease surgical morbidity but there is no established protocol and no r and omized study has been published to date . We tested two preoperative PR interventions in patients undergoing lung cancer resection and with moderate-severe COPD in a r and omized single blinded design . Outcomes were length of hospital stay and postoperative complications . The first study tested 4 weeks of guideline -based PR vs. usual care : that study proved to be very difficult to recruit as patients and providers were reluctant to delay surgery . Nine patients were r and omized and no differences were found between arms . The second study tested ten preoperative PR sessions using a customized protocol with nonst and ard components ( exercise prescription based on self efficacy , inspiratory muscle training , and the practice of slow breathing ) ( n=10 ) vs. usual care ( n=9 ) . The PR arm had shorter length of hospital stay by 3 days ( p=0.058 ) , fewer prolonged chest tubes ( 11 % vs. 63 % , p=0.03 ) and fewer days needing a chest tube ( 8.8 vs. 4.3 days p=0.04 ) compared to the controlled arm . A ten-session preoperative PR intervention may improve post operative lung reexpansion evidence d by shorter chest tube times and decrease the length of hospital stay , a crude estimator of post operative morbidity and costs . Our results suggest the potential for short term preoperative pulmonary rehabilitation interventions in patients with moderate-severe COPD undergoing curative lung resection . 4 weeks of conventional preoperative PR seems non feasible",
"BACKGROUND Lung-volume-reduction surgery has been proposed as a palliative treatment for severe emphysema . Effects on mortality , the magnitude and durability of benefits , and criteria for the selection of patients have not been established . METHODS A total of 1218 patients with severe emphysema underwent pulmonary rehabilitation and were r and omly assigned to undergo lung-volume-reduction surgery or to receive continued medical treatment . RESULTS Overall mortality was 0.11 death per person-year in both treatment groups ( risk ratio for death in the surgery group , 1.01 ; P=0.90 ) . After 24 months , exercise capacity had improved by more than 10 W in 15 percent of the patients in the surgery group , as compared with 3 percent of patients in the medical-therapy group ( P a subgroup of 140 patients at high risk for death from surgery according to an interim analysis , overall mortality in the surgery group was 0.09 death per person-year , as compared with 0.10 death per person-year in the medical-therapy group ( risk ratio , 0.89 ; P=0.31 ) ; exercise capacity after 24 months had improved by more than 10 W in 16 percent of patients in the surgery group , as compared with 3 percent of patients in the medical-therapy group ( P patients with predominantly upper-lobe emphysema and low exercise capacity , mortality was lower in the surgery group than in the medical-therapy group ( risk ratio for death , 0.47 ; P=0.005 ) . Among patients with non-upper-lobe emphysema and high exercise capacity , mortality was higher in the surgery group than in the medical-therapy group ( risk ratio , 2.06 ; P=0.02 ) . CONCLUSIONS Overall , lung-volume-reduction surgery increases the chance of improved exercise capacity but does not confer a survival advantage over medical therapy . It does yield a survival advantage for patients with both predominantly upper-lobe emphysema and low base-line exercise capacity . Patients previously reported to be at high risk and those with non-upper-lobe emphysema and high base-line exercise capacity are poor c and i date s for lung-volume-reduction surgery , because of increased mortality and negligible functional gain",
"Introduction : Impairment in aerobic fitness is a potential modifiable risk factor for postoperative complications . In this r and omized controlled trial , we hypothesized that a high‐intensity interval training ( HIIT ) program enhances cardiorespiratory fitness before lung cancer surgery and therefore reduces the risk of postoperative complications . Methods : Patients with operable lung cancer were r and omly assigned to usual care ( UC ) ( n = 77 ) or preoperative rehabilitation based on HIIT ( Rehab ) ( n = 74 ) . Maximal cardiopulmonary exercise testing and the 6‐minute walk test were performed twice before surgery . The primary outcome measure was a composite of death and in‐hospital postoperative complications . Results : The groups were well balanced in terms of patient characteristics . During the preoperative waiting period ( median 25 days ) , the peak oxygen consumption and the 6‐minute walking distance increased ( median + 15 % , interquartile range , 25th to 75 percentile [ IQR25%–75 % , % ] = + 9 % to + 22 % , p = 0.003 and + 15 % , IQR25%–75 % = + 8 % to + 28 % , p whereas peak oxygen consumption declined in the UC group ( median –8 % , IQR25%–75 % = –16 % to 0 % ] , p = 0.005 ) . The primary end point did not differ significantly between the two groups : at least one postoperative complication developed in 27 of the 74 patients ( 35.5 % ) in the Rehab group and 39 of 77 patients ( 50.6 % ) in the UC group ( p = 0.080 ) . Notably , the incidence of pulmonary complications was lower in the Rehab compared with in the UC group ( 23 % versus 44 % , p = 0.018 ) , owing to a significant reduction in atelectasis ( 12.2 % versus 36.4 % , p a shorter length of stay in the postanesthesia care unit ( median –7 hours , IQR25%–75 % = –4 to –10 ) . Conclusions : In this r and omized controlled trial , preoperative HIIT result ed in significant improvement in aerobic performances but failed to reduce early complications after lung cancer resection"
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41171446-06ff-11f0-808a-c43d1ab1c353
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This study aim ed to summarize earlier studies on the effects of RS consumption on the serum levels of inflammatory biomarkers . A comprehensive search was done in the electronic data bases that published from 1988 up to May 2019 . Two review ers independently performed screening , data extraction , and risk-of-bias assessment . We used from the effect size , as estimated by the mean difference to perform the fixed method meta- analysis . Overall , 13 studies with 14 effect sizes met the inclusion criteria and were included in the final analysis . Sample size of these studies ranged from 15 to 75 and intervention duration ranged from 4 to 14 weeks . Meta- analysis revealed that higher consumption of resistant starch caused a significant reduction in the interleukin 6 ( weighted mean difference = − 1.11 pg/mL ; 95 % CI : − 1.72 , − 0.5 pg/mL ; P = and tumor necrosis factor alpha ( weighted mean difference = − 2.19 pg/mL ; 95 % CI : − 3.49 , − 0.9 pg/mL ; P = 0.001 ) levels . However , no significant changes were found in C-reactive protein concentration ( weighted mean difference = − 0.21 mg/L ; 95 % CI : − 1.06 , 0.63 mg/L ; P = 0.61 ) . Moreover , the changes in interleukin 6 concentration was dependent on study quality and intervention duration . The current meta- analysis indicated that RS intake can improve some inflammatory biomarkers . More research , with a large sample sizes and accurate design is recommended
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"BACKGROUND The bridge between food intake and weight is not fully understood . Recently , the role of gut microbiota and bacterial lipopolysacharides ( LPS ) in weight has been noted . OBJECTIVE The objective was to evaluate the relation between plasma LPS concentration and food intake . DESIGN A dietary survey was conducted in 1015 subjects r and omly recruited in France . The participants were given oral and written instructions on how to keep a consecutive 3-d food record . Plasma LPS was measured in a sub sample of 201 men . To assess , under controlled conditions , the differential impact of various high-energy diets , plasma LPS concentrations were measured in mice fed a high-fat or a high-carbohydrate diet over a 4-wk period . RESULTS In humans , no significant relation was observed between cardiovascular disease risk factors , carbohydrate and protein intakes , and plasma LPS concentration . Conversely , positive correlations were observed with fat and energy intakes . In a multivariate analysis , endotoxemia was independently associated with energy intake . Compared with the control mice , mice fed a high-energy diet showed an increase in plasma LPS . However , in mice fed a high-carbohydrate diet , the increase in plasma LPS was blunted compared with mice fed a high-fat diet . CONCLUSIONS In this large sample of healthy men from a population -based sample , we found a link between food intake and plasma LPS . Experimental data suggest that fat was more efficient in transporting bacterial LPS from the gut lumen into the bloodstream . The results of this study add to the knowledge of mechanisms responsible for relations between food intake and metabolic diseases",
"Improvement of insulin resistance and inflammation is a basic strategy in the management of type 2 diabetes . There is limited evidence that prebiotics improve insulin resistance and inflammation . However , the ameliorating effect of resistant dextrin , as a prebiotic , on insulin resistance and inflammation in patients with type 2 diabetes has not been investigated so far . Therefore , the present study aim ed to examine the effects of resistant dextrin on insulin resistance and inflammation in type 2 diabetic patients . In a r and omised controlled clinical trial , fifty-five women with type 2 diabetes were assigned to two groups : the intervention group ( n 30 ) and the control group ( n 25 ) . The intervention group received a daily supplement of 10 g resistant dextrin and the control group received a similar amount of maltodextrin as placebo for 8 weeks . Fasting plasma glucose ( FPG ) , HbA1c , insulin , high-sensitivity C-reactive protein ( hs-CRP ) , IL-6 , TNF-α , malondialdehyde ( MDA ) and serum endotoxin concentrations were measured before and after the intervention . Data were analysed using SPSS ( version 13 ) . Paired and unpaired t tests and ANCOVA were used to compare quantitative variables after the intervention . Patients supplemented with resistant dextrin exhibited a significant decrease in fasting insulin ( 20.1 pmol/l , 22.8 % ) , homeostasis model assessment of insulin resistance ( 1.3 , 24.9 % ) , quantitative insulin sensitivity check index ( 0.2 , 7.2 % ) , IL-6 ( 1.4 pg/ml , 28.4 % ) , TNF-α ( 5.4 pg/ml , 18.8 % ) , MDA ( 1.2 nmol/ml , 25.6 % ) and endotoxin ( 6.2 endotoxin units/ml , 17.8 % ) concentrations than those supplemented with maltodextrin ( P in FPG ( 0.05 mmol/l , 0.6 % ) , HbA1c ( 0.5 % , 9.6 % ) and hs-CRP ( 2.7 ng/ml , 35.1 % ) concentrations in the resistant dextrin group were not significant when compared with the maltodextrin group . In conclusion , resistant dextrin supplementation can modulate inflammation and improve insulin resistance in women with type 2 diabetes",
"Aims : This trial aims to determine the effects of resistant starch ( RS ) subtype 2 ( RS2 ) on glycemic status , metabolic endotoxemia and markers of oxidative stress . Methods : A r and omized , controlled , parallel-group clinical trial group of 56 females with type 2 diabetes mellitus ( T2DM ) was divided to 2 groups . The intervention group ( n = 28 ) and control group ( n = 28 ) received 10 g/day RS2 or placebo for 8 weeks , respectively . Fasting blood sample s were taken to determine glycemic status , endotoxin , high sensitivity C-reactive protein ( hs-CRP ) , malondialdehyde ( MDA ) , total antioxidant capacity ( TAC ) , antioxidant enzymes concentrations as well as uric acid at baseline and after the intervention . Results : After 8 weeks , RS2 caused a significant decrease in the levels of MDA ( -34.10 % ) , glycosylated hemoglobin ( -9.40 % ) , insulin ( -29.36 % ) , homeostasis model of insulin resistance ( -32.85 % ) and endotoxin ( -25.00 % ) , a significant increase in TAC ( 18.10 % ) and glutathione peroxidase ( 11.60 % ) as compared with control . No significant changes were observed in fasting plasma glucose , quantitative insulin sensitivity check index , hs-CRP , superoxide dismutase , catalase and uric acid in the RS2 group as compared with the control group . Conclusion : Supplementation with RS2 may be improved glycemic status , endotoxemia and markers of oxidative stress in patients with T2DM",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"Introduction Type 2 diabetes ( T2D ) has reached epidemic proportions in North America . Recent evidence suggests that prebiotics can modulate the gut microbiome , which then plays an important role in regulating lipid metabolism , blood glucose , and insulin sensitivity . As such , prebiotics are appealing potential therapeutic strategies for prediabetes and T2D . The key objectives of this study were to determine the tolerability as well as the glucose and insulin modulating ability of MSPrebiotic ® digestion resistant starch ( DRS ) in healthy mid-age ( MID ) and elderly ( ELD ) adults . Material s and methods This was a prospect i ve , blinded , placebo-controlled study . Prediabetes and diabetes were among the exclusion factors . ELD ( > 70 years ) and MID ( 30–50 years ) Canadian adults were recruited and , after 2 weeks of consuming placebo , they were r and omized to consume 30 g of either MSPrebiotic ® or placebo per day for 12 weeks . In total , 42 ELD and 42 MID participants completed the study . Blood sample s were collected over the 14-week study and analyzed for glucose , lipid profile , and CRP , lipid particles , TNF-α , IL-10 , insulin , and insulin resistance ( IR ) . Results At baseline , the ELD population had a significantly higher percentage ( p elevated glucose and significantly higher TNF-α ( p MSPrebiotic ® DRS was well tolerated in both MID and ELD adults . There was a significant difference over time in blood glucose ( p = 0.0301 ) and insulin levels ( p = 0.009 ) , as well as IR ( HOMA-IR ; p = 0.009 ) in ELD adults who consumed MSPrebiotic ® compared to placebo . No significant changes were found in MID adults . Conclusion Our results suggest that dietary supplementation with prebiotics such as MSPrebiotic ® may be part of an effective strategy to reduce IR , a major risk factor for developing T2D , in the ELD . Clinical Trial Registration NCT01977183 listed on NIH website : Clinical Trials.gov , The meta data generated in this study have been su bmi tted to the NCBI Sequence Read Archive ( http://www.ncbi.nlm.nih.gov/bioproject/381931 )",
"The objective of the present study was to determine the effectiveness of a soluble dietary fiber , NUTRIOSE ® , on body weight , body composition , energy intake and hunger in overweight Chinese men . The volunteers were r and omized in double-blind fashion to 250 ml fruit juice supplemented with NUTRIOSE ® ( Test , n = 60 ) or a maltodextrin ( Control , n = 60 ) at a dosage of 17 g twice daily for 12 weeks . Body weight , body composition were performed at 0 , 4 , 8 and 12 weeks while daily energy intake and hunger were assessed every 3 days . Test subjects had reductions in body weight ( 1.5 kg , P body mass index ( 0.5 kg/m2 , P and body fat percentage ( 0.3 % , P lower daily energy intake ( 3,079 kJ/day , P less hunger across the study period versus Controls ( P in body composition improvements and reduces body weight , energy intake and hunger in overweight men",
"OBJECTIVE The aim of the present study was to determine effects of Resistant Starch ( RS2 ) on metabolic parameters and inflammation in women with type 2 diabetes ( T2DM ) . METHODS In this r and omized controlled clinical trial , 60 females with T2DM were divided into intervention ( n = 28 ) and placebo groups ( n = 32 ) . They received 10 g/d RS2 or placebo for 8 weeks , respectively . Fasting blood sugar ( FBS ) , glycated hemoglobin ( HbA1c ) , lipid profile , high-sensitive C-reactive protein ( hs-CRP ) , interleukin-6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF-α ) were measured at baseline and at the end of the trial . Paired t test , unpaired t-test and ANCOVA were used to compare the quantitative variables . The data were analyzed using SPSS software version 13.0 . RESULTS RS2 decreased HbA1c ( -0.3 % , -3.6 % ) , TNF-α ( -3.4 pg/mL , -18.9 % ) , triglyceride ( -33.4 mg/dL , -15.4 % ) , and it increased HDL-c ( + 9.4 mg/dL , + 24.6 % ) significantly compared with the placebo group ( p were not significant in the RS2 group compared with the control group . RS2 can improve glycemic status , inflammatory markers and lipid profile in women with T2DM . CONCLUSIONS Although findings of the present study indicated positive effects of RS2 on inflammation and metabolic parameters , more studies are needed to confirm efficacy of RS2 as an adjunct therapy in diabetes",
"INTRODUCTION Many of the deleterious effects associated with chronic kidney disease ( CKD ) are secondary to the result ant systemic inflammation . The gut microbial changes caused by CKD are thought to perpetuate systemic inflammation . Therefore , strategies aim ed at modulating the gut microbiota may be helpful in reducing complications associated with CKD . We hypothesized that supplementation with high-amylose maize resistant starch type 2 ( HAM-RS2 ) would beneficially alter the gut microbiome and lead to lower levels of systemic inflammation . METHODS A double-blind , parallel , r and omized , placebo-controlled trial was performed comparing dietary supplementation of HAM-RS2 with placebo in patients with end-stage CKD . Fecal microbial data were obtained from a subset of patients after DNA extraction and 16s sequencing . FINDINGS Supplementation of HAM-RS2 led to a decrease in serum urea , IL-6 , TNFα , and malondialdehyde ( P The Faecalibacterium genus was significantly increased in relative abundance following HAM-RS2 supplementation ( HAM-RS2-Day 0 : 0.40 ± 0.50 vs. HAM-RS2-Day 56 : 3.21 ± 4.97 P = 0.03 ) and was unchanged by placebo ( Control-Day 0 : 0.72 ± 0.72 vs. Control-Day 56 : 0.83 ± 1.57 P = 0.5 ) . DISCUSSION Supplementation of amylose resistant starch , HAM-RS2 , in patients with CKD led to an elevation in Faecalibacterium and decrease in systemic inflammation . Microbial manipulation in CKD patients by using the prebiotic fiber may exert an anti-inflammatory effect through an elevation in the bacterial genera Faecalibacterium",
"OBJECTIVE The objective of this study is to explore the effect of high-resistant starch ( RS ) , low-protein flour as a source of RS on patients with early type 2 diabetic nephropathy ( DN ) through the clinical intervention trial . DESIGN This was a single center , r and omized , comparative , open-label trial . Seventy-five patients with early DN , aged 18 to 80 y , were recruited and r and omly assigned to two groups . During the 12-week intervention , the control group patients ( 38 cases ) followed protein-restriction diet daily with a common staple . The intervention group ( 37 cases ) received 50 g of high-RS , low-protein flour instead of a common staple of equal quality at lunch and dinner each day . The blood glucose , blood lipids , nutritional parameters , indicators of renal function , oxidative stress , and inflammatory markers were measured . RESULTS Compared with the control group , high-RS , low-protein flour intake led to a significant reduction in fasting blood glucose , HbA1c , total cholesterol , and triglycerides levels ( P changes in serum uric acid ( UA ) and β2-microglobulin ( β2-MG ) level were observed after high-RS , low-protein flour intervention ( uric acid [ mean ± st and ard deviation ] : -24.7 ± 38.5 μmol/L , P = .001 ; β2-MG : 0.5 ± 0.9 mg/L , P = 0.018 ) . In addition , high-RS , low-protein flour intake increased serum superoxide dismutase level by 10.1 ± 27.7 U/mL ( P the interleukin-6 and Tumor Necrosis Factor α ( TNF-α ) concentration . CONCLUSIONS Twelve-week intervention with high-RS , low-protein flour improved the blood glucose and blood lipid levels , decreased the serum uric acid ( UA ) and urine β2-MG , and enhanced the ability to prevent antioxidative stress in patients with early DN"
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41171482-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The antioxidant lutein is suggested as being beneficial to cardiometabolic health because of its protective effect against oxidative stress , but evidence has not systematic ally been evaluated . OBJECTIVE We aim ed to evaluate systematic ally the effects of lutein ( intake or concentrations ) on cardiometabolic outcomes in different life stages . DESIGN This is a systematic review with meta- analysis of literature published in MEDLINE , Embase , Cochrane Central , Web of Science , PubMed , and Google Scholar up to August 2014 . Included were trials and cohort , case-control , and cross-sectional studies in which the association between lutein concentrations , dietary intake , or supplements and cardiometabolic outcomes was reported . Two independent investigators review ed the articles . RESULTS Seventy-one relevant articles were identified that included a total of 387,569 participants . Only 1 article investigated the effects of lutein during pregnancy , and 3 studied lutein in children . Furthermore , 31 longitudinal , 33 cross-sectional , and 3 intervention studies were conducted in adults . Meta- analysis showed a lower risk of coronary heart disease ( pooled RR : 0.88 ; 95 % CI : 0.80 , 0.98 ) and stroke ( pooled RR : 0.82 ; 95 % CI : 0.72 , 0.93 ) for the highest compared with the lowest tertile of lutein blood concentration or intake . There was no significant association with type 2 diabetes mellitus ( pooled RR : 0.97 ; 95 % CI : 0.77 , 1.22 ) , but higher lutein was associated with a lower risk of metabolic syndrome ( pooled RR : 0.75 ; 95 % CI : 0.60 , 0.92 ) for the highest compared with the lowest tertile . The literature on risk factors for cardiometabolic diseases showed that lutein might be beneficial for atherosclerosis and inflammatory markers , but there were inconsistent associations with blood pressure , adiposity , insulin resistance , and blood lipids . CONCLUSIONS Our findings suggest that higher dietary intake and higher blood concentrations of lutein are generally associated with better cardiometabolic health . However , evidence mainly comes from observational studies in adults , whereas large-scale intervention studies and studies of lutein during pregnancy and childhood are scarce
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"Background —Carotenoids are hypothesized to explain some of the protective effects of fruit and vegetable intake on risk of cardiovascular disease . The present study assessed the protective effects of the oxygenated carotenoid lutein against early atherosclerosis . Methods and Results —Epidemiology : Progression of intima-media thickness ( IMT ) of the common carotid arteries over 18 months was determined ultrasonographically and was related to plasma lutein among a r and omly sample d cohort of utility employees age 40 to 60 years ( n=480 ) . Coculture : The impact of lutein on monocyte response to artery wall cell modification of LDL was assessed in vitro by quantification of monocyte migration in a coculture model of human intima . Mouse models : The impact of lutein supplementation on atherosclerotic lesion formation was assessed in vivo by assigning apoE-None mice to chow or chow plus lutein ( 0.2 % by weight ) and LDL receptor-None mice to Western diet or Western diet plus lutein . IMT progression declined with increasing quintile of plasma lutein ( P for trend=0.007 , age-adjusted;P = 0.0007 , multivariate ) . Covariate-adjusted IMT progression ( mean±SEM ) was 0.021±0.005 mm in the lowest quintile of plasma lutein , whereas progression was blocked in the highest quintile ( 0.004±0.005 mm;P = 0.01 ) . In the coculture , pretreatment of cells with lutein inhibited LDL-induced migration in a dose-dependent manner ( P , lutein supplementation reduced lesion size 44 % in apoE-None mice ( P = 0.009 ) and 43 % in LDL receptor-None mice ( P = 0.02 ) . Conclusions —These epidemiological , in vitro , and mouse model findings support the hypothesis that increased dietary intake of lutein is protective against the development of early atherosclerosis",
"Many male birds use carotenoid pigments to acquire brilliant colors that advertise their health and condition to prospect i ve mates . The direct means by which the most colorful males achieve superior health has been debated , however . One hypothesis , based on studies of carotenoids as antioxidants in humans and other animals , is that carotenoids directly boost the immune system of colorful birds . We studied the relationship between carotenoid pigments , immune function , and sexual coloration in zebra finches ( Taeniopygia guttata ) , a species in which males incorporate carotenoid pigments into their beak to attract mates . We tested the hypotheses that increased dietary carotenoid intake enhances immunocompetence in male zebra finches and that levels of carotenoids circulating in blood , which also determine beak coloration , directly predict the immune response of individuals . We experimentally supplemented captive finches with two common dietary carotenoid pigments ( lutein and zeaxanthin ) and measured cell-mediated and humoral immunity a month later . Supplemented males showed elevated blood-carotenoid levels , brighter beak coloration , and increased cell-mediated and humoral immune responses than did controls . Cell-mediated responses were predicted directly by changes in beak color and plasma carotenoid concentration of individual birds . These experimental findings suggest that carotenoid-based color signals in birds may directly signal male health via the immunostimulatory action of ingested and circulated carotenoid pigments",
"Antioxidants , particularly carotenoids and tocopherols , may protect against cardiovascular disease . The objective of this study was to determine whether dietary and adipose tissue carotenoids and tocopherols are associated with the risk of myocardial infa rct ion ( MI ) . Cases ( n = 1456 ) of a first acute MI were identified and matched by age , sex , and residence to r and omly selected population controls ( n = 1456 ) living in Costa Rica . Carotenoids and tocopherols were measured in adipose tissue using HPLC . Dietary intake was assessed using a vali date d FFQ . Anthropometrical and lifestyle data were collected using an interviewer-administered question naire . Subjects were distributed into quintiles of intake or adipose tissue concentration of carotenoids or tocopherols . The lowest quintile was used as the referent in conditional logistic regression analyses . Adipose tissue beta-carotene showed a significant inverse relation with MI risk ; the odds ratio ( OR ) comparing the highest to the lowest quintile was 0.70 ( 95 % CI : 0.51 - 0.96 , P for trend = 0.02 ) . Intake of fruits and vegetables that are rich in beta-carotene was also inversely associated with the risk of MI ( OR = 0.74 ; CI : 0.54 - 1.01 , P for trend = 0.09 ) . In contrast , lutein + zeaxanthin in adipose tissue ( OR = 1.46 ; CI : 1.05 - 2.05 , P for trend = 0.02 ) and diet ( OR = 1.18 ; CI : 0.88 - 1.57 , P for trend = 0.02 ) was positively associated with MI risk . MI risk was not associated with any of the other carotenoids or tocopherols in the diet or adipose tissue . Thus , the inverse association between beta-carotene and MI risk suggests that beta-carotene protects against MI or it is a marker of some protective factor in foods containing beta-carotene . The mechanism underlying the positive association between lutein + zeaxanthin and the risk of MI warrants investigation",
"BACKGROUND Epidemiologic evidence suggests that serum carotenoids are potent antioxidants and may play a protective role in the development of chronic diseases including cancers , cardiovascular disease , and inflammatory diseases . The role of these antioxidants in the pathogenesis of diabetes mellitus remains unclear . OBJECTIVE This study examined data from a cross-sectional survey to investigate the association between serum carotenoids and type 2 diabetes . DESIGN Study participants were adults aged > or = 25 y ( n = 1597 ) from 6 r and omly selected cities and towns in Queensl and , Australia . Study examinations conducted between October and December 2000 included fasting plasma glucose , an oral-glucose-tolerance test , and measurement of the serum concentrations of 5 carotenoid compounds . RESULTS Mean 2-h postload plasma glucose and fasting insulin concentrations decreased significantly with increasing quintiles of the 5 serum carotenoids -- alpha-carotene , beta-carotene , beta-cryptoxanthin , lutein/zeaxanthin , and lycopene . Geometric mean concentrations for all serum carotenoids decreased ( all decreases were significant except that of lycopene ) with declining glucose tolerance status . Beta-carotene had the greatest decrease , to geometric means of 0.59 , 0.50 , and 0.42 micromol/L in persons with normal glucose tolerance , impaired glucose metabolism , and type 2 diabetes , respectively ( P type 2 diabetes and impaired glucose metabolism . R and omized trials of diets high in carotenoid-rich vegetables and fruit are needed to confirm these results and those from other observational studies . Such evidence would have very important implication s for the prevention of diabetes",
"BACKGROUND Emerging evidence suggests a possible role of lycopene in the primary prevention of cardiovascular disease ( CVD ) . OBJECTIVE We examined whether plasma lycopene concentrations in the Physicians ' Health Study were associated with CVD in a prospect i ve , nested , case-control design . DESIGN Baseline blood sample s were collected starting in 1996 . During a mean follow-up of 2.1 y , we identified 499 cases of CVD ( confirmed myocardial infa rct ion , stroke , CVD death , or revascularization procedures ) and an equal number of men free of CVD and matched for age ( x : 69.7 y ) , follow-up time , and smoking status . We collected self-reported coronary disease risk factors and measured plasma carotenoids , retinol , lipids , and C-reactive protein . RESULTS In matched analyses with additional adjustment for plasma total cholesterol and r and omized treatment , the relative risks ( RRs ) of CVD for men in the lowest to highest quartiles of plasma lycopene were 1.00 ( reference ) , 0.92 , 1.04 , and 0.95 ( P for linear trend = 0.93 ) . With multivariate adjustment , the RRs of total CVD were 1.00 ( reference ) , 1.08 , 0.94 , and 1.03 ( P for linear trend = 0.98 ) . For important vascular events ( 241 cases ) , excluding revascularization procedures , the multivariate RRs remained nonsignificant ( P for linear trend = 0.50 ) . Adding plasma carotenoids , lipids , or C-reactive protein to multivariate models had a minimal effect on the RRs of total CVD for plasma lycopene . Compared with lycopene , higher concentrations of plasma lutein/zeaxanthin and retinol suggested a moderate increase in CVD risk , whereas no association was found for beta-cryptoxanthin , alpha-carotene , and beta-carotene . CONCLUSIONS Higher plasma lycopene concentrations were not associated with the risk of CVD in this study of older men . Further evaluation in diverse population s is necessary",
"BACKGROUND Growing evidence suggests that lycopene has significant in vitro antioxidant potential . Lycopene has rarely been tested in prospect i ve studies for its role in cardiovascular disease ( CVD ) prevention . OBJECTIVE We examined the association between plasma lycopene and the risk of CVD in middle-aged and elderly women . DESIGN A prospect i ve , nested , case-control study was conducted in 39 876 women initially free of CVD and cancer in the Women 's Health Study . Baseline blood sample s were collected from 28 345 ( 71 % ) of the women . During a mean of 4.8 y of follow-up , we identified 483 CVD cases and 483 control subjects matched by age , smoking status , and follow-up time . Plasma lycopene , other carotenoids , retinol , and total cholesterol were measured . RESULTS In analyses matched for age and smoking , with adjustment for plasma cholesterol , the relative risks ( RRs ) and 95 % CIs of CVD in increasing quartiles of plasma lycopene were 1.00 ( referent ) , 0.78 ( 95 % CI : 0.55 , 1.11 ) , 0.56 ( 0.39 , 0.82 ) , and 0.62 ( 0.43 , 0.90 ) . In multivariate models , the RRs were 1.00 ( referent ) , 0.94 ( 0.60 , 1.49 ) , 0.62 ( 0.39 , 1.00 ) , and 0.67 ( 0.41 , 1.11 ) ; those in the upper compared with the lower half of plasma lycopene had an RR of 0.66 ( 0.47 , 0.95 ) . For CVD , exclusive of angina , women in the upper 3 quartiles had a significant multivariate 50 % risk reduction compared with those in the lowest quartile . The stepwise addition of individual plasma carotenoids did not affect the RRs . CONCLUSIONS Higher plasma lycopene concentrations are associated with a lower risk of CVD in women . These findings require confirmation in other cohorts , and the determinants of plasma lycopene concentrations need to be better understood",
"The role of beta-carotene , alpha-tocopherol , and vitamin C in the prevention of cardiovascular diseases ( CVD ) is controversial . Prospect i ve studies on gamma-tocopherol and carotenoids other than beta-carotene are sparse . We assessed relations between the intake of different carotenoids , alpha- and gamma-tocopherol , and vitamin C with 15-y CVD mortality in elderly men who participated in the Zutphen Elderly Study . Information on diet and potential confounding factors was collected in 1985 , 1990 , and 1995 . In 1985 , 559 men ( mean age approximately 72 y ) free of chronic diseases were included in the current analysis . After 15 y of follow-up , comprising 5744 person-years , 197 men had died from CVD . After adjustment for age , smoking , and other potential lifestyle and dietary confounders , relative risks ( RR ) ( 95 % CI ) of CVD death for a 1-SD increase in intake were 0.81 ( 0.66 - 0.99 ) for alpha-carotene and 0.80 ( 0.66 - 0.97 ) for beta-carotene . Carrots were the primary source of alpha- and beta-carotene and their consumption was related to a lower risk of death from CVD ( adjusted RR , 0.83 ; 95 % CI = 0.68 - 1.00 ) . Intakes of carotenoids other than alpha- and beta-carotene were not associated with CVD mortality , nor were vitamin C and alpha- and gamma tocopherol . In conclusion , dietary intakes of alpha-carotene and beta-carotene are inversely associated with CVD mortality in elderly men . This study does not indicate an important role for other carotenoids , tocopherols , or vitamin C in lowering the risk of CVD death",
"BACKGROUND Numerous studies have shown that higher intakes or higher blood concentrations of carotenes are associated with a lower risk of coronary artery disease ( CAD ) . Given the None results in trials of beta-carotene supplementation , considerable attention has focused on the potential role of other dietary carotenoids in the prevention of CAD . OBJECTIVE Our objective was to prospect ively examine the relation between dietary intakes of specific carotenoids and risk of CAD in women . DESIGN In 1984 , 73 286 female nurses completed a semiquantitative food-frequency question naire that assessed their consumption of carotenoids and various other nutrients . The women were followed for 12 y for the development of incident CAD ( nonfatal myocardial infa rct ion and fatal CAD ) , and dietary information was up date d in 1986 , 1990 , and 1994 . RESULTS During 12 y of follow-up ( 803 590 person-years ) , we identified 998 incident cases of CAD . After adjustment for age , smoking , and other CAD risk factors , we observed modest but significant inverse associations between the highest quintiles of intake of beta-carotene and alpha-carotene and risk of CAD but no significant relation with intakes of lutein/zeaxanthin , lycopene , or beta-cryptoxanthin . For women in the highest compared with the respective lowest quintile of intake , the relative risks for beta-carotene and alpha-carotene were 0.74 ( 95 % CI : 0.59 , 0.93 ) and 0.80 ( 95 % CI : 0.65 , 0.99 ) , respectively . The association between the specific carotenoids and CAD risk did not vary significantly by current smoking status . CONCLUSION Higher intakes of foods rich in alpha-carotene or beta-carotene are associated with a reduction in risk of CAD",
"BACKGROUND Adverse postnatal health effects have been associated with compromised fetal growth , which makes it essential to underst and its determinants . Significant effects of environmental pollutants on birth outcomes have been observed in our study population , and nutritional status may be an additional factor influencing fetal development and effects of environmental toxins . OBJECTIVE The objective of the study was to examine the relations between birth outcomes and lipid-soluble plasma micronutrient concentrations and to explore interactions between micronutrients and environmental pollutant exposure in newborns in Krakow , Pol and . DESIGN In this prospect i ve cohort study , retinol , alpha-tocopherol , and carotenoids were measured in maternal and cord blood sample s obtained at delivery ( 251 maternal-newborn pairs ) , and birth weight , birth length , head circumference ( HC ) , and gestational age were evaluated . Linear regression analysis was used to estimate the effects of micronutrients while covariates were controlled for . Interaction terms assessed whether the effects of polycyclic aromatic hydrocarbons ( PAHs ) , common environmental pollutants , varied by nutrient status . RESULTS Infants whose mothers had low plasma alpha-tocopherol concentrations ( below the median ) weighed 92.9 g less and had 0.41-cm smaller HCs than did infants whose mothers had high alpha-tocopherol concentrations . Infants with low plasma retinol ( below the median ) weighed 125.9 g less and had 0.31-cm smaller HCs . There was no evidence of an interaction between PAHs and micronutrients , although power was limited . CONCLUSION Maternal alpha-tocopherol and cord retinol concentrations were significantly and positively associated with BW and HC . These micronutrients may have direct effects or may be markers for other underlying determinants of these pregnancy outcomes",
"The aim of the present study was to evaluate the effects of lutein and lycopene supplementation on carotid artery intima-media thickness ( C AIM T ) in subjects with sub clinical atherosclerosis . A total of 144 subjects aged 45 - 68 years were recruited from local communities . All the subjects were r and omly assigned to receive 20 mg lutein/d ( n 48 ) , 20 mg lutein/d+20 mg lycopene/d ( n 48 ) or placebo ( n 48 ) for 12 months . C AIM T was measured using Doppler ultrasonography at baseline and after 12 months , and serum lutein and lycopene concentrations were determined using HPLC . Serum lutein concentrations increased significantly from 0·34 to 1·96 μmol/l in the lutein group ( P Similarly , serum lycopene concentrations increased significantly from 0·18 to 0·71 μmol/l in the combination group at month 12 ( P . The mean values of C AIM T decreased significantly by 0·035 mm ( P= 0·042 ) and 0·073 mm ( P in C AIM T was inversely associated with the increase in serum lutein concentrations ( P that in serum lycopene concentrations ( β = - 0·342 , P= 0·031 ) in the combination group . Lutein and lycopene supplementation significantly increased the serum concentrations of lutein and lycopene with a decrease in C AIM T being associated with both concentrations . In addition , the combination of lutein and lycopene supplementation was more effective than lutein alone for protection against the development of C AIM T in Chinese subjects with sub clinical atherosclerosis , and further studies are needed to confirm whether synergistic effects of lutein and lycopene exist",
"OBJECTIVES The acute effect of smoking and snuffing on insulin sensitivity was studied in a group of healthy habitual smokers . DESIGN The euglycaemic clamp technique was combined with the subcutaneous injection of a bolus ( 0.1 U kg-1 ) of fast-acting insulin ( Actrapid ) . R and omized subjects smoked either one cigarette per hour for 6 h , took one bag-packed snuff per hour for 6 h or refrained from nicotine for 48 h before as well as during the clamp . SUBJECTS Seven healthy smokers , four females and three males , of normal weight ( BMI , mean + /- SEM , 21 + /- 0.7 kg m-2 with a range of 18.6 - 23.9 ) , aged 31 + /- 2 years ( range 24 - 35 years ) , who had consumed at least 20 cigarettes per day for at least 5 years were studied . They were recruited through an advertisement in a newspaper . RESULTS The steady-state plasma nicotine levels were similar during smoking and snuffing . The insulin and glucose levels were also similar during all three clamps . Smoking , but not snuffing , impaired insulin action ( P uptake . The mean growth hormone levels during the 6-h study were more than doubled during smoking ( P insulin action and leads to insulin resistance . Thus , smoking can be of importance for the development of the insulin resistance syndrome associated with risk for cardiovascular disease",
"Background —Increased intake of carotenoids and vitamin E may protect against myocardial infa rct ion ( MI ) . However , prospect i ve data on blood levels of carotenoids other than & bgr;-carotene and vitamin E ( tocopherol ) and risk of MI are sparse . Methods and Results —We conducted a prospect i ve , nested case-control analysis among male physicians without prior history of cardiovascular disease who were followed for up to 13 years in the Physicians ’ Health Study . Sample s from 531 physicians diagnosed with MI were analyzed together with sample s from paired control subjects , matched for age and smoking , for 5 major carotenoids ( & agr;- and & bgr;-carotene , & bgr;-cryptoxanthin , lutein , and lycopene ) , retinol , and & agr;- and & ggr;-tocopherol . Overall , we found no evidence for a protective effect against MI for higher baseline plasma levels of retinol or any of the carotenoids measured . Among current and former smokers but not among never-smokers , higher baseline plasma levels of & bgr;-carotene tended to be associated with lower risk ( P for interaction=0.02 ) . Men with higher plasma levels of & ggr;-tocopherol tended to have an increased risk of MI ( P for trend=0.01 ) . Conclusions —These prospect i ve data do not support an overall protective relation between plasma carotenoids or tocopherols and future MI risk among men without a history of prior cardiovascular disease",
"Background and Purpose — Intake of fruits and vegetables has been related to lower risk of ischemic stroke , but nutrients responsible for this apparent benefit remain ill-defined . Tocopherols ( vitamin E ) have also been proposed to be protective . Methods — We conducted a prospect i ve , nested case-control analysis among male physicians without diagnosed cardiovascular disease followed-up for up to 13 years in the Physicians ’ Health Study . Sample s from 297 physicians with ischemic stroke were analyzed with paired controls , matched for age and smoking , for 5 major carotenoids ( & agr;- and β-carotene , β-cryptoxanthin , lutein , and lycopene ) , retinol , and & agr;- and γ-tocopherol . Results — Baseline plasma levels of & agr;-carotene and β-carotene and lycopene tended to be inversely related to risk of ischemic stroke with an apparent threshold effect . As compared with men whose plasma levels were in the lowest quintile , the multivariate adjusted odds ratios ( ORs ) of ischemic stroke among men with levels in the second through fifth quintiles were 0.59 ( 95 % CI , 0.36 to 0.98 ) for & agr;-carotene , 0.62 ( 95 % CI , 0.38 to 1.01 ) for β-carotene , and 0.61 ( 95 % CI , 0.37 to 1.00 ) for lycopene . A tendency toward an inverse association was found for β-cryptoxanthin , but the result was not statistically significant . No association was found for lutein , retinol , and tocopherols . Conclusion — Our data suggest that higher plasma levels of carotenoids , as markers of fruit and vegetable intake , are inversely related to risk of ischemic stroke and provide support for recommendations to consume fruits and vegetables regularly",
"Background / Objectives Breast milk contains lutein derived from the mother 's diet . This carotenoid is currently not added to infant formula , which has a small and variable lutein content from innate ingredients . This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification . Subjects/ Methods This 16-week study was prospect i ve , r and omized , controlled , and double-blind with parallel groups of healthy term infants fed either control formula ( Wyeth S-26 Gold , design ated as Gold ) or experimental formula ( Wyeth S-26 Gold fortified with lutein at 200 mcg/l , design ated as Gold + Lutein ) . Two hundred thirty-two ( 232 ) infants ≤ 14 days postnatal age were r and omized and 220 ( 94.8 % ) completed the study . Weight ( g ) , head circumference ( cm ) , and length ( cm ) were measured at Weeks 4 , 8 , 12 , and 16 . The primary endpoint was weight gain ( g/day ) from baseline to Week 16 . Safety was assessed through monitoring of study events ( SEs ) throughout the study and evaluation of selected blood chemistry tests performed at Week 16 . Results Infants in both treatment groups demonstrated appropriate growth . No differences between treatment groups were found in any of the measures of growth at any of the measurement time points . Both study formulas were well tolerated . The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants , and the values for both groups for any measured parameter were similar . Conclusions Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula",
"Objective . The aim of this study was to investigate how serum retinol and carotenoids ( β-carotene , β-cryptoxanthin , lutein/zeaxanthin , lycopene ) are associated with biomarkers of insulin resistance . Research Methods and Procedures . The BioCycle Study ( 2005–2007 ) is a prospect i ve cohort of 259 healthy premenopausal women . Fasting serum sample s were collected at up to sixteen clinic visits , from which retinol , carotenoids , insulin , glucose , and sex hormone-binding globulin ( SHBG ) were measured . Insulin resistance was estimated by the homeostasis model assessment ( HOMA-IR ) . Linear mixed models were used to determine associations adjusting for age , race , body mass index ( BMI ) , education , smoking , physical activity , triglycerides , and energy intake . Results . Retinol was positively associated with HOMA-IR ( β = 0.19 ( 95 % CI : 0.07 , 0.32 ) ) units per ug/mL increase in retinol ; the relationship was driven by insulin ( β = 0.20 ( 95 % CI : 0.08 , 0.31 ) ) . Retinol was inversely associated with SHBG ( β = −0.22 ( 95 % CI : −0.28 , −0.16 ) ) . Although no significant associations were found between serum carotenoids and HOMA-IR , β-carotene was positively associated with SHBG and β-cryptoxanthin inversely with fasting plasma glucose . Conclusion . Results indicate a possible role for serum retinol in the pathogenesis of type 2 diabetes . However , they do not support a strong association between individual or total serum carotenoids and insulin resistance",
"Evidence regarding the health benefits of carotenoids is controversial . Effects of serum carotenoids and their interactions on mortality have not been examined in a representative sample of US adults . The objective was to examine whether serum carotenoid concentrations predict mortality among US adults . The study consisted of adults aged ≥20 years enrolled in the Third National Health and Nutrition Examination Survey , 1988 to 1994 , with measured serum carotenoids and mortality follow-up through 2006 ( N = 13,293 ) . Outcomes were all-cause , cardiovascular disease , and cancer mortality . In adjusted Cox proportional hazards models , participants in the lowest total carotenoid quartile ( higher all-cause mortality ( mortality rate ratio , 1.38 ; 95 % confidence interval , 1.15 - 1.65 ; P = .005 ) than those in the highest total carotenoid quartile ( > 1.75 μmol/L ) . For α-carotene , the highest quartile ( > 0.11 μmol/L ) had the lowest all-cause mortality rates ( P lowest all-cause mortality rates ( P = .047 ) . Analyses with continuous carotenoids confirmed associations of serum total carotenoids , α-carotene , and lycopene with all-cause mortality ( P of all-cause mortality , followed by very low total carotenoids . α-Carotene/β-cryptoxanthin , α-carotene/lutein+zeaxanthin and lycopene/lutein+zeaxanthin interactions were significantly related to all-cause mortality ( P associated with cardiovascular disease mortality ( P = .002 ) . No carotenoids were significantly associated with cancer mortality . Very low serum total carotenoid , α-carotene , and lycopene concentrations may be risk factors for mortality , but carotenoids show interaction effects on mortality . Interventions of balanced carotenoid combinations are needed for confirmation",
"The authors conducted a nested case-control study from 1992 to 2003 among US women aged 45 years or older and free from cardiovascular disease and cancer to examine the prospect i ve association among plasma lycopene , other carotenoids , and the risk of developing type 2 diabetes . During 10 years of follow-up , 470 cases of incident type 2 diabetes were selected and individually matched on age ( + /- 1 year ) and follow-up time to 470 nondiabetic controls . Baseline plasma levels of lycopene , alpha-carotene , beta-carotene , beta-cryptoxanthin , and lutein/zeaxanthin were similar in cases and controls ( all p > 0.05 ) . A possible crude inverse association between plasma lycopene and risk of type 2 diabetes was attenuated upon multivariate adjustment . After control for plasma total cholesterol and known diabetes risk factors , the multivariate odds ratios of type 2 diabetes in the highest versus the lowest quartile of plasma carotenoids were 1.13 ( 95 % confidence interval ( CI ) : 0.60 , 2.13 ) for lycopene , 1.27 ( 95 % CI : 0.63 , 2.57 ) for alpha-carotene , 1.10 ( 95 % CI : 0.57 , 2.13 ) for beta-carotene , 0.91 ( 95 % CI : 0.46 , 1.81 ) for beta-cryptoxanthin , and 1.35 ( 95 % CI : 0.68 , 2.69 ) for lutein/zeaxanthin . There was no prospect i ve association between baseline plasma carotenoids and the risk of type 2 diabetes in middle-aged and older women",
"The aim of the present study was to compare the effect of lutein- and zeaxanthin-rich foods and supplements on macular pigment level ( MPL ) and serological markers of endothelial activation , inflammation and oxidation in healthy volunteers . We conducted two 8-week intervention studies . Study 1 ( n 52 ) subjects were r and omised to receive either carrot juice ( a carotene-rich food ) or spinach powder ( a lutein- and zeaxanthin-rich food ) for 8 weeks . Study 2 subjects ( n 75 ) received supplements containing lutein and zeaxanthin , β-carotene , or placebo for 8 weeks in a r and omised , double-blind , placebo-controlled trial . MPL , serum concentrations of lipid-soluble antioxidants , inter-cellular adhesion molecule 1 , vascular cell adhesion molecule 1 , C-reactive protein and F2-isoprostane levels were assessed at baseline and post-intervention in both studies . In these intervention studies , no effects on MPL or markers of endothelial activation , inflammation or oxidation were observed . However , the change in serum lutein and zeaxanthin was associated or tended to be associated with the change in MPL in those receiving lutein- and zeaxanthin-rich foods ( lutein r 0.40 , P = 0.05 ; zeaxanthin r 0.30 , P = 0.14 ) or the lutein and zeaxanthin supplement ( lutein r 0.43 , P = 0.03 ; zeaxanthin r 0.22 , P = 0.28 ) . In both studies , the change in MPL was associated with baseline MPL ( food study r - 0.54 , P supplementation with lutein and zeaxanthin , whether as foods or as supplements , had no significant effect on MPL or serological markers of endothelial activation , inflammation and oxidation in healthy volunteers , but may improve MPL in the highest serum responders and in those with initially low MPL",
"OBJECTIVE We studied the effect of beta-carotene supplementation on the concentrations and distribution in plasma lipoprotein and non-lipoprotein fractions of carotenoids , alpha-tocopherol , retinol , and cholesterol . METHODS Ten women ingested either 90 mg of beta-carotene or placebo daily for 3 weeks while residing in their homes and eating their usual meals . Carotenoids ( beta-carotene , lycopene , lutein/zeaxanthin ) , retinol , alpha-tocopherol , and cholesterol were measured in plasma lipoprotein and non-lipoprotein fractions before and after treatment . RESULTS In the beta-carotene-supplemented group , total plasma beta-carotene increased 14-fold from 0.48 + /- 0.13 to 6.83 + /- 2.12 mumol/L ( p = 0.04 ) . Although the greatest increase in beta-carotene was in low-density-lipoproteins ( LDL ) , the magnitude of increase was similar in LDL , high-density-lipoproteins ( HDL ) , and very-low-density-lipoproteins ( VLDL ) . Thus , the relative distribution of beta-carotene in lipoproteins was unchanged : approximately 71 % was in LDL , approximately 15 % in HDL and approximately 12 % in VLDL , before and after beta-carotene supplementation . There were no changes in amounts and distribution in lipoproteins of the other carotenoids , alpha-tocopherol , and cholesterol . There was no change in the amount of retinol in lipoprotein-deficient plasma . There were no changes in total plasma triglycerides . Significant positive correlations were found between LDL- or VLDL-cholesterol and alpha-tocopherol in LDL or VLDL , respectively ; between LDL- or VLDL-cholesterol and lutein/zeaxanthin in LDL or VLDL , respectively ; and between HDL-cholesterol and beta-carotene in HDL . CONCLUSIONS beta-Carotene supplementation ( 90 mg/day for 3 weeks ) in healthy older women results in an enrichment of all plasma lipoprotein fractions with beta-carotene , but does not alter the relative distribution of beta-carotene in lipoproteins . beta-Carotene supplementation has no effect on the amounts and relative distribution of lycopene , lutein/zeaxanthin , and alpha-tocopherol in lipoproteins , or of retinol in the non-lipoprotein fraction of plasma . Short-term beta-carotene supplementation has no effect on the concentrations of plasma total triglycerides , total cholesterol , HDL- , LDL- , and VLDL-cholesterol",
"BACKGROUND AND AIM Modification of low-density lipoprotein due to oxidative stress is essential in the development of coronary atherosclerosis . Data of specific carotenoids except β-carotene on cardioprotective effects in humans are limited . METHODS AND RESULTS This study examined the associations between plasma concentrations of specific carotenoids and incidence of acute myocardial infa rct ion . The study included 280 incident cases of acute myocardial infa rct ion and 560 matched controls nested within the Singapore Chinese Health Study , a prospect i ve cohort of 63,257 Chinese men and women aged 45 - 74 years old enrolled in 1993 - 1998 in Singapore . Retinol and carotenoids in prediagnostic plasma were quantified using high-performance liquid chromatography . High levels of plasma β-cryptoxanthin and lutein were associated with decreased risk of acute myocardial infa rct ion after adjustment for multiple risk factors for coronary heart disease . For β-cryptoxanthin , the odds ratio ( 95 % confidence interval ) for the highest ( Q5 ) versus the lowest ( Q1 ) quintile was 0.67 ( 0.37 - 1.21 ) ( P for trend=0.03 ) . For lutein , the odds ratios ( 95 % confidence intervals ) for the combined Q2-Q3 and the combined Q4-Q5 versus Q1 were 0.71 ( 0.45 - 1.12 ) and 0.58 ( 0.35 - 0.94 ) respectively ( P for trend=0.03 ) . There was no statistically significant association between other carotenoids or retinol and risk of acute myocardial infa rct ion . CONCLUSIONS High plasma levels of β-cryptoxanthin and lutein were associated with decreased risk of acute myocardial infa rct ion . The findings of this study support a cardioprotective role of these two carotenoids in humans",
"Considerable evidence supports the hypothesis that vitamin E reduces the risk for atherosclerosis ( 1 ) . Vitamin E inhibits the proliferation of smooth-muscle cells in vitro ( 2 ) and increases the resistance of low-density lipoprotein to oxidation when it is added to plasma or administered to humans ( 3 , 4 ) . Furthermore , platelets from persons taking vitamin E supplements had markedly reduced adhesiveness to collagen ( 5 ) . Consistent with these findings , vitamin E intake has been inversely associated with risk for coronary heart disease ( 6 - 8 ) and for peripheral arterial disease ( 9 ) and with carotid artery wall thickness ( 10 , 11 ) . Risk for ischemic stroke also increases with atherosclerosis and might therefore be reduced by vitamin E. However , few studies have addressed the relation between vitamin E and risk for ischemic stroke , and those that have been done were small , had little variation in vitamin E intake , or did not distinguish between ischemic and hemorrhagic stroke ( 12 - 15 ) . Risk for hemorrhagic stroke is unlikely to be reduced by high doses of vitamin E and could even be increased by the reduced platelet adhesion that these doses cause ( 5 ) . The most informative previous studies a large r and omized trial in men ( 16 , 17 ) and a prospect i ve investigation in women (6)supported a modest beneficial effect of vitamin E with respect to ischemic stroke , but the results were not statistically significant . Moreover , in the trial in men ( 16 ) , this apparent benefit was offset by an increased risk for hemorrhagic stroke . Like vitamin E , vitamin C and carotenoids have antioxidant properties ( 18 , 19 ) and have been hypothesized to reduce risk for stroke , but epidemiologic evidence to support these hypotheses is limited ( 14 - 17 , 20 - 22 ) . Of the carotenoids , we considered -carotene , -carotene , lutein , and lycopene because they are present in relatively large amounts in the diet and have distinct antioxidant properties ( 23 ) . Our primary hypothesis was that high intake of these antioxidants would reduce risk for ischemic stroke . We report here the associations between intakes of vitamin E , vitamin C , and specific carotenoids and risks for ischemic and hemorrhagic stroke in a large cohort of men in the United States . Methods Study Sample The Health Professionals Follow-up Study began in 1986 , when 51 529 health professionals 40 to 75 years of age [ 24 ] completed a 131-item food-frequency question naire and supplied information about medical history and lifestyle . Follow-up question naires were sent every 2 years so that we could up date information on potential risk factors , including use of vitamin supplements , and identify newly diagnosed cases of stroke and other diseases . We excluded from analysis 1595 men who did not have 1 ) a daily caloric intake between 800 and 4200 kcal and 2 ) fewer than 70 blanks ( among 131 listed food items ) on the food-frequency question naire . We also excluded men with previous myocardial infa rct ion , angina , coronary artery surgery , stroke , transient ischemic attack , peripheral arterial disease , or diabetes . We followed the 43 738 eligible men for incidence of stroke for 8 years . The average response rate for the 2-year follow-up cycles was more than 94 % . Nonresponding participants who were not matched to the National Death Index were assumed to be alive . This study was approved by the institutional review board of the Harvard School of Public Health . Assessment of Diet and Other Exposure Variables On the 1986 question naire , we asked about 1 ) the average frequency of intake over the previous year of specified portions of 131 foods and 2 ) the use of vitamin and mineral supplements . We specifically asked about dose and duration of use of multivitamin , vitamin E , and vitamin C supplements . Nutrient calculations took into account the specific br and s of breakfast cereal and multivitamin supplements reported by each participant . We assessed the question naire 's validity in a r and om sample of 127 men who completed two 1-week diet records ( 25 ) ; 121 of these men also provided blood sample s ( 26 , 27 ) . The correlations between the food-frequency assessment s of intake and plasma concentrations were 0.51 for -tocopherol , 0.47 for -carotene and lycopene , 0.35 for -carotene , and 0.40 for lutein . These correlations were similar to those seen between plasma levels of these nutrients and intake of these nutrients as estimated by the two 1-week diet records ( 25 ) , and they support the validity of the food-frequency question naire . Even if dietary measurements were perfect , vitamin intake and plasma levels would not be highly correlated because multiple factors contribute to between-person variations in plasma vitamin levels . The correlation between the food-frequency and diet-record assessment s was 0.92 for both vitamin C and vitamin E ( 25 ) . In 1986 , in addition to reporting on diet , participants were asked to report their usual systolic and diastolic blood pressures and whether they had physician-diagnosed hypertension . The validity of these variables has been documented ( 28 ) . Other potential risk factors for stroke that were assessed at baseline and in the follow-up question naire included smoking history , body mass index , history of hypercholesterolemia , physical activity , parental history of myocardial infa rct ion , and alcohol consumption . Events End points were fatal or nonfatal stroke occurring between the return of the baseline question naire and 31 January 1994 . If a participant reported an incident stroke on a follow-up question naire , we asked for permission to review that participant 's medical records . Strokes were confirmed if they were characterized by a typical neurologic defect of sudden or rapid onset that lasted at least 24 hours and was attributable to a cerebrovascular event . Strokes caused by infection or neoplasia were excluded . Review s were conducted by physicians who had no knowledge of participants ' risk factor status . Strokes were subclassified , according to the criteria of the National Survey of Stroke , as due to ischemia ( embolism or thrombosis ) , subarachnoid hemorrhage , intracerebral hemorrhage , or an unknown cause ( 29 ) . If no records could be obtained , a stroke was considered probable if it necessitated hospitalization and was corroborated by additional information provided in a letter or interview . Deaths were initially reported by next-of-kin , coworkers , postal authorities , or the National Death Index . Fatal strokes were confirmed by medical records ( 84 % ) or autopsy reports ( 2 % ) or were considered probable if medical records or autopsy reports could not be obtained and stroke was listed as the underlying cause of death on the death certificate ( 14 % ) . Statistical Analysis Participants contributed follow-up time from the return of the 1986 question naire to the occurrence of a confirmed stroke or death or 31 January 1994 . Men who had nonfatal myocardial infa rct ion or coronary surgery during the follow-up period were retained in the analysis . Intake of vitamin E and other nutrients was energy-adjusted to 2000 kcal/d ( 30 ) . Relative risks were calculated by dividing the incidence of stroke among men in each quintile of energy-adjusted vitamin E intake at baseline by the incidence of stroke among men in the lowest quintile of intake . Similar calculations were done for the other nutrients . Quintiles were used to avoid assumptions about the shape of the dose-response relation and to provide sufficient power to compare men in the extreme categories of intake . For vitamin E , vitamin C , and -carotene , additional analyses separately considered supplemental and dietary intake . We adjusted relative risks for age ( in 5-year categories ) ( 31 ) and used the Mantel extension test ( 32 ) to test for linear trends . To adjust for other risk factors , we used pooled logistic regression with 2-year intervals . Where the probability of an event within an interval is small , this method is equivalent to a Cox proportional-hazards analysis ( 33 ) . The multivariate models included the following as covariates : calendar time ( in 2-year intervals ) , total energy intake ( continuous variable ) , smoking ( current ; past ; or 1 to 14 , 15 to 24 , and 25 cigarettes/d ) , alcohol consumption ( , 5 to 9 , 10 to 14 , 15 to 29 , or 30 g/d ) , history of hypertension , history of hypercholesterolemia , parental history of myocardial infa rct ion before 65 years of age , profession , and quintiles of body mass index and physical activity . In these models , we evaluated monotonic trends by using the median value of each category and modeling it as a continuous variable . Analyses were also conducted to up date dietary intake and other covariates during follow-up . In these analyses , the incidence of stroke in 1986 - 1990 was related to vitamin and carotenoid intake reported in 1986 , whereas the incidence of stroke in 1990 - 1994 was related to the average intake reported in 1986 and 1990 . Because dietary changes made after the development of intermediate end points , such as coronary heart disease , peripheral arterial disease , transient ischemic attacks , diabetes , and hypercholesterolemia , may confound the associations between diet and disease ( 34 ) , we repeated the analyses without updating information on diet for men who reached an intermediate end point before completing the 1990 dietary question naire . All P values are two-sided . Role of the Funding Source The National Institutes of Health had no role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the paper for publication . Results During 323 394 person-years of follow-up , we documented 328 strokes : 210 ischemic , 70 hemorrhagic , and 48 unclassified . Fifty of the 328 strokes were fatal . The distribution of risk factors for stroke differed somewhat by vitamin E , vitamin C , and -carotene intake ( Table 1 ) . Men in the top quintiles of vitamin E or vitamin C intakemost of whom used multivitamin or specific vitamin supplementswere less likely to smoke , were more likely to use aspirin , and were",
"Objective : To assess the carotenoid status in young type I diabetic patients and its relationship to the glycaemic control of the disease . Design : A follow-up study . Setting : Hospital Universitario Puerta de Hierro , Health Area VI of Madrid (Spain).Subjects : Forty-seven type I diabetic patients , followed for 2.5 years . Interventions : Coinciding with physical examination and laboratory tests , serum levels of carotenoids were analysed by HPLC , and dietary intake of carotenoids was evaluated by a semiquantitative food frequency question naire and 3-day prospect i ve dietary records . Results : In type I diabetic patients , average intake , serum levels and correlations between diet and serum levels of carotenoids were comparable to those in reference non-diabetic groups . Between-subjects seasonal variations were observed for β-cryptoxanthin intake and serum levels ( higher in winter ) and serum lycopene ( higher in summer ) . Significant within-subjects seasonal changes were shown for dietary and serum β-cryptoxanthin and serum β-carotene . Serum carotenoids were unrelated to glycaemic control markers . Subjects with clinical ly acceptable glycaemic control showed lower lycopene intake than those with unacceptable control . Intake of carotenoids did not explain variance in insulin dose , fasting glycaemia , fructosamine or HbA1c . With the exception of lycopene , serum carotenoids were predicted by dietary intake , but in no case by fasting glycaemia , HbA1c or fructosamine . Conclusion : In type I diabetic patients , serum carotenoid concentrations and their variance are determined by dietary intake patterns , and are unrelated to the glycaemic control of the disease , as assessed by biochemical markers",
"Smoking is associated with low serum carotenoid concentrations . Prospect i ve studies have found lower diabetes risk among persons with high-carotenoid diets . Whether diabetes risk is low in the rare smoker who has high serum carotenoid levels is unknown . The authors investigated the interaction of serum carotenoid concentrations and smoking with diabetes mellitus in 4,493 Black and White men and women aged 18 - 30 years in the Coronary Artery Risk Development in Young Adults ( CARDIA ) Study . The authors assessed 15-year ( 1985 - 2001 ) incident diabetes ( 148 cases ) , insulin concentration , and insulin resistance ( homeostasis model assessment ) in smokers and nonsmokers according to baseline levels of serum alpha-carotene , beta-carotene , zeaxanthin , beta-cryptoxanthin , and lycopene . Diabetes incidence was inversely associated with the sum of carotenoid concentrations in nonsmokers ( per st and ard deviation ( SD ) increase , relative hazard = 0.74 , 95 % confidence interval : 0.55 , 0.99 ) but not in current smokers ( relative hazard = 1.13 , 95 % confidence interval : 0.83 , 1.53 ) ( p for interaction = 0.02 ) . Similarly , year 15 insulin and insulin resistance values , adjusted for baseline levels , were inversely related to sum of carotenoids only in nonsmokers ( per SD increase in insulin level , slope = -0.46 ( p = 0.03 ) ; per SD increase in insulin resistance , slope = -0.14 ( p = 0.01 ) ) . In CARDIA , higher serum carotenoid concentrations are associated with lower risk of diabetes and insulin resistance in nonsmokers but not in smokers",
"BACKGROUND the evidence of a potential beneficial role of antioxidants in preventing atherosclerotic disease is not entirely consistent . OBJECTIVE to assess the longitudinal association of serum total antioxidant capacity and serum antioxidants with the presence of sub clinical carotid atherosclerosis . METHODS Prospect i ve case-control study nested within an historical cohort . Cases were 150 individuals with elevated carotid intimal-medial thickness measured by B-mode ultrasound at the first two examinations of the Atherosclerosis Risk in Communities Study ( 1987 - 92 ) . Controls were 150 age-gender-matched individuals with low carotid intimal-medial thickness . Serum antioxidant vitamins , uric acid , and serum total antioxidant capacity were measured in frozen serum sample s collected from the same individuals in 1974 ( 13 - 15 years prior to the determination of case-control status ) . RESULTS Compared to controls , atherosclerosis cases had significantly higher levels of serum total antioxidant capacity in 1974 than controls . This difference was almost entirely explained by increased serum concentration of uric acid in cases . In contrast with cross-sectional results , uric acid serum concentration in 1974 , was significantly higher in cases than in controls , even after adjusting for the main cardiovascular risk factors . Cases had significantly lower levels of alpha-carotene in the 1974 sera than controls , but no other differences in serum antioxidant vitamin concentrations were observed . CONCLUSIONS The higher serum uric acid concentration seemed associated with elevated total serum antioxidant capacity among individuals with atherosclerosis . This finding is consistent with experimental evidence suggesting that hyperuricemia may be a compensatory mechanism to counteract oxidative damage related to atherosclerosis and aging in humans",
"BACKGROUND AND PURPOSE A large number of studies have contributed to the hypothesis that carotenoids , vitamins A and E are protective against atherosclerosis by acting as antioxidants . The aim of this study was to assess the relationship between plasma levels of carotenoids ( alpha- and beta- carotene , lutein , lycopene , zeaxanthin , beta-cryptoxanthin ) , vitamins A and E , and atherosclerosis in the carotid and femoral arteries . METHODS This prospect i ve and cross sectional study involved a r and omly selected population sample of 392 men and women aged 45 - 65 years . Carotid and femoral artery atherosclerosis was assessed by high-resolution duplex ultrasound . RESULTS alpha- and beta- carotene plasma levels were inversely associated with the prevalence of atherosclerosis in the carotid and femoral arteries ( P=0.004 ) and with the 5-year incidence of atherosclerotic lesions in the carotid arteries ( P=0.04 ) . These findings were obtained after adjustment for other cardiovascular risk factors ( sex , age , LDL ( low density lipoproteins ) , ferritin , systolic blood pressure , smoking , categories of alcohol consumption , social status , C-reactive protein ) . Atherosclerosis risk gradually decreased with increasing plasma alpha- and beta-carotene concentrations ( P=0.004 ) . No associations were found between vitamin A and E plasma levels and atherosclerosis . CONCLUSIONS This study provides further epidemiological evidence of a protective role of high alpha- and beta- carotene in early atherogenesis",
"AIM The purpose of this study was to determine the effects of lutein supplement on serum cytokines , apoE and lipoprotein profiles in early atherosclerosis population . METHODS Early atherosclerosis patients ( n= 65 ) were r and omized to receive placebo ( A+P , n= 31 ) or 20 mg/d lutein ( A+L , n= 34 ) for 3 months . RESULTS Serum lutein increased significantly compared to baseline after lutein supplements in A+L group ( p Lutein supplements result ed in a significant decrease in serum interleukin-6 ( IL-6 ) and monocyte chemoattractant protein-1 ( MCP-1 ) at 3 month in A+L group ( p serum MCP-1 between A+L and A+P groups ( p= 0.021 ) . The serum low-density lipoprotein ( LDL ) and triglyceride ( TG ) significantly decreased in A+L group ( p changes in serum lutein were negatively associated with those in serum LDL in A+L group ( r=-0.384 , p=0.043 ) , while no such relationship was observed in A+P group ( r= 0.087 , p= 0.685 ) . CONCLUSION An increase in serum lutein after supplementation can reduce inflammatory cytokines and regulate serum lipids , which may pay important roles in early atherosclerosis",
"OBJECTIVE The aim of this study was to determine whether lutein affected biomarkers related to cardiovascular diseases ( CVD ) in healthy nonsmokers . METHODS A r and omized , double-blind , placebo-controlled trial of lutein supplementation was conducted in healthy nonsmokers . 117 eligible subjects were r and omly assigned to receive 10 or 20 mg/d of lutein or placebo for 12 weeks . Levels of plasma carotenoid concentrations , total antioxidant capacity ( TAOC ) , the lipoprotein profile , and antioxidant enzymes activities were determined at baseline and at 6 , and 12 weeks after the initiation of treatment . Biomarkers of oxidative damage to protein and lipids , and C-reactive protein ( CRP ) concentrations were measured at baseline and after supplementation . RESULTS Plasma lutein and TAOC significantly increased in both active treatment groups during 12 weeks . A significant reduction was found in malondialdehyde in the 20 mg lutein group . CRP concentration decreased in a dose-dependent manner for lutein supplementation , and there was a significant between-group difference in CRP between the 20 mg lutein and the placebo group . Serum CRP was directly related to the change in plasma lutein and TAOC for both active treatment groups . CONCLUSION The results support the possibility that lutein supplementation reduce biomarkers of CVD risk via decreased lipid peroxidation and inflammatory response by increasing plasma lutein concentrations and antioxidant capacity",
"The role of plasma retinol and carotenoids in coronary heart disease ( CHD ) remains unclear . The PRIME Study prospect ively evaluated these in France and Northern Irel and in 9758 men aged 50 - 59 years who were free of CHD at baseline . After five years ' follow-up 150 incident cases of CHD ( non-fatal myocardial infa rct ion and fatal CHD ) were compared with 285 controls matched for age , date of blood collection and study centre . Geometric means of major carotenoids did not differ significantly between cases and controls ( P>0.05 ) , whereas the absolute and lipid-st and ardized plasma retinol levels were 9 % lower in cases than controls in both countries ( P relative risks ( RRs ) of CHD in the first four quintiles of retinol distribution in controls ( 0.05 ) respectively , relative to the top quintile ( retinol > or = 846 microg/l ; linear trend P=0.0001 ) . The 10th percentile of lipid-st and ardized retinol ( RR of 4.7 ( P retinol was comparable to strong risk factors ( e.g. HDL-cholesterol , Interleukin-6 ) and behaved additively . In conclusion , plasma retinol levels of fifth of middle-aged European men place them at an approximately threefold RR of developing CHD . Thus the intake of vitamin A might be too low in middle-aged men . These findings must be confirmed",
"Objective : To study the relationship between the CD4 + cell response after initiation of protease inhibitors and the occurrence of opportunistic infections and survival . Design : Prospect i ve observational cohort study . Methods : HIV-1-seropositive subjects followed-up in HIV centres of Bordeaux University Hospital , Southwest France who were prescribed at least one available protease inhibitor between January and December 1996 were included in this analysis . A Cox model estimated the independent effect of baseline covariates and CD4 + cell response , considered as a time-dependent covariate , on the occurrence of new AIDS-defining opportunistic infection , new AIDS-defining events , new AIDS-defining opportunistic infection or death . Results : A total of 556 HIV-positive patients were prescribed at least one protease inhibitor : 34 % saquinavir , 52 % indinavir , and 14 % ritonavir . Median CD4 + cell count at baseline was 95 × 106/l and mean plasma HIV RNA was 5.0 log10 copies/ml . After a median follow-up of 230 days , 65 patients experienced a new episode of opportunistic infection , 79 patients experienced at least one AIDS-defining event , and 24 had died . On average , the increase in CD4 + cell count was 42 × 106/l ( SD , 74 ) after a median of 49 days . In the multivariate analysis of opportunistic infection or death , each 50 % higher CD4 + cell count at baseline was associated with a 23 % reduction [ 95 % confidence interval ( CI ) , 14–30 ] of risk . Each 50 % increase in CD4 + cell count during follow-up was associated with a 9 % reduction ( 95 % CI , 2–15 ) of risk , adjusted for the presence of AIDS prior to protease inhibitor therapy ( hazard ratio , 3.76 versus absence of AIDS ; P protease inhibitors might produce clinical stabilization . This result may be due to improved functionality of CD4 + cells in patients started on protease inhibitors "
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411714be-06ff-11f0-808a-c43d1ab1c353
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STUDY DESIGN Systematic review . OBJECTIVES The aim of this systematic review was to summarize and evaluate intra- and interrater reliability research of physical examination tests used for the assessment of scapular dyskinesis . BACKGROUND Scapular dyskinesis , defined as alteration of normal scapular kinematics , is described as a non-specific response to different shoulder pathologies . METHODS A systematic literature search was conducted in MEDLINE , EMBASE , AMED and PEDro until March 20th , 2015 . Method ological quality was assessed with the Quality Appraisal of Reliability Studies ( QAREL ) by two independent review ers . RESULTS The search strategy revealed 3259 articles , of which 15 met the inclusion criteria . These studies evaluated the reliability of 41 test and test variations used for the assessment of scapular dyskinesis . CONCLUSION This review identified a lack of high- quality studies evaluating intra- as well as interrater reliability of tests used for the assessment of scapular dyskinesis . In addition , reliability measures differed between included studies hindering proper cross- study comparisons . The effect of manual correction of the scapula on shoulder symptoms was evaluated in only one study , which is striking , since symptom alteration tests are used in routine care to guide further treatment . Thus , there is a strong need for further research in this area . LEVEL OF EVIDENCE Diagnosis , level 3a
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"Purpose To prospect ively identify preseason physical factors for shoulder and elbow injuries during the season in high school baseball pitchers . Methods The study included 105 high school baseball pitchers [ median age 16 ( 15–17 ) years ] . The range of motion of the shoulder ( 90 ° abducted external and internal rotation ) and elbow ( extension/flexion ) , shoulder muscle strength ( abduction and prone internal and external rotation ) , shoulder and elbow laxity , horizontal flexion , and scapular dyskinesis were assessed . After the season , the participants completed question naires regarding shoulder and /or elbow injuries , with injury defined as an inability to play for ≥1 week due to elbow/shoulder problems . The results of two groups ( injured and noninjured ) were compared using t tests and Chi-square analyses . Stepwise forward logistic regression models were developed to identify risk factors . Results Twenty-one injuries were observed . In univariate analysis , 90 ° abducted internal rotation and total arc of the dominant shoulder and the ratio of prone external rotation in the dominant to nondominant sides in the injured group were significantly less than those in the noninjured group ( P = 0.02 , 0.04 , and 0.01 , respectively ) . In logistic regression analysis , 90 ° abducted internal rotation in the dominant shoulder and prone external rotation ratio were significantly associated with injuries ( P = 0.02 and 0.03 , respectively ) . Conclusion A low prone external rotation ratio and decreased 90 ° abducted internal rotation in the dominant shoulder in the preseason were significant risk factors for shoulder and elbow injuries in high school baseball pitchers . The results may contribute to reduce the incidence of these injuries . Level of evidence II",
"OBJECTIVES To assess interobserver reproducibility ( agreement and reliability ) of visually estimated shoulder range of motion ( ROM ) and to study the influence of clinical characteristics on the reproducibility . DESIGN Test-retest analyses . SETTING Various health care setting s in the Netherl and s. PARTICIPANTS Consecutive patients with shoulder complaints ( N = 201 ) referred by 20 general practitioners , 2 orthopedic physicians , and 20 rheumatologists . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Independent visual estimation by 2 physiotherapists of the ROM . Agreement was calculated as the mean difference in visual estimation between examiners + /-1.96 x st and ard deviations of this mean difference . The intraclass correlation coefficient ( ICC ) was calculated as a measure of reliability , based on a 2-way r and om effects analysis of variance . RESULTS The lowest level of agreement was for visual estimation of active and passive elevation ( limits of agreement , -43.4 to 39.8 and -46.7 to 41.5 , respectively , for the difference between the affected and contralateral sides ) , for which the level of agreement was most clearly associated with pain severity and disability . The ability to differentiate between subjects was acceptable for all movements for the difference between the affected and contralateral sides ( ICCs , > .70 ) except for horizontal adduction ( ICC = .49 ) . CONCLUSIONS Interobserver agreement was low for the assessment of active and passive elevation , especially for patients with a high pain severity and disability . Except for horizontal adduction , visual estimation seems suitable for distinguishing differences between affected and contralateral ROM between subjects",
"Background Postural abnormality and muscle imbalance are thought to contribute to pain and a loss of normal function in the upper body . A shortened pectoralis minor muscle is commonly identified as part of this imbalance . Clinical tests have been recommended to test for shortening of this muscle . The aim of this study was to evaluate the intra-rater reliability and diagnostic accuracy of the pectoralis minor length test . Methods Measurements were made in 45 subjects with and 45 subjects without shoulder symptoms . Measurements were made with the subjects lying in supine . In this position the linear distance from the treatment table to the posterior aspect of the acromion was measured on two occasions ( separated by a minimum of 30 minutes and additional data collection on other subjects to reduce bias ) by one rater . The reliability of the measurements was analyzed using intraclass correlation coefficients ( ICC ) , 95 % confidence intervals ( CI ) and st and ard error of measurement ( SEM ) . The diagnostic accuracy of the test was investigated by determining the sensitivity , specificity , positive and negative likelihood ratios of the test against a ' gold st and ard ' reference . The assessor remained ' blinded ' to data input and the measurements were staggered to reduce examiner bias . Results The pectoralis minor length test was found to have excellent intra-rater reliability for dominant and non-dominant side of the subjects without symptoms , and for the painfree and painful side of the subjects with symptoms . The values calculated for the sensitivity , specificity , positive and negative likelihood ratios suggest this test performed in the manner investigated in this study and recommended in the literature , lacks diagnostic accuracy . Conclusion The findings of this study suggest that although the pectoralis minor length test demonstrates acceptable clinical reliability , its lack of specificity suggests that clinicians using this test to inform the clinical reasoning process with regard treatment planning must do so with caution .Trial registration National Research Register :",
"Background Decreased scapulothoracic motion has been associated with various pathologies of the shoulder . Reliable and simple assessment methods of scapular mobility are , however lacking . The aim of this study was to evaluate the interrater reliability of four clinical tests to assess scapulothoracic motion in patients with a slightly restricted shoulder flexion . Methods A total of nineteen patients with a symptomatic slight restriction of shoulder flexion and twenty asymptomatic subjects were evaluated . The investigation consisted of four palpatory tests to assess scapulothoracic motion . A two-level rating scale ( positive , negative ) was utilised . Interrater reliability was evaluated using kappa coefficients . Results We found substantial to almost perfect ( Kappa = 0.63 - 0.4 ) interrater reliability for the four tests . Conclusion Our study demonstrates that the four mobility tests of the shoulder are a reliable and simple instrument to assess patients with a slightly restricted shoulder flexion . Future studies should be conducted to evaluate the validity of these tests and to establish their clinical usefulness",
"OBJECTIVE The study investigated the effectiveness of stretching , strengthening exercises , and the scapular stabilization exercises on the pain , shoulder range of motion ( ROM ) , muscle strength , joint position sense ( JPS ) , scapular dyskinesis and quality of life ( OL ) in the patients with subacromial impingement syndrome ( SIS ) . METHODS 27 women and 13 men , mean age 51 ( 24 - 71 ) years old , were included in this study . All the patients were separated into 2 groups according to simple r and om table . Stretching and strengthening exercises were given to the group I ( n=20 ) and scapular stabilization exercises were added to the group II ( n=20 ) . The pain severity , shoulder ROM , muscle strength , JPS , lateral scapular slide test ( LSST ) , Western Ontario Rotator Cuff ( WORC ) Index were evaluated before and after treatment . Patients completed a 6-week rehabilitation program , three times a week . RESULTS The results showed that all measurements improved statistically in both groups after treatment ( p muscle strength , JPS and scapular dyskinesia were significantly different in group II ( p scapular stabilization exercises , given with stretching and strengthening exercises , can be more effective in increasing the muscle strength , developing the JPS and decreasing the scapular dyskinesis",
"HYPOTHESIS AND BACKGROUND Though commonly suggested as an injury risk factor , scapular dysfunction has not been established as a prospect i ve cause of throwing-related upper extremity injury in baseball players . The purpose is to determine whether scapular dysfunction identified during preseason screening is predictive of increased risk of throwing-related shoulder and elbow injuries in high school baseball players . MATERIAL S AND METHODS The presence or absence of scapular dysfunction was obtained prospect ively during preseason screenings in 246 high school baseball players over the 2010 and 2011 seasons . Exposure and injury surveillance data were then obtained weekly over the course of each season to determine whether scapular dysfunction was predictive of subsequent throwing-related upper extremities sustained . RESULTS There were 12 throwing-related upper extremity injuries sustained in the 246 participants , yielding an injury rate of 1.0 per 1,000 athlete exposures . There were no significant differences in injury rates between the participants with normal scapular function versus subtle scapular dysfunction ( P = .62 ) , normal scapular function versus obvious scapular dysfunction ( P = .26 ) , or subtle versus obvious scapular dysfunction ( P = .45 ) . CONCLUSION This study showed that scapular dysfunction identified during preseason screenings is not associated with subsequent throwing-related upper extremity injury",
"STUDY DESIGN Prospect i ve , blinded interrater reliability study . OBJECTIVE To determine the interrater reliability of the modified Scapular Assistance Test ( mSAT ) with and without the use of additional h and held weights . METHODS 110 Shoulder patients with various shoulder pathologies were consecutively recruited . Tests were performed independently and r and omly on each participant by 2 different examiners , which were blinded to further clinical information ( e.g. patient history , former diagnostic results ) . Percent agreement , Cohen 's kappa ( Κ ) , proportion of positive/negative agreement , maximum Κ , prevalence and bias indexes and prevalence-adjusted-bias-adjusted kappa ( PABAK ) were calculated as estimates of interrater reliability of the mSAT with and without additional h and held weights . Weights were chosen according to body weight . RESULTS The reliability measures for the mSAT ( Cohen 's Κ : 0.68 , confidence interval ( CI ) : 0.51 - 0.85 ; PABAK : 0.78 , CI : 0.67 - 0.90 ) as well as for the mSAT with h and held weights ( Cohen 's Κ : 0.63 , CI : 0.44 - 0.81 ; PABAK : 0.76 , CI : 0.64 - 0.88 ) showed substantial agreement according to the classification system proposed by L and is and Koch . CONCLUSIONS Based on the results of this study , the mSAT with and without additional weights can be considered as reliable for clinical use . Since both tests showed substantial agreement , the use of additional h and held weights might not be necessary in case of obvious scapula dyskinesis . However , to perform the mSAT with/without additional weights should depend not only on its reliability values . Name of the public trials registry and the registration number : German Clinical Trials Register , protocol number DRKS00005377",
"Background Altered muscle activity in the scapular muscles is commonly believed to be a factor contributing to shoulder impingement syndrome . However , one important measure of the muscular coordination in the scapular muscles , the timing of the temporal recruitment pattern , is undetermined . Purpose To evaluate the timing of trapezius muscle activity in response to an unexpected arm movement in athletes with impingement and in normal control subjects . Study Design Prospect i ve cohort study . Methods Muscle latency times were measured in all three parts of the trapezius muscle and in the middle deltoid muscle of 39 “ overh and athletes ” with shoulder impingement and compared with that of 30 overh and athletes with no impingement during a sudden downward falling movement of the arm . Results There were significant differences in the relative muscle latency times between the impingement and the control group subjects . Those with impingement showed a delay in muscle activation of the middle and lower trapezius muscle . Conclusion The results of this study indicate that overh and athletes with impingement symptoms show abnormal muscle recruitment timing in the trapezius muscle . The findings support the theory that impingement of the shoulder may be related to delayed onset of contraction in the middle and lower parts of the trapezius muscle",
"OBJECTIVE To examine the interobserver reliability , internal consistency , and clinical importance of 3 clinical tests for the assessment of scapular positioning in patients with shoulder pain . DESIGN Prospect i ve repeated- measures design . SETTING Private practice s for physical therapy and hospital outpatient physical therapy divisions . PARTICIPANTS Twenty-nine patients with shoulder pain who were diagnosed by a physician as having a shoulder disorder . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Study participants filled in a visual analog scale for pain and the Shoulder Disability Question naire . Next , 2 assessors performed the following tests : measurement of the distance between the posterior border of the acromion and the table , measurement of the distance from the medial scapular border to the fourth thoracic spinous processes , and the lateral scapular slide test . RESULTS The interobserver reliability coefficients were greater than .88 ( intraclass correlation coefficients ) for the measurement of the distance between the posterior border of the acromion and the table , were greater than .50 for the measurement of the distance from the medial scapular border to the fourth thoracic spinous processes , and were greater than .70 for the lateral scapular slide test . The Cronbach alpha coefficient for internal consistency for all tests was .88 . No associations between the outcome of the tests and self-reported pain severity or disability were found . CONCLUSIONS These data provide evidence favoring the interobserver reliability of 2 of 3 tests for the assessment of scapular positioning in patients with shoulder pain . The clinical importance of the tests ' outcomes , however , is question able"
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This report presents the results of a systematic review of the effectiveness of worksite nutrition and physical activity programs to promote healthy weight among employees . These results form the basis for the recommendation by the Task Force on Community Preventive Services on the use of these interventions . Weight-related outcomes , including weight in pounds or kilograms , BMI , and percentage body fat were used to assess effectiveness of these programs . This review found that worksite nutrition and physical activity programs achieve modest improvements in employee weight status at the 6 - 12-month follow-up . A pooled effect estimate of -2.8 pounds ( 95 % CI=-4.6 , -1.0 ) was found based on nine RCTs , and a decrease in BMI of -0.5 ( 95 % CI=-0.8 , -0.2 ) was found based on six RCTs . The findings appear to be applicable to both male and female employees , across a range of worksite setting s. Most of the studies combined informational and behavioral strategies to influence diet and physical activity ; fewer studies modified the work environment ( e.g. , cafeteria , exercise facilities ) to promote healthy choices . Information about other effects , barriers to implementation , cost and cost effectiveness of interventions , and research gaps are also presented in this article . The findings of this systematic review can help inform decisions of employers , planners , research ers , and other public health decision makers
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"To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results",
"Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design",
"Background . Worksite wellness programs vary considerably in their design . This study tested four models to compare effectiveness at controlling high blood pressure , obesity , and cigarette smoking . Methods . Baseline screening was conducted in four manufacturing plants . Site 1 offered screening only , with referral recommendations for those found to have CVD risks . Site 2 also provided health education information and classes . Site 3 added routine follow-up counseling and a menu of intervention types , and Site 4 added social organization within the plant . R and om sample s of 400 to 500 employees were rescreened at the end of three years . Results . Major improvements in risk levels were found with the addition of routine follow-up counseling and a menu of interventions ( Sites 3 and 4 , compared with Sites 1 and 2 ) . More hypertensives entered treatment and showed greater reductions in blood pressure . Participation in worksite weight loss and smoking cessation programs was significantly increased , and those who participated showed significantly better maintenance of improvements where follow-up was provided . Discussion . The program models that offered short-term interventions promoted through local media suffered in comparison with models that included personal outreach to people at risk , a variety of health improvement intervention modalities , and ongoing follow-up counseling to help people make decisions and sustain health improvements",
" Middle-aged people with a serum total cholesterol of more than 220 mg/dl at the latest health examination ( n=197 ) at a chemical company were invited to join a health education program for 6 months . Participants meeting inclusion criteria were r and omly assigned to an intervention ( n=96 ) and a control group ( n=92 ) . Periodical interviews and blood tests were performed every 2 months for both groups . The intervention group was educated by health professionals in the factories through programs developed for hypercholesterolemia . After a 6-month intervention , the reduction of cholesterol levels and the differences between the groups were analysed . The mean total cholesterol ( TCH ) levels at the baseline measurement were 239.7 mg/dl in the intervention group and 236.5 mg/dl in the control group . During the intervention period , decreased levels of TCH were 27.1 mg/dl for the intervention group and 18.5 mg/dl for the control group . Declines in body weight , TCH and triglyceride levels in the intervention group were significantly larger than those in the control group . The decline of apoprotein-B was also significantly larger in the intervention group while high-density lipoprotein cholesterol levels essentially did not change . The health education by health professionals proved to be useful in reducing the risk factor levels for coronary heart disease . These results suggest that health education would also be useful against other major risk factors in cardiovascular diseases",
"BACKGROUND Physical inactivity and obesity are major public health problems . Our objective was to investigate the effectiveness of an individual counseling intervention at the workplace on physical activity fitness and health . Counseling content derived from the Patient-centered Assessment and Counseling for Exercise and Nutrition ( PACE ) program . METHODS A total of 299 employees of three municipal services in the Dutch town of Enschede were r and omly allocated into intervention ( n = 131 ) and control group ( n = 168 ) . Over a 9-month period , intervention group subjects were offered seven counseling sessions . Counseling was based on the individual 's stage of behavioral change using PACE physical activity and nutrition protocol s. Subjects in both the intervention and control group received written information about several lifestyle factors . Primary outcome measures were physical activity ( total energy expenditure , during sports activities , during physical activity leisure time other than sports , and meeting the moderate-intensity public health recommendations ) ; cardiorespiratory fitness ; and prevalence of musculoskeletal symptoms . Secondary outcome measures were body composition ( body mass index [ BMI ] , and percentage of body fat measured via skinfold thicknesses ) ; blood pressure ; and blood cholesterol . RESULTS There were significant positive effects on total energy expenditure , physical activity during sports , cardiorespiratory fitness , percentage of body fat , and blood cholesterol . No effects were found for the proportion of subjects meeting the public health recommendation of moderate-intensity physical activity , physical activity during leisure time other than sports , prevalence of musculoskeletal symptoms , body mass index , and blood pressure . CONCLUSIONS Individual face-to-face counseling at the workplace based on PACE protocol s positively influenced physical activity levels and some components of physical fitness . The implementation of workplace counseling programs for individuals should therefore be promoted",
"OBJECTIVE The effects and constancy of a worksite physical exercise intervention were examined in relation to the physical fitness , perceived health status , and work ability of female service workers during periods of 1 and 5 years . METHODS The subjects comprised female home care workers divided into an intervention group ( n = 50 , mean age 41.8 ( SD 10.4 ) years ) and a control group ( n = 37 , mean age 43.3 ( SD 8.8 ) years ) . The intervention group participated in 9 months of supervised exercise intervention twice a week during the workday . Functional capacity , perceived health , and work ability were assessed at the beginning of the study and after a 1- and a 5-year period of follow-up . RESULTS In the 1-year follow-up measurements , body fat had decreased ( 4 % ) and dynamic muscle performance and maximal oxygen consumption in relation to body mass ( 30 - 38 and 7 % , respectively ) had increased in the intervention group . The differences in outcome variables between the intervention and the control groups were significant ( from P = 0.014 to P worksite exercise were observed despite the age of the subjects , and the changes were consistent during a 5-year period . In the control group the decline of the work ability index ( L smean ) was about three times faster than in the intervention group during the 5-year period . CONCLUSIONS Physical exercise executed in work units can be used to improve the physical capacity of female home care aides and prevent the early decline of their work ability . In jobs that are physically dem and ing , such as home care work , early prevention must start before the age-related deterioration of health and physical capacity",
"Three consecutive studies of weight reduction at the work site were conducted with 172 female union members , who participated in 16-week behavioral group programs . There was no significant difference in weight loss over the three studies , but attrition decreased from 57.5 % to 33.8 % and weight loss maintenance improved . Groups that met three to four times weekly had less attrition than those which met once a week , but had no more weight loss . These behavioral weight reduction programs were as effective as self-help and commercial groups , and lay leaders produced results equivalent to those produced by professional therapists at one-third the cost",
"OBJECTIVES This study tested a feasible method for screening for cardiovascular risk at the worksite and investigated the effects of a long-term comprehensive program of life-style intervention to prevent cardiovascular disease . METHODS Employees in the public sector filled out a self-administered question naire with questions on social , medical , and work-related factors . The respondents numbered 454 ( 80 % ) . A score sum for cardiovascular risk was calculated ( range 1 - 20 , median 7.0 ) , and the 128 subjects with a sum above 8 were invited to a health examination including blood sampling . Thereafter the subjects were invited to participate , following r and omization , in a comprehensive , 18-month , life-style intervention program to improve cardiovascular risk or in a control group . RESULTS The intervention group significantly decreased body mass index , diastolic blood pressure , heart rate , low-density lipoprotein ( LDL ) cholesterol , and smoking habits during the intervention . The initially elevated serum cortisol , as a marker of stress reaction , normalized in the intervention group . In the control group LDL cholesterol also decreased , but the glucose and triglyceride levels increased , and smoking habits were unchanged . Sick days for a given period decreased after 1 year in the intervention group but not in the control group . CONCLUSIONS Several cardiovascular risk factors can be improved and morning serum cortisol normalized during a long-term life-style intervention program with a r and omized design using a worksite population of middle-aged subjects . The use of a 2-step screening program , with an initial question naire followed by a health check of subjects with elevated risk , is feasible for worksite setting",
"Methods of effective cardiovascular risk reduction that are suitable for use in clinical setting s are needed . Several behavioral interventions were design ed to be compatible with office-based medical practice , to be delivered by paraprofessional counselors , and to be of low intensity and low cost . Eighty-three hypercholesterolemic volunteers were assigned to one of three experimental conditions ( face-to-face counseling , mail and telephone counseling , initial session only ) . Twenty-six nonr and omized subjects served as a no-contact group and were followed for 1 year . Participants in the first three groups received risk factor education , behavioral recommendations , and a packet of material s , while those in the face-to-face and mail/telephone counseling groups were contacted for five brief follow-up sessions over a 4-month period . At the 1-year follow-up evaluation , subjects in the face-to-face and mail/telephone counseling conditions showed decreases in plasma cholesterol of 6.2 and 4.6 % , respectively ( P less than 0.01 ) , while the other two groups evidence d small increases . There were no differences by condition for plasma triglycerides , systolic or diastolic blood pressure , or weight . Low-intensity , low-cost behavioral interventions delivered by paraprofessionals can produce long-term decreases in a major cardiovascular risk factor . Physicians are encouraged to incorporate similar interventions into their practice",
"Seventy-five persons ( 57 male and 18 female ) with a high risk of coronary heart disease ( CHD ) were r and omly assigned in equal numbers to three 8-week behavioral treatment programs . All three treatments were design ed to alter simultaneously a number of risk-elevating behavior patterns , in the expectation that change in any one behavior pattern would reinforce change in others . Weight , blood pressure , and aerobic fitness were regularly assessed in all subjects . Serum lipids were also measured , but less frequently . All three interventions produced significant beneficial changes in the major objective measures , and the changes were well maintained after 12 months . The most improved group exhibited the following mean changes : weight loss of 9.2 kg , reductions in blood pressure of 12.9/8.8 mm Hg , improvement in aerobic capacity of 33 % , reduction in serum cholesterol of 0.45 mmol/liter , and reduction in current overall CHD risk of 41 % . The effectiveness of the interventions was positively related to the degree to which the programs emphasized training in , and detailed application of , behavioral change principles",
"The aim of the present controlled study was to evaluate the effect of a general fitness program , performed by an occupational health service , using pre-post assessment for a number of different outcome measures . A total of 160 employees working in the central home care service district of Umeå , Sweden were asked to participate in a program of a 1-year long exercise program . Of the 160 selected , 54 subjects declined to participate and nine subjects were rejected after a medical check up . The remaining 97 subjects participated in a schedule consisting of pre-post medical and physiotherapy examinations , question naires concerning sociodemography , musculoskeletal and general health complaints and work environment , physiological tests of cardiovascular fitness , and of strength and endurance of shoulder flexors and knee extensors , and registration of sick leave . The subjects were r and omly assigned to an exercise ( treatment ) or control group . The exercise group trained twice a week for 1 year using a mixed program including exercises for coordination , strength/endurance , and fitness . The test schedule was repeated for both groups after 1 year . The exercise intervention was associated with positive changes in prevalence and intensity of musculoskeletal and psychosomatic complaints , better physiotherapy status ( less muscle tightness , better neck mobility , and less tender points ) , increased shoulder strength and increased coordination in thigh muscles . However , the exercise group reported worse situations post-exercise concerning aspects of their physical and psychosocial work-environment ( i.e. , concerning ergonomy , influence , appreciation and communication with work manager ) , which might have been due to stress associated with the exercise situation",
"It was the purpose of this investigation to examine the influence of a worksite aerobic training program on serum lipid and lipoproteins and cardiovascular fitness in female employees . Thirty-seven healthy but previously untrained , female employees ( Ss ) from Westinghouse Corporation , ( College Station , Texas ) volunteered for the study . Ss were r and omly assigned to either an exercise group ( Ex ) ( n = 20 ) or control group ( C ) ( n = 17 ) . Prior to training ( PRE ) and following training ( POST ) , all Ss were measured for weight ( WT ) , body composition ( % FAT ) and tested for maximal oxygen consumption ( VO2 max ) . PRE and POST Lipid analysis included : total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDL-C ) , low-density lipoprotein cholesterol ( LDL-C ) , very low-density lipoprotein cholesterol ( VLDL-C ) , and triglycerides ( TG ) . Following PRE testing , the Ex group aerobically trained by walking , jogging and /or cycling , at least 3 days per wk for 24 wks . Exercise training result ed in an improvement in VO2 max ( p Ex ( p in % -FAT ( p TC ( p LDL-C ( p VLDL-C or TG . Although HDL-C increased 6 mg/dl in the Ex group but not in C , this difference did not reach statistical significance ( p improves cardiovascular fitness without altering lipids or lipoproteins",
"This study evaluated the long-term effects of the NASA/Johnson Space Center Health Related Fitness Program ( HRFP ) which includes a 12-week educational component ( EC ) and quarterly fitness retests ( RT ) . The groups studied were : Compliers ( completed EC and greater than or equal to 75 % of RT , N = 64 ) ; Non-compliers ( completed EC but less than 75 % of RT , N = 106 ) ; Drop-outs ( disenrolled from EC , N = 36 ) and Controls ( r and omly selected from eligible program pool , N = 52 ) . Pretest medical examination and maximum stress test data showed the groups did not differ on age , % fat , weight , blood lipids , and VO2max ( p greater than 0.05 ) . Multivariate analysis of pre- and posttest change data greater than or equal to 2 years from start showed group differences in blood lipids , body composition and VO2max . Results showed that changes in physical activity were related to program completion and periodic fitness reevaluations , and that these group-related changes were associated with changes in VO2max , percent body fat , body weight , and blood lipids",
"OBJECTIVE : To evaluate prospect ively the influence of habitual physical activity on body weight of men and women and to develop a model that defines the role of physical activity on longitudinal weight change . DESIGN AND SETTING : Occupational cohort study conducted for a mean of 5.5 y . SUBJECTS : A total of 496 ( 341 male and 155 female ) NASA/Johnson Space Center employees who completed the 3 month education component of the employee health-related fitness program and remained involved for a minimum of 2 y. MEASUREMENTS : Body weights were measured at baseline ( T1 ) and follow-up ( T2 ) , and habitual physical activity was obtained from the mean of multiple ratings of the 11-point ( 0–10 ) NASA Activity Scale ( NAS ) recorded quarterly between T1 and T2 . Other measures included age , gender , VO2 max obtained from maximal treadmill testing , body mass index ( BMI ) , and body fat percentage . RESULTS : Multiple regression demonstrated that mean NAS , T1 weight , aging and gender all influence long-term T2 weight . T1 age was significant for the men only . Independently , each increase in mean NAS significantly ( P reduced T2 weight in men ( b=−0.91 kg ; 95 % CI:−1.4 to−0.42 kg ) and women ( b=−2.14 kg ; 95 % CI:−2.93 to−1.35 kg ) . Mean NAS had a greater effect on T2 weight as T1 weight increased , and the relationship was dose-dependent . CONCLUSIONS : Habitual physical activity is a significant source of long-term weight change . The use of self-reported activity level is helpful in predicting long-term weight changes and may be used by health care professionals when counseling patients about the value of physical activity for weight control",
"A prospect i ve longitudinal study of a group of participants in an industrial physical fitness program during a five-year period compares the disability and major medical costs incurred by the subjects before and after entry into the program . The members of the cohort were employees of an insurance company ; most were well educated and held sedentary , white-collar jobs . Participation was voluntary and without financial incentives . The group experienced 45.7 % reduction in major medical costs in the postentry year , rather than the expected inflationary increase . There was a reduction of 20.1 % in the average number of disability days , and a 31.7 % reduction in direct disability dollar costs in the one-year postentry period . The average combined savings per participant were $ 353.38 ; the average operational cost was $ 120.60 . Results suggest that work-site wellness programs can make a substantial contribution to the reduction of health care and disability costs",
"Eighty management-level male employees participated in a company-sponsored comprehensive physical that included determination of plasma total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and triglyceride levels and percentage of body fat . After the lipid screening , each employee met with a registered dietitian who explained the results of the lipid analysis and discussed risk factors for coronary heart disease with an emphasis on diet . Seventy employees had a triglyceride level above 5.17 mmol/L and were invited to participate in a nutrition education program . Thirty-three ( mean age = 44 years ) chose to participate ( intervention group ) ; the other 37 ( mean age = 35 years ) served as controls ( control group ) . Thus , the design of the study was not r and om . All subjects completed 3-day dietary records before and after the nutrition education program . Nutrition intervention consisted of ( a ) individualized instruction about the step 1 diet ; ( b ) group sessions ( 1 hour every 3 months ) on eating out , dietary fiber , and maintaining heart healthy behaviors ; and ( c ) individualized follow-up by telephone ( one call per month ) . The results of the year-long program revealed that men in the intervention group decreased dietary intake of energy ( 2,546 + /- 162 kcal to 2,246 + /- 125 kcal ) and cholesterol ( 444 + /- 5.3 mg to 304 + /- 1.6 mg ) and percentage of energy from total fat ( 38 + /- 3.4 % to 31 + /- 2.6 % ) and protein ( 24 + /- 3.5 % to 20 + /- 2.2 % ) . Their consumption of carbohydrate and dietary fiber increased ( 38 + /- 2.1 % to 45 + /- 2.5 % and 8.0 + /- 2.3 g to 23.0 + /- 3.5 g , respectively ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Objective : This study determined the behavioral and clinical impact of a worksite chronic disease prevention program . Methods : Working adults participated in r and omized clinical trial of an intensive lifestyle intervention . Nutrition and physical activity behavior and several chronic disease risk factors were assessed at baseline , 6 weeks , and 6 months . Results : Cognitive underst and ing of the requirements for a healthy lifestyle increased at the end of the program . Program participants significantly improved their cognitive underst and ing of good nutrition and physical activity and had significantly better nutrition and physical activity behavior at both 6 weeks and 6 months . Participants had significantly lower body fat , blood pressure , and cholesterol . Conclusions : This worksite chronic disease prevention program can significantly increase health knowledge , can improve nutrition and physical activity , and can improve many employee health risks in the short term",
"BACKGROUND The long-term effectiveness of multicomponent worksite health promotion programs targeting cardiovascular disease risk factors remains unclear in Japan . This study was conducted to evaluate the effectiveness of such a health promotion program consisting of a main program provided over 4 days and a follow-up program provided over 1 year . METHODS The subjects of this r and omized controlled trial were male employees working for a building maintenance company in Japan . The intervention group ( n = 152 ) and the control group ( n = 150 ) consisted of employees having abnormal findings in at least one of the following items at baseline health examination : body mass index ( BMI ) , systolic ( SBP ) or diastolic blood pressure , total cholesterol , HDL cholesterol , triglycerides , and fasting blood glucose . Evaluation was conducted at 18 months after the main program . RESULTS BMI , SBP , total cholesterol , and triglycerides improved significantly in the intervention group compared with the control group ( P BMI , total cholesterol , and triglycerides improved significantly in the intervention group ( P multicomponent health promotion program provided to employees was shown to be effective in improving obesity , high blood pressure , and hyperlipidemia when evaluated 18 months after the main intervention program",
"Many have studied the effects of different lifestyles on disease , mortality or risk factors for a disease , but little is known about how behaviour is changed in the population . We studied the need for counselling and its effect on willingness and ability to change lifestyle , and subsequent changes in CHD risk factors . All 152 male employees in a computer company , 25 - 45 years of age , were invited to participate . Subjects were r and omized into an intervention group ( I-group ) and a control group . The I-group was divided into subgroups based on baseline behaviour and risk factor status . Changes were evaluated after 1 year . After an initial health examination , participants from the I-group were counselled at baseline and after 5 months . Eighty-five ( 56 % ) males participated . Twenty-nine were assigned to a control group and 56 to an intervention group ( I-group ) ( dropout = 8) . An exercise group ( E-group ) was advised to exercise aerobically three times/week , a diet group to reduce the intake of saturated fat and increase fish products , and smokers to quit smoking . Forty subjects were recommended one or more behavioural changes and eight had no need . Thirty-four were willing to make behavioural changes . Compared to the control group , the fitness level increased ( P body weight decreased in the I-group ( P CHD risk factors . The diet- and smoking counselling models were less successful in terms of adherence",
"The study purpose was to determine whether group intervention or an individual self help program proved to be more effective at lowering heart disease risk factors among employees in different worksites . Eight worksites and 502 employees in the Denver metropolitan area were selected for the project , with four r and omized to Usual Care and four to the Special Intervention . Most worksites had Employees were r and omly assigned to either a control group receiving usual nutrition education or one of two special intervention groups in which employees selected to attend group nutrition education classes or complete an individual self paced nutrition education program . Results indicated that offering a choice of methods for the special nutrition education intervention was valuable , and both approaches modified behavior and certain physiological outcomes . Results suggested that enhanced nutrition education efforts in worksites may be effective and will realize greater benefits than a pamphlet or brief discussion following a worksite screening",
"BACKGROUND Worksites are considered to be a key channel for the delivery of interventions to prevent cardiovascular disease . The aim of this study was to evaluate the effect on the blood cholesterol levels of an intervention program offered by an occupational health service . METHODS The intervention group consisted of 95 employees and the reference group consisted of 74 employees , in all , 169 subjects , with a serum cholesterol > or = 5.2 mmol/l . Both groups completed a st and ardized question naire . Occupational health nurses carried out the blood sampling before and after the program . The intervention group was then offered counseling on physical activity and a dietician offered individual counseling on healthy food habits . The reference group was not the subject of the intervention program . RESULTS The mean cholesterol level decreased by 0.3 mmol/l ( 5 % ) in the intervention group and for the men the decrease was 0.5 mmol/l , while the mean level of the reference group was unchanged . Furthermore , there was a nonsignificant decrease of the mean triglyceride level in the intervention group . CONCLUSION The results of this controlled trial indicates that risk factors for cardiovascular disease can be reduced by interventions at the worksite . Even modest reductions of cholesterol levels may reduce the risk to a tangible degree",
"This paper reports the evaluation of a pilot health promotion initiative among hospital staff . Health screening and advice were available during one week . Staff who attended completed a question naire about diet , alcohol , exercise , smoking , stress and health perceptions . They were r and omly assigned to receive advice and set targets for changing their lifestyle or simply to be given their results . A sample of non-attending staff was sent the same question naire . Attenders were invited to return after six months . Of the 297 staff who attended the first session , 83 returned after six months . Of the non-attending staff , 192 returned a question naire . Attenders were older , more concerned and more knowledgeable about their health and under-represented by clinical and manual staff . Weight , exercise frequency and perceptions of health were related to the likelihood of re-attending . Those in the ' advice ' group were more likely to lose weight and increase their exercise . It is difficult to achieve wide participation in health promotion activities but a simple intervention can have useful effects",
"In a work-site weight control program using a self-motivational program of financial incentives implemented through payroll deduction , 131 university employees chose weight loss goals ( 0 to 60 lb ) and incentives ( + 5 to + 30 ) to be deducted from each paycheck for six months . Return of incentive money was contingent on progress toward weight goals . Participants were assigned r and omly to one of four protocol s , involving group educational sessions v self-instruction only and required v optional attendance at weigh-ins and sessions . Overall , dropout rates ( 21.4 % ) and mean weight loss ( 12.2 lb ) were encouraging , especially compared with those of other work-site programs . Weight loss was positively associated with attendance at weigh-ins and educational sessions . However , requiring attendance did not increase program effectiveness and seemed also to discourage enrollment among men . The weight control program was equally effective when offered with professionally led educational sessions or when accompanied by self-instructional material s only",
"Three weight loss competitions were held in business/industrial setting s. One competition was between three banks ; the other two were within industries , either between employee teams selected at r and om or between divisions of the industry . Attrition in the competitions was less than 1 per cent and weight loss averaged 5.5 kg . Both employees and management reported positive changes in morale and employee/management relations , and both considered the competition important to the success of the program . The cost-effectiveness ratio ( $ 2.93 per 1 per cent reduction in percentage overweight ) is the best yet reported",
"OBJECTIVES A r and omized trial was conducted to evaluate the effectiveness of a work-site health promotion program in reducing obesity and the prevalence of cigarette smoking . METHODS Thirty-two work sites were r and omized to treatment or no treatment for 2 years . Treatment consisted of health education classes combined with a payroll-based incentive system . Evaluation was based on cohort and cross-sectional surveys . RESULTS Of 10,000 total employees in treatment work sites , 2041 and 270 participated in weight control and smoking cessation programs , respectively . Weight losses averaged 4.8 lbs , and 43 % of smoking participants quit . Net 2-year reductions in smoking prevalence in treatment vs control work sites were 4.0 % and 2.1 % in cross-sectional and cohort surveys , respectively . No treatment effect was found for weight . Treatment effects for smoking prevalence and weight were both positively correlated with participation rates in the intervention programs ( r = .45 for smoking and r = .55 for weight ) . CONCLUSIONS This work-site health promotion program was effective in reducing smoking prevalence at a cost that is believed to make the investment worthwhile",
"OBJECTIVES This study reports an efficacy trial of four work-site health promotion programs . It was predicted that strategies making use of behavioral counseling would produce a greater reduction in cardiovascular disease risk factors than screening and educational strategies . METHODS Twenty-eight work sites were r and omly allocated to a health risk assessment , risk factor education , behavioral counseling , or behavioral counseling plus incentives intervention . Participants were assessed before the intervention and at 3 , 6 , and 12 months . RESULTS Compared with the average of the health risk assessment and risk factor education conditions , there were significantly higher vali date d continuous smoking cessation rates and smaller increases in body mass index and estimated percentage of body fat in the two behavioral counseling conditions . The behavioral counseling condition was associated with a greater reduction in mean blood pressure than was the behavioral counseling plus incentives condition . On average among all groups , there was a short-term increase in aerobic capacity followed by a return to baseline levels . CONCLUSIONS Work-site interventions that use behavioral approaches can produce lasting changes in some cardiovascular risk factors and , if implemented routinely , can have a significant public health impact",
"OBJECTIVES The Staff Healthy Heart Project was established to run a work-site cholesterol screening project and a r and omized controlled trial of dietary interventions . METHODS Screening was offered to all staff at six Australian hospitals . Participants with blood cholesterol of 5.2 mmol/L ( 200 mg/dL ) or above were r and omly allocated to receive screening only ( control group ) , a self-help package , or a nutrition course . Participants were seen 3 and 6 months after intervention to measure blood cholesterol and dietary changes . RESULTS Eighty percent of available staff ( n = 2638 ) were screened . Of those eligible , 67 % ( n = 683 ) entered the trial . Follow-up measures of blood cholesterol and dietary intake were obtained for 63 % and 38 % of trial participants , respectively . A reduction in reported dietary fat was found for all groups , but there were no significant differences between groups . Reported dietary fiber rose by 0.6 g/MJ/day for those in the nutrition course . There were no changes in total blood or high-density lipoprotein cholesterol . CONCLUSIONS Cholesterol reduction was not demonstrated , but this result is difficult to interpret given the poor ongoing participation rates . Strategies to improve ongoing participation in work-site projects are needed to achieve adequate assessment of dietary interventions used in cholesterol screening",
"Under experimental clinical conditions diet modification has been shown to reduce serum cholesterol levels . This paper reports such a positive response to a nonpharmacologic , behavioral education program at the worksite . Employees at the New York Telephone Company corporate headquarters were assigned r and omly to treatment and control groups . Treatment consisted of an 8-week group cholesterol reduction program conducted during employee lunch hours . It comprised a multiple-treatment approach -- food behavior change techniques combined with nutrition education , physical activity planning , and self-management skills . The treatment group showed substantial change compared with the control group at the program 's completion . Those treated displayed a significant 6.4 % reduction in total serum cholesterol ( 266 mg% average at baseline ) as compared with control subjects with a corresponding decrease in high-density lipoprotein levels . A significant increase in nutrition knowledge and moderate weight loss were also documented for this group . The magnitudes of a participant 's baseline serum cholesterol level and his/her reduction in percentage of ideal body weight were positively and independently correlated with percentage changes in serum cholesterol levels . Over the same period , decreases in high-density lipoprotein levels and no changes in serum cholesterol , weight , and nutrition knowledge were observed for the control group . Overall , participants in the treatment program successfully reduced the coronary heart disease risk factors of elevated cholesterol and weight . Directions for future study are suggested",
"OBJECTIVE To assess efficacy of 2 worksite health promotion interventions . METHODS R and omly assign 3 fire stations to ( a ) team-based curriculum , ( b ) individual counselor meetings , and ( c ) control . RESULTS Both interventions were feasible and acceptable , and they result ed in significant reductions in LDL cholesterol . The team approach significantly increased coworker cohesion , personal exercise habits , and coworkers ' healthy behaviors . The one-on-one strategy significantly increased dietary self-monitoring , decreased fat intake , and reduced depressed feelings . CONCLUSIONS Although both interventions promoted healthy behaviors , specific outcomes differed and reflected their conceptual underpinnings . The team-based curriculum is innovative and may enlist influences not accessed with individual formats",
"The need to provide nutritional information in the behavioral treatment of obesity is now generally recognized . However , the comparative efficacy of various delivery modes remains to be demonstrated . Two commercial software packages ( The Eating Machine and EATS ) were embedded in Ferguson 's ( 1975 ) prototypical behavioral program and contrasted with the Ferguson approach deployed alone . Assessment s of weight , nutritional knowledge , eating behavior , and related cognitive variables were made at pretest , posttest , 1-month follow-up and 6-month follow-up occasions . No incremental effects attributable to the software programs appeared"
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Abstract The aim of the study was to assess the effect of timing of preoperative surgical antibiotic prophylaxis ( SAP ) on surgical site infection ( SSI ) and compare the different timing intervals . The benefit of routine use of SAP prior to surgery has long been recognized . However , the optimal timing has not been defined . For the purpose of developing recommendations for the World Health Organization guideline for SSI prevention , a systematic review and meta- analysis of all relevant evidence was conducted . Major medical data bases were search ed from 1990 to 2016 . The primary outcome was SSI after preoperative-SAP comparing different timing intervals . Adjusted odds ratios ( OR ) with 95 % confidence intervals ( CI ) were extracted and pooled for each comparison with a r and om effects model . Fourteen papers with 54,552 patients were included in this review . In a quantitative analysis , there was no significant difference when SAP was administered 120–60 minutes prior to incision compared to administration 60–0 minutes prior to incision . Studies investigating different timing intervals within the last 60 minutes time frame reported contradictive results . The risk of SSI almost doubled when SAP was administered after first incision ( OR:1.89 ; 95%CI:[1.05–3.40 ] ) and was 5 times higher when administered more than 120 minutes prior to incision ( OR5.26 ; 95%CI:[3.29–8.39 ] ) . Administration of antibiotic prophylaxis more than 120 minutes before incision or after incision is associated a higher risk of surgical site infections than administration less than 120 minutes before incision . Within this 120-minute time frame prior to incision , no differential effects could be identified . The broadly accepted recommendation to administer prophylaxis within a 60-minute time frame prior to incision could not be substantiated
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"We determined the intraoperative serum and wound-muscle concentrations of cefazolin and cefoxitin in 40 patients who were undergoing cholecystectomies . The study employed an open-label design in which all of the patients r and omly received cefazolin sodium ( 20 mg/kg ) or cefoxitin sodium ( 30 mg/kg ) intravenously while the patient was in the ward ( \" on call \" ) or with the induction of anesthesia . Multiple blood and wound-muscle sample s were collected intraoperatively and assayed for their cephalosporin concentrations . Considerable differences in intraoperative serum and tissue concentrations between antibiotics were apparent ; there were usually higher levels of cefazolin . In all of the patients who received cefazolin sodium , the antimicrobial was detectable in wound tissue at wound closure , while it was detectable in 86 % and 38 % of patients who received cefoxitin sodium with anesthesia and on call , respectively . Because cefoxitin has a much shorter elimination half-life than cefazolin it seems prudent to administer the agent as close to the start of the operation as possible , and readminister the agent every two to three hours until the wound is closed . For cefazolin , on-call administration appears to be acceptable , with readministration not required for at least four hours",
"A prospect i ve , double-blind study comparing a 6 day with a 2 day regimen of cephalothin prophylaxis was conducted among 200 patients undergoing prosthetic valve replacement . No cases of endocarditis occurred during the 2 month follow-up . Sternal wound infection developed in 2.8 per cent of the 6 day group and 2.1 per cent of the 2 day group . Pneumonia developed in 8.5 per cent of the 6 day and 5.3 per cent of the 2 day group ; most of the bacteria isolated were susceptible to cephalothin . Urinary tract infection developed more frequently in the 2 day group ( 17.0 versus 8.5 per cent ) , particularly during the first 6 postoperative days . Three of 11 patients with no detectable cephalothin in their sera at the close of operation developed staphylococcal wound infections , compared with 2 of 175 patients whose sera contained cephalothin at the close of surgery ( p = 0.002 , Fisher 's exact test ) . A short course of prophylactic antibiotics is prudent , but there is no justification for prolonging their administration",
"Background No data currently exist about use of antibiotics to prevent surgical site infections ( SSI ) among patients undergoing appendectomy in Thail and . We therefore examined risk factors , use , and efficacy of prophylactic antibiotics for surgical site infection SSI among patients with uncomplicated open appendectomy . Methods From July 1 , 2003 to June 30 , 2004 we conducted a prospect i ve cohort study in eight hospitals in Thail and . We used the National Nosocomial Infection Surveillance ( NNIS ) system criteria to identify SSI associated with appendectomy . We used logistic regression analysis to obtain relative risk estimates for predictors of SSI . Results Among 2139 appendectomy patients , we identified 26 SSIs , yielding a SSI rate of 1.2 infections/100 operations . Ninety-two percent of all patients ( 95 % CI , 91.0–93.3 ) received antibiotic prophylaxis . Metronidazole and gentamicin were the two most common antibiotic agents , with a combined single dose administered in 39 % of cases . In 54 % of cases , antibiotic prophylaxis was administered for one day . We found that a prolonged duration of operation was significantly associated with an increased SSI risk . Antibiotic prophylaxis was significantly associated with a decreased risk of SSI regardless of whether the antibiotic was administered preoperatively or intraoperatively . Compared with no antibiotic prophylaxis , SSI relative risks for combined single-dose of metronidazole and gentamicin , one-day prophylaxis , and multiple-day antibiotic prophylaxis were 0.28 ( 0.09–0.90 ) , 0.30 ( 0.11–0.88 ) and 0.32 ( 0.10–0.98 ) , respectively . ConclusionS ingle-dose combination of metronidazole and gentamicin seems sufficient to reduce SSIs in uncomplicated appendicitis patients despite whether the antibiotic was administered preoperatively or intraoperatively",
"OBJECTIVE To quantify surgical-infection rate , to assess adherence with the antibiotic prophylaxis protocol , and to identify independent factors associated with surgical-wound infection ( SWI ) . METHODS We carried out a prospect i ve study of a cohort of 2,237 general surgery patients with postsurgery stays of more than 48 hours . Odds ratios ( OR ) were estimated using unconditional multiple logistic regression . SETTING A 1,300-bed , university-affiliated , tertiary-care hospital in Madrid , Spain . RESULTS 254 patients developed SWI . The rate of adherence to the antibiotic prophylaxis protocol was 63.5 % . Eight factors were independently associated with risk of SWI : age ( OR = 1.2 for every 10 years of age ) ; wound classification ( clean-contaminated , OR = 6.4 ; contaminated , OR = 3.7 ; dirty or infected , OR = 9.3 ) ; antimicrobial prophylaxis ( OR = 0.5 ) ; stay prior to surgery ( OR = 1.1 for every 3 days ) ; duration of operation ( OR = 1.5 for every 60 minutes ) ; malignant neoplasm ( OR = 1.7 ) ; emergency procedure ( OR = 1.99 ) ; intensive-care unit stay prior to surgery ( OR = 2.6 ) ; and antimicrobial prophylaxis administered 2 or more hours before operation ( OR = 5.3 ) . CONCLUSION In general , antimicrobial prophylaxis protects against SWI ( OR = 0.5 ) ; however , administration 2 hours or more before the operation increases the risk of SWI by a factor of 5.3 . Therefore , measures should be taken to ensure the correct timing of antimicrobial prophylaxis",
"BACKGROUND Currently , no single U.S. surveillance system can provide estimates of the burden of all types of health care-associated infections across acute care patient population s. We conducted a prevalence survey in 10 geographically diverse states to determine the prevalence of health care-associated infections in acute care hospitals and generate up date d estimates of the national burden of such infections . METHODS We defined health care-associated infections with the use of National Healthcare Safety Network criteria . One-day surveys of r and omly selected in patients were performed in participating hospitals . Hospital personnel collected demographic and limited clinical data . Trained data collectors review ed medical records retrospectively to identify health care-associated infections active at the time of the survey . Survey data and 2010 Nationwide Inpatient Sample data , stratified according to patient age and length of hospital stay , were used to estimate the total numbers of health care-associated infections and of in patients with such infections in U.S. acute care hospitals in 2011 . RESULTS Surveys were conducted in 183 hospitals . Of 11,282 patients , 452 had 1 or more health care-associated infections ( 4.0 % ; 95 % confidence interval , 3.7 to 4.4 ) . Of 504 such infections , the most common types were pneumonia ( 21.8 % ) , surgical-site infections ( 21.8 % ) , and gastrointestinal infections ( 17.1 % ) . Clostridium difficile was the most commonly reported pathogen ( causing 12.1 % of health care-associated infections ) . Device-associated infections ( i.e. , central -catheter-associated bloodstream infection , catheter-associated urinary tract infection , and ventilator-associated pneumonia ) , which have traditionally been the focus of programs to prevent health care-associated infections , accounted for 25.6 % of such infections . We estimated that there were 648,000 patients with 721,800 health care-associated infections in U.S. acute care hospitals in 2011 . CONCLUSIONS Results of this multistate prevalence survey of health care-associated infections indicate that public health surveillance and prevention activities should continue to address C. difficile infections . As device- and procedure-associated infections decrease , consideration should be given to exp and ing surveillance and prevention activities to include other health care-associated infections",
"Background Surgical site infections are the most common hospital-acquired infections among surgical patients . The administration of surgical antimicrobial prophylaxis reduces the risk of surgical site infections . The optimal timing of this procedure is still a matter of debate . While most studies suggest that it should be given as close to the incision time as possible , others conclude that this may be too late for optimal prevention of surgical site infections . A large observational study suggests that surgical antimicrobial prophylaxis should be administered 74 to 30 minutes before surgery . The aim of this article is to report the design and protocol of a r and omized controlled trial investigating the optimal timing of surgical antimicrobial prophylaxis . Methods / Design In this bi-center r and omized controlled trial conducted at two tertiary referral centers in Switzerl and , we plan to include 5,000 patients undergoing general , oncologic , vascular and orthopedic trauma procedures . Patients are r and omized in a 1:1 ratio into two groups : one receiving surgical antimicrobial prophylaxis in the anesthesia room ( 75 to 30 minutes before incision ) and the other receiving surgical antimicrobial prophylaxis in the operating room ( less than 30 minutes before incision ) . We expect a significantly lower rate of surgical site infections with surgical antimicrobial prophylaxis administered more than 30 minutes before the scheduled incision . The primary outcome is the occurrence of surgical site infections during a 30-day follow-up period ( one year with an implant in place ) . When assuming a 5 % surgical site infection risk with administration of surgical antimicrobial prophylaxis in the operating room , the planned sample size has an 80 % power to detect a relative risk reduction for surgical site infections of 33 % when administering surgical antimicrobial prophylaxis in the anesthesia room ( with a two-sided type I error of 5 % ) . We expect the study to be completed within three years . Discussion The results of this r and omized controlled trial will have an important impact on current international guidelines for infection control strategies in the hospital . Moreover , the results of this r and omized controlled trial are of significant interest for patient safety and healthcare economics . Trial registration This trial is registered on Clinical Trials.gov under the identifier NCT01790529",
"The results of two prospect i ve , r and omized trials , comparing single dose piperacillin with multidose cefoxitin prophylaxis in elective surgical procedures of the gastrointestinal tract were combined to examine some basic aspects of clinical ly , applied antibiotic prophylaxis . As there was no difference in the efficacy of prophylaxis between the groups , data from both centers and both drug groups were combined for analysis . Patients whose ages were greater than 40 years , the presence of cancer and the administration of an antibiotic for longer than 60 minutes preoperatively were associated with a higher rate of infectious complications . Duration of operation was also related to subsequent infection , ranging from 6 per cent in procedures lasting less than two hours to 27 per cent in operations lasting more than four hours . There was a greater failure of prophylaxis in patients undergoing rectal procedures , with a 29 per cent rate of infectious complications compared with 14 per cent in patients undergoing operations upon the colon . This difference was present even when duration of operation was taken into account",
"BACKGROUND Increased incidence of methicillin-resistant Staphylococcus species has required some hospitals to choose vancomycin for surgical prophylaxis . Guidelines for appropriate timing of vancomycin prophylaxis state that the infusion should begin within 120 min before the first surgical incision . However , no studies have investigated the proper timing of vancomycin prophylaxis in relationship to surgical site infections ( SSI ) . The objective of the present study was to assess the effect of vancomycin prophylaxis timing in relation to the first surgical incision on the incidence of SSI . METHODS We prospect ively monitored vancomycin prophylaxis timing and incidence of SSI in 2048 patients undergoing coronary bypass graft or valve replacement surgery . The timing of vancomycin was categorized into five groups based on the relation between the start of the infusion and the surgical cut time . Study hypotheses were tested using logistic analysis and further vali date d using a Heckman two-stage model . RESULTS The incidence of SSI were lowest in the 176 patients given vancomycin between 16 and 60 min before the surgical incision ( 3.4 % ) compared with 15 patients given vancomycin between 0 and 15 min [ 26.7 % ; relative risk ( RR ) : 7.8 ; 95 % CI : 2.5 - 24.7 ] , 888 patients given vancomycin between 61 and 120 min ( 7.7 % ; RR : 2.2 ; 95 % CI : 0.99 - 5.09 ) , 700 patients given vancomycin between 121 and 180 min ( 6.9 % ; RR : 2.0 ; 95 % CI : 0.87 - 4.62 ) or 269 patients given vancomycin > 180 min ( 7.8 % ; RR : 2.3 ; 95 % CI : 0.94 - 5.56 ) ( P = 0.0119 by chi(2 ) analysis ) . Stepwise logistic regression analysis and a Heckman two-stage model confirmed that vancomycin administration between 16 and 60 min before the first surgical incision was associated with the lowest incidence of SSI . CONCLUSIONS Vancomycin administration within 16 - 60 min before the first surgical incision reduced the risk of SSI in cardiac surgery patients",
"BACKGROUND Surgical site infections ( SSIs ) following total hip arthroplasty can lead to prolonged hospitalization , increased morbidity and mortality , and high costs . This article analyzes the effect of various parameters of surgical antibiotic prophylaxis on the risk of SSI following total hip arthroplasty . METHODS Data about SSI and potential prophylaxis- , patient- , and procedure-related risk factors were prospect ively collected for 1922 patients who underwent elective total hip arthroplasty in 11 hospitals that participated in the Dutch intervention project , Surgical Prophylaxis and Surveillance . Multivariate logistic regression analysis was performed to correct for r and om variation among hospitals . RESULTS SSIs ( superficial and deep ) occurred in 50 patients ( 2.6 % ) . The highest odds ratios for SSI were found in patients who received prophylaxis after incision ( 2.8 , 95 % confidence interval [ CI ] , 0.9 - 8.6 ; P=.07 ) , had an American Society of Anesthesiology score that was > 2 ( 2.8 , 95 % CI , 0.8 - 9.2 ; P=.09 ) , and experienced a duration of surgery that was > 75th percentile ( 2.5 ; 95 % CI , 1.1 - 5.8 ; P=.04 ) . Prolonged prophylaxis after the end of surgery and the use of antibiotic-impregnated cement did not contribute to fewer SSIs in this study . CONCLUSIONS This study suggests that intervention programs in search of amendable factors to prevent SSI should focus on timely administration of antibiotic prophylaxis",
"BACKGROUND Surgical site infections ( SSIs ) cause morbidity after elective colorectal surgery , and antibiotic prophylaxis can decrease SSIs . The aim of this study was to determine compliance with an antibiotic administration protocol , including regimen , initial dose timing , and re-dosing , and determine the risk of SSI associated with each . We hypothesized that appropriate antibiotic administration reduces the risk of SSI . METHODS Retrospective review from a prospect i ve data base of a r and om sample of patients undergoing elective abdominal colorectal procedures with anastomosis . Antibiotic regimens , initial dose timing ( IDT ) , and re-dosing were evaluated . Appropriate regimens covered gram-positive cocci , gram-negative bacilli , and anaerobes . The IDT was considered proper if completed within 30 min prior to incision ; re-dosing parameters were determined pharmacokinetically for each agent . The main outcome was SSI . Sequential logistic models were generated : Model 1 assessed antibiotic administration factors , whereas Model 2 controlled for patient and clinical factors , including disease process , patient characteristics , intra-operative factors , and post-operative factors . RESULTS Six hundred five patients ( mean age 59.7 [ st and ard deviation 17.8 ] years , 42.8 % male ) were included . The most common diagnoses were cancer ( 38.8 % ) and inflammatory bowel disease ( 22.0 % ) . Seventy-six patients ( 12.6 % ) had superficial or deep incisional SSI , and 54 ( 8.9 % ) had organ/space SSI . Regimens included cefazolin + metronidazole for 219 patients ( 36.2 % ) , cefoxitin for 214 ( 35.4 % ) , and levofloxacin + metronidazole for 48 ( 7.9 % ) . One hundred fourteen patients ( 18.8 % ) received other/nonst and ard regimens , and ten had no documented antibiotic prophylaxis . Fifty-five patients ( 9.1 % ) received insufficient coverage , whereas 361 patients ( 59.7 % ) had proper IDT , and 401 regimens ( 66.3 % ) were re-dosed properly . In Model 1 , the use of other/nonst and ard regimens ( odds ratio [ OR ] 2.069 ; 95 % confidence interval [ CI ] 1.078 - 1.868 ) and early administration of the initial prophylaxis dose ( OR 1.725 ; 95 % CI 1.147 - 2.596 ) were associated with greater odds of SSI . After adding clinical factors in Model 2 , both of these factors remained significant ( OR 2.505 ; 95 % CI 1.066 - 5.886 and OR 1.733 ; 95 % CI 1.017 - 2.954 , respectively ) . CONCLUSIONS Appropriate antibiotic selection and timing of administration for prophylaxis are crucial to reduce the likelihood of SSI after elective colorectal surgery with intestinal anastomosis",
"Objective : The objective of this study is to determine the optimal timing for surgical antimicrobial prophylaxis ( AMP ) . Summary Background Data : National AMP guidelines should be supported by evidence from large contemporary data sets . Methods : Twenty-nine hospitals prospect ively obtained information on AMP from 4472 r and omly selected cardiac , hip/knee arthroplasty , and hysterectomy cases . Surgical site infections ( SSIs ) were ascertained through routine surveillance , using National Nosocomial Infections Surveillance system methodology . The association between the prophylaxis timing and the occurrence of SSI was assessed using conditional logistic regression ( conditioning on hospital ) . Results : One-hundred thirteen SSI were detected in 109 patients . SSI risk increased incrementally as the interval of time between antibiotic infusion and the incision increased ( overall association between timing and infection risk P = 0.04 ) . When antibiotics requiring long infusion times ( vancomycin and fluoroquinolones ) were excluded , the infection risk following administration of antibiotic within 30 minutes prior to incision was 1.6 % compared with 2.4 % associated with administration of antibiotic between 31 to 60 minutes prior to surgery ( OR : 1.74 ; 95 % confidence interval , 0.98–3.04 ) . The infection risk increased as the time interval between preoperative antibiotic and incision increased or if the antibiotic was first infused after incision . Intraoperative redosing ( performed in only 21 % of long operations ) appeared to reduce SSI risk in operations lasting more than 4 hours ( OR of 3.08 with no redosing ; 95 % confidence interval 0.74–12.90 ) , but only when the preoperative dose was given correctly . Conclusions : These data from a large multicenter collaborative study confirm and extend previous observations and show a consistent relationship between the timing of AMP and SSI risk with a trend toward lower risk occurring when AMP with cephalosporins and other antibiotics with short infusion times were given within 30 minutes prior to incision",
"ABSTRACT The objective of this study was to characterize the relationship between gentamicin concentrations during surgery and the development of wound infection following colorectal operations . Despite decades of research in surgical prophylaxis , the relationship between intraoperative antibiotic concentrations and postoperative infection and the concentrations required for effective prophylaxis have not been established . A pharmacodynamic analysis was conducted using data from a previous prospect i ve , r and omized , double-blind clinical study which compared two dosage regimens of gentamicin plus metronidazole for prophylaxis in connection with elective colorectal surgery . Univariate and multivariate analyses of risk factors for postoperative wound infection were conducted , and the relationship between intraoperative gentamicin concentrations and surgical outcome was characterized . The gentamicin concentration at the time of surgical closure was one of the strongest independent risk factors for infection ( P = 0.02 ) , along with the presence of diabetes mellitus ( P = 0.02 ) , stoma ( P = 0.04 ) , and advanced age ( P = 0.05 ) . Gentamicin concentrations at closure of less than 0.5 mg/liter were associated with an infection rate of 80 % ( representing 8 of 10 patients with concentrations below that level ) ( P = 0.003 ) . Receiver operating characteristic curve analysis identified a critical closure concentration of 1.6 mg/liter for effective surgical prophylaxis ( P = 0.002 ; sensitivity , 70.8 % ; specificity , 65.9 % ) . This study provides new and important information on antibiotic pharmacodynamics in surgical prophylaxis . It demonstrates the critical effect of the antibiotic concentration at closure on wound infection and suggests a significant association between the concentration and other well-established risk factors , like the timing of preoperative antibiotic administration and surgery duration",
"BACKGROUND R and omized , controlled trials have shown that prophylactic antibiotics are effective in preventing surgical-wound infections . However , it is uncertain how the timing of antibiotic administration affects the risk of surgical-wound infection in actual clinical practice . METHODS We prospect ively monitored the timing of antibiotic prophylaxis and studied the occurrence of surgical-wound infections in 2847 patients undergoing elective clean or \" clean-contaminated \" surgical procedures at a large community hospital . The administration of antibiotics 2 to 24 hours before the surgical incision was defined as early ; that during the 2 hours before the incision , as preoperative ; that during the 3 hours after the incision , as perioperative ; and that more than 3 but less than 24 hours after the incision , as postoperative . RESULTS Of the 1708 patients who received the prophylactic antibiotics preoperatively , 10 ( 0.6 percent ) subsequently had surgical-wound infections . Of the 282 patients who received the antibiotics perioperatively , 4 ( 1.4 percent ) had such infections ( P = 0.12 ; relative risk as compared with the preoperatively treated group , 2.4 ; 95 percent confidence interval , 0.9 to 7.9 ) . Of 488 patients who received the antibiotics postoperatively , 16 ( 3.3 percent ) had wound infections ( P less than 0.0001 ; relative risk , 5.8 ; 95 percent confidence interval , 2.6 to 12.3 ) . Finally , of 369 patients who had antibiotics administered early , 14 ( 3.8 percent ) had wound infections ( P less than 0.0001 ; relative risk , 6.7 ; 95 percent confidence interval , 2.9 to 14.7 ) . Stepwise logistic-regression analysis confirmed that the administration of antibiotics in the preoperative period was associated with the lowest risk of surgical-wound infection . CONCLUSIONS We conclude that in surgical practice there is considerable variation in the timing of prophylactic administration of antibiotics and that administration in the two hours before surgery reduces the risk of wound infection"
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OBJECTIVE To conduct a systematic review to evaluate the evidence of the use of incentive spirometry ( IS ) for the prevention of postoperative pulmonary complications and for the recovery of pulmonary function in patients undergoing abdominal , cardiac and thoracic surgeries . METHODS Search es were performed in the following data bases : Medline , Embase , Web of Science , PEDro and Scopus to select r and omized controlled trials which the IS was used in pre- and /or post-operative in order to prevent postoperative pulmonary complications and /or recover lung function after abdominal , cardiac and thoracic surgery . Two review ers independently assessed all studies . In addition , the studies quality was assessed using the PEDro scale . RESULTS Thirty studies were included ( 14 abdominal , 13 cardiac and 3 thoracic surgery ; n=3,370 patients ) . In the analysis of the method ological quality , studies achieved a PEDro average score of 5.6 , 4.7 and 4.8 points in abdominal , cardiac and thoracic surgeries , respectively . Five studies ( 3 abdominal , 1 cardiac and 1 thoracic surgery ) compared the effect of the IS with control group ( no intervention ) and no difference was detected in the evaluated outcomes . CONCLUSION There was no evidence to support the use of incentive spirometry in the management of surgical patients . Despite this , the use of incentive spirometry remains widely used without st and ardization in clinical practice
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"OBJECTIVES Little is known about the physiologic and clinical effects of noninvasive positive pressure ventilation ( NPPV ) in patients who have acute respiratory failure ( ARF ) after abdominal surgery . We evaluated our clinical experience with the use of NPPV in the treatment of ARF after abdominal surgery . METHODS We prospect ively evaluated NPPV use during a 2-year period in a medical-surgical ICU of a university hospital . We documented demographic and diagnostic data , gas exchange , and clinical outcomes . We compared patients who were not intubated to those who were intubated after a trial of NPPV . RESULTS Of 72 patients with ARF after abdominal surgery who were treated with NPPV , 48 patients avoided intubation ( 67 % ) . Patients in the intubated and nonintubated groups had similar demographic characteristics , and similar American Society of Anesthesiologists physical status and simplified acute physiology score II scores at admission . The intubated group had a significantly lower Pa(O2)/fraction of inspired oxygen ( Fi(O2 ) ) ratio ( 123 + /- 62 mm Hg vs 194 + /- 76 mm Hg , p bilateral alveolar infiltrates ( 67 % vs 31 % , p NPPV observation period , the Pa(O2)/Fi(O2 ) increased ( + 36 + /- 29 % [ + /- SD ] , p = 0.04 ) and the respiratory rate decreased ( 28.2 + /- 3.4 breaths/min vs 23.1 + /- 3.8 breaths/min , p length of ICU stay ( 17.3 + /- 10.9 days vs 34.1 + /- 28.5 days , p mortality rate ( 6 % vs 29 % , p NPPV may be an alternative to conventional ventilation in selected patients with ARF after abdominal surgery who require ventilatory support",
"BACKGROUND Elders undergo approximately 40 % of more than 1 million major abdominal operations annually . Yet evidence about recovery to preoperative levels of functional independence is limited . This study details course and predictors of functional recovery after elective major abdominal operations in the elderly . STUDY DESIGN This was a prospect i ve cohort of 372 consecutive patients , 60 years old or more , enrolled from surgeons in private practice and two university-affiliated hospitals , assessed preoperatively and postoperatively at 1 , 3 , and 6 weeks , 3 and 6 months , using self-report and performance-based measures ( Activities of Daily Living [ ADL ] , Instrumental Activities of Daily Living [ IADL ] , Medical Outcomes Study Short Form-36 Physical Component and Mental Component Scales [ PCS , MCS ] , Geriatric Depression Scale [ GDS ] , Folstein Mini-Mental State Exam [ MMSE ] , timed walk , functional reach , h and grip strength ) . RESULTS Mean age was 69 + /- 6 years with 56 % men , 47 % nonHispanic Caucasian , and 42 % Mexican American ; hospital distribution was 49 % private , 51 % university-affiliated . Maximum functional declines ( 95 % CI ) occurred 1 week postoperatively : ADL , 2.8 points ( 2.4 to 3.2 ) ; IADL , 7.6 points ( 7 to 8.3 ) ; SF-36 PCS , 6.5 points ( 5.4 to 7.6 ) ; Mini-Mental State Exam , 0.5 points ( 0.2 to 0.7 ) ; timed walk , 6.8 seconds ( 5.2 to 8.4 ) ; functional reach , 1.7 inches ( 1.2 to 2.2 ) ; grip strength , 2 kilograms ( 1.3 to 2.7 ) ( p SF-36 mental component scale and Geriatric Depression Scale scores did not worsen . Mean recovery times were : Mini-Mental State Exam , 3 weeks ; timed walk , 6 weeks ; ADL , SF-36 PCS , and functional reach , 3 months ; and IADL , 6 months . Mean grip strength did not return to preoperative status by 6 months . The incidence of persistent disability at 6 months , compared with preoperative status , was : ADL , 9 % ; IADL , 19 % ; PCS , 16 % ; mental component scale , 17 % ; timed walk , 39 % ; functional reach , 58 % ; and grip strength , 52 % . Potentially modifiable independent predictors of ADL and IADL recovery were preoperative physical conditioning and depression plus serious postoperative complications . CONCLUSIONS The clinical course of functional recovery varied across different measures . Protracted disability at 6 months after operation was substantial . Several potentially modifiable factors consistently predicted recovery",
"OBJECTIVE To evaluate inspiratory volume in patients undergoing cardiac surgery and to determine the effects that incentive spirometry ( IS ) and the breath stacking ( BS ) technique have on the recovery of FVC in such patients . METHODS A prospect i ve , controlled , r and omized clinical trial involving 35 patients undergoing cardiac surgery at the Hospital de Força Aérea do Galeão ( HFAG , Galeão Air Force Hospital ) , in the city of Rio de Janeiro , Brazil . The patients , all of whom performed mobilization and cough procedures , were r and omly divided into three groups : exercise control ( EC ) , performing only the abovementioned procedures ; IS , performing the abovementioned procedures and instructed to take long breaths using an incentive spirometer ; and BS , performing the abovementioned procedures , together with successive inspiratory efforts using a facial mask coupled to a unidirectional valve . Forced spirometry was carried out in the preoperative period and on postoperative days 1 to 5 . During the maneuvers , inspiratory volume was measured in the IS and BS groups . RESULTS On postoperative day 1 , FVC significantly decreased in all groups ( EC : 87.1 vs. 32.0 % ; IS : 75.3 vs. 29.5 % ; and BS : 81.9 vs. 33.2 % ; p inspiratory volume in the IS and BS groups ( 2.29 vs. 0.82 L ; and 2.56 vs. 1.34 L , respectively ; p FVC partially normalized in all groups ( EC : 32.0 vs. 51.3 % ; IS : 29.5 vs. 46.7 % ; and BS : 33.3 vs. 54.3 % ; p period , inspiratory volume was significantly higher in the BS group than in the IS group . CONCLUSIONS The three protocol s were equivalent concerning the recovery of FVC on the first five postoperative days . When compared with IS , the BS technique promoted higher inspiratory volumes in this sample of postoperative cardiac patients",
"Background : Current knowledge of the risk for postoperative pulmonary complications ( PPCs ) rests on studies that narrowly selected patients and procedures . Hypothesizing that PPC occurrence could be predicted from a reduced set of perioperative variables , we aim ed to develop a predictive index for a broad surgical population . Methods : Patients undergoing surgical procedures given general , neuraxial , or regional anesthesia in 59 hospitals were r and omly selected for this prospect i ve , multicenter study . The main outcome was the development of at least one of the following : respiratory infection , respiratory failure , bronchospasm , atelectasis , pleural effusion , pneumothorax , or aspiration pneumonitis . The cohort was r and omly divided into a development sub sample to construct a logistic regression model and a validation sub sample . A PPC predictive index was constructed . Results : Of 2,464 patients studied , 252 events were observed in 123 ( 5 % ) . Thirty-day mortality was higher in patients with a PPC ( 19.5 % ; 95 % [ CI ] , 12.5–26.5 % ) than in those without a PPC ( 0.5 % ; 95 % CI , 0.2–0.8 % ) . Regression modeling identified seven independent risk factors : low preoperative arterial oxygen saturation , acute respiratory infection during the previous month , age , preoperative anemia , upper abdominal or intrathoracic surgery , surgical duration of at least 2 h , and emergency surgery . The area under the receiver operating characteristic curve was 90 % ( 95 % CI , 85–94 % ) for the development sub sample and 88 % ( 95 % CI , 84–93 % ) for the validation sub sample . Conclusion : The risk index based on seven objective , easily assessed factors has excellent discriminative ability . The index can be used to assess individual risk of PPC and focus further research on measures to improve patient care",
"STUDY OBJECTIVES To investigate the effects of deep-breathing exercises on pulmonary function , atelectasis , and arterial blood gas levels after coronary artery bypass graft ( CABG ) surgery . DESIGN , SETTING , AND PATIENTS In a prospect i ve , r and omized trial , patients performing deep-breathing exercises ( n = 48 ) were compared to a control group ( n = 42 ) who performed no breathing exercises postoperatively . Patient management was similar in the groups in terms of assessment , positioning , and mobility . INTERVENTIONS The patients in the deep-breathing group were instructed to perform breathing exercises hourly during daytime for the first 4 postoperative days . The exercises consisted of 30 slow , deep breaths performed with a positive expiratory pressure blow-bottle device ( + 10 cm H(2)O ) . MEASUREMENTS AND RESULTS Spirometric measurements , spiral CT ( three transverse levels ) , arterial blood gas analysis , and scoring of subjective experience of the breathing exercises were performed on the fourth postoperative day . Atelectasis was only half the size in the deep-breathing group compared to the control group , amounting to 2.6 + /- 2.2 % vs 4.7 + /- 5.7 % ( p = 0.045 ) at the basal level and 0.1 + /- 0.2 % vs 0.3 + /- 0.5 % ( mean + /- SD ) [ p = 0.01 ] at the apical level . Compared to the control subjects , the patients in the deep-breathing group had a significantly smaller reduction in FVC ( to 71 + /- 12 % , vs 64 + /- 13 % of the preoperative values ; p = 0.01 ) and FEV(1 ) ( to 71 + /- 11 % , vs 65 + /- 13 % of the preoperative values ; p = 0.01 ) . Arterial oxygen tension , carbon dioxide tension , fever , or length of ICU or hospital stay did not differ between the groups . In the deep-breathing group , 72 % of the patients experienced a subjective benefit from the exercises . CONCLUSIONS Patients performing deep-breathing exercises after CABG surgery had significantly smaller atelectatic areas and better pulmonary function on the fourth postoperative day compared to a control group performing no exercises",
"BACKGROUND A predicted postoperative forced expiratory volume in 1 second ( FEV1 ) of less than 800 ml or 40 % of predicted is a common criterion for exclusion of patients from lung resection for cancer . Usually , the predicted postoperative lung function is calculated according to a formula based on the number of lung segments that will be resected . Incentive spirometry and specific inspiratory muscle training are two maneuvers that have been used to enhance lung expansion and inspiratory muscle strength in patients with chronic obstructive pulmonary disease and after lung operation . METHODS Thirty-two patients with chronic obstructive pulmonary disease who were c and i date s for lung resection were r and omized into two groups : 17 patients received specific inspiratory muscle training and incentive spirometry , 1 hour per day , six times a week , for 2 weeks before and 3 months after lung resection ( group A ) and 15 patients were assigned to the control group and received no training ( group B ) . RESULTS Inspiratory muscle strength increased significantly in the training group , both before and 3 months after the operation . In group B , the predicted postoperative FEV1 value consistently underestimated the actual postoperative FEV1 by approximately 70 ml in the lobectomy subgroup and by 110 ml in the pneumonectomy subgroup . In group A , the actual postoperative FEV1 was higher than the predicted postoperative FEV1 by 570 ml in the lobectomy subgroup and by 680 ml in the pneumonectomy subgroup of patients . CONCLUSIONS In patients undergoing lung resection the simple calculation of predicted postoperative FEV1 underestimates the actual postoperative FEV1 by a small fraction . Lung functions can be increased significantly when incentive spirometry and specific inspiratory muscle training are used before and after operation",
" Forty-nine adults who had undergone cardiopulmonary bypass surgery were r and omly assigned to one of three exercise programs to determine if either maximal inspiratory breathing exercises or incentive spirometry offered a therapeutic advantage over early mobilization alone . After extubation , the patients started their assigned exercise programs . A physical examination and pulmonary function tests were performed preoperatively , at the start of the exercise program , and 24 and 48 hours after the start of the program . The results showed a significant decrease ( approximately 50 % ) in lung volumes but no airflow obstruction in patients who had coronary artery bypass graft . In those patients who had valve replacement , lung volumes fell , and in addition , mild airflow obstruction occurred . A majority of patients had postoperative pulmonary complications . There were no significant differences among the exercise programs in improving lung volumes and airflow or in preventing postoperative complications . We conclude that maximal inspiratory breathing exercises or incentive spirometry , when used in addition to early mobilization , offers no therapeutic advantage over early mobilization alone after cardiopulmonary bypass surgery",
"Postoperative pulmonary complications , alveolar-arteriolar oxygen difference ( [A-a]O2-diff ) , peak expiratory flow ( PEF ) and forced vital capacity ( FVC ) were compared in patients using continuous positive airway pressure ( CPAP ) and positive expiratory pressure ( PEP ) administered by face mask against those of a control group using a deep-breathing device ( Triflo ) . Forty-three consecutive , r and omized patients undergoing elective upper abdominal surgery were included . CPAP , PEP and Triflo were administered for 30 consecutive breaths in every waking hour for three days postoperatively . The (A-a)O2-difference increased equally and significantly in the three groups after surgery , reaching a maximum on the first postoperative day . After this day , however , (A-a)O2-diff decreased in the CPAP and PEP groups , being significantly lower in the PEP group compared to the control group , two days postoperatively ( p less than 0.05 ) and significantly lower in both the PEP and CPAP groups three days postoperatively ( p less than 0.001 and p less than 0.05 , respectively . ) PEF did not differ significantly between the groups before or after surgery , while FVC was significantly higher in the PEP and CPAP groups , compared to control , on the third postoperative day ( p less than 0.05 ) . Atelectatic consolidation was observed in six of 15 patients in the control group three days postoperatively , the incidence being significantly lower in both the PEP group ( 0 of 15 , p less than 0.001 ) and the CPAP group ( one of 13 , p less than 0.05 ) . We concluded that periodic face mask administration of CPAP and PEP are superior to deep breathing exercises with respect to gas exchange , preservation of lung volumes and development of atelectasis after upper abdominal surgery . We also conclude that the simple and commercially available PEP mask is as effective as the more complicated CPAP system",
"One hundred and ten men undergoing coronary artery bypass grafting took part in a prospect i ve r and omised study comparing three physiotherapy protocol s. All patients were taught self supported huffing and coughing by a physiotherapist and encouraged to move about . This comprised the sole treatment for the 37 control patients ( group 3 ) . Additional physiotherapy included breathing exercises for the 35 patients in group 1 and use of an incentive spirometer for the 38 patients in group 2 . Functional residual capacity ( FRC ) was measured daily at the bedside until the fifth postoperative day and arterial blood gas tensions were measured on the second and fourth postoperative days . After surgery patients developed a severe restrictive ventilatory defect and profound arterial hypoxaemia . There were no differences between the three groups . Mean FRC on day 2 was 1.90 litres ( 61 % of the preoperative value ) , increasing to 2.32 1 by day 5 ( 76 % of the preoperative value ) . The mean arterial oxygen tension was 7.37 kPa on day 2 and 8.58 kPa on day 4 . Four patients in group 1 , two in group 2 , and five in group 3 developed a chest infection . It is concluded that the addition of breathing exercises or incentive spirometry to a regimen of early mobilisation and huffing and coughing confers no extra benefit after uncomplicated coronary artery bypass grafting",
"BACKGROUND AND PURPOSE The purpose of this study was to determine whether the addition of incentive spirometry ( IS ) to postoperative pulmonary physical therapy is more effective than physical therapy alone in reducing postoperative pulmonary complications in high-risk patients after coronary artery bypass grafting ( CABG ) . Patients were given the spirometer and instructed in its use , as often occurs in clinical setting s. SUBJECTS Patients with chronic airflow limitation following CABG ( N = 185 ) participated . METHODS Subjects were r and omly assigned to receive either postoperative pulmonary physical therapy ( breathing exercises , secretion removal , mobility ) or physical therapy combined with IS . RESULTS No difference was found between the two groups in atelectasis , spirometry , oxygen saturation , pulmonary infection , or hospital stay . CONCLUSION AND DISCUSSION Incentive spirometry combined with physical therapy is no more effective than postoperative physical therapy alone in reducing atelectasis for this population . Use of the spirometer , however , was not monitored , and although the study mimicked practice as it often occurs , the effectiveness of the spirometer can not be fully evaluated",
"We have studied the efficacy of routine use of incentive spirometry ( IS ) in two groups of patients : group 1 ( n = 18 ) with IS , and group 2 ( n = 19 ) , no IS . All patients suffered from lung or esophagus neoplasm and received respiratory physiotherapy before and after the operation . They underwent high chest and abdomen surgery . The incidence of alterations of pulmonary auscultation , roentgenologic abnormalities and alterations of the alveolar-arterial difference of oxygen ( D[A-a]O2 ) as well as postoperative complications were similar in both groups . Patients undergoing digestive surgery presented a higher frequency of pleural effusion ( p less than 0.05 ) and of them , the subgroup with IS stayed at the hospital for a longer time ( 47.2 + /- 32 days ) than the subgroup undergoing digestive surgery not su bmi tted to IS ( p less than 0.01 ) probably because of the higher incidence of neoplasms of the mean third of the esophagus in such group . In our study and in the context of the type of surgery studied , the routine use of IS does not decrease the frequency of clinical and roentgenologic alterations neither improves the efficacy of postoperative gas interchange",
"Morbidly obese patients undergoing general anesthesia for laparoscopic bariatric surgery are considered at increased risk of a postoperative decrease in lung function . The purpose of this study was to determine whether a systematic use of incentive spirometry ( IS ) prior to surgery could help patients to preserve their respiratory function better in the postoperative period . Forty-one morbidly obese ( body mass index [ BMI ] > 40 kg/m² ) c and i date s for laparoscopic bariatric surgery were consented in the study . All patients were taught how to use an incentive spirometer but then were r and omized blindly into 2 groups . The control group was instructed to use the incentive spirometer for 3 breaths , once per day . The treatment group was requested to use the incentive spirometer for 10 breaths , 5 times per day . Twenty experimental ( mean BMI of 48.9 ± 5.67 kg/m² ) and 21 control patients ( mean BMI of 48.3 ± 6.96 kg/m² ) were studied . The initial mean inspiratory capacity ( IC ) was 2155 ± 650.08 ( SD ) cc and 2171 ± 762.98 cc in the experimental and control groups , respectively . On the day of surgery , the mean IC was 2275 ± 777.56 cc versus 2254.76 ± 808.84 cc , respectively . On postoperative day 1 , both groups experienced a significant drop of their IC , with volumes of 1458 ± 613.87 cc ( t test P to significant improvements of inspiratory capacity and that it is a not a useful re source to prevent postoperative decrease in lung function ",
"Background : Coronary artery bypass graft ( CABG ) surgery with the use of mammary arteries is associated with severe alteration of lung function parameters . The purpose of the present study was to compare the effect on lung function tests of conventional physiotherapy using incentive spirometry ( IS ) with non‐invasive ventilation on continuous positive airway pressure ( CPAP ) and with non‐invasive ventilation on bilevel positive airway pressure ( BiPAP or NIV‐2P )",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"To determine the potential benefit of incentive spirometry , which has been advocated to prevent pulmonary complications after upper-abdominal surgery , we compared a group of patients receiving incentive spirometry to another group receiving no specialized postoperative respiratory care . Forty patients in the American Society of Anesthesiologists ' class 1 and 2 who were undergoing cholecystectomy ( through right subcostal incision ) were included in the study and were r and omly allocated to one of the two groups . Patients receiving incentive spirometry were encouraged by a specialized respiratory physiotherapist to breathe deeply for five minutes hourly , 12 times daily , for three postoperative days . No statistically significant difference between the two groups was found in the radiologic evidence of postoperative pulmonary complications , arterial oxygen pressure , spirometric measurement , and clinical evaluation at the second or fourth postoperative day ( or both ) . In particular , deterioration on the chest x-ray film at the fourth postoperative day was observed in eight of 20 patients in the group receiving incentive spirometry and in six of 20 in the control group . Our study confirms the postoperative deterioration of respiratory function after upper-abdominal surgery and demonstrates the lack of therapeutic values of incentive spirometry in these patients at low risk for pulmonary complications",
"Objective : To investigate the additional effect of incentive spirometry to chest physiotherapy to prevent postoperative pulmonary complications after thoracic surgery for lung and esophageal resections . Design : R and omized controlled trial . Setting : University hospital , intensive care unit , and surgical department . Patients : Sixty‐seven patients ( age , 59 ± 13 yrs ; forced expiratory volume in 1 sec , 93 % ± 22 % predicted ) undergoing elective thoracic surgery for lung ( n = 40 ) or esophagus ( n = 27 ) resection . Interventions : Physiotherapy ( breathing exercises , huffing , and coughing ) ( PT ) plus incentive spirometry ( IS ) was compared with PT alone . Measurements and Main Results : Lung function , body temperature , chest radiograph , white blood cell count , and number of hospital and intensive care unit days were all measured . Pulmonary function was significantly reduced after surgery ( 55 % of the initial value ) and improved significantly in the postoperative period in both groups . However , no differences were observed in the recovery of pulmonary function between the groups . The overall score of the chest radiograph , based on the presence of atelectasis , was similar in both treatment groups . Eight patients ( 12 % ) ( three patients with lobectomy and five with esophagus resection ) developed a pulmonary complication ( abnormal chest radiograph , elevated body temperature and white blood cell count ) , four in each treatment group . Adding IS to regular PT did not reduce hospital or intensive care unit stay . Conclusions : Pulmonary complications after lung and esophagus surgery were relatively low . The addition of IS to PT did not further reduce pulmonary complications or hospital stay . Although we can not rule out beneficial effects in a subgroup of high‐risk patients , routine use of IS after thoracic surgery seems to be ineffective",
"Controversy exists regarding the routine use of aids to lung expansion in the prevention of pulmonary complications after abdominal surgery . We prospect ively r and omized 172 patients into 1 of 4 groups : the control group ( 44 patients ) received no respiratory treatment , the IPPB group ( 45 patients ) received intermittent positive pressure breathing therapy for 15 min 4 times daily , the IS group ( 42 patients ) was treated with incentive spirometry 4 times daily , and the DBE group ( 41 patients ) carried out deep breathing exercises under supervision for 15 min 4 times daily . Roentgenographic changes , observed 24 h after surgery , were comparable in the 4 groups ( 20.5 to 36.6 % ) . Pulmonary complications were defined as the development of 3 or more of 6 new findings : cough , phlegm , dyspnea , chest pain , temperature greater than 38 degrees C , pulse rate more than 100 beats/min . The frequency of development of pulmonary complications was 48 % in the control group , 22 % in the IPPB group ( p less than 0.05 ) , 21 % in the IS group ( p less than 0.05 ) , and 22 % in the DBE group ( p less than 0.05 ) . Side effects of respiratory treatment were observed only in the IPPB group ( 18 % ; p less than 0.05 ) . Hospital stay in patients undergoing upper abdominal surgery was significantly shorter in the IS group ( mean + /- SD , 8.6 + /- 3 days ) than in the control group ( 13 + /- 5 days ) . This difference was not observed for the other 2 treatment groups . ( ABSTRACT TRUNCATED AT 250 WORDS",
"We entered 876 patients into a clinical trial aim ed at preventing pulmonary complications after abdominal surgery . Patients either received conventional chest physiotherapy or were encouraged to perform maximal inspiratory manoeuvres for 5 min during each hour while awake , using an incentive spirometer . The incidence of pulmonary complications did not differ significantly between the groups : incentive spirometry 68 of 431 ( 15.8 % , 95 % CI 14.0 - 17.6 % ) , and chest physiotherapy 68 of 445 ( 15.3 % , CI 13.6 - 17.0 % ) . Nor was there a difference between the groups in the incidence of positive clinical signs , pyrexia , abnormal chest radiographs , pathogens in sputum , respiratory failure ( PO2 less than 60 mm Hg ) , or length of stay in hospital . We conclude that prophylactic incentive spirometry and chest physiotherapy are of equivalent clinical efficacy in the general management of patients undergoing abdominal surgery",
" Fifty-two patients were r and omized to receive either incentive spirometry ( IS ) or intermittent positive pressure breathing ( IPPB ) in addition to conventional chest physical therapy following coronary artery bypass grafting . Slow vital capacity and peak expiratory flow readings decreased rapidly and to an equal extent in both groups after surgery , and partly recovered by the sixth postoperative day ( POP ) . Arterial PO2 values were similar for the groups on the first three POPs . On the POPs 2 , 3 , and 6 , the number of chest films showing atelectases as well as the number of individual patients having atelectases revealed no statistically significant differences between the two groups . Based on the three variables studied , we consider both devices equal in efficiency after coronary surgery",
"Of 38 patients undergoing median sternotomy for cardiac operations all developed profound restrictive defects in pulmonary function during the first 72 h after tracheal extubation . Although decreased lung volumes were refractory to correction by vigorous , aggressive pulmonary therapy during this period , frequent and supervised treatment may prevent further deterioration in pulmonary function . The overall incidence of pneumonia was only 3 % ( 1/38 ) . Continuous positive airway pressure delivered by mask proved to be a nearly effortless form of postoperative respiratory therapy that was less painful than incentive spirometry or coughing and deep breathing , and therefore may be preferable",
" Following cardiac operations , 145 patients were treated with either intermittent positive-pressure breathing ( IPPB ) , blod bottles , or an incentive spirometer in an attempt to alter the incidence of atelectasis . Pulmonary complications occurred in 30 % of the patients receiving IPPB , 15 % of those using an incentive spirometer , and 8 % of those using blow bottles . Gastrointestinal side-effects occurred in 20 % of the IPPB group and were rare in other groups . The cost of IPPB is also considerably greater than either incentive spirometry or blow bottles . IPPB is not essential to prevention of atelectasis in postoperative cardiac surgical patients and may be inferior to other methods",
"BACKGROUND The use of the incentive spirometry ( IS ) with expiratory positive airway pressure ( EPAP ) to prevent postoperative pulmonary complications ( PPC ) after coronary artery bypass graft ( CABG ) is not well established . This study sought to determine the effects of IS+EPAP after CABG . METHODS Thirty-four patients undergoing CABG were r and omly assigned to a control group or IS+EPAP group . Maximal respiratory pressures , pulmonary function test , 6-minute walk test and chest x-ray were performed at baseline as well as 1 week and 1 month after CABG . RESULTS Maximal inspiratory pressure was significantly higher in the IS+EPAP group compared to controls at both 1 week and 1 month ( P Maximal expiratory pressure was significantly higher at 1 month compared to 1 week in IS+EPAP group ( P forced vital capacity and forced expiratory volume in 1 second was significantly higher in IS+EPAP compared to controls ( P Inspiratory capacity was higher at 1 month in IS+EPAP group compared to controls ( P distance walked in 6-minute walk test was higher at 1 month in IS+EPAP group ( P radiological injury score at 1 week was lower in IS+EPAP compared to controls ( P patients undergoing CABG , IS+EPAP results in improved pulmonary function and 6-minute walk distance as well as a reduction in PPC",
"OBJECTIVE Pulmonary complications are common after abdominal surgery . Although a variety of risk factors have been described for these complications , studies so far have focused on elective interventions . The aim of this study was to determine the incidence and predictors of pulmonary complications following emergency abdominal surgery . METHODS This was a prospect i ve cohort study . Pre and intra-operative data were collected through interview and chart review and their association with the occurrence of postoperative pulmonary complications ( PPC ) were analyzed . RESULTS Two hundred and sixty-six consecutive adult patients were included and seventy-five ( 28.2 % ) developed PPC . Age > 50 years ( adjusted OR=3.86 ; P PPC . Patients su bmi tted to multiple procedures tended to be at a higher risk for PPC ( adjusted OR=1.73 ; P=0.079 ) . The development of PPC was associated with prolonged hospital stay ( P death rate ( P patients undergoing abdominal emergency surgery and lead to increased length of hospital stay and death rate . Older age , abnormal BMI , upper or upper/lower abdominal incision and multiple procedures are predictors of PPC in this setting",
"Twenty patients undergoing an upper abdominal procedure were r and omly assigned in two groups . One group was treated with both chest physical therapy and incentive spirometry and the other was treated with chest physical therapy alone . Spirometric values , respiratory rate , tidal volume and vital capacity were determined during the postoperative course . We observed that patients treated with incentive spirometry bad a faster return to preoperative pulmonary volumes . This observation confirms the prophylactic role of incentive spirometry in the prevention of pulmonary complications after laparotomy",
"This study was design ed to compare the effects of preoperative and postoperative incentive spirometry on lung functions after laparoscopic cholecystectomy in 50 otherwise normal healthy adults . Patients were r and omized into a control group ( group PO , n=25 ) and a study group ( group PR , n=25 ) . Patients in group PR were instructed to carry out incentive spirometry before the surgery 15 times , every fourth hourly , for 1 week whereas in group PO , incentive spirometry was carried out during the postoperative period . Lung functions were recorded at the time of preanesthetic evaluation , on the day before the surgery , postoperatively at 6 , 24 , and 48 hours , and at discharge . Significant improvement in the lung functions was seen after preoperative incentive spirometry ( group PR ) , P lung functions were significantly reduced till the time of discharge in both the groups . However , lung functions were better preserved in group PR at all times when compared with group PO ; P lung functions are better preserved with preoperative than postoperative incentive spirometry",
"Forty patients who underwent elective cholecystectomy were allocated r and omly to one of two groups . Patients in one group used an incentive spirometer as part of their postoperative chest physiotherapy ; those in the other received routine postoperative physiotherapy as dictated by their needs . Each group contained equal numbers of smokers and nonsmokers , and the data from each group were analysed separately . The use of the incentive spirometer did not confer any benefits as judged by clinical evidence of pulmonary complications , pulmonary function tests or length of hospital stay",
"Abstract Objective : To evaluate the prevention of respiratory complications after abdominal surgery by a comparison of a global policy of incentive spirometry with a regimen consisting of deep breathing exercises for low risk patients and incentive spirometry plus physiotherapy for high risk patients . Design : Stratified r and omised trial . Setting : General surgical service of an urban teaching hospital . Patients : 456 patients undergoing abdominal surgery . Patients less than 60 years of age with an American Society of Anesthesia classification of 1 were considered to be at low risk . Outcome measures : Respiratory complications were defined as clinical features consistent with collapse or consolidation , a temperature above 38 ° C , plus either confirmatory chest radiology or positive results on sputum microbiology . We also recorded the time that staff devoted to prophylactic respiratory therapy . Results : There was good baseline equivalence between the groups . The incidence of respiratory complications was 15 % ( 35/231 ) for patients in the incentive spirometry group and 12 % ( 28/225 ) for patients in the mixed therapy group ( P=0.40 ; 95 % confidence interval -3.6 % to 9.0 % ) . It required similar amounts of staff time to provide incentive spirometry and deep breathing exercises for low risk patients . The inclusion of physiotherapy for high risk patients , however , result ed in the utilisation of an extra 30 minutes of staff time per patient . Conclusions : When the use of re sources is taken into account , the most efficient regimen of prophylaxis against respiratory complications after abdominal surgery is deep breathing exercises for low risk patients and incentive spirometry for high risk patients . Key messages Key messages Most postoperative respiratory complications were due to atelectasis : less than 1 % of the patients developed pneumonia An American Society of Anesthesia classification > 1 and an age > /=60 years is a simple way of defining patients at high risk of respiratory complications and other adverse events after abdominal surgery A regimen consisting of deep breathing exercises ( low risk patients ) and incentive spirometry ( high risk patients ) is an efficient way of providing prophylaxis against respiratory complications after abdominal"
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Objective To compare the effects of moderate intensity continuous training ( MICT ) and high intensity interval training ( HIIT ) on adult lipid profiles ; to identify training or participant characteristics that may determine exercise-induced change in total cholesterol ( TC ) , triglycerides ( TRG ) , high-density lipoprotein cholesterol ( HDL-C ) and low-density lipoprotein cholesterol ( LDL-C ) . Design Systematic review and meta- analysis . Data sources English language search es of several data bases were conducted from inception until September 2019 . Eligibility criteria for excluding studies Inclusion : ( 1 ) published r and omised controlled human trials with group population n≥5 ; ( 2 ) intervention duration ≥4 weeks ; ( 3 ) comparing HIIT with MICT ; and ( 4 ) reporting pre – post intervention lipid measurements . Exclusion : subjects with chronic disease , Results Twenty-nine data sets ( mmol/L ) of 823 participants were pooled and analysed . Neither HIIT nor MICT was better in decreasing TC ( 0.10 ( −0.06 to 0.19 ) , p=0.12 , I2=0 % ) , TRG ( −0.05 ( −0.11 to 0.01 ) , p=0.10 , I2=0 % ) , LDL-C ( 0.05 ( −0.06 to 0.17 ) , p=0.37 , I2=0 % ) , or TC/HDL-C ( −0.03 ( −0.36 to 0.29 ) , p=0.85 , I2=0 % ) . HIIT significantly raised HDL-C ( 0.07 ( 0.04 to 0.11 ) , p with MICT . Conclusion Neither HIIT nor MICT is superior for altering TC , TRG , or LDL-C , or TC-HDL-C ratio . Compared with MICT , HIIT appeared to significantly improve HDL-C. Clinicians may prescribe either protocol to encourage participation in exercise and reduce cardiovascular risk . To raise HDL-C , HIIT may result in a larger effect size compared with MICT . PROSPERO registration number CRD42019136722
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"We examined the effects of an 8-week exercise intervention on aerobic fitness , and roid and gynoid fat mass , and blood lipids in overweight and obese participants . Twenty-four sedentary participants ( average BMI = 30 ± 2 kg/m2 ; 18 females , 6 males ) were r and omized into either interval training and diet education ( INT group ) , continuous aerobic exercise and diet education ( CON group ) , or diet education only ( DIET group ) . Duration s of exercise sessions were similar ( ∼30 minutes ) , with both exercise groups completing the same amount of work . The INT and CON groups demonstrated significant improvements over time for ( p 1.2 , respectively ) and time to exhaustion on a grade d exercise test ( p recorded for the loss in and roid fat mass over time in the INT group only",
"Regular exercise training is recognized as a powerful tool to improve work capacity , endothelial function and the cardiovascular risk profile in obesity , but it is unknown which of high-intensity aerobic exercise , moderate-intensity aerobic exercise or strength training is the optimal mode of exercise . In the present study , a total of 40 subjects were r and omized to high-intensity interval aerobic training , continuous moderate-intensity aerobic training or maximal strength training programmes for 12 weeks , three times/week . The high-intensity group performed aerobic interval walking/running at 85 - 95 % of maximal heart rate , whereas the moderate-intensity group exercised continuously at 60 - 70 % of maximal heart rate ; protocol s were isocaloric . The strength training group performed ' high-intensity ' leg press , abdominal and back strength training . Maximal oxygen uptake and endothelial function improved in all groups ; the greatest improvement was observed after high-intensity training , and an equal improvement was observed after moderate-intensity aerobic training and strength training . High-intensity aerobic training and strength training were associated with increased PGC-1alpha ( peroxisome-proliferator-activated receptor gamma co-activator 1alpha ) levels and improved Ca(2 + ) transport in the skeletal muscle , whereas only strength training improved antioxidant status . Both strength training and moderate-intensity aerobic training decreased oxidized LDL ( low-density lipoprotein ) levels . Only aerobic training decreased body weight and diastolic blood pressure . In conclusion , high-intensity aerobic interval training was better than moderate-intensity aerobic training in improving aerobic work capacity and endothelial function . An important contribution towards improved aerobic work capacity , endothelial function and cardiovascular health originates from strength training , which may serve as a substitute when whole-body aerobic exercise is contra-indicated or difficult to perform",
"BACKGROUND AND PURPOSE Exercise training is commonly prescribed for individuals diagnosed with nonalcoholic fatty liver disease ( NAFLD ) ; however , consensus regarding the volume and intensity of exercise for optimal benefits is lacking . Thus , we determined whether high intensity interval exercise training ( HIIT ) produced greater reductions in intrahepatic lipid ( IHL ) content and NAFLD risk factors compared with energy-matched moderate intensity continuous exercise training ( MICT ) in obese adults with liver steatosis . METHODS Eighteen obese adults were r and omized to either 4weeks of HIIT ( 4min 80 % VO2peak/3min , 50 % VO2peak ) or MICT ( 55 % VO2peak , ~60min ) , matched for energy expenditure ( ~400kcal/session ) and compared to five non-exercising age-matched control subjects . IHL was measured by 1H-MRS and frequent blood sample s were analyzed for glucose , insulin , c-peptide , and NEFA levels during a liquid meal test ( 180min ) to characterize metabolic phenotype . RESULTS Baseline body weight , visceral abdominal adiposity , and fasting insulin concentrations were greater in the MICT vs HIIT group ( P IHL was tightly matched between MICT and HIIT subjects ( P>0.05 ) , albeit higher than control subjects ( P ) . Visceral abdominal adiposity , body mass , liver aminotransferases ( ALT , AST ) , and hepatic apoptotic/inflammatory markers ( cytokeratin 18 and fetuin a ) were not reduced with either exercise training intervention ( P>0.05 ) . Both HIIT and MICT lowered IHL ( HIIT , -37.0±12.4 % ; MICT , -20.1±6.6 % , P reduction in IHL was not statistically different between exercise intensities ( P=0.25 ) . Furthermore , exercise training decreased postpr and ial insulin , c-peptide , and lipid peroxidation levels ( iAUC , P high intensity and moderate intensity exercise are effective at decreasing IHL and NAFLD risk that is not contingent upon reductions in abdominal adiposity or body mass",
"Aging is associated with decreased aerobic fitness and cardiac remodeling leading to increased risk for cardiovascular disease . High-intensity interval training ( HIIT ) on the treadmill has been reported to be more effective in ameliorating these risk factors compared with moderate-intensity continuous training ( MICT ) in patients with cardiometabolic disease . In older adults , however , weight-bearing activities are frequently limited due to musculoskeletal and balance problems . The purpose of this study was to examine the feasibility and safety of non-weight-bearing all-extremity HIIT in older adults . In addition , we tested the hypothesis that all-extremity HIIT will be more effective in improving aerobic fitness , cardiac function , and metabolic risk factors compared with all-extremity MICT . Fifty-one healthy sedentary older adults ( age : 65±1years ) were r and omized to HIIT ( n=17 ) , MICT ( n=18 ) or non-exercise control ( CONT ; n=16 ) . HIIT ( 4 × 4min 90 % of peak heart rate ; HRpeak ) and isocaloric MICT ( 70 % of HRpeak ) were performed on a non-weight-bearing all-extremity ergometer , 4 × /week for 8weeks under supervision . All-extremity HIIT was feasible in older adults and result ed in no adverse events . Aerobic fitness ( peak oxygen consumption ; VO2peak ) and ejection fraction ( echocardiography ) improved by 11 % ( P Greater improvements in ejection fraction were associated with greater improvements in VO2peak ( r=0.57 ; P ) decreased only in HIIT by 26 % ( P=0.016 ) . Diastolic function , body composition , glucose and lipids were unaffected ( P≥0.1 ) . In conclusion , all-extremity HIIT is feasible and safe in older adults . HIIT , but not MICT , improved aerobic fitness , ejection fraction , and insulin resistance ",
"Musa , DI , Adeniran , SA , Dikko , AU , and Sayers , SP . The effect of a high-intensity interval training program on high-density lipoprotein cholesterol in young men . J Strength Cond Res 23(2 ) : 587 - 592 , 2009-This study examined the impact of an 8-week program of high-intensity interval training on high-density lipoprotein cholesterol ( HDL-C ) , total cholesterol ( TC ) , and the atherogenic index ( TC/HDL-C ) in 36 untrained men ages 21 - 36 years . Participants were r and omly assigned to an interval training group ( n = 20 ) or a control group ( n = 16 ) . Participants in the experimental group performed 3.2 km of interval running ( 1:1 work : rest ratio ) 3 times a week for 8 weeks at an intensity of 90 % of maximal heart rate ( ∼423 kcal per session ) . Results indicated significant pre- to posttraining changes in HDL-C ( 1.1 vs. 1.3 mmol·L−1 , p 0.0001 ) and TC/HDL-C ( 3.8 vs. 3.1 , p changes in TC ( 3.9 vs. 3.8 mmol·L−1 , p > 0.05 ) with interval training . It was concluded that an 8-week program of high-intensity interval training is effective in eliciting favorable changes in HDL-C and TC/HDL-C but not TC in young adult men with normal TC levels . Our findings support the recommendations of high-intensity interval training as an alternative mode of exercise to improve blood lipid profiles for individuals with acceptable physical fitness levels",
"Purpose It remains to be established how high-intensity aerobic interval training ( HAIT ) affects risk factors associated with type 2 diabetes ( TD2 ) . This study investigated effects of HAIT on maximal oxygen uptake ( VO2max ) , glycated Hemoglobin type A1C ( HbA1c ) , insulin resistance ( IR ) , fat oxidation ( FatOx ) , body weight ( BW ) , percent body fat ( % BF ) , lactate threshold ( LT ) , blood pressure ( BP ) , and blood lipid profile ( BLP ) among persons with T2D . Results were compared to the effects after a moderate-intensity training ( MIT ) program . Methods Thirty-eight individuals with T2D completed 12 weeks of supervised training . HAIT consisted of 4 × 4 min of walking or running uphill at 85–95 % of maximal heart rate , and MIT consisted of continuous walking at 70–75 % of maximal heart rate . Results A 21 % increase in VO2max ( from 25.6 to 30.9 ml kg−1 min−1 , p reduction in HbA1c by −0.58 % points ( from 7.78 to 7.20 % , p in HAIT . BW and body mass index ( BMI ) was reduced by 1.9 % ( p improved FatOx at 60 % VO2max ( 14 % , p = 0.065 ) . These improvements were significant different from MIT . Both HAIT and MIT increased velocity at LT , and reduced % BF , waist circumference , hip circumference , and BP , with no significant differences between the two groups . Correlations were found between change in VO2max and change in HbA1c when the two intervention groups were combined ( R = −0.52 , p Conclusion HAIT is an effective exercise strategy to improve aerobic fitness and reduce risk factors associated with T2D",
"Introduction : Several established tools are available to assess study quality and reporting of r and omized controlled trials ; however , these tools were design ed with clinical intervention trials in mind . In exercise training intervention trials some of the traditional study quality criteria , such as participant or research er blinding , are extremely difficult to implement . Methods : We developed the Tool for the assEssment of Study qualiTy and reporting in EXercise ( TESTEX ) – a study quality and reporting assessment tool , design ed specifically for use in exercise training studies . Our tool is a 15-point scale ( 5 points for study quality and 10 points for reporting ) and addresses previously unmentioned quality assessment criteria specific to exercise training studies . Results : There were no systematic differences between the summated TESTEX scores of each observer [ H(2 ) = 0.392 , P = 0.822 ] . There was a significant association between the summated TESTEX scores of the three observers , with almost perfect agreement between observers 1 and 2 [ intra-class correlation coefficient ( ICC ) = 0.93 , 95 % confidence interval ( CI ) 0.82–0.97 , P TESTEX scale is a new , reliable tool , specific to exercise scientists , that facilitates a comprehensive review of exercise training trials",
"The purpose of this study was to examine the effect of interval and continuous exercise programs on plasma lipoproteins , apoproteins , and lecithin : cholesterol acyltransferase ( LCAT ) . Thirty-six college male students ( age 18 - 25 yrs . ) were r and omly assigned to a 5 mile continuous exercise group , 4 minute interval ( 1:1 , work : rest ) , 2 minute interval ( 1:1 - 1/2 , work : rest ) , or control . Workloads were equated by kcal expenditure/workout . The training groups exercised for one hour three times a week for 11 weeks . Neither interval or continuous exercise programs significantly altered plasma total cholesterol , high density lipoprotein cholesterol ( HDL-C ) , apoprotein A-1 ( Apo A-1 ) , apoprotein B ( Apo B ) , or LCAT . Posttest maximal oxygen consumption was significantly higher than pretest for the 4 minute interval and 5 mile continuous groups . Thus continuous exercise and long interval programs result ed in gains in aerobic capacity , but none of the training programs were effective in altering the plasma lipoproteins or apoproteins investigated",
"Abstract Background : High-intensity interval training ( HIIT ) has been shown to improve cardiometabolic health during supervised lab-based studies but adherence , enjoyment , and health benefits of HIIT performed independently are yet to be understood . We compared adherence , enjoyment , and cardiometabolic outcomes after 8 weeks of HIIT or moderate-intensity continuous training ( MICT ) , matched for energy expenditure , in overweight and obese young adults . Methods : 17 adults were r and omized to HIIT or MICT . After completing 12 sessions of supervised training over 3 weeks , participants were asked to independently perform HIIT or MICT for 30 min , 4 times/week for 5 weeks . Cardiometabolic outcomes included cardiorespiratory fitness ( VO2 peak ) , lipids , and inflammatory markers . Exercise enjoyment was measured by the vali date d Physical Activity Enjoyment Scale . Results : Exercise adherence ( 93.4 ± 3.1 % vs. 93.1 ± 3.7 % , respectively ) and mean enjoyment across the intervention ( 100.1 ± 4.3 vs. 100.3 ± 4.4 , respectively ) were high , with no differences between HIIT and MICT ( p > .05 ) . Similarly , enjoyment levels did not change over time in either group ( p > .05 ) . After training , HIIT exhibited a greater decrease in low-density lipoprotein cholesterol than MICT ( −0.66 mmol L−1 vs. −0.03 mmol L−1 , respectively ) and a greater increase in VO2 peak than MICT ( p min−1 , respectively ) . Interleukin-6 and C-reactive protein increased in HIIT ( + 0.5 pg mL−1 and + 31.4 nmol L−1 , respectively ) and decreased in MICT ( −0.6 pg mL−1 and −6.7 nmol L−1 , respectively , p that HIIT is enjoyable and has high unsupervised adherence rates in overweight and obese adults . However , HIIT may be associated with an increase in inflammation with short-term exercise in this population",
"Background — Higher levels of physical activity are associated with fewer cardiovascular disease ( CVD ) events . Although the precise mechanisms underlying this inverse association are unclear , differences in several cardiovascular risk factors may mediate this effect . Methods and Results — In a prospect i ve study of 27 055 apparently healthy women , we measured baseline levels of hemoglobin A1c , traditional lipids ( total , low-density lipoprotein , and high-density lipoprotein cholesterol ) , novel lipids [ lipoprotein(a ) and apolipoprotein A1 and B-100 ] , creatinine , homocysteine , and inflammatory/hemostatic biomarkers ( high-sensitivity C-reactive protein , fibrinogen , soluble intracellular adhesion molecule-1 ) and used women 's self-reported physical activity , weight , height , hypertension , and diabetes . Mean follow-up was 10.9±1.6 years , and 979 incident CVD events occurred . The risk of CVD decreased linearly with higher levels of activity ( P for linear trend relative risk reductions associated with 200 to 599 , 600 to 1499 , and ≥1500 kcal/wk of 27 % , 32 % , and 41 % , respectively . Differences in known risk factors explained a large proportion ( 59.0 % ) of the observed inverse association . When sets of risk factors were examined , inflammatory/hemostatic biomarkers made the largest contribution to lower risk ( 32.6 % ) , followed by blood pressure ( 27.1 % ) . Novel lipids contributed less to CVD risk reduction compared with traditional lipids ( 15.5 % and 19.1 % , respectively ) . Smaller contributions were attributed to body mass index ( 10.1 % ) and hemoglobin A1c/diabetes ( 8.9 % ) , whereas homocysteine and creatinine had negligible effects ( physical activity and CVD risk is mediated in substantial part by known risk factors , particularly inflammatory/hemostatic factors and blood pressure ",
"Reduced-exertion high-intensity interval training ( REHIT ) is a genuinely time-efficient intervention that can improve aerobic capacity and insulin sensitivity in sedentary individuals . The present study compared the effects of REHIT and moderate-intensity walking on health markers in patients with type 2 diabetes ( T2D ) in a counter-balanced crossover study . Sixteen men with T2D ( mean ± SD age : 55 ± 5 years , body mass index : 30.6 ± 2.8 kg·m-2 , maximal aerobic capacity : 27 ± 4 mL·kg-1·min-1 ) completed 8 weeks of REHIT ( three 10-min low-intensity cycling sessions/week with two \" all-out \" 10 - 20-s sprints ) and 8 weeks of moderate-intensity walking ( five 30-min sessions/week at an intensity corresponding to 40%-55 % of heart-rate reserve ) , with a 2-month wash-out period between interventions . Before and after each intervention , participants underwent an incremental fitness test , an oral glucose tolerance test ( OGTT ) , a whole-body dual-energy X-ray absorptiometry scan , and continuous glucose monitoring . REHIT was associated with a significantly larger increase in maximal aerobic capacity compared with walking ( 7 % vs. 1 % ; time × intervention interaction effect : p 0.05 ) . Both REHIT and walking decreased resting mean arterial pressure ( -4 % ; main effect of time : p ) and plasma fructosamine ( -5 % ; main effect of time : p significantly improved OGTT-derived measures of insulin sensitivity , glycaemic control measured using continuous glucose monitors , blood lipid profile , or body composition . We conclude that REHIT is superior to a 5-fold larger volume of moderate-intensity walking in improving aerobic fitness , but similar to walking REHIT is not an effective intervention for improving insulin sensitivity or glycaemic control in T2D patients in the short term",
"PURPOSE The purpose of this study was to determine the effectiveness of brief intense interval training as exercise intervention for promoting health and to evaluate potential benefits about common interventions , that is , prolonged exercise and strength training . METHODS Thirty-six untrained men were divided into groups that completed 12 wk of intense interval running ( INT ; total training time 40 min wk(-1 ) ) , prolonged running ( approximately 150 min wk(-1 ) ) , and strength training ( approximately 150 min wk(-1 ) ) or continued their habitual lifestyle without participation in physical training . RESULTS The improvement in cardiorespiratory fitness was superior in the INT ( 14 % + /- 2 % increase in V˙O2max ) compared with the other two exercise interventions ( 7 % + /- 2 % and 3 % + /- 2 % increases ) . The blood glucose concentration 2 h after oral ingestion of 75 g of glucose was lowered to a similar extent after training in the INT ( from 6.1 + /- 0.6 to 5.1 + /- 0.4 mM , P efficient than prolonged running for lowering the subjects ' resting HR , fat percentage , and reducing the ratio between total and HDL plasma cholesterol . Furthermore , total bone mass and lean body mass remained unchanged in the INT group , whereas both these parameters were increased by the strength-training intervention . CONCLUSIONS INT for 12 wk is an effective training stimulus for improvement of cardiorespiratory fitness and glucose tolerance , but in relation to the treatment of hyperlipidemia and obesity , it is less effective than prolonged training . Furthermore and in contrast to strength training , 12 wk of INT had no impact on muscle mass or indices of skeletal health",
"Objective . The purpose of this study was to assess the effect of high intensity interval training ( HIIT ) versus continuous aerobic exercise training ( CONT ) or placebo ( PLA ) on body composition by r and omized controlled design . Methods . Work capacity and body composition ( dual-energy X-ray absorptiometry ) were measured before and after 12 weeks of intervention in 38 previously inactive overweight adults . Results . There was a significant group × time interaction for change in work capacity ( P percentage trunk fat , with trunk fat reducing in CONT by 3.1 ± 1.6 % and in PLA by 1.1 ± 0.4 % , but not in HIIT ( increase of 0.7 ± 1.0 % ) ( P = 0.07 ) . There was a significant reduction in and roid fat percentage in CONT ( 2.7 ± 1.3 % ) and PLA ( 1.4 ± 0.8 % ) but not HIIT ( increase of 0.8 ± 0.7 % ) ( P = 0.04 ) . Conclusion . These data suggest that HIIT may be advocated as a time-efficient strategy for eliciting comparable fitness benefits to traditional continuous exercise in inactive , overweight adults . However , in this population HIIT does not confer the same benefit to body fat levels as continuous exercise training ",
"UNLABELLED High intensity interval training ( HIIT ) has become an increasingly popular form of exercise due to its potentially large effects on exercise capacity and small time requirement . This study compared the effects of two HIIT protocol s vs steady-state training on aerobic and anaerobic capacity following 8-weeks of training . Fifty-five untrained college-aged subjects were r and omly assigned to three training groups ( 3x weekly ) . Steady-state ( n = 19 ) exercised ( cycle ergometer ) 20 minutes at 90 % of ventilatory threshold ( VT ) . Tabata ( n = 21 ) completed eight intervals of 20s at 170 % VO2max/10s rest . Meyer ( n = 15 ) completed 13 sets of 30s ( 20 min ) @ 100 % PVO2 max/ 60s recovery , average PO = 90 % VT . Each subject did 24 training sessions during 8 weeks . RESULTS There were significant ( p VO2max ( + 19 , + 18 and + 18 % ) and PPO ( + 17 , + 24 and + 14 % ) for each training group , as well as significant increases in peak ( + 8 , + 9 and + 5 % ) & mean ( + 4 , + 7 and + 6 % ) power during Wingate testing , but no significant differences between groups . Measures of the enjoyment of the training program indicated that the Tabata protocol was significantly less enjoyable ( p enjoyment of all protocol s declined ( p time efficient , they are not superior to conventional exercise training in sedentary young adults . Key pointsSteady state training equivalent to HIIT in untrained studentsMild interval training presents very similar physiologic challenge compared to steady state trainingHIIT ( particularly very high intensity variants were less enjoyable than steady state or mild interval trainingEnjoyment of training decreases across the course of an 8 week experimental training program",
"This is the first study to show that enjoyment for high-intensity interval exercise increases with chronic training . Prior acute studies typically report high-intensity interval training ( HIT ) as being more enjoyable than moderate continuous training ( MCT ) unless the high-intensity intervals are too strenuous or difficult to complete . It follows that exercise competency may be a critical factor contributing to the enjoyment of HIT , and therefore building competency through chronic training may be one way to increase its enjoyment . To test this , we r and omly assigned sedentary young adults to six weeks of HIT or MCT , and tracked changes in their enjoyment for the exercise . Enjoyment for HIT increased with training whereas enjoyment for MCT remained constant and lower . Changes in exercise enjoyment were predicted by increases in workload , suggesting that strength adaptions may be important for promoting exercise enjoyment . The results point to HIT as a promising protocol for promoting exercise enjoyment and adherence in sedentary young adults",
"Background In research clinic setting s , overweight adults undertaking HIIT ( high intensity interval training ) improve their fitness as effectively as those undertaking conventional walking programs but can do so within a shorter time spent exercising . We undertook a r and omized controlled feasibility ( pilot ) study aim ed at extending HIIT into a real world setting by recruiting overweight/obese , inactive adults into a group based activity program , held in a community park . Methods Participants were allocated into one of three groups . The two interventions , aerobic interval training and maximal volitional interval training , were compared with an active control group undertaking walking based exercise . Supervised group sessions ( 36 per intervention ) were held outdoors . Cardiorespiratory fitness was measured using VO2max ( maximal oxygen uptake , results expressed in ml/min/kg ) , before and after the 12 week interventions . Results On ITT ( intention to treat ) analyses , baseline ( N = 49 ) and exit ( N = 39 ) O2 was 25.3±4.5 and 25.3±3.9 , respectively . Participant allocation and baseline/exit VO2max by group was as follows : Aerobic interval training N = 16 , 24.2±4.8/25.6±4.8 ; maximal volitional interval training N = 16 , 25.0±2.8/25.2±3.4 ; walking N = 17 , 26.5±5.3/25.2±3.6 . The post intervention change in VO2max was + 1.01 in the aerobic interval training , −0.06 in the maximal volitional interval training and −1.03 in the walking subgroups . The aerobic interval training subgroup increased VO2max compared to walking ( p = 0.03 ) . The actual ( observed , rather than prescribed ) time spent exercising ( minutes per week , ITT analysis ) was 74 for aerobic interval training , 45 for maximal volitional interval training and 116 for walking ( p = 0.001 ) . On descriptive analysis , the walking subgroup had the fewest adverse events . Conclusions In contrast to earlier studies , the improvement in cardiorespiratory fitness in a cohort of overweight/obese participants undertaking aerobic interval training in a real world setting was modest . The most likely reason for this finding relates to reduced adherence to the exercise program , when moving beyond the research clinic setting . Trial Registration ACTR.org.au",
"Purpose To compare the effects of self-paced high-intensity interval and continuous cycle training on health markers in premenopausal women . Methods Forty-five inactive females were r and omised to a high-intensity interval training ( HIIT ; n = 15 ) , continuous training ( CT ; n = 15 ) or an inactive control ( CON ; n = 15 ) group . HIIT performed 5 × 5 min sets comprising repetitions of 30-s low- , 20-s moderate- and 10-s high-intensity cycling with 2 min rest between sets . CT completed 50 min of continuous cycling . Training was completed self-paced , 3 times weekly for 12 weeks . Results Peak oxygen uptake ( 16 ± 8 and 21 ± 12 % ) , resting heart rate ( HR ) ( −5 ± 9 and −4 ± 7 bpm ) and visual and verbal learning improved following HIIT and CT compared to CON ( P ) . Total body mass ( −0.7 ± 1.4 kg ) , submaximal walking HR ( −3 ± 4 bpm ) and verbal memory were enhanced following HIIT ( P whereas mental well-being , systolic ( −5 ± 6 mmHg ) and mean arterial ( −3 ± 5 mmHg ) blood pressures were improved following CT ( P similar levels of enjoyment following HIIT and CT , and there were no changes in fasting serum lipids , fasting blood [ glucose ] or [ glucose ] during an oral glucose tolerance test following either HIIT or CT ( P > 0.05 ) . No outcome variable changed in the CON group ( P > 0.05 ) . Conclusions Twelve weeks of self-paced HIIT and CT were similarly effective at improving cardiorespiratory fitness , resting HR and cognitive function in inactive premenopausal women , whereas blood pressure , submaximal HR , well-being and body mass adaptations were training-type-specific . Both training methods improved established health markers , but the adaptations to HIIT were evoked for a lower time commitment",
"BACKGROUND Increased physical activity is related to reduced risk of cardiovascular disease , possibly because it leads to improvement in the lipoprotein profile . However , the amount of exercise training required for optimal benefit is unknown . In a prospect i ve , r and omized study , we investigated the effects of the amount and intensity of exercise on lipoproteins . METHODS A total of 111 sedentary , overweight men and women with mild-to-moderate dyslipidemia were r and omly assigned to participate for six months in a control group or for approximately eight months in one of three exercise groups : high-amount-high-intensity exercise , the caloric equivalent of jogging 20 mi ( 32.0 km ) per week at 65 to 80 percent of peak oxygen consumption ; low-amount-high-intensity exercise , the equivalent of jogging 12 mi ( 19.2 km ) per week at 65 to 80 percent of peak oxygen consumption ; or low-amount-moderate-intensity exercise , the equivalent of walking 12 mi per week at 40 to 55 percent of peak oxygen consumption . Subjects were encouraged to maintain their base-line body weight . The 84 subjects who complied with these guidelines served as the basis for the main analysis . Detailed lipoprotein profiling was performed by nuclear magnetic resonance spectroscopy with verification by measurement of cholesterol in lipoprotein subfractions . RESULTS There was a beneficial effect of exercise on a variety of lipid and lipoprotein variables , seen most clearly with the high amount of high-intensity exercise . The high amount of exercise result ed in greater improvements than did the lower amounts of exercise ( in 10 of 11 lipoprotein variables ) and was always superior to the control condition ( 11 of 11 variables ) . Both lower-amount exercise groups always had better responses than the control group ( 22 of 22 comparisons ) . CONCLUSIONS The highest amount of weekly exercise , with minimal weight change , had widespread beneficial effects on the lipoprotein profile . The improvements were related to the amount of activity and not to the intensity of exercise or improvement in fitness",
"Lifestyle interventions for weight loss are the cornerstone of obesity therapy , yet their optimal design is debated . This is particularly true for postmenopausal women ; a population with a high prevalence of obesity yet toward whom fewer studies are targeted . We conducted a year-long , 4-arm r and omized trial among 439 overweight-to-obese postmenopausal sedentary women to determine the effects of a calorie-reduced , low-fat diet ( D ) , a moderate-intensity , facility-based aerobic exercise program ( E ) , or the combination of both interventions ( D+E ) , vs. a no-lifestyle-change control ( C ) on change in body weight and composition . The group-based dietary intervention had a weight-reduction goal of ≥10 % , and the exercise intervention consisted of a gradual escalation to 45-min aerobic exercise 5 day/week . Participants were predominantly non-Hispanic whites ( 85 % ) with a mean age of 58.0 ± 5.0 years , a mean BMI of 30.9 ± 4.0 kg/m(2 ) and an average of 47.8 ± 4.4 % body fat . Baseline and 12-month weight and adiposity measures were obtained by staff blinded to participants ' intervention assignment . Three hundred and ninety nine women completed the trial ( 91 % retention ) . Using an intention-to-treat analysis , average weight loss at 12 months was -8.5 % for the D group ( P decrease . BMI , waist circumference , and % body fat were also similarly reduced . Among postmenopausal women , lifestyle-change involving diet , exercise , or both combined over 1 year improves body weight and adiposity , with the greatest change arising from the combined intervention",
"The first aim of this study was to determine the exercise intensity that elicited the highest rate of fat oxidation in sedentary , obese subjects ( OB ; n=10 men , n=10 women ) compared with endurance athletes ( AT ; n=10 men , n=10 women ) . The second aim was to investigate the relationship between VO2 at the intensity eliciting the highest rate of fat oxidation and the corresponding VO2 at the lactate threshold . Peak oxygen consumption ( VO2peak ) was determined in 20 AT and 20 OB using an incremental exercise protocol on a cycle ergometer . Based on their VO2peak values , subjects completed a protocol requiring them to exercise for 20 min at three different workloads ( 55 , 65 and 75 % VO2peak ) , r and omly assigned on two separate occasions . The oxidation rates of fat and carbohydrate were measured by indirect calorimetry . The highest rates of fat oxidation were at 75 % VO2peak ( AT ) , and at 65 % VO2peak ( OB ) . The rate of fat oxidation was significantly higher in AT ( 18.2 ± 6.1 ) compared with OB women ( 10.6 ± 4.5 kJ min(-1)·kg(-1 ) ) ( p difference in the rate of fat oxidation for the men ( AT 19.7 ± 8.1 vs. OB 17.6 ± 8.2 kJ min(-1)·kg(-1 ) ) . AT reached LT at a significantly ( p expressed in VO2peak than obese subjects ( AT women 76.4 ± 0.1 , men 77.3 ± 0.1 vs. OB women , 49.7 ± 0.1 , men 49.5 ± 0.1 % VO2peak ) . A significant correlation was found between VO2 at LT and VO2 ( L·min(-1 ) ) eliciting the maximal rate of fat oxidation in athletes ( women ; r = 0.67 ; p = 0.03 ; men : r = 0.75 ; p = 0.01 ) but not in the obese . In summary , we observed higher rates of fat oxidation at higher relative work rates in AT compared with OB . A significant correlation was found between LT and the exercise intensity eliciting a high rate of fat oxidation in AT ( r=0.89 ; p rate of fat oxidation and LT . Key PointsWithin the tested intensities of 55 , 65 and 75 % VO2peak athletes reached higher rates of fat oxidation at higher relative work rates compared with obese subjects . We found in obese women and men the intensity of the highest rate of fat oxidation at 65 % VO2peak . Between the lactate threshold and the intensity eliciting a high rate of fat oxidation a significant correlation was found in athletes but not in obese subjects",
"AIM This study compared the effect of high-intensity interval training ( HIIT ) and moderate-intensity continuous training ( MICT ) for 16 weeks on whole-body and abdominal fat mass ( FM ) in postmenopausal women with type 2 diabetes ( T2D ) . METHODS Seventeen women ( 69±1 years ; BMI : 31±1kg.m-2 ) were r and omly assigned to either a HIIT [ 60 × (8s at 77 - 85 % HRmax , 12s of active recovery ) ] or MICT ( 40min at 55 - 60 % of their individual HRR ) cycling program for 16 weeks , 2 days/week . Dual-energy X-ray absorptiometry was used to measure whole-body and regional FM content , including abdominal adiposity and visceral adipose tissue . Plasma cholesterol , HDL , LDL , triglycerides , glucose and HbA1c levels were measured . Levels of nutritional intake and physical activity were evaluated by 7-day self-reports . RESULTS Dietary energy ( caloric ) intake , physical activity level and total body mass did not vary in either group from the beginning to the end of the training intervention . Overall , total FM decreased and total fat-free mass significantly increased over time ( by around 2 - 3 % ) . Total FM reduction at the end of the intervention was not significantly different between groups . However , significant loss of total abdominal ( -8.3±2.2 % ) and visceral ( -24.2±7.7 % ) FM was observed only with HIIT . Time effects were noted for HbA1c and total cholesterol/HDL ratio . CONCLUSION With no concomitant caloric restriction , an HIIT program in postmenopausal women with T2D ( twice a week for 16 weeks ) appeared to be more effective for reducing central obesity than MICT , and could be proposed as an alternative exercise training program for this population",
"Background Following publication of the PRISMA statement , the UK Centre for Review s and Dissemination ( CRD ) at the University of York in Engl and began to develop an international prospect i ve register of systematic review s with health-related outcomes . The objectives were to reduce unplanned duplication of review s and provide transparency in the review process , with the aim of minimizing reporting bias . Methods An international advisory group was formed and a consultation undertaken to establish the key items necessary for inclusion in the register and to gather views on various aspects of functionality . This article describes the development of the register , now called PROSPERO , and the process of registration . Results PROSPERO offers free registration and free public access to a unique prospect i ve register of systematic review s across all areas of health from all around the world . The dedicated web-based interface is electronically search able and available to all prospect i ve registrants . At the moment , inclusion in PROSPERO is restricted to systematic review s of the effects of interventions and strategies to prevent , diagnose , treat , and monitor health conditions , for which there is a health-related outcome .Ideally , registration should take place before the research ers have started formal screening against inclusion criteria but review s are eligible as long as they have not progressed beyond the point of completing data extraction .The required data set captures the key attributes of review design as well as the administrative details necessary for registration .Su bmi tted registration forms are checked against the scope for inclusion in PROSPERO and for clarity of content before being made publicly available on the register , rejected , or returned to the applicant for clarification . The public records include an audit trail of major changes to planned methods , details of when the review has been completed , and links to result ing publications when provided by the authors . Conclusions There has been international support and an enthusiastic response to the principle of prospect i ve registration of protocol s for systematic review s and to the development of PROSPERO .In October 2011 , PROSPERO contained 200 records of systematic review s being undertaken in 26 countries around the world on a diverse range of interventions",
"This study was design ed to investigate the effect of exercise intensity on cardiorespiratory fitness and coronary heart disease risk factors . Maximum oxygen consumption ( Vo(2 max ) ) , lipid , lipoprotein , and fibrinogen concentrations were measured in 64 previously sedentary men before r and om allocation to a nonexercise control group , a moderate-intensity exercise group ( three 400-kcal sessions per week at 60 % of Vo(2 max ) ) , or a high-intensity exercise group ( three 400-kcal sessions per week at 80 % of Vo(2 max ) ) . Subjects were instructed to maintain their normal dietary habits , and training heart rates were represcribed after monthly fitness tests . Forty-two men finished the study . After 24 wk , Vo(2 max ) increased by 0.38 + /- 0.14 l/min in the moderate-intensity group and by 0.55 + /- 0.27 l/min in the high-intensity group . Repeated- measures analysis of variance identified a significant interaction between monthly Vo(2 max ) score and exercise group ( F = 3.37 , P total cholesterol , low-density lipoprotein cholesterol , non-high-density lipoprotein cholesterol , and fibrinogen concentrations changed favorably across control , moderate-intensity , and high-intensity groups . However , significant changes in total cholesterol ( -0.55 + /- 0.81 mmol/l ) , low-density lipoprotein cholesterol ( -0.52 + /- 0.80 mmol/l ) , and non-high-density lipoprotein cholesterol ( -0.54 + /- 0.86 mmol/l ) were only observed in the high-intensity group ( all P high-intensity training is more effective in improving cardiorespiratory fitness than moderate-intensity training of equal energy cost . These data also suggest that changes in coronary heart disease risk factors are influenced by exercise intensity",
"KEY POINTS Skeletal muscle capillary density and vasoreactivity are reduced in obesity , due to reduced nitric oxide bioavailability . Sprint interval training ( SIT ) has been proposed as a time efficient alternative to moderate-intensity continuous training ( MICT ) , but its effect on the skeletal muscle microvasculature has not been studied in obese individuals . We observed that SIT and MICT led to equal increases in capillarisation and endothelial eNOS content , while reducing endothelial NOX2 content in microvessels of young obese men . We conclude that SIT is equally effective at improving skeletal muscle capillarisation and endothelial enzyme balance , while being a time efficient alternative to traditional MICT . ABSTRACT Sprint interval training ( SIT ) has been proposed as a time efficient alternative to moderate-intensity continuous training ( MICT ) , leading to similar improvements in skeletal muscle capillary density and microvascular function in young healthy humans . In this study we made the first comparisons of the muscle microvascular response to SIT and MICT in an obese population . Sixteen young obese men ( age 25 ± 1 years , BMI 34.8 ± 0.9 kg m(-2 ) ) were r and omly assigned to 4 weeks of MICT ( 40 - 60 min cycling at ∼65 % V̇O2 peak , 5 times per week ) or constant load SIT ( 4 - 7 constant workload intervals of 200 % Wmax 3 times per week ) . Muscle biopsies were taken before and after training from the m. vastus lateralis to measure muscle microvascular endothelial eNOS content , eNOS serine(1177 ) phosphorylation , NOX2 content and capillarisation using quantitative immunofluorescence microscopy . Maximal aerobic capacity ( V̇O2 peak ) , whole body insulin sensitivity and arterial stiffness were also assessed . SIT and MICT increased skeletal muscle microvascular eNOS content and eNOS ser(1177 ) phosphorylation in terminal arterioles and capillaries ( P 0.217 ) . SIT and MICT also reduced microvascular endothelial NOX2 content ( P both increased capillary density and capillary-fibre perimeter exchange index ( P parallel , SIT and MICT increased V̇O2 peak ( P 0.05 ) and whole body insulin sensitivity ( P 0.05 ) , and reduced central artery stiffness ( P between SIT and MICT it is concluded that SIT is a time efficient alternative to MICT to improve aerobic capacity , insulin sensitivity and muscle capillarisation and endothelial eNOS/NAD(P)Hoxidase protein ratio in young obese men",
"To test the hypothesis that high-intensity swim training improves cardiovascular health status in sedentary premenopausal women with mild hypertension , sixty-two women were r and omized into high-intensity ( n = 21 ; HIT ) , moderate-intensity ( n = 21 ; MOD ) , and control groups ( n = 20 ; CON ) . HIT performed 6 - 10 × 30 s all-out swimming interspersed by 2 min recovery and MOD swam continuously for 1 h at moderate intensity for a 15-week period completing in total 44 ± 1 and 43 ± 1 sessions , respectively . In CON , all measured variables were similar before and after the intervention period . Systolic BP decreased ( P respectively . Resting heart rate declined ( P HIT and MOD , fat mass decreased ( P while the blood lipid profile was unaltered . In HIT and MOD , performance improved ( P Yo-Yo IE1 running performance ( 58 ± 5 % and 45 ± 4 % ) . In conclusion , high-intensity intermittent swimming is an effective training strategy to improve cardiovascular health and physical performance in sedentary women with mild hypertension . Adaptations are similar with high- and moderate-intensity training , despite markedly less total time spent and distance covered in the high-intensity group"
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Objective To produce a best evidence synthesis of the clinical effects of topical glyceryl trinitrate ( GTN ) in the treatment of tendinopathies . Design A systematic review of published r and omised controlled trials ( RCTs ) of the use of GTN in patients with tendinopathy . Data sources MEDLINE , Embase , Scopus and CINAHL from data base inception to January 2018 . Methods We examined RCTs comparing the effects of topical GTN with either placebo or other treatments on tendinopathy . Overall quality of each eligible study was determined based on a combined assessment of internal validity , external validity and precision . The level of evidence for each assessed parameter was rated based on the system by van Tulder et al. Results A total of 10 eligible RCTs were identified including patients with tendinopathy of the rotator cuff ( n=4 ) , wrist extensors ( n=3 ) , Achilles ( n=2 ) and patellar ( n=1 ) tendons . For all tendinopathies , improvements in pain were significant when comparing GTN versus placebo in the short term ( GTN versus placebo included the following : patient satisfaction ( strong evidence ) ; chances of being asymptomatic with activities of daily living ( strong evidence ) ; range of movement ( moderate evidence ) ; strength ( moderate evidence ) ; pain ( at night and with activity ; poor evidence ) and local tenderness ( poor evidence ) . Patients treated with topical GTN reported a higher incidence of headaches than those who received placebo ( moderate evidence ) . Conclusions and relevance Treatment of tendinopathies with topical GTN for up to 6 months appears to be superior to placebo and may therefore be a useful adjunct to the treating healthcare professions
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"AIMS To compare transdermal nitroglycerin ( NTG ) and corticosteroid infiltration in patients with rotator cuff tendinitis ( RCT ) . DESIGN Experimental , r and omized controlled study . SETTING Semirural basic health area in the Garraf region of Barcelona province , Spain , with a population of public health service users of 12000 . PATIENTS AND METHODS Patients diagnosed as having RCT of less than 6 weeks ' evolution who had not responded to treatment with oral nonsteroid antiinflammatory drugs . The patients were distributed r and omly into two groups : a ) group A , local infiltration via a posterior approach with a depot corticosteroid and local anesthesia , and b ) group B , treated for 3 days with a 5-mg NTC patch . MAIN MEASURES Age , sex , pain ( measured with an analog visual scale ) and adverse events . In patients who showed a partial response , treatment was repeated up to 3 times at 15-day intervals . Pain was tested after 7 - 10 days of treatment . Complete improvement was considered a reduction in pain of more than 5 points on the analog visual scale ; partial improvement was considered a reduction of 3 - 5 points , and treatment failure was recorded when there was no improvement in pain or when there was a decrease of less than 3 points . RESULTS A total of 48 patients were included ; 33 ( 69 % ) were women and 15 ( 31 % ) were men . Mean age was 61 years . In group A , complete improvement was seen in 19 patients and partial improvement in 3 ; treatment failed in 2 patients . In group B complete improvement was seen in 5 patients , partial improvement in 5 , and failure of treatment in 14 . The difference between groups was statistically significant . Adverse events were mild pain at the injection site in 4 patients from group A , and headache in 15 patients from group B , 8 of whom ab and oned treatment for this reason . CONCLUSION Treatment with NTG is not a clear alternative to infiltration of corticosteroids in patients with RCT , because of its lack of effectiveness and because of the greater number of patients who had adverse events that lead them to ab and on treatment",
"Background Painful shoulders pose a substantial socioeconomic burden . A prospect i ve cost-of-illness study was performed to assess the costs associated with healthcare use and loss of productivity in patients with shoulder pain in primary health care in Sweden . Methods The study was performed in western Sweden , in a region with 24 000 inhabitants . Data were collected during six months from electronic patient records at three primary healthcare centres in two municipalities . All patients between 20 and 64 years of age who presented with shoulder pain to a general practitioner or a physiotherapist were included . Diagnostic codes were used for selection , and the cases were manually controlled . The cost for sick leave was calculated according to the human capital approach . Sensitivity analysis was used to explore uncertainty in various factors used in the model . Results 204 ( 103 women ) patients , mean age 48 ( SD 11 ) years , were registered . Half of the cases were closed within six weeks , whereas 32 patients ( 16 % ) remained in the system for more than six months . A fifth of the patients were responsible for 91 % of the total costs , and for 44 % of the healthcare costs . The mean healthcare cost per patient was € 326 ( SD 389 ) during six months . Physiotherapy treatments accounted for 60 % . The costs for sick leave contributed to 84 % of the total costs . The mean annual total cost was € 4139 per patient . Estimated costs for secondary care increased the total costs by one third . Conclusions The model applied in this study provides valuable information that can be used in cost evaluations . Costs for secondary care and particularly for sick leave have a major influence on total costs and interventions that can reduce long periods of sick leave are warranted",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Objectives To assess if continuous topical glyceryl trinitrate ( GTN ) treatment improves outcome in patients with chronic patellar tendinopathy when compared with eccentric training alone . Methods R and omised double-blind , placebo-controlled clinical trial comparing a 12-week programme of using a GTN or placebo patch in combination with eccentric squats on a decline board . Measurements were performed at baseline , 6 , 12 and 24 weeks . Primary outcome measure was the Victorian Institute of Sports Assessment -Patella ( VISA-P ) question naire . Secondary outcome measures were patient satisfaction and pain scores during sports . Generalised estimated equation was used to analyse the treatment , time and treatment × time effect . Analyses were performed following the intention-to-treat principle . Results VISA-P scores for both groups improved over the study period to 75.0±16.2 and 80.7±22.1 at 24 weeks . Results showed a significant effect for time ( p ( p=0.80 ) . Mean Visual Analogue Scores pain scores during sports for both groups increased over the study period to 6.6±3 and 7.8±3.1 . Results showed a significant effect for time ( p × time ( p=0.38 ) . Patient satisfaction showed no difference between GTN and placebo groups ( p=0.25 ) after 24 weeks , but did show a significant difference over time ( p=0.01 ) . Three patients in the GTN group reported some rash . Conclusion It seems that continuous topical GTN treatment in addition to an eccentric exercise programme does not improve clinical outcome compared to placebo patches and an eccentric exercise programme in patients with chronic patellar tendinopathy",
"Study design : A clinical blind study was conducted to determine the efficacy of transdermal nitroglycerine treatment on the awareness of shoulder pain . Objective : This study aims to determine the effects of transdermal nitroglycerine on shoulder pain and on functional shoulder movement in patients with spinal cord injuries and shoulder tendinopathies . A second aim is to establish the side effects of the treatment . Setting : Hospital “ La Fe ” in Valencia , Spain . Methods : A total of 45 spinal cord injury patients , all of whom are wheelchair users with shoulder tendinopathy , were r and omly divided into two groups : placebo ( n=12 ) and experimental ( n=33 ) . The experimental group ( EG ) received transdermal treatment for 6 months in the form of a 1.25 mg nitroglycerine ( NT ) patch on the greater tubercle . A placebo patch was used with the placebo subjects . Functional shoulder movements were assessed by articular range of motion and pain , using a visual analogical scale . Results : NT treatment reduced the awareness of shoulder pain and increased the functional movement and range of articular motion in the shoulders of the EG members ( P transdermal NT is an efficient method for treating shoulder tendinopathies in wheelchair users with spinal cord injuries",
"Background Topical glyceryl trinitrate therapy has previously demonstrated short-term pain reduction in patients with supraspinatus tendinopathy . Hypothesis Topical glyceryl trinitrate improves outcome measures in patients with supraspinatus tendinopathy . Study Design R and omized controlled clinical trial ; Level of evidence , 1 . Methods Fifty-three patients ( 57 shoulders ) were recruited , and the authors completed a prospect i ve , r and omized , double-blinded , placebo-controlled clinical trial of continuous topical glyceryl trinitrate treatment ( 1.25 mg/24-h glyceryl trinitrate ) . Results The glyceryl trinitrate group had significantly reduced shoulder pain with activity , at night , and at rest at week 24 ( P = . 03 ) ; reduced internal rotation impingement at week 24 ( P = . 02 ) ; increased range of motion in abduction and internal rotation at week 24 ( P = . 04 ) ; and increased force at weeks 12 and 24 with supraspinatus muscle testing ( P = . 001 ) , external rotation ( P = . 04 ) , internal rotation ( P = . 01 ) , adduction ( P = . 04 ) , and subscapularis pushoff ( P = . 01 ) . Forty-six percent of patients on glyceryl trinitrate patches were asymptomatic with activities of daily living at 6 months compared with 24 % of patients with tendon rehabilitation alone ( P = . 007 , χ2 analysis ) . Mean effect size for all outcome measures was 0.26 . Discussion Topical glyceryl trinitrate treatment significantly improved pain scores , range of motion , internal rotation impingement , muscular force , and patient outcomes in patients with supraspinatus tendinopathy . Topical glyceryl trinitrate should be included as part of nonsurgical management of chronic tendinopathies",
"Background : Extensor tendinosis ( “ tennis elbow ” ) is a degenerative overuse tendinopathy of the wrist extensors at their attachment to the lateral humeral epicondyle . No treatment has been universally successful . Topical application of nitric oxide has been used effectively to treat fractures and cutaneous wounds in animal models , presumably by stimulation of collagen synthesis in fibroblasts . Purpose : To determine whether topical nitric oxide can improve outcome of patients with extensor tendinosis . Study Design : Prospect i ve , r and omized , double-blinded clinical trial . Methods : Eighty-six patients with extensor tendinosis were r and omized into two equal groups ; both were instructed to perform a st and ard tendon rehabilitation program . One group received an active glyceryl trinitrate transdermal patch , and the other group received a placebo patch . Results : Patients in the glyceryl trinitrate group had significantly reduced elbow pain with activity at 2 weeks , reduced epicondylar tenderness at 6 and 12 weeks , and an increase in wrist extensor mean peak force and total work at 24 weeks . At 6 months , 81 % of treated patients were asymptomatic during activities of daily living , compared with 60 % of patients who had tendon rehabilitation alone . Conclusions : Application of topical nitric oxide improved early pain with activity , late functional measures , and outcomes of patients with extensor tendinosis",
"Nitric oxide is a small free radical generated by a family of enzymes , the nitric oxide synthases ( NOSs ) . In a series of experiments performed over the last 15 years , we showed that nitric oxide is induced by all 3 isoforms of NOS during tendon healing and that it plays a crucial beneficial role in restoring tendon function . In normal tendons , very little NOS activity was found , whereas in injured rat and human tendons , NOS activity was expressed in healing fibroblasts in a temporal fashion . In healing rat Achilles tendon fibroblasts , the first isoform to be expressed was endothelial NOS , followed by inducible NOS and then brain or neuronal NOS . Systemic inhibition of NOS activity decreased the cross-sectional area and mechanical properties of the healing rodent Achilles tendons . The addition of nitric oxide via nitric oxide-flurbiprofen enhanced rat Achilles tendon healing . The addition of nitric oxide to cultured human tendon cells via chemical means and via adenoviral transfection enhanced collagen synthesis , suggesting that one mechanism for the beneficial effect of nitric oxide on tendon healing might be via matrix synthesis . Most recently , 3 r and omized , double-blind clinical trials evaluated the efficacy of nitric oxide donation via a patch in the management of the tendinopathy . In all 3 clinical trials , there was a significant positive beneficial effect of nitric oxide donation to the clinical symptoms and function of patients with Achilles tendinopathy , tennis elbow , and supraspinatus tendinitis",
"OBJECTIVE The aim of this study was to evaluate the treatment results of the application of nitric oxide ( NO ) in the form of topical glyceryl trinitrate ( GTN ) for the treatment of lateral epicondylitis ( LE ) . METHODS The study included 40 patients with LE r and omized into 2 equal groups . Selection criteria included the presence of pain , tenderness , and positive pain stimulating maneuvers . Glyceryl trinitrate patches were applied to the area of maximal tenderness once a day in the treatment group and placebo patches in the control group . Outcomes in terms of pain relief was assessed using the visual analog scale ( VAS ) and were evaluated according to the criteria of Verhaar et al. Excellent or good results were considered successful . Differences in VAS scores between the two groups were calculated using the Mann-Whitney U-test and the chi-square test was used to investigate distributions of categorical variables ( sex , affected side ) and good and excellent results among groups . RESULTS There were no significant differences in any of the baseline clinical parameters between groups . At the 3rd week follow-up , there were statistically significant differences in the pain measured using VAS between groups ( mean VAS score of the control and treatment groups were 6.45 and 3.15 , respectively ) ( p=0.001 ) . Patients in the GTN group and control group had lower VAS pain scores and reduced elbow pain at 3 weeks ( 3.15 vs 8.05 in the GTN and 6.45 vs 8.80 in the control group ) . In the control group , no patient had excellent or good results while 18 ( 90 % ) patients in treatment group reported successful treatment . There was statistically significant difference in the VAS measured at 6 months between groups ( mean VAS score of the control and treatment groups were 4.85 and 0.70 , respectively ) ( p=0.001 ) . CONCLUSION The administration of NO directly over an area of tendinopathy through a GTN patch reduces pain and other symptoms in chronic LE",
"& NA ; We have conducted a prospect i ve double blind r and omized and placebo controlled clinical study in 20 patients with shoulder pain syndrome caused by supraspinatus tendinitis to determine whether transdermal nitroglycerin ( NTG ) has analgesic action in this condition . In a r and omized manner we used a 5‐mg NTG ( Nitroplast ® ) patch per day over 3 days or similar placebo patches applied in the most painful area . Patients were evaluated before treatment was initiated and after 24 and 48 h. The assessment was made blindly by the same clinical investigator . The follow‐up showed a significant decrease in intensity of pain at 24 h ( 7.05 ± 0.4 to 4.5 ± 0.5 ) and 48 h ( 2 ± 0.3 ) in the NTG group ( P . The mean pain duration , activity of the extremity and hours of sleep also improved in the NTG group , with no significant modification in the placebo group . Two patients experienced headache as a side effect 24 h after treatment was started . Patients in the NTG group remained free of symptoms when they were assessed 15 days later . We conclude that NTG is useful in the treatment of shoulder pain syndrome caused by supraspinatus tendinitis and that this treatment could be a useful approach to the management of this common disturbance and probably also in other tendon musculoskeletal disorders",
"BACKGROUND Noninsertional Achilles tendinopathy is a degenerative overuse disorder . No method has been universally successful in treating this condition . Topically applied nitric oxide has been shown , in animal models , to be effective for the treatment of fractures and cutaneous wounds through mechanisms that may include stimulation of collagen synthesis in fibroblasts . The goal of the present study was to determine if topical glyceryl trinitrate improves clinical outcome measures in patients with Achilles tendinopathy . METHODS A prospect i ve , r and omized , double-blind , placebo-controlled trial involving a total of sixty-five patients ( eighty-four Achilles tendons ) was performed to compare continuous application of topical glyceryl trinitrate ( at a dosage of 1.25 mg per twenty-four hours ) with rehabilitation alone for the treatment of noninsertional Achilles tendinopathy . RESULTS Compared with the control group , the glyceryl trinitrate group showed reduced pain with activity at twelve weeks ( p = 0.02 ) and twenty-four weeks ( p = 0.03 ) , reduced night pain at twelve weeks ( p = 0.04 ) , reduced tenderness at twelve weeks ( p = 0.02 ) , decreased pain scores after the hop test at twenty-four weeks ( p = 0.005 ) , and increased ankle plantar flexor mean total work compared with the baseline level at twenty-four weeks ( p = 0.04 ) . Twenty-eight ( 78 % ) of thirty-six tendons in the glyceryl trinitrate group were asymptomatic with activities of daily living at six months , compared with twenty ( 49 % ) of forty-one tendons in the placebo group ( p = 0.001 , chi-square analysis ) . The mean effect size for all outcome measures was 0.14 . CONCLUSIONS Topical glyceryl trinitrate significantly reduced pain with activity and at night , improved functional measures , and improved outcomes in patients with Achilles tendinopathy",
"Background Topical glyceryl trinitrate ( GTN ) therapy has been advocated in the treatment of Achilles tendinopathy . The mechanism of action is unknown but may be related to modulation of local nitric oxide levels . Hypothesis Topical GTN therapy for noninsertional Achilles tendinopathy will significantly enhance clinical improvement and will be associated with increased collagen synthesis within the tendon . Study Design R and omized controlled clinical trial ; Level of evidence , 1 . Methods Forty patients were recruited . Twenty underwent st and ard nonoperative physical therapy , and 20 underwent physical therapy and topical GTN daily . Clinical outcome was assessed using the Ankle Osteoarthritis Scale ( AOS ) visual analog score . Patients who failed to improve with conservative measures and who underwent surgical decompression had histological and immunohistochemical examination of sample s from the Achilles tendon . Results Glyceryl trinitrate did not offer any additional clinical benefit over st and ard nonoperative treatment for noninsertional Achilles tendinopathy . After 6 months of treatment , there was no significant difference in scores between the groups for pain ( 3.0 vs 3.1 , P = .42 ) or disability ( 2.15 vs 2.25 , P = .38 ) . Histological examination did not show any difference in neovascularization , collagen synthesis , or stimulated fibroblasts between the 2 groups . There was no evidence of modulation of nitric oxide synthase , a marker of nitric oxide production , in those tendons treated with GTN . Conclusion and Clinical Relevance This study has failed to support the clinical benefit of GTN patches previously described in the literature . In the available tissue sample s , there did not appear to be any histological or immunohistochemical change in Achilles tendinopathy treated with GTN compared with those undergoing st and ard nonoperative therapy",
"Objective : This study aim ed to determine whether a new glyceryl trinitrate patch preparation is effective in treating chronic lateral epicondylosis . Design : R and omised double-blind controlled clinical trial . Setting : Private practice patients : 154 adult patients with chronic lateral epicondylosis were recruited , with 136 patients completing the trial . Interventions : 8 weeks of glyceryl trinitrate patch application ( dosages of 72 mg/24 h , 1.44 mg/24 h , and 3.6 mg/24 h ) , or placebo patch application . Main outcome measures : Subjective global assessment of change in elbow symptoms , patient-rated tennis elbow evaluation , visual analogue pain at rest , visual analogue pain with activity , visual analogue pain intensity , grip strength , and strength testing using the Orthopaedic Research Institute-Tennis Elbow Testing System . Results : At 8 weeks there was a significant decrease in elbow pain with activity in the glyceryl trinitrate 0.72 mg/24 h group compared with placebo ( p = 0.04 ) . There were no other significant differences . Conclusions : Continuous 1.25 mg/24 h topical glyceryl trinitrate treatment , when combined with daily exercise rehabilitation , has previously demonstrated efficacy in treating chronic lateral epicondylosis . There was significantly decreased elbow pain with activity at 8 weeks in the glyceryl trinitrate 0.72 mg/24 h group ( p = 0.04 ) . This short-term dose-ranging study did not demonstrate a treatment effect of a new topical glyceryl trinitrate patch in dosages of 1.44 mg/24 h or 3.6 mg/24 h , which conflicts with previous studies on topical glyceryl trinitrate treatment . Trial registration number : NCT00447928"
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BACKGROUND Lack of physical stimulation may contribute to metabolic bone disease of preterm infants , result ing in poor bone mineralization and growth . Physical activity programs combined with adequate nutrition might help to promote bone mineralization and growth . OBJECTIVES The primary objective was to assess whether physical activity programs in preterm infants improve bone mineralization and growth and reduce the risk of fracture . The secondary objectives included other potential benefits in terms of length of hospital stay , skeletal deformities and neurodevelopmental outcomes , and adverse events . Subgroup analysis : • Given that the smallest infants are most vulnerable for developing osteopenia ( Bishop 1999 ) , a subgroup analysis was planned for infants with birth weight Calcium and phosphorus intake may affect an infant 's ability to increase bone mineral content ( Kuschel 2004 ) . Therefore , an additional subgroup analysis was planned for infants receiving different amounts of calcium and phosphorus , along with full enteral feeds as follows . ∘ Below 100 mg/60 mg calcium/phosphorus or equal to/above 100 mg/60 mg calcium/phosphorus per 100 mL milk . ∘ Supplementation of calcium without phosphorus . ∘ Supplementation of phosphorus without calcium . SEARCH METHODS The st and ard search strategy of the Cochrane Neonatal Review Group ( CNRG ) was used . The search included the Cochrane Central Register of Controlled Trials ( CENTRAL ) ( 2012 , Issue 9 ) , MEDLINE , EMBASE , CINAHL ( 1966 to March 2013 ) , and cross-references , as well as h and search ing of abstract s of the Society for Pediatric Research and the International Journal of Sports Medicine . SELECTION CRITERIA R and omized and quasi-r and omized controlled trials comparing physical activity programs ( extension and flexion , range-of-motion exercises ) versus no organized physical activity programs in preterm infants . DATA COLLECTION AND ANALYSIS Data collection , study selection , and data analysis were performed according to the methods of the CNRG . MAIN RESULTS Eleven trials enrolling 324 preterm infants ( gestational age 26 to 34 weeks ) were included in this review . All were small ( N = 16 to 50 ) single-center studies that evaluated daily physical activity for three and one-half to eight weeks during initial hospitalization . Method ological quality and reporting of included trials were variable . Four trials demonstrated moderate short-term benefits of physical activity for bone mineralization at completion of the physical activity program . The only trial assessing long-term effects on bone mineralization showed no effect of physical activity administered during initial hospitalization on bone mineralization at 12 months corrected age . Meta- analysis from four trials demonstrated a positive effect of physical activity on daily weight gain ( weighted mean difference ( WMD ) 2.21 g/kg/d , 95 % confidence interval ( CI ) 1.23 to 3.19 ) . Data from four trials showed a positive effect on linear growth ( WMD 0.12 cm/wk , 95 % CI 0.01 to 0.24 ) but not on head growth ( WMD -0.03 cm/wk , 95 % CI -0.14 to 0.08 ) during the study period . Only one trial reported on fractures ( this outcome did not occur in intervention and control groups ) and complications of preterm birth ( no significant differences between intervention and control groups ) . None of the trials assessed other outcomes relevant to this review . AUTHORS ' CONCLUSIONS Some evidence suggests that physical activity programs might promote short-term weight gain and bone mineralization in preterm infants . Data are inadequate to allow assessment of harm or long-term effects . Current evidence does not support the routine use of physical activity programs in preterm infants . Further trials incorporating infants with a high baseline risk of osteopenia are required . These trials should address adverse events , long-term outcomes , and the effects of nutritional intake ( calories , protein , calcium , phosphorus )
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"BACKGROUND Because recent data on the effects of mineral concentrations in preterm infant formula on bone mineralization are lacking , recommendations for the mineral content of preterm infant formula differ greatly between committees . OBJECTIVE The goal of the study was to assess the effects of an isocaloric , nutrient-enriched preterm formula , which was fed from the age when full enteral feedings were tolerated through expected term , on bone mineralization in preterm infants . DESIGN We conducted a prospect i ve , r and omized , double-blind study in healthy , preterm infants ( gestational age of 28 - 32 wk ) who were fed either a control preterm formula ( n=20 ) or an isocaloric , nutrient-enriched preterm formula ( n=21 ) until 3 mo of age ( ie , approximate expected term ) . Serum calcium indexes were taken throughout the study , and bone mass was determined by using dual-energy X-ray absorptiometry at hospital discharge and expected term . RESULTS A total of 37 infants ( experimental formula , n=19 ; control formula , n=18 ) completed the study . Compared with control subjects , infants fed the experimental formula had 25 % and 40 % higher intakes of calcium and phosphorus , respectively . Serum calcium , phosphorus , osteocalcin , and alkaline phosphatase concentrations and urinary collagen type I cross-linked N-telopetide concentrations were not significantly different between the groups at any time point . The bone mineral content of infants fed the experimental formula was 23 % ( P=0.039 ) and 35 % ( P=0.002 ) higher at hospital discharge and expected term , respectively . CONCLUSIONS Bone mineralization at hospital discharge and expected term was significantly higher in preterm infants fed the isocaloric , nutrient-enriched formula than in those fed control formula . Continuation of the experimental formula beyond hospital discharge , through expected term , further improved bone mineralization",
"OBJECTIVES Preterm infants are frequently discharged from the hospital growth retarded and show reduced growth throughout childhood . In a large efficacy and safety trial , we tested the hypothesis that nutritional intervention in the first 9 months postterm would reverse postdischarge growth deficits and improve neurodevelopment without adverse safety outcomes . PARTICIPANTS AND INTERVENTION Two hundred eighty-four infants ( mean gestation : 30.9 weeks ) were studied ; 229 were r and omly assigned a protein , energy , mineral , and micronutrient-enriched postdischarge formula ( PDF ; N = 113 ) or st and ard term formula ( TF ; N = 116 ) from discharge ( mean 36.5 weeks ' postmenstrual age ) . A reference group ( N = 65 ) was breastfed until at least 6 weeks ' postterm . Outcome measures . Anthropometry was performed at 6 weeks and 3 , 6 , 9 , and 18 months . Development was measured at 9 months ( Knobloch , Passamanick , and Sherrard 's developmental screening inventory ) and 18 months ( Bayley Scales of Infant Development II ; primary outcome ) postterm . RESULTS At 9 months , compared with the TF group , those fed PDF were heavier ( difference 370 g ; 95 % confidence interval [ CI ] : 84 - 660 ) and longer ( difference 1.1 cm ; 95 % CI : 0.3 - 1.9 ) ; the difference in length persisted at 18 months ( difference 0.82 cm ; 95 % CI : -0.04 - 1.7 ) . There was no effect on head circumference . The effect of diet was greatest in males ; at 9 months length deficit with TF was 1.5 cm ( 95 % CI : 0.3 - 2.7 ) , and this remained at 18 months ( 1.5 cm [ 95 % CI : 0.3 - 2.7 ] ) . There was no significant difference in developmental scores at 9 or 18 months , although PDF infants had a 2.8 ( -1.3 - 6.8 ) point advantage in Bayley motor score scales . At 6 weeks ' postterm , exclusively breastfed infants were already 513 g ( 95 % CI : 310 - 715 ) lighter and 1.6 cm ( 95 % CI : 0.8 - 2.3 ) shorter than the PDF group , and they remained smaller up to 9 months ' postterm . CONCLUSIONS 1 ) Improving postdischarge nutrition in the first 9 months may \" reset \" subsequent growth-at least until 18 months for body length . We intend to follow-up the children at older ages . The observed efficacy of PDF was not associated with adverse safety outcomes . 2 ) We can not reject the hypothesis that postdischarge nutrition benefits motor development and this requires additional study . 3 ) Our data raise the possibility that breastfed postdischarge preterm infants may require nutritional supplementation , currently under investigation",
"OBJECTIVE : To assess the effect of daily movements on weight gain , serum leptin , and insulin-like growth factor I ( IGF-I ) in premature infants . STUDY DESIGN : Twenty very-low-birth-weight premature infants were matched and r and omized to a daily movement ( n=10 ) and control groups ( n=10 ) . Daily movement consisted of passive range of motion with gentle compression of both the upper and lower extremities 5 days per week for 4 weeks . RESULTS : Daily movements led to a significant increase in weight gain ( 784±51 vs 608±26 g in movements and controls , respectively , p increase in leptin ( 0.60±0.19 vs 0.13±0.06 ng/ml in movements and controls , respectively , p correlated with changes in serum leptin ( r=0.48 , p also increased following daily movements ( 18.8±4.1 vs 9.2±4.1 ng/ml in movements and controls , respectively ) ; however , this increase was not statistically significant . CONCLUSION : A relatively brief range of motion daily movement intervention was associated with greater weight gain and increased leptin levels in very-low-birth-weight premature infants . This may suggest that at least part of the daily movements associated with increase in body weight result ed from an increase in adipose tissue",
"Exercise during growth has a positive influence on bone mineral accrual , yet little is known about how bone geometry and strength adapt to loading during growth . Our primary objective was to compare changes in proximal femur bone geometry and strength between 31 prepubertal ( Tanner Stage 1 ) boys who participated in a school-based , high-impact circuit intervention ( 12 min , three times a week ) for 20 months and 33 maturity-matched controls . Our secondary objective was to compare changes in total body ( TB ) , proximal femur ( PF ) , and lumbar spine ( LS ) bone mineral content ( BMC ) and bone area ( BA ) in these groups . We assessed geometric variables and bone strength at the narrow neck ( NN ) , intertrochanteric ( TR ) region , and femoral shaft regions by applying the Hip Structure Analysis program to proximal femur dual energy X-ray absorptiometry scans ( DXA , Hologic QDR 4500 ) . Further , we assessed total body , lumbar spine , and proximal femur BMC and BA by DXA and derived total body lean mass and fat mass from total body scans . Intervention ( 10.2 + /- 0.5 years ) and control boys ( 10.1 + /- 0.5 years ) had similar baseline height ( 140.8 vs. 141.3 cm ) and weight ( 36.9 vs. 35.4 kg ) , and average 20-month physical activity scores ( Physical Activity Question naire for Children , PAQ-C ) and calcium intakes ( 861 vs. 852 mg/day , food frequency question naire ) . Twenty-month height and weight changes were not significantly different between groups ; lean mass changed more ( P intervention boys ( 22.8 % ) than control boys ( 18.6 % ) . At the NN region , intervention boys had greater bone expansion on both the periosteal ( + 2.6 % , P = 0.1 ) and endosteal ( + 2.7 % , P = 0.2 ) surfaces , result ing in significantly greater changes in section modulus ( bone bending strength ) ( + 7.5 % , P = 0.02 , ANCOVA , adjusting for height change , final Tanner Stage , and baseline bone values ) . Changes at the intertrochanteric and femoral shaft regions were not significantly different between groups . Femoral neck ( FN ) BMC changes were significantly greater in intervention boys ( + 4.3 % , P in BA and BMC for other regions were not significantly different between groups . In summary , a school-based , high-impact exercise intervention implemented three times a week for 12 min is an effective strategy for site-specific gains in bone strength at the narrow neck region of the proximal femur",
"Seventy-four infants with birth weights 1009 + /- 28 grams and gestational age 28.6 + /- 0.3 weeks ( M + /- SEM ) were studied prospect ively to test the hypotheses that bone mineral content ( BMC ) measured by photon absorptiometry , would be : ( 1 ) lower in very low birth weight ( VLBW ) infants with radiographic evidence of fractures and /or rickets ( F/R ) , and ( 2 ) will continue to be lower over the first year when compared to VLBW infants without F/R. BMC and bone width ( BW ) of the distal one-third of left radius and ulna were measured at 5 weeks ( n = 8) , 14 weeks ( n = 61 ) , 26 weeks ( n = 58 ) , 40 weeks ( n = 59 ) , and 1 year ( n = 52 ) . St and ardized radiographs of both forearms , and weight , length , and head circumference were also determined at each study age . Investigators and technicians involved in the photon absorptiometry measurements were unaware of the radiographic findings and vice versa . Twenty-three of 74 infants were found to have F/R. BMC of studied infants remained markedly below our previously determined range of \" intrauterine bone mineralization , \" even at 26 weeks after birth . There was no significant difference in BMC or BW between infants with and without F/R , either at the time of confirmation of F/R or during early follow-up ; however , BMC was lower at greater than or equal to 6 months and BW was lower at greater than or equal to 9 months in infants with F/R. We suggest that the extremely low BMC measurements in early infancy predispose all VLBW infants to fractures and rickets",
"Studies have previously demonstrated that brief ( 4 weeks ) passive range-of-motion exercise is beneficial for bone development in very low birth weight ( VLBW ) preterm infants . However , the optimal duration of exercise for bone development in preterm infants is yet unknown . The aim of the present study was to examine the effect of 8 weeks of assisted exercise on bone strength and metabolism in VLBW premature infants . Sixteen infants ( mean ± st and ard error of the mean birth weight 1,009 ± 55 g and gestational age 27.3 ± 0.3 weeks ) were r and omly assigned into exercise ( n = 8) and control ( n = 8) groups . The intervention started at the first week of life and involved 8 weeks of daily passive extension and flexion range-of-motion exercise of the upper and lower extremities . Biochemical markers of bone turnover were measured at enrollment and after 8 weeks . Bone strength was measured weekly by quantitative ultrasound measurement of tibial bone speed of sound ( SOS ) . Bone SOS decreased significantly in the control group ( −108.1 ± 33.7 m/second , P The main beneficial effect of exercise occurred in the first 4 weeks of the intervention . There were no significant differences in the bone turnover marker changes between the groups . There is a significant postnatal decrease in bone SOS in VLBW preterm infants . Eight weeks of assisted range-of-motion exercise attenuates the decrease in bone strength and may decrease the risk of osteopenia in premature infants",
"Preterm delivery ( is associated with suboptimal bone mass . We hypothesized that tactile/kinesthetic stimulation ( TKS ) , a form of infant massage that incorporates kinesthetic movement , would increase bone strength and markers of bone accretion in preterm infants . Preterm , AGA infants ( 29 - 32 weeks ) were r and omly assigned to TKS ( N=20 ) or Control ( N=20 ) . Twice daily TKS was provided 6 days per week for 2 weeks . Control infants received the same care without TKS treatment . Treatment was masked to parents , health care providers , and study personnel . Baseline and week two measures were collected for tibial speed of sound ( tSOS , m/sec ) , a surrogate for bone strength , by quantitative ultrasound ( Sunlight8000 ) and urine markers of bone metabolism , pyridinium crosslinks and osteocalcin ( U-MidOC and unOC ) . Infant characteristics at birth and study entry as well as energy/nutrient intake were similar between TKS and Control . TKS intervention attenuated the decrease in tSOS observed in Control infants ( p Urinary pyridinium crosslinks decreased over time in both TKS and CTL ( p TKS infants experienced greater increases in urinary osteocalcin ( U-MidOC , p TKS improves bone strength in premature infants by attenuating the decrease that normally follows preterm birth . Further , biomarkers of bone metabolism suggest a modification in bone turnover in TKS infants in favor of bone accretion . Taken together , we speculate that TKS improves bone mineralization",
"BACKGROUND : Osteopenia of prematurity is a known source for morbidity in preterm infants . Premature infants have shown favorable outcomes in response to massage and physical activity . Whether such intervention can stimulate bone formation or decrease bone resorption is yet to be determined . OBJECTIVE : To test the hypothesis that massage combined with physical activity can stimulate bone formation and ameliorate bone resorption in premature infants . DESIGN / METHODS : A prospect i ve double-blinded r and omized trial was conducted at the Neonatal Intensive Care Unit of Ain Shams University in Cairo , Egypt . Thirty preterm infants ( 28 to 35 weeks ' gestation ) were r and omly assigned to either control group ( Group I , n=15 ) or intervention group ( Group II , n=15 ) . Infants in the intervention group received a daily protocol of combined massage and physical activity . Serum type I collagen C-terminal propeptide ( PICP ) and urinary pyridinoline crosslinks of collagen ( Pyd ) were used as indices for bone formation and resorption , respectively . PICP and Pyd were measured at enrollment and at discharge for all subjects . t-Test , ANOVA and linear regression analysis were used for statistical analyses . RESULTS : There was no difference between groups I and II in gestational age ( 32.1±1.8 vs 31.5±1.4 weeks ) or birth weight ( 1.429±0.148 vs 1.467±0.132 g ) . In the control group , serum PICP decreased over time from 82.3±8.5 to 68.78±14.6 ( p while urinary Pyd increased from 447.7±282.8 to 744.9±373.6 ( p decreased bone formation and increased bone resorption , respectively . In the intervention group , serum PICP increased over time from 62.5±13.8 to 73.84±12.9 ( p ) . Urinary Pyd also increased over time from 445.7±266.5 to 716.8±301.8 ( p intervention , serum PICP increased significantly in the intervention group ( regression coefficient 18.8±4.6 , p=0.0001 ) while urinary Pyd did not differ between groups ( regression coefficient=5.6±114.3 , p=0.961 ) . CONCLUSIONS : A combined massage and physical activity protocol improved bone formation ( PICP ) but did not affect bone resorption ( Pyd ) . Pyd increased over time in both groups , possibly due to continuous bone resorption and Ca mobilization",
"Objective : To determine if physical activity delivered by an infant 's mother would be as effective in promoting bone mineral acquisition in preterm very low birth weight ( VLBW ) infants as the same intervention administered by a trained therapist . Patients and methods : Preterm VLBW infants were r and omized to receive daily physical activity administered by the infant 's mother ( MOM , n=11 ) or a trained therapist ( OT , n=11 ) , or control ( n=11 ) . Physical activity consisted of range of motion movements against passive resistance to all extremities for 5 to 10 min daily . All infants were fed mother 's milk with fortification to 24 kcal oz−1 . Dual energy x-ray of the forearm bone area ( BA , cm2 ) , mineral content ( BMC , g ) , and density ( BMD , g/cm2 ) and measurement of bone formation ( bone-specific alkaline phosphatase , BAP ) and resorption ( urine pyridinium crosslinks of collagen , Pyd ) were obtained at study entry and at 2.0 kg of body weight . Result : Forearm BA and BMC gains were greater in MOM and OT infants compared to the control infants despite similar postnatal growth rate and nutrient intake . Serum BAP levels decreased in controls but remained unchanged in MOM and OT infants . Urine Pyd levels were similar at baseline to 2.0 kg for all groups . These findings suggest greater bone growth and mineral acquisition in MOM and OT infants than control infants . Conclusion : This study demonstrates that a physical activity program administered by the infant 's own mother is as equally effective as therapist-administered physical activity in promoting greater bone growth and mineral acquisition in preterm VLBW infants",
"We assessed the effect of a four weeks exercise training intervention on bone turnover markers in premature infants . Twenty-four very low birth weight premature infants were matched for gestational age , birth weight , gender , as well as for corrected age and weight at initiation of the study . Then the subjects were r and omly divided into an exercise ( n = 12 ) and a control group ( n = 12 ) . Exercise consisted of passive range of motion exercise with gentle compression of both the upper and lower extremities lasting 5 - 10 minutes each day , 5 days per week for 4 weeks . This protocol has been shown to increase bone mineral density in premature infants . Bone formation was assessed by measurements of circulating bone specific alkaline phosphatase ( BSAP ) and the C-terminal procollagen peptide ( PICP ) . Bone resorption was determined by serum measurements of C- terminal cross-links telopeptide of type-I collagen ( ICTP ) . Training led to a significant ( P weight gain ( 767 + /- 49 versus 586 + /- 24 gr in trained and control premature infants , respectively ) ; and to a significant increase in BSAP ( 37.2 + /- 14.6 versus 4.1 + /- 8.4 % in trained and control premature infants , respectively ) . PICP increased also following exercise ( 34.6 + /- 18.9 versus 5.4 + /- 9.1 % in trained and control subjects , respectively ) , however , this increase was not statistically significant . Exercise led to a significant decrease in ICTP ( -24.7 + /- 3.1 versus -5.5 + /- 5.4 % in trained and control subjects , respectively ) . A relatively brief exercise intervention was associated with a biochemical evidence of bone formation in very low birth weight premature infants",
"Objective . A study of daily physical activity was performed with 32 preterm infants to evaluate changes in body weight and bone mineralization . Study Design . Subjects were matched by birth weight and gestational age and r and omly assigned to the physical activity ( PA;n = 16 ) or to the control ( C ; n= 16 ) program . PA consisted of range of motion against passive resistance to all extremities for 5 to 10 minutes daily . Peripheral dual-energy x-ray of the right forearm ( ulna and radius ) ; biomarkers of bone formation ( serum type I collagen C-terminal propeptide [ PICP ] ) and resorption ( urine pyridinoline cross-links of collagen [ Pyd ] ) ; serum calcium , phosphate , alkaline phosphatase , parathyroid hormone ( PTH ) , and 1,25-(OH)2 vitamin D ; and urine levels of calcium , phosphate , and creatinine were obtained . All measurements were made at study entry and at 2.0 kg of body weight . Results . Despite a similar nutrient intake at advised levels for preterm infants , gains in body weight ( g ) and forearm bone length ( cm ) , bone area ( BA ; cm2 ) , bone mineral content ( BMC ; mg ) , and fat-free mass ( g ) were greater in PA infants . Forearm bone mineral density and fat mass gains did not differ between groups . Serum PICP levels remained constant in PA infants but decreased in C infants suggesting a slower rate of bone formation . Urine Pyd or bone resorption activity was similar between groups . A higher level of serum PTH was observed in PA infants at 2.0 kg of body weight ; however , the change from study entry to completion did not differ between groups . All other serum and urine values were similar and within normal limits . Conclusion . A daily PA program promotes greater gains in body weight , forearm length , BA , BMC , and fat-free mass in premature infants",
"AIM To evaluate whether assisted exercise could prevent the development of osteopenia of prematurity , we performed assisted exercise in the study group of very low birthweight ( VLBW ) premature infants . METHODS Sixteen premature infants with birthweight below 1500 g were enrolled in this study and r and omly assigned into the exercise ( n = 8) and control ( n = 8) groups . Assisted exercise involved full extension and flexion range of motion of the upper and lower extremities by a trained nurse with a schedule of 5 days a week for a total of 4 weeks . Bone strength was determined by quantitative ultrasound measurement of tibial bone speed of sound every 2 weeks during the study period . RESULTS No difference in gender , birthweight , and gestation age between the exercise and control groups was noted . There was statistically significant less tibial bone speed of sound decrease in the exercise group on the sixth and eighth week of life . During the study period , there were no statistically significant differences in blood biochemistry data , including calcium , phosphorus , magnesium , alkaline phosphatase , osteocalcin and osteoprotegerin , between the two groups . CONCLUSIONS This study revealed that early assisted exercise could improve bone strength in very low birthweight infants . The biochemical markers of bone metabolism , osteocalcin and osteoprotegerin , could not be the indicators for early diagnosis of osteopenia of prematurity",
"Objective : The aim of this study was to evaluate the effects of massage with or without kinesthetic stimulation on weight gain and length of hospital stay in the preterm infant . Study Design : A prospect i ve r and omized clinical trial was conducted evaluating the effects of massage with or without kinesthetic stimulation ( KS ) on weight gain and length of stay ( LOS ) in medically stable premature ( were r and omized either to receive no intervention ( control ) , massage therapy alone ( massage ) , or massage therapy with KS ( M/KS ) . Linear regression analysis was performed to evaluate differences in the primary outcomes between the groups after controlling for covariates . Post hoc analysis with stratification by birthweight ( BW > and A total of 60 premature infants were recruited for this study ; 20 infants in each group . Average daily weight gain and LOS were similar between the groups after controlling for covariates . For infants with BW>1000 g , average daily weight gain was increased in the intervention groups compared to control . This effect was mainly attributable to the M/KS group . Conclusion : Massage with KS is a relatively simple and inexpensive intervention that can improve weight gain in selected preterm infants . Length of hospital stay is not impacted by massage with or without KS . Further studies are needed to evaluate the effect of massage in the extremely low BW(<1000 g ) infant",
"OBJECTIVE To evaluate the effect of early range-of-motion intervention on bone strength and bone turnover in very low birth weight infants . METHODS Twenty-four infants ( mean birth weight : 1135 + /- 247 g ; mean gestational age : 28.5 + /- 2.3 weeks ) were matched for gestational age and birth weight and then r and omly assigned into exercise ( n = 12 ) and control ( n = 12 ) groups . Exercise protocol started at the first week of life and involved daily extension and flexion range of motion against passive resistance of the upper and lower extremities ( 5 minutes per day , 5 days per week , 4 weeks ) . Growth parameters , bone strength , and biochemical markers of bone homeostasis were measured at enrollment and after 4 weeks . Bone strength was determined using quantitative ultrasound measurement of bone speed of sound ( SOS ) at the middle left tibial shaft . RESULTS Bone SOS decreased significantly in the control group during the study period ( from 2892 + /- 30 m/sec to 2799 + /- 26 ) , whereas bone SOS of the exercise group remained stable ( 2825 + /- 32 m/sec and 2827 + /- 26 m/sec at baseline and 4 weeks , respectively ) . This significant difference in bone SOS was not expressed in the biochemical markers of bone homeostasis . CONCLUSIONS There is a significant postnatal decrease in the bone SOS of very low birth weight infants . A brief range-of-motion exercise attenuates the decrease in bone strength and may decrease the risk of osteopenia",
"AIM To evaluate bone metabolism in newborn preterm infants before and after a physical therapy protocol . METHOD This r and omized controlled clinical trial included 30 newborn preterm infants with gestational age ≤ 35 weeks and appropriate weight for gestational age , who were r and omized into control group ( CG ) and physiotherapy group ( PG ) . The PG protocol consisted of 15 minutes of daily passive movements with gentle joint compression 5 days a week . Daily data were obtained on feeding and body weight . Measurements of bone-specific alkaline phosphatase ( BAP ) and urinary deoxypyridinoline ( DPD ) were collected before and after intervention in both groups . The analysis of covariance test was performed to compare the means of both groups . RESULTS At baseline , gestational age and corrected gestational age , birth weight , and gender were similar between both groups . Nutrient supply , length of total parenteral nutrition , and mechanical ventilation were also similar . BAP level increase in PG was 22.44 ± 3.49 U/L , whereas in CG was 2.87 ± 3.99 U/L ( p = 0.003 ) . There was a reduction of DPD levels in PG of 28.21 ± 11.05 nmol/mmol , and an increase of 49.95 ± 11.05 nmol/mmol ( p metabolic bone disease of prematurity , in addition to an adequate diet , should include these passive exercises with gentle joint compressions to improve the quality of premature infant 's bones",
"Objective : To study the effect of physical therapy on bone mineralization , weight gain and growth in preterm infants . Method : After fulfilling the inclusion criteria , preterm infants were matched for gestational age and birth weight and then r and omly assigned to the physiotherapy group ( PG , n=15 ) and control group ( CG , n=14 ) . The PG received motor physical therapy for 15 min daily , 5 times per week until hospital discharge . Bone mineralization was measured by total body dual energy X-ray beam absorptiometry ( DEXA ) at the onset and end of the study . Statistical analysis was realized by ANCOVA and linear correlation tests . Result : The physical therapy group ( PG ) presented greater body weight gain per day ( 27.4±2.4 vs 21.01±4.4 g , P and length ( 1.3±0.3 vs 0.8±0.2 cm week−1 , P . Body composition values verified by DEXA were greater for the PG . The mean gain in bone mineral content ( BMC ) ( mg ) was greater in the PG ( 434±247.5 vs −8.9±11.4 , P was the mean bone mineral density ( BMD ) gain ( mg cm−2 ) ( 8.4±5.6 vs −3.1±5.5 , P ) . The gain in bone area ( BA , cm2 ) was 10.3±5 in the PG vs 1.5 ±2 in the CG ( P ) . The gain in lean mass ( LM ) ( g ) in the PG was also greater than in the CG ( 271.1±21.4 vs 109.1±1.0 , P ) . The fat mass ( g ) was similar between the groups ( P=0.432 ) . Conclusion : These results showed that physiotherapy in preterm infants produced greater gains in growth , body weight , BMC , BMD , BA and LM",
"Underst and ing the stress/strain relationship between exercise and bone is critical to underst and ing the potential benefit of exercise in preventing postmenopausal bone loss . This study examined the effect of a 2-year exercise intervention and calcium supplementation ( 600 mg ) on bone mineral density ( BMD ) in 126 postmenopausal women ( mean age , 60 + /- 5 years ) . Assignment was by block r and omization to one of three groups : strength ( S ) , fitness ( F ) , or nonexercise control ( C ) . The two exercise groups completed three sets of the same nine exercises , three times a week . The S group increased the loading , while the F group had additional stationary bicycle riding with minimal increase in loading . Retention at 2 years was 71 % ( 59 % in the S group , 69 % in the F group , and 83 % in the C group ) , while the exercise compliance did not differ between the exercise groups ( S group , 74 + /- 13 % ; F group , 77 + /- 14 % ) . BMD was measured at the hip , lumbar spine , and forearm sites every 6 months using a Hologic 4500 . Whole body BMD also was measured every 6 months on a Hologic 2000 . There was no difference between the groups at the forearm , lumbar spine , or whole body sites . There was a significant effect of the strength program at the total ( 0.9 + /- 2.6 % ; p intertrochanter hip site ( 1.1 + /- 3.0 % ; p strength program in increasing bone density at the clinical ly important hip site . We concluded that a strength program could be recommended as an adjunct lifestyle approach to osteoporosis treatment or used in combination with other therapies",
"BACKGROUND Osteoporotic fractures among the elderly are common , and without preventive measures the burden of these fractures on health-care systems will increase further . The purpose of this r and omised controlled study was to evaluate , in premenopausal women , the effects of high-impact loading on several determinants osteoporotic fractures . METHODS 98 healthy , sedentary female volunteers aged 35 - 45 years were r and omly assigned to either a training ( n = 49 ) or a control group ( n = 49 ) . Progressive high-impact exercises were done three times per week for 18 months . We measured bone mineral density ( BMD ) in specific axial and lower-limb sites , by dual-energy X-ray absorptiometry , at baseline and after 12 and 18 months . Maximum isometric strength , muscular and cardiovascular performance , and dynamic balance were also assessed . FINDINGS BMD at the femoral neck , a weightbearing site , increased significantly more in the training group ( mean 1.6 % [ 95 % CI 0.8 - 2.4 ] ) than in the control group ( 0.6 % [ -0.2 to 1.4 ] , p = 0.006 ) . By contrast , at non-weightbearing sites , such as the distal radius , there was no significant difference between the training and control groups ( -1.5 % [ -2.7 to -0.3 ] vs -0.7 % [ -1.9 to -0.5 ] , p = 0.60 ) . In the training group there was a significant improvement in vertical jump and predicted oxygen consumption per min at maximum exercise compared with controls . INTERPRETATION High-impact exercises that load bones with a rapidly rising force profile in versatile movements improve skeletal integrity , muscular performance , and dynamic balance in premenopausal women . If done on a regular basis , this type of exercise may help decrease the risk of osteoporotic fractures in later life . Long-term studies are required to show whether these 18-month results can be translated into long-term benefit",
"The National Institute of Child Health and Human Development conducts and supports research on all stages of human development from preconception to adulthood in order to better underst and the health of children , youths , adults , families , and communities . Health and human development information is made easily available on the site with a simple A to Z list , along with clinical trials and health education campaign information . Links to clinical trials , news releases , publications , and related web sites are also available , as well as information on research being conducted at present and supported by the National Institute of Child Health and Human Development",
" A group of 118 children , aged 5.3 - 14 years , were enrolled in a prospect i ve study of calcium supplementation and bone mass . At entry to the study , question naires regarding the child 's usual physical activity were administered to the children and their mothers . Repeated activity assessment s at 6 month intervals indicated good within-person agreement for total activity and for most individual activities . Consistent positive associations were observed between bone mineral densities ( BMD ) in the radius , spine , and hip and most activities . A summary measure ( total hours of weight-bearing activity ) was significantly related to BMD in the radius and hip , independently of age or gender effects . Self-reported sports and play activities were associated with BMD , but neither time spent watching television nor hours of physical education classes were associated either positively or negatively with skeletal mass . These data suggest that important increments in skeletal mass may result from physical activity during childhood",
"OBJECTIVE A 4-week pilot study was done with 26 preterm infants to evaluate whether a physical activity program would result in greater bone mineralization . DESIGN Subjects were matched by birth weight , gender , and gestational age , and r and omly assigned to the physical activity program ( group EX ; n = 13 ) or to the control group ( group C ; n = 13 ) . Physical activity consisted of range of motion with passive resistance to all extremities for 5 to 10 minutes daily . Baseline and 4-week values were determined for both bone mineral analyses and serum levels of calcium , phosphate , alkaline phosphatase , parathyroid hormone , and 25-hydroxy-vitamin D. RESULTS Despite similar nutrient intake at advised levels for preterm infants , EX infants gained more weight than control subjects ( 17.8 vs 13.4 gm/kg body weight per day ; p = 0.01 ) . A difference in radial bone mass and density change as determined by single-beam photon absorptiometry ( + /- 2 % error ) was found between groups ( p = 0.006 by analysis of covariance ) . Changes in bone width and in bone mineral content and density were enhanced by physical activity . Group EX infants had 12 % , 18 % , and 34 % gains in bone width and in bone mineral density and content , respectively ; group C infants had only a 2 % gain in bone width and 11 % and 14 % losses from baseline in bone mineral content and density , respectively , during the 4-week study . Serum biochemical values were similar in the groups except for lower alkaline phosphatase levels in group EX . There was a negative association between bone mineral content and parathyroid hormone values : r = -0.83 , p = 0.01 . CONCLUSIONS A physical activity program may increase the effects of adequate nutrition in healthy preterm very low birth weight infants by promoting weight gain and bone mass and by decreasing the risk of osteopenia"
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Background : The effect of soy products on the weight of overweight or obese people is controversial , so we aim ed to conduct a systematic review and a meta- analysis of published r and omized controlled trials to analyze whether supplementation with soy products can help them to lose weight . Methods : The relevant data before January 2019 in PubMed , Embase and Cochrane Library were search ed . A r and om-effect model was adopted to calculate the weighted average difference of net changes of body weight , body mass index ( BMI ) , body fat percentage , fat mass , waist circumference , etc . Results : A total of 22 trials ( 870 overweight or obese participants ) were reflected in the present meta- analysis . Analysis showed that soy products significantly reduced body weight , BMI , body fat percent and waist circumference in overweight or obese Asian population s ( −0.37 kg , P = 0.010 ; −0.27 kg/m2 , P = 0.042 ; −0.36 % , P = 0.032 ; −0.35 cm , P = 0.049 ) and more significant effects were observed in non-menopausal women reduced body weight ( −0.59 kg , P = 0.041 ) , BMI ( −0.59 , P = 0.041 ) and waist circumference ( −0.59 cm , P = 0.041 ) in overweight or obese population s. Conclusion : This meta- analysis showed that soy products have weight loss effects , mainly due to soy protein , isoflavone and soy fiber
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"Fibres which are soluble or insoluble in water have different physiochemical properties and may therefore be expected to exert different effects on post-ingestive satiety signals . This study compared the effects on short-term ( 24 h ) appetite of two equienergetic high ( 22 g ) fibre breakfasts , an equienergetic low fibre breakfast and a low energy , ' light ' breakfast . Psyllium gum ( the soluble fibre ) and wheat bran ( the insoluble fibre ) were incorporated into breakfast cereals and consumed at breakfast by sixteen healthy , normal weight males after an overnight fast using a repeated measures , counterbalanced design . Ad libitum energy intake was assessed at a test snack 1.5 h after breakfast , later in the day using food boxes and the following day using food diaries . Motivation to eat and gastrointestinal sensations were tracked for the next 24 h. Hunger ratings showed a trend towards the subjects being less hungry and they consumed significantly less energy at snack time after the high insoluble than after the high soluble fibre breakfast cereal . The soluble fibre breakfast produced a greater suppression of snack intake than the light breakfast , but smaller suppression than the other breakfasts . Interestingly there was a trend toward reduced hunger and voluntary energy consumption following the soluble fibre compared with the insoluble fibre much later in the day ( 9.5 - 13.5 h after breakfast ) although this was not significant . There was no significant effect of breakfast type on total day energy intake . The results suggest that different types of fibre modulate the timecourse of appetite control and may produce alterations in the experience of motivation and patterns of eating without necessarily effecting total energy intake",
"Health benefits of Kochujang ( KCJ ) and its bioactive compounds have been reported in several in vitro and animal studies . Objective The aim of this study was to investigate the efficacy of KCJ supplementation on body composition and blood lipid profiles in overweight adults . Methods Sixty overweight men and women with BMI ≥23 kg/m2 and waist-hip-ratio ( WHR ) ≥0.90 for men and ≥0.85 for women were r and omly assigned to a KCJ supplement ( n=30 , 32 g/day ) or placebo ( n=30 , 32 g/day ) group for a 12-week , double-blind , placebo controlled study . We measured anthropometric parameters , serum lipid profiles , abdominal fat distribution by computerized tomography and calculated the atherosclerosis indices in 53 subjects ( n=26 in KCJ group , n=27 in placebo group ) who completed the study . Results After 12 weeks , the KCJ group showed a significant reduction in visceral fat ( cm2 ) ( p although body weight ( kg ) and WHR did not change . Serum concentration of triglycerides and ApoB were decreased when compared to those of the placebo group . Conclusion KCJ supplementation ( 32 g/day ) for 12 weeks in overweight adults showed anti-atherosclerotic and anti-obesogenic effects . Trial registration Clinical trials.gov Identifier :",
"BACKGROUND Epidemiologic studies that directly examine changes in whole-grain consumption in relation to weight gain are sparse , and characterization of this association has been obscured by method ologic inconsistencies in the assessment of whole grains . OBJECTIVE We aim ed to ascertain the associations between changes in new quantitative estimates of whole-grain intake and 8-y weight gain among US men . DESIGN The study was conducted in a prospect i ve cohort of 27 082 men aged 40 - 75 y at baseline in 1986 . Data on lifestyle factors were obtained periodically by using self-reported question naires , and participants measured and reported their body weight in 1986 and 1994 . RESULTS In multivariate analyses , an increase in whole-grain intake was inversely associated with long-term weight gain ( P for trend weight gain was reduced by 0.49 kg . Bran that was added to the diet or obtained from fortified-grain foods further reduced the risk of weight gain ( P for trend = 0.01 ) , and , for every 20 g/d increase in intake , weight gain was reduced by 0.36 kg . Changes in cereal and fruit fiber were inversely related to weight gain . No associations were observed between changes in refined-grain or added germ consumption and body weight . CONCLUSIONS The increased consumption of whole grains was inversely related to weight gain , and the associations persisted after changes in added bran or fiber intakes were accounted for . This suggests that additional components in whole grains may contribute to favorable metabolic alterations that may reduce long-term weight gain",
"BACKGROUND Although increased consumption of dietary fiber and grain products is widely recommended to maintain healthy body weight , little is known about the relation of whole grains to body weight and long-term weight changes . OBJECTIVE We examined the associations between the intakes of dietary fiber and whole- or refined-grain products and weight gain over time . DESIGN In a prospect i ve cohort study , 74,091 US female nurses , aged 38 - 63 y in 1984 and free of known cardiovascular disease , cancer , and diabetes at baseline , were followed from 1984 to 1996 ; their dietary habits were assessed in 1984 , 1986 , 1990 , and 1994 with vali date d food-frequency question naires . Using multiple models to adjust for covariates , we calculated average weight , body mass index ( BMI ; in kg/m(2 ) ) , long-term weight changes , and the odds ratio of developing obesity ( BMI > or = 30 ) according to change in dietary intake . RESULTS Women who consumed more whole grains consistently weighed less than did women who consumed less whole grains ( P for trend intake of dietary fiber gained an average of 1.52 kg less than did those with the smallest increase in intake of dietary fiber ( P for trend dietary fiber intake had a 49 % lower risk of major weight gain than did women in the highest quintile ( OR = 0.51 ; 95 % CI : 0.39 , 0.67 ; P Weight gain was inversely associated with the intake of high-fiber , whole-grain foods but positively related to the intake of refined-grain foods , which indicated the importance of distinguishing whole-grain products from refined-grain products to aid in weight control",
"Background Single-nucleotide polymorphisms ( SNPs ) , which are located in the first intron of the FTO gene , are reported to be associated with body weight and the body mass index ( BMI ) . However , their effects on anthropometric measurements in adolescents are poorly understood . Objective This study aim ed to investigate the association of three adjacent polymorphisms ( rs9930506 , rs9930501 , & rs9932754 ) in the FTO gene with anthropometric indices in Iranian adolescent males . Design The participants comprised a total of 237 adolescent males who were recruited r and omly from two high schools in Tehran , Iran . The DNA sample s were genotyped for the FTO gene polymorphisms by DNA sequencing . BMI , body fat percentage ( BF% ) , and body muscle percentage ( BM% ) were determined using a vali date d bioelectrical impedance analysis scale . The association of the FTO polymorphisms with weight , height , BMI , BF% , and BM% was investigated . Results A haplotype of rs9930506 , rs9930501 , and rs9932754 ( GGT ) in the first intron of the FTO with complete linkage disequilibrium ( LD ) was found to be significantly associated with higher weight ( OR = 1.32 ) , BMI ( OR = 5.36 ) and BF% ( OR = 1.46 ) , and lower BM% ( OR = 3.59 ) ( all P students with GGC genotypes were underweight , while all of the students with AAT genotypes had high muscle mass . Conclusions A haplotype in the first intron of the FTO gene had a strong association with obesity indices in Iranian adolescent males . The FTO gene polymorphisms might have greater effects on anthropometric indices than what was previously imagined . Moreover , we suggested that the FTO gene exerted their effects on anthropometric measurements through haplotypes ( and not single SNPs )",
"OBJECTIVE To examine demographic , socioeconomic , and biological risk factors for all-cause , cardiovascular , and noncardiovascular mortality in patients with type 2 diabetes over 8 years and to construct mortality prediction equations . RESEARCH DESIGN AND METHODS Beginning in 2000 , survey and medical record information was obtained from 8,334 participants in Translating Research Into Action for Diabetes ( TRIAD ) , a multicenter prospect i ve observational study of diabetes care in managed care . The National Death Index was search ed annually to obtain data on deaths over an 8-year follow-up period ( 2000–2007 ) . Predictors examined included age , sex , race , education , income , smoking , age at diagnosis of diabetes , duration and treatment of diabetes , BMI , complications , comorbidities , and medication use . RESULTS There were 1,616 ( 19 % ) deaths over the 8-year period . In the most parsimonious equation , the predictors of all-cause mortality included older age , male sex , white race , lower income , smoking , insulin treatment , nephropathy , history of dyslipidemia , higher LDL cholesterol , angina/myocardial infa rct ion/other coronary disease/coronary angioplasty/bypass , congestive heart failure , aspirin , β-blocker , and diuretic use , and higher Charlson Index . CONCLUSIONS Risk of death can be predicted in people with type 2 diabetes using simple demographic , socioeconomic , and biological risk factors with fair reliability . Such prediction equations are essential for computer simulation models of diabetes progression and may , with further validation , be useful for patient management",
"Objective : The phytoestrogen genistein has been shown to be the most efficacious in clinical and experimental studies . We studied whether genistein treatment affects some cardiovascular risk markers in postmenopausal women . Design : Sixty healthy postmenopausal women , who were 52 to 60 years of age , were enrolled in a 6-month double-blind , placebo-controlled , r and omized study . After a 4-week stabilization on a st and ard fat-reduced diet , participants were r and omly assigned to receive either genistein ( n = 30 ; 54 mg/d ) or placebo ( n = 30 ) . At baseline and after a 6-month treatment , we measured fasting glucose , insulin , insulin resistance ( HOMA-IR ) , osteoprotegerin ( OPG ) , fibrinogen , and sex hormone-binding globulin ( SHBG ) . Results : By comparison with placebo , genistein treatment decreased significantly fasting glucose ( genistein = −8.7 ± 2.3 % ; placebo = 3.2 ± 2.3 % ; P 0.001 ) , fasting insulin ( genistein = −12 ± 3.33 % ; placebo = 36 ± 3.29 % ; P ) , and HOMA-IR ( genistein = −14 ± 5.8 % ; placebo = 42 ± 0.6 % ; P fibrinogen decreased ( genistein = 3.18 ± 0.12 g/L ; placebo = 3.83 ± 0.04 g/L ; P the genistein group , serum OPG was lower ( −2 ± 0.3 % ) than in placebo ( 9 ± 1.5 % ; P ) , and serum SHBG was higher ( 63 ± 3.8 nmol/L ) compared with placebo ( 53 ± 2.9 nmol/L ; P < 0.05 ) . Conclusion : Our study suggests that genistein may have a favorable effect on some cardiovascular markers",
"BACKGROUND Higher dietary energy as protein during weight loss results in a greater loss of fat mass and retention of muscle mass ; however , the impact of protein quality on the rates of myofibrillar protein synthesis ( MPS ) and lipolysis , processes that are important in the maintenance of muscle and loss of fat , respectively , are unknown . OBJECTIVE We aim ed to determine how the consumption of different sources of proteins ( soy or whey ) during a controlled short-term ( 14-d ) hypoenergetic diet affected MPS and lipolysis . METHODS Men ( n = 19 ) and women ( n = 21 ) ( age 35 - 65 y ; body mass index 28 - 50 kg/m(2 ) ) completed a 14-d controlled hypoenergetic diet ( -750 kcal/d ) . Participants were r and omly assigned , double blind , to receive twice-daily supplements of isolated whey ( 27 g/supplement ) or soy ( 26 g/supplement ) , providing a total protein intake of 1.3 ± 0.1 g/(kg · d ) , or isoenergetic carbohydrate ( 25 g maltodextrin/supplement ) result ing in a total protein intake of 0.7 ± 0.1 g/(kg · d ) . Before and after the dietary intervention , primed continuous infusions of L-[ring-(13)C6 ] phenylalanine and [(2)H5]-glycerol were used to measure postabsorptive and postpr and ial rates of MPS and lipolysis . RESULTS Preintervention , MPS was stimulated more ( P . Postintervention , postabsorptive MPS decreased similarly in all groups ( all P was reduced by 9 ± 1 % in the whey group , which was less ( P intervention . Lipolysis was suppressed during the postpr and ial period ( P < 0.05 ) , but more so with ingestion of carbohydrate ( P < 0.05 ) than soy or whey . CONCLUSION We conclude that whey protein supplementation attenuated the decline in postpr and ial rates of MPS after weight loss , which may be of importance in the preservation of lean mass during longer-term weight loss interventions . This trial was registered at clinical trials.gov as NCT01530646",
"Objective : To investigate whether 6 months of exercise combined with isoflavone supplementation could improve clinical risk factors that predispose to cardiovascular disease in obese postmenopausal women . Design : This was a r and omized , double-blind , controlled trial in which 50 healthy obese postmenopausal women were divided into two groups and assigned to isoflavone supplementation ( n = 25 ) or a placebo ( n = 25 ) for 1 year . For the last 6 months , both groups participated in an exercise program ( three times per week ) , at the end of which cardiovascular disease risk factors were compared between groups . Body composition ( using dual-energy x-ray absorptiometry ) , metabolic profile ( blood lipids , fasting insulin , fasting glucose , sex hormone-binding globulin , C-reactive protein ) were determined at baseline and at 6 and 12 months . Results : We observed a significant effect of exercise and isoflavone supplementation on body weight , total and abdominal fat mass ( kilograms and percentage ) , body mass index , appendicular fat-free mass , fat-free mass/fat mass ratio , and sex hormone-binding globulin , but not with exercise alone . No difference was observed for other biochemical characteristics , although the quantitative insulin sensitivity check index increased equally in both groups . Conversely , although not significant , we observed a tendency for a treatment effect on body mass index ( P = 0.07 ) and on absolute ( kilograms ) ( P = 0.07 ) and percentage of ( P = 0.053 ) abdominal fat mass , whereas no effect of treatment was found for other variables using the Mann-Whitney test . Conclusions : Compared to an aerobic exercise program alone , 70 mg/day of isoflavones combined with exercise may promote significant improvements in body composition parameters that are known to influence cardiovascular disease risk in postmenopausal women",
"OBJECTIVE To determine whether a supplement of soy protein improves body composition , body fat distribution , and glucose and insulin metabolism in postmenopausal women without diabetes compared with an isocaloric casein placebo . DESIGN R and omized , double-blind , placebo-controlled 3-month trial . SETTING Clinical Research Center . PATIENT(S ) Fifteen postmenopausal women . INTERVENTION(S ) Computed tomographic scans at L4/L5 , dual energy x-ray absorptiometry , hyperglycemic clamps . MAIN OUTCOME MEASURE(S ) Total fat , total abdominal fat , visceral fat , subcutaneous abdominal fat , and insulin secretion . RESULT ( S ) Weight by dual energy x-ray absorptiometry did not change between groups ( + 1.38 + /- 2.02 kg for placebo vs. + 0.756 + /- 1.32 kg for soy , mean + /- SD ) . Total and subcutaneous abdominal fat increased more in the placebo group than in the soy group ( for differences between groups in total abdominal fat : + 38.62 + /- 22.84 cm(2 ) for placebo vs. -11.86 + /- 31.48 cm(2 ) for soy ; subcutaneous abdominal fat : + 22.91 + /- 28.58 cm(2 ) for placebo vs. -14.73 + /- 22.26 cm(2 ) for soy ) . Insulin secretion , visceral fat , total body fat , and lean mass did not differ between groups . Isoflavone levels increased more in the soy group . CONCLUSION ( S ) A daily supplement of soy protein prevents the increase in subcutaneous and total abdominal fat observed with an isocaloric casein placebo in postmenopausal women",
"Soy protein and isoflavones ( phytoestrogens ) have gained considerable attention for their potential role in improving risk factors for cardiovascular disease . This scientific advisory assesses the more recent work published on soy protein and its component isoflavones . In the majority of 22 r and omized trials , isolated soy protein with isoflavones , as compared with milk or other proteins , decreased LDL cholesterol concentrations ; the average effect was ≈3 % . This reduction is very small relative to the large amount of soy protein tested in these studies , averaging 50 g , about half the usual total daily protein intake . No significant effects on HDL cholesterol , triglycerides , lipoprotein(a ) , or blood pressure were evident . Among 19 studies of soy isoflavones , the average effect on LDL cholesterol and other lipid risk factors was nil . Soy protein and isoflavones have not been shown to lessen vasomotor symptoms of menopause , and results are mixed with regard to soy 's ability to slow postmenopausal bone loss . The efficacy and safety of soy isoflavones for preventing or treating cancer of the breast , endometrium , and prostate are not established ; evidence from clinical trials is meager and caution ary with regard to a possible adverse effect . For this reason , use of isoflavone supplements in food or pills is not recommended . Thus , earlier research indicating that soy protein has clinical ly important favorable effects as compared with other proteins has not been confirmed . In contrast , many soy products should be beneficial to cardiovascular and overall health because of their high content of polyunsaturated fats , fiber , vitamins , and minerals and low content of saturated fat",
"Fourteen subjects consumed four realistic isoenergetic ( 2035 kJ ) breakfasts , varying in macronutrient content ( two fat-rich , two carbohydrate-rich ( low- and high-fibre ) ) , in r and om order on separate mornings . After breakfast , subjects left the laboratory and completed appetite and alertness ratings at specific times and recorded all subsequent fluid and food intake for the rest of the day . The high-fibre , carbohydrate-rich breakfast was the least palatable but most filling meal and was associated with less food intake during the morning and at lunch . Hunger returned at a slower rate after this meal than after the low-fibre , carbohydrate-rich meal . Both fat-rich breakfasts were more palatable but less satiating than the carbohydrate-rich meals and were followed by greater food intake during the morning , which may be a compensatory response to ingest a sufficient amount of food and /or carbohydrate to match the level of fullness produced by the subjects ' habitual breakfasts . By the end of the day , the average total energy intake was significantly greater after the fat-rich EB meal than after the high-fibre , carbohydrate-rich meal ( P Total day fat intakes were also significantly greater when the high-fat breakfasts were eaten . For every individual test , alertness ratings increased immediately after breakfast was consumed . On average , the high-fibre carbohydrate-rich meal was associated with the highest post-breakfast alertness ratings and with the greatest cumulative amount of alertness during the period between breakfast and lunch ( AUC ) . Alertness AUC values up until lunch correlated positively with fullness AUC values ( r = 0.36 , P high-fibre , carbohydrate-rich breakfast may assist weight control efforts by maintaining fullness . Further research is required to determine whether satiety directly enhances alertness and whether low-GI carbohydrate-rich meals enhance alertness to a greater degree than high-GI meals",
"Results from a pilot project indicate that isoflavones and exercise could have an additive effect on body composition and clinical risk factors of CVD in postmenopausal women . The objective of the present study was to assess the combined effect of exercise and isoflavones in overweight-to-obese postmenopausal women . In this double-blind r and omised controlled trial , 100 overweight-to-obese ( BMI 29·9 ( sd 3·2 ) kg/m2 ) postmenopausal women were assigned to four groups : ( 1 ) placebo ( PLA ) ; ( 2 ) isoflavones ( ISO ) ; ( 3 ) exercise and placebo ( Ex+PLA ) ; ( 4 ) exercise and isoflavones ( Ex+ISO ) . The supplementation contained 70 mg/d of isoflavones . Exercise consisted of three weekly sessions of resistance training and aerobics . Outcome measures included fat mass ( FM ) , lean body mass ( LBM ) , bone mineral density , lipid profile , fasting glucose , fasting insulin and insulin resistance ( homeostasis assessment model ) . The main effects of exercise were observed for total FM ( P = 0·02 ) , FM% ( P 0·01 ) , trunk FM% ( P = 0·05 ) , arm FM% ( P leg FM% ( P = 0·02 ) , arm LBM ( P leg LBM ( P = 0·02 ) and C-reactive protein ( P for isoflavones in improving leg FM% ( P = 0·05 ) . No interactions were observed between isoflavones and exercise . In conclusion , it was observed that 6 months of exercise brought favourable changes in total FM , FM% and LBM in overweight postmenopausal women . No synergistic effects were observed between exercise and isoflavones . However , isoflavones could have a beneficial effect on leg FM% ",
"BACKGROUND Soy drink replacement in the diet might have beneficial effects on anthropometric and blood pressure values for overweight and obese subjects . Therefore , we are going to determine the effects of soy drink replacements on the weight , waist circumference and blood pressure among overweight and obese female youths . PATIENTS AND METHODS This was a cross-over r and omized clinical trial on 23 overweight and obese female subjects . All patients were on a weight reducing diet . There were two trial periods for six weeks ( soy drink period and cow 's milk period ) and a washout period for 3 weeks . In the soy drink period only one glass of soy drink ( 240 cc ) was consumed instead of one glass of cow 's milk . RESULTS The mean age of the patients was 22±2 years . Mean of BMI was 28.1±0.5 . Weight and waist circumference did not changed significantly after the soy drink period compared to the cow 's milk period . Systolic blood pressure reduced significantly following the soy drink period ( mean percent change in soy drink period : -4.0±0.9 vs -1.7±0.5 in the cow 's milk period ; p also reduced in the soy drink period ( -0.4±0.1 vs 0.4±0.1 ; p CONCLUSION Soy drink replacement could reduce both systolic and diastolic blood pressure among overweight and obese female youths . However , this replacement had no significant results on weight and waist circumference",
"Various forms of fermented soybean products are well documented for their health benefits . The efficacy of anti-obesogenic effect of Doenjang , one of the most commonly used seasonings in Korean cuisine , has been reported only in animal models ; thus , an evaluation of Doenjang needs to be conducted in human studies . We aim ed to test the hypothesis that Doenjang supplementation reduces body weight and changes body composition in overweight adults . A total of 51 overweight adults participated in this study . A group of males with BMI ≥ 23 kg/m2 and waist to hip ratio ( WHR ) ≥ 0.90 , and a group of females with BMI ≥ 23 kg/m2 and WHR ≥ 0.85 were r and omly assigned to either a Doenjang supplement ( 9.9 g dry/day ) group or a placebo group for a 12-week r and omized , double-blind and placebo-controlled study . Anthropometric parameters , abdominal fat distribution by computerized tomography ( CT ) and blood components were measured before and after the intervention period . After the 12-week study , the Doenjang supplementation group had significant reductions in body weight ( kg ) , body fat mass ( kg ) and body fat ( % ) compared to the placebo group , the supplementation of Doenjang result ed in a significant reduction in visceral fat ( cm2 ) , although no changes were observed in total and subcutaneous fat are as ( cm2 ) , serum lipid profiles and dietary intakes . The present study demonstrated that daily supplementation of 9.9 g dry/day of Doenjang for 12 weeks reduces body weight and visceral fat in overweight adults",
"SCOPE Studies have suggested that food rich in dietary fiber may facilitate body weight loss , lower total and LDL-cholesterol levels , and reduce body fat . This study examined the effects of soy fiber ( SF ) on body weight , body composition , and blood lipids in overweight and obese participants . METHODS AND RESULTS Thirty-nine overweight and obese college adults ( 19 - 39 years of age ) were r and omly assigned to consume control biscuits or biscuits supplemented with SF for their breakfast for 12 wk ( approximately 100 g/day ) . There were significant differences in changes on body weight , BMI , and LDL-cholesterol ( LDL-C ) between the two groups after 12-wk intervention ( p body weight , BMI , waist circumference , diastolic blood pressure , serum levels of total cholesterol , LDL-C , and glucose , body fat , and trunk fat of participants in SF group were observed significantly after 12 wk . CONCLUSION SF had favorable effects on body weight , BMI , and fasting LDL-C levels in overweight and obese adults . These effects may be beneficial in antiobesity and the improvement of hyperlipidemia and hypertension ( Clinical Trials.gov registration number-NCT01802840 )",
"Objective Isoflavones and exercise have been shown to affect C-reactive protein ( CRP ) and body composition and to act synergistically on trunk and total fat mass ( FM ) , glucose metabolism , and lean body mass in postmenopausal women with a body mass index higher than 25 kg/m2 . We hypothesized that exercise and isoflavone supplementation ( Ex + ISO ) could reduce inflammation in the same sub population of women . The objective of this study was to investigate if 6 months of mixed exercise combined with isoflavones could have greater effects on specific inflammatory markers than exercise alone in overweight or obese postmenopausal women . Methods Thirty-four postmenopausal women aged 50 to 70 years were r and omly assigned to exercise and placebo ( Ex + PLA ; n = 15 ) or Ex + ISO ( n = 19 ) . At baseline and after 6 months , waist circumference , hip circumference , total FM , trunk FM , leg FM , and muscle mass index ( MMI ; = total fat free mass [ kg ] / height2 [ m ] ) were assessed ( dual-energy x-ray absorptiometry ) . Inflammatory markers ( CRP , tumor necrosis factor-&agr ; [ TNF-&agr ; ] , and interleukin-6 ) were obtained by enzyme-linked immunosorbent assay . T tests were used to compare groups at baseline . Results The Ex + PLA group showed significant changes in MMI ( + 0.33 kg/m2 , P ⩽ 0.009 ) and FM compartments ( waist circumference , −5.13 cm ; % FM , −1.31 % ; P ⩽ 0.001 ) , whereas inflammation remained unchanged . However , the Ex + ISO group showed significant changes in total FM ( −1.70 kg , P compartments ( hip circumference [ −2.51 cm , P = 0.019 ] , leg FM [ −1.16 kg , P = 0.037 ] , and trunk FM [ −0.72 kg , P = 0.006 ] ) , MMI ( + 0.39 kg , P = 0.011 ) , and inflammation ( CRP , −1.14 mg/L , P = 0.029 ; TNF-&agr ; , + 0.29 pg/mL , P = 0.010 ) . Conclusions Despite an increase in TNF-&agr ; , the use of isoflavones — when body weight remains stable — seems to enhance the beneficial effects of mixed-exercise training on body composition and CRP in overweight or obese postmenopausal women",
"BACKGROUND AND AIMS Recent studies suggest that calcium metabolism and perhaps other components of dairy products may contribute to shifting the energy balance and thus play a role in weight regulation . We compared the effects of cows ' milk , calcium fortified soy milk and calcium supplement on weight and body fat reduction in premenopausal overweight and obese women . METHODS AND RESULTS In this clinical trial , 100 healthy overweight or obese premenopausal women were r and omized to one of the following dietary regimens for 8 weeks : ( 1 ) a control diet providing a 500kcal/day deficit , with 500 - 600mg/day dietary calcium ; ( 2 ) a calcium-supplemented diet identical to the control diet with 800mg/day of calcium as calcium carbonate ; ( 3 ) a milk diet providing a 500kcal/day deficit and containing three servings of low-fat milk ; ( 4 ) a soy milk diet providing a 500kcal/day deficit and containing three servings of calcium fortified soy milk . At baseline and after 8 weeks , weight , waist circumference , and hip circumference were measured . Three 24-h dietary records and physical activity records were also taken . Comparing the mean differences in weight , waist circumference , body mass index ( BMI ) and waist-to-hip ratio ( WHR ) using repeated measure of variance analysis showed that changes in waist circumference and WHR were significant among the four groups ( p=0.029 and p=0.015 , respectively ) . After adjustment for baseline values , changes in weight and BMI were also significant ( p=0.017 and p=0.019 , respectively ) . Weight reductions in high milk , soy milk , calcium supplement and control groups were 4.43±1.93(kg ) , 3.46±1.28(kg ) , 3.89±2.40(kg ) and 2.87±1.55(kg ) , respectively . The greatest changes were seen in the high dairy group in all variables . CONCLUSION Increasing low fat milk consumption significantly reduces the general and central obesity beyond a low calorie diet",
"ABSTRACT Objectives Postmenopausal women are particularly inclined to an increased risk of developing non-alcoholic hepatic steatosis . The purpose of this study was to investigate whether adding isoflavone supplementation to exercise training could reduce the risk . Methods In a 6-month , double-blind , r and omized , controlled trial , 54 healthy overweight-to-obese ( body mass index 28–40 kg/m2 ) postmenopausal women were r and omly assigned to one of the following groups : ( 1 ) exercise and isoflavones ( Ex-Iso ; n = 26 ) , ( 2 ) exercise and placebo ( Ex-Pla ; n = 28 ) . Exercise training consisted of three weekly sessions of mixed training . We examined the plasma level of specific hepatic enzymes ( alanine aminotransferase , aspartate aminotransferase , γ-glutamyltransferase , and alkaline phosphatase ) as a reflection of fatty liver along with the calculation of the fatty liver index . All measures were obtained at baseline and after the 6-month intervention . Results Following the intervention , a lower fatty liver index ( p and plasma γ-glutamyltransferase ( p that exercise training appears to bring favorable changes in the plasma level of hepatic enzymes , possibly due to the lowering of liver fat content . While postmenopausal women can benefit from this intervention to decrease the risk of developing non-alcoholic hepatic steatosis , it seems that the addition of isoflavones to exercise training provides some additional effects to those provided by exercise alone",
"Recent studies suggest that obese individuals lose weight more rapidly and lose more total weight with soy protein than with animal protein as a major diet component . The purpose of the present study was to evaluate the weight-loss efficacy and changes in body composition , waist circumference , blood pressure , and levels of plasma glucose , insulin , serum lipids , C-reactive protein , and homocysteine from consumption of either 3 soy shakes or 3 casein shakes daily as part of a 16-week , energy-restricted diet for obese women . Forty-three women with body mass index values of 30 to 40 kg/m(2 ) were r and omized to intensive dietary interventions using either casein ( n = 21 ) or soy ( n = 22 ) shakes . Subjects were instructed to consume 3 shakes , 1 prepackaged entrée , and 5 servings of fruits or vegetables daily to achieve an energy intake of 4.5 to 5.0 MJ/d . Subjects attended classes weekly or biweekly . Weight , body fat , lipid , and glucose measurements were obtained at baseline and at 8 and 16 weeks . For both groups combined , subjects lost 8.1 % of initial body weight ( 7.7 kg ) at 8 weeks and 13.4 % ( 12.7 kg ) at 16 weeks . Weight loss from baseline did not differ significantly by group and , for completing subjects , was 14.0 % + /- 1.2 % ( mean + /- SE ) for casein and 12.8 % + /- 1.4 % for soy . With the intention-to-treat analysis , weight losses at 16 weeks were 12.5 % + /- 1.4 % for casein and 11.3 % + /- 1.2 % for soy . Body fat losses were 23.7 % + /- 2.0 % for casein and 21.8 % + /- 2.4 % for soy and did not differ significantly . Both study groups lost significant amounts of weight with a highly structured behavioral program incorporating 4 meal replacements and vegetables and fruits . Differences in weight loss and body composition changes between casein and soy treatments were not significant",
"Background : Soy milk replacement in the diet might have beneficial effects on waist circumference and cardiovascular risk factors for overweight and obese subjects . Therefore , we are going to determine the effects of soy milk replacements on the waist circumference and cardiovascular risk factors among overweight and obese female adults . Methods : In this crossover r and omized clinical trail , 24 over weight and obese female adults were on a diet with soy milk or the diet with cow 's milk for four weeks . In the diet with soy milk only one glass of soy milk ( 240 cc ) was replaced instead of one glass of cow 's milk ( 240 cc ) . Measurements were done according to the st and ard protocol . Results : Waist circumference reduced significantly following soy milk period ( mean percent change in soy milk period for waist circumference : -3.79 ± 0.51 vs. -1.78 ± 0.55 % ; P = 0.02 in the cow 's milk period ) . Blood pressure , weight , liver enzymes and glycemic control indices did not changed significantly after soy milk period compared to the cow 's milk period . Conclusion : Among over weight and obese patients , soy milk can play an important role in reducing waist circumference . However , soy milk replacement had no significant effects on weight , glycemic control indices , liver enzymes , fibrinogen and blood pressure in a short term trial",
"AIMS To investigate whether 6 months of isoflavone supplementation , which has been shown to be sufficient to improve menopausal symptoms , could also improve clinical cardiovascular disease ( CVD ) risk factors in obese postmenopausal women , compared with a placebo . METHODS A r and omized double-blind placebo-controlled trial in which 50 obese postmenopausal women were divided into two groups ( isoflavones vs. placebo ) to examine the effect of 6 months of isoflavone supplement ( 70 mg ) on clinical CVD risk factors . Body composition ( DXA ) , medical and social characteristics , daily energy expenditure ( accelerometry ) , dietary intake ( 3-day dietary record ) , and blood biochemical analyses ( lipid profile , insulin , glucose ) were obtained . RESULTS At baseline , no differences were found between groups except for fasting insulin level . Women were thus considered at risk of CVD based on body composition but not biochemical variables . After 6 months , we observed that isoflavones did not favorably affect risk factors predisposing to CVD ( biochemical or body composition ) compared with placebo . CONCLUSIONS Isoflavones given for 6 months should not be considered protective against clinical CVD risk factors in obese postmenopausal women . Nevertheless , further research is needed to verify if isoflavones protect against CVD disease risk factors when administered for a longer duration or when combined with nutritional or exercise interventions . It would also be pertinent to study their effects in women with specific metabolic abnormalities",
"Objective : The aim of this study was to determine the effect of DRIs on hot flash symptoms in menopausal women . Design : This was a r and omized , double-blind , placebo-controlled trial of menopausal women , aged 38 to 60 years , who experienced 4 to 14 hot flashes per day . After a 1-week run-in period , a total of 190 menopausal women were r and omized to receive a placebo or 40 or 60 mg/day of a DRI for 12 weeks . The primary outcome was the mean changes from baseline to week 12 in the frequency of hot flashes recorded in the participant diary . The secondary outcomes included changes in quality of life and hormonal profiles . Results : A total of 147 women ( 77 % ) completed the study . It was found that 40 and 60 mg of DRI improved hot flash frequency and severity equally . At 8 weeks hot flash frequency was reduced by 43 % in the 40-mg DRI group and by 41 % in the 60-mg DRI group , compared with 32 % in the placebo group ( P = not significant vs placebo ) . The corresponding numbers for 12 weeks were 52 % , 51 % , and 39 % , respectively ( P = 0.07 and 0.09 vs placebo ) . When comparing the two treatment groups with the placebo group , there were significant reductions in mean daily hot flash frequency . The supplement ( either 40 or 60 mg ) reduced hot flash frequency by 43 % at 8 weeks ( P = 0.1 ) and 52 % at 12 weeks ( P = 0.048 ) but did not cause any significant changes in endogenous sex hormones or thyroid hormones . Menopausal quality of life improved in all three groups , although there were no statistically significant differences between groups . Conclusions : DRI supplementation may be an effective and acceptable alternative to hormone treatment for menopausal hot flashes",
"Background This study explores the relationship between BMI and national-wealth and the cross-level interaction effect of national-wealth and individual household-wealth using multilevel analysis . Methods Data from the World Health Survey conducted in 2002–2004 , across 70 low- , middle- and high-income countries was used . Participants aged 18 years and over were selected using multistage , stratified cluster sampling . BMI was used as outcome variable . The potential determinants of individual-level BMI were participants ’ sex , age , marital-status , education , occupation , household-wealth and location(rural/urban ) at the individual-level . The country-level factors used were average national income ( GNI-PPP ) and income ine quality ( Gini-index ) . A two-level r and om-intercepts and fixed-slopes model structure with individuals nested within countries was fitted , treating BMI as a continuous outcome . Results The weighted mean BMI and st and ard-error of the 206,266 people from 70-countries was 23.90 ( 4.84 ) . All the low-income countries were below the 25.0 mean BMI level and most of the high-income countries were above . All wealthier quintiles of household-wealth had higher scores in BMI than lowest quintile . Each USD10000 increase in GNI-PPP was associated with a 0.4 unit increase in BMI . The Gini-index was not associated with BMI . All these variables explained 28.1 % of country-level , 4.9 % of individual-level and 7.7 % of total variance in BMI . The cross-level interaction effect between GNI-PPP and household-wealth was significant . BMI increased as the GNI-PPP increased in first four quintiles of household-wealth . However , the BMI of the wealthiest people decreased as the GNI-PPP increased . Conclusion Both individual-level and country-level factors made an independent contribution to the BMI of the people . Household-wealth and national-income had significant interaction effects",
"Calcium from dairy sources is beneficial to weight loss ; however , no studies have compared the effects of dairy to nondairy sources of calcium on weight loss . This pilot study explored differences between soy and skim milk on changes in anthropometric values in premenopausal women . In a prospect i ve r and omized controlled trial , 14 women with overweight/obesity were r and omly assigned to 720 mL soy milk ( n=7 ) or an equivalent volume of skim milk ( n=7 ) daily for 8 weeks . Subjects followed a 500-kcal deficit diet based on metabolic rate data . There were no anthropometric differences between soy and skim milk groups at baseline . Subjects followed an energy-restricted diet ; both groups experienced reductions in kilogram weight ( 4.27+/-2.05 vs 3.76+/-2.25 ; P=0.668 ) , body fat percent ( 1.30+/-1.37 vs 1.87+/-1.45 ; P=0.464 ) , and abdominal circumference ( 11.28+/-5.23 vs 8.66+/-2.51 ; P=0.259 ) while attenuating losses of fat-free mass ( 1.12+/-1.29 vs 0.43+/-1.12 ; P=0.299 ) during the 8-week study . There were no significant differences in weight , fat percent , abdominal circumference , and fat-free mass between groups . To optimize the weight loss effects of calcium , one can consume 720 mL of either soy milk or skim milk daily",
"Objectives : Soy protein intake has favorable effects on body weight and fat distribution in experimental animals but these effects have not been demonstrated in humans . To compare effects of soy- vs. milk-based meal replacements ( MR ) we assessed weight loss and serum lipoproteins changes for obese subjects who consumed low-energy diets ( LED ) including either milk-based or soy-based MR . Methods : Overweight or obese women and men ( body mass indices 27–40 kg/m2 ) were r and omly assigned to LED providing 1200 kcal/day , with consumption of five soy-based or two milk-based liquid MR for a 12-week weight loss trial . Serum lipoprotein measurements were obtained at baseline , 6 and 12 weeks . Results : For soy and milk MR groups , subject numbers were , respectively , 51 and 39 r and omized and 30 and 22 completers . MR use averaged : soy , 3.7/day ; and milk , 1.9/day . Weight losses for completers at 12 weeks were : soy MR , 9.0 % of initial body weight ( 95 % confidence intervals , 7.3–10.6 % ) ; and milk MR , 7.9 % ( 5.8–8.8 % ) with no significant differences . Reductions from baseline in serum cholesterol and LDL-cholesterol values , respectively , at six weeks were significantly greater ( P soy MR ( 15.2 % and 17.4 % ) than with milk MR ( 7.9 % and 7.7 % ) . Soy MR use was associated with significant reductions in serum triglycerides at 6 and 12 weeks while milk MR use was not . Conclusions : Soy MR use , as part of a low-energy diet , was associated with slightly but not significantly greater weight loss over a 12-week period than milk MR use . These observations confirm previous studies documenting the effectiveness of MR use for weight loss",
"CONTEXT Genistein , a soy isoflavone , has received wide attention over the last few years because of its potential preventive role for cardiovascular disease . OBJECTIVE Our objective was to assess the effects of genistein administration ( 54 mg/d ) on some predictors of cardiovascular risk in osteopenic , postmenopausal women . DESIGN AND SETTING We conducted a r and omized , double-blind , placebo-controlled trial at three Italian university medical centers . INTERVENTION After a 4-wk stabilization on a st and ard isocaloric , fat-reduced diet , participants were r and omly assigned to receive genistein ( n = 198 ) or placebo ( n = 191 ) daily for 24 months . Both intervention and placebo contained calcium and vitamin D(3 ) . OUTCOME MEASURES Blood lipid profiles , fasting glucose and insulin , homeostasis model assessment for insulin resistance , fibrinogen , soluble intercellular adhesion molecule-1 , soluble vascular cellular adhesion molecule-1 , F2-isoprostanes , and osteoprotegerin at baseline and after 12 and 24 months of treatment were measured . RESULTS Compared with placebo , genistein significantly reduced fasting glucose and insulin as well as homeostasis model assessment for insulin resistance after both 12 and 24 months of treatment . By contrast , genistein administration did not affect blood lipid levels although fibrinogen , F2-isoprostanes , soluble intercellular adhesion molecule-1 , and soluble vascular cellular adhesion molecule-1 decreased significantly compared with placebo after 24 months . Serum osteoprotegerin was higher in the genistein group compared with placebo . At 24 months , the genistein group showed no change in endometrial thickness compared with placebo . Most treatment-related adverse events were moderate and composed of gastrointestinal side effects [ genistein , n = 37 ( 19 % ) ; placebo , n = 15 ( 8 % ) ] . CONCLUSIONS These results suggest that 54 mg genistein plus calcium , vitamin D(3 ) , and a healthy diet was associated with favorable effects on both glycemic control and some cardiovascular risk markers in a cohort of osteopenic , postmenopausal women",
"A weight-reducing potential has been ascribed to high dietary fibre intake . To investigate the practical reliability of this hypothesis , fifty-three moderately overweight females ( BMI > 27.5 kg/m2 ) on reduced energy intake ( 1200 kcal/day ) were treated for 24 weeks with a fibre supplement on a r and omly , double-blind , placebo-controlled basis . The fibre was administered as an initial dose of 6 g and a maintenance dose of 4 g. Body weight and blood pressure were recorded weekly during the first 3 months and thereafter every second week . Blood sample s were drawn at start and at end of the study . Initial body weights were 75.6 + /- 1.6 kg in the fibre group versus 75.5 + /- 1.6 kg in the placebo group . After treatment , mean weight loss in the fibre group was 8.0 kg versus 5.8 kg in the placebo group ( p Systolic and diastolic blood pressures were significantly reduced in both groups without differences between the groups . Serum concentrations of cholesterol , triglycerides and uric acid were significantly reduced in the group with reduced energy intake , whereas no additional effect was observed when fibre was supplemented . Serum concentrations of potassium and sodium did not change significantly . The results suggest that a dietary fibre supplement in combination with a hypocaloric diet is of value as an adjunct in the management of overweight",
"The present study determined the effect of black soy peptide supplementation on body weight and body fat in overweight/obese subjects . In a double-blind controlled trial , participants ( n = 80 ) were r and omized to either soy peptide supplementation ( the test group ) or to a placebo ( the placebo group ) . Sixty-four people completed the study , and anthropometric parameters , serum inflammatory markers , and leptin and lipid profiles were measured . After 6 weeks , the test group ( n = 35 ) had significant reductions in body weight ( p = 0.003 ) and body mass index ( BMI ) ( p = 0.004 ) , body fat mass ( p = 0.038 ) . After 12 weeks , they also had significant reductions in body weight ( p 0.001 ) , BMI ( p 0.001 ) , body fat percentage ( p = 0.002 ) , and body fat mass ( p = 0.001 ) . However , these significance s were not observed in the placebo group ( n = 29 ) . In addition , net changes in body weight and body fat mass in the test group were significantly bigger than those in the placebo group after 12 weeks . Leptin levels were significantly reduced in the test groups ( p = 0.047 ) , but were not observed in the placebo group ( p = 0.323 ) . Interestingly , the subjects with weight reductions ≥1 kg in the test group had greater reductions in circulating leptin levels ( p = 0.002 ) . Additionally , fasting insulin levels were significantly reduced in the test groups . The conclusion is that black soy peptide supplementation may be beneficial for body weight control in overweight/obese subjects",
"Summary Objective This 12‐month r and omized , non‐inferiority clinical trial sought to determine the impact of consuming soy protein as part of an energy‐restricted , high‐protein diet on weight loss , body composition and cardiometabolic health . Methods Seventy‐one adults ( 58 female ) with overweight or obesity ( body mass index : 32.9 ± 3.6 kg m−2 ) were r and omly assigned to consume three servings of soy ( S ) or non‐soy ( NS ) protein foods per day for 12 months . All participants completed a group‐based behavioural weight loss program lasting 4 months ( M4 ) , and follow‐up assessment s were completed at month 12 ( M12 ) . Results Body weight was reduced in both groups at M4 ( S : −7.0 % ± 5.2 % , NS : −7.1 % ± 5.7 % ) and M12 ( S : 3.6 % ± 5.1 % , NS : −4.8 % ± 7.3 % ) . Body weight reductions ( mean difference [ 90 % confidence interval ] ) were not different between S and NS at either time point ( M4 : −0.16 % [ −1.4 , 3.6 ] , P = 0.90 ; M12 : 1.1 % [ −1.4 , 3.6 ] , P = 0.44 ) . Differences in body fat mass loss were not different between S and NS at M4 ( 0.29 ± 0.84 kg , P = 0.73 ) or M12 ( 0.78 ± 1.5 kg , P = 0.59 ) . Weight loss‐induced improvements in cholesterol , triglycerides and blood pressure did not differ between S and NS . Conclusion These results indicate that soy‐based protein foods can be effectively incorporated into an energy‐restricted , high‐protein diet for improving body weight , body composition and cardiometabolic health ",
"Background Available preliminary data on menopause does not relate changes in body fat mass ( BFM ) and h and grip strength ( HGS ) ( an indicator of body/muscle strength ) to gait parameters . Objective To determine the relationship between BFM , HGS and gait parameters , namely , stride length ( SL ) ( an indicator of walking balance/postural stability ) , stride frequency ( SF ) , and velocity ( V ) ( gait output ) , to guide gait training . Methods Ninety consenting ( 45 postmenopausal and 45 premenopausal ) female staff of the University of Nigeria Teaching Hospital , Enugu , were r and omly selected and assessed for BFM and HGS with a hydration monitor and dynamometer , respectively , in an observational study . The mean of 2 trials of the number of steps and time taken to cover a 10-m distance at normal speed was used to calculate SF , SL , and V. Data were analyzed using an independent t test and a Pearson correlation coefficient at P Premenopausal ( BFM = 42.93 % [ 12.61 % ] , HGS = 27.89 [ 7.52 ] kg , stride ratio = 1.43 , and velocity = 1.04 [ 0.01 ] m/sec ) and postmenopausal ( BFM = 41.55 % [ 12.71 % ] , HGS = 30.91 [ 7.07 ] kg , stride ratio = 1.44 , and velocity = 1.06 [ 0.01 ] m/sec ) women showed no significant differences in gait output/velocity ( t = 0.138 ; P = 0.89 ; d = 0.029 ) . At postmenopause , BFM was significantly and negatively ( r = –0.369 ; r2 = 0.1362 ; P = 0.013 ) correlated with SL , whereas HGS was positively and significantly ( r = 0.323 ; r2 = 0.104 ; P = 0.030 ) correlated with gait output at premenopause . Conclusions BFM may adversely influence walking balance at postmenopause , whereas HGS may enhance gait output at premenopause but not postmenopause . Therefore , muscle strengthening alone may not enhance gait output in postmenopausal women without balance training"
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Background Given the rapid development during the early years ( 0 - 4 years ) , an underst and ing of the health implication s of physical activity is needed . The purpose of this systematic review was to examine the relationships between objective ly and subjectively measured physical activity and health indicators in the early years . Methods Electronic data bases were originally search ed in April , 2016 . Included studies needed to be peer- review ed , written in English or French , and meet a priori study criteria . The population was apparently healthy children aged 1 month to 59.99 months/4.99 years . The intervention/exposure was objective ly and subjectively measured physical activity . The comparator was various volumes , duration s , frequencies , patterns , types , and intensities of physical activity . The outcomes were health indicators ranked as critical ( adiposity , motor development , psychosocial health , cognitive development , fitness ) and important ( bone and skeletal health , cardiometabolic health , and risks/harm ) . The Grading of Recommendations Assessment , Development , and Evaluation ( GRADE ) framework was used to assess the quality of evidence for each health indicator by each study design . Results Ninety-six studies representing 71,291 unique participants from 36 countries were included . Physical activity interventions were consistently ( > 60 % of studies ) associated with improved motor and cognitive development , and psychosocial and cardiometabolic health . Across observational studies , physical activity was consistently associated with favourable motor development , fitness , and bone and skeletal health . For intensity , light- and moderate-intensity physical activity were not consistently associated with any health indicators , whereas moderate- to vigorous-intensity , vigorous-intensity , and total physical activity were consistently favourably associated with multiple health indicators . Across study design s , consistent favourable associations with health indicators were observed for a variety of types of physical activity , including active play , aerobic , dance , prone position ( infants ; ≤1 year ) , and structured/organized . Apart from ≥30 min/day of the prone position for infants , the most favourable frequency and duration of physical activity was unclear . However , more physical activity appeared better for health . Evidence ranged from “ very low ” to “ high ” quality . Conclusions Specific types of physical activity , total physical activity , and physical activity of at least moderate- to vigorous-intensity were consistently favourably associated with multiple health indicators . The majority of evidence was in preschool-aged children ( 3 - 4 years ) . Findings will inform evidence -based guidelines
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"We previously reported that calcium intake enhanced the leg bone response to physical activity of preschool children in a 12-month r and omized trial of calcium supplementation and physical activity . To determine whether the intervention-induced changes in leg bone mineral content and size were maintained through the subsequent 12-month follow-up period , total body bone measurements by DXA and 20 % distal tibia pQCT bone measurements were obtained at 24 months ( 12 months post-intervention ) . Children also were measured for height and weight , and accelerometer readings were obtained in a subset of children at 18 and 24 months ( 6 and 12 months post-intervention ) . Regression analyses were performed controlling for covariates and indicated that increases from 12 to 24 months were greater in the gross motor ( GM ) activity group ( bone loading , large muscle exercises ) vs. fine motor ( FM ) activity group ( arts and crafts program ) for arm bone area ( BA ) ( P total body ( P=0.04 ) and arm ( P bone mineral content ( BMC ) . There were no differences in BA or BMC changes from 12 to 24 months by calcium supplementation . Differences in tibia periosteal circumference by pQCT persisted at 24 months ( GM 51.4 + /- 0.4 mm vs. FM 50.2 + /- 0.4 mm , P=0.03 ) with a trend for greater endosteal circumferences in the children in the GM vs. FM groups at both 12 and 24 months ( both , P=0.08 ) . There were no significant differences in cortical area or thickness by activity or supplement group at 24 months . Children in the GM group had greater accelerometer counts/day ( P=0.04 ) and more time in vigorous activity ( P=0.05 ) at 18 months compared to FM group . No differences in accelerometer readings were noted at 24 months . In conclusion , we found higher activity levels in children r and omized to gross motor vs. fine motor activities 6 months after the intervention program ceased . Whether the greater periosteal circumference that was observed 12 months post-intervention was a persistent biological bone effect or due to persistently higher activity levels is not known",
"Background Little is known about preschool-aged children ’s levels of physical activity ( PA ) over the course of the day . Using time-stamped data , we describe the levels and patterns of PA in a population -based sample of four-year-old British children . Methods Within the Southampton Women ’s Survey the PA levels of 593 4-year-old children ( 51 % female ) were measured using ( Actiheart ) accelerometry for up to 7 days . Three outcome measures : minutes spent sedentary ( in light ( LPA : ≥20 – 399 cpm ) and in moderate-to-vigorous activity ( MVPA : ≥400 cpm ) were derived . Average daily activity levels were calculated and then segmented across the day ( morning , afternoon and evening ) . MVPA was log-transformed . Two-level r and om intercept models were used to analyse associations between activity level and temporal and demographic factors . Results Children were active for 67 % ( mean 568.5 SD 79.5 minutes ) of their daily registered time on average , with 88 % of active time spent in LPA . All children met current UK guidelines of 180 minutes of daily activity . There were no differences in children ’s average daily levels of sedentary activity and LPA by temporal and demographic factors : differences did emerge when activity was segmented across the day . Sex differences were largest in the morning , with girls being more sedentary , spending fewer minutes in LPA and 18 % less time in MVPA than boys . Children were more sedentary and less active ( LPA and MVPA ) in the morning if they attended childcare full-time compared to part-time , and on weekend mornings compared to weekdays . The reverse was true for weekend afternoons and evenings . Children with more educated mothers were less active in the evenings . Children were less sedentary and did more MVPA on summer evenings compared to winter evenings . Conclusions Preschool-aged children meet current physical activity guidelines , but with the majority of their active time spent in LPA , investigation of the importance of activity intensity in younger children is needed . Activity levels over the day differed by demographic and temporal factors , highlighting the need to consider temporality in future interventions . Increasing girls ’ morning activity and providing opportunities for daytime activity in winter months may be worthwhile",
"Objective To assess the effect of a governmentally-led center based child care physical activity program ( Youp’là Bouge ) on child motor skills . Patients and methods We conducted a single blinded cluster r and omized controlled trial in 58 Swiss child care centers . Centers were r and omly selected and 1:1 assigned to a control or intervention group . The intervention lasted from September 2009 to June 2010 and included training of the educators , adaptation of the child care built environment , parental involvement and daily physical activity . Motor skill was the primary outcome and body mass index ( BMI ) , physical activity and quality of life secondary outcomes . The intervention implementation was also assessed . Results At baseline , 648 children present on the motor test day were included ( age 3.3 ± 0.6 , BMI 16.3 ± 1.3 kg/m2 , 13.2 % overweight , 49 % girls ) and 313 received the intervention . Relative to children in the control group ( n = 201 ) , children in the intervention group ( n = 187 ) showed no significant increase in motor skills ( delta of mean change ( 95 % confidence interval : -0.2 ( −0.8 to 0.3 ) , p = 0.43 ) or in any of the secondary outcomes . Not all child care centers implemented all the intervention components . Within the intervention group , several predictors were positively associated with trial outcomes : 1 ) free-access to a movement space and parental information session for motor skills 2 ) highly motivated and trained educators for BMI 3 ) free-access to a movement space and purchase of mobile equipment for physical activity ( all p child care centers confirms the complexity of implementing an intervention outside a study setting and identified potentially relevant predictors that could improve future programs . Trial registration Clinical trials.gov",
"Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results",
"Exercise has been found to be effective for prevention of weight gain and maintenance of a stable weight in adults . The objective of this study was to evaluate the effect of a school-based aerobic exercise program on the obesity indexes of preschool children . Subjects were 292 second-year elementary school pupils from 2 kindergartens in Hat Yai municipality , Songkhla province , southern Thail and . A specially design ed exercise program , including a 15-min walk before beginning the morning class and a 20-min aerobic dance session after the afternoon nap , 3 times a week , was conducted for 29.6 wk . Weight , height , and triceps skinfold thickness were measured 4 times . At the end of the study , the prevalence of obesity , using 95th percentile National Center for Health Statistics triceps-skinfold-thickness cutoffs , of both the exercise and control groups decreased . That of the exercise group decreased from 12.2 % at baseline to 8.8 % ( Wilcoxon signed-rank test , P = 0.058 ) , whereas that of the control group decreased from 11.7 % to 9.7 % ( Wilcoxon signed-rank test , P = 0.179 ) . A sex difference in the response of body mass index ( BMI ) to exercise was observed . Girls in the exercise group had a lower likelihood of having an increasing BMI slope than the control girls did ( odds ratio : 0.32 ; 95 % CI : 0.18 , 0.56 ) . In conclusion , our study suggests that a 29.6-wk school-based exercise program can prevent BMI gain in girls and may induce a remission of obesity in preschool-age children",
"The aim of this study was to assess the feasibility , acceptability and potential efficacy of a physical activity program for preschool children . A 20-week , 2-arm parallel cluster r and omized controlled pilot trial was conducted . The intervention comprised structured activities for children and professional development for staff . The control group participated in usual care activities , which included design ated inside and outside playtime . Primary outcomes were movement skill development and objective ly measured physical activity . At follow-up , compared with children in the control group , children in the intervention group showed greater improvements in movement skill proficiency , with this improvement statically significant for overall movement skill development ( adjust diff . = 2.08 , 95 % CI 0.76 , 3.40 ; Cohen 's d = 0.47 ) and significantly greater increases in objective ly measured physical activity ( counts per minute ) during the preschool day ( adjust diff . = 110.5 , 95 % CI 33.6 , 187.3 ; Cohen 's d = 0.46 ) . This study demonstrates that a physical activity program implemented by staff within a preschool setting is feasible , acceptable and potentially efficacious",
"In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias",
"Background Over the last decades , a decline in motor skills and in physical activity and an increase in obesity has been observed in children . However , there is a lack of data in young children . We tested if differences in motor skills and in physical activity according to weight or gender were already present in 2- to 4-year-old children . Methods Fifty-eight child care centers in the French part of Switzerl and were r and omly selected for the Youp'là bouge study . Motor skills were assessed by an obstacle course including 5 motor skills , derived from the Zurich Neuromotor Assessment test . Physical activity was measured with accelerometers ( GT1 M , Actigraph , Florida , USA ) using age-adapted cut-offs . Weight status was assessed using the International Obesity Task Force criteria ( healthy weight vs overweight ) for body mass index ( BMI ) . Results Of the 529 children ( 49 % girls , 3.4 ± 0.6 years , BMI 16.2 ± 1.2 kg/m2 ) , 13 % were overweight . There were no significant weight status-related differences in the single skills of the obstacle course , but there was a trend ( p = 0.059 ) for a lower performance of overweight children in the overall motor skills score . No significant weight status-related differences in child care-based physical activity were observed . No gender-related differences were found in the overall motor skills score , but boys performed better than girls in 2 of the 5 motor skills ( p ≤ 0.04 ) . Total physical activity as well as time spent in moderate-vigorous and in vigorous activity during child care were 12 - 25 % higher and sedentary activity 5 % lower in boys compared to girls ( all p in global motor skills . However , in accordance to data in older children , child care-based physical activity was higher in boys compared to girls . These results are important to consider when establishing physical activity recommendations or targeting health promotion interventions in young children",
"Objective To assess whether a physical activity intervention reduces body mass index in young children . Design Cluster r and omised controlled single blinded trial over 12 months . Setting Thirty six nurseries in Glasgow , Scotl and . Participants 545 children in their preschool year , mean age 4.2 years ( SD 0.2 ) at baseline . Intervention Enhanced physical activity programme in nursery ( three 30 minute sessions a week over 24 weeks ) plus home based health education aim ed at increasing physical activity through play and reducing sedentary behaviour . Main outcome measure Body mass index , expressed as a st and ard deviation score relative to UK 1990 reference data . Secondary measures were objective ly measured physical activity and sedentary behaviour ; fundamental movement skills ; and evaluation of the process . Results Group allocation had no significant effect on the primary outcome measure at six and 12 months or on measures of physical activity and sedentary behaviour by accelerometry . Children in the intervention group had significantly higher performance in movement skills tests than control children at six month follow-up ( P=0.0027 ; 95 % confidence interval 0.3 to 1.3 ) after adjustment for sex and baseline performance . Conclusions Physical activity can significantly improve motor skills but did not reduce body mass index in young children in this trial . Trial registration Current Controlled Trials IS RCT N36363490",
"Objective The purpose of this study was to investigate the effect of SPARK Physical Education ( PE ) program on fundamental motor skills in 4 - 6 year children . SPARK ( Sports , Play , and Active Recreation for Kids ) is an evidence based PE program design ed in order to promote the lifelong wellbeing . Methods In total , 90 children aged 4 to 6 years were selected r and omly . The children were allocated into 3 groups with separate PE programs : 1-SPARK , 2-Gymnastics and 3-Routine activity . Using the Test of Gross Motor Development ( TGMD-2 ) , a pretest was done in all groups . Afterwards , SPARK and Gym PE programs were performed for 8 weeks and 3 sessions each week . The third group used to do the routine physical education program in their daycare . After 8 weeks ( 24 sessions ) , the post tests were done for all groups with the same scoring system as the pretest . Findings The results showed that the SPARK program had a higher efficacy on the promotion of the fundamental motor skills comparing to the routine physical education programs or gymnastics PE group . Conclusion SPARK can be used as an appropriate alternative in order to promote the children 's motor skills",
"This study was undertaken to identify factors that influence total body bone area ( TBBA ) , total body bone mineral content ( TB BMC ) , and tibial cortical bone measures in 239 children aged 3 - 5 years . We obtained information on demographic and anthropometric characteristics and measurements of diet , physical activity , and strength . In multiple regression analysis , TBBA correlated with height ( p TB BMC correlated with TBBA ( p Children born preterm had lower TB BMC compared with children born at term ( p = 0.02 ) . Both periosteal and endosteal circumferences were correlated with weight ( both , p Endosteal circumference was greater and cortical bone area was lower in children born preterm compared with those born at term ( both , p = 0.04 ) . Findings of higher TBBA and lower TB BMC in children with high percent body fat indicate undermineralization of bone and suggest that obesity in preschool children may have detrimental effects on total body bone mass accretion . A smaller tibial periosteal circumference and thus cross-sectional area in children with the same weight but higher percent body fat also would lead to a biomechanical disadvantage in these children . Findings of low TB BMC and cortical bone area among children born preterm need to be confirmed in other population s. We speculate that differences in these measurements between children born preterm and at term may be caused by differences in activity",
"Although increased physical activity early in life is recommended for optimizing bone health , no controlled trials on the effect of activity on bone mass accretion during periods of rapid growth have been reported . The purpose of this study was to determine whether infants r and omized to a 1 year gross motor activity program had a greater bone mass accretion than infants r and omized to a fine motor activity program . The gross motor program included activities that focused on loading the skeleton and were performed for 15 - 20 minutes/day , 5 days/week by study personnel . Infants ( n = 72 ) were enrolled at 6 months of age , and total body bone mineral content ( BMC ) , 3-day diet records , and activity levels were obtained at 6 , 9 , 12 , 15 , and 18 months . BMC was associated with weight , length , and bone area at all ages and correlated with earlier calcium intakes . Calcium intake appeared to modify the effect of gross motor activity on bone mass accretion ; infants in both groups had similar bone accretion at moderately high calcium intakes , but at low calcium intakes infants in the gross motor program had less bone accretion than infants in the fine motor program . Compliant infants in the gross motor group had lower BMC at 18 months compared with noncompliant infants . These results indicate that BMC in infants is related to calcium intake , and we speculate that participation in a gross motor program during rapid bone growth may lead to reduced bone accretion in the presence of a moderate to moderately low calcium intake",
"OBJECTIVE To report dietary intake and physical activity among preschool-aged children living in rural American Indian communities before participation in a family-based healthy lifestyle intervention and to compare data to current age-specific recommendations . SUBJECTS/ DESIGN One hundred thirty-five preschool-aged children , living in rural American Indian communities , provided diet and physical activity data before participating in a 2-year r and omized healthy lifestyle intervention . Three 24-hour dietary recalls assessed nutrient and food and added sugar intake , which were compared to the National Academy of Science 's Dietary Reference Intakes , the US Department of Agriculture 's MyPyramid , and American Heart Association recommendations . Time watching television and moderate plus vigorous activity was compared to MyPyramid and American Academy of Pediatrics recommendations . STATISTICAL ANALYSIS Nutrient , food group , added sugar intake , and time watching television and in moderate or vigorous activity were compared to recommendations by computing the percent of recommendations met . Nonparametric tests identified differences in diet and physical activity among age groups and normal and overweight children ( body mass index or = 85th percentile ) . RESULTS Average nutrient intakes met recommendations whereas food group intakes did not . Mean fruit and vegetable intakes for 2- to 3-year-olds were 0.36 c/day fruit and 0.45 c/day vegetables and , for 4- to 5-year-olds , 0.33 c/day fruit and 0.48 c/day vegetables . Both age groups reported consuming more than 50 g added sugar , exceeding the recommendation of 16 g. Overweight vs normal weight children reported significantly more sweetened beverage intake ( 8.0+/-0.10 vs 5.28+/-0.08 oz/day , P watching television 2.0 hours/day and significant differences were observed for total television viewing and nonviewing time between overweight and normal weight children ( 8.52+/-0.6 vs 6.54+/-0.6 hours/day , P 20 minutes/day of moderate or vigorous activity . CONCLUSIONS Overall , children in this sample did not meet MyPyramid recommendations for fruits or vegetables and exceed added sugar intake recommendations . Television viewing time and time when the television was on in the home was highly prevalent along with low levels of moderate or vigorous activity . The Healthy Children Strong Families intervention we studied has potential for improving nutrition and physical activity among preschool-aged children living in rural American Indian communities",
"OBJECTIVE To assess the prevalence of overweight among Chinese preschool children and to explore risk factors of childhood obesity focusing on parental characteristics , feeding practice and lifestyle . METHODS Data on 930 families with 2- to 6-year-old children in five kindergartens were obtained in a cross sectional study . Families were r and omly selected from two of all six urban districts in Beijing , China . Information on parental characteristics , dietary habits , lifestyle habits , and feeding practice was collected by parental self-report question naires . The children 's stature and weight were measured in light clothing and without shoes . Overweight and obesity were defined according to international cut-off values , as proposed by the International Obesity Task Force . Multivariate regression analysis was used to explore risk factors of child overweight . RESULTS The overall prevalence of overweight and obesity was 10.7 % and 4.2 % , respectively , and increased with age . The prevalence of child overweight was 14.1 % and 7.5 % in obese and non-obese families , respectively . Significant associations were observed between child and parent characteristics for overweight , frequency of eating in restaurant , television hours , and hours of physical activity . Child overweight was associated with parental overweight ( Odds Ratio [ OR ] 2.43 , 95 % CI 0.78 , 6.59 ) , low maternal education level ( OR 2.22 , 95 % CI 1.39 , 3.55 ) , food restriction ( OR 2.68 , 95 % CI 1.64 , 4.29 ) , and television watching > 2h/d ( OR 1.56 , 95 % CI 1.17 , 2.09 ) , after adjusting for sex , age , family income and kindergarten ( for cluster study design ) . CONCLUSIONS Overweight prevalence among Chinese preschool children in Beijing is comparable to some European countries . Prevention strategies should include identified lifestyle risk factors",
"In a prospect i ve study , we evaluated familial aggregation of blood pressure in a sample of 175 normotensive families with children 3 to 6 yr old . Systolic and diastolic blood pressure measurements of parents and children were correlated at 1 , 2 , and 3 yr intervals . Spearman rank-order correlation coefficients between parents and children were significant for mother-son pairs . In particular , mother-son blood pressure correlation coefficients were significant for systolic blood pressure across all 3 yr and for diastolic blood pressure during yr 2 . Further analyses were performed adjusting for body mass index ( BMI ) , age , physical activity , sodium intake , potassium intake , and parental smoking status , and alcohol use . The Spearman correlation coefficients for mother-son pairs remained significant for yr 1 and 3 after adjusting for these blood pressure correlates . These results are consistent with cross-sectional studies and suggest that both genetic and environmental contributions to blood pressure status are important in young children",
"OBJECTIVE To examine the relationships among indicators of physical activity , physical fitness , and body composition with serum lipid and lipoprotein levels in young children . DESIGN Cross-sectional and 1-year prospect i ve cohort . SETTING Studies of Child Activity and Nutrition ( SCAN ) program , Galveston , Tex . SUBJECTS One hundred twenty-three 4- or 5-year-old black , Hispanic ( of Mexican origin ) , and white children . MEASUREMENTS Body composition , resting heart rate , and cardiovascular fitness variables and serum lipid and lipoprotein levels were measured at age 3 or 4 years ( study year 1 ) and at age 4 or 5 years ( study year 2 ) , and day-long heart rate was measured and the Children 's Activity Rating Scale was administered between study years 1 and 2 . RESULTS Year-1 waist/hip ratios were inversely correlated with total serum cholesterol ( TSC ) and low-density lipoprotein ( LDL ) levels . Mean activity level was inversely correlated with waist/hip ratios . On the basis of multiple regression analysis , the sum of seven skin-fold measurements , height , and gender explained 15.4 % of the variation in triglyceride levels . The sum of seven skin-fold measurements was inversely correlated with the high-density lipoprotein ( HDL ) level . Resting heart rate , waist/hip ratio , and the slope of the exercise heart rate during fitness testing explained 19.5 % of the variation in the concentration of an HDL subclass , HDL2 . These children 's levels of physical activity were associated with higher fitness levels . Year-1 waist/hip ratios and year-2 sum of seven skin-fold measurements were positively correlated with the LDL/HDL and TSC/HDL ratios . CONCLUSION Higher levels of cardiovascular fitness and lower levels of fatness were associated with more favorable serum lipid and lipoprotein levels in these young children . Physical activity appeared to have an indirect association with serum lipid and lipoprotein values through its relationship with higher fitness levels and lower levels of fatness",
"The aim of the study is the analysis of body composition , motor development and cardiovascular parameters of preschool-children . In 2001/2002 a longitudinal study started in 17 nursery schools in Berlin . A total of 160 children out of the 264 children participated in a regular exercise programme . After 24 months of training significant differences of body composition , motor skills and cardiovascular parameters between 5 complete year old children of the intervention and the control group were observed . The results show that such an exercise programme is successful as a preventive measure to decrease the risk of obesity",
"OBJECTIVE To examine , using an Ecological Systems Theoretical framework , relationships between weight status and child , parent and community characteristics and risk factors among preschool children . METHODS Cross-sectional data was collected from 140 children and their parents from 11 r and omly selected preschools . Outcome variables included : motor development ; perceived competence ; objective ly measured physical activity ; time spent in active and quiet play ; location and number of televisions ; parental rules around physical activity and time spent watching television ; availability of sport and physical activity programs ; and parks and open spaces and access to footpaths . RESULTS Overweight children spent more time in quiet play and watching television and less time in active play and physical activity . Perceived competence and motor development were similar for both overweight and non-overweight children . Associations between weight status and several parent and community characteristics were not evident , except for access to footpaths . Overweight children had greater access to footpaths compared with non-overweight children ( p=0.046 ) . CONCLUSION The results reported here showed little difference between overweight and non-overweight children in relation to a variety of child , parent and community variables . However , for some characteristics , differences in older children have been reported . Longitudinal studies are required to confirm when these characteristics begin to differ , what effects these differences have on behaviour and weight-status , and therefore when targeted treatment should be provided during a child 's development",
"PURPOSE To test for relationships between objective ly measured habitual physical activity and fundamental movement skills in a relatively large and representative sample of preschool children . METHODS Physical activity was measured over 6 d using the Computer Science and Applications ( CSA ) accelerometer in 394 boys and girls ( mean age 4.2 , SD 0.5 yr ) . Children were scored on 15 fundamental movement skills , based on the Movement Assessment Battery , by a single observer . RESULTS Total physical activity ( r=0.10 , P percent time spent in moderate to vigorous physical activity ( MVPA ) ( r=0.18 , P total movement skills score . Time spent in light-intensity physical activity was not significantly correlated with motor skills score ( r=0.02 , P>0.05 ) . CONCLUSIONS In this sample and setting , fundamental movement skills were significantly associated with habitual physical activity , but the association between the two variables was weak . The present study questions whether the widely assumed relationships between motor skills and habitual physical activity actually exist in young children",
"A growing body of research has illuminated beneficial effects of a single bout of physical activity ( i.e. , acute exercise ) on cognitive function in school-age children . However , the influence of acute exercise on preschoolers ' cognitive function has not been reported . To address this shortcoming , the current study examined the effects of a 30-min bout of exercise on preschoolers ' cognitive function . Preschoolers ' cognitive function was assessed following a single bout of exercise and a single sedentary period . Results revealed that , after engaging in a bout of exercise , preschoolers exhibited markedly better ability to sustain attention , relative to after being sedentary ( p = .006 , partial eta square = .400 ) . Based on these findings , providing exercise opportunities appears to enhance preschoolers ' cognitive function",
"A meta- analysis of adult exercise studies and an infant activity trial show a possible interaction between physical activity and calcium intake on bone . This r and omized trial of activity and calcium supplementation was conducted in 239 children aged 3 - 5 years ( 178 completed ) . Children were r and omized to participate in either gross motor or fine motor activities for 30 minutes/day , 5 days per week for 12 months . Within each group , children received either calcium ( 1000 mg/day ) or placebo . Total body and regional bone mineral content by DXA and 20 % distal tibia measurements by peripheral quantitative computed tomography ( pQCT ) were obtained at 0 and 12 months . Three-day diet records and 48-h accelerometer readings were obtained at 0 , 6 , and 12 months . Higher activity levels were observed in gross motor versus fine motor activity groups , and calcium intake was greater in calcium versus placebo ( 1354 + /- 301 vs. 940 + /- 258 mg/day , p total body bone mineral content or leg bone mineral content by DXA . However , the difference in leg bone mineral content gain between gross motor and fine motor was more pronounced in children receiving calcium versus placebo ( interaction , p = 0.05 ) . Children in the gross motor group had greater tibia periosteal and endosteal circumferences by pQCT compared with children in the fine motor group at study completion ( p activity groups in both cortical thickness and cortical area : among children receiving placebo , thickness and area were smaller with gross motor activity compared with fine motor activity , but among children receiving calcium , thickness and area were larger with gross motor activity . These findings indicate that calcium intake modifies the bone response to activity in young children",
"OBJECTIVE . The purpose of this work was to identify risk factors for deformational plagiocephaly within 48 hours of birth and at 7 weeks of age . PATIENTS AND METHODS . This was a prospect i ve cohort study in which 380 healthy neonates born at term in Bernhoven Hospital in Veghel were followed at birth and at 7 weeks of age . Data regarding obstetrics , sociodemographics , asymmetry of the skull , anthropometrics , motor development , positioning , and care factors related to potentially provoking deformational plagiocephaly were gathered , with special interest for putative risk factors . The main outcome measure at birth and at 7 weeks of age was deformational plagiocephaly , assessed using the plagiocephalometry parameter oblique diameter difference index , a ratio variable , calculated as the longest divided by the shortest oblique diameter of the skull × 100 % . A cutoff point of ≥104 % was used to indicate severe deformational plagiocephaly . RESULTS . Only in 9 of 23 children who presented deformational plagiocephaly at birth was deformational plagiocephaly present at follow-up , whereas in 75 other children , deformational plagiocephaly developed between birth and follow-up . At birth , 3 of 14 putative risk factors were associated with severe flattening of the skull : gender , birth rank , and brachycephaly . At 7 weeks of age , 8 of 28 putative risk factors were associated with severe flattening : gender , birth rank , head position when sleeping , position on chest of drawers , method of feeding , positioning during bottle-feeding , and tummy time when awake . Early achievement of motor milestones was a protective factor for developing deformational plagiocephaly . Deformational plagiocephaly at birth was not a predictor for deformational plagiocephaly at 7 weeks of age . There was no significant relation between supine sleeping and deformational plagiocephaly . CONCLUSIONS . Three determinants were associated with an increased risk of deformational plagiocephaly at birth : male gender , first-born birth rank , and brachycephaly . Eight factors were associated with an increased risk of deformational plagiocephaly at 7 weeks of age : male gender , first-born birth rank , positional preference when sleeping , head to the same side on chest of drawers , only bottle feeding , positioning to the same side during bottle feeding , tummy time when awake motor milestones probably protects the child from developing deformational plagiocephaly . Implementation of practice s based on this new evidence of preventing and diminishing deformational plagiocephaly in child health care centers is very important",
" Forty‐seven infants four to 40 weeks of age in Dumaguete City , the Philippines , were given a cycling motion exercise of the upper and lower limbs for Jour five‐minute periods a day , six days a week , for two months . They were measured , against a control group of 17 infants of the same age and sex . Pretest , mid test , and pastiest measurements were taken for weight gain , length gain , and development of motor , language , adaptive , and personal‐social behaviors . Significant differences were found between the two groups of infants to substantiate the hypothesis that increases in growth and development of infants who receive physical care and emotional support plus planned physical‐physiological activity in the form of passive cycling exercises would be greater than those of infants who receive only physical care and , emotional support",
"OBJECTIVE : To identify the risk factors of obesity in preschool children in China . DESIGN : A nationwide case — control study in eight cities in China . SUBJECTS : A total of 748 boys and 574 girls ( age 0.1–6.9 y ) , including the obese and non-obese . One obese child was matched with one non-obese child by sex and age . MEASUREMENTS : Weight , height and other measurements were taken for all the subjects . The information on child activity , feeding pattern and family background was collected by our study team from the parents and the kindergarten teacher . RESULTS : Birth weight ≥ 4.0 kg , high eating speed , obesity among the child 's relatives ≥ 25 % , mother 's body mass index ( BMI ) > 25 kg/m2 and father 's BMI > 25 kg/m2 were identified as the major significant ( P obesity in preschool children in China . CONCLUSION : Family history of obesity , high birth weight and eating speed were identified as the risk factors of obesity in preschool children in China . Our results show the need for family therapy as part of an intervention program for childhood obesity , which includes behavior modification",
"The development of body fatness and leanness is examined in an ongoing prospect i ve nutrition and growth study . Individual skinfold thicknesses , relative weights , weight gains , activity levels , and caloric intakes were examined at seven ages between 6 months and 9 years . Changes in body fatness in this group of children provide evidence that the obese infant usually does not become the obese child . Weight gain in infancy is also a poor predictor of 9-year old obesity . Changes from obese to non-obese or lean are often not linear . There is evidence that impending or actual obesity begins at ages 6 to 9 years with some predictability provided as early as age 2 years for girls , age 3 years for boys ",
"OBJECTIVE The impact of physical activity patterns and sleep duration on growth and body composition of preschool-aged children remains unresolved . Aims were ( 1 ) to delineate cross-sectional associations among physical activity components , sleep , total energy expenditure ( TEE ) , and body size and composition ; and ( 2 ) to determine whether physical activity components , sleep , and TEE predict 1-year changes in body size and composition in healthy preschool-aged children . METHODS Anthropometry , body composition , accelerometry , and TEE by doubly labeled water were measured at baseline ; anthropometry and body composition were repeated 1 year later ( n = 111 ) . RESULTS Cross-sectionally , positive associations between sedentary activity and weight and fat-free mass ( FFM ) ( P = 0.009 - 0.047 ) , and a negative association between moderate-vigorous physical activity ( MVPA ) and percent fat mass ( FM ) ( P = 0.015 ) were observed . TEE and activity energy expenditure ( AEE ) were positively associated with weight , body mass index ( BMI ) , FFM , and FM ( P = 0.0001 - 0.046 ) . Prospect ively , TEE , AEE , physical activity level , and MVPA , but not sedentary activity , were positively associated with changes in BMI ( P = 0.0001 - 0.051 ) and FFM ( P = 0.0001 - 0.037 ) , but not percent FM . Sleep duration inversely predicted changes in FM ( P = 0.005 ) and percent FM ( P = 0.006 ) . CONCLUSIONS Prospect ively , MVPA , TEE , AEE , and physical activity level promote normal growth and accretion of FFM , whereas sleep duration inversely predicts changes in adiposity in preschool-aged children"
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R and omised trials reported up to Dec 31 , 2012 , did not confirm that vitamin D supplementation could protect from non-skeletal health conditions affecting adults , as was expected on the basis of data from observational studies . To examine whether the more recently published meta-analyses and trials would change past conclusions , we systematic ally review ed meta-analyses of vitamin D supplementation and non-skeletal disorders published between Jan 1 , 2013 , and May 31 , 2017 , that included study participants of all ages , including pregnant women . We also search ed for r and omised trials not included in meta-analyses . We identified 87 meta-analyses , of which 52 were excluded because they contained less recent literature or were of suboptimal quality . We retrieved 202 articles on trials that were not included in meta-analyses . Recent meta-analyses reinforce the finding that 10 - 20 μg per day of vitamin D can reduce all-cause mortality and cancer mortality in middle-aged and older people . Although vitamin D doses were greater than those assessed in the past , we found no new evidence that supplementation could have an effect on most non-skeletal conditions , including cardiovascular disease , adiposity , glucose metabolism , mood disorders , muscular function , tuberculosis , and colorectal adenomas , or on maternal and perinatal conditions . New data on cancer outcomes were scarce . The compilation of results from 83 trials showed that vitamin D supplementation had no significant effect on biomarkers of systemic inflammation . The main new finding highlighted by this systematic review is that vitamin D supplementation might help to prevent common upper respiratory tract infections and asthma exacerbations . There remains little evidence to suggest that vitamin D supplementation has an effect on most conditions , including chronic inflammation , despite use of increased doses of vitamin D , strengthening the hypothesis that low vitamin D status is a consequence of ill health , rather than its cause . We further hypothesise that vitamin D supplementation could exert immunomodulatory effects that strengthen resistance to acute infections , which would reduce the risk of death in debilitated individuals . We identified many meta-analyses of suboptimal quality , which is of concern . Future systematic review s on vitamin D should be based on data sharing so that data for participants with the same outcomes measured in the same way can be pooled to generate stronger evidence
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"RATIONALE Vitamin D has been shown to be involved in the host immune response toward Mycobacterium tuberculosis . OBJECTIVES To test whether vitamin D supplementation of patients with tuberculosis ( TB ) improved clinical outcome and reduced mortality . METHODS We conducted a r and omized , double-blind , placebo-controlled trial in TB clinics at a demographic surveillance site in Guinea-Bissau . We included 365 adult patients with TB starting antituberculosis treatment ; 281 completed the 12-month follow-up . The intervention was 100,000 IU of cholecalciferol or placebo at inclusion and again 5 and 8 months after the start of treatment . MEASUREMENTS AND MAIN RESULTS The primary outcome was reduction in a clinical severity score ( TBscore ) for all patients with pulmonary TB . The secondary outcome was 12-month mortality . No serious adverse effects were reported ; mild hypercalcemia was rare and present in both arms . Reduction in TBscore and sputum smear conversion rates did not differ among patients treated with vitamin D or placebo . Overall mortality was 15 % ( 54 of 365 ) at 1 year of follow-up and similar in both arms ( 30 of 187 for vitamin D treated and 24 of 178 for placebo ; relative risk , 1.19 [ 0.58 - 1.95 ] ) . HIV infection was seen in 36 % ( 131 of 359 ) : 21 % ( 76 of 359 ) HIV-1 , 10 % ( 36 of 359 ) HIV-2 , and 5 % ( 19 of 357 ) HIV-1 + 2 . CONCLUSIONS Vitamin D does not improve clinical outcome among patients with TB and the trial showed no overall effect on mortality in patients with TB ; it is possible that the dose used was insufficient . Clinical trial registered with www.controlled-trials.com/is rct n ( IS RCT N35212132 )",
"BACKGROUND Low serum concentrations of 25-hydroxyvitamin D [ 25(OH)D ] have been associated with impaired glucose tolerance and diabetes . OBJECTIVE This study aim ed to compare the effects of daily intake of vitamin D- or vitamin D(3 ) + calcium-fortified yogurt drink on glycemic status in subjects with type 2 diabetes ( T2D ) . DESIGN Ninety diabetic subjects were r and omly allocated to 3 groups to consume plain yogurt drink ( PY ; containing no vitamin D and 150 mg Ca/250 mL ) , vitamin D-fortified yogurt drink ( DY ; containing 500 IU vitamin D(3 ) and 150 mg Ca/250 mL ) , or vitamin D + calcium-fortified yogurt drink ( DCY ; containing 500 IU vitamin D(3 ) and 250 mg Ca/250 mL ) twice per day for 12 wk . Fasting serum glucose ( FSG ) , glycated hemoglobin ( Hb A(1c ) ) , homeostasis model assessment of insulin resistance ( HOMA-IR ) , serum lipid profile , and percentage fat mass ( FM ) were assessed before ( baseline ) and after the intervention . RESULTS In both the DY and DCY groups , mean serum 25(OH)D(3 ) improved ( + 32.8 ± 28.4 and + 28.8 ± 16.1 nmol/L , respectively ; P but FSG [ -12.9 ± 33.7 mg/dL ( P = 0.015 ) and -9.6 ± 46.9 mg/dL ( P = 0.035 ) ] , Hb A(1c ) [ -0.4 ± 1.2 % ( P [ -0.6 ± 1.4 ( P = 0.001 ) and -0.6 ± 3.2 ( P 0.001 ) ] , waist circumference ( -3.6 ± 2.7 and -2.9 ± 3.3 ; P both ) , and body mass index [ in kg/m(2 ) ; -0.9 ± 0.6 ( P between changes in serum 25(OH)D(3 ) and FSG ( r = -0.208 , P = 0.049 ) , FM ( r = -0.219 , P = 0.038 ) , and HOMA-IR ( r = -0.219 , P = 0.005 ) . CONCLUSION Daily intake of a vitamin D-fortified yogurt drink , either with or without added calcium , improved glycemic status in T2D patients . This trial was registered at clinical trials.gov as NCT01229891",
"Background Observational studies suggest high prenatal vitamin D intake may be associated with reduced childhood wheezing . We examined the effect of prenatal vitamin D on childhood wheezing in an interventional study . Methods We r and omised 180 pregnant women at 27 weeks gestation to either no vitamin D , 800 IU ergocalciferol daily until delivery or single oral bolus of 200,000 IU cholecalciferol , in an ethnically stratified , r and omised controlled trial . Supplementation improved but did not optimise vitamin D status . Research ers blind to allocation assessed offspring at 3 years . Primary outcome was any history of wheeze assessed by vali date d question naire . Secondary outcomes included atopy , respiratory infection , impulse oscillometry and exhaled nitric oxide . Primary analyses used logistic and linear regression . Results We evaluated 158 of 180 ( 88 % ) offspring at age 3 years for the primary outcome . Atopy was assessed by skin test for 95 children ( 53 % ) , serum IgE for 86 ( 48 % ) , exhaled nitric oxide for 62 ( 34 % ) and impulse oscillometry of acceptable quality for 51 ( 28 % ) . We found no difference between supplemented and control groups in risk of wheeze [ no vitamin D : 14/50 ( 28 % ) ; any vitamin D : 26/108 ( 24 % ) ( risk ratio 0.86 ; 95 % confidence interval 0.49 , 1.50 ; P = 0.69 ) ] . There was no significant difference in atopy , eczema risk , lung function or exhaled nitric oxide between supplemented groups and controls . Conclusion Prenatal vitamin D supplementation in late pregnancy that had a modest effect on cord blood vitamin D level , was not associated with decreased wheezing in offspring at age three years . Trial Registration Controlled-Trials.com IS RCT",
"Objective To investigate whether vitamin D supplementation can decrease the mortality and morbidity of low birthweight infants in low income countries . Design R and omised controlled trial . Setting Large government hospital in New Delhi , India . Participants 2079 low birthweight infants born at term ( > 37 weeks ’ gestation ) . Main outcome measures Primary outcome was admission to hospital or death during the first six months of life . Main secondary outcome was growth . Interventions Weekly vitamin D supplements for six months at a dose of one recommended nutrient intake per day ( 35 µg/week ) . Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements . Results Between group differences were not significant for death or hospital admissions ( 92 among 1039 infants in the vitamin D group v 99 among 1040 infants in the placebo group ; adjusted rate ratio 0.93 , 95 % confidence interval 0.68 to 1.29 ; P=0.68 ) , or referral to the outpatient clinic for moderate morbidity . Vitamin D supplementation result ed in better vitamin D status as assessed by plasma calcidiol levels at six months . In adjusted analyses , vitamin D treatment significantly increased st and ard deviation ( z ) scores at six months for weight , length , and arm circumference and decreased the proportion of children with stunted growth ( length for age z score ≤2 ) or with arm circumference z scores of 2 or less . Conclusion A weekly dose of vitamin D result ed in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants . Trial registration Clinical Trials.gov NCT00415402",
"Proper r and omisation means little if investigators can not include all r and omised participants in the primary analysis . Participants might ignore follow-up , leave town , or take aspartame when instructed to take aspirin . Exclusions before r and omisation do not bias the treatment comparison , but they can hurt generalisability . Eligibility criteria for a trial should be clear , specific , and applied before r and omisation . Readers should assess whether any of the criteria make the trial sample atypical or unrepresentative of the people in which they are interested . In principle , assessment of exclusions after r and omisation is simple : none are allowed . For the primary analysis , all participants enrolled should be included and analysed as part of the original group assigned ( an intent-to-treat analysis ) . In reality , however , losses frequently occur . Investigators should , therefore , commit adequate re sources to develop and implement procedures to maximise retention of participants . Moreover , research ers should provide clear , explicit information on the progress of all r and omised participants through the trial by use of , for instance , a trial profile . Investigators can also do secondary analyses on , for instance , per- protocol or as-treated participants . Such analyses should be described as secondary and non-r and omised comparisons . Mish and ling of exclusions causes serious method ological difficulties . Unfortunately , some explanations for mish and ling exclusions intuitively appeal to readers , disguising the seriousness of the issues . Creative mismanagement of exclusions can undermine trial validity",
"Definitive solutions wo n’t come from another million observational papers or small r and omized trials",
"Importance Cohort studies have reported increased incidence of cardiovascular disease ( CVD ) among individuals with low vitamin D status . To date , r and omized clinical trials of vitamin D supplementation have not found an effect , possibly because of using too low a dose of vitamin D. Objective To examine whether monthly high-dose vitamin D supplementation prevents CVD in the general population . Design , Setting , and Participants The Vitamin D Assessment Study is a r and omized , double-blind , placebo-controlled trial that recruited participants mostly from family practice s in Auckl and , New Zeal and , from April 5 , 2011 , through November 6 , 2012 , with follow-up until July 2015 . Participants were community-resident adults aged 50 to 84 years . Of 47 905 adults invited from family practice s and 163 from community groups , 5110 participants were r and omized to receive vitamin D3 ( n = 2558 ) or placebo ( n = 2552 ) . Two participants retracted consent , and all others ( n = 5108 ) were included in the primary analysis . Interventions Oral vitamin D3 in an initial dose of 200 000 IU , followed a month later by monthly doses of 100 000 IU , or placebo for a median of 3.3 years ( range , 2.5 - 4.2 years ) . Main Outcomes and Measures The primary outcome was the number of participants with incident CVD and death , including a prespecified subgroup analysis in participants with vitamin D deficiency ( baseline deseasonalized 25-hydroxyvitamin D [ 25(OH)D ] levels myocardial infa rct ion , angina , heart failure , hypertension , arrhythmias , arteriosclerosis , stroke , and venous thrombosis . Results Of the 5108 participants included in the analysis , the mean ( SD ) age was 65.9 ( 8.3 ) years , 2969 ( 58.1 % ) were male , and 4253 ( 83.3 % ) were of European or other ethnicity , with the remainder being Polynesian or South Asian . Mean ( SD ) baseline deseasonalized 25(OH)D concentration was 26.5 ( 9.0 ) ng/mL , with 1270 participants ( 24.9 % ) being vitamin D deficient . In a r and om sample of 438 participants , the mean follow-up 25(OH)D level was greater than 20 ng/mL higher in the vitamin D group than in the placebo group . The primary outcome of CVD occurred in 303 participants ( 11.8 % ) in the vitamin D group and 293 participants ( 11.5 % ) in the placebo group , yielding an adjusted hazard ratio of 1.02 ( 95 % CI , 0.87 - 1.20 ) . Similar results were seen for participants with baseline vitamin D deficiency and for secondary outcomes . Conclusions and Relevance Monthly high-dose vitamin D supplementation does not prevent CVD . This result does not support the use of monthly vitamin D supplementation for this purpose . The effects of daily or weekly dosing require further study . Trial Registration clinical trials.gov Identifier :",
"BACKGROUND Recent studies suggest that reduced right ventricular function is an important predictor of outcome in patients with heart failure and preserved ejection fraction ( HFpEF ) . Because affected patients suffer from a broad spectrum of non-cardiac co-morbidities , it remains unclear , whether they actually die from right heart failure ( RHF ) or as a consequence of other conditions . METHODS Consecutive patients with a confirmed diagnosis of HFpEF were enrolled in this prospect i ve registry . Local and external medical records , as well as telephone interviews with relatives were used to ascertain modes of death . RHF was accepted as a mode of death , if the following criteria were met : 1 . right ventricular dysfunction assessed by transthoracic echocardiography , and 2 . clinical signs of right heart decompensation at the time of death . RESULTS Out of 230 patients with complete follow-up , 16.5 % ( n=38 ) died after a mean of 30±17months . 60.5 % deaths were classified as cardiovascular and 34.2 % as non-cardiovascular . In 5.3 % patients , the reason for death remained unknown . Of the cardiovascular cases ( n=23 ) , 91.4 % of deaths were attributed to RHF , 4.3 % died from stroke and 4.3 % from sudden cardiac death . Of the non-cardiovascular deaths ( n=13 ) , 46.2 % of deaths were attributed to major infections and 38.4 % deaths were related to cancer . Other reasons for death included ileus ( 7.7 % ) and major bleeding ( 7.7 % ) . CONCLUSION In our well-characterised HFpEF cohort , more than half of all deaths could directly be attributed to RHF . The right ventricle seems to be a meaningful therapeutic target in a subset of patients",
"Background : Vitamin D supplementation during pregnancy has been supposed to defend against adverse gestational outcomes . Objective : This r and omized clinical trial study was conducted to assess the effects of 50,000 IU of vitamin D every two weeks supplementation on the incidence of gestational diabetes ( GDM ) , gestational hypertension , preeclampsia and preterm labor , vitamin D status at term and neonatal outcomes contrasted with pregnant women that received 400 IU vitamin D daily . Material s and Methods : 500 women with gestational age 12 - 16 weeks and serum 25 hydroxy vitamin D ( 25 ( OH ) D ) less than 30 ng/ml r and omly categorized in two groups . Group A received 400 IU vitamin D daily and group B 50,000 IU vitamin D every 2 weeks orally until delivery . Maternal and Neonatal outcomes were assessed in two groups . Results : The incidence of GDM in group B was significantly lower than group A ( 6.7 % versus 13.4 % ) and odds ratio ( 95 % Confidence interval ) was 0.46 ( 0.24 - 0.87 ) ( P=0.01 ) . The mean ± SD level of 25 ( OH ) D at the time of delivery in mothers in group B was significantly higher than A ( 37.9 ± 19.8 versus 27.2 ± 18.8 ng/ml , respectively ) ( P=0.001 ) . There were no differences in the incidence of preeclampsia , gestational hypertension , preterm labor , and low birth weight between two groups . The mean level of 25 ( OH ) D in cord blood of group B was significantly higher than group A ( 37.9 ± 18 versus 29.7 ± 19ng/ml , respectively ) . Anthropometric measures between neonates were not significantly different . Conclusion : Our study showed 50,000 IU vitamin D every 2 weeks decreased the incidence of GDM ",
"Background Plasma 25-hydroxyvitamin D ( 25(OH ) D ) deficiencies are associated with several diseases . The magnitude of systemic inflammatory response , as evidence d by C-reactive protein ( CRP ) , is a major factor associated with lower 25(OH)D. Other aspects of the systemic inflammatory response may be important in determining plasma 25 (OH)D concentrations . Aim To examine the relationship between plasma 25(OH)D , CRP and albumin concentrations in two patient cohorts . Methods 5327 patients referred for nutritional assessment and 117 patients with critical illness were examined . Plasma 25 ( OH ) D concentrations were measured using st and ard methods . Intra and between assay imprecision was plasma 25 ( OH ) D was significantly associated with CRP ( r s = −0.113 , p 3711 patients had CRP concentrations ≤10 mg/L ; with decreasing albumin concentrations ≥35 , 25–34 and , median concentrations of 25 ( OH ) D were significantly lower from 35 to 28 to 14 nmol/l ( p had CRP concentrations between 11–80 mg/L ; with decreasing albumin concentrations ≥35 , 25–34 and , median concentrations of 25 ( OH ) D were significantly lower from 31 to 24 to 19 nmol/l ( p when albumin concentration were 25–34 g/L ( p 80 mg/L ; with decreasing albumin concentrations ≥35 , 25–34 and g/l , median concentrations of 25 ( OH ) D were not significantly altered varying from 19 to 23 to 23 nmol/l . Similar relationships were also obtained in the cohort of patients with critical illness . Conclusion Plasma concentrations of 25(OH ) D were independently associated with both CRP and albumin and consistent with the systemic inflammatory response as a major confounding factor in determining vitamin D status",
"CONTEXT Vitamin D deficiency is associated with insulin resistance and risk of future diabetes . OBJECTIVE The objective of the study was to test whether supplementation with vitamin D to subjects with prediabetes will prevent progression to type 2 diabetes mellitus ( T2DM ) . DESIGN This was a r and omized controlled trial performed in 2008 through 2015 . SETTING The study was conducted at the clinical research unit at a teaching hospital . PATIENTS Five hundred eleven subjects ( mean age 62 y , 314 males ) with prediabetes diagnosed with an oral glucose tolerance test as part of the Tromsø Study 2007–2008 were included . A total of 256 were r and omized to vitamin D and 255 to placebo . Twenty-nine subjects in the vitamin D and 24 in the placebo group withdrew because of adverse events . INTERVENTIONS Interventions included vitamin D ( cholecalciferol ) 20 000 IU/wk vs placebo for 5 years . Annual oral glucose tolerance tests were performed . MAIN OUTCOME MEASURE Progression to T2DM was the main outcome measure . Secondary outcomes were change in glucose levels , insulin resistance , serum lipids , and blood pressure . RESULTS The mean baseline serum 25-hydroxyvitamin D level was 60 nmol/L ( 24 ng/mL ) . One hundred three in the vitamin D and 112 in the placebo group developed T2DM ( hazard risk 0.90 ; 95 % confidence interval 0.69–1.18 , Cox regression , P = .45 , intention to treat analysis ) . No consistent significant effects on the other outcomes were seen . Subgroup analyses in subjects with low baseline 25-hydroxyvitamin D yielded similar results . No serious side effects related to the intervention were recorded . CONCLUSIONS In subjects without vitamin D deficiency , vitamin D supplementation is unlikely to prevent progression from prediabetes to diabetes . Very large studies with inclusion of vitamin D-deficient subjects will probably be needed to show such a putative effect . This study tested if supplementation with vitamin D to subjects with prediabetes will prevent progression to type 2 diabetes ( T2DM )",
"Background Endothelial dysfunction has been proposed as the underlying cause of diabetic angiopathy that eventually leads to cardiovascular disease , the major cause of death in diabetes . We recently demonstrated the ameliorating effect of regular vitamin D intake on the glycemic status of patients with type 2 diabetes ( T2D ) . In this study , the effects of improvement of vitamin D status on glycemic status , lipid profile and endothelial biomarkers in T2D subjects were investigated . Methods Subjects with T2D were r and omly allocated to one of the two groups to receive either plain yogurt drink ( PYD ; containing 170 mg calcium and no vitamin D/250 mL , n1 = 50 ) or vitamin D3-fortified yogurt drink ( FYD ; containing 170 mg calcium and 500 IU/250 mL , n2 = 50 ) twice a day for 12 weeks . Anthropometric measures , glycemic status , lipid profile , body fat mass ( FM ) and endothelial biomarkers including serum endothelin-1 , E-selectin and matrix metalloproteinase (MMP)-9 were evaluated at the beginning and after the 12-week intervention period . Results The intervention result ed in a significant improvement in fasting glucose , the Quantitative Insulin Check Index ( QUICKI ) , glycated hemoglobin ( HbA1c ) , triacylglycerols , high-density lipoprotein cholesterol ( HDL-C ) , endothelin-1 , E-selectin and MMP-9 in FYD compared to PYD ( P of endothelin-1 , E-selectin and MMP-9 concentrations in FYD compared to PYD ( -0.35 ± 0.63 versus -0.03 ± 0.55 , P = 0.028 ; -3.8 ± 7.3 versus 0.95 ± 8.3 , P = 0.003 and -2.3 ± 3.7 versus 0.44 ± 7.1 ng/mL , respectively , P significant for endothelin-1 and MMP-9 ( P = 0.009 and P = 0.005 , respectively ) but disappeared for E-selectin ( P = 0.092 ) . On the contrary , after controlling for serum 25(OH)D , the differences disappeared for endothelin-1(P = 0.066 ) and MMP-9 ( P = 0.277 ) but still remained significant for E-selectin ( P = 0.011 ) . Conclusions Ameliorated vitamin D status was accompanied by improved glycemic status , lipid profile and endothelial biomarkers in T2D subjects . Our findings suggest both direct and indirect ameliorating effects of vitamin D on the endothelial biomarkers . Trial registration Clinical Trials.gov :",
"Abstract Objective : To determine the effect of four monthly vitamin D supplementation on the rate of fractures in men and women aged 65 years and over living in the community . Design : R and omised double blind controlled trial of 100 000 IU oral vitamin D3 ( cholecalciferol ) supplementation or matching placebo every four months over five years . Setting and participants : 2686 people ( 2037 men and 649 women ) aged 65 - 85 years living in the general community , recruited from the British doctors register and a general practice register in Suffolk . Main outcome measures : Fracture incidence and total mortality by cause . Results : After five years 268 men and women had incident fractures , of whom 147 had fractures in common osteoporotic sites ( hip , wrist or forearm , or vertebrae ) . Relative risks in the vitamin D group compared with the placebo group were 0.78 ( 95 % confidence interval 0.61 to 0.99 , P=0.04 ) for any first fracture and 0.67 ( 0.48 to 0.93 , P=0.02 ) for first hip , wrist or forearm , or vertebral fracture . 471 participants died . The relative risk for total mortality in the vitamin D group compared with the placebo group was 0.88 ( 0.74 to 1.06 , P=0.18 ) . Findings were consistent in men and women and in doctors and the general practice population . Conclusion : Four monthly supplementation with 100 000 IU oral vitamin D may prevent fractures without adverse effects in men and women living in the general community . What is already known in this topic Vitamin D and calcium supplements are effective in preventing fractures in elderly women Whether isolated vitamin D supplementation prevents fractures is not clear What this paper adds Four monthly oral supplementation with 100 000 IU vitamin D reduces fractures in men and women aged over 65 living in the general community Total fracture incidence was reduced by 22 % and fractures in major osteoporotic sites by 33",
"Importance Evidence suggests that low vitamin D status may increase the risk of cancer . Objective To determine if dietary supplementation with vitamin D3 and calcium reduces the risk of cancer among older women . Design , Setting , and Participants A 4-year , double-blind , placebo-controlled , population -based r and omized clinical trial in 31 rural counties ( June 24 , 2009 , to August 26 , 2015—the final date of follow-up ) . A total of 2303 healthy postmenopausal women 55 years or older were r and omized , 1156 to the treatment group and 1147 to the placebo group . Duration of treatment was 4 years . Interventions The treatment group ( vitamin D3 + calcium group ) received 2000 IU/d of vitamin D3 and 1500 mg/d of calcium ; the placebo group received identical placebos . Main Outcomes and Measures The primary outcome was the incidence of all-type cancer ( excluding nonmelanoma skin cancers ) , which was evaluated using Kaplan-Meier survival analysis and proportional hazards modeling . Results Among 2303 r and omized women ( mean age , 65.2 years [ SD , 7.0 ] ; mean baseline serum 25-hydroxyvitamin D level , 32.8 ng/mL [ SD , 10.5 ] ) , 2064 ( 90 % ) completed the study . At year 1 , serum 25-hydroxyvitamin D levels were 43.9 ng/mL in the vitamin D3 + calcium group and 31.6 ng/mL in the placebo group . A new diagnosis of cancer was confirmed in 109 participants , 45 ( 3.89 % ) in the vitamin D3 + calcium group and 64 ( 5.58 % ) in the placebo group ( difference , 1.69 % [ 95 % CI , −0.06 % to 3.46 % ] ; P = .06 ) . Kaplan-Meier incidence over 4 years was 0.042 ( 95 % CI , 0.032 to 0.056 ) in the vitamin D3 + calcium group and 0.060 ( 95 % CI , 0.048 to 0.076 ) in the placebo group ; P = .06 . In unadjusted Cox proportional hazards regression , the hazard ratio was 0.70 ( 95 % CI , 0.47 to 1.02 ) . Adverse events potentially related to the study included renal calculi ( 16 participants in the vitamin D3 + calcium group and 10 in the placebo group ) , and elevated serum calcium levels ( 6 in the vitamin D3 + calcium group and 2 in the placebo group ) . Conclusions and Relevance Among healthy postmenopausal older women with a mean baseline serum 25-hydroxyvitamin D level of 32.8 ng/mL , supplementation with vitamin D3 and calcium compared with placebo did not result in a significantly lower risk of all-type cancer at 4 years . Further research is necessary to assess the possible role of vitamin D in cancer prevention . Trial Registration clinical trials.gov Identifier :",
"BACKGROUND Higher intake of calcium and vitamin D has been associated with a reduced risk of colorectal cancer in epidemiologic studies and polyp recurrence in polyp-prevention trials . However , r and omized-trial evidence that calcium with vitamin D supplementation is beneficial in the primary prevention of colorectal cancer is lacking . METHODS We conducted a r and omized , double-blind , placebo-controlled trial involving 36,282 postmenopausal women from 40 Women 's Health Initiative centers : 18,176 women received 500 mg of elemental calcium as calcium carbonate with 200 IU of vitamin D3 [ corrected ] twice daily ( 1000 mg of elemental calcium and 400 IU of vitamin D3 ) and 18,106 received a matching placebo for an average of 7.0 years . The incidence of pathologically confirmed colorectal cancer was the design ated secondary outcome . Baseline levels of serum 25-hydroxyvitamin D were assessed in a nested case-control study . RESULTS The incidence of invasive colorectal cancer did not differ significantly between women assigned to calcium plus vitamin D supplementation and those assigned to placebo ( 168 and 154 cases ; hazard ratio , 1.08 ; 95 percent confidence interval , 0.86 to 1.34 ; P=0.51 ) , and the tumor characteristics were similar in the two groups . The frequency of colorectal-cancer screening and abdominal symptoms was similar in the two groups . There were no significant treatment interactions with baseline characteristics . CONCLUSIONS Daily supplementation of calcium with vitamin D for seven years had no effect on the incidence of colorectal cancer among postmenopausal women . The long latency associated with the development of colorectal cancer , along with the seven-year duration of the trial , may have contributed to this None finding . Ongoing follow-up will assess the longer-term effect of this intervention . ( Clinical Trials.gov number , NCT00000611 . )",
"BACKGROUND AND OBJECTIVE To conduct a pilot study to compare the frequency of errors that accompany single vs. double data extraction , compare the estimate of treatment effect derived from these methods , and compare the time requirements for these methods . METHODS Review ers were r and omized to the role of data extractor or data verifier , and were blind to the study hypothesis . The frequency of errors associated with each method of data extraction was compared using the McNemar test . The data set for each method was used to calculate an efficacy estimate by each method , using st and ard meta-analytic techniques . The time requirement for each method was compared using a paired t-test . RESULTS Single data extraction result ed in more errors than double data extraction ( relative difference : 21.7 % , P = .019 ) . There was no substantial difference between methods in effect estimates for most outcomes . The average time spent for single data extraction was less than the average time for double data extraction ( relative difference : 36.1 % , P = .003 ) . CONCLUSION In the case that single data extraction is used in systematic review s , review ers and readers need to be mindful of the possibility for more errors and the potential impact these errors may have on effect estimates",
"IMPORTANCE Observational studies have suggested that increased dietary vitamin D intake during pregnancy may protect against wheezing in the offspring , but the preventive effect of vitamin D supplementation to pregnant women is unknown . OBJECTIVE To determine whether supplementation of vitamin D3 during the third trimester of pregnancy reduces the risk of persistent wheeze in the offspring . DESIGN , SETTING , AND PARTICIPANTS A double-blind , single-center , r and omized clinical trial conducted within the Copenhagen Prospect i ve Studies on Asthma in Childhood 2010 cohort . Enrollment began March 2009 with a goal of 708 participants , but due to delayed ethical approval , only 623 women were recruited at 24 weeks of pregnancy . Follow-up of the children ( N = 581 ) was completed when the youngest child reached age 3 years in March 2014 . INTERVENTIONS Vitamin D3 ( 2400 IU/d ; n = 315 ) or matching placebo tablets ( n = 308 ) from pregnancy week 24 to 1 week postpartum . All women received 400 IU/d of vitamin D3 as part of usual pregnancy care . MAIN OUTCOMES AND MEASURES Age at onset of persistent wheeze in the first 3 years of life . Secondary outcomes included number of episodes of troublesome lung symptoms , asthma , respiratory tract infections , and neonatal airway immunology . Adverse events were assessed . RESULTS Of the 581 children , persistent wheeze was diagnosed during the first 3 years of life in 47 children ( 16 % ) in the vitamin D3 group and 57 children ( 20 % ) in the control group . Vitamin D3 supplementation was not associated with the risk of persistent wheeze , but the number of episodes of troublesome lung symptoms was reduced , and the airway immune profile was up-regulated ( principal component analysis , P = .04 ) . There was no effect on additional end points . Intrauterine death was observed in 1 fetus ( vitamin D3 group vs 3 fetuses ( 1 % ) in the control group and congenital malformations in 17 neonates ( 5 % ) in the vitamin D3 group vs 23 neonates ( 8 % ) in the control group . [ table : see text ] . CONCLUSIONS AND RELEVANCE The use of 2800 IU/d of vitamin D3 during the third trimester of pregnancy compared with 400 IU/d did not result in a statistically significant reduced risk of persistent wheeze in the offspring through age 3 years . However , interpretation of the study is limited by a wide CI that includes a clinical ly important protective effect . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00856947",
"Background —Vitamin D supplementation may be an inexpensive intervention to reduce heart failure ( HF ) incidence . However , there are insufficient data to support this hypothesis . This study evaluates whether vitamin D plus calcium ( CaD ) supplementation is associated with lower rates of HF in postmenopausal women and whether the effects differ between those at high versus low risk for HF . Methods and Results —Analyses were restricted to 35 983 ( of original 36 282 ) women aged 50 to 79 years old in the Women ’s Health Initiative r and omized trial of CaD supplementation who were r and omized 1:1 in a double-blinded fashion to receive 1000 mg/d of calcium plus 400 IU/d of vitamin D3 or placebo . Overall , 744 adjudicated incident HF cases ( intervention , 363 ; control , 381 ) occurred during a median follow-up of 7.1 ( interquartile range , 1.6 ) years . CaD supplementation , compared with placebo , was not associated with reduced HF risk in the overall population , hazard ratio , 0.95 ; P=0.46 . However , CaD supplementation had differential effects ( P interaction=0.005 ) in subgroups stratified by baseline risk status of HF defined by the presence ( high risk=17 449 ) or absence ( low risk=18 534 ) of pre-existing HF precursors including coronary heart diseases , diabetes mellitus , or hypertension : 37 % ( hazard ratio , 0.63 [ 95 % confidence interval , 0.46–0.87 ] ) lower risk of HF in the low-risk versus hazard ratio , 1.06 ; P=0.51 , in the high-risk subgroups . Conclusions —CaD supplementation did not significantly reduce HF incidence in the overall cohort , however , it was beneficial among postmenopausal women without major HF precursors while of little value in high-risk subgroups . Additional studies are warranted to confirm these findings and investigate the underlying mechanism . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00000611",
"Abstract Background : In observational studies vitamin D deficiency is associated with increased risk of infections , whereas the effect of vitamin D supplementation in r and omized controlled trials is non-conclusive . Methods : Five hundred and eleven subjects with prediabetes were r and omized to vitamin D3 ( 20,000 IU per week ) versus placebo for five years . Every sixth month , a question naire on respiratory tract infections ( RTI ) ( common cold , bronchitis , influenza ) and urinary tract infection ( UTI ) was filled in . Results : Mean baseline serum 25-hydroxyvitamin D ( 25(OH)D ) level was 60 nmol/L. Two hundred and fifty-six subjects received vitamin D and 255 placebo . One hundred and sixteen subjects in the vitamin D and 111 in the placebo group completed the five-year study . Eighteen subjects in the vitamin D group and 34 subjects in the placebo group reported UTI during the study ( p RTI . The effect on UTI was most pronounced in males . The effect of vitamin D on UTI was unrelated to baseline serum 25(OH)D level . Conclusion : Supplementation with vitamin D might prevent UTI , but confirmatory studies are needed",
"CONTEXT Vitamin D or calcium supplementation may have effects on vascular disease and cancer . OBJECTIVE Our objective was to investigate whether vitamin D or calcium supplementation affects mortality , vascular disease , and cancer in older people . DESIGN AND SETTING The study included long-term follow-up of participants in a two by two factorial , r and omized controlled trial from 21 orthopedic centers in the United Kingdom . PARTICIPANTS Participants were 5292 people ( 85 % women ) aged at least 70 yr with previous low-trauma fracture . INTERVENTIONS Participants were r and omly allocated to daily vitamin D(3 ) ( 800 IU ) , calcium ( 1000 mg ) , both , or placebo for 24 - 62 months , with a follow-up of 3 yr after intervention . MAIN OUTCOME MEASURES All-cause mortality , vascular disease mortality , cancer mortality , and cancer incidence were evaluated . RESULTS In intention-to-treat analyses , mortality [ hazard ratio ( HR ) = 0.93 ; 95 % confidence interval ( CI ) = 0.85 - 1.02 ] , vascular disease mortality ( HR = 0.91 ; 95 % CI = 0.79 - 1.05 ) , cancer mortality ( HR = 0.85 ; 95 % CI = 0.68 - 1.06 ) , and cancer incidence ( HR = 1.07 ; 95 % CI = 0.92 - 1.25 ) did not differ significantly between participants allocated vitamin D and those not . All-cause mortality ( HR = 1.03 ; 95 % CI = 0.94 - 1.13 ) , vascular disease mortality ( HR = 1.07 ; 95 % CI = 0.92 - 1.24 ) , cancer mortality ( HR = 1.13 ; 95 % CI = 0.91 - 1.40 ) , and cancer incidence ( HR = 1.06 ; 95 % CI = 0.91 - 1.23 ) also did not differ significantly between participants allocated calcium and those not . In a post hoc statistical analysis adjusting for compliance , thus with fewer participants , trends for reduced mortality with vitamin D and increased mortality with calcium were accentuated , although all results remain nonsignificant . CONCLUSIONS Daily vitamin D or calcium supplementation did not affect mortality , vascular disease , cancer mortality , or cancer incidence",
"RATIONALE Sepsis is a major cause of mortality among critically ill patients with cancer . Information about clinical outcomes and factors associated with increased risk of death in these patients is necessary to help physicians recognize those patients who are most likely to benefit from ICU therapy and identify possible targets for intervention . OBJECTIVES In this study , we evaluated cancer patients with sepsis chosen from a multicenter prospect i ve study to characterize their clinical characteristics and to identify independent risk factors associated with hospital mortality . METHODS Subgroup analysis of a multicenter prospect i ve cohort study conducted in 28 Brazilian intensive care units ( ICUs ) to evaluate adult cancer patients with severe sepsis and septic shock . We used logistic regression to identify variables associated with hospital mortality . MEASUREMENTS AND MAIN RESULTS Of the 717 patients admitted to the participating ICUs , 268 ( 37 % ) had severe sepsis ( n = 142 , 53 % ) or septic shock ( n = 126 , 47 % ) . These patients comprised the population of the present study . The mean score on the third version of the Simplified Acute Physiology Score was 62.9 ± 17.7 points , and the median Sequential Organ Failure Assessment score was 9 ( 7 - 12 ) points . The most frequent sites of infection were the lungs ( 48 % ) , intraabdominal region ( 25 % ) , bloodstream as primary infection ( 19 % ) , and urinary tract ( 17 % ) . Half of the patients had microbiologically proven infections , and Gram-negative bacteria were the most common pathogens causing sepsis ( 31 % ) . ICU and hospital mortality rates were 42 % and 56 % , respectively . In multivariable analysis , the number of acute organ dysfunctions ( odds ratio [ OR ] , 1.48 ; 95 % confidence interval [ CI ] , 1.16 - 1.87 ) , hematological malignancies ( OR , 2.57 ; 95 % CI , 1.05 - 6.27 ) , performance status 2 - 4 ( OR , 2.53 ; 95 % CI , 1.44 - 4.43 ) , and polymicrobial infections ( OR , 3.74 ; 95 % CI , 1.52 - 9.21 ) were associated with hospital mortality . CONCLUSIONS Sepsis is a common cause of critical illness in patients with cancer and remains associated with high mortality . Variables related to underlying malignancy , sepsis severity , and characteristics of infection are associated with a grim prognosis",
"BACKGROUND Calcium and vitamin D ( CaD ) supplementation trials including the Women 's Health Initiative ( WHI ) trial of CaD have shown nonsignificant reductions in total mortality . This report examines intervention effects on total and cause-specific mortality by age and adherence . METHODS The WHI CaD trial was a r and omized , double-blind , placebo-controlled trial that enrolled 36,282 postmenopausal women aged 51 - 82 years from 40 U.S. clinical centers . Women were assigned to 1,000 mg of elemental calcium carbonate and 400 IU of vitamin D(3 ) daily or placebo with average follow-up of 7.0 years . RESULTS The hazard ratio ( HR ) for total mortality was 0.91 ( 95 % confidence interval [ CI ] , 0.83 - 1.01 ) with 744 deaths in women r and omized to CaD versus 807 deaths in the placebo group . HRs were in the direction of reduced risk but nonsignificant for stroke and cancer mortality , but near unity for coronary heart disease and other causes of death . HRs for total mortality were 0.89 in the 29,942 women younger than 70 years ( 95 % CI , 0.79 - 1.01 ) and 0.95 in the 6,340 women aged 70 and older ( 95 % CI , 0.80 - 1.12 ; p value for age interaction = .10 ) . No statistically significant interactions were observed for any baseline characteristics . Treatment effects did not vary significantly by season . CONCLUSIONS In the WHI CaD trial , supplementation did not have a statistically significant effect on mortality rates but the findings support the possibility that these supplements may reduce mortality rates in postmenopausal women . These data can neither support nor refute recommendations for higher dose vitamin D supplementation to reduce cancer or total mortality",
"BACKGROUND Epidemiologic and pre clinical data suggest that higher intake and serum levels of vitamin D and higher intake of calcium reduce the risk of colorectal neoplasia . To further study the chemopreventive potential of these nutrients , we conducted a r and omized , double-blind , placebo-controlled trial of supplementation with vitamin D , calcium , or both for the prevention of colorectal adenomas . METHODS We recruited patients with recently diagnosed adenomas and no known colorectal polyps remaining after complete colonoscopy . We r and omly assigned 2259 participants to receive daily vitamin D3 ( 1000 IU ) , calcium as carbonate ( 1200 mg ) , both , or neither in a partial 2 × 2 factorial design . Women could elect to receive calcium plus r and om assignment to vitamin D or placebo . Follow-up colonoscopy was anticipated to be performed 3 or 5 years after the baseline examinations , according to the endoscopist 's recommendation . The primary end point was adenomas diagnosed in the interval from r and omization through the anticipated surveillance colonoscopy . RESULTS Participants who were r and omly assigned to receive vitamin D had a mean net increase in serum 25-hydroxyvitamin D levels of 7.83 ng per milliliter , relative to participants given placebo . Overall , 43 % of participants had one or more adenomas diagnosed during follow-up . The adjusted risk ratios for recurrent adenomas were 0.99 ( 95 % confidence interval [ CI ] , 0.89 to 1.09 ) with vitamin D versus no vitamin D , 0.95 ( 95 % CI , 0.85 to 1.06 ) with calcium versus no calcium , and 0.93 ( 95 % CI , 0.80 to 1.08 ) with both agents versus neither agent . The findings for advanced adenomas were similar . There were few serious adverse events . CONCLUSIONS Daily supplementation with vitamin D3 ( 1000 IU ) , calcium ( 1200 mg ) , or both after removal of colorectal adenomas did not significantly reduce the risk of recurrent colorectal adenomas over a period of 3 to 5 years . ( Funded by the National Cancer Institute ; Clinical Trials.gov number , NCT00153816 . )",
"IMPORTANCE Low vitamin D status is linked to increased mortality and morbidity in patients who are critically ill . It is unknown if this association is causal . OBJECTIVE To investigate whether a vitamin D3 treatment regimen intended to restore and maintain normal vitamin D status over 6 months is of health benefit for patients in ICUs . DESIGN , SETTING , AND PARTICIPANTS A r and omized double-blind , placebo-controlled , single-center trial , conducted from May 2010 through September 2012 at 5 ICUs that included a medical and surgical population of 492 critically ill adult white patients with vitamin D deficiency ( ≤20 ng/mL ) assigned to receive either vitamin D3 ( n = 249 ) or a placebo ( n = 243 ) . INTERVENTIONS Vitamin D3 or placebo was given orally or via nasogastric tube once at a dose of 540,000 IU followed by monthly maintenance doses of 90,000 IU for 5 months . MAIN OUTCOMES AND MEASURES The primary outcome was hospital length of stay . Secondary outcomes included , among others , length of ICU stay , the percentage of patients with 25-hydroxyvitamin D levels higher than 30 ng/mL at day 7 , hospital mortality , and 6-month mortality . A predefined severe vitamin D deficiency ( ≤12 ng/mL ) subgroup analysis was specified before data unblinding and analysis . RESULTS A total of 475 patients were included in the final analysis ( 237 in the vitamin D3 group and 238 in the placebo group ) . The median ( IQR ) length of hospital stay was not significantly different between groups ( 20.1 days [ IQR , 11.1 - 33.3 ] for vitamin D3 vs 19.3 days [ IQR , 11.1 - 34.9 ] for placebo ; P = .98 ) . Hospital mortality and 6-month mortality were also not significantly different ( hospital mortality : 28.3 % [ 95 % CI , 22.6%-34.5 % ] for vitamin D3 vs 35.3 % [ 95 % CI , 29.2%-41.7 % ] for placebo ; hazard ratio [ HR ] , 0.81 [ 95 % CI , 0.58 - 1.11 ] ; P = .18 ; 6-month mortality : 35.0 % [ 95 % CI , 29.0%-41.5 % ] for vitamin D3 vs 42.9 % [ 95 % CI , 36.5%-49.4 % ] for placebo ; HR , 0.78 [ 95 % CI , 0.58 - 1.04 ] ; P = .09 ) . For the severe vitamin D deficiency subgroup analysis ( n = 200 ) , length of hospital stay was not significantly different between the 2 study groups : 20.1 days ( IQR , 12.9 - 39.1 ) for vitamin D3 vs 19.0 days ( IQR , 11.6 - 33.8 ) for placebo . Hospital mortality was significantly lower with 28 deaths among 98 patients ( 28.6 % [ 95 % CI , 19.9%-38.6 % ] ) for vitamin D3 compared with 47 deaths among 102 patients ( 46.1 % [ 95 % CI , 36.2%-56.2 % ] ) for placebo ( HR , 0.56 [ 95 % CI , 0.35 - 0.90 ] , P for interaction = .04 ) , but not 6-month mortality ( 34.7 % [ 95 % CI , 25.4%-45.0 % ] for vitamin D3 vs 50.0 % [ 95 % CI , 39.9%-60.1 % ] for placebo ; HR , 0.60 [ 95 % CI , 0.39 - 0.93 ] , P for interaction = .12 ) . CONCLUSIONS AND RELEVANCE Among critically ill patients with vitamin D deficiency , administration of high-dose vitamin D3 compared with placebo did not reduce hospital length of stay , hospital mortality , or 6-month mortality . Lower hospital mortality was observed in the severe vitamin D deficiency subgroup , but this finding should be considered hypothesis generating and requires further study . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01130181",
"IMPORTANCE Asthma and wheezing begin early in life , and prenatal vitamin D deficiency has been variably associated with these disorders in offspring . OBJECTIVE To determine whether prenatal vitamin D ( cholecalciferol ) supplementation can prevent asthma or recurrent wheeze in early childhood . DESIGN , SETTING , AND PARTICIPANTS The Vitamin D Antenatal Asthma Reduction Trial was a r and omized , double-blind , placebo-controlled trial conducted in 3 centers across the United States . Enrollment began in October 2009 and completed follow-up in January 2015 . Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma were r and omized at 10 to 18 weeks ' gestation . Five participants were deemed ineligible shortly after r and omization and were discontinued . INTERVENTIONS Four hundred forty women were r and omized to receive daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D , and 436 women were r and omized to receive a placebo plus a prenatal vitamin containing 400 IU vitamin D. MAIN OUTCOMES AND MEASURES Co primary outcomes of ( 1 ) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and ( 2 ) third trimester maternal 25-hydroxyvitamin D levels . RESULTS Eight hundred ten infants were born in the study , and 806 were included in the analyses for the 3-year outcomes . Two hundred eighteen children developed asthma or recurrent wheeze : 98 of 405 ( 24.3 % ; 95 % CI , 18.7%-28.5 % ) in the 4400-IU group vs 120 of 401 ( 30.4 % , 95 % CI , 25.7%-73.1 % ) in the 400-IU group ( hazard ratio , 0.8 ; 95 % CI , 0.6 - 1.0 ; P = .051 ) . Of the women in the 4400-IU group whose blood levels were checked , 289 ( 74.9 % ) had 25-hydroxyvitamin D levels of 30 ng/mL or higher by the third trimester of pregnancy compared with 133 of 391 ( 34.0 % ) in the 400-IU group ( difference , 40.9 % ; 95 % CI , 34.2%-47.5 % , P pregnant women at risk of having a child with asthma , supplementation with 4400 IU/d of vitamin D compared with 400 IU/d significantly increased vitamin D levels in the women . The incidence of asthma and recurrent wheezing in their children at age 3 years was lower by 6.1 % , but this did not meet statistical significance ; however , the study may have been underpowered . Longer follow-up of the children is ongoing to determine whether the difference is clinical ly important . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00920621"
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41171720-06ff-11f0-808a-c43d1ab1c353
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CONTEXT Conservative therapies for Peyronie 's disease ( PD ) aim to treat early-stage disease by improving clinical outcomes such as penile curvature , penile length erectile dysfunction , and pain . OBJECTIVE To summarise the available evidence regarding injection and mechanical therapies for PD treatment . EVIDENCE ACQUISITION An extensive search of Medline , Embase , and Scopus data bases retrieved English- language articles up to 15 May 2018 . The systematic review protocol was registered on PROSPERO ( CRD42017077050 ) . Inclusion criteria were as follows : adults with early or chronic PD receiving treatment with injection therapy , penile traction , or a vacuum device . EVIDENCE SYNTHESIS Fifty-two articles were selected according to the inclusion criteria -17 comparative studies and 35 cohort studies -analysing the effects of calcium channel blockers ( verapamil , nicardipine ) , collagenase Clostridium histolyticum ( CCH ) , interferon α-2b ( IFNα-2b ) , hyaluronic acid ( HA ) , onabotulinum toxin A , thiocolchicine , penile extender devices , and vacuum devices . Qualitative data from these studies suggest a clinical ly significant effect of CCH and IFNα-2b injection therapy to decrease penile curvature and conserve penile length . Verapamil and HA performed well in single-arm or case-control studies . Studies of penile traction and vacuum devices in patients with PD demonstrated some benefits in terms of curvature and penile length but only in small , underpowered , nonr and omised studies . Studies of onabotulinum toxin A injections or thiocolchicine showed significant improvements in penile curvature , but only in studies of single-arm or case-control design . CONCLUSIONS CCH and IFNα-2b injected into stable PD plaques can decrease penile curvature ; CCH can also improve penile length . However , based on available data , strong conclusions can not be drawn for other treatments , including calcium channel blockers , HA , or mechanical therapies . PATIENT SUMMARY Our systematic review of injection therapies provides evidence for improvements in penile curvature for patients with Peyronie 's disease . No robust evidence is available to support the use of other local treatments including calcium channel blockers , hyaluronic acid , or mechanical therapies
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"Purpose We aim ed to assess the effect of intralesional verapamil on the treatment of Peyronie ’s disease . Material s and methods This r and omized study involved 80 patients . First , they were divided into two groups . The first group ( case : 40 patients ) received intralesional verapamil and the second group ( control : 40 patients ) local saline injection . They were followed about 24 weeks and evaluated for the size of plaques , plaque softening , reduction of pain and amelioration of penile deformity and erectile dysfunction ( estimated by the International Index of Erectile Function ) before and after treatment . Results Reduction of plaque size was seen in 17.5 % of the case group and 12.8 % of the control group ( P : 0.755 ) . Pain was reduced in 30 % of the case group and 28.2 % of the control group ( P : 0.99 ) . Curvature was decreased in 17.5 % of the case group and 23.1 % the control group ( P : 0.586 ) . Plaque softening was seen in 30 % of the case group compared with 25.6 % improvement in the control group ( P : 0.803).Also we found 5 % and 2.6 % improvement in sexual dysfunction in the case and control groups , respectively . ( P : 0.985 ) . Conclusion Although in some studies verapamil has been found to be effective in the treatment of Peyronie ’s disease , we did not find any improvement in comparison with the control group . Furthermore , larger scale studies are warranted to assess the effect of this drug on the treatment of Peyronie ’s disease",
"OBJECTIVES Multiple conservative therapies for the treatment of Peyronie 's disease have been offered with variable and poor response rates . Calcium channel blockers have been shown in vitro and in vivo to inhibit secretion and synthesis of extracellular matrix , including collagen , glycosaminoglycans , and fibronectin , as well as causing increased collagenase and anti transforming growth factor-beta activity . Calcium antagonists , including verapamil , are effective in stimulating the remodeling and degradation of extracellular matrix in tissue by altering the metabolic pathways of fibroblasts . Recently , a pilot study ( 1994 ) showed preliminary promising results in treating plaque caused by Peyronie 's disease . This r and omized single-blind placebo-based study ( 1994 to 1996 ) was undertaken to confirm the hypothesis . METHODS In this r and omized single-blind study , 14 patients completed the study and were divided into two groups : the verapamil treatment group ( n = 7 ) or the control saline group ( n = 7 ) . Verapamil or saline was injected directly into the Peyronie 's plaque once a week for 6 months . Patients were evaluated before and after treatment with duplex ultrasound to confirm the extent of the lesion and to measure volume of the plaque , and by interview and mailed question naire 3 months after treatment . Patients being treated with oral calcium antagonists were excluded from the study . RESULTS A decreased plaque volume was measured in 57 % of the verapamil-treated men versus 28 % in the control group ( P Penile curvature demonstrated an improvement trend of 37.71 + /- 9.3 degrees to 29.57 + /- 7.3 degrees in the verapamil-treated patients , but the difference was not significant ( P Plaque softening was noted in all patients treated with verapamil . There was significant objective improvement in plaque-associated penile narrowing in all patients in the verapamil group . Subjective plaque-associated erectile dysfunction ( quality of erection ) showed improvement in 42.87 % of the verapamil group versus none in the control group ( P local or systemic toxicity except for an occasional ecchymosis/bruise at the injection site . After a positive clinical response , plaque size , penile angulation , and symptoms continued to improve . Decrease in plaque size was noted in each of the responders in the first 3 months . CONCLUSIONS This r and omized single-blind study suggests that intralesional injection of calcium channel blocker may be a reasonable approach in some selected patients for the treatment of Peyronie 's disease with noncalcified plaque and penile angulation of less than 30 degrees . Patients whose plaque failed to respond to intralesional verapamil therapy within 3 months or whose angulation was greater than 30 degrees at presentation were more likely to benefit from surgery",
"OBJECTIVE To assess the outcomes of a new protocol of intralesional injections of verapamil ( ILIV ) to treat Peyronie disease ( PD ) and to look for predictors of response . METHODS Patients followed up for PD in our center were prospect ively enrolled between 2007 and 2013 . The following data were collected : age , degree of curvature of the penis , Lue score ( severity score of PD [ 0 - 15 ] ) , and pain ( analogic Likert scale : 0 - 5 ) . The protocol consisted of 1 verapamil injection per session ( 15 mg in 6 mL ) in the main plaque using a single-puncture approach . Injections were repeated once every 3 weeks , at least 6 times . RESULTS Sixty men were included . Mean number of injections per patient was 12.6 ( ±8.9 ) . Average Lue scores before and after ILIV were 9.4 ( ±2 ) and 4.5 ( ±2 ; P = .05 ) , respectively . Average penile curvatures during erection before and after ILIV were 37.3 ° ( ±13.3 ) and 21 ° ( ±13 ) , respectively ( P = .02 ) . There were no serious side effects . At the end of follow-up , 47 patients ( 78 % ) considered themselves globally improved . Younger age was the only predictor of response to ILIV in univariate ( odds ratio = 0.91 ; P = .04 ) and multivariate analyses ( odds ratio = 0.87 ; P = .03 ) . CONCLUSION ILIV had a favorable impact reducing PD in 78 % of patients with minimal side effects . Most patients required at least 12 injections to obtain optimal improvement . A protocol consisting of repeated courses of 6 injections using a single-puncture approach appears a valid option . Younger age was the only predictor of success",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"To compare the efficacy of transdermal electromotive administration and intra‐lesional injection of verapamil plus dexamethasone for the treatment of Peyronie 's disease . Patients with Peyronie 's disease of less than 2‐year duration were r and omized into two groups of transdermal electromotive administration and intra‐lesional injection of verapamil plus dexamethasone . During the 6‐week therapy period , a single weekly dose of 10 mg verapamil and 4 mg dexamethasone solution was administered to 30 patients in each group either by transdermal electromotive method or via the conventional injection method by a syringe connected to a 25 G needle . Evaluations of plaque length , width , and volume , penile curvature , erectile dysfunction and penile deviations were carried out before and after 1 and 3 months of the interventions . Erectile pain was reduced in the electromotive group from a mean of 5.1–1.0 in scale of 10 and from 5.4 to 3.6 in the injection group ( p = 0.006 ) . Regarding plaque length , plaque width , penile curvature plaque volume and erectile dysfunction , the electromotive administration group showed better results which , however , were not statistically significant . ( p > 0.05 ) . Transdermal electromotive drug administration yielded comparable results as against current conventional intra‐lesional injection technique and fared better in controlling erectile pain ",
"PURPOSE We investigated the efficacy and safety of intralesional interferon alpha-2b for the treatment of Peyronie 's disease . MATERIAL S AND METHODS A total of 117 consecutive patients with a mean age of 55.1 years who had Peyronie 's disease were enrolled in a single-blind , multicenter , placebo controlled , parallel study to determine the efficacy and safety of intralesional interferon alpha-2b therapy ( Schering , Kenilworth , New Jersey ) , including 62 who received placebo and 55 who received interferon alpha-2b . Saline ( 10 ml ) in controls and interferon alpha-2b ( 5 x 10(6 ) U ) were administered biweekly for 12 weeks . Each patient was evaluated for penile curvature , plaque size and density , penile pain , erectile function and penile hemodynamics before and after study completion . Improvement in these parameters was statistically compared between the groups . RESULTS A total of 53 patients in the control arm and 50 in the interferon alpha-2b arm completed the study . Improvement in penile curvature , plaque size and density , and pain resolution was significantly greater in patients treated with interferon alpha-2b vs placebo . The increase in mean International Index of Erectile Function scores was not significantly different between the groups . Penile blood flow improvement was observed in interferon alpha-2b treated patients but not in those who received placebo . The decrease in the number of penile vascular pathologies was significantly higher in interferon alpha-2b cases . Side effects , mostly flu-like symptoms , which were frequently noted in patients on interferon alpha-2b , were mild to moderate in degree and of short duration . CONCLUSIONS This single-blind , multicenter , placebo controlled , parallel study demonstrates that intralesional interferon alpha-2b at a dose of 5 x 10(6 ) units biweekly for 12 weeks is effective and safe as minimally invasive therapy for Peyronie 's disease",
"Aim To determine the effectiveness of transdermal electromotive administration ( TEA ) of verapamil and dexamethasone in the treatment of Peyronie ’s disease ( PD ) . Method Totally , 51 patients with PD were prospect ively included in the study . All patients were evaluated by history , subjective score scales , physical examination , photographs , and penile USG , before and after therapy . All patients were treated with TEA of the combination of verapamil and dexamethasone . The treatment plan included a total of 20 sessions ( at 3-day intervals for a period of 2 months ) , each with a duration of 20 min . At the end of the study , improvements in penile plaques , penile deviation , pain on erection , and erectile dysfunction were determined . Results The findings in 41 of the 51 patients were eligible to present . Median patient age was 52 years . Median duration of disease at presentation was 8 months . Remarkable reduction in palpable plaques and in penile angulation was observed in 10 patients ( 24 % ) and 11 ( 26 % ) patients , respectively . There were significant decreases in median plaque volume from 72 mm2 to 45 mm2 ( P 0.001 ) , and in median penile angulation from 25º to 15º ( P 0.001 ) . Impaired sexual activity and pain on erection had completely resolved in 11 ( 55 % ) patients and in 16 ( 80 % ) , respectively . Conclusion The results of our study have shown that TEA of the combination of verapamil and dexamethasone is a more effective therapy for improving subjective symptoms rather than objective symptoms . Therefore , we think that this treatment can be individualized according to the clinical features of PD patients",
"OBJECTIVE To evaluate the effect of intralesional injection of verapamil in Peyronie 's plaque with confirmed lesion . METHODS This r and omized clinical trial was carried out between March 2005 and March 2006 on 16 patients with Peyronie 's disease who were referred to the Urology Clinic of Shohadaye Ashayer Hospital in Khorram Abad , Iran . Performing a comprehensive physical exam , the genitalia of the patients were checked to confirm the diagnosis and reject other sexual disorders . Besides , parameters such as penis curving , lesion size were measured . Then , based on the 10-point visual analogue scale , sexual satisfaction of patients and their wives were recorded in a question naire . Patients got intralesional verapamil every 14 days and were treated for 6 months . After that , the parameters were assessed and data collected was analyzed using paired t-test . P-value lesion size and penis curving decreased 30 % . Almost 20 % of patients and their wives were satisfied with the outcome of the treatment . No significant side effect was seen during the treatment . CONCLUSION Injection of calcium channel blockers are effective for treatment of the Peyronie 's disease ; however , more studies with more patients are",
"BACKGROUND Intralesional therapies provide an alternative to surgical treatment of Peyronie 's disease ( PD ) . This study examines the efficacy of intraplaque injections of interferon-alpha-2B ( IFN-alpha-2B ) in the treatment of PD . METHODS Twenty-five patients were enrolled in the study with 21 completing the study . The average age of the study participants was 55.8 years , with 10 of the 21 having diabetes , hypertension , or both . Seven patients received placebo injections using 10 ml saline biweekly for 6 weeks before interferon therapy , and all 21 patients received biweekly injections of 2 x 10(6 ) U IFN-alpha-2B for 6 weeks before reevaluation . Patients were evaluated with duplex Doppler ultrasonography to assess penile curvature and blood flow . RESULTS The International Index of Erectile Function question naire was completed by 14 of 21 men to assess severity of erectile dysfunction ( ED ) before and after treatment . Improvements of 20 % or more in penile curvature occurred in 14 ( 67 % ) of 21 men . Penile pain decreased in eight ( 80 % ) of 10 , and plaque size decreased subjectively in 15 ( 71 % ) of 21 participants . The International Index of Erectile Function question naire showed significant improvement of ED in five ( 71 % ) of seven men with baseline moderate to severe ED . Peak systolic blood flow improved in three ( 43 % ) of seven men with baseline hemodynamic impairment , and veno-occlusive disease resolved in three ( 18 % ) of 17 individuals . IFN-alpha-2B injections led to significant improvements in penile pain and curvature caused by PD . CONCLUSION Results of intralesional IFN-alpha-2B injections in improving ED are encouraging . The study findings warrant further investigation of the effectiveness of IFN-alpha-2B injections for treatment of PD",
"PURPOSE We evaluate the efficacy of iontophoresis of dexamethasone , lidocaine and verapamil to treat Peyronie 's disease . MATERIAL S AND METHODS In an uncontrolled prospect i ve study 100 unselected patients with Peyronie 's disease were treated with 3 weekly courses of iontophoresis . The drug mixture was administered by an electrical current of 5 mA. and a self-adhesive receptacle fixed to the penile skin overlying the plaque . RESULTS Resolution of pain was observed in 96 % of patients , plaque diminution in 53 % and improvement of penile deviation in 37 % . Impaired sexual function was improved in 19 of 43 patients ( 44 % ) . The benefit of iontophoresis therapy was more pronounced in patients with a short history of disease . Because of lack of side effects and painless administration iontophoresis was well tolerated and accepted by all patients . CONCLUSIONS Iontophoresis of dexamethasone , lidocaine and verapamil may be regarded as first line nonsurgical treatment for Peyronie 's disease",
"Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies",
"Introduction Hyaluronic acid has been shown to be efficacious in decreasing scar formation , inflammation , and oxidative stress . Aim To assess the efficacy of intralesional injection of hyaluronic acid in patients affected by Peyronie 's disease . Methods In this prospect i ve , single-arm , self-controlled , interventional , multicenter pilot study , 65 patients underwent a 10-week cycle of weekly intraplaque injections with hyaluronic acid ( 0.8 % highly purified sodium salt hyaluronic acid 16 mg/2 mL ; Sinovial , IBSA , Lodi , Italy ) . Patients were re-evaluated 2 months after the end of therapy . Main Outcome Measures Plaque size ( millimeters ) , penile curvature ( degrees ) , International Index of Erectile Function ( IIEF-5 ) score , visual analog scale ( VAS ) score for sexual satisfaction , and Patient 's Global Impressions of Improvement ( PGI-I ) score . Results Median age was 57 years ( range = 23–70 ) . At baseline , mean plaque size was 10 mm ( range = 3–30 mm ) , mean penile curvature was 30 ° ( range = 0 ° –50 ° ) , and mean IIEF-5 score was 20 ( range = 0–25 ) , with slight to moderate erectile dysfunction ( IIEF score median VAS score of 6 ( range = 2–10 ) was found . Mean follow-up was 12 months ( range = 6–24 months ) . Statistically significant post-treatment improvements were detected for plaque size ( before treatment = 10 mm [ 3–30 mm ] , after treatment = 8 mm [ 1–30 mm ] , P .0001 ) , penile curvature ( before treatment = 30 ° [ 0 ° –50 ° ] , after treatment = 20 ° [ 0 ° –40 ° ] , P .0001 ) , IIEF-5 score ( before treatment = 20 [ 11–25 ] , after treatment = 21 [ 15–25 ] , P score ( before treatment = 6 [ 2–10 ] , after treatment 8 [ 2–10 ] , P the rate of patients with an IIEF score lower than 21 decreased from 55 % ( 36 patients ) to 40 % ( 25 patients ) . Overall improvement on the PGI-I question naire was 69 % . Conclusion Intralesional treatment with hyaluronic acid can improve plaque size , penile curvature , and overall sexual satisfaction and seems preferably indicated in the early ( active ) phase of the disease . Furthermore , it is easy to perform and well tolerated",
"ABSTRACT Objectives : To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie 's disease . Material s and Methods : Prospect i ve , single-blind , r and omized study , selecting patients who have presented Peyronie 's disease for less than 18 months . Thiocolchicine 4 mg or verapamil 5 mg were given in 7 injections ( once a week ) . Patients who had received any treatment for Peyronie 's disease in the past three months were excluded . The parameters used were the International Index of Erectile Function ( IIEF-5 ) score , analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography . Results : Twenty-five patients were r and omized , 13 received thiocolchicine and 12 were treated with verapamil . Both groups were statistically similar . The mean curvature was 46.7 ° and 36.2 ° before and after thiocolchicine , respectively ( p=0.019 ) and 50.4 ° and 42.08 ° before and after verapamil , respectively ( p=0.012 ) . The curvature improved in 69 % of patients treated with thiocolchicine and in 66 % of those who received verapamil . Regarding sexual function , there was an increase in the IIEF-5 from 16.69 to 20.85 ( p=0.23 ) in the thiocolchicine group . In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 ( p=0.58 ) . In the thiocolchicine group , the plaque was reduced in 61 % of patients . In the verapamil group , 8 % presented decreased plaque size . No adverse event was associated to thiocolchicine . Conclusion : The use of thiocolchicine in Peyronie 's disease demonstrated improvement on penile curvature and reduction in plaque size . Thiocolchicine presented similar results to verapamil in curvature assessment . No significant side effects were observed with the use of tiocolchicine",
"INTRODUCTION Peyronie 's disease afflicts at least 3 % of sexually active men over the age of 30 . Many pharmacologic therapies have been tried , but to date , no systemic or local therapy has been proven to provide predictable and lasting results . AIM This study was design ed to assess the efficacy and safety of intralesional clostridial collagenase injection therapy in a series of patients with Peyronie 's disease . METHODS Twenty-five patients aged 21 - 75 years who were referred to a single institution with a well-defined Peyronie 's disease plaque were treated with three intralesional injections of clostridial collagenase 10,000 units in a small volume ( 0.25 cm(3 ) per injection ) administered over 7 - 10 days , with a repeat treatment ( i.e. , three injections of collagenase 10,000 units/25 cm(3 ) injection over 7 - 10 days ) at 3 months . Primary efficacy measures were changes from baseline in the deviation angle and plaque size . Secondary efficacy end points were patient responses to a Peyronie 's disease question naire and improvement according to the investigators ' global evaluation of change . MAIN OUTCOME MEASURE The primary efficacy measures were change in deviation angle and change in plaque size . Secondary end points were patient question naire responses and improvement according to the investigators ' global evaluation of change . RESULTS Significant decreases from baseline were achieved in the mean deviation angle at months 3 ( P = 0.0001 ) and 6 ( P = 0.0012 ) , plaque width at months 3 ( P = 0.0052 ) , 6 ( P = 0.0239 ) , and 9 ( P = 0.0484 ) , and plaque length at months 3 ( P = 0.0018 ) and 6 ( P = 0.0483 ) . More than 50 % of patients in this series considered themselves \" very much improved \" or \" much improved \" at all time points in the study , and the drug was generally well tolerated . CONCLUSION The benefits of intralesional clostridial collagenase injections in this trial lend support to prior studies supporting its use in the management of Peyronie 's disease . A double-blind , placebo-controlled study is currently under development",
"OBJECTIVES To compare the efficacy and safety of intralesional interferon-alpha 2b combined with oral vitamin E or intralesional interferon-alpha 2b alone or oral vitamin E alone for the treatment of Peyronie 's disease . METHODS From January 2000 to March 2002 , a total of 30 consecutive men with Peyronie 's disease were r and omized prospect ively into three different treatment groups . All the patients were assessed objective ly with penile duplex Doppler ultrasonography for plaque size , location , and presence of calcification before and after treatment . Subjective data were obtained by querying about the improvement in penile pain and by using the \" global efficacy question \" for the assessment of the quality of sexual intercourse at the end of the study . A total of 5.0 x 10(6 ) U of interferon-alpha 2b was given once per week directly into the plaque for a period of 12 weeks . Patients received 400 IU of vitamin E orally twice daily for 6 months . RESULTS At the 6-month follow-up visit , we did not find any statistically significant changes in the objective parameters when compared with the initial findings in each group or among the three groups ( P > 0.05 ) . We did not observe any clinical ly significant improvement in the subjective parameters among the three groups ( P > 0.05 ) . However , all patients who were treated with interferon-alpha 2b experienced brief flu-like side effects . CONCLUSIONS Our findings indicate that 5 million units of intralesional interferon-alpha 2b injection therapy either alone or in combination with vitamin E does not appear to be clinical ly effective in the management of early stage Peyronie 's disease compared with only oral vitamin",
"In this clinical study , to determine the therapeutic efficacy of interferon ( IFN ) treatment for Peyronie 's disease , we applied interferon alpha-2A ( IFN alpha-2A ) intralesionally in the treatment of Peyronie plaques in 15 patients and results were evaluated by magnetic resonance imaging ( MRI ) . Patients whose plaque sizes were 0.5 and 1 cm responded better to the treatment . There was about a 90 % lessening in the sizes of the plaques of 1.5 cm , 83.3 % of 2 cm , as the ones which were 0.5 cm and 1 cm disappeared completely after treatment . As a conclusion , the treatment of Peyronie 's disease with IFN alpha-2A is effective and side effects are minimum",
"Peyronie 's disease remains a therapeutic dilemma for the practicing urologist . Multiple nonoperative therapies have been offered with variable suboptimal response rates . Calcium channel blockers have been shown to alter the metabolism of fibroblasts , result ing in decreased extracellular matrix secretion of collagen as well as increased collagenase activity . In this nonr and omized dose-escalating format study 14 men received biweekly injections of verapamil into the Peyronie 's plaques for 6 months . Subjectively , there was significant improvement in plaque-associated penile narrowing ( 100 % ) and curvature ( 42 % ) . Objective ly , a decreased plaque volume of greater than 50 % was noted in 30 % of the subjects . Plaque softening was noted in all patients , while 83 % noticed that plaque-related changes in erectile function had arrested or improved . There was no toxicity nor did symptoms recur when improvement was noted . This preliminary study suggests that intralesional calcium antagonist ( verapamil ) therapy offers an economical and sensible nonoperative approach to the treatment of Peyronie 's disease",
"Introduction Collagenase Clostridium histolyticum ( CCH ) intralesional injection was efficacious for the management of Peyronie 's disease ( PD ) in the double-blinded , r and omized , placebo-controlled Investigation for Maximal Peyronie 's Reduction Efficacy and Safety Studies I and II ( IMPRESS I and II ) . Little is known about the consequences of PD or treatment on the sexual partners of affected men . Aim To assess the safety and efficacy of CCH treatment in men who received placebo in the IMPRESS I or II study and to evaluate the men 's PD symptoms and partner bother as reported by female sexual partners . Methods In this phase 3 , open-label study ( NCT01685437 ) , men ( n = 189 ) received up to eight injections of CCH ( 0.58 mg/injection ) . Female sexual partners who provided informed consent at screening ( n = 30 ) participated in the study . Main Outcome Measures Co- primary end points were change or percentage of change in penile curvature deformity and change in PD symptom bother domain score of the Peyronie 's Disease Question naire ( PDQ ) from baseline to week 36 . Participating women completed the PDQ for female sexual partners ( PDQ-FSP ) and the Female Sexual Function Index ( FSFI ) . Results Statistically significant mean improvements were observed in penile curvature deformity ( 36.3 % decrease ; 95 % CI = −41.6 to −30.9 ) and PDQ symptom bother score ( 2.4-point decrease ; 95 % CI = −3.0 to −1.8 ) from baseline to week 36 . Most treatment-emergent adverse events were mild or moderate . After CCH treatment of their male partners , female sexual partners reported improvement ( using the PDQ-FSP ) in their male partner 's PD symptoms and female bother regarding their partner 's PD . The percentage of female sexual partners with sexual dysfunction ( FSFI total score ≤ 26.55 ) also decreased after male partner treatment , from 75.0 % at baseline to 33.3 % . Conclusions These results support the safety and efficacy of CCH in the management of appropriate patients with PD and the potential benefits for patients ' partners . Goldstein I , Knoll LD , Lipshultz LI , et al. Changes in the Effects of Peyronie 's Disease After Treatment With Collagenase Clostridium histolyticum : Male Partners and Their Female Partners . Sex Med 2017;5:e124–e130",
"INTRODUCTION Collagenase clostridium histolyticum ( CCH ; Xiaflex , Auxilium Pharmaceuticals , Inc. , Chesterbrook , PA , USA ) is a Food and Drug Administration-approved , intralesional treatment for Peyronie 's disease ( PD ) . AIM The aim of this study was to assess the safety and effectiveness of CCH in the treatment of PD . METHODS This phase 3 , open-label study enrolled subjects who were CCH-naïve , were enrolled in a previous pharmacokinetic study , or had received placebo in an earlier phase 2 CCH study . Each treatment cycle included two intralesional injections of CCH 0.58 mg , approximately 24 - 72 hours apart , and plaque modeling 24 - 72 hours after the second injection of each cycle . The treatment cycle was repeated after 6 weeks for ≤4 treatment cycles . MAIN OUTCOME MEASURES The co- primary end points were the mean percent change in penile curvature deformity and the mean improvement in PD bother score ( range 0 - 16 ) from baseline to week 36 . RESULTS Of the 347 subjects treated with ≥1 injection , 238 had both a penile curvature measurement and a Peyronie 's Disease Question naire response at baseline and ≥1 subsequent time point . Mean baseline penile curvature deformity was 53.0 ° and mean PD symptom bother was 7.3 . Statistically significant mean improvements from baseline to week 36 were observed in both penile curvature deformity ( 34.4 % [ 95 % confidence interval { CI } , 31.2 % , 37.6 % ] ) and PD symptom bother score ( 3.3 [ 95 % CI , 2.8 , 3.7 ] ) . Most adverse events ( AEs ) were mild or moderate in severity and local to the penis . There were three serious treatment-related AEs , two penile hematomas and one corporal rupture ; all resolved with treatment . CONCLUSIONS Potentially clinical ly meaningful and statistically significant improvements in penile curvature deformity and PD symptom bother scores were observed with intralesional injection of CCH compared with baseline in men with PD . CCH was generally well tolerated , with AEs primarily transient and local to injection site . In conjunction with previous studies , the results of this open-label study support the use of CCH in the treatment of PD",
"PURPOSE To determine the effectiveness of intralesional administration of onabotulinumtoxinA in patients with Peyronie ’s disease ( PD ) . MATERIAL S AND METHODS A prospect i ve therapeutic cohort study was undertaken in patients aged ≥ 18 years with stable PD . Intervention included one-time intralesional application of 100 U of onabotulinumtoxinA. We included 22 patients who attended the urology clinic from October 1 , 2011 to June 30 , 2012 . Primary outcome measure was degree of curvature . Secondary outcome measures were thickness of the fibrous plaque , improvement in erectile function and pain . Erectile function was evaluated using the International Index of Erectile Function ( IIEF-5 ) question naire . The Visual Analog Scale ( VAS ) was used to measure pain during an erection . Statistical analyses were performed by Pearson ’s chi-squared test for categorical variables and student ’s t-test for quantitative variables . Any P value RESULTS The size of the fibrous plaque was reduced from 0.34 ± 0.20 to 0.27 ± 0.13 cm after treatment ( P = .014 ) . The curvature initially averaged 32.95 ± 9.21 ° , and improved to 25 ± 9.38 ° ( P = .025 ) . According to the Kelami classification , the curvature was the curvature was 13.6 % ) . The IIEF-5 score was 16.18 ± 4.46 before treatment and 18.22 ± 4.55 after treatment ( P = .002 ) . Pain was reduced from 3.36 ± 3.48 before treatment to 1.14 ± 1.58 after treatment ( P = .001 ) . CONCLUSION The administration of onabotulinumtoxinA may improve the clinical manifestations of PD result ing from fibrosis , thus improving sexual function in patients",
"BACKGROUND Collagenase Clostridium histolyticum ( CCH ) is indicated for the treatment of penile curvature in adult men with Peyronie 's disease ( PD ) with palpable plaque and curvature deformity of at least 30 ° at the start of therapy . AIM To evaluate the efficacy and safety of CCH plus vacuum-pump therapy with and without penile modeling for the management of PD . METHODS Adult men with PD and penile curvature of at least 30 ° were r and omly assigned to receive CCH 0.58 mg plus vacuum therapy alone ( n = 15 ) or with penile plaque modeling ( n = 15 ) . Patients received no more than four treatment cycles ( cycle = ∼6-week duration ) , each consisting of two intralesional injections of CCH administered 24 to 72 hours apart . Vacuum therapy was applied twice daily from 14 days after the second injection of each cycle until the following cycle . Modeling was performed 24 to 72 hours after the second injection of each cycle . OUTCOMES The primary end point was change in penile curvature from baseline to week 36 ; additional end points included changes in Peyronie 's Disease Question naire ( PDQ ) domain scores , composite response ( ≥20 % decrease in penile curvature and decrease in PDQ bother score ≥ 1 point ) , and global response ( small but important , moderate , or much improvement in the Global Assessment of PD ) . RESULTS At week 36 , improvement in penile curvature from baseline was similar in the two groups ( mean change from baseline = -23.7 ° [ SD = 10.9 ] for CCH + vacuum + modeling and -23.3 ° [ SD = 7.2 ] for CCH + vacuum ; between-group difference = -0.3 ° , 95 % CI = -7.3 to 6.6 ) . Improvements in most PDQ domains , including bother , were observed from baseline to week 36 in the two groups . Most patients were composite ( 66.7 % and 84.6 % with CCH + vacuum + modeling and CCH + vacuum , respectively ) and global ( 86.7 % and 92.3 % , respectively ) responders . The most common adverse events were penile contusion , penile swelling , and penile pain . CLINICAL IMPLICATION S Vacuum-pump therapy administered alone or in combination with modeling after CCH treatment could improve PD symptoms . STRENGTHS AND LIMITATIONS This was a pilot study with a small sample and limited follow-up duration . CONCLUSION CCH and vacuum-pump therapy ( alone or combined with modeling ) could be an appropriate consideration for men with PD and warrants further investigation . Ralph DJ , Abdel Raheem A , Liu G. Treatment of Peyronie 's Disease With Collagenase Clostridium histolyticum and Vacuum Therapy : A R and omized , Open-Label Pilot Study . J Sex Med 2017;14:1430 - 1437",
"PURPOSE Collagenase clostridium histolyticum is approved for the treatment of Peyronie 's disease . To date , no post-release study to our knowledge has evaluated patient perceived outcomes and satisfaction . Therefore , we evaluated patient perceived experience with collagenase clostridium histolyticum injection for Peyronie 's disease in a clinical practice . MATERIAL S AND METHODS From March 2014 to July 2015 , 69 patients underwent 1 to 4 series of collagenase clostridium histolyticum injections for Peyronie 's disease at our institution . Objective changes in penile curvature as well as patient reported functional outcomes and patient perceived curvature improvements were evaluated . RESULTS By the time of analysis 31 patients ( 45 % ) had completed 4 trials , 47 ( 68 % ) completed 3 trials and 59 ( 86 % ) completed 2 trials . Patient reported improvements ( percentage ) in curvature increased with each series ( trial 1 - 14 % , trial 2 - 28 % , trial 3 - 30 % and trial 4 - 37 % , p collagenase clostridium histolyticum injections negated a need for surgery and 52 % reported restoration of penetration . Overall 81 % of men perceived collagenase clostridium histolyticum treatment as meaningful and 88 % reported subjective improvements after 4 series of injections . Objective measures demonstrated a mean 23-degree curvature improvement ( 38 % , p penile hematomas and no patients experienced tunical rupture . CONCLUSIONS Collagenase clostridium histolyticum reduced the need for surgery and restored penetration in the majority of patients completing 4 series of injections . It also significantly reduced the degree of objective ly measured penile curvature . Subjective improvements in curvature increased with each series of collagenase clostridium histolyticum injections as well and the majority of patients considered the therapy worthwhile",
"OBJECTIVES To define the impact of intralesional verapamil injection therapy on penile deformity in men with Peyronie 's disease . METHODS Patients underwent a total of 6 intralesional injections of verapamil . Penile deformity was assessed at baseline and 3 months after the last intralesional injection of verapamil during penile erection after the administration of intracavernosal medication . Measurement was recorded using a goniometer at maximum penile rigidity . Endpoints included change in magnitude of curvature , stretched penile length , penetration ability , and resolution of pain . RESULTS Ninety-four consecutive patients met all inclusion criteria . Mean ( + /- st and ard deviation ) patient age and duration of Peyronie 's disease at time of baseline deformity assessment were 44 + /- 18 years and 5.2 + /- 2.7 months , respectively . At baseline 86 % had dorsal and 14 % lateral curvature . The mean curvature and stretched flaccid length were 50 degrees + /- 28 degrees and 12.6 + /- 3.1 cm , respectively . At the follow-up evaluation , patients were 5.2 + /- 1.8 months after their last ILV injection and were 11.7 + /- 4.2 months after the onset of Peyronie 's disease . Eighteen percent of patients had improvement of curvature , 60 % were unchanged , and 22 % worsened . Pain resolved in 100 % of patients . CONCLUSIONS In response to intralesional verapamil , a minority of men experienced improvement in penile deformity ; however , the majority of patients had stabilization of their deformity . This information may permit clinicians to give realistic expectations to patients considering intralesional verapamil therapy",
"OBJECTIVE To evaluate the outcomes in men undergoing collagenase Clostridium histolyticum ( CCH ) with concurrent penile traction therapy ( PTT ) for the treatment of Peyronie disease ( PD ) . MATERIAL S AND METHODS We identified patients treated with CCH between March 2014 and July 2016 . Patients were recommended to perform modeling and PTT between injection series . A final curve assessment was performed after patients completed CCH . A prospect i ve data base was maintained , including patient-reported frequency and duration of PTT . Statistical analysis was performed to evaluate outcomes based on use and duration of PTT . RESULTS A total of 51 patients completed CCH and had complete objective data available for analysis . Mean ( st and ard deviation [ SD ] ) baseline curvature was 66.7 ( 25.0 ) degrees , and mean ( SD ) improvement post CCH was 20.9 ( 17.3 ) degrees ( P Thirty-five ( 69 % ) men reported daily PTT for a mean ( SD ) of 9.8 ( 6.3 ) hours per week . No significant difference was identified in the degree of curve improvement based on frequency or duration of PTT ( P = .40 ) . Similarly , no associations between PTT and functional outcomes including intercourse restoration and surgery prevention were identified . Stretched penile length increased nonsignificantly by a mean ( SD ) of + 0.4 ( 1.5 ) cm in the PTT group , compared with -0.35 ( 1.5 ) in the non-PTT group ( P = .21 ) . CONCLUSION The current series represents a \" true-to-life \" experience , wherein utilization patterns , attrition , and compliance issues are relevant factors impacting efficacy . PTT use with the And ropenis declined in both frequency and duration with subsequent injection series , and there was no significant difference in curve improvement or stretched penile length with a mean 10 hours of weekly concurrent PTT",
"Intralesional therapy is a less invasive method for the treatment of Peyronie 's disease . The objective of this study was to evaluate intralesional injections of interferon alpha 2B ( IFN-alpha-2B ) as an effective alternative to the surgical treatment of Peyronie 's disease . Twenty-one patients with Peyronie 's disease were evaluated by use of penile duplex Doppler ultrasonography for cavernosal blood flows , degree of penile curvature , and plaque size . A question naire was given to all patients to assess sexual function . Each patient then received biweekly intralesional injections of 1 x 10(6 ) units of IFN-alpha-2B in 10 ml of normal saline over a period of 6 months . There was no placebo control group in this study . At the conclusion of the study , penile duplex Doppler imaging was repeated . A question naire was completed by all patients to assess changes in sexual function after treatment . Twenty patients completed the study , with all men reporting subjective softening of their plaques . Nine of 10 patients initially reporting penile pain with erection ( 90 % ) had resolution of their phallalgia while on study protocol . Thirteen patients ( 65 % ) had significant improvement in curvature , ranging from 20 to 90 % . Seventeen patients ( 85 % ) demonstrated an objective 10 to 80 % decrease in plaque size . Biweekly intralesional injections of Peyronie 's plaques with IFN-alpha-2B result ed in a significant improvement in penile curvature , diminished pain , and reduced plaque size , and result ed in a subjective improvement in sexual function",
"The purpose of this study was to clarify the actual therapeutic potential of a new transdermal drug delivery system ( electromotive drug administration ; EMDA ) for selected patients with Peyronie 's disease . Forty patients with Peyronie 's disease were treated by electromotive administration of the 3-drug association orgotein-dexamethasone-lidocaine in a double-blind , placebo-controlled , partial crossover study ( study 1 ) . Another 25 patients were treated by EMDA with a combination of verapamil-dexamethasone in an uncontrolled study ( study 2 ) . Treatment sessions lasted 20 minutes each and took place 3 times a week for 3 weeks with a current of 3 mA. Patients were assessed before treatment and at 1- and 3-month follow-up examinations . Assessment s were based on sexual history , physical examination , and dynamic color Doppler ultrasonographic results . Adverse effects of EMDA were not reported . In study 1 , the clinical results observed after treatment proved to be significantly better than those of the placebo . Penile pain disappeared in all patients in both studies . Penile lesion ( nodule or plaque ) either disappeared or significantly improved in 79 % and 90 % of patients treated by the 3- and 2-drug association , respectively . The improvement of penile deformity also was notable although it did not match the effect observed on penile nodules or plaque ( 62 % and 88 % , in studies 1 and 2 , respectively ) . In both studies , more than 80 % of patients reported a definite amelioration of penile rigidity , which paralleled the improvement of penile dynamic color Doppler ultrasonographic parameters . Overall , the combination of verapamil-dexamethasone achieved better clinical results than the 3-drug combination . Electromotive drug administration is a novel technique capable of safely achieving satisfactory results in selected patients with Peyronie 's disease not only in terms of improvement of patient 's symptoms but also due to the reduced need for penile surgery",
"PURPOSE While surgery remains the gold st and ard of therapy to correct the acquired curvature of Peyronie 's disease , the search for a less invasive therapy continues . Transdermal drug delivery was proposed to be superior to oral or injection therapy because it bypasses hepatic metabolism and minimizes the pain of injection . After electromotive drug administration with verapamil tunica albuginea specimens were demonstrated to contain detectable levels of the drug . Due to varying success with verapamil as injectable therapy for Peyronie 's disease we performed a double-blind , placebo controlled trial to determine the effectiveness of verapamil delivered through electromotive drug administration . MATERIAL S AND METHODS A total of 42 men with Peyronie 's disease volunteered to participate in this study , which was approved by our institutional review board . A genitourinary examination was performed on all patients , including plaque location , stretched penile length , objective measurement of curvature after papaverine injection and duplex ultrasound . Each subject was r and omized to receive 10 mg verapamil in 4 cc saline or 4 cc saline via electromotive drug administration . A Mini-Physionizer ( Physion , Mir and ola , Italy ) device was used at a power of 2.4 mA for 20 minutes . Treatments were performed 2 times weekly for 3 months . After 3 months each patient was reevaluated with physical examination and duplex ultrasound by a technician blinded to the treatment received . A modified erectile dysfunction index of treatment satisfaction question naire was also completed by each patient . RESULTS A total of 23 patients were r and omized to the verapamil treatment group ( group 1 ) and 19 were r and omized to the saline group ( group 2 ) . There were no significant differences between patient groups with respect to patient age , disease duration or pretreatment curvature . In group 1 , 15 patients ( 65 % ) had measured improvement ( mean 9.1 degrees , range 5 to 30 ) , 5 ( 22 % ) had no change and in 3 ( 13 % ) the condition worsened . In group 2 , 11 patients ( 58 % ) had measured improvement ( mean 7.6 degrees , range 5 to 30 ) , 7 ( 37 % ) showed no change and in 1 ( 5 % ) the condition worsened . To better evaluate effectiveness the total number of patients experiencing significant improvement ( 20 degrees or greater ) was calculated and compared . Seven patients ( 30 % ) in group 1 and 4 ( 21 % ) in group 2 achieved this criterion . Although a greater percent of patients treated with verapamil had improved curvature , the results were not statistically significant . CONCLUSIONS Although a greater percent of patients treated with verapamil in our electromotive drug administration protocol had a measured decrease in curvature , the results were not statistically significant . Further research is necessary to determine whether electric current may have a role in the treatment of Peyronie 's disease as well as if verapamil delivered via electromotive drug administration may have a role as effective treatment . Electromotive drug administration is a treatment option in the patient whose major complaint is pain or in the patient with mild curvature who does not wish to undergo intralesional therapy or surgical correction",
"INTRODUCTION Penile duplex Doppler ultrasound ( PDDU ) is currently the preferred method for the functional evaluation of penile hemodynamics . PDDU may be used to monitor objective ly changes in penile vascular parameters in men who undergo treatment for Peyronie 's disease ( PD ) , including intralesional interferon alpha-2b ( IFN alpha-2b ) . AIM To investigate the impact of intralesional IFN alpha-2b therapy for PD on penile hemodynamics by using PDDU and to assess the objective role of PDDU in monitoring treatment outcomes . MATERIAL S AND METHODS Thirty-nine patients ( 20 in the placebo and 19 in the IFN alpha-2b treatment arm ) were enrolled in this prospect i ve , placebo-controlled , parallel study . Patients received either 10 mL saline or 5 x 10(6 ) units of IFN alpha-2b intralesional injections every other week for a total of six injections . Patients in each group were evaluated at baseline and after completion of treatment regarding changes in penile hemodynamic parameters , penile curvature , plaque size and density , pain on erection , and erectile function . Specific published criteria were used for PDDU measurements . Outcomes were statistically compared between each group by using Mann-Whitney U and chi-square tests . RESULTS The mean age of the patients and the duration of PD were similar in both groups . The improvement in penile blood flow was significantly greater in IFN alpha-2b-treated patients than those in the placebo group . The number with the nonvascular classification increased significantly in the IFN alpha-2b arm from 31.5 % to 57.8 % . Additionally , improvements in penile curvature , plaque size and density , and pain on erection were better in the IFN alpha-2b group compared with the control . No significant improvement was observed in the erectile function domain in either group . CONCLUSION This study reveals that intralesional IFN alpha-2b injections have a significant benefit on penile hemodynamic parameters . Moreover , intralesional IFN alpha-2b is an effective , minimally invasive treatment for PD , and PDDU is a useful adjunct to monitor objective ly changes in penile vascular parameters . interferon alpha-2b injection therapy on penile hemodynamics in men with Peyronie 's disease",
"INTRODUCTION Various conservative treatments for Peyronie 's disease ( PD ) have been attempted over the years . Intralesional verapamil injection has been tested in prospect i ve r and omized studies , but the effect of this treatment seems insufficient . Nicardipine is a calcium antagonist alternative to verapamil and is reportedly more effective in vitro . AIM The objective of our study was to evaluate the usefulness of intralesional nicardipine injection as a conservative treatment for PD in the transition period of acute and chronic phase . METHODS Eighty-six patients ( age : 38 - 72 years , mean : 52 ) were enrolled in this study . A total of 74 patients were assigned r and omly to nicardipine group ( 10 mg diluted in 10 mL of distilled water daily , N=37 ) and control group ( 10 mL of saline water , N=37 ) . A total of six injections were administrated biweekly . MEAN OUTCOME MEASURE The subjects were assessed by International Index of Erectile Function (IIEF)-5 and international pain scale . The plaque size was measured by ultrasonography after 20 µg intracavernosal injection of alprostadil ( prostagl and in E1 ) . The penile curvature was also measured by taking a photograph at maximum rigidity . RESULTS A reduction of pain score was seen throughout the course of treatment in both groups with a significant difference between the nicardipine and control groups ( multiple analysis of variance test , P=0.019 ) . A significant improvement of IIEF-5 score occurred only in the nicardipine group at 48 weeks after the initiation of treatment ( P The plaque size was significantly reduced at 48 weeks only in the nicardipine group ( 12 points , P=0.0004 by paired t-test ) . The penile curvature was significantly improved in both groups ( P were no severe side effects , such as hypotension or other cardiovascular events . CONCLUSION Our findings indicate that intralesional nicardipine injection is clinical ly effective as a conservative treatment for PD in the transition period of acute and chronic phase",
"Introduction . There is no current consensus as to the most effective non-surgical therapy for Peyronie 's disease ( PD ) . Aim . To assess the benefit of penile traction therapy ( PTT ) when added to intralesional verapamil injections ( IVI ) combined with oral L-arginine 1 g bid and pentoxifylline 400 mg tid in men with PD . Methods . 74 men with PD completed 12 IVI . Patients electing to add PTT were advised to wear the device for 2 - 8 hours daily , and no longer than 2 hours per session . Subjective responses were measured using patient question naires . Stretched penile length ( SPL ) and erect penile curvature ( EPC ) using penile duplex ultrasound ( DU ) were measured . Response to therapy was defined as at least a 10 degree reduction in EPC.Main Outcome Measures . Change in SPL ( cm ) , change in EPC ( degrees ) . Results . 39 patients in the PTT group ( I ) vs. 35 patients in group ( II ) completed the protocol . 54 % of men in group I responded to therapy vs. 46 % in group II ( p = 0.75 ) . Responders had a mean EPC improvement of 26.9 degrees in group I vs. 20.9 in group II ( p = 0.22 ) . Mean PTT use was 3.3 hours per day , and men with > 3 hours per day use gained 0.6 cm in SPL vs 0.07 cm using less than or equal to 3 hours per day ( p= 0.09 ) , while men in group I on lost 0.74 cm of SPL on average . Multivariate analysis revealed that duration of PTT use significantly predicts length gain ( 0.38 cm gain for every additional hour per day of PTT use , p = 0.007 ) . Conclusion . There was a trend toward measured curvature improvement , and a significant gain in SPL in men using the combination therapy protocol . Length improvement is related to duration of use of the traction device [ corrected ]",
"INTRODUCTION Outcome data of penile traction therapy ( PTT ) for the acute phase ( AP ) of Peyronie 's disease ( PD ) have not been specifically studied . AIM The aim of this study was to assess the effectiveness of a penile extender device for the treatment of patients with AP of PD . METHODS A total of 55 patients underwent PTT for 6 months and were compared with 41 patients with AP of PD who did not receive active treatment ( \" no intervention group \" [ NIG ] ) . MAIN OUTCOMES MEASURES Pre- and posttreatment variables included degree of curvature , penile length and girth , pain by 0 - 10 cm visual analog scale ( VAS ) , erectile function ( EF ) domain of the International Index of Erectile Function question naire , Erection Hardness Scale , Sexual Encounter Profile 2 question , and penile sonographic evaluation ( only patients in the intervention group ) . RESULTS The mean curvature decreased from 33 ° at baseline to 15 ° at 6 months and 13 ° at 9 months with a mean decrease 20 ° ( P PTT group . VAS score for pain decreased from 5.5 to 2.5 after 6 months ( P 0.05 ) . EF and erection hardness also improved significantly . The percentage of patients who were not able to achieve penetration decreased from 62 % to 20 % ( P deformity increased significantly , stretched flaccid penile length decreased , VAS score for pain increased , and EF and erection hardness worsened . PTT was associated with the disappearance of sonographic plaques in 48 % of patients . Furthermore , the need for surgery was reduced in 40 % of patients who would otherwise have been c and i date s for surgery and simplified the complexity of the surgical procedure ( from grafting to plication ) in one out of every three patients . CONCLUSIONS PTT seems an effective treatment for the AP of PD in terms of pain reduction , penile curvature decrease , and improvement in sexual function ",
"We investigated 49 men with Peyronie 's disease in a prospect ively r and omized placebo controlled double-blind study , comparing the effects on plaque size and penile deformity of intralesional purified clostridial collagenase and saline placebo . For the group as a whole , treatment out-performed placebo ( p absolute angular change in patients responding to treatment was small . No significant side effects were noted within a 3-month followup",
"OBJECTIVE To evaluate the efficacy of subcutaneous interferon-alpha 2b in the treatment of Peyronie 's disease . PATIENTS AND METHODS Twenty-three men ( mean age 53 years , range 27 - 69 ) received interferon-alpha 2b in an unr and omized prospect i ve study . The drug was injected subcutaneously adjacent to the plaque three times a week for 3 weeks at a dose of 2 x 106 IU . The effect of interferon-alpha 2b on the extent of penile deviation , plaque size and erectile pain were investigated , and the drug 's side-effects were documented . The mean ( range ) follow-up was 22 ( 4 - 48 ) months RESULTS All patients had pain relief and 13 of 19 with pain before treatment became pain-free . The penile deviation was reduced in one patient ; the deviation increased despite therapy in one patient and remained stable in the others . Plaque size remained unchanged in all patients . Impaired sexual function was improved in seven ( 30 % ) of the patients . Side-effects ( myalgia , fever ) occurred after only four of 207 injections ( 2 % ) . CONCLUSIONS Subcutaneous interferon-alpha 2b is safe , well tolerated and relieves pain . However , with no objective reduction in penile deviation and plaque size , the outcome of interferon-alpha 2b therapy is generally unconvincing and the drug can not be recommended for the conservative treatment of Peyronie 's disease",
"PURPOSE In a previous study , 83 % of 14 patients noted that their symptoms of Peyronie 's disease had arrested or improved after intralesional injection of verapamil . This nonr and omized , prospect i ve study further investigates the use of verapamil in a larger , thoroughly characterized patient population . MATERIAL S AND METHODS Forty-six men began treatment ; 38 completed the study . Using a multiple puncture technique , 10 mg . of verapamil diluted to 10 cc were distributed throughout the plaque every 2 weeks for a total of 12 injections . Response to treatment was evaluated through subjective and objective measurements of pain , plaque size , deformity , duration of disease and sexual function , and with the Kelami classification system based on plaque size and curvature . RESULTS Pain resolved in 97 % of the patients who presented with pain after a mean of 2.5 injections . After therapy , 76 % reported a subjective decrease in curvature , 9.5 % noted an increase and 14.5 % remained unchanged . Of the treated patients 72 % reported an improvement in the ability to engage in coitus . Objective measurements demonstrated that curvature was decreased in 54 % of the patients , increased in 11 % and remained unchanged in 34 % . There were no substantial differences in response to treatment based on duration of disease or within the 3 Kelami classification groups . Other than transient post-injection ecchymosis , there were no significant acute or chronic side effects . CONCLUSIONS Verapamil injection therapy result ed in a reduction of pain in 97 % of the patients , an improvement in sexual function in 72 % , a reduction of deformity in 86 % , an improvement in distal rigidity in 93 % and an objective reduction of curvature in 54 % . Further studies are required to determine the effectiveness of this nontoxic , inexpensive , nonsurgical approach to Peyronie 's disease"
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4117175c-06ff-11f0-808a-c43d1ab1c353
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AIM To identify factors that promote a positive start to school for children with autism spectrum disorder ( ASD ) . METHODS Web of Science , MEDLINE , Scopus , and PsychINFO search es were conducted to identify literature published after 1991 and relevant to school transition processes in children with ASD . Twenty studies were deemed eligible for inclusion . These studies evaluated a range of factors including school readiness , parent and teacher perspectives on transition practice s , characteristics of children with ASD that are associated with successful transition to school and the impact of school based intervention programs . RESULTS A review of these studies showed that children with ASD are less school ready emotionally than their peers and those children with ASD appear to have more externalising behaviours and self-regulation difficulties that affect their school engagement and their relationships with their teachers . There was a paucity of research looking at interventions targeting school readiness . However , school-based behavioural interventions appear to improve cognitive , language and daily living skills , but have less impact on socialisation and peer inclusion . CONCLUSION Children with ASD face more challenges transitioning to school , particularly with social interaction . Further development and implementation of specific school-based interventions is needed in order to assist children with autism to maximise their success in starting school
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"BACKGROUND Children with autism spectrum disorders ( ASD ) are increasingly included in general education classrooms in an effort to improve their social involvement . METHODS Seventy-nine children with ASD and 79 r and omly selected , gender-matched peers ( 88.6 % male ) in 75 early ( K-1 ) , middle ( 2nd-3rd ) , and late ( 4th-5th ) elementary classrooms across 30 schools completed social network surveys examining each child 's reciprocal friendships , peer rejection , acceptance , and social involvement . RESULTS Across grade levels , peers less frequently reciprocated friendships with children with ASD than students in the matched sample . While children with ASD were not more likely to be rejected by peers , they were less accepted and had fewer reciprocal friendships than matched peers at each grade level . Although 48.1 % of children with ASD were involved in the social networks of their classrooms , children with ASD were more likely to be isolated or peripheral to social relationships within the classroom across all grade levels , and this difference is even more dramatic in later elementary grade s. CONCLUSIONS In inclusive classrooms , children with ASD are only involved in peers ' social relationships about half of the time , and appear to be even less connected with increasing grade level . Promoting children with ASD 's skills in popular activities to share with peers in early childhood may be a key preventive intervention to protect social relationships in late elementary school grade",
"This study examined the extent to which clinical and demographic characteristics predicted outcome for children with autism spectrum disorder . Participants included 152 students with autism spectrum disorder in 53 kindergarten-through-second- grade autism support classrooms in a large urban public school district . Associations between child characteristics ( including age , language ability , autism severity , social skills , adaptive behavior , co-occurring psychological symptoms , and restrictive and repetitive behavior ) and outcome , as measured by changes in cognitive ability following one academic year of an intervention st and ardized across the sample were evaluated using linear regression with r and om effects for classroom . While several scales and subscales had statistically significant bivariate associations with outcome , in adjusted analysis , only age and the presence of symptoms associated with social anxiety , such as social avoidance and social fearfulness , as measured through the Child Symptom Inventory-4 , were associated with differences in outcome . The findings regarding the role of social anxiety are new and have important implication s for treatment . Disentangling the construct of social anxiety to differentiate between social fearfulness and social motivation has important implication s for shifting the focus of early treatment for children with autism spectrum disorder",
"The purpose of this r and omized control group study was to examine the effects of a peer network intervention that included peer mediation and direct instruction for Kindergarten and First- grade children with autism spectrum disorders . Trained school staff members provided direct instruction for 56 children in the intervention group , and 39 children participated in a comparison group . Results showed children in the intervention group displayed significantly more initiations to peers than did the comparison group during non-treatment social probes and generalization probes . Treatment session data showed significant growth for total communications over baseline levels . Children in treatment also showed more growth in language and adaptive communication . Finally , teachers ’ ratings of prosocial skills revealed significantly greater improvements for the intervention group"
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41171798-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Attention Deficit Hyperactivity Disorder ( ADHD ) in children is associated with hyperactivity and impulsitivity , attention problems , and difficulties with social interactions . Pharmacological treatment may alleviate symptoms of ADHD but seldom solves difficulties with social interactions . Social skills training may benefit ADHD children in their social interactions . We examined the effects of social skills training on children 's social competences , general behaviour , ADHD symptoms , and performance in school . OBJECTIVES To assess the effects of social skills training in children and adolescents with ADHD . SEARCH METHODS We search ed the following electronic data bases : CENTRAL ( 2011 , Issue1 ) , MEDLINE ( 1948 to March 2011 ) , EMBASE ( 1980 to March 2011 ) , ERIC ( 1966 to March 2011 ) , AMED ( 1985 to June 2011 ) , PsycINFO ( 1806 to March 2011 ) , CINAHL ( 1980 to March 2011 ) , and Sociological Abstract s ( 1952 to March 2011 ) . We also search ed the metaRegister of Controlled Trials on 15 October 2010 . We did not apply any language or date restrictions to the search es . We search ed online conference abstract s and contacted 176 experts in the field for possible information about unpublished or ongoing RCTs . SELECTION CRITERIA R and omised trials investigating social skills training for children with ADHD as a st and alone treatment or as an adjunct to pharmacological treatment . DATA COLLECTION AND ANALYSIS We conducted the review according to the Cochrane H and book for Systematic Review s of Intervention . Two authors ( OJS , MS ) extracted data independently using an appropriate data collection form . We performed the analyses using Review Manager 5 software . MAIN RESULTS We included 11 r and omised trials described in 26 records ( all full text articles ) in the review . The trials included a total of 747 participants . All participants were between five and 12 years of age . No trials assessed adolescents . In 10 of the trials the participants suffered from different comorbidities . The duration of the interventions ranged from eight to 10 weeks ( eight trials ) up to two years . The types of social skills interventions were named social skills training , cognitive behavioural intervention , multimodal behavioural/psychosocial therapy , behavioural therapy/treatment , behavioural and social skills treatment , and psychosocial treatment . The content of the social skills interventions were comparable and based on a cognitive behavioural model . Most of the trials compared child social skills training and parent training plus medication versus medication alone . Some of the experimental interventions also included teacher consultations . More than half of the trials were at high risk of bias regarding generation of the allocation sequence and allocation concealment . No trial reported blinding of participants and personnel and most of the trials had no reports regarding differences between groups in collateral medication for comorbid disorders . Overall , the trials had high risk of bias due to systematic errors . Even so , as recommended by the Cochrane H and book of Systematic Review s of Interventions , we used all eligible trials in the meta- analysis , but the results are down grade d to low quality evidence .There were no statistically significant treatment effects either on social skills competences ( positive value = better for the intervention group ) ( SMD 0.16 ; 95 % CI -0.04 to 0.36 ; 5 trials , n = 392 ) , on the teacher-rated general behaviour ( negative value = better for the intervention group ) ( SMD 0.00 ; 95 % CI -0.21 to 0.21 ; 3 trials , n = 358 ) , or on the ADHD symptoms ( negative value = better for the intervention group ) ( SMD -0.02 ; 95 % CI -0.19 to 0.16 ; 6 trials , n = 515).No serious or non-serious adverse events were reported . AUTHORS ' CONCLUSIONS The review suggests that there is little evidence to support or refute social skills training for adolescents with ADHD . There is need for more trials , with low risk of bias and with a sufficient number of participants , investigating the efficacy of social skills training versus no training for both children and adolescents
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"Background Children with attention deficit hyperactivity disorder ( ADHD ) are hyperactive and impulsive , can not maintain attention , and have difficulties with social interactions . Medical treatment may alleviate symptoms of ADHD , but seldom solves difficulties with social interactions . Social-skills training may benefit ADHD children in their social interactions . We want to examine the effects of social-skills training on difficulties related to the children 's ADHD symptoms and social interactions . Methods / Design The design is r and omised two-armed , parallel group , assessor-blinded trial . Children aged 8 - 12 years with a diagnosis of ADHD are r and omised to social-skills training and parental training plus st and ard treatment versus st and ard treatment alone . A sample size calculation estimated that at least 52 children must be included to show a 4-point difference in the primary outcome on the Conners 3rd Edition subscale for ' hyperactivity-impulsivity ' between the intervention group and the control group . The outcomes will be assessed 3 and 6 months after r and omisation . The primary outcome measure is ADHD symptoms . The secondary outcome is social skills . Tertiary outcomes include the relationship between social skills and symptoms of ADHD , the ability to form attachment , and parents ' ADHD symptoms . Discussion We hope that the results from this trial will show that the social-skills training together with medication may have a greater general effect on ADHD symptoms and social and emotional competencies than medication alone . Trial registration Clinical Trials ( NCT ) :",
"This study evaluated the separate and combined effects of behavior modification and 2 doses of methylpheni date ( MPH ; 0.3 and 0.6 mg/kg ) compared with baseline ( no behavior modification and a placebo ) on the classroom behavior and academic performance of 31 ADHD ( attention deficit-hyperactivity disorder ) boys attending a summer treatment program . Results revealed significant effects of both interventions , with the mean effect size of medication being more than twice as great as that of behavior modification . Relatively small incremental value was gained by the higher dose of medication or the addition of behavior modification , compared with the effects of the low dose of MPH . In contrast , the addition of either dose of MPH result ed in improvement beyond the effects of behavior modification alone . These group effects reflected those obtained in analyses of individual differences . Furthermore , comparisons of individual responsiveness showed that boys who responded to one treatment also responded to the other",
"Objective : To examine the rate of psychotic and mood-congruent psychotic side effects of stimulant medications in children treated for attention-deficit hyperactivity disorder ( ADHD ) . Method : A chart review was completed of all children diagnosed with ADHD in an outpatient clinic from January 1989 to March 1995 . Results : Over 5 years , 192 children were diagnosed with ADHD . Ninety-eight children received treatment at the clinic with stimulants . Six children developed psychotic or mood-congruent psychotic symptoms during treatment . Children on medication were followed for an average of 1 year and 9 months . Conclusions : Awareness of the potential for psychotic side effects from stimulant medications is important when prescribing for children . A large prospect i ve study would be useful to predict the frequency and classification of the side effects in children",
"OBJECTIVE To test the hypotheses that in children with attention-deficit/hyperactivity disorder ( ADHD ) ( 1 ) symptoms of ADHD , oppositional defiant disorder , and overall functioning are significantly improved by methylpheni date combined with intensive multimodal psychosocial treatment compared with methylpheni date alone and with methylpheni date plus attention control and ( 2 ) more children receiving combined treatment can be taken off methylpheni date . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to ( 1 ) methylpheni date alone ; ( 2 ) methylpheni date plus psychosocial treatment that included parent training and counseling , social skills training , psychotherapy , and academic assistance , or ( 3 ) methylpheni date plus attention psychosocial control treatment . Assessment s included parent , teacher , and psychiatrist ratings , and observations in academic and gym classes . RESULTS Combination treatment did not lead to superior functioning and did not facilitate methylpheni date discontinuation . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In stimulant-responsive children with ADHD , there is no support for adding ambitious long-term psychosocial intervention to improve ADHD and oppositional defiant disorder symptoms . Significant benefits from methylpheni date were stable over 2 years",
"Background Clinical evidence continues to exp and and is increasingly difficult to overview . We aim ed at conceptualizing a visual assessment tool , i.e. , a matrix for overviewing studies and their data in order to assess the clinical evidence at a glance . Methods A four-step matrix was constructed using the three dimensions of systematic error , r and om error , and design error . Matrix step I ranks the identified studies according to the dimensions of systematic errors and r and om errors . Matrix step II orders the studies according to the design errors . Matrix step III assesses the three dimensions of errors in studies . Matrix step IV assesses the size and direction of the intervention effect . Results The application of this four-step matrix is illustrated with two examples : peri-operative beta-blockade initialized in relation to surgery versus placebo for major non-cardiac surgery , and antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation . When clinical evidence is deemed both internally and externally valid , the size of the intervention effect is to be assessed . Conclusion The error matrix provides an overview of the validity of the available evidence at a glance , and may assist in deciding which interventions to use in clinical practice",
"OBJECTIVE In the intent-to-treat analysis of the Multimodal Treatment Study of Children With ADHD ( MTA ) , the effects of medication management ( MedMgt ) , behavior therapy ( Beh ) , their combination ( Comb ) , and usual community care ( CC ) differed at 14 and 24 months due to superiority of treatments that used the MTA medication algorithm ( Comb+MedMgt ) over those that did not ( Beh+CC ) . This report examines 36-month outcomes , 2 years after treatment by the study ended . METHOD For primary outcome measures ( attention-deficit/hyperactivity disorder [ ADHD ] and oppositional defiant disorder [ ODD ] symptoms , social skills , reading scores , impairment , and diagnostic status ) , mixed-effects regression models and orthogonal contrasts examined 36-month outcomes . RESULTS At 3 years , 485 of the original 579 subjects ( 83.8 % ) participated in the follow-up , now at ages 10 to 13 years , ( mean 11.9 years ) . In contrast to the significant advantage of MedMgt+Comb over Beh+CC for ADHD symptoms at 14 and 24 months , treatment groups did not differ significantly on any measure at 36 months . The percentage of children taking medication > 50 % of the time changed between 14 and 36 months across the initial treatment groups : Beh significantly increased ( 14 % to 45 % ) , MedMed+Comb significantly decreased ( 91 % to 71 % ) , and CC remained constant ( 60%-62 % ) . Regardless of their treatment use changes , all of the groups showed symptom improvement over baseline . Notably , initial symptom severity , sex ( male ) , comorbidity , public assistance , and parental psychopathology ( ADHD ) did not moderate children 's 36-month treatment responses , but these factors predicted worse outcomes over 36 months , regardless of original treatment assignment . CONCLUSIONS By 36 months , the earlier advantage of having had 14 months of the medication algorithm was no longer apparent , possibly due to age-related decline in ADHD symptoms , changes in medication management intensity , starting or stopping medications altogether , or other factors not yet evaluated",
"OBJECTIVE To test that methylpheni date combined with intensive multimodal psychosocial intervention , which includes social skills training , significantly enhances social functioning in children with attention-deficit/hyperactivity disorder ( ADHD ) compared with methylpheni date alone and methylpheni date plus nonspecific psychosocial treatment ( attention control ) . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to receive ( 1 ) methylpheni date alone , ( 2 ) methylpheni date plus multimodal psychosocial treatment that included social skills training , or ( 3 ) methylpheni date plus attention control treatment . Assessment s included parent , child , and teacher ratings of social function and direct school observations in gym . RESULTS No advantage was found on any measure of social functioning for the combination treatment over methylpheni date alone or methylpheni date plus attention control . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In young children with ADHD , there is no support for clinic-based social skills training as part of a long-term psychosocial intervention to improve social behavior . Significant benefits from methylpheni date were stable over 2 years",
"In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias",
"OBJECTIVES This study examines the tolerability and efficacy of methylpheni date ( MPH ) and behavior modification therapy ( BMOD ) in children with attention-deficity/hyperactivity disorder ( ADHD ) and severe mood dysregulation ( SMD ) . METHODS Children ( ages 5 - 12 ) from a summer program for ADHD were screened for SMD and additional manic-like symptoms using structured assessment s and direct clinical interview with the Young Mania Rating Scale ( YMRS ) . The SMD group was comprised of 33 subjects with SMD and elevated YMRS scores ( mean = 23.7 ) . They underwent weekly mood assessment s plus the daily ADHD measures that are part of the program . The comparison group ( n = 68 ) was comprised of the rest of the program participants . Using a crossover design , all subjects in both groups were treated with three varying intensities of BMOD ( no , low , high ) each lasting 3 weeks , with MPH dose ( placebo , 0.15 mg/kg t.i.d . , 0.3mg/kg t.i.d . , and 0.6 mg/kg t.i.d . ) varying daily within each behavioral treatment . RESULTS Groups had comparable ADHD symptoms at baseline , with the SMD group manifesting more oppositional defiant disorder/conduct disorder ( ODD/CD ) symptoms ( p externalizing symptoms ( p treatment efficacy or tolerability . Treatment produced a 34 % reduction in YMRS ratings in SMD subjects ( p - 0.001 ) . However , they still exhibited elevated YMRS ratings , more ODD/CD symptoms ( p significantly impaired at home than non-SMD subjects ( p MPH and BMOD are tolerable and effective treatments for children with ADHD and SMD , but additional treatments may be needed to optimize their functioning",
"The aim of this article was to analyze the prevalence of Attention Deficit/ Hyperactivity Disorder ( ADHD ) in Colombian Paisa children and adolescents . A r and omized sample of 4- to 17-year-old children and adolescents--176 males and 154 females -- was selected from schools in Manizales , Colombia . The diagnosis of ADHD was obtained using a semistructured psychiatric and neurological interview , medical histories revision , and neurological or psychiatric evaluations . Several rating scales and a neuropsychological assessment were administered in order to confirm the diagnosis . Children with Full Scale Intelligence Quotient ( FSIQ ) between 71 and 84 were recorded as having Borderline Intellectual Functioning ( BIF ) , and those with a history of mild motor retardation , and /or Performance Intelligence Quotient ( PIQ ) lower than 71 , were recorded as having a Developmental Coordination disorder ( DCD ) , after confirmation by neurological and neuropsychological examinations . BIF and DCD children were excluded from the ADHD group . Total prevalence of ADHD adjusted by sex was 16.4 % ( males 19.8 % and females 12.3 % ) . Prevalence of clean ADHD cases was 11.5 % , distrib uted as follows : combined type , 6.4 % ; inattentive , 4.8 % ; and hyperactive-impulsive , 0.3 % . Distribution by sex was as follows : males , 14.8 % ; and females , 7.7 % ; with an odds ratio of 2.1 ( 95 % CI : 1 - 4.5 , h 2 = 4.0 , p prevalence of ADHD adjusted by equal sex distribution was 11.3 % . Prevalence of BIF was 5.8 % , DCD 3.0 % , and mild mental retardation 3.9 % . Prevalence of ADHD did not show differences by socioeconomic status ( SES ) , in contrast to mild mental retardation in which BIF and DCD were significantly more frequent in the lower SES",
"OBJECTIVES To determine any long-term effects , 6 and 8 years after childhood enrollment , of the r and omly assigned 14-month treatments in the NIMH Collaborative Multisite Multimodal Treatment Study of Children With Attention-Deficit/Hyperactivity Disorder ( MTA ; N = 436 ) ; to test whether attention-deficit/hyperactivity disorder ( ADHD ) symptom trajectory through 3 years predicts outcome in subsequent years ; and to examine functioning level of the MTA adolescents relative to their non-ADHD peers ( local normative comparison group ; N = 261 ) . METHOD Mixed-effects regression models with planned contrasts at 6 and 8 years tested a wide range of symptom and impairment variables assessed by parent , teacher , and youth report . RESULTS In nearly every analysis , the originally r and omized treatment groups did not differ significantly on repeated measures or newly analyzed variables ( e.g. , grade s earned in school , arrests , psychiatric hospitalizations , other clinical ly relevant outcomes ) . Medication use decreased by 62 % after the 14-month controlled trial , but adjusting for this did not change the results . ADHD symptom trajectory in the first 3 years predicted 55 % of the outcomes . The MTA participants fared worse than the local normative comparison group on 91 % of the variables tested . CONCLUSIONS Type or intensity of 14 months of treatment for ADHD in childhood ( at age 7.0 - 9.9 years ) does not predict functioning 6 to 8 years later . Rather , early ADHD symptom trajectory regardless of treatment type is prognostic . This finding implies that children with behavioral and sociodemographic advantage , with the best response to any treatment , will have the best long-term prognosis . As a group , however , despite initial symptom improvement during treatment that is largely maintained after treatment , children with combined-type ADHD exhibit significant impairment in adolescence . Innovative treatment approaches targeting specific areas of adolescent impairment are needed",
"Past research has suggested that the aggregation of deviant peers during treatment may cause harmful effects ( T. J. Dishion , J. McCord , & F. Poulin , 1999 ) . This study compared the effectiveness of problem-solving skills training groups in which all members had conduct problems ( “ pure ” group condition ) with groups that consisted of adolescents with and without behavior problems ( “ mixed ” group condition ) . Participants were 139 sixth- and seventh- grade rs ( mean age = 12.7 ; 63 % male ; 55 % White ) enrolled at public middle schools . Pre- , post- , and 6-month follow-up data were collected , along with intervention process variables . Results showed that , contrary to the deviancy training hypothesis , adolescents in the pure-group condition engaged in more adaptive in-session behavior and received lower scores on the parent and teacher ratings of externalizing behavior at postintervention than those in the mixed-group condition . Mediation analyses showed that the deviancy training that occurred in the mixed-group condition accounted for their worse postintervention scores , findings consistent with the deviancy training hypothesis",
"BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes",
"OBJECTIVE To evaluate the efficacy of a behavioral psychosocial treatment integrated across home and school ( Child Life and Attention Skills Program ) with attention-deficit/hyperactivity disorder ( ADHD ) predominantly inattentive type ( ADHD-I ) . METHOD Sixty-nine children ages 7 to 11 years were r and omized to the Child Life and Attention Skills Program or a control group who did not receive the intervention . We compared groups posttreatment and at 3- to 5-month follow-up on parent and teacher ratings of inattention , sluggish cognitive tempo , and functional impairment . RESULTS Children r and omized to the Child Life and Attention Skills Program were reported to have significantly fewer inattention and sluggish cognitive tempo symptoms , and significantly improved social and organizational skills , relative to the control group . Gains were maintained at follow-up . CONCLUSIONS Behavioral psychosocial treatment , when specifically adapted for ADHD-I and coordinated among parents , teachers , and children , appears efficacious in reducing symptoms and impairment associated with",
"Families of 99 children with early-onset conduct problems , aged 4 - 8 years , were r and omly assigned to a child training treatment group ( CT ) utilizing the Incredible Years Dinosaur Social Skills and Problem Solving Curriculum or a waiting-list control group ( CON ) . Post-treatment CT children had significantly fewer externalizing problems at home , less aggression at school , more prosocial behavior with peers , and more positive conflict management strategies than CON children . Significantly more CT than CON children showed clinical ly significantly improvements on reports and independent observations of aggressive and noncompliant behavior . The differential treatment response was evaluated according to child comorbidity with attention deficit hyperactivity disorder ( ADHD ) , parenting discipline practice s. and family risk factors . The only risk factor related to failure to make improvements in child conduct problems after treatment was negative parenting ( i.e. , maternal critical statements and physical force ) . The long-term follow-up 1 year later indicated that most of the significant post-treatment changes were maintained",
"As part of the behavioral treatment in the Multimodal Treatment Study of Children with ADHD ( MTA ) , children participated in an intensive summer treatment program ( STP ) . This study examined the differences between 57 children in the combined treatment ( Comb ) group , who were medicated , and 60 children in the behavioral treatment ( Beh ) group , who were unmedicated throughout the STP . Comb children were significantly better than Beh on 5 measures : rule following , good sportsmanship , peer negative nominations , and STP teacher posttreatment ratings of inattention/overactivity . Groups did not differ on any of the other 30 measures , and responded similarly to the STP over time . Comparisons to normative data revealed that Comb children were more likely to fall within the normative range on 6 measures . The differences between these results and the main MTA results , in which Comb was always superior to Beh , are discussed in terms of the relative intensity of combined treatments . The implication s for future studies of pharmacological and behavioral treatment for ADHD are discussed",
"Abstract Background The meaning of different components within a multimodal treatment of ADHD remains to be further clarified . Objective To evaluate the effectiveness of behaviour therapy and drug treatment within an adaptive and individually tailored multimodal treatment for children with ADHD . Method After an initial psychoeducation n = 75 school-children aged 6–10 years with a diagnosis of ADHD/HKD were assigned to either behaviour therapy ( including continued psychoeducation ) or medical management with methylpheni date plus psychoeducation . Depending on the effectiveness , the treatment was either terminated ( if totally effective ) with long – term aftercare and continuation of medication if needed , or ( if partially effective ) the other treatment component was added ( combined treatment ) , or ( if ineffective ) the treatment components were replaced . Thus a treatment rationale was applied which result ed in an adaptive and individually tailored therapy – similar to a strategy that may be useful in clinical practice . Results Of the children who started with behaviour therapy after initial psychoeducation 26 % received a combined treatment in later treatment stages . In most of the cases ( 82 % ) with initial medical management , behaviour therapy was added . ADHD symptoms , individually defined behaviour problems and comorbid symptoms were significantly reduced during the course of treatment . On core measures large pre – post effect sizes were found . On teacher ratings combined treatment was more effective than behaviour therapy . Conclusions Both , behaviour therapy and combined treatment are effective interventions within an adaptive and individually tailored multimodal treatment strategy",
"OBJECTIVE Accumulating evidence highlights the importance of using psychosocial approaches to intervention for children with attention-deficit/hyperactivity disorder ( ADHD ) that target the family and school , as well as the intersection of family and school . This study evaluated the effectiveness of a family-school intervention , Family-School Success ( FSS ) , design ed to improve the family and educational functioning of students in Grade s 2 - 6 who meet criteria for ADHD combined and inattentive types . Key components of FSS were conjoint behavioral consultation , daily report cards , and behavioral homework interventions . METHOD FSS was provided over 12 weekly sessions , which included 6 group sessions , 4 individualized family sessions , and 2 school-based consultations . Participating families were given the choice of placing their children on medication ; 43 % of children were on medication at the time of r and om assignment . Children ( n = 199 ) were r and omly assigned to FSS or a comparison group controlling for non-specific treatment effects ( Coping With ADHD Through Relationships and Education [ CARE ] ) . Outcomes were assessed at post-intervention and 3-month follow-up . The analyses controlled for child medication status . RESULTS FSS had a significant effect on the quality of the family-school relationship , homework performance , and parenting behavior . CONCLUSIONS The superiority of FSS was demonstrated even though about 40 % of the participants in FSS and CARE were on an optimal dose of medication and there were significant time effects on each measure . This relatively brief intervention produced effect sizes comparable to those of the more intensive Multimodal Treatment Study of Children With ADHD ( MTA ) behavioral intervention",
"Objective To investigate the effects of social-skills training and parental training programme for children with attention deficit hyperactivity disorder ( ADHD ) . Methods We conducted a r and omized two-armed , parallel group , assessor-blinded superiority trial consisting of social-skills training plus parental training and st and ard treatment versus st and ard treatment alone . A sample size calculation showed at least 52 children should be included for the trial with follow up three and six months after r and omization . The primary outcome measure was ADHD symptoms and secondary outcomes were social skills and emotional competences . Results 56 children ( 39 boys , 17 girls , mean age 10.4 years , SD 1.31 ) with ADHD were r and omized , 28 to the experimental group and 27 to the control group . Mixed-model analyses with repeated measures showed that the time course ( y = a + bt + ct2 ) of ADHD symptoms ( p = 0.40 ) , social skills ( p = 0.80 ) , and emotional competences ( p = 0.14 ) were not significantly influenced by the intervention . Conclusions Social skills training plus parental training did not show any significant benefit for children with attention deficit hyperactivity disorder when compared with st and ard treatment . More and larger r and omized trials are needed . Trial Registration Clinical Trials.gov",
"The impact of the Fast Track intervention on externalizing disorders across childhood was examined . Eight hundred-ninety-one early-starting children ( 69 % male ; 51 % African American ) were r and omly assigned by matched sets of schools to intervention or control conditions . The 10-year intervention addressed parent behavior-management , child social cognitive skills , reading , home visiting , mentoring , and classroom curricula . Outcomes included psychiatric diagnoses after grade s 3 , 6 , 9 , and 12 for conduct disorder , oppositional defiant disorder , attention deficit hyperactivity disorder , and any externalizing disorder . Significant interaction effects between intervention and initial risk level indicated that intervention prevented the lifetime prevalence of all diagnoses , but only among those at highest initial risk , suggesting that targeted intervention can prevent externalizing disorders to promote the raising of healthy children",
"One of the least documented \" known \" effects of methylpheni date in hyperactive children is the suppression of peer aggression . In this study , 11 aggressive-hyperactive children received a low ( 0.3 mg/kg ) and moderate ( 0.6 mg/kg ) dose of methylpheni date and placebo for 2 weeks each under double-blind conditions . Children were observed in public school setting s during classroom seatwork activities , lunch , and recess . Results showed that methylpheni date suppressed nonphysical aggression ( p = 0.06 ) in the classroom , and a moderate dose decreased physical aggression ( p less than 0.01 ) and verbal aggression ( p = 0.07 ) on the playground . The effect on the rate of appropriate social interaction was variable . The majority of subjects exhibited either the same or higher levels of appropriate social interaction on the 0.6 mg/kg dose compared with placebo . In the classroom , both doses of methylpheni date also result ed in reduced levels of motor movement , off-task behavior , noncompliance , and disruptiveness . Teacher ratings of hyperactivity and conduct problem symptoms revealed drug effects , whereas parallel parent instruments did not",
"Parent-report of child homework problems was examined as a treatment outcome variable in the MTA – Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder ( ADHD ) . Five hundred seventy-nine children ages 7.0 to 9.9 were r and omly assigned to either medication management , behavioral treatment , combination treatment , or routine community care . Results showed that only participants who received behavioral treatment ( behavioral and combined treatment ) demonstrated sustained improvements in homework problems in comparison to routine community care . The magnitude of the sustained effect at the 10-month follow-up assessment was small to moderate for combined and behavioral treatment over routine community care ( d = .37 , .40 , respectively ) . Parent ratings of initial ADHD symptom severity was the only variable found to moderate these effects",
"Background : Several parent training programmes and behavioural teacher training programmes built on learning theory have been developed for problem prevention and treatment of attention-deficit/hyperactivity disorder ( ADHD ) and /or oppositional defiant disorder ( ODD ) during the last few decades . Group format has often been used for parent training but single-subject design s are more common in teacher training . More studies have focussed on pre-school children than on older children , and a minority have been conducted in public mental health setting s. Aim : This study aim ed to evaluate a combined parent and teacher manual-based group training programme for children with ADHD conducted by the staff at a child and adolescent psychiatric clinic in Sweden . Method : The intervention was a modified version of Barkley 's programme . Children were r and omized to an Intervention or a Control group . Sixty-one parents and 68 teachers answered questions about ADHD and ODD symptoms , and about behavioural problems when the study started and at a 3-month follow-up . Results : Results showed that the intervention result ed in a reduction of the number of children who met DSM-IV criteria for ADHD and /or ODD . Effects were more pronounced in the home setting than in the school setting , and were further accentuated when both parents and teachers of the same child took part in the intervention . Teachers with more problematic classroom situations benefited most from the intervention . Conclusion : The programme , “ Strategies in Everyday Life ” , has , in a regular clinical setting , demonstrated promising effects on children 's disruptive behaviour , and a clinical implication was to recommend involving both parents and teachers in the programme",
"Using a within-subject design and both high- and low-interest tasks , this study examined the effects of reward ( R ) , response cost ( RC ) , and no contingency ( NR ) on performance and motivation of 22 children with attention deficit-hyperactivity disorder ( ADHD ) and 22 controls . Dependent variables included performance measures , self-rated performance and motivation , and a new measure of behavioral motivation based on a 2-min postcontingency task . Both contingencies benefited some aspects of the performance of ADHD children ; relative to R , RC showed stronger effects but at the expense of decreased self-rated motivation on the low-interest task . The performance of controls did not differ across tasks , whereas ADHD children performed relatively better on the high-interest task . Neither contingency decreased motivation measures relative to NR for either group . For ADHD children , motivational effects appeared to be influenced by self-perceptions of performance",
"The effectiveness of brief social skills training ( SST ) was evaluated in a controlled outcome study with 27 children meeting criteria of the Diagnostic and Statistical Manual of Mental Disorders ( 3rd ed . , revised ; American Psychiatric Association , 1987 ) for an attention deficit disorder . Children were r and omly assigned to either SST with parent-mediated generalization ( SST-PG ) , child-only SST , or a wait-list control group . SST consisted of 8 group sessions in which skill modules were taught sequentially . Parents of children in the SST-PG group simultaneously participated in group generalization training design ed to support their children 's transfer of skills . Significant improvement in children 's skill knowledge and in parent reports of social skills and disruptive behavior occurred for both treatment groups relative to the wait-list control group and maintained at a 4-month follow-up . More modest evidence was found for generalization of SST to the school setting",
"The objective of this study was to evaluate the efficacy of a multicomponent program for treating attention-deficit/hyperactivity disorder ( ADHD ) carried out by teachers in a classroom context . Dependent measures included neuropsychological tasks , behavioral rating scales for parents and teachers , direct observation of behavior in the classroom , and academic records of children with ADHD . Fifty children with ADHD participated in the study . The teachers of 29 of the 50 students were trained in the use of behavior modification techniques , cognitive behavior strategies , and instructional management strategies . The other 21 students formed the control group . Parents ' and teachers'ratings detected improvements in primary symptoms ( inattention — disorganization , hyperactivity — impulsivity ) and in behavioral difficulties usually associated with ADHD ( e.g. , antisocial behavior , psychopathological disorders , anxiety ) . Furthermore , the results showed increased academic scores , enhanced classroom behavioral observations , and improved teachers ' knowledge about the strategies directed toward responding to the children 's educational needs",
"OBJECTIVE Numerous studies have examined the adolescent and young adult fate of children with attention deficit hyperactivity disorder ( ADHD ) . In marked contrast , relatively little is known about the adult outcome of these children . There have been only two controlled , prospect i ve studies of psychiatric status into adulthood . The present study was conducted to gain further underst and ing of the natural course of this common childhood condition . METHOD This was a prospect i ve follow-up of clinical ly diagnosed , white boys of average intelligence who were referred by teachers to a child psychiatric research clinic at an average age of 7.3 years . At a mean age of 24.1 years , 85 prob and s ( 82 % of the childhood cohort ) and 73 comparison subjects ( 94 % of adolescent comparison subjects ) were directly interviewed by trained clinicians who were blind to group status . RESULTS Evaluations of the prob and s and comparison subjects indicated significantly higher prevalences of antisocial personality disorder ( 12 % versus 3 % ) and nonalcohol substance abuse ( 12 % versus 4 % ) in the prob and s , whereas mood disorders ( 4 % versus 4 % ) and anxiety disorders ( 2 % versus 7 % ) were not significantly different . At adult follow-up , ADHD was rare , occurring in only 4 % of the prob and s ( no comparison subjects ) . CONCLUSIONS The results of the present study are consistent with the authors ' previously reported major findings . They strongly suggest that children with ADHD are at significantly higher risk for a specific negative course marked by antisocial and substance-related disorders",
"The objective of this study was to assess whether trials with a positive ( i.e. , statistically significant ) outcome are cited more often than negative trials . We review ed 530 r and omized clinical trials on hepato-biliary diseases published in 11 English- language journals indexed in MEDLINE from 1985 - 1996 . From each trial , we extracted the statistical significance of the primary study outcome ( positive or negative ) , the disease area , and method ological quality ( r and omization and double blinding ) . The number of citations during two calendar years after publication was obtained from Science Citation Index . There was a significant positive association between a statistically significant study outcome and the citation frequency ( beta , 0.55 , 95 % confidence interval , 0.39 - 0.72 ) . The disease area and adequate generation of the allocation sequence were also significant predictors of the citation frequency . We concluded that positive trials are cited significantly more often than negative trials . The association was not explained by disease area or method ological quality",
"Objective : This pilot study tests the feasibility and preliminary efficacy of an after-school treatment program for middle schoolers with ADHD using a r and omized clinical trial design . Method : A total of 23 students with ADHD ( 25 % female , 48 % African American ) from a large public middle school were r and omly assigned to a 10-week program or to community comparison . Manualized treatment targeted educational , social , and recreational skills , homework completion , and school and home behavior . Parents participated . Results : Recruitment and r and omization targets were easily met ( 87 % completion ) . Parent and teacher satisfaction was positive . Small to medium treatment effects result ed despite greater medication use in the control group , with improvements in functioning for the program-treated youth or absence of deterioration relative to the comparison group . Conclusion : Despite testing an abbreviated version of the after-school program ( feasibility and palatability for this intervention and modest beneficial effects on behavioral and academic outcomes . ( J. of Att . Dis . 2008 ; 12(3 ) 207 - 217",
"Eight hyperactive children were treated with a behavioral intervention focusing on teacher and parent training over a period of 5 months . Three times , before therapy and after 3 weeks and 13 weeks of intervention , children received methylpheni date during 3-week probe periods . Each week in a probe they received either a placebo , .25 mg/kg , or .75 mg/kg methylpheni date . Classroom observation of on-task behavior suggested that effectiveness of the behavioral intervention was between that of the two dosages of medication before therapy . Both dosages result ed in higher levels of on-task behavior when administered after 13 weeks of behavioral intervention than when administered before therapy . Teacher rating data showed equivalent effects of therapy and the low dosage of methylpheni date alone but a stronger effect of the high dose alone ; only the high dose result ed in improved behavior after 13 weeks of behavioral intervention . As a group , only when they received the high dose of methylpheni date after 13 weeks of behavioral intervention did children reach the level of appropriate behavior shown by nonhyperactive controls . However , this level was also reached by two children with the low dose and by one child without medication , and it was not reached by one child . The results suggest that the combination of psychostimulant medication and behavior therapy may be more effective in the short-term than either treatment alone for hyperactive children in school setting s. In addition , parent ratings and clinic observation of parent-child interactions suggested that children had improved in the home setting , high-lighting the importance of behavioral parent training in the treatment of hyperactivity",
"Objective The additional value of a short-term , clinical ly based , intensive multimodal behavior therapy to optimally titrated methylpheni date in children with attention-deficit hyperactivity disorder ( ADHD ) was investigated . Method Fifty children with ADHD ( ages 8–12 ) were r and omized to treatment of methylpheni date or treatment with methylpheni date combined with 10 weeks of multimodal behavior therapy . The multimodal behavior therapy consisted of a child and parent behavioral therapy and a teacher behavioral training . Assessment s included parent , teacher and child ratings of ADHD symptoms , oppositional and conduct behavior , social skills , parenting stress , anxiety and self-worth . Results Both treatment conditions yielded significant improvements on all outcome domains . No significant differences were found between both treatments . Conclusions No evidence was found for the additive effect of multimodal behavior therapy next to optimally titrated methylpheni date . Clinical implication sThis study does not support the expectation that optimally dosed stimulant treated children with ADHD should routinely receive psychosocial treatment to further reduce ADHD- and related symptoms",
"Evaluated efficacy of social skills training ( SST ) on children with 2 subtypes of attention deficit hyperactivity disorder ( ADHD ) . Participants were 120 children ( 30 girls , 90 boys ) , ages 8 to 12 with ADHD-Inattentive type ( ADHD-I ; n = 59 ) or Combined type ( ADHD-C ; n = 61 ) . The children were r and omly assigned within diagnosis subtype to the treatment condition ( 8 weeks of SST ) or the no-intervention control condition . SST led to greater improvements in both parent- and child-perceived assertion skills in the children with ADHD , yet did not affect the other domains of social competence . Diagnostically heterogeneous groups led to greater improvements on parent-report of their child 's cooperation and assertion abilities as well as children 's report of their own empathy skills . Diagnostically homogeneous groups led to greater decreases in externalizing behaviors at posttreatment but not at follow-up . Children with comorbid oppositional defiant disorder ( ODD ) did not benefit as much from the intervention . Children with ADHD-I improved in assertion skills more than children with ADHD-C , yet the 2 diagnostic entities did not differ in improvement levels across all other social skills",
"We evaluated whether , among hyperactive children who required maintenance stimulant treatment , cognitive training enhanced academic performance ; improved the functioning of youngsters who had only a partial behavioral response to medication ; facilitated withdrawal of stimulant treatment ; and enhanced maintenance effects of academic gains following termination of stimulants . A 16-week cognitive training program that emphasized reflective problem-solving strategies and social problem-solving skills was compared with an attention control treatment and with no training . There was virtually no evidence of efficacy of cognitive training . No significant treatment effects were obtained on academic , behavioral , and cognitive measures . Cognitive training did not improve behavior among children with residual problems , nor did it facilitate the withdrawal of medication . With placebo substitution , the overwhelming majority of children required remedication , regardless of previous exposure to cognitive training",
"OBJECTIVE To determine the behavioral , situational , and temporal effects of 4 months of methylpheni date ( MPH ) treatment for attention-deficit hyperactivity disorder ( ADHD ) . METHOD Ninety-one children with ADHD were r and omly assigned to receive either MPH ( titrated to a target dose of 0.7 mg/kg twice a day ) or a placebo . Treatment effects were investigated with measures sensitive to various behaviors ( core and associated symptoms ) , situations ( home and school ) , time periods ( morning and afternoon , after reaching the target dose , and after 4 months of treatment ) , and side effects . RESULTS MPH treatment improved symptoms of ADHD and oppositional behavior at school , both in the morning and afternoon , but not at home . Side effects ( increase in physiological and effective symptoms , lack of weight gain ) were significantly more frequent with MPH than with placebo treatment . Benefit was evident after titration , but the onset of some side effects was delayed . Side effects were reported by parents but not by teachers . CONCLUSIONS Positive effects of MPH on behavior are evident in the classroom , but with MPH given twice daily , parents do not report that MPH improves behavior at home . Greater impact on home behavior may require three times daily MPH and combined treatments",
"OBJECTIVE To test the hypothesis that intensive multimodal psychosocial intervention ( that includes academic assistance and psychotherapy ) combined with methylpheni date significantly enhances the academic performance and emotional status of children with attention-deficit/hyperactivity disorder ( ADHD ) compared with methylpheni date alone and with methylpheni date combined with nonspecific psychosocial treatment ( attention control ) . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to receive one of three treatments : ( 1 ) methylpheni date alone , ( 2 ) methylpheni date plus psychosocial treatment that included academic remediation , organizational skills training , and psychotherapy as well as parent training and counseling and social skills training , or ( 3 ) methylpheni date plus attention control treatment . Children 's function was assessed through academic testing , parent ratings of homework problems , and self-ratings of depression and self-esteem . RESULTS No advantage was found on any measure of academic performance or emotional status for the combination treatment over methylpheni date alone and over methylpheni date plus attention control . Significant improvement occurred across all treatments and was maintained over 2 years . CONCLUSIONS In stimulant-responsive young children with ADHD without learning and conduct disorders , there is no support for academic assistance and psychotherapy to enhance academic achievement or emotional adjustment . Significant short-term improvements were maintained over 2 years",
"We evaluated the efficacy of a manualized multimodal treatment program for young externalizing children . Families were assigned r and omly to an immediate 12-week parent and child treatment condition ( n = 24 ) or to a delayed-treatment condition ( n = 23 ) . Parents had high attendance , high satisfaction with treatment , and increased knowledge of behavior management principles . Relative to the waitlist condition , treatment parents reported statistically and clinical ly significant reductions in child behavior problems , improved parenting practice s ( i.e. , increased consistency , decreased power assertive techniques ) , an increased sense of efficacy , and reduced parenting stress . There was a trend toward parents improving their attitudes toward their children . In considering the process of change , we found evidence that improved parenting practice s mediated reductions in child behavior problems and that child improvements mediated changes in parent attitudes and stress . Five months following treatment , teachers reported significant improvements in child behaviors , whereas parents reported that reductions in child behavior problems and parenting stress were maintained",
"In 1992 , the National Institute of Mental Health and 6 teams of investigators began a multisite clinical trial , the Multimodal Treatment of Attention-Deficit Hyperactivity Disorder ( MTA ) study . Five hundred seventy-nine children were r and omly assigned to either routine community care ( CC ) or one of three study -delivered treatments , all lasting 14 months . The three MTA treatments-monthly medication management ( usually methylpheni date ) following weekly titration ( MedMgt ) , intensive behavioral treatment ( Beh ) , and the combination (Comb)-were design ed to reflect known best practice s within each treatment approach . Children were assessed at four time points in multiple outcome . Results indicated that Comb and MedMgt interventions were substantially superior to Beh and CC interventions for attention-deficit hyperactivity disorder symptoms . For other functioning domains ( social skills , academics , parent-child relations , oppositional behavior , anxiety/depression ) , results suggested slight advantages of Comb over single treatments ( MedMgt , Beh ) and community care . High quality medication treatment characterized by careful yet adequate dosing , three times daily methylpheni date administration , monthly follow-up visits , and communication with schools conveyed substantial benefits to those children that received it . In contrast to the overall study findings that showed the largest benefits for high quality medication management ( regardless of whether given in the MedMgt or Comb group ) , secondary analyses revealed that Comb had a significant incremental effect over MedMgt ( with a small effect size for this comparison ) when categorical indicators of excellent response and when composite outcome measures were used . In addition , children with parent-defined comorbid anxiety disorders , particularly those with overlapping disruptive disorder comorbidities , showed preferential benefits to the Beh and Comb interventions . Parental attitudes and disciplinary practice s appeared to mediate improved response to the Beh and Comb interventions",
"Twenty hyperactive 6- to 9-year-old children of normal intelligence were studied in a half-day laboratory classroom in a 2-week period baseline-treatment-reversal design for behavior modification . Under double-blind conditions half the children were placed on .3 mg/kg of Ritalin and half on placebo for the entire program . The classroom program consisted of a group period with immediate reinforcement possible , and an individual time period without immediate reinforcement possible . Behavior modification caused a significant decrease in nonattending , out-of-seat , inappropriate vocalizing and inappropriate peer interaction behavior in the group period . Fidgeting , a nontargeted behavior , was not significantly decreased during this period but did signficantly decrease as a result of medication . No other drug effects occurred during this period . During the individual period , the results were essentially reversed . There were no significant behavior modification effects observed . Significant reductions result ed from medication in all behaviors except out-of-seat and fidgeting . Behavior modification alone significantly affected the two academic measures . No significant effects were seen on the Conners Abbreviated Teacher Rating Scale . No significant interactions were noted between medication and behavior modification",
"Stimulant medication and behavioral treatments are evidence -based for children with attention-deficit/hyperactivity disorder , but the combination of the 2 treatments has been understudied . In this investigation , methylpheni date ( MPH ) was crossed with 2 levels of behavior modification ( BMOD ) in a summer treatment program . Twenty-seven children with attention-deficit/hyperactivity disorder , aged 6 - 12 , participated . Children received placebo and 3 doses of transdermal MPH ( 12.5 cm(2 ) , 25.0 cm(2 ) , and 37.5 cm(2 ) ) . BMOD was implemented on alternating weeks . Both treatments produced large and significant effects . Combined treatment was superior to either treatment alone . The effects of transdermal MPH were comparable to those found in this setting in previous studies with multiple stimulant medications and formulations . Consistent with other research , low doses of MPH -- even lower than in previous studies --yielded enhanced effects in combination with behavior modification",
"OBJECTIVE Intent-to-treat analyses of the Multimodal Treatment Study of ADHD ( MTA ) revealed group differences on attention-deficit/hyperactivity disorder symptoms ratings , with better outcome in groups of participants who were assigned the medication algorithm-medication alone ( MedMgt ) and combined (Comb)--than in those who were not-behavior modification ( Beh ) alone and community comparison ( CC ) . However , the effect size was reduced by 50 % from the end of treatment to the first follow-up . The convergence of outcomes suggests differential changes by treatment group beween 14 and 24 months , which this report explores , both for benefits of treatment and for side effects on growth . METHODS We documented reported medication use at 14- and 24-month assessment s and formed 4 naturalistic subgroups ( Med/Med , Med/NoMed , NoMed/Med , and NoMed/NoMed ) . Then we performed exploratory mediator analyses to evaluate effects of changes in medication use on 14- to 24-month change scores of effectiveness ( symptom ratings ) and growth ( height and weight measures ) . RESULTS The r and omly assigned groups with the greatest improvement at the end of the treatment phase ( Comb and MedMgt ) deteriorated during the follow-up phase , but the other 2 groups ( Beh and CC ) did not . There were no significant differences in the 14- to 24-month growth rates among the r and omly assigned groups , in contrast to significant growth suppression in the Comb and MedMgt at the end of the treatment phase . Changes in medication use mediated the 14- to 24-month change in attention-deficit/hyperactivity disorder symptom ratings : the subgroup that reported stopping medication ( Med/NoMed ) showed the largest deterioration , the subgroup that consistently reported ( Med/Med ) or never reported ( NoMed/NoMed ) medication use showed modest deterioration , and the subgroup that reported starting medication ( NoMed/Med ) showed improvement . Changes in medication use also mediated growth effects : the subgroup that consistently reported medication use ( Med/Med ) showed reduced height gain compared with the subgroup that never reported medication use ( NoMed/NoMed ) , which actually grew faster than predicted by population norms . CONCLUSION In the MTA follow-up , exploratory naturalistic analyses suggest that consistent use of stimulant medication was associated with maintenance of effectiveness but continued mild growth suppression",
"OBJECTIVE In the Multimodal Treatment Study of ADHD ( MTA ) , the effects of medication management ( MedMgt ) and behavior modification therapy ( Beh ) and their combination ( Comb ) and usual community comparison ( CC ) in the treatment of attention-deficit/hyperactivity disorder ( ADHD ) differed at the 14-month assessment as a result of superiority of the MTA MedMgt strategy ( Comb or MedMgt ) over Beh and CC and modest additional benefits of Comb over MedMgt alone . Here we evaluate the persistence of these beneficial effects 10 months beyond the 14 months of intensive intervention . METHODS Of 579 children who entered the study , 540 ( 93 % ) participated in the first follow-up 10 months after the end of treatment . Mixed-effects regression models explored possible persisting effects of the MTA medication strategy , the incremental benefits of Comb over MedMgt alone , and the possible superiority of Beh over CC on 5 effectiveness and 4 service use domains . RESULTS The MTA medication strategy showed persisting significant superiority over Beh and CC for ADHD and oppositional-defiant symptoms at 24 months , although not as great as at 14 months . Significant additional benefits of Comb over MedMgt and of Beh over CC were not found . The groups differed significantly in mean dose ( methylpheni date equivalents 30.4 , 37.5 , 25.7 , and 24.0 mg/day , respectively ) . Continuing medication use partly mediated the persisting superiority of Comb and MedMgt . CONCLUSION The benefits of intensive MedMgt for ADHD extend 10 months beyond the intensive treatment phase only in symptom domains and diminish over time",
"BACKGROUND We wanted to study the effects of amphetamine on symptoms of attention-deficit hyperactivity disorder ( ADHD ) over a longer period than has been reported in previous studies of central stimulants in this condition . METHODS Sixty-two children , aged 6 to 11 years , meeting DSM-III-R symptom criteria for ADHD participated in a parallel-group design , r and omized , double-blind , placebo-controlled study of amphetamine treatment . Treatment was not restricted to children with \" pure \" ADHD , ie , some had comorbid diagnoses . In the amphetamine group , children received active treatment for 15 months . RESULTS Amphetamine was clearly superior to placebo in reducing inattention , hyperactivity , and other disruptive behavior problems and tended to lead to improved results on the Wechsler Intelligence Scale for Children -- Revised . Treatment failure rate was considerably lower and time to treatment failure was longer in the amphetamine group . Adverse effects were few and relatively mild . CONCLUSION The results of this long-term , placebo-controlled study of the central stimulant amphetamine in the treatment of ADHD indicate that there are remaining positive effects of the drug 15 months after starting treatment",
"OBJECTIVE To describe the rationale , methodology , and sample characteristics of a dual-site treatment study ( New York and Montreal ) of children with attention-deficit/hyperactivity disorder ( ADHD ) conducted between 1990 and 1995 . The hypotheses were that ( 1 ) methylpheni date combined with comprehensive multimodal psychosocial treatment was superior to methylpheni date alone in improving multiple functions and ( 2 ) the efficacy of the psychosocial intervention result ed from its specific components and not from nonspecific treatment effects . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to methylpheni date , were r and omized for 2 years to ( 1 ) methylpheni date treatment alone ; ( 2 ) methylpheni date combined with multimodal psychosocial treatment that included parent training and counseling , academic assistance , psychotherapy , and social skills training ; or ( 3 ) methylpheni date plus attention control treatment that excluded specific aspects of the psychosocial intervention . Children were switched to single-blind placebo after 12 months ; methylpheni date was reinstituted when clinical ly indicated . Assessment s included ratings by parents , teachers , children , and psychiatrists ; school observations in academic and gym classes ; and academic performance tests . Almost 80 % of families completed the 2-year study . Companion papers present treatment effects . CONCLUSIONS A comprehensive 2-year psychosocial treatment was delivered successfully to children with ADHD and their families",
"We examined 9-month data from the 14-month NIMH Multimodal Treatment Study of Children with ADHD ( the MTA ) as a further check on the relative effect of medication ( MedMgt ) and behavioral treatment ( Beh ) for attention – deficit/hyperactivity disorder ( ADHD ) while Beh was still being delivered at greater intensity than at 14-month endpoint , and conversely as a check on the efficacy of the MTA behavioral generalization/maintenance procedures . Intention-to-treat analysis at 9 months showed essentially the same results as at 14 months , after Beh had been completely faded ; MedMgt and the combination ( Comb ) of medication and Beh were significantly superior to Beh and community care ( CC ) for ADHD and oppositional – defiant ( ODD ) symptoms , with mixed results for social skills and internalizing symptoms . All treatment-group differences examined as changes in slopes from 9 to 14 months were nonsignificant ( we found general improvement for all groups ) . Slopes from baseline to 9 months correlated highly ( r > .74 , p outcome measure ( a composite of parent- and teacher-rated ADHD and ODD symptoms ) for all groups . Findings suggest that in contrast to the hypothesized deterioration in the relative benefit of Beh between 9 and 14 months ( after completion of fading ) , the MTA Beh generalization and maintenance procedures implemented through 9 months apparently yielded continuing improvement through 14 months , with preservation of the relative position of Beh compared to other treatment strategies",
"PROBLEM What is the effectiveness of a stress-management program on self-concept , locus of control , and acquisition of appropriate coping strategies in children with attention deficit hyperactivity disorder ( ADHD ) ? METHODS Forty-two children with ADHD ( age range 9 - 12 ) were r and omly assigned to a control group , a therapist-led group , or a group in which the stress-management techniques were taught by the parents . The subjects were pre- and posttested on self-concept , locus of control , and acquisition of coping skills . FINDINGS Although there were no significant changes in any of the three groups for acquisition of coping skills , the children in the therapist-led group reported more appropriate coping strategies . CONCLUSIONS Involving parents in a cognitive-behavioral approach could improve parent-child relationships and further increase the opportunities for successful academic and social functioning",
"To eluci date processes underlying therapeutic change in a large-scale r and omized clinical trial , we examined whether alterations in self-reported parenting practice s were associated with the effects of behavioral , medication , or combination treatments on teacher-reported outcomes ( disruptive behavior , social skills , internalizing symptoms ) in children with attention-deficit hyperactivity disorder ( ADHD ) . Participants were 579 children with Combined-type ADHD , aged 7–9.9 years , in the Multimodal Treatment Study of Children with ADHD ( MTA ) . We uncovered 2 second-order factors of parenting practice s , entitled Positive Involvement and Negative/Ineffective Discipline . Although Positive Involvement was not associated with amelioration of the school-based outcome measures , reductions in Negative/Ineffective Discipline mediated improvement in children 's social skills at school . For families showing the greatest reductions in Negative/Ineffective Discipline , effects of combined medication plus behavioral treatment were pronounced in relation to regular community care . Furthermore , only in combination treatment ( and not in behavioral treatment alone ) was decreased Negative/Ineffective Discipline associated with reduction in children 's disruptive behavior at school . Here , children in families receiving combination treatment who showed the greatest reductions in Negative/Ineffective Discipline had teacher-reported disruptive behavior that was essentially normalized . Overall , the success of combination treatment for important school-related outcomes appears related to reductions in negative and ineffective parenting practice s at home ; we discuss problems in interpreting the temporal sequencing of such process- outcome linkages and the means by which multimodal treatment may be mediated by psychosocial processes related to parenting",
"To examine Swanson , Nolan , and Pelham — IV ( SNAP-IV ) psychometric properties , parent ( N = 1,613 ) and teacher ( N = 1,205 ) data were collected from a r and om elementary school student sample in a longitudinal attention deficit hyperactivity disorder ( ADHD ) detection study . SNAP-IV reliability was acceptable . Factor structure indicated two ADHD factors and an oppositional defiant disorder ( ODD ) factor . Parent and teacher scores varied by gender and poverty status ( d = .49-.56 ) but not age ; only teacher scores varied by race ( d = .25-.55 ) . Screening and diagnostic utility was evaluated with likelihood ratios ( LRs ) and posttest probabilities . Parent SNAP-IV scores above 1.2 increased probability of concern ( LR > 10 ) and above 1.8 , of ADHD diagnosis ( LR > 3 ) . Teacher hyperactivity/impulsivity scores above 1.2 and inattention scores above 1.8 increased probabilities of concern only ( LR = 4.2 and > 5 , respectively ) . Higher teacher scores for African American children and race differences in measurement models require future study",
"The Collaborative Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder ( ADHD ) , the MTA , is the first multisite , cooperative agreement treatment study of children , and the largest psychiatric/psychological treatment trial ever conducted by the National Institute of Mental Health . It examines the effectiveness of Medication vs. Psychosocial treatment vs. their combination for treatment of ADHD and compares these experimental arms to each other and to routine community care . In a parallel group design , 579 ( male and female ) ADHD children , aged 7–9 years , 11 months , were r and omly assigned to one of the four experimental arms , and then received 14 months of prescribed treatment ( or community care ) with periodic re assessment s. After delineating the theoretical and empirical rationale s for Psychosocial treatment of ADHD , we describe the MTA 's Psychosocial Treatment strategy applied to all children in two of the four experimental arms ( Psychosocial treatment alone ; Combined treatment ) . Psychosocial treatment consisted of three major components : a Parent Training component , a two-part School Intervention component , and a child treatment component anchored in an intensive Summer Treatment Program . Components were selected based on evidence of treatment efficacy and because they address comprehensive symptom targets , setting s , comorbidities , and functional domains . We delineate key conceptual and logistical issues faced by clinical research ers in design and implementation of Psychosocial research with examples of how these issues were addressed in the MTA study",
"The present investigation examined the effects of methylpheni date on impulsivity in children with attention-deficit hyperactivity disorder ( ADHD ) . A task was design ed to measure empirically the ADHD child 's proclivity to blurt out incorrect answers before giving a final and /or correct response . Twenty-six ADHD children referred for double-blind placebo-controlled assessment of medication responsiveness and 14 non-ADHD controls were given a visual search word-matching task to assess impulsive responding . An analysis of covariance showed that ADHD children on methylpheni date made fewer impulsive errors than ADHD children on placebo . The control group made fewer impulsive errors than the ADHD children in the placebo condition , but the performance of the ADHD children on medication approximated the performance of the children without ADHD . These preliminary findings suggest that the word-matching task may be a useful tool for assessing impulsive responding and determining the benefits of stimulant medication on impulsivity . ( J Child Neurol 1993;8:157 - 163 )",
"OBJECTIVE Although the combination of methylpheni date ( MPH ) and behavior modification ( BMOD ) has been advocated to enhance clinical outcome for children with attention-deficit hyperactivity disorder ( ADHD ) and comorbid disruptive disorders , few group studies have been conducted . This study evaluates the separate and incremental effects of these modalities on rating scale and observational measures in multiple setting s. METHOD Sixteen of 22 children with ADHD and comorbid disruptive disorder completed a r and omized , placebo-controlled study examining the separate and incremental effects of 2 doses of MPH and BMOD during a partial hospitalization program . Of the 6 who did not complete the study , 2 children developed significant side effects . For the 16 who did complete the study , effects were examined on measures of symptom ratings , behavioral frequencies , and stimulant side effects across program activities . RESULTS Based on alpha-adjusted analyses of variance , there were several main effects of MPH and BMOD on ADHD symptoms , oppositional behavior , and positive social behavior , with certain effects unique to each intervention and setting . One incremental effect each was found for MPH ( positive mood/behavior ) and BMOD ( negative behavior ) . MPH and BMOD were associated with few side effects . Effect sizes for each intervention showed considerable variability in clinical response . CONCLUSIONS That MPH and BMOD had certain unique main and incremental effects extends findings supporting their combination and suggests that integrated studies evaluate multiple dimensions of functioning and in novel setting s ( e.g. , home , school ) . The incorporation of other intervention components in combined treatments may be warranted to enhance clinical efficacy",
"From the Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder -- a r and omized clinical trial of 579 children ages 7 - 9 years receiving 14 months of medication management , behavioral treatment , combination , or community care -- the authors matched each African American and Latino participant with r and omly selected Caucasian participants of same sex , treatment group , and site . Although Caucasian children were significantly less symptomatic than African American and Latino children on some ratings , response to treatment did not differ significantly by ethnicity after controlling for public assistance . Ethnic minority families cooperated with and benefited significantly from combination ( multimodal ) treatment ( d = 0.36 , compared with medication ) . This incremental gain withstood statistical control for mother 's education , single-parent status , and public assistance . Treatment for lower socioeconomic status minority children , especially if comorbid , should combine medication and behavioral treatment",
"OBJECTIVE To evaluate the effects of atomoxetine alone and in combination with behavior therapy on the school functioning of children with attention-deficit/hyperactivity disorder ( ADHD ) . Most atomoxetine studies have not assessed school functioning other than by measuring the change in ADHD symptoms . Combining behavior therapy with atomoxetine may be particularly beneficial for the academic domain as medication has not been found to produce sustained benefits in this realm . However , there is little research examining the effects of combining atomoxetine and behavior therapy . METHOD In an 8-week open-label trial , 56 children aged 6 - 12 years with ADHD diagnosed according to DSM-IV-TR were r and omly assigned to receive atomoxetine and behavior therapy or atomoxetine alone . Behavior therapy consisted of an 8-week parenting course , a child social skills course , and a teacher-implemented daily report card of classroom behavior . The primary outcome was direct observation of the subject 's classroom behavior . Secondary outcomes included change in ADHD symptoms and functioning at home and school . All data were collected between March 2007 and May 2008 . RESULTS Classroom observations showed that atomoxetine decreased rule violations ( P atomoxetine was associated with significant improvements in ADHD and oppositional defiant disorder symptoms at home and school and enhanced functioning in both domains ( Impairment Rating Scale : all P parent-rated symptoms of inattention ( P problem behaviors ( P academic impairment ( P Atomoxetine improved ADHD symptoms and classroom functioning as measured by parents , teachers , and direct observation . The addition of behavior therapy led to further improvements at home but not at school . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00918567",
"ABSTRACT . The objective of this study was to evaluate the effectiveness of an 8-week behavioral and social skill ( BSS ) class for children newly diagnosed with attention-deficit hyperactivity disorder ( ADHD ) and their parents , initiating stimulant treatment in primary care . The subjects were 100 children , aged 5 to 12 years , recently diagnosed with ADHD and treated with stimulant medication , and their parents or guardians . Eligible families were r and omly assigned to an intervention group ( IG : n = 59 ) or control group ( CG : n = 41 ) . The BSS function of each child was assessed using DuPaul ’s ADHD Parent Rating Scale ( 18-item ) and Child Attention Profile ( 12-item ) during blinded baseline and follow-up interviews . Parent discipline practice was assessed using a five-item inventory based on Likert-scale ratings during identical periods . Computerized pharmacy records were used to track psychostimulant use over time . IG children exhibited significantly lower parent-rated ADHD symptoms , whereas IG parents reported significantly better and more consistent discipline practice s compared with CG parents across time . No significant differences were found between groups in Child Attention Profile scores across time . Psychostimulant use did not significantly differ between groups across time . BSS training was well accepted and seemed to significantly improve BSS functioning among IG children in the home setting only",
"Published evidence suggests that aspects of trial design lead to biased intervention effect estimates , but findings from different studies are inconsistent . This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses containing 1973 trials . Outcome measures were classified as \" mortality , \" \" other objective , \" \" or subjective , \" and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity . Intervention effect estimates seemed to be exaggerated in trials with inadequate or unclear ( vs. adequate ) r and om-sequence generation ( ratio of odds ratios , 0.89 [ 95 % credible interval { CrI } , 0.82 to 0.96 ] ) and with inadequate or unclear ( vs. adequate ) allocation concealment ( ratio of odds ratios , 0.93 [ CrI , 0.87 to 0.99 ] ) . Lack of or unclear double-blinding ( vs. double-blinding ) was associated with an average of 13 % exaggeration of intervention effects ( ratio of odds ratios , 0.87 [ CrI , 0.79 to 0.96 ] ) , and between-trial heterogeneity was increased for such studies ( SD increase in heterogeneity , 0.14 [ CrI , 0.02 to 0.30 ] ) . For each characteristic , average bias and increases in between-trial heterogeneity were driven primarily by trials with subjective outcomes , with little evidence of bias in trials with objective and mortality outcomes . This study is limited by incomplete trial reporting , and findings may be confounded by other study design characteristics . Bias associated with study design characteristics may lead to exaggeration of intervention effect estimates and increases in between-trial heterogeneity in trials reporting subjectively assessed outcomes"
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BACKGROUND The results obtained from previous trials regarding the effects of vitamin D supplementation on muscle strength and mobility in postmenopausal women have been inconsistent . This systematic review and meta- analysis of r and omised controlled trials ( RCTs ) aim ed to investigate the effect of vitamin D supplementation on muscle strength and mobility in postmenopausal women . METHODS A comprehensive search on EMBASE , PubMed , MEDLINE and SCOPUS was performed to identify relevant articles published up to 28 March 2019 . RCTs published in English measuring the effect of all forms and doses of vitamin D supplementation with or without calcium on muscle strength and mobility outcomes in postmenopausal women were included . RESULTS In total , 29 eligible studies were included in the systematic review . The pooled findings using a r and om effects model showed that vitamin D supplementation insignificantly increased h and grip strength ( HGS ) as the measurement of muscle strength ( MD = 0.656 ; 95 % confidence interval = -0.037 to 1.350 , P = 0.06 ) . However , it did not affect timed-up- and -go ( TUG ) as the measurement of mobility ( MD = 0.118 ; 95 % confidence interval = -0.655 to 0.892 , P = 0.76 ) . The subgroup analyses showed that vitamin D supplementation improved HGS with respect to dosages > 1000 IU day- 1 ( P = 0.016 ) , a treatment duration of 3 months ( P ˂ 0.001 ) and subjects with baseline vitamin D demonstrates that vitamin D supplementation result ed in small but nonsignificant improvements in muscle strength compared to control in postmenopausal women . No significant effect was observed in mobility after vitamin D administration
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"Summary Fall prevention is a key strategy for reducing osteoporotic fractures . We investigated the association between vitamin D receptor ( VDR ) polymorphisms and reported falls in postmenopausal women . Bsm1 polymorphisms were associated with falls , balance and muscle power measurements . These results may explain some of the excess fracture risk associated with VDR in some studies . Introduction Fall prevention is a key strategy for reducing osteoporotic fractures . It has been suggested that vitamin D supplementation may reduce the incidence of falls by reducing body sway and increasing muscle power . The vitamin D receptor gene is a well-studied c and i date gene for osteoporosis . We investigated the association between VDR polymorphisms and reported falls in postmenopausal women . Methods Falls data were collected in two separate population cohorts . Five polymorphisms of the VDR gene were analysed ( Cdx-2 , Fok-1 , BsmI , Taq1 and Apa1 ) in the Aberdeen Prospect i ve Osteoporosis Screening Study ( APOSS ) cohort . Results found in APOSS were then vali date d in an independent cohort — the Osteoporosis and Ultrasound ( OPUS ) study ( Bsm1 and Fok1 only ) , where muscle power and balance were also measured . Results Carriers of the ‘ B ’ allele ( Bsm1 ) showed an increased risk for falls . In APOSS , this was statistically significant for visit 3 multiple falls ( p = 0.047 ) and for recurrent falls ( p = 0.043 ) . Similar results were found in OPUS for visit 1 falls ( p = 0.025 ) and visit 1 multiple falls ( p = 0.015 ) . Bsm1 polymorphisms were also associated with balance and muscle power measurements . Conclusions In conclusion , these results demonstrate an association between the Bsm1 polymorphism and risk of falling that may explain some of the excess fracture risk associated with VDR in some studies",
"Summary The present study investigates the effects of vitamin D on muscle function in postmenopausal women . It has been shown that vitamin D supplementation in postmenopausal women with hypovitaminosis D provides significant protective factor against sarcopenia , with significant increases in muscle strength and control of progressive loss of lean mass . Introduction We aim ed to evaluate the effect of supplementation of vitamin D ( VITD ) alone on muscle function in younger postmenopausal women . Methods In this double-blind , placebo-controlled clinical trial , 160 Brazilian postmenopausal women were r and omized into two groups : VITD group consisting of patients receiving vitamin D3 1000 IU/day orally ( n = 80 ) or placebo group ( n = 80 ) . Women with amenorrhea for more than 12 months and age 50–65 years , with a history of falls ( previous 12 months ) , were included . The intervention time was 9 months , with assessment s at two points , start and end . Lean mass was estimated by total-body dual-energy X-ray absorptiometry ( DXA ) and muscle strength by h and grip strength and chair rising test . The plasma concentrations of 25-hydroxyvitamin D [ 25(OH)D ] were measured by high-performance liquid chromatography ( HPLC ) . Statistical analysis was by intention to treat ( ITT ) , using ANOVA , Student ’s t test , and Tukey ’s test . Results After 9 months , average values of 25(OH)D increased from 15.0 ± 7.5 to 27.5 ± 10.4 ng/ml ( + 45.4 % ) in the VITD group and decreased from 16.9 ± 6.7 to 13.8 ± 6.0 ng/ml ( −18.5 % ) in the placebo group ( p VITD group , there was significant increase in muscle strength ( + 25.3 % ) of the lower limbs by chair rising test ( p = 0.036 ) . In women in the placebo group , there was considerable loss ( −6.8 % ) in the lean mass ( p = 0.030 ) . Conclusion The supplementation of vitamin D alone in postmenopausal women provided significant protective factor against the occurrence of sarcopenia , with significant increases in muscle strength and control of progressive loss of lean mass",
"AIM To determine the effect of alfacalcidol on muscle strength and functional mobility in Indonesian older women whose h and grip strength was low . METHODS A r and omized , double-blind controlled trial was carried out among 95 older women whose h and grip strength was ≤22 kg . Participants were r and omized into two groups : 47 participants received alfacalcidol 0.5 μg/day and 48 participants received a placebo . Each participant in both groups was given calcium 500 mg/day . H and grip strength as well as the Timed-Up and Go test were measured before and after 90 days of intervention . Per protocol analysis after intervention between two groups was carried out . RESULTS There was a significant improvement of h and grip strength in the group that received alfacalcidol compared with the placebo group ( 15.50 vs 13.75 ; P = 0.003 ) . The median time for the Timed-Up and Go test in the alfacalcidol group also improved significantly compared with the placebo group ( 9.01 vs 10.07 , P = 0.028 ) . CONCLUSIONS Alfacalcidol with daily doses of 0.5 μg significantly improved muscle strength and functional mobility in Indonesian older women . Geriatr Gerontol Int 2018 ; 18 : 434 - 440",
"Abstract Aim : To observe the efficacy and safety of Rocaltrol ( calcitriol ) and /or Caltrate D ( calicum carbonate plus vitamin D ) in elderly Chinese women with osteopenia or osteoporosis . Methods : One hundred fifty Chinese women aged over 65 years with osteopenia or osteoporosis from three centers were r and omly divided into two groups . Seventy-six participants received Caltrate D as one pill daily ; the other 74 participants received 0.25 μg Caltrate D plus Rocaltrol daily . The changes in bone mineral density ( BMD ) served as primary end-points . Height changes , the presence of new vertebral fractures , muscle strength and balance were evaluated . Results : The following are the mean percentage changes ( and SD ) in BMD over 12 months : at L2-L4 , 0.83±3.88 in the Caltrate D group and 2.84±4.04 in the Rocaltrol+Caltrate D group ( P=0.003 , by ANCOVA ) ; at the femoral neck , 0.04±3.94 in the Caltrate D group and 2.01±5.45 in the Rocaltrol+Caltrate D group ( P=0.085 , by ANCOVA ) ; and in the trochanter , 1.59±4.57 in the Caltrate D group and 3.76±6.25 in the Rocaltrol+Caltrate D group ( P=0.053 , by ANCOVA ) . The st and and maximal forward reach test ( SMFRT ) was significantly enhanced in both groups during the 12 months of treatment , but no significant differences were found between these two groups . No severe adverse event related to these medications occurred throughout the study . Conclusion : Treatment with Rocaltrol plus Caltrate D or Caltrate D for 12 months in elderly Chinese postmenopausal women effectively increased BMD at the lumbar spine . Rocaltrol plus Caltrate D was more effective at the lumbar spine than Caltrate D alone ",
"Objective The aim of this study was to investigate the additive effect of the active form of vitamin D3 on the gain in back extensor strength through a back extensor exercise . Design A total of 107 postmenopausal women with osteoporosis were r and omly divided into two groups : the D3 group and the control group . Both groups were treated with calcium and alendronate and undertook the back extensor exercise . Alfacalcidol was prescribed only to the D3 group . Results There was no significant difference in the demographic data between the two groups . Ninety-four participants who completed a 4-mo intervention were subjected to per- protocol analysis . There was no significant difference in the improvement in back extensor strength between two the groups ( P = 0.349 ) . All subjects were further categorized into two subgroups by age . In the older subgroup ( ≥68 yrs ) , no significant difference was found in the improvement in back extensor strength ( P = 0.316 ) . In the younger subgroup ( , the back extensor strength in the D3 group was significantly more improved than in the control group ( P = 0.034 ) . Conclusions The results of this study suggest that the administration of the active form of vitamin D3 enhances the beneficial effects of the back extensor exercise in patients younger than those in their late 60s",
"Aim : To investigate the effects of calcium and vitamin D supplementation on bone turnover marker levels , muscle strength and quality of life in postmenopausal Chinese women . Methods : A total of 485 healthy postmenopausal Chinese women ( 63.44±5.04 years ) were enrolled in this open-label , 2-year , prospect i ve , community-based trial . The participants were divided into group A , B , C , which were treated with calcium ( 600 mg/d ) alone , calcium ( 600 mg/d ) and cholecalciferol ( 800 IU/d ) or calcium ( 600 mg/d ) and calcitriol ( 0.25 μg/d ) , respectively , for 2 years . Serum levels of 25-hydroxyvitamin D , parathyroid hormone , β-CTX and P1NP were measured , and the muscle strength and quality of life were assessed at baseline and at 12- and 24-month follow-ups . Results : Four hundred and sixty one participants completed this study . Serum levels of 25-hydroxyvitamin D were significantly increased in group C , but not changed in groups A and B at 24-month follow-up . Serum levels of parathyroid hormone , bone turnover marker β-CTX and bone formation marker P1NP were significantly decreased in group C , while serum levels of β-CTX were increased in group A at 24-month follow-up . The participants in group C maintained the grip strength , while those in groups A and B exhibited decreased grip strength at 24-month follow-up . The quality of life for the participants in groups B and C remained consistent , but that in group A was deteriorated at 24-month follow-up . Conclusion : Supplementation with calcitriol and calcium modifies the bone turnover marker levels , and maintains muscle strength and quality of life in postmenopausal Chinese women , whereas supplementation with cholecalciferol and calcium prevents aging-mediated deterioration in quality of life",
"Background and aims : Insufficient vitamin D status , commonly found in older people , has been associated with muscle weakness which , in old age , impairs mobility and is a risk factor for falling . In a r and omized , double-blind placebo-controlled trial , we tested the hypothesis that vitamin D + calcium supplementation improves muscle strength and mobility , compared with calcium mono-therapy in vitamin D-insufficient female geriatric patients . Methods : Seventy female geriatric patients > 65 years of age with serum 25-hydroxyvitamin D3 ( 25OHD ) concentrations between 20 and 50 nmol/L , visiting an outpatient geriatric department , were included . Participants received either cholecalciferol 400 IU/day + calcium 500 mg/day ( D/Cal group ) or a placebo + calcium 500 mg/day ( Plac/Cal group ) for 6 months . At baseline and 6 months , muscle strength , power and functional mobility were tested . Results : At baseline , 25OHD was significantly ( p with knee extension strength ( r=0.42 ) , h and grip strength ( r=0.28 ) , leg extension power ( r=0.34 ) , Timed Get Up and Go ( r=−0.31 ) and Modified Cooper test ( r=0.44 ) . At 6 months , a significant difference in 25OHD ( 77.2 vs 41.6 nmol/L , p and 1,25OHD was found between the two groups . Significantly improving vitamin D status in the D/Cal group compared with the Plac/Cal group did not result in a significant difference in strength or functional mobility between the two groups . Conclusions : Daily 400IU vitamin D + 500 mg calcium supplementation is not enough to significantly improve strength or mobility in vitamin D-insufficient female geriatric patients",
"Sarcopenia and osteoporosis represent a growing public health problem . We studied the potential benefit of whole-body vibration ( WBV ) training given a conventional or a high dose of daily vitamin D supplementation in improving strength , muscle mass , and bone density in postmenopausal women . In a 2 × 2 factorial- design trial , 113 institutionalized elderly females aged over 70 years ( mean age 79.6 years ) were r and omly assigned either to a WBV or a no-training group , receiving either a conventional dose ( 880 IU/day ) or a high dose ( 1600 IU/day ) of vitamin D(3 ) . The primary aim was to determine the effects of 6 months of WBV and /or vitamin D supplementation on isometric and dynamic strength , leg muscle mass , and hip bone mineral density ( BMD ) . Additionally , the increase in 25-hydroxyvitamin D [ 25(OH)D ] levels between conventional and high-dose supplementation was compared . After 6 months of treatment , dynamic muscle strength , hip BMD , and vitamin D serum levels improved significantly in all groups , whereas isometric strength and muscle mass did not change . When compared with no training , the WBV program did not result in additional improvements . When compared with 880 IU , a high dose of 1600 IU of vitamin D did result in higher serum vitamin D levels but did not result in additional improvements . In institutionalized women older than 70 years , the WBV training protocol tested is not more efficient in enhancing muscle mass , strength , and hip BMD compared with vitamin D supplementation . A higher dose of 1600 IU of vitamin D does not provide additional musculoskeletal benefit in this population compared with conventional doses",
"Daily vitamin D in addition to calcium supplementation reduces falls and fractures in older women . However , poor adherence to therapy is a common clinical problem . To examine the effects of supervised oral 3-monthly vitamin D therapy on falls , muscle strength , and mobility , we conducted a 9-month r and omized , double-blind , placebo-controlled trial in 686 community-dwelling ambulant women aged over 70 years . Participants received either oral cholecalciferol 150,000 IU every 3 months ( n = 353 ) or an identical placebo ( n = 333 ) . All participants were advised to increase dietary calcium intake . Falls data were collected 3-monthly . At baseline , 3 , 6 , and 9 months , muscle strength was measured by a h and held dynamometer and mobility by the Timed Up and Go ( TUG ) test . Serum 25 hydroxyvitamin D ( 25OHD ) was measured in a subgroup of 40 subjects . Mean age at baseline was 76.7 ± 4.1 years . The average serum 25OHD value at baseline was 65.8 ± 22.7 nmol/L. By 3 , 6 , and 9 months after supplementation , 25OHD levels of the vitamin D group were approximately 15 nmol/L higher than the placebo group . Calcium intake did not change significantly between baseline ( 864 ± 412 mg/day ) and 9 months ( 855 ± 357 mg/day ) . Faller rates in the two groups did not differ : vitamin D group , 102 of 353 ( 29 % ) ; placebo group , 89 of 333 ( 27 % ) . At 9 months , compared to placebo or baseline , muscle strength , and TUG were not altered by vitamin D. In conclusion , oral cholecalciferol 150,000 IU therapy administered 3-monthly had neither beneficial nor adverse effects on falls or physical function . These data together with previous findings confirm that intermittent large doses of vitamin D are ineffective or have a deleterious effect on falls . Thus despite adherence issues with daily vitamin D replacement , an intermittent , high-dose vitamin D regimen can not be supported as a strategy to reduce falls and fractures",
"Specific receptors for vitamin D have been identified in human muscle tissue . Cross-sectional studies show that elderly persons with higher vitamin D serum levels have increased muscle strength and a lower number of falls . We hypothesized that vitamin D and calcium supplementation would improve musculoskeletal function and decrease falls . In a double-blind r and omized controlled trial , we studied 122 elderly women ( mean age , 85.3 years ; range , 63 - 99 years ) in long-stay geriatric care . Participants received 1200 mg calcium plus 800 IU cholecalciferol ( Cal+D-group ; n = 62 ) or 1200 mg calcium ( Cal-group ; n = 60 ) per day over a 12-week treatment period . The number of falls per person ( 0 , 1 , 2 - 5 , 6 - 7 , > 7 falls ) was compared between the treatment groups . In an intention to treat analysis , a Poisson regression model was used to compare falls after controlling for age , number of falls in a 6-week pretreatment period , and baseline 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D serum concentrations . Among fallers in the treatment period , crude excessive fall rate ( treatment - pretreatment falls ) was compared between treatment groups . Change in musculoskeletal function ( summed score of knee flexor and extensor strength , grip strength , and the timed up&go test ) was measured as a secondary outcome . Among subjects in the Cal+D-group , there were significant increases in median serum 25-hydroxyvitamin D ( + 71 % ) and 1,25-dihydroxyvitamin D ( + 8 % ) . Before treatment , mean observed number of falls per person per week was 0.059 in the Cal+D-group and 0.056 in the Cal-group . In the 12-week treatment period , mean number of falls per person per week was 0.034 in the Cal+D-group and 0.076 in the Cal-group . After adjustment , Cal+D-treatment accounted for a 49 % reduction of falls ( 95 % CI , 14 - 71 % ; p crude average number of excessive falls was significantly higher in the Cal-group ( p = 0.045 ) . Musculoskeletal function improved significantly in the Cal+D-group ( p = 0.0094 ) . A single intervention with vitamin D plus calcium over a 3-month period reduced the risk of falling by 49 % compared with calcium alone . Over this short-term intervention , recurrent fallers seem to benefit most by the treatment . The impact of vitamin D on falls might be explained by the observed improvement in musculoskeletal function",
"Summary In this double-blind RCT , 4-month treatment with calcifediol compared with vitamin D3 improved gait speed by 18 % among young postmenopausal women . Consistently , change in 25(OH)D blood levels over time were significantly correlated with improvement in gait speed in these women . No effect could be demonstrated for trunk sway . Introduction The aim of this study is to test the effect of calcifediol compared with vitamin D3 on gait speed and trunk sway . Methods Twenty healthy postmenopausal women with an average 25(OH)D level of 13.2 ng/ml ( SD = ±3.9 ) and a mean age of 61.5 years ( SD = ±7.2 ) were r and omized to either 20 μg of calcifediol or 20 μg ( 800 IU ) of vitamin D3 per day in a double-blind manner . At baseline and at 4 months of follow-up , the same physiotherapist blinded to treatment allocation tested 8-m gait speed and a body sway test battery ( Sway star pitch and roll angle plus velocity while walking 8 m , and st and ing on both legs on a hard and soft surface ) . All analyses adjusted for baseline measurement , age , and body mass index . Results Mean 25(OH)D levels increased to 69.3 ng/ml ( SD = ±9.5 ) in the calcifediol group and to 30.5 ng/ml ( SD = ±5.0 ) in the vitamin D3 group ( p Women receiving calcifediol compared with vitamin D3 had an 18 % greater improvement in gait speed at 4-month follow-up ( p = 0.046 ) adjusting for baseline gait speed , age , and body mass index . Also , change in gait speed was significantly correlated with change in serum 25(OH)D concentrations ( r = 0.5 ; p = 0.04 ) . Across three tests of trunk sway , there were no consistent differences between groups and no significant correlation between change in 25(OH)D serum concentrations and change in trunk sway . Conclusions Calcifediol improved gait speed in early postmenopausal women compared with vitamin D3 and change in 25(OH)D level was moderately correlated with improvement in gait speed . A benefit on trunk sway could not be demonstrated",
"The antifracture efficacy of vitamin D in osteoporosis is due to its direct action on bones and indirect extraskeletal effects to prevent falls . Eldecalcitol is an analog of active vitamin D3 that improves bone mineral density and reduces the risk of osteoporotic fractures . However , the effects of eldecalcitol on muscle strength and static and dynamic postural balance are unclear . In this open-label r and omized controlled study , we assessed the effects of eldecalcitol on muscle strength and static and dynamic postural balance in 50 postmenopausal women ( mean age 74 years ) with osteoporosis treated with bisphosphonate . Participants were r and omly divided into a bisphosphonate group ( alendronate at 35 mg/week ; n = 25 ) or an eldecalcitol group ( eldecalcitol at 0.75 μg/day and alendronate at 35 mg/week ; n = 25 ) and were followed up for 6 months . Trunk muscle strength , including back extensor strength and iliopsoas muscle strength , was measured . Static st and ing balance was evaluated and the one leg st and ing test was performed to assess static postural balance . Dynamic sitting balance was evaluated and the 10-m walk test , functional reach test , and timed up and go test were performed to assess dynamic postural balance . At 6 months , there were no significant changes in any measure of muscle strength or balance in the bisphosphonate group , whereas eldecalcitol significantly increased back extensor strength ( p = 0.012 ) and iliopsoas muscle strength ( p = 0.035 ) . Eldecalcitol also significantly improved findings on the timed up and go test ( p = 0.001 ) and dynamic sitting balance ( p = 0.015 ) at 6 months . These results with eldecalcitol may have an impact on prevention of falls",
"Summary Vitamin D may affect skeletal muscle function . In a double-blind , r and omised , placebo-controlled trial , we found that vitamin D3 supplementation ( 400 or 1,000 I.U. vs. placebo daily for 1 year with bimonthly study visits ) does not improve grip strength or reduce falls . Introduction This study aim ed to test the supplementation effects of vitamin D3 on physical function and examine associations between overweight/obesity and the biochemical response to treatment . Methods In a parallel group double-blind RCT , healthy postmenopausal women from North East Scotl and ( latitude—57 ° N ) aged 60–70 years ( body mass index ( BMI ) , 18–45 kg/m2 ) were assigned ( computer r and omisation ) to daily vitamin D3 ( 400 I.U. ( n = 102)/1,000 I.U. ( n = 101 ) ) or matching placebo ( n = 102 ) ( 97 , 96 and 100 participants analysed for outcomes , respectively ) from identical coded containers for 1 year . Grip strength ( primary outcome ) , falls , diet , physical activity and ultraviolet B radiation exposure were measured bimonthly , as were serum 25(OH)D , adjusted calcium ( ACa ) and phosphate . Fat/lean mass ( dual energy X-ray absorptiometry ) , anthropometry , 1,25-dihydroxyvitamin D and parathyroid hormone were measured at baseline and 12 months . Participants and research ers were blinded throughout intervention and analysis . Results Treatment had no effect on grip strength ( mean change (SD)/year = −0.5 ( 2.5 ) , −0.9 ( 2.7 ) and −0.4 ( 3.3 ) kg force for 400/1,000 I.U. vitamin D3 and placebo groups , respectively ( P = .10 , ANOVA ) ) or falls ( P = .65 , chi-squared test ) . Biochemical responses were similar across BMI categories ( in serum ACa in overweight compared to non-overweight participants ( P = .01 , ANOVA ; 1,000 I.U. group ) . In the placebo group , 25(OH)D peak concentration change ( winter to summer ) was negatively associated with weight ( r = −.268 ) , BMI ( r = −.198 ) , total ( r = −.278 ) and trunk fat mass ( r = −.251 ) , with total and trunk fat mass predictive of winter to summer 25(OH)D change ( P = .01/.004 respectively , linear regression ) . Conclusion We found no evidence of an improvement in physical function following vitamin D3 supplementation for 1 year",
"IMPORTANCE Experts debate optimal 25-hydroxyvitamin D ( 25[OH]D ) levels for musculoskeletal health . OBJECTIVE To compare the effects of placebo , low-dose cholecalciferol , and high-dose cholecalciferol on 1-year changes in total fractional calcium absorption , bone mineral density , Timed Up and Go and five sit-to-st and tests , and muscle mass in postmenopausal women with vitamin D insufficiency . DESIGN , SETTING , AND PARTICIPANTS This r and omized , double-blind , placebo-controlled clinical trial was conducted at a single center in Madison , Wisconsin , from May 1 , 2010 , through July 31 , 2013 , and the final visit was completed on August 8 , 2014 . A total of 230 postmenopausal women 75 years or younger with baseline 25(OH)D levels of 14 through 27 ng/mL and no osteoporosis were studied . INTERVENTIONS Three arms included daily white and twice monthly yellow placebo ( n=76 ) , daily 800 IU vitamin D3 and twice monthly yellow placebo ( n=75 ) , and daily white placebo and twice monthly 50,000 IU vitamin D3 ( n=79 ) . The high-dose vitamin D regimen achieved and maintained 25(OH)D levels≥30 ng/mL. MAIN OUTCOMES AND MEASURES Outcome measures were 1-year change in total fractional calcium absorption using 2 stable isotopes , bone mineral density and muscle mass using dual energy x-ray absorptiometry , Timed Up and Go and five sit-to-st and tests , functional status ( Health Assessment Question naire ) , and physical activity ( Physical Activity Scale for the Elderly ) , with Benjamini-Hochberg correction of P values to control for the false discovery rate . RESULTS After baseline absorption was controlled for , calcium absorption increased 1 % ( 10 mg/d ) in the high-dose arm but decreased 2 % in the low-dose arm ( P = .005 vs high-dose arm ) and 1.3 % in the placebo arm ( P = .03 vs high-dose arm ) . We found no between-arm changes in spine , mean total-hip , mean femoral neck , or total-body bone mineral density , trabecular bone score , muscle mass , and Timed Up and Go or five sit-to-st and test scores . Likewise , we found no between-arm differences for numbers of falls , number of fallers , physical activity , or functional status . CONCLUSIONS AND RELEVANCE High-dose cholecalciferol therapy increased calcium absorption , but the effect was small and did not translate into beneficial effects on bone mineral density , muscle function , muscle mass , or falls . We found no data to support experts ' recommendations to maintain serum 25(OH)D levels of 30 ng/mL or higher in postmenopausal women . Instead , we found that low- and high-dose cholecalciferol were equivalent to placebo in their effects on bone and muscle outcomes in this cohort of postmenopausal women with 25(OH)D levels less than 30 ng/mL. TRIAL REGISTRATION clinical trials.gov Identifier : NCT00933244",
"OBJECTIVES To evaluate the effects of vitamin D treatment on muscle strength and mobility in older women with vitamin D insufficiency . DESIGN One-year population -based , double-blind , r and omized , controlled trial . SETTING Perth , Australia ( latitude 32 ° S ) . PARTICIPANTS Three hundred two community-dwelling ambulant elderly women aged 70 to 90 with a serum 25-hydroxyvitamin D ( 25(OH)D ) concentration less than 24 ng/mL. INTERVENTION Vitamin D(2 ) 1,000 IU/d or identical placebo ; calcium citrate ( 1 g calcium/d ) in both groups . MEASUREMENTS Lower limb muscle strength and mobility as assessed using the Timed Up and Go Test ( TUAG ) . RESULTS At baseline , mean ± st and ard deviation serum 25(OH)D was 17.7 ± 4.2 ng/mL ; this increased to 24.0 ± 5.6 ng/mL in the vitamin D group after 1 year but remained the same in the placebo group . For hip extensor and adductor strength and TUAG , but not for other muscle groups , a significant interaction between treatment group and baseline values was noted . In those with baseline values in the lowest tertile , vitamin D improved muscle strength and TUAG more than calcium alone ( mean ( st and ard error ) : hip extensors 22.6 % ( 9.5 % ) ; hip adductors 13.5 % ( 6.7 % ) , TUAG 17.5 % ( 7.6 % ) , P .05 ) . Baseline 25(OH)D levels did not influence patient response to supplementation . CONCLUSION Vitamin D therapy was observed to increase muscle function in those who were the weakest and slowest at baseline . Vitamin D should be given to people with insufficiency or deficiency to improve muscle strength and mobility",
"The long-term protective effect of stronger back muscles on the spine was determined in 50 healthy white postmenopausal women , aged 58 - 75 years , 8 years after they had completed a 2 year r and omized , controlled trial . Twenty-seven subjects had performed progressive , resistive back-strengthening exercises for 2 years and 23 had served as controls . Bone mineral density , spine radiographs , back extensor strength , biochemical marker values , and level of physical activity were obtained for all subjects at baseline , 2 years , and 10 years . Mean back extensor strength ( BES ) in the back-exercise ( BE ) group was 39.4 kg at baseline , 66.8 kg at 2 years ( after 2 years of prescribed exercises ) , and 32.9 kg at 10 years ( 8 years after cessation of the prescribed exercises ) . Mean BES in the control ( C ) group was 36.9 kg at baseline , 49.0 kg at 2 years , and 26.9 kg at 10 years . The difference between the two groups was still statistically significant at 10 year follow-up ( p = 0.001 ) . The difference in bone mineral density , which was not significant between the two groups at baseline and 2 year follow-up , was significant at 10 year follow-up ( p = 0.0004 ) . The incidence of vertebral compression fracture was 14 fractures in 322 vertebral bodies examined ( 4.3 % ) in the C group and 6 fractures in 378 vertebral bodies examined ( 1.6 % ) in the BE group ( chi-square test , p = 0.0290 ) . The relative risk for compression fracture was 2.7 times greater in the C group than in the BE group . To our knowledge , this is the first study reported in the literature demonstrating the long-term effect of strong back muscles on the reduction of vertebral fractures in estrogen-deficient women",
"This article summarizes the new 2011 report on dietary requirements for calcium and vitamin D from the Institute of Medicine ( IOM ) . An IOM Committee charged with determining the population needs for these nutrients in North America conducted a comprehensive review of the evidence for both skeletal and extraskeletal outcomes . The Committee concluded that available scientific evidence supports a key role of calcium and vitamin D in skeletal health , consistent with a cause- and -effect relationship and providing a sound basis for determination of intake requirements . For extraskeletal outcomes , including cancer , cardiovascular disease , diabetes , and autoimmune disorders , the evidence was inconsistent , inconclusive as to causality , and insufficient to inform nutritional requirements . R and omized clinical trial evidence for extraskeletal outcomes was limited and generally uninformative . Based on bone health , Recommended Dietary Allowances ( RDAs ; covering requirements of ≥97.5 % of the population ) for calcium range from 700 to 1300 mg/d for life-stage groups at least 1 yr of age . For vitamin D , RDAs of 600 IU/d for ages 1–70 yr and 800 IU/d for ages 71 yr and older , corresponding to a serum 25-hydroxyvitamin D level of at least 20 ng/ml ( 50 nmol/liter ) , meet the requirements of at least 97.5 % of the population . RDAs for vitamin D were derived based on conditions of minimal sun exposure due to wide variability in vitamin D synthesis from ultraviolet light and the risks of skin cancer . Higher values were not consistently associated with greater benefit , and for some outcomes U-shaped associations were observed , with risks at both low and high levels . The Committee concluded that the prevalence of vitamin D inadequacy in North America has been overestimated . Urgent research and clinical priorities were identified , including re assessment of laboratory ranges for 25-hydroxyvitamin D , to avoid problems of both undertreatment and overtreatment",
"Summary Our findings imply that simple functional tests can predict both hip fracture risk and excess mortality in postmenopausal women . Since the tests characterize general functional capacity ( one-legged stance , squatting down , and grip strength ) , these simple measures should have clinical utility in the assessment of women at risk of falls and fragility fracture . Introduction Functional impairment is associated with the risk of fall , which is the leading cause of hip fracture . We aim ed to determine how clinical assessment s of functional impairment predict long-term hip fracture and mortality . Methods A population -based prospect i ve cohort involved 2815 Caucasian women with the average baseline age of 59.1 years . The mean follow-up time in 1994–2014 was 18.3 years . Three functional tests and their combinations assessed at baseline were treated as dichotomous risk factors : ( 1 ) inability to squat down and touch the floor ( SQ ) , ( 2 ) inability to st and on one leg for 10 s ( SOL ) , and ( 3 ) having grip strength ( GS ) within the lowest quartile ( ≤ 58 kPa , mean 45.6 kPa ) . Bone mineral density ( BMD ) at the proximal femur was measured by DXA . Fractures and deaths were verified from registries . Hazard ratios were determined by using Cox proportional models . Age , body mass index ( BMI ) , and BMD were included as covariates for fracture risk estimates . Age , BMI , and smoking were used for mortality . Results Altogether , 650 ( 23.1 % ) women had 718 follow-up fractures , including 86 hip fractures . The mortality during the follow-up was 16.8 % ( n = 473 ) . Half of the women ( 56.8 % , n = 1600 ) had none of the impairments and were regarded as the referent group . Overall , women with any of the three impairments ( 43.2 % , n = 1215 ) had higher risks of any fracture , hip fracture , and death , with hazard ratios ( HR ) of 1.3 ( ( 95 % CI ) 1.0–1.5 , p for hip fracture was failing to achieve a one-leg st and for 10 s ( prevalence 7.1 % , n = 200 ) , followed by inability to squat down ( 27.0 % , n = 759 ) and weak grip strength ( 24.4 % , n = 688 ) , with their respective HRs of 4.3 ( 2.3–8.0 , p of fracture and death in postmenopausal women . Whether reversal of these impairments is associated with a reduction in adverse outcomes is an area for future trials",
"OBJECTIVES The Women 's Health Initiative ( WHI ) r and omized trial of calcium/vitamin D supplementation found reduced bone loss with active treatment compared to placebo . Now we examine whether the treatment affected self-reported physical functioning and objective measures of physical functioning . DESIGN A r and omized , double-blind , placebo-controlled trial of 1,000 mg calcium carbonate plus 400 IU vitamin D(3 ) per day or matching placebo pills . SUBJECTS/ SETTING The study included 33,067 women ( 50 to 79 years old ) at 40 US study centers . MAIN OUTCOME MEASURES Physical functioning was assessed by question naire at enrollment in WHI , 1 year prior to calcium/vitamin D trial r and omization and at study close-out ( average follow-up 7.1 years ) . Objective physical performance and self-reported exercise measures were collected at WHI baseline ( 1 year prior to calcium/vitamin D enrollment ) and 2 years and 4 years after calcium/vitamin D trial enrollment in a sub sample ( n=3,137 ) . STATISTICAL ANALYSES PERFORMED Calcium/vitamin D effects were tested in unadjusted and interaction linear models for each of the physical function measures . Covariates were baseline total calcium intake , fracture risk score , treatment arm in the hormone therapy and dietary modification trials ( ie , active drug or placebo , low-fat diet intervention or usual diet , respectively ) and age . RESULTS Neither intention to treat nor high adherence analyses produced substantial effects of calcium/vitamin D compared to placebo on physical functioning or performance . The interaction analyses also did not result in differences because of calcium/vitamin D. CONCLUSIONS As the first long-term r and omized trial to examine the effectiveness of calcium and vitamin D in protecting against decline of physical functioning in older women , the results did not support benefit",
"Vitamin D insufficiency and hyperparathyroidism have been associated with reduced muscle strength , physical performance , postural stability , well-being , and quality of life . In a double-blinded , r and omized placebo-controlled trial , we aim ed to investigate effects of vitamin D3 supplementation on above-mentioned outcomes in healthy community-dwelling postmenopausal women with plasma levels of 25-hydroxyvitamin D ( 25(OH)D ) below with vitamin D3 , 70 µg ( 2800 IU)/day or identical placebo for three months during wintertime ( 56 ° N ) . Vitamin D3 supplementation increased levels of 25(OH)D and 1,25(OH)2D by 230 % ( 95 % CI 189 to 272)% , p reduced PTH by 17 % ( − 23 to − 11 % ) , p with placebo , vitamin D3 significantly reduced maximal h and grip strength by 9 % ( − 15 to − 3 % ; p 0.01 ) and knee flexion strength by 13 % ( − 24 to − 2 % ; p = 0.02 ) and increased the time spent on performing the Timed Up and Go test by 4.4 % ; ( 0.1–8.6 % ; p did not change in response to treatment . Compared with placebo , a daily supplement with a relatively high dose of vitamin D3 had no beneficial effects on any outcomes . In some measures of muscle strength and physical performance , we even saw a small unfavorable effect . Our data call for caution on use of relatively high daily doses of vitamin D3 in the treatment of vitamin D insufficiency",
"Abstract Background : Low serum 25-hydroxyvitamin D [ 25(OH)D ] has been shown to be associated with low muscle mass and loss of muscle strength , result ing in increased disability and frailty in older men and women . Vitamin D deficiency is common in postmenopausal women . The primary objective of the present study was to evaluate the effects of vitamin D supplementation on muscle strength in early postmenopausal women . The effects of vitamin D2 supplementation on muscle mass and muscle cross-sectional area ( CSA ) were secondarily investigated . Methods : A 12-week , prospect i ve , r and omized , double-blind , placebo-controlled trial was conducted in early postmenopausal women ( 45–60 years old ) with vitamin D deficiency ( serum 25(OH)D A total of 88 subjects were r and omized into group I : vitamin D2 supplement 40 000 IU/week ( n = 44 ) , or group II : placebo ( n = 44 ) . Serum 25(OH)D level , muscle strength , muscle mass and muscle CSA were assessed at baseline and 12 weeks after the supplementation . Results : After 12 weeks of supplementation , 70 % of women in group I achieved a sufficient level of serum 25(OH)D ( > 30 ng/ml ) . There were significant differences in changes of serum 25(OH)D levels between the two groups ( p in group I increased significantly after 12 weeks ( p = 0.015 , 0.045 , respectively ) . However , there were no significant differences in the mean changes of muscle strength , muscle mass and muscle CSA between the two groups ( p = 0.16 , 0.89 , 0.84 , respectively ) . Conclusion : In this study , we found no obvious effect of vitamin D supplementation on the changes in muscle strength , muscle mass and muscle CSA when compared to placebo . However , there were significant changes in muscle strength and muscle CSA from baseline in the vitamin D supplementation group",
"Objective This study aim ed to determine the effect of calcitriol on serum concentrations of fibroblast growth factor-23 ( FGF-23 ) , sclerostin , intact parathyroid hormone ( PTH ) , and h and grip strength in postmenopausal women with low bone mass . Methods A r and omized , double-blind controlled trial was carried out among 141 postmenopausal women with low bone mass . Participants were r and omized into two groups : 75 participants received calcitriol 0.5 µg/day and 66 participants received a placebo for 12 weeks . Results After 12-week calcitriol treatment , significant decreases in serum intact PTH ( P=0.035 ) and sclerostin ( P=0.039 ) , as well as significant increases in serum creatinine ( P=0.027 ) , uric acid ( P=0.032 ) , 24-hour urinary calcium ( P=0.0026 ) , and left h and grip strength ( P=0.03 ) , were observed , compared to placebo group . Level of serum sclerostin was weakly but significantly positively correlated with serum PTH ( r=0.277 ; P=0.01 ) and negatively correlated with 24-hour urinary calcium ( r=−0.221 ; P=0.04 ) and left h and grip strength ( r=−0.338 ; P=0.03 ) after calcitriol treatment . Multiple regression analysis demonstrated that decrease in serum sclerostin was associated with decrease in PTH serum level after calcitriol treatment ( OR , 7.90 ; 95 % CI , 2.28–27.42 ; P=0.002 ) . However , no significant change in FGF-23 level was observed after calcitriol treatment . Conclusion Calcitriol treatment yields a considerable decrease in serum sclerostin and significant increase of h and grip strength , and the change in serum sclerostin is regulated by serum PTH and by muscle strength",
"Background Vitamin D inadequacy is common in institutionalized post-menopausal women who are at the highest risk for osteoporotic fracture . Aim To evaluate efficacy and safety of ergocalciferol 40,000 versus 100,000 IU per week for 12 weeks for vitamin D inadequacy in institutionalized postmenopausal women . Method A r and omized double-blinded placebo-controlled trial was conducted in 94 institutionalized subjects with baseline 25(OH)D levels Subjects were r and omized to receive ergocalciferol 40,000 ( st and ard dose ) or ergocalciferol 100,000 IU ( high dose ) per week . Serum 25(OH)D levels , calcium , phosphate , h and grip strength , time up and go ( TUG ) test and quality of life by EQ-5D-5L were measured at baseline and 12 weeks after r and omization . Results Of the 94 subjects enrolled , 85 subjects completed the study . Subjects in the high dose group had higher mean 25(OH)D levels than subjects in the st and ard group ( 51.73 ± 19.35 and 34.5 ± 9.12 , p optimal 25(OH)D levels ( > 30 ng/mL ) than those in the st and ard group ( 65.9 % ) , p = 0.007 . In a subgroup analysis of subjects with vitamin D deficiency ( optimal 25(OH)D levels than those in the st and ard group ( 88 % and 100 % versus 47.4 % and 16.7 % with p of 0.007 and 0.018 , respectively ) . There were no differences in h and grip strength , TUG , EQ-5D-5L and adverse events between groups . Discussion / conclusions Subjects who received high dose ergocalciferol achieved more optimal 25(OH)D levels than those who received st and ard dose . High dose ergocalciferol is preferred to optimize 25(OH)D levels in subjects with severe vitamin D deficiency",
"IMPORTANCE While vitamin D supplementation and exercise are recommended for prevention of falls for older people , results regarding these 2 factors are contradictory . OBJECTIVE To determine the effectiveness of targeted exercise training and vitamin D supplementation in reducing falls and injurious falls among older women . DESIGN , SETTING , AND PARTICIPANTS A 2-year r and omized , double-blind , placebo-controlled vitamin D and open exercise trial conducted between April 2010 and March 2013 in Tampere , Finl and . Participants were 409 home-dwelling women 70 to 80 years old . The main inclusion criteria were at least 1 fall during the previous year , no use of vitamin D supplements , and no contraindication to exercise . INTERVENTIONS Four study groups , including placebo without exercise , vitamin D ( 800 IU/d ) without exercise , placebo and exercise , and vitamin D ( 800 IU/d ) and exercise . MAIN OUTCOMES AND MEASURES The primary outcome was monthly reported falls . Injurious falls and the number of fallers and injured fallers were reported as secondary outcomes . In addition , bone density , physical functioning ( muscle strength , balance , and mobility ) , and vitamin D metabolism were assessed . RESULTS Intent-to-treat analyses showed that neither vitamin D nor exercise reduced falls . Fall rates per 100 person-years were 118.2 , 132.1 , 120.7 , and 113.1 in the placebo without exercise , vitamin D without exercise , placebo and exercise , and vitamin D and exercise study groups , respectively ; however , injurious fall rates were 13.2 , 12.9 , 6.5 , and 5.0 , respectively . Hazard ratios for injured fallers were significantly lower among exercisers with vitamin D ( 0.38 ; 95 % CI , 0.17 - 0.83 ) and without vitamin D ( 0.47 ; 95 % CI , 0.23 - 0.99 ) . Vitamin D maintained femoral neck bone mineral density and increased tibial trabecular density slightly . However , only exercise improved muscle strength and balance . Vitamin D did not enhance exercise effects on physical functioning . CONCLUSIONS AND RELEVANCE The rate of injurious falls and injured fallers more than halved with strength and balance training in home-dwelling older women , while neither exercise nor vitamin D affected the rate of falls . Exercise improved physical functioning . Future research is needed to determine the role of vitamin D in the enhancement of strength , balance , and mobility . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00986466",
"To test the effect of 25(OH)D(3 ) ( HyD ) compared to vitamin D(3 ) on serum 25-hydroxyvitamin D levels ( 25(OH)D ) , lower extremity function , blood pressure , and markers of innate immunity . Twenty healthy postmenopausal women with an average 25(OH)D level of 13.2 ± 3.9 ng/mL ( mean ± SD ) and a mean age of 61.5 ± 7.2 years were r and omized to either 20 µg of HyD or 20 µg ( 800 IU ) of vitamin D(3 ) per day in a double-blind manner . We measured on 14 visits over 4 months , 25(OH)D serum levels , blood pressure , and seven markers of innate immunity ( eotaxin , interleukin [IL]-8 , IL-12 , interferon gamma-induced protein 10 kDa [ IP-10 ] , monocyte chemotactic protein-1 [ MCP-1 ] , macrophage inflammatory protein beta [ MIP-1β ] , and \" Regulated upon Activation , Normal T-cell Expressed , and Secreted \" [ RANTES ] ) . At baseline and at 4 months , a test battery for lower extremity function ( knee extensor and flexor strength , timed up and go , repeated sit-to-st and ) was assessed . All analyses were adjusted for baseline measurement , age , and body mass index . Mean 25(OH)D levels increased to 69.5 ng/mL in the HyD group . This rise was immediate and sustained . Mean 25(OH)D levels increased to 31.0 ng/mL with a slow increase in the vitamin D(3 ) group . Women on HyD compared with vitamin D(3 ) had a 2.8-fold increased odds of maintained or improved lower extremity function ( odds ratio [ OR ] = 2.79 ; 95 % confidence interval [ CI ] , 1.18 - 6.58 ) , and a 5.7-mmHg decrease in systolic blood pressure ( p = 0.0002 ) . Both types of vitamin D contributed to a decrease in five out of seven markers of innate immunity , significantly more pronounced with HyD for eotaxin , IL-12 , MCP-1 , and MIP-1 β . There were no cases of hypercalcemia at any time point . Twenty micrograms ( 20 µg ) of HyD per day result ed in a safe , immediate , and sustained increase in 25(OH)D serum levels in all participants , which may explain its significant benefit on lower extremity function , systolic blood pressure , and innate immune response compared with vitamin D(3 )",
"OBJECTIVES To compare the effects of 12 months of vitamin D3 supplementation with that placebo on lean mass , bone mineral density ( BMD ) , and muscle strength in overweight or obese postmenopausal women completing a structured weight-loss program . DESIGN Double-blind , placebo-controlled r and omized clinical trial . SETTING Fred Hutchinson Cancer Research Center , Seattle , Washington . PARTICIPANTS Postmenopausal women aged 50 to 75 with a body mass index ( BMI ) of 25 kg/m(2 ) or greater and a serum 25-hydroxyvitamin D ( 25(OH)D ) concentration between 10.0 and 32.0 ng/mL ( insufficient ) ( N = 218 ) . INTERVENTION Oral vitamin D3 2,000 IU/d or placebo in combination with a lifestyle-based weight loss intervention consisting of a reduction of 500 kcal to 1,000 kcal per day and 225 min/wk of moderate- to vigorous-intensity aerobic exercise . MEASUREMENTS Serum 25(OH)D , body composition , and muscle strength were measured before r and omization ( baseline ) and at 12 months . Mean changes of the groups were compared ( intention to treat ) using generalized estimating equations . RESULTS Change in 25(OH)D was significantly different between the vitamin D and placebo groups at 12 months ( 13.6 ng/mL vs -1.3 ng/mL , P change in lean mass ( -0.8 kg vs -1.1 kg , P = .53 ) or BMD of the spine ( -0.01 g/cm(2 ) vs 0.0 g/cm(2 ) , P = .82 ) or right femoral neck ( both -0.01 g/cm(2 ) , P = .49 ) were detected between the groups . Leg strength decreased in the vitamin D group but not in the placebo group ( -2.6 pounds vs 1.8 pounds , P = .03 ) . In women r and omized to vitamin D , achieving repletion ( 25(OH)D ≥ 32 ng/mL ) did not alter results . CONCLUSION Vitamin D3 supplementation during weight-loss decreased leg strength but did not alter changes in lean mass or BMD in postmenopausal women with vitamin D insufficiency",
"CONTEXT Studies examining whether vitamin D supplementation increases muscle mass or muscle-specific vitamin D receptor ( VDR ) concentration are lacking . OBJECTIVE Our objective was to determine whether vitamin D₃ 4000 IU/d alters muscle fiber cross-sectional area ( FCSA ) and intramyonuclear VDR concentration over 4 months . DESIGN AND SETTING This was a r and omized , double-blind , placebo-controlled study in a single center . PARTICIPANTS Participants were 21 mobility-limited women ( aged ≥ 65 years ) with serum 25-hydroxyvitamin D ( 25OHD ) levels of 22.5 to 60 nmol/L. MAIN OUTCOME MEASURES Baseline and 4-month FCSA and intramyonuclear VDR were measured from vastus lateralis muscle cross-sections probed for muscle fiber type ( I/IIa/IIx ) and VDR using immunofluorescence . RESULTS At baseline , mean ( ±SD ) age was 78 ± 5 years ; body mass index was 27 ± 5 kg/m² , 25OHD was 46.3 ± 9.5 nmol/L , and a short physical performance battery score was 7.95 ± 1.57 out of 12 . At 4 months , 25OHD level was 52.5 ± 17.1 ( placebo ) vs 80.0 ± 11.5 nmol/L ( vitamin D [ VD ] ; P , and change in 25OHD level was strongly associated with percent change in intramyonuclear VDR concentration-independent of group ( r = 0.87 , P change in intramyonuclear VDR concentration was 7.8 % ± 18.2 % ( placebo ) vs 29.7 % ± 11.7 % ( VD ; P = .03 ) with a more pronounced group difference in type II vs I fibers . Percent change in total ( type I/II ) FCSA was -7.4 % ± 18.9 % ( placebo ) vs 10.6 % ± 20.0 % ( VD ; P = .048 ) . CONCLUSION Vitamin D₃ supplementation increased intramyonuclear VDR concentration by 30 % and increased muscle fiber size by 10 % in older , mobility-limited , vitamin D-insufficient women . Further work is needed to determine whether the observed effect of vitamin D on fiber size is mediated by the VDR and to identify which signaling pathways are involved"
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41171810-06ff-11f0-808a-c43d1ab1c353
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Abstract Background Prevalence of atrial fibrillation ( AF ) in patients with congenital heart disease ( CHD ) is on the rise . Anti-arrhythmic drugs are usually the first line of treatment in CHD , however , it is often ineffective and poorly tolerated . We aim ed to perform a systematic review to assess the efficacy and safety of catheter ablation for AF in CHD . Methods We performed a comprehensive search on catheter ablation for atrial fibrillation in congenital heart disease up until July 2019 through several electronic data bases . Results Ablation of AF in patients with CHD had a modest 12 months AF freedom ranging from 32.8 % to 63 % , which can be increased by subsequent/repeat ablation . The complexity of CHD appears to have a significant effect on a study but not in others . Catheter ablation in ASD and persistent left superior vena cava had a high success rate . Overall , catheter ablation is safe whichever the type of CHD is . Conclusion Catheter ablation for AF in CHD had modest efficacy that can be increased by subsequent/repeat ablation and it also has an excellent safety profile . Ablation in complex CHD could also have similar efficacy , however , it is preferably done by experts in a high volume tertiary center
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"BACKGROUND Atrial fibrillation ( AF ) is a common arrhythmia in adults with congenital heart disease ( CHD ) . Long-term antiarrhythmic therapy ( AAT ) in these patients has significant shortcomings . The safety and efficacy of pulmonary vein antrum isolation ( PVAI ) for the treatment of AF in CHD is presently unknown . HYPOTHESIS We hypothesized that PVAI for AF in patients with CHD is effective and safe . METHODS We review ed a prospect i ve cohort of 4315 patients ( age ≥ 18 ) undergoing PVAI for drug refractory AF at a single institution and identified 36 consecutive patients with CHD ( single ventricle physiology , tetralogy of Fallot , coa rct ation of the aorta , ventricular septal defects , atrial septal defects ( ASD ) and cardiomyopathy result ing from anomalous origin of the left main coronary from the pulmonary artery ) . A second cohort of 355 consecutive patients with noncongenital structural heart disease ( NSHD ) ( coronary artery disease , valvular heart disease , ejection fraction PVAI during the same time period was used as a control . Success was defined as freedom from AF starting two months after PVAI in the absence AAT until the end of follow-up . Partial success was defined as freedom from AF in the presence of AAT until the end of follow-up . Combined success was defined as the sum of success and partial success . We compared the outcomes with the use of propensity-score matching in the overall cohort . RESULTS Patients with NSHD were older and had higher prevalence of hypertension ( P , success was achieved in 42 % and 53 % at 300 days in the CHD and NSHD groups respectively . Four-year success was achieved in 27 % and 36 % in the CHD and NSHD groups , respectively . There were no significant differences in the success rates between patients groups ( P= .46 ) , nor were there any differences in left atrial size or changes in ejection fraction after one or two PVAI in the respective groups . Complication rates between the CHD and NSHD groups were similar ( 15 % vs. 11 % , P= .42 ) except for a higher risk of vascular site complications in patients with CHD ( 8 % vs. 1 % , P drug refractory AF in CHD , with combined success rates in excess of 60 % . The maintenance of sinus rhythm after PVAI in CHD appears similar to that of NSHD and warrants prospect i ve validation",
"Introduction Atrial fibrillation ( AF ) is commonly found in patients with structural heart disease ( SHD ) , including atrial septal defect ( ASD ) . The feasibility and safety of ablation for AF in patients with unrepaired ASD is seldom reported . Objectives This study aims to evaluate and compare the long-term efficacy of AF ablation in patients with and without ASD . Methods From January 2008 to December 2012 , 18 consecutive patients were identified with medically refractory AF and an unrepaired ASD under catheter ablation . For each ASD patient , four control subjects were matched from our data base . Results There were no significant differences between groups in terms of age , sex , type of AF , LA diameter , LVIDD , and EF . The mean procedural and fluoroscopy times were not different between the groups ( p = NS ) . After a median follow-up of 20 months , the patients in the ASD group had 44.4 % AF recurrence after a single procedure compared with 34.7 % in the control group ( p = 0.11 ) . The mean LA diameter in non-recurrent patients was smaller than in recurrent patients ( p = 0.03 ) . In univariate Cox proportional hazards analyses , the factor found to have a significant association with arrhythmia recurrences was left atrial diameter ( hazard ratio 1.059 , 95 % confidence interval 1.002 to 1.120 , p = 0.03 ) . Conclusions These results indicate that in patients with AF and an ASD amenable to percutaneous closure , a staged approach with radiofrequency ablation of AF preceding closure is a rational strategy",
"UNLABELLED Intracardiac Echo-Guided Radiofrequency Catheter . INTRODUCTION Patients with atrial septal defect ( ASD ) are at higher risk for atrial fibrillation ( AF ) even after repair . Transseptal access in these patients is perceived to be difficult . We describe the feasibility , safety , and efficacy of pulmonary vein antral isolation ( PVAI ) in these patients . METHOD We prospect ively compared post-ASD/patent foramen ovale ( PFO ) repair patients ( group I , n = 45 ) with age-gender-AF type matched controls ( group II , n = 45 ) . All the patients underwent PVAI through a double transseptal puncture with a roving circular mapping catheter technique guided by intracardiac echocardiography ( ICE ) . The short-term ( 3 months ) and long-term ( 12 month ) failure rates were assessed . RESULTS In group I , 23 ( 51 % ) had percutaneous closure devices and 22 ( 49 % ) had a surgical closure . There was no significant difference between group I and II in the baseline characteristics . Intracardiac echo-guided double transseptal access was obtained in 98 % of patients in group I and in 100 % of patients in group II . PVAI was performed in all patients , with right atrial flutter ablation in 7 patients in group I and in 4 patients in group II . Over a mean follow-up of 15 + /- 4 months , group I had higher short-term ( 18 % vs 13 % , P = 0.77 ) and long-term recurrence ( 24 % vs 18 % , P = 0.6 ) than group II . There was no significant difference in the perioperative complications between the two groups . Echocardiography at 3 months showed interatrial communication in 2 patients in group I and 1 patient in group II , which resolved at 12 months . CONCLUSION Percutaneous AF ablation using double transseptal access is feasible , safe , and efficacious in patients with ASD and PFO repairs",
"Background Atrial tachycardias ( ATs ) are a significant source of morbidity in adults with congenital heart disease ( CHD ) . This study evaluates the incidence and clinical predictors of AT in a cohort of patients with CHD . Methods and Results We included 3311 adults ( median age at entry 22.6 years , 50.6 % males ) with CHD ( 49 % simple , 39 % moderate , and 12 % complex ) prospect ively followed up in a tertiary center for 37 607 person-years . Predictors of AT were identified by multivariable Cox regression analysis accounting for left truncation . An external validation was performed in a contemporary cohort of 1432 patients . Overall , 153 ( 4.6 % ) patients presented AT . AT burden was highest in complex CHD , such as single ventricle ( 22.8 % ) and D-transposition of the great arteries ( 22.1 % ) . Hazard rates of AT across lifetime , age at presentation , and the time lapse between surgery and the first AT episode varied among the most common CHD . Independent risk factors for developing AT were univentricular physiology , previous intracardiac repair , systemic right ventricle , pulmonary hypertension , pulmonary regurgitation , pulmonary atrioventricular valve regurgitation , pulmonary and systemic ventricular dysfunction . At the age of 40 years , AT-free survival in patients with 0 , 1 , 2 , and ≥3 risk factors was 100 % , 94 % , 76 % , and 50 % , respectively . These findings were confirmed in the validation cohort . Conclusions Natural history of AT differed among the most common forms of CHD . Simple clinical parameters , easily obtained by noninvasive means , were independent predictors of AT in adults with CHD . Although risk was negligible in patients without any of these factors , their addition progressively increased AT burden"
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4117184c-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Turner syndrome ( TS ) affects about one in 1500 to 2500 live-born females . One of the most prevalent and salient features of the syndrome is extremely short stature . Untreated women are approximately 20 to 21 cm shorter than normal women within their respective population s. Recombinant human growth hormone ( hGH ) has been used to increase growth and final height in girls who have Turner syndrome . OBJECTIVES To assess the effects of recombinant growth hormone in children and adolescents with TS . SEARCH STRATEGY MEDLINE , EMBASE , The Cochrane Library , LILACS , BIOSIS , Science Citation Index and reference lists were used to identify relevant trials . SELECTION CRITERIA R and omised controlled trials were included if they were carried out in children with TS before achieving final height . Growth hormone had to be administered for a minimum of six months and compared with a placebo or no treatment control condition . DATA COLLECTION AND ANALYSIS Two review ers assessed studies for inclusion criteria and for method ological quality . The primary outcomes were final height and growth . Secondary outcomes included bone age , quality of life , cognitive performance , and adverse effects . MAIN RESULTS Four RCTs that included 365 participants after one year of treatment were included . Only one trial reported final height in 61 treated women to be 148 cm and 141 cm in 43 untreated women ( mean difference ( MD ) seven cm , 95 % CI 6 to 8) . Short-term growth velocity was greater in treated than untreated girls after one year ( two trials , MD three cm per year , 95 % CI 2 to 4 ) and after two years ( one trial , MD two cm per year , 95 % CI 1 to 2.3 ) . Skeletal maturity was not accelerated by treatment with recombinant growth hormone ( hGH ) . Adverse effects were minimally reported . AUTHORS ' CONCLUSIONS Recombinant human growth hormone ( hGH ) doses between 0.3 to 0.375 mg/kg/wk increase short-term growth in girls with Turner syndrome by approximately three ( two ) cm in the first ( second ) year of treatment . Treatment in one trial increased final height by approximately six cm over an untreated control group . Despite this increase , the final height of treated women was still outside the normal range . Additional trials of the effects of hGH carried out with control groups until final height is achieved would allow better informed decisions about whether the benefits of hGH treatment outweigh the requirement of treatment over several years at considerable cost
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[
"Short stature and ovarian failure are the main features in Turner syndrome ( TS ) . To optimize GH and estrogen treatment , we studied 68 previously untreated girls with TS , age 2 - 11 yr , who were r and omly assigned to one of three GH dosage groups : group A , 4 IU/m2 day ( approximately 0.045 mg/kg x day ) ; group B , first yr 4 , thereafter 6 IU/m2 x day ( approximately 0.0675 mg/kg/day ) ; group C , first yr 4 , second yr 6 , thereafter 8 IU/m2 x day ( approximately 0.090 mg/kg x day ) . In the first 4 yr of GH treatment , no estrogens for pubertal induction were given to the girls . Thereafter , girls started with 17beta-estradiol ( 5 microg/kg bw x day , orally ) when they had reached the age of 12 yr . Subjects were followed up until attainment of adult height or until cessation of treatment because of satisfaction with the height achieved . Seven-year data of all girls were evaluated to compare the growth-promoting effects of three GH dosages during childhood . After 7 yr , 85 % of the girls had reached a height within the normal range for healthy Dutch girls . The 7-yr increment in height SD-score was significantly higher in groups B and C than in group A. In addition , we evaluated the data of 32 of the 68 girls who had completed the trial after a mean duration of treatment of 7.3 yr ( range , 5.0 - 8.75 ) . Mean ( SD ) height was 158.8 cm ( 7.1 ) , 161.0 cm ( 6.8 ) , and 162.3 cm ( 6.1 ) in groups A , B , and C , respectively . The mean ( SD ) difference between predicted adult height before treatment and achieved height was 12.5 cm ( 2.1 ) , 14.5 cm ( 4.0 ) , and 16.0 cm ( 4.1 ) for groups A , B , and C , respectively , being significantly different between group A and group C. GH treatment was well tolerated in all three GH dosage groups . In conclusion , GH treatment starting in relatively young girls with TS results in normalization of height during childhood , as well as of adult height , in most of the individuals . With this GH and estrogen treatment regimen , most girls with TS can grow and develop much more in conformity with their healthy peers",
"To assess body proportions in girls with Turner syndrome ( TS ) during long term GH treatment , height , sitting height ( SH ) , h and ( H and ) and foot ( Foot ) lengths , and biacromial ( Biac ) and biiliacal ( Biil ) diameters were measured in 68 girls with TS participating in a GH dose-response trial . These previously untreated girls with TS , aged 2 - 11 yr , were r and omly assigned to 1 of 3 GH dosage groups : group A , 4 IU/m2 x day ; group B , first year 4 and thereafter 6 IU/m2 x day ; group C , first year 4 , second year 6 , and thereafter 8 IU/m2 x day . Seven-year data were evaluated to assess the effect of GH treatment on body proportions during childhood . In addition , data from all girls who had reached adult height were evaluated to determine the effect on the adult body proportions . All results were adjusted for age and sex and expressed as SD scores using reference values of healthy Dutch girls . To describe the proportions of SH , H and , Foot , Biac , and Biil to height , these values were adjusted for the SD score of height and were expressed as shape values , using the formula , e.g. for SH : shape SH = ( SH SD score - height SD score)/square root(2 - 2 x correlation coefficient between SH and height in the reference population ) . Furthermore , SD scores using references of untreated girls with TS were calculated for height and SH . Values less than -2 or more than + 2 were considered outside the normal range . At baseline , the shape values of all measurements were significantly higher than zero , but most mean shape values were still within the normal range . Seven-year data of 64 girls and adult height data of 32 girls showed that an increase in height was accompanied by an even higher increase in Foot , result ing in mean SD scores above zero and shape values of + 2 and higher . The increase in the shape value of Foot was significantly higher in groups B and C compared to that in group A after 7 yr of GH treatment , but there were no significant differences between the GH dosage groups in the girls who had reached adult height . The shape values of SH had decreased to values closer to zero after reaching adult height , especially in group A. A similar pattern in the relationship of SH to height was seen using references of girls with TS . No significant changes in the other proportions were found after reaching adult height . In conclusion , on the average , untreated girls with TS have relatively large trunk , h and s , and feet , and broad shoulders and pelvis compared to height . The increase in height after long term GH treatment is accompanied by an even higher increase in Foot and a moderate improvement of the disproportion between height and SH . Recently published reference data from untreated adults with TS and the results of a different patient group receiving a comparable GH dosage suggest that the disproportionate growth of feet has to be considered a part of the natural development in TS , but might be influenced by higher GH dosages . The development of large feet can play a role in the decision of the girl to discontinue GH treatment in the last phase of growth",
" Seventy girls with Turner syndrome , verified by karyotype , were r and omly assigned to observation or treatment with human growth hormone ( hGH ) , ox and rolone , or a combination of hGH plus ox and rolone for a period of 12 to 24 months , to assess the effect of treatment on growth velocity and adult height . Subsequently , all subjects received either hGH alone or hGH plus ox and rolone . Data are presented for 62 subjects treated for a period of 3 to 6 years . When compared with the anticipated growth rate in untreated patients , the growth rate after treatment with hGH , both alone and in combination with ox and rolone , showed a sustained increase for at least 6 years . Treatment is continuing in over half of the subjects ; at present , 14 ( 82 % ) of 17 girls receiving hGH alone and 41 ( 91 % ) of 45 girls receiving combination therapy exceeded their expected adult heights . Thirty girls have completed treatment ; mean height for these 30 patients is 151.9 cm , compared with their mean original projected adult height of 143.8 cm . We conclude that therapy with hGH , alone and in combination with ox and rolone , can result in a sustained increase in growth rate and a significant increase in adult height for most prepubertal girls with Turner syndrome",
"To optimize the growth promoting effect of growth hormone ( GH ) , 65 previously untreated girls with Turner syndrome ( TS ) , chronological age ( CA ) 2 - 11 yr , were r and omized into 3 dosage regimen groups : A , B , and C , with a daily recombinant-human GH dose during 4 study years of 4 - 4 - 4 - 4 , 4 - 6 - 6 - 6 , and 4 - 6 - 8 - 8 IU/m2 b.s . The first GH dosage increase in groups B and C result ed in a significantly higher mean height velocity ( HV ) compared with constant dose group A. During the third year , when the dose was raised again only in group C , mean HV was significantly higher in groups B and C than in group A , and in group C compared with group B. In year 4 only group C mean HV remained significantly higher than group A. The pattern of change in HSDSCA ( Dutch-Swedish-Danish Turner references ) was identical ; however , in year 4 mean delta HSDSCA in group B also remained significantly higher than group A. After 4 yr GH treatment , the following was determined . 1 ) The mean delta HSDSCA was significantly higher for groups B and C compared with group A , but not significantly different between groups B and C. 2 ) Although significantly higher compared with estimated values for untreated Dutch girls with TS , bone maturation of the GH treated girls was not significantly different between groups . 3 ) It was positively related with the degree of bone age ( BA ) retardation at start of study and negatively with baseline CA . 4 ) Both the modified Index of Potential Height ( mIPHRUS ) and a recently developed Turner-specific final height ( FH ) prediction method ( PTSRUS ) , based on regression coefficients for H , CA , and bone age , showed significant increases in mean FH prediction , without significant differences between groups . PTSRUS values were markedly higher than the mIPHRUS values . Dose dependency could be shown for the area under the curve ( AUC ) for GH , but delta HSDSCA was not linearly related with AUC . Baseline GH binding protein ( BP ) levels were in 84 % of the cases within the normal age range ; the decrease in mean levels after 6 months GH was not significant . Mean insulin-like growth factor I ( IGF-I ) and IGFBP-3 plasma levels increased significantly , without significant differences between groups . delta HSDSCA during GH was dependent on IGF-I plasma levels at baseline and during the study period , beta-0.002 and beta-0.0004 . Thus , a stepwise GH-dosing approach reduced the \" waning \" effect of the growth response after 4 yr treatment without undue bone maturation . FH prediction was not significantly different between treatment groups . Irrespective of the GH dose used , initiation of GH treatment at a younger age was beneficial after 4 yr GH when expressed as actual cm gained or as gain in FH prediction , but was not statistically significant when expressed as delta HSDSCA over the study period",
"In 1983 , a multicenter , collaborative , prospect i ve study was begun to investigate the efficacy of human growth hormone ( hGH ) , alone and in combination with ox and rolone , in girls with Turner syndrome . While subjects in the control group grew 3.8 cm/yr ( -0.1 SD for untreated Turner patients ) , subjects receiving hGH alone grew 6.6 , 5.4 and 4.6 cm/yr in years 1 - 3 , respectively ( + 3.1 , + 2.0 , + 1.4 SD ) . Subjects in the combination therapy group grew 9.8 , 7.4 and 6.1 cm/yr ( + 6.6 , + 4.3 , + 3.0 SD ) . Turner subjects in both treatment groups showed increased in Bayley-Pinneau predicted adult heights and in Turner projected adult heights",
"Preliminary results are presented after 2 years of the Canadian long-term multicentre study on the impact of hormone therapy on the final height , sexual development and psychological status of girls with Turner syndrome . Girls entering the study were r and omized either to be treated with recombinant human growth hormone or to act as controls . Both groups received oestrogen replacement therapy in the same dose and format at the age of 13 years . However , for the purpose s of the psychological study at this time , children receiving oestrogen were excluded from analysis . Girls treated with GH for a period of 2 years showed a significant increase in growth rate , which declined with continued treatment , while the growth rate in the control group remained constant throughout . There was a correlation between the higher growth rate and the girls ' perceptions of themselves as more intelligent , more attractive , having more friends , greater popularity and experiencing less teasing than the untreated group . Growth rate was not correlated with family or school functioning",
"STUDY OBJECTIVE To determine the influence of the injection frequency and the initial bone age on the efficacy of treatment with biosynthetic growth hormone in Turner 's syndrome . DESIGN R and omized study . SETTING Referral-based pediatric endocrinology departments of seven university medical centers . PATIENTS Fifty-two patients with Turner 's syndrome confirmed with chromosomal analysis . TREATMENT Somatotropin recombinant DNA ( 24 IU/m2 of body surface area ) subcutaneously administered in three or six injections per week for 2 years . Patients who were older than 12 years at the beginning of the study received low doses of estrogen . RESULTS The following statistically significant findings supported the use of six injections per week compared with three injections per week : the mean ( + /- SD ) increment in height during 2 years was 11.3 cm ( 3.8 cm ) with six injections vs 8.6 cm ( 3.4 cm ) with three injections ; the increment in height st and ard deviation score was 0.9 cm ( 0.5 cm ) vs 0.6 cm ( 0.3 cm ) ; the growth velocity was 6.6 cm/y ( 2.0 cm/y ) vs 5.2 cm/y ( 1.7 cm/y ) in year 1 and 4.7 cm/y ( 2.0 cm/y ) vs 3.4 cm/y ( 1.7 cm/y ) in year 2 ; and the increment in height st and ard deviation score for bone age was 0.8 cm ( 0.5 cm ) vs 0.4 cm ( 0.6 cm ) . For patients whose initial bone age was more than 13 years , growth velocity increased by 1 to 2 cm in year 1 ; in year 2 no increment was observed . We did not observe adverse effects . CONCLUSIONS Biosynthetic growth hormone in a higher-frequency regimen in Turner 's syndrome is more efficient in terms of increment in height , growth velocity , and height st and ard deviation score for bone age than treatment in a lower-frequency regimen . In patients with an initial bone age of more than 13 years , the response was poor . Longer follow-up is necessary to assess the effect on final height",
"OBJECTIVES To study final height in girls with Turner ’s syndrome treated with once or twice daily injections of growth hormone ( GH ) in combination with low dose ethinyl oestradiol . DESIGN Until final height was reached , the effect of fractionated subcutaneous injections given twice daily was compared with once daily injections of a total GH dose of 6 IU/m2/day . Twice daily injections were given as one third in the morning and two thirds at bedtime . All girls concurrently received low dose oestradiol ( 0.05 μg ethinyl oestradiol/kg/day , increased to 0.10 μg/kg/day after 2.25 years ) . PATIENTS Nineteen girls with Turner ’s syndrome aged ⩾ 11 years ( mean ( SD ) 13.6 ( 1.7 ) years ) . MEASUREMENTS To determine final height gain , we assessed the difference between the attained final height and the final height predictions at the start of treatment . These final height predictions were calculated using the Bayley-Pinneau ( BP ) prediction method , the modified projected adult height ( mPAH ) , the modified index of potential height ( mIPHRUS ) , and the Turner ’s specific prediction method ( PTSRUS ) . RESULTS The gain in final height ( mean ( SD ) ) was not significantly different between the once daily and the twice daily regimens ( 7.6 ( 2.3 ) v 5.1 ( 3.2 ) cm ) . All girls exceeded their adult height prediction ( range , 1.6–12.3 cm ) . Thirteen of the 19 girls had a final height gain > 5.0 cm . Mean ( SD ) attained final height was 155.5 ( 5.4 ) cm . A “ younger bone age ” at baseline and a higher increase in height st and ard deviation score for chronological age ( Dutch – Swedish – Danish references ) in the first year of GH treatment predicted a higher final height gain after GH treatment . CONCLUSIONS Division of the total daily GH dose ( 6 IU/m2/day ) into two thirds in the evening and one third in the morning is not advantageous over the once daily GH regimen with respect to final height gain . Treatment with a GH dose of 6 IU/m2/day in combination with low dose oestrogens can result in a significant increase in adult height in girls with Turner ’s syndrome , even if they start GH treatment at a relatively late age",
"Forty patients with Turner 's syndrome , aged 5.0 - 16.6 yr , were r and omly allocated to receive daily sc injections of recombinant human GH ( hGH ) at a dose of 1 IU/kg.week alone ( group I ) or in combination with 25 ng/kg.day ethinyl estradiol ( E2 ; group II ) . The mean pretreatment height velocity was 3.8 cm/yr for both groups . During the first year of treatment height velocity increased significantly ( P less than 0.001 ) in both groups , to 7.5 + /- 1.3 and 8.1 + /- 1.6 cm/yr , respectively . The difference between the two groups was not significant . The mean ( + /- SD ) height velocity expressed as the SD score for chronological age ( Turner references ) was 0.0 + /- 1.2 for group I and 0.2 + /- 1.4 for group II and increased significantly ( P less than 0.001 ) during the first year of treatment to + 4.3 + /- 1.1 in group I and + 5.4 + /- 1.2 in group II . The difference between both groups was statistically significant ( P less than 0.01 ) . Height SD score for chronological age ( Turner references ) increased from -0.2 + /- 0.9 to + 0.6 + /- 1.0 in group I and from -0.2 + /- 1.0 to + 0.7 + /- 1.1 in group II . Mean bone age progressed similarly in both treatment groups ( 1.1 + /- 0.6 yr during 1 yr of treatment ) . However , bone age maturation accelerated more rapidly in younger patients . Twelve girls ( three in group I and nine in group II ) had minor breast development . No major adverse effects were reported . We conclude that daily sc therapy with hGH stimulates height velocity in Turner 's syndrome . The beneficial effect on height velocity increment of E2 addition was small . Furthermore , even very low doses of E2 may induce breast development at an early age and accelerate bone maturation . For these reasons , the addition of E2 to hGH is not warranted in young patients with Turner 's syndrome",
" 91 girls with Turner syndrome ( TS ) with a mean chronological age ( CA ) and bone age ( BA ) of 10.3 + /- 2.3 and 8.9 + /- 1.9 years , respectively , were r and omly assigned to subcutaneous treatment with recombinant human growth hormone ( rhGH ) alone ( n = 47 ) , 2.6 IU/m2 body surface area daily or combination treatment ( n = 44 ) with the same dose of rhGH and ox and rolone 0.1 mg/kg body weight orally , for the first 12 months of this study . During the 1st year of therapy , there was a striking increase in height velocity ( HV ) in both groups , from 4.0 + /- 0.8 to 6.3 + /- 1.3 cm/year [ HV st and ard ( st and ards of untreated Turner patients ) deviation score ( SDS ) for CA from 0.0 + /- 0.7 to 2.9 + /- 1.3 ] in the rhGH group and from 4.2 + /- 1.2 to 8.5 + 2- 1.7 cm/year ( HV SDS-CA from + 0.3 + /- 1.0 to 5.6 + /- 1.6 ) in the combination group . The difference between the groups was statistically significant ( p rhGH dose was increased to 3.4 IU/m2 daily for the rhGH-alone group , whereas in the combination treatment group the ox and rolone dose was reduced to 0.05 mg/kg daily . HV was maintained at significantly higher levels than those prior to treatment , at 5.3 + /- 1.1 cm/year ( HV SDS-CA : + 2.1 + /- 1.3 ) and 6.2 + /- 1.5 cm/year ( HV SDS-CA : + 3.6 + /- 1.4 ) in the rhGH-alone and the combination group , respectively ( p < 0.001 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE To carry out a multicenter , prospect i ve , r and omized trial of human growth hormone ( GH ) , alone or in combination with ox and rolone ( OX ) , in patients with Turner 's syndrome ( TS ) . METHODS In an initial phase lasting 12 to 24 months , 70 girls with TS , verified by karyotype , were r and omly assigned to one of four groups : ( 1 ) observation , ( 2 ) OX , ( 3 ) GH , or ( 4 ) GH plus OX . After completion of the first phase , group 3 subjects continued to receive GH only . All other subjects were treated with GH plus OX . Subjects were followed up until attainment of adult height and /or cessation of treatment . Data from this trial were compared with growth characteristics of 25 American historical subjects with TS ( matched for age , height , parental target height , and karyotype ) who never received either GH or and rogens . RESULTS Of the 70 subjects enrolled , 60 completed the clinical trial . The 17 subjects receiving GH alone all completed the trial and reached a height of 150.4+/-5.5 cm ( mean + /- SD ) , 8.4+/-4.5 cm taller than their mean projected adult height at enrollment ( 95 % confidence interval [ CI ] : 6.3 to 10.6 cm ) . The 43 subjects receiving GH plus OX attained a mean height of 152.1+/-5.9 cm , 10.3+/-4.7 cm taller than their mean projected adult height ( 95 % CI : 8.9 to 11.7 cm ) . The historical control subjects had a mean adult height of 144.2+/-6.0 cm , precisely matching their original projected adult height of 144.2+/-6.1 cm . CONCLUSIONS GH , either alone or in combination with OX , is capable of stimulating short-term growth and augmenting adult height in girls with TS . With early diagnosis and initiation of treatment , an adult height of more than 150 cm is a reasonable goal for most girls with TS",
"In 1987 a multicentre trial of recombinant human growth hormone ( GH ) was started in girls with Turner syndrome . Fifty-four patients were r and omly assigned to receive GH , 8 IU/m2 3 times/week ( group 1 ) , or 4 IU/m2 6 times/week ( group 2 ) . In addition , the 35 patients older than 12 years received ethinyloestradiol , 100 ng/kg body weight/day , and after 2 years GH therapy was increased to 6 IU/m2 6 times/week . Recombinant human GH treatment was stopped when the height increment during the previous 6 months of treatment was less than 0.5 cm . Treatment has so far been stopped in 48 patients : treatment was stopped early in 2 patients due to lack of motivation , 1 patient died suddenly and the treatment protocol was completed in 45 patients . The last height measurement obtained , which was considered as ( near ) final height , was 152.3 + /- 5.3 cm ( mean + /- SD ) in these patients , which is higher ( p 63 untreated adult Dutch patients with Turner syndrome . No differences in outcome were found between the two dose regimens",
"OBJECTIVE There have been few studies of GH dose responses in Turner 's syndrome . We have therefore compared the growth effect of two doses of subcutaneous rGH : 0.45 ( D1 ) or 0.90 ( D2 ) IU/kg/week",
"Clinical trials of recombinant human GH therapy in Turner syndrome that began more than a decade ago show that GH accelerates the linear growth rate . Several studies indicate that final height is also improved , although the magnitude of the increase has been debated . The age at which feminization is induced could be an important factor in determining the patient 's ultimate growth response . To test this , 60 patients from a large ( n = 117 ) , previously unreported , clinical trial of GH treatment were r and omly assigned to begin conjugated estrogens at either 12 or 15 yr of age . The 60 patients were all less than 11 yr of age at entry ( mean , 9.5 yr ) and received 0.375 mg/kg x week of GH for nearly 6 yr on a daily or three times weekly regimen . Height gain was calculated by comparing the study patients ' final or near final heights to their pretreatment projected heights as well as to those of a separate set of age-matched , historical control patients . Patients in whom estrogen treatment was delayed until age 15 yr gained an average of 8.4 + /- 4.3 cm over their projected height , whereas those starting estrogen at 12 yr gained only 5.1 + /- 3.6 cm , on the average ( P growth was stimulated for approximately 2 yr after estrogen initiation , but then declined in association with bone age advancement . Patients who were older than 11 yr at entry ( n = 57 ) all initiated estrogen 1 yr after beginning GH and showed a mean gain in adult height of 4.7 cm , similar to those given estrogen at age 12 yr . Multivariate analysis revealed that the number of years of GH therapy before estrogen treatment was a strong factor in predicting height gained , indicating that the timing of estrogen introduction is an important determinant of final height in this cohort of GH-treated patients with Turner syndrome matched for baseline age and other characteristics",
"BACKGROUND Turner syndrome accounts for 15–20 % of childhood usage of growth hormone ( GH ) in the UK but final height benefit remains uncertain . The most effective strategy for oestrogen replacement is also unclear . METHODS Fifty eight girls who , at start of treatment , were of mean age 9.1 years and projected final height 142.2 cm were r and omised to receive in year 1 , either low dose ethinyloestradiol 50–75 ng/kg/day , GH 28 IU/m2 surface area/week as a daily injection , or a combination of ethinyloestradiol and GH . After the first year , the ethinyloestradiol treated girls received combination treatment . After two years , girls aged over 12 years were given escalating ethinyloestradiol to promote pubertal development . RESULTS Near final height was available for 49 girls at age 16.5 years , 146.8 cm , representing a gain of 4.6 cm , range −7.9 to + 11.7 cm . Twelve of the 49 girls gaining 7.5 cm or more were less than 13 years at the start and had received GH for at least four years . Height gain was correlated with greater initial height deficit . Fifteen girls ( 31 % ) reached 150 cm or more compared to a predicted 10 % . Early supplementation with ethinyloestradiol provided no final height advantage . CONCLUSIONS Final height gain was modest at 4.6 cm . Younger , shorter girls gained greatest height advantage from GH . Low dosage ethinyloestradiol before planned induction of puberty was not beneficial",
"GH is known to improve height velocity in girls with Turner syndrome ( TS ) but the optimal dosage regimen has yet to be defined",
"A cardinal clinical feature of Turner syndrome ( TS ) is linear growth failure result ing in extreme short stature : the median adult height of untreated women with TS is 143 cm , 20 cm ( 8 in . ) below that of the general female population . In the largest multicenter , r and omized , long-term , dose-response study conducted in the United States , 232 subjects with TS received either 0.27 or 0.36 mg/kg.wk of recombinant human GH with either low dose ethinyl E2 or oral placebo . The study was placebo-controlled for both GH and estrogen for the first 18 months and remained placebo-controlled for estrogen for its duration . The near-final height of the 99 subjects whose bone age was at least 14 yr was 148.7 + /- 6.1 cm after 5.5 + /- 1.8 yr of GH started at a mean age of 10.9 + /- 2.3 yr ; this represents an average increase of 1.3 + /- 0.6 SD scores from baseline ( TS st and ard ) . Height was greater than 152.4 cm ( 60 in . ) in 29 % of subjects compared with the expected 5 % of untreated patients . Mean near-final heights of subjects who received the lower GH dose , with or without estrogen , were 145.1 + /- 5.4 and 149.9 + /- 6.0 cm , respectively ; those who received the higher GH dose with or without estrogen achieved mean near-final heights of 149.1 + /- 6.0 and 150.4 + /- 6.0 cm , respectively . Factors that most impacted outcome were younger age , lower bone age/chronological age ratio , lower body weight , and greater height SD score at study entry . This study demonstrates significant GH-induced improvement in height SD score , with correction of height to within the normal channels for a significant number of patients , and provides evidence of a GH dose-response effect . These data also indicate that early administration of estrogen , even at relatively low doses , does not improve gain in near-final height in patients with TS",
" In 44 girls with Turner 's syndrome , aged 4.0 - 15.3 yr , the effects of biosynthetic GH ( 25 U/m2.week ) given as once daily or twice daily injections were compared . During 1 yr of treatment , the growth rate increased similarly by 3.5 + /- 1.3 cm/yr in the once daily group and 2.7 + /- 1.8 cm/yr in the twice daily group . Although pretreatment height velocity was negatively related to age , the increase in height velocity during therapy was not . The mean progression in bone age ( TW2-RUS method ) , during therapy was 1.3 yr in both groups . No significant change in the median insulin secretory response to an oral glucose tolerance test was found . Serum cholesterol and triglyceride concentrations did not change significantly throughout the study in either treatment group . Thyroid hormone concentrations remained within normal limits . Normal increments in left ventricular wall thickness and left ventricular mass for age and body surface were observed after 1 yr of GH treatment . We conclude that division of the daily GH dose given to Turner 's syndrome patients into two injections does not result in either a significantly different growth response or different side-effects from once daily treatment during the first year of therapy",
"Thirty-nine girls with Ullrich-Turner syndrome ( UTS ) ( median age 9.5 years ) were treated with growth hormone ( GH ) with either 12 or 18 IU/m2 per week for 12 months followed by combination therapy with either ox and rolone ( Ox ) ( 0.0625 mg/kg/day po ) or low-dose testosterone ( T ) ( 5 mg i m every 2 weeks ) . Growth velocity improved significantly after 12 IU/m2 per week ( 6.4±1.7 cm/year vs 4.0±1.3 cm/year , x±SD , P of GH ( 6.5±1.3 cm/year vs 4.5±1.4 cm/year , P maintaining growth velocity during the 2nd year of therapy ( 6.9±1.3 vs 5.3±1.5 cm/year ) . Basal insulin-like growth factor-I ( IGF-I ) concentrations were in the lower normal range and increased significantly in patients treated with 18 IU/m2 per week ( 357±180 ng/ml vs 160±84 ng/ml ) and 12 IU/m2 per week ( 273±121 ng/ml vs 140±77 ng/ml ) . IGF-I concentrations increased further after addition of Ox ( 533±124 ng/ml , P ) . IGFBP-3 concentrations were in the upper normal range before therapy and increased only moderately in both GH dosage groups . However , IGF binding protein-3 ( IGFBP-3 ) concentrations were not affected by additional Ox or T treatment . Conclusions 1 . Conventional GH doses are effective in increasing growth velocity in UTS , especially , when combined with Ox . This additive effect is not evident when GH is combined with low dose T. 2 . Changes in growth velocity are accompanied by an increase of the IGF-I/IGFBP-3 ratio . 3 . Ox obviously acts by increasing IGF-I levels independent of the GH status",
"Turner syndrome ( TS ) is a genetic disorder characterized by short stature , gonadal dysgenesis , and a particular neurocognitive profile of normally developed language abilities ( particularly verbal IQ ) and impaired visual-spatial and /or visual-perceptual abilities . We have followed a large sample of girls with Turner syndrome who were enrolled in a long-term , double-blind , placebo-controlled trial of the effects of growth hormone ( GH ) treatment on final adult height . This study provides a unique opportunity to prospect ively evaluate the effects of GH treatment on neurocognitive function in this population of girls with Turner syndrome . The GH- and placebo-treated Turner syndrome subjects were well matched for age , treatment duration , race , karyotype , and socioeconomic status . Treatment ( GH or placebo ) duration s ranged from 1 - 7 yr . Whether GH deficiency and /or treatment in childhood and adolescence influences cognitive outcome in short children or GH-children is controversial . The major result of this study was the absence of GH treatment effects on cognitive function in girls with Turner syndrome . Our findings are in agreement with most of the previous studies that found no apparent growth hormone treatment effects on cognitive function in growth-hormone deficient children . We conclude that this study does not support a role for growth hormone in influencing childhood brain development in girls with Turner syndrome . Their characteristic nonverbal neurocognitive deficits were not altered with GH treatment into early adolescence",
"The Genentech National Cooperative Study of growth hormone ( GH ) therapy in Turner 's syndrome was initiated in 1983 ; 70 girls with Turner 's syndrome were r and omly assigned to observation or to treatment with GH alone , ox and rolone alone , or a combination of GH plus ox and rolone for a period of 12 - 24 months . After completion of this phase , patients receiving GH alone were continued on GH , while all other patients received the combination of GH plus ox and rolone . Data are currently available on the 62 girls who were treated for a minimum of 3 - 6 years . When compared with the height velocities anticipated for girls of comparable ages with untreated Turner 's syndrome , both GH alone and a combination of GH plus ox and rolone result ed in an increase in height velocity , which was most prominent during the first 2 years of treatment and was sustained for at least 6 years . Although GH therapy is continuing at present in half of the patients , 14 of 17 girls ( 82 % ) receiving GH alone and 42 of 45 girls ( 93 % ) receiving combination therapy have exceeded their projected adult heights . For the 30 girls who have stopped therapy , the current mean height is 151.9 cm , compared with their original mean projected adult height of 143.8 cm . These results demonstrate that GH therapy can result in short-term ( 3 - 6 years ) acceleration of growth , as well as in improved adult height",
"In the Dutch growth hormone ( GH ) registration data base there are currently 552 GH-deficient children being treated , subcutaneously , with recombinant human GH six to seven times per week . Of those , 112 who have been treated for at least 2 years have reached final height . Mean age at start of therapy was 11.70 years . Mean GH dose was 15.5 IU/m2 body surface per week . Mean final height was 173.2 cm ( boys ) and 159.7 cm ( girls ) and –1.36 SD of the population mean . Of the patients , 73.2 % and 63.4 % , respectively , reached a final height above –2 SD of the population or within target limits . FH-SDS was higher compared with the results of earlier cohorts with different treatment regimens . Target height , GH peak value at diagnosis , age at start of GH therapy , height SDS ( HSDS ) at start of puberty , and duration of GH therapy were significantly correlated with final height . These results , combined with those of a prospect i ve GH dose-response study , suggest that better long-term results can be obtained with early and prolonged treatment and if the GH dose is individually adapted to the short-term growth response . In an ongoing dose-response study , 68 girls with Turner ’s syndrome , aged 2–11 years , were r and omized into three dosage groups with a daily GH dose of : ( group A ) 4 IU/m2 body surface ; ( group B ) 4 IU/m2 in the first year of therapy and 6 IU/m2 thereafter ; ( group C ) 4 IU/m2 in the first year , 6 IU/m2 in the second year , and 8 IU/m2 thereafter . After 4 years of GH therapy , girls aged 12 years or older started low-dose oestrogen therapy . After 7 years of GH therapy , mean HSDS in all three groups had increased to values above the third percentile for healthy girls . Mean final height and final height gain of 25 girls was 159.1 and 12.5 cm , 161.8 and 14.6 cm , and 162.7 and 16.0 cm in groups A , B and C respectively . These long-term and final height results are more favourable than the results of earlier Dutch Turner ’s syndrome studies . Possible explanations are the higher GH doses and /or the younger age at start of GH therapy ",
"22 girls with Turner syndrome aged 10.8 + /- 2.4 years with bone age 8.58 + /- 1.32 years , r and omized in two groups , were treated for 3 years with either growth hormone ( GH ) , 0.1 U/kg daily ( group A ) , or GH , 0.1 U/kg , plus ox and rolone , 0.06 mg/kg ( group B ) . This result ed in a sharp increase in growth rate for the first year of treatment , followed in the second and third years by a growth rate near to the normal mean for age . The growth velocity was better in group B , the difference being significant during the first year only . After 3 years , the predicted adult height had increased by 2.1 cm as a mean in group A and by 4.5 cm in group B , with important individual variations , result ing in a gain of at least 3 cm in 3/10 patients of group A and 9/12 of group B. No metabolic or other side effects occurred . These 3-year data confirm that GH improves the predictable height in Turner girls . They suggest that it may be useful for at least 3 years and that adding a small dose of ox and rolone for 2 years in girls aged more than 8 years could be of good practice . However , earlier and more protracted treatment with GH has to be studied with the hope to better improve the predictable adult height"
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Background Atypical antipsychotics are increasingly used for treatment of mental illnesses like schizophrenia and bipolar disorder , and considered to have fewer extrapyramidal effects than older antipsychotics . Methods We examined efficacy in r and omised trials of bipolar disorder where the presenting episode was either depression , or manic/mixed , comparing atypical antipsychotic with placebo or active comparator , examined withdrawals for any cause , or due to lack of efficacy or adverse events , and combined all phases for adverse event analysis . Studies were found through systematic search ( PubMed , EMBASE , Cochrane Library ) , and data combined for analysis where there was clinical homogeneity , with especial reference to trial duration . Results In five trials ( 2,206 patients ) participants presented with a depressive episode , and in 25 trials ( 6,174 patients ) the presenting episode was manic or mixed . In 8-week studies presenting with depression , quetiapine and olanzapine produced significantly better rates of response and symptomatic remission than placebo , with NNTs of 5–6 , but more adverse event withdrawals ( NNH 12 ) . With mania or mixed presentation atypical antipsychotics produced significantly better rates of response and symptomatic remission than placebo , with NNTs of about 5 up to six weeks , and 4 at 6–12 weeks , but more adverse event withdrawals ( NNH of about 22 ) in studies of 6–12 weeks . In comparisons with established treatments , atypical antipsychotics had similar efficacy , but significantly fewer adverse event withdrawals ( NNT to prevent one withdrawal about 10 ) . In maintenance trials atypical antipsychotics had significantly fewer relapses to depression or mania than placebo or active comparator . In placebo-controlled trials , atypical antipsychotics were associated with higher rates of weight gain of ≥7 % ( mainly olanzapine trials ) , somnolence , and extrapyramidal symptoms . In active controlled trials , atypical antipsychotics were associated with lower rates of extrapyramidal symptoms , but higher rates of weight gain and somnolence . Conclusion Atypical antipsychotics are effective in treating both phases of bipolar disorder compared with placebo , and as effective as established drug therapies . Atypical antipsychotics produce fewer extrapyramidal symptoms , but weight gain is more common ( with olanzapine ) . There is insufficient data confidently to distinguish between different atypical antipsychotics
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"OBJECTIVE This study evaluated the efficacy and safety of risperidone monotherapy in the treatment of acute bipolar mania . METHOD Patients with DSM-IV bipolar I disorder experiencing an acute manic episode ( baseline Young Mania Rating Scale score > /== \" BORDER=\"0\">20 ) were r and omly assigned to 3 weeks of treatment with risperidone ( flexible dose : 1 - 6 mg/day ) or placebo . The primary efficacy measure was the mean baseline-to-endpoint change in total score on the Young Mania Rating Scale . Secondary efficacy measures included the Clinical Global Impression ( CGI ) severity rating and scores on the Montgomery-Asberg Depression Rating Scale , Positive and Negative Syndrome Scale , and Global Assessment Scale ( GAS ) . Safety assessment s consisted of monitoring adverse events , vital signs , electrocardiogram and laboratory results , and scores on the Extrapyramidal Symptom Rating Scale . RESULTS Subjects ( N=259 ) received treatment with either risperidone ( N=134 ) or placebo ( N=125 ) . The mean modal dose of risperidone was 4.1 mg/day . Improvement in mean Young Mania Rating Scale total score ( adjusted for covariates ) was significantly greater in the risperidone than in the placebo group at endpoint ( mean change=-10.6 [ SD=9.5 ] versus -4.8 [ SD=9.5 ] , respectively ) , with significant between-group differences seen as early as 3 days after start of treatment ( change with risperidone : mean=-6.8 [ SD=5.8 ] ; change with placebo : mean=-4.0 [ SD=5.8 ] ) and continuing throughout all time points . Improvements in CGI severity ratings and scores on the Montgomery-Asberg Depression Rating Scale , Positive and Negative Syndrome Scale , and GAS were also significantly greater among patients receiving risperidone than those given placebo . The most common adverse event reported among risperidone patients was somnolence . While Extrapyramidal Symptom Rating Scale scores were significantly greater in patients receiving risperidone , mean total and subscale scores were low . CONCLUSIONS Risperidone monotherapy was significantly more efficacious than placebo in the treatment of acute mania and demonstrated a rapid onset of action . Risperidone was well tolerated by patients in this study",
"Recent empirical evidence supports the importance of adequate r and omization in controlled trials . Trials with inadequate allocation concealment have been associated with larger treatment effects compared with trials in which authors reported adequate allocation concealment . While that provides empirical evidence of bias being interjected into trials , trial investigators rarely document the sensitive details of subverting the intended purpose of r and omization . This article relates anonymous accounts run the gamut from simple to intricate operations , from transillumination of envelopes to search ing for code in the office files of the principal investigator . They indicate that deciphering is something more frequent than a rate occurrence . These accounts prompt some method ological recommendations to help prevent deciphering . R and omized controlled trials appear to annoy human nature -- if properly conducted , indeed they should",
"Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size",
"Abstract : Quetiapine ( QTP ) combined with lithium ( Li ) or divalproex ( DVP ) for the treatment of mania was evaluated in 2 double-blind , placebo-controlled studies . Patients were r and omized to 3 or 6 weeks of treatment with QTP plus Li/DVP or placebo ( PBO ) plus Li/DVP . Quetiapine was dosed up to 800 mg/d ; Li was dosed to achieve serum concentrations of 0.7 - 1.0 mEq/L and DVP to 50 - 100 μg/mL. A total of 402 patients were r and omized : 197 to QTP + Li/DVP and 205 to PBO + Li/DVP . The mean quetiapine dose in responders was 492 ( ±204 ) mg/d . Improvement in the Young Mania Rating Scale ( YMRS ) at day 21 in the QTP + Li/DVP group ( −15.29 ) was statistically superior to the PBO + Li/DVP group ( −12.19 ) ( P achieved a response ( ≥50 % decrease in the YMRS ) at day 21 ( QTP + Li/DVP , 55.7 % ; PBO + Li/DVP , 41.6%;P scores by day 21 were also significantly greater in QTP + Li/DVP-treated patients ( −1.59 ) versus PBO + Li/DVP ( −1.19 ) ( P . Common adverse events ( ≥5 % and twice that in the PBO + Li/DVP group ) in the QTP + Li/DVP group were somnolence , dry mouth , and asthenia . Quetiapine combined with Li/DVP was not associated with extrapyramidal symptoms ( including akathisia ) or emergent depression . More QTP + Li/DVP-treated patients completed the trial , and there was no difference in discontinuation rates due to adverse events between the two groups . Quetiapine , in combination with lithium or divalproex , is well tolerated and has superior efficacy to lithium or divalproex alone in the treatment of bipolar mania",
"BACKGROUND Despite several treatmentoptions , adherenceto therapy is poor in patients with bipolar disorder . AIMS A double-blind , controlled comparison of aripiprazole and haloperidol in patients with bipolar I disorder experiencing acute manic or mixed episodes . METHOD Patients ( n=347 ) were r and omised to receive aripiprazole or haloperidol in this 12-week , multicentre study . The primary outcome measure was the number of patients in response ( greater , similar 50 % improvement from baseline in Young Mania Rating Scale score ) and receiving therapy at week 12 . RESULTS At week 12 , significantly more patients taking aripiprazole ( 49.7 % ) were in response and receiving therapy compared with those taking haloperidol ( 28.4 % ; P Continuation rates differed markedly between treatments ( week 12 : aripiprazole , 50.9 % ; haloperidol , 29.1 % ) . Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole ( 62.7 % v. 24.0 % ) . CONCLUSIONS Aripiprazole showed superior levels of response and tolerability to haloperidol in the treatment of an acute manic episode for up to 12 weeks",
"OBJECTIVE Evaluate the efficacy and tolerability of quetiapine ( QTP ) combined with lithium ( Li ) or divalproex ( DVP ) in the treatment of acute mania . METHODS Patients were r and omized to 21 days of double-blind treatment with QTP plus Li/DVP , or placebo ( PBO ) plus Li/DVP . QTP was rapidly dosed up to a maximum of 800 mg/day ; Li was dosed to 0.7 - 1.0 mEq/L ; or DVP to 50 - 100 microg/mL. RESULTS Fifty-six of 91 ( 61.5 % ) individuals in the QTP + Li/DVP group compared with 49 of 100 ( 49 % ) taking PBO + Li/DVP completed the study . A significantly greater mean reduction in total Young Mania Rating Scale ( YMRS ) score was observed at end-point in patients receiving QTP + Li/DVP compared with those in the PBO + Li/DVP group ( -13.76 versus -9.93 ; p = 0.021 ) . The response rate ( > or = 50 % YMRS improvement ) was significantly higher in the QTP + Li/DVP group than in PBO + Li/DVP-treated patients ( 54.3 % versus 32.6 % ; p = 0.005 ) , as was the proportion of patients achieving clinical remission ( YMRS + Li/DVP also had a significantly greater improvement in Clinical Global Impressions-Bipolar ( CGI-BP ) Severity of Illness scores ( -1.38 versus -0.78 ; p = 0.001 ) . The mean last-week dose of QTP was 584 mg/day in patients meeting response criteria . Common adverse events ( at least 10 % and twice the rate of Li/DVP ) in the QTP + Li/DVP group included somnolence , dry mouth , asthenia , and postural hypotension . CONCLUSIONS Quetiapine combined with either Li or DVP has superior efficacy compared with Li or DVP monotherapy for treating patients with bipolar mania . Combination therapy was well-tolerated and most adverse events were mild , withdrawal because of adverse events being only 5 % compared with 6 % on Li or DVP monotherapy",
"BACKGROUND Traditional and largely qualitative review s of evidence are now giving way to much more structured systematic overviews that use a quantitative method to calculate the overall effect of treatment . The latter approach is dependent on the quality of primary studies , which may introduce bias if they are of poor method ologic quality . OBJECTIVE To test the hypothesis that the inclusion of poor- quality trials in meta-analyses would bias the conclusions and produce incorrect estimates of treatment effect . METHODS An overview of r and omized trials of antiestrogen therapy in subfertile men with oligospermia was performed to test the hypothesis . Data sources included online search ing of MEDLINE and Science Citation Index data bases between 1966 and 1994 , scanning the bibliography of known primary studies and review articles , and contacting experts in the field . After independent , blind assessment , nine of 149 originally identified studies met the inclusion criteria and were selected . We assessed study quality independently . Outcome data from each study were pooled and statistically summarized . RESULTS There was a marginal improvement in pregnancy rate with antiestrogen treatment ( odds ratio , 1.6 ; 95 % confidence interval , 0.9 to 2.6 ) . Sensitivity analyses on the basis of method ologic quality demonstrated that poor- quality studies produced a positive effect with treatment , whereas no benefit was observed with high- quality studies . CONCLUSION The results of a meta- analysis are influenced by the quality of the primary studies included . Method ologically , poor studies tend to exaggerate the overall estimate of treatment effect and may lead to incorrect inferences",
"& NA ; The objective was to investigate the relationship between pain relief scores produced by placebo and by active interventions in r and omised controlled trials ( RCTs ) . Individual patient categorical pain relief scores from 5 placebo‐controlled single‐dose parallel‐group RCTs in acute postoperative pain were used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) for the different treatments . One hundred and thirty of the 525 patients in the 5 trials had a placebo . Individual patients ' scores with placebo varied from 0 to 100 % of the maximum possible pain relief . The proportion who obtained more than 50 % of the maximum possible pain relief with placebo varied from 7 % to 37 % across the trials ; with the active drugs the variation was from 5 to 63 % . Mean placebo scores were related to the mean score for the active treatments in each study ; the higher the mean active score , the higher the mean placebo score . This relationship disappeared when median values were used . Medical folklore has it that the amount of relief obtained with placebo is one‐third of the maximum possible ( and does not vary ) , and that one‐third of patients respond to placebo . The results show that the amount of relief obtained with placebo varies considerably between patients , that 38 % of patients obtained more than 10 % of the maximum possible relief , and 16 % obtained greater than 50 % . In double‐blind , r and omised parallel‐group studies of high quality placebo scores should not vary . Despite these conditions being met the placebo scores did vary . The previous explanation , of a relationship between the mean placebo scores and the mean scores for the active treatments was not supported",
"OBJECTIVE Determine the efficacy and tolerability of olanzapine/fluoxetine combination ( OFC ) for treatment of acute bipolar I depression compared with lamotrigine . METHOD The 7-week , acute phase of a r and omized , double-blind study compared OFC ( 6/25 , 6/50 , 12/25 , or 12/50 mg/day ; N = 205 ) with lamotrigine ( [ LMG ] titrated to 200 mg/day ; N = 205 ) in patients with DSM-IV-diagnosed bipolar I disorder , depressed . The study was conducted from November 2003 to August 2004 . RESULTS Completion rates were similar between treatments ( OFC , 66.8 % vs. LMG , 65.4 % ; p = .835 ) . OFC-treated patients had significantly greater improvement than lamotrigine-treated patients in change from baseline across the 7-week treatment period on the Clinical Global Impressions-Severity of Illness scale ( primary outcome ) ( p = .002 , effect size = 0.26 ) , Montgomery-Asberg Depression Rating Scale ( MADRS ) ( p = .002 , effect size = 0.24 ) , and Young Mania Rating Scale total scores ( p = .001 , effect size = 0.24 ) . Response rates did not significantly differ between groups when defined as > or = 50 % reduction in MADRS score ( OFC , 68.8 % vs. LMG , 59.7 % ; p = .073 ) . Time to response was significantly shorter for OFC-treated patients ( median days [ 95 % CI ] = OFC , 17 [ 14 to 22 ] vs. LMG , 23 [ 21 to 34 ] ; p = .010 ) . There was a significant difference in incidence of \" suicidal and self-injurious behavior \" adverse events ( OFC , 0.5 % vs. LMG , 3.4 % ; p = .037 ) . Somnolence , increased appetite , dry mouth , sedation , weight gain , and tremor occurred more frequently ( p OFC-treated patients than lamotrigine-treated patients . Weight , total cholesterol , and triglyceride levels were significantly elevated in OFC-treated patients compared with lamotrigine-treated patients ( all p Patients with acute bipolar I depression had statistically significantly greater improvement in depressive and manic symptoms , more treatment-emergent adverse events , greater weight gain , and some elevated metabolic factors with OFC than lamotrigine . Treatment differences were of modest size",
"BACKGROUND Few controlled studies have examined the use of atypical antipsychotic drugs for prevention of relapse in patients with bipolar I disorder . Aims To evaluate whether olanzapine plus either lithium or valproate reduces the rate of relapse , compared with lithium or valproate alone . METHOD Patients achieving syndromic remission after 6 weeks'treatment with olanzapine plus either lithium ( 0.6 - 1.2 mmol/l ) or valproate ( 50 - 125 microg/ml ) received lithium or valproate plus either olanzapine 5 - 20 mg/day ( combination therapy ) or placebo ( monotherapy ) , and were followed in a double-masked trial for 18 months . RESULTS The treatment difference in time to relapse into either mania or depression was not significant for syndromic relapse ( median time to relapse : combination therapy 94 days , monotherapy 40.5 days ; P=0.742 ) , but was significant for symptomatic relapse ( combination therapy 163 days , monotherapy 42 days ; P=0.023 ) . CONCLUSIONS Patients taking olanzapine added to lithium or valproate experienced sustained symptomatic remission , but not syndromic remission , for longer than those receiving lithium or valproate monotherapy",
"BACKGROUND This r and omized controlled trial compares the efficacy and safety of olanzapine vs haloperidol , as well as the quality of life of patients taking these drugs , in patients with bipolar mania . METHODS The design consisted of 2 successive , 6-week , double-blind periods and compared flexible dosing of olanzapine ( 5 - 20 mg/d , n = 234 ) with haloperidol ( 3 - 15 mg/d , n = 219 ) . RESULTS Rates of remission ( Young-Mania Rating Scale score of 21-item Hamilton Rating Scale for Depression score of olanzapine- and haloperidol-treated patients ( 52.1 % vs 46.1 % , respectively ; P = .15 ) . For the subgroup of patients whose index episode did not include psychotic features , rates of remission were significantly greater for the olanzapine group compared with the haloperidol group ( 56.7 % vs 41.6 % , P = .04 ) . Relapse into an affective episode ( mania and /or depression ) occurred in 13.1 % and 14.8 % of olanzapine- and haloperidol-treated patients , respectively ( P = .56 ) . Switch to depression occurred significantly more rapidly with haloperidol than with olanzapine when using survival analysis techniques ( P = .04 ) , and significantly more haloperidol-treated patients experienced worsening of extrapyramidal symptoms , as indicated by several measures . Weight gain was significantly greater in the olanzapine group compared with the haloperidol group ( 2.82 vs 0.02 kg , P quality of life on several dimensions compared with the haloperidol group . CONCLUSIONS These data suggest that olanzapine does not differ from haloperidol in achieving overall remission of bipolar mania . However , haloperidol carries a higher rate of extrapyramidal symptoms , whereas olanzapine is associated with weight gain",
"OBJECTIVE The authors compared the efficacy and safety of aripiprazole , a novel antipsychotic , to placebo for treatment of patients in an acute manic or mixed episode of bipolar disorder . METHOD This 3-week , multicenter , double-blind study r and omly assigned 262 bipolar disorder patients in an acute manic or mixed episode to aripiprazole , 30 mg/day ( reduced to 15 mg/day if needed for tolerability ) , or placebo . Patients remained hospitalized for at least 2 of the weeks . The primary efficacy measure was mean change from baseline in total score on the Young Mania Rating Scale ; response was defined as a decrease in score of > or = 50 % . RESULTS Aripiprazole produced statistically significant mean improvements in total score on the Young Mania Rating Scale compared with placebo ( -8.2 versus -3.4 , respectively ) and produced a significantly higher response rate ( 40 % versus 19 % ) . For key efficacy variables ( response per Young Mania Rating Scale ; Clinical Global Impression-Bipolar Version scores for severity of illness [ mania ] and change from preceding phase [ mania ] ) , aripiprazole separated from placebo by day 4 . The completion rate was significantly higher with aripiprazole than with placebo ( 42 % versus 21 % ) . Discontinuations due to adverse events did not differ significantly between the aripiprazole and placebo groups . There were no significant changes in body weight versus placebo , and aripiprazole was not associated with elevated serum prolactin or QTc prolongation . CONCLUSIONS Aripiprazole had significantly greater efficacy than placebo for the treatment of bipolar disorder patients in acute manic or mixed episodes and was safe and well tolerated in this r and omized controlled trial",
"BACKGROUND We compared the efficacy and safety of olanzapine vs placebo for the treatment of acute bipolar mania . METHODS Four-week , r and omized , double-blind , parallel study . A total of 115 patients with a DSM-IV diagnosis of bipolar disorder , manic or mixed , were r and omized to olanzapine , 5 to 20 mg/d ( n = 55 ) , or placebo ( n = 60 ) . The primary efficacy measure was the Young-Mania Rating Scale ( Y-MRS ) total score . Response and euthymia were defined , a priori , as at least a 50 % improvement from baseline to end point and as a score of no less than 12 at end point in the Y-MRS total score , respectively . Safety was assessed using adverse events , Extrapyramidal Symptom ( EPS ) rating scales , laboratory values , electrocardiograms , vital signs , and weight change . RESULTS Olanzapine-treated patients demonstrated a statistically significant greater mean ( + /- SD ) improvement in Y-MRS total score than placebo-treated patients ( -14.8 + /- 12.5 and -8.1 + /- 12.7 , respectively ; P Olanzapine-treated patients demonstrated a higher rate of response ( 65 % vs 43 % , respectively ; P = .02 ) and euthymia ( 61 % vs 36 % , respectively ; P = . 01 ) than placebo-treated patients . There were no statistically significant differences in EPSs between groups . However , olanzapine-treated patients had a statistically significant greater mean ( + /- SD ) weight gain than placebo-treated patients ( 2.1 + /- 2.8 vs 0.45 + /- 2.3 kg , respectively ) and also experienced more treatment-emergent somnolence ( 21 patients [ 38.2 % ] vs 5 [ 8.3 % ] , respectively ) . CONCLUSION Olanzapine demonstrated greater efficacy than placebo in the treatment of acute bipolar mania and was generally well tolerated",
"BACKGROUND Few double-blind trials have examined the efficacy of a combination of a mood stabiliser and an atypical antipsychotic in acute mania . AIMS To determine the efficacy of risperidone in combination with a mood stabiliser in acute mania . METHOD Patients taking a mood stabiliser were r and omised to 3 weeks ' treatment with risperidone ( n=75 ) or placebo ( n=76 ) . RESULTS Young Mania Rating Scale ( YMRS ) scores improved rapidly with significantly greater reductions at week 1 in the risperidone group compared with the placebo group . At end-point YMRS scores decreased by 14.5 and 10.3 points in the risperidone and placebo groups , respectively . Significant improvements v. placebo ( P YMRS scores in the risperidone group than in the placebo group . Incidence of adverse events was similar in both groups . CONCLUSIONS Risperidone is superior to placebo when used in combination with lithium or divalproex in acute mania",
"BACKGROUND A 6-week double-blind , r and omized , placebo-controlled trial was conducted to determine the efficacy of combined therapy with olanzapine and either valproate or lithium compared with valproate or lithium alone in treating acute manic or mixed bipolar episodes . METHODS The primary objective was to evaluate the efficacy of olanzapine ( 5 - 20 mg/d ) vs placebo when added to ongoing mood-stabilizer therapy as measured by reductions in Young Mania Rating Scale ( YMRS ) scores . Patients with bipolar disorder ( n = 344 ) , manic or mixed episode , who were inadequately responsive to more than 2 weeks of lithium or valproate therapy , were r and omized to receive cotherapy ( olanzapine + mood-stabilizer ) or monotherapy ( placebo + mood-stabilizer ) . RESULTS Olanzapine cotherapy improved patients ' YMRS total scores significantly more than monotherapy ( -13.11 vs -9.10 ; P = .003 ) . Clinical response rates ( > or = 50 % improvement on YMRS ) were significantly higher with cotherapy ( 67.7 % vs 44.7 % ; P 21-item Hamilton Depression Rating Scale ( HAMD-21 ) total scores significantly more than monotherapy ( 4.98 vs 0.89 points ; P or = 20 at baseline ) , olanzapine cotherapy improved HAMD-21 scores by 10.31 points compared with 1.57 for monotherapy ( P ( Simpson-Angus Scale , Barnes Akathisia Scale , Abnormal Involuntary Movement Scale ) were not significantly changed from baseline to end point in either treatment group . Treatment-emergent symptoms that were significantly higher for the olanzapine cotherapy group included somnolence , dry mouth , weight gain , increased appetite , tremor , and slurred speech . CONCLUSION Compared with the use of valproate or lithium alone , the addition of olanzapine provided superior efficacy in the treatment of manic and mixed bipolar episodes",
"BACKGROUND Typical experimental categorizations of treatment responses in bipolar disorder ( BPD ) patients may have limited relationship to clinical recovery or functional status , and there is inadequate research on such clinical ly important outcomes . METHODS We analyzed data from a study of open continuation of olanzapine treatment following a 3-week placebo-controlled trial involving initially hospitalized adult subjects with DSM-IV BP-I mania to estimate rates and times to symptomatic remission ( low scores on st and ardized symptomatic assessment s ) and clinical recovery ( remission sustained > or=8 weeks ) , associated clinical factors , and functional outcomes . RESULTS During treatment with olanzapine for 27.9+/-20.1 weeks , symptomatic remission was attained by 70 % of subjects , half by 8 weeks ( 95 % CI 6 - 10 ) weeks , and later lost by 82 % of remitted subjects ; remitted ( versus non-remitted ) subjects had slightly lower baseline clinical global impression scores and greater trial-completion . Sustained clinical recovery was attained by only 40 of 113 ( 35 % ) of subjects , half by 36 ( 95 % CI 20 - 40 ) weeks , and later lost by 45 % . Subjects with above-median ( > 12 ) initial Hamilton-Depression rating scale depression scores were half as likely to recover ( p=0.016 ) and did so much later ( 36 versus 12 weeks ) than those with lower scores . At final assessment , self-rated well being ( SF-36 psychosocial functioning scores ) improved substantially more among recovered versus non-recovered subjects ( mean changes : 87 % versus 23 % ) , and two-thirds of recovered subjects remained unemployed-for-pay while half received disability-compensation . CONCLUSIONS Clinical ly meaningful symptomatic remission and recovery in relatively severely ill adult bipolar I manic patients were achieved slowly and sustained by only some patients within an average of 7 months of continuous treatment . These clinical ly relevant outcomes were worse with relatively high initial dysphoria ratings . Well-being was rated higher by recovered subjects , but their ability to work and live independently were markedly impaired . These findings underscore the emerging view that BPD can often be severe , slow to remit , and disabling , particularly in association with prominent depression-dysphoria symptoms . Improved treatments for BPD are needed , guided by longitudinal assessment s of clinical ly meaningful measures of symptomatic recovery and functional outcome",
"OBJECTIVE Few double-blind trials have compared longer-term efficacy and safety of medications for bipolar disorder . The authors report a 47-week comparison of olanzapine and divalproex . METHOD This 47-week , r and omized , double-blind study compared flexibly dosed olanzapine ( 5 - 20 mg/day ) to divalproex ( 500 - 2500 mg/day ) for manic or mixed episodes of bipolar disorder ( N=251 ) . The only other psychoactive medication allowed was lorazepam for agitation . The primary efficacy instrument was the Young Mania Rating Scale ; a priori protocol -defined threshold scores were > or = 20 for inclusion , or = 15 for relapse . Analytical techniques included mixed model repeated- measures analysis of variance for change from baseline , Fisher 's exact test ( two-tailed ) for categorical comparisons , and Kaplan-Meier estimates of time to events of interest . RESULTS Over 47 weeks , mean improvement in Young Mania Rating Scale score was significantly greater for the olanzapine group . Median time to symptomatic mania remission was significantly shorter for olanzapine , 14 days , than for divalproex , 62 days . There were no significant differences between treatments in the rates of symptomatic mania remission over the 47 weeks ( 56.8 % and 45.5 % , respectively ) and subsequent relapse into mania or depression ( 42.3 % and 56.5 % ) . Treatment-emergent adverse events occurring significantly more frequently during olanzapine treatment were somnolence , dry mouth , increased appetite , weight gain , akathisia , and high alanine aminotransferase levels ; those for divalproex were nausea and nervousness . CONCLUSIONS In this 47-week study of acute bipolar mania , symptomatic remission occurred sooner and overall mania improvement was greater for olanzapine than for divalproex , but rates of bipolar relapse did not differ",
"OBJECTIVE The authors compared the efficacy of olanzapine and lithium in the prevention of mood episode relapse/recurrence . METHOD Patients with a diagnosis of bipolar disorder ( manic/mixed ) , a history of two or more manic or mixed episodes within 6 years , and a Young Mania Rating Scale total score > or = 20 entered the study and received open-label co-treatment with olanzapine and lithium for 6 - 12 weeks . Those meeting symptomatic remission criteria ( Young Mania Rating Scale score ; 21-item Hamilton depression scale score olanzapine , 5 - 20 mg/day ( N=217 ) , or lithium ( target blood level : 0.6 - 1.2 meq/liter ) ( N=214 ) . RESULTS Symptomatic relapse/recurrence ( score > or = 15 on either the Young Mania Rating Scale or Hamilton depression scale ) occurred in 30.0 % of olanzapine-treated and 38.8 % of lithium-treated patients . The noninferiority of olanzapine relative to lithium ( primary objective ) in preventing relapse/recurrence was met , since the lower limit of the 95 % confidence interval on the 8.8 % risk difference ( -0.1 % to 17.8 % ) exceeded the predefined noninferiority margin ( -7.3 % ) . Secondary results showed that compared with lithium , olanzapine had significantly lower risks of manic episode and mixed episode relapse/recurrence . Depression relapse/recurrence occurred in 15.7 % of olanzapine-treated and 10.7 % of lithium-treated patients . Mean weight gain during open-label co-treatment was 2.7 kg ; during double-blind monotherapy , weight gain was significantly greater with olanzapine ( 1.8 kg ) than with lithium ( -1.4 kg ) . CONCLUSIONS These results suggest that olanzapine was significantly more effective than lithium in preventing manic and mixed episode relapse/recurrence in patients acutely stabilized with olanzapine and lithium co-treatment . Both agents were comparable in preventing depression relapse/recurrence",
"BACKGROUND Bipolar depression is a major clinical problem that remains under- research ed . The current study was intended to evaluate the effects of the novel antipsychotic risperidone , the selective serotonin reup-take inhibitor ( SSRI ) paroxetine , and the combination in patients with bipolar disorder . METHOD Thirty patients with DSM-IV bipolar ( I or II ) disorder , depressed phase , who were receiving a stable dose of a mood stabilizer were r and omly assigned to 12 weeks of double-blind treatment with risperidone ( plus placebo ) , paroxetine ( plus placebo ) , or the combination of risperidone and paroxetine . Data were gathered from August 1999 to September 2001 . RESULTS All 3 groups experienced significant reductions in depression ratings from baseline to endpoint ; there were no significant differences in outcome between groups . There were statistically significant differences in paroxetine dose contrasting paroxetine plus placebo against the combined condition . The switch rate into mania or hypomania was very low , with only 1 patient in the paroxetine plus placebo condition experiencing mild hypomania . CONCLUSION These results suggest that risperidone , paroxetine , and the combination of risperidone and paroxetine are equally but modestly effective when added to a mood stabilizer in bipolar depression . The paroxetine dose differed between groups , possibly because of drug-drug interactions . Using another SSRI in the combined condition could have produced a more robust effect and should be tested",
"BACKGROUND This study compared the efficacy , safety , and tolerability of divalproex and olanzapine in the treatment of acute mania associated with bipolar disorder . METHOD This r and omized , 12-week , double-blind , parallel-group , multicenter study included DSM-IV-defined bipolar disorder type I patients hospitalized for acute mania and r and omly assigned to treatment with divalproex or olanzapine . After an inpatient period of up to 21 days , subjects were followed as out patients . Dose adjustment was permitted during the inpatient period . Efficacy was assessed using change from baseline in Mania Rating Scale ( MRS ) score to day 21 ; other efficacy measures included the Brief Psychiatric Rating Scale , the Hamilton Rating Scale for Depression , and the Clinical Global Impressions-Part I , Severity of Illness scale . The primary safety endpoint was change from baseline in weight . Other safety and tolerability endpoints included spontaneous adverse event reporting and changes from baseline in laboratory measures and vital signs . RESULTS 120 subjects ( N = 63 divalproex , N = 57 olanzapine ) were r and omly assigned to treatment . No significant differences between groups were found for any efficacy variable for change from baseline to day 21 . Mean MRS score changes from baseline to day 21 were -14.8 for divalproex and -17.2 for olanzapine ( p = .210 ) . A significantly ( p olanzapine-treated subjects experienced somnolence , weight gain , edema , rhinitis , and speech disorder ( slurred speech ) ; no adverse events were significantly greater in the divalproex group . A number of laboratory measures also demonstrated significant treatment differences , but the clinical significance of many of these is uncertain . Mean body weight changes were significantly greater in the olanzapine group ( + 8.8 lb [ + 4.0 kg ] ) than the divalproex group ( + 5.5 lb [ + 2.5 kg ] , p death occurred during the study ( olanzapine group , diabetic ketoacidosis ) . CONCLUSION No significant difference in efficacy was found between treatment groups . Divalproex was associated with a more favorable adverse event profile and significantly less weight gain than olanzapine",
"Neuroleptics are of established efficacy in mania . Controlled data on the use of olanzapine in mania is however , absent . In this study , 30 patients meeting DSM-IV criteria for mania were r and omly allocated to receive either olanzapine or lithium in a 4 week double-blind r and omized controlled design . There were no significant outcome differences between the two groups on any of the primary outcome measures , the Brief Psychiatric Rating Scale ( lithium 28.2 ; olanzapine 28.0 ; P = 0.44 ) ; Clinical Global Impression ( CGI ) improvement scale ( lithium 2.75 , olanzapine 2.36 ; P = 0.163 ) or the Mania Scale ( lithium 13.2 , olanzapine 10.2 ; P = 0.315 ) . Olanzapine was however , significantly superior to lithium on the CGI-severity scale at week 4 ( lithium 2.83 , olanzapine 2.29 ; P = 0.025 ) . Olanzapine did not differ from lithium in terms of treatment emergent extrapyramidal side-effects as measured by the Simpson-Angus Scale . Olanzapine appears to be at least as effective as lithium in the treatment of mania",
"OBJECTIVE Little is known about clinical features associated with the risk of recurrence in patients with bipolar disorder receiving treatment according to contemporary practice guidelines . The authors looked for the features associated with risk of recurrence . METHOD The authors examined prospect i ve data from a cohort of patients with bipolar disorder participating in the multicenter Systematic Treatment Enhancement Program for Bipolar Disorder ( STEP-BD ) study for up to 24 months . For those who were symptomatic at study entry but subsequently achieved recovery , time to recurrence of mania , hypomania , mixed state , or a depressive episode was examined with Cox regression . RESULTS Of 1,469 participants symptomatic at study entry , 858 ( 58.4 % ) subsequently achieved recovery . During up to 2 years of follow-up , 416 ( 48.5 % ) of these individuals experienced recurrences , with more than twice as many developing depressive episodes ( 298 , 34.7 % ) as those who developed manic , hypomanic , or mixed episodes ( 118 , 13.8 % ) . The time until 25 % of the individuals experienced a depressive episode was 21.4 weeks and until 25 % experienced a manic/hypomanic/mixed episode was 85.0 weeks . Residual depressive or manic symptoms at recovery and proportion of days depressed or anxious in the preceding year were significantly associated with shorter time to depressive recurrence . Residual manic symptoms at recovery and proportion of days of elevated mood in the preceding year were significantly associated with shorter time to manic , hypomanic , or mixed episode recurrence . CONCLUSIONS Recurrence was frequent and associated with the presence of residual mood symptoms at initial recovery . Targeting residual symptoms in maintenance treatment may represent an opportunity to reduce risk of recurrence",
"OBJECTIVE The study evaluated the efficacy and tolerability of ziprasidone , compared with placebo , in the treatment of adult patients with acute bipolar mania . METHOD Patients with a primary DSM-IV diagnosis of bipolar I disorder and a current manic or mixed episode ( confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders , Patient Edition ) ( N=210 ) were r and omly assigned in a 2:1 ratio to 3 weeks of double-blind treatment with ziprasidone ( 40 - 80 mg twice daily ) or placebo . Efficacy was assessed with the Schedule for Affective Disorders and Schizophrenia , Change Version ( which contains the Mania Rating Scale ) , Positive and Negative Syndrome Scale , Clinical Global Impression ( CGI ) severity scale , CGI improvement scale , and Global Assessment of Functioning Scale . Primary efficacy variables were differences from baseline to endpoint ( last observation carried forward ) in mean Mania Rating Scale and CGI severity scale scores between the ziprasidone and placebo groups . Safety evaluations included monitoring of adverse events , vital signs , electrocardiogram results , and clinical laboratory values and assessment of movement disorders and akathisia . RESULTS Ziprasidone produced rapid , sustained improvements relative to baseline and placebo on all primary and most secondary efficacy measures at endpoint . Significant improvements were typically observed within 2 days after treatment commenced and were maintained throughout the 3 weeks . Ziprasidone was well tolerated and associated with a low rate of extrapyramidal symptoms ; neither weight gain nor clinical ly significant changes in vital signs or other safety parameters were observed with ziprasidone . CONCLUSIONS Ziprasidone monotherapy was significantly superior to placebo in reducing symptoms of acute mania in patients with bipolar I disorder . Onset of action was rapid , and tolerability of ziprasidone was generally comparable to that of placebo",
"BACKGROUND Severe mania is life-threatening , carries an increased risk of suicide and has a serious impact on patients and their families . Efficient and rapid control of episodes of acute mania is needed . AIMS To evaluate the safety and efficacy of risperidone monotherapy for acute mania . METHOD In a 3-week , r and omised , double-blind trial , 290 in- patients with bipolar I disorder with current manic or mixed episode and a baseline Young Mania Rating Scale ( YMRS ) score of 20 or more received flexible doses of risperidone ( 1 - 6 mg per day ) or placebo . RESULTS Risperidone was received by 146 patients and placebo by144 . Their mean baseline YMRS score was 37.2 ( s.e.=0.5 ) . Significantly greater improvements were observed with risperidone than with placebo at weeks 1 and 2 and at end-point ( total YMRS : P Extrapyramidal symptoms were the most frequently reported adverse events in the risperidone group . CONCLUSIONS In patients with severe manic symptoms , risperidone produced significant improvements in YMRS scores as early as week 1 and substantial changes at end-point . Treatment was well tolerated",
"This study compares the efficacy , safety , and tolerability of a partial dopamine agonist , aripiprazole , with placebo in the treatment of patients with bipolar I disorder experiencing an acute manic or mixed episode . In total , 272 hospitalized patients were r and omized to aripiprazole 30mg/day or placebo in this 3-week , double-blind , placebo-controlled trial . Dosing could be reduced to 15mg/day for tolerability and , subsequently , increased to 30mg/day based on clinical response . Primary efficacy measure was mean change from baseline to endpoint in Young Mania Rating Scale ( YMRS ) total score ; response was defined as 50 % decrease from baseline YMRS score . Aripiprazole-treated patients demonstrated significantly greater improvement from baseline to endpoint in mean YMRS total scores compared with placebo-treated patients as early as Day 4 and sustained through Week 3 . A significantly higher response rate was observed in aripiprazole-treated patients ( 53 % vs. 32 % at endpoint ) . Aripiprazole produced significantly greater improvements from baseline on other efficacy assessment s compared with placebo , including Clinical Global Impression – Bipolar Version Severity and Improvement scores . The 30mg/day dose was maintained by 85 % of aripiprazole-treated patients . Incidence of discontinuations due to adverse events was similar for aripiprazole ( 8.8 % ) and placebo ( 7.5 % ) . Aripiprazole treatment result ed in no significant difference from placebo in change in mean body weight and was not associated with elevated serum prolactin or QTc prolongation . In conclusion , aripiprazole demonstrated superior efficacy to placebo in the treatment of patients with bipolar I disorder presenting with acute manic or mixed episodes , and exhibited a favourable safety and tolerability profile ",
"In a r and omized , double-blind trial , patients with acute bipolar mania received 1 - 6 mg/day of risperidone , 2 - 12 mg/day of haloperidol , or placebo for 3 weeks , followed by double-blind risperidone or haloperidol for 9 weeks . Of 438 patients , 154 were r and omized to risperidone , 144 to haloperidol , and 140 to placebo . The mean+/-S.D. modal doses were 4.2+/-1.7 mg/day of risperidone and 8.0+/-3.6 mg/day of haloperidol during the initial 3-week phase and 4.1+/-1.8 and 7.4+/-3.7 mg/day during the 12-week period . At week 3 , mean Young Mania Rating Scale ( YMRS ) score reductions from baseline were significantly greater in patients receiving risperidone than placebo ( p risperidone and haloperidol on this efficacy measure were not significant . Further reductions in YMRS scores were seen in patients receiving risperidone or haloperidol during the subsequent 9 weeks . No unexpected adverse events were reported . Extrapyramidal disorder and hyperkinesias , the most commonly reported adverse events with antipsychotic use , occurred less frequently with risperidone than haloperidol . We conclude that risperidone monotherapy was an effective and well-tolerated treatment for bipolar mania and that efficacy was maintained over the long term",
"This study evaluated the efficacy and tolerability of quetiapine monotherapy for depressive episodes in patients with bipolar I or II disorder ( Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition ) who were r and omized to 8 weeks of double-blind treatment with quetiapine ( 300 or 600 mg/d ; once daily , evening dosing ) or placebo . Patients were assessed weekly using the Montgomery-Åsberg Depression Rating Scale ( MADRS ) and Hamilton Depression Rating Scale ( HAM-D ) . The primary end point was change in MADRS total score from baseline to Week 8 ( analysis of covariance/last-observation-carried-forward analysis ) . Of 509 patients r and omized , 59 % completed the study . Improvements from baseline in mean MADRS total scores were significantly greater with quetiapine 300 and 600 mg/d than with placebo from first evaluation ( Week 1 ) through Week 8 ( both P ≤ 0.001 vs. placebo ) . Therapeutic effect sizes at Week 8 were 0.61 and 0.54 for quetiapine 300 and 600 mg/d , respectively . Improvements in mean HAM-D scores were also significantly greater with both quetiapine doses than with placebo ( P The MADRS response and remission rates were also significantly greater in both quetiapine dose groups compared with placebo . Improvements in primary and secondary outcomes were observed with both 300 and 600 mg/d quetiapine without major differences between the doses . Common adverse events included dry mouth , sedation , somnolence , dizziness , and constipation . The incidence of treatment-emergent mania or hypomania was lower with quetiapine treatment than placebo . This study demonstrates that quetiapine monotherapy is an effective and well-tolerated treatment for depressive episodes in bipolar disorder , confirming the results observed from a previous study ( BipOLar DEpRession [ BOLDER ] I )",
"METHODS Patients ( n=302 ) with bipolar I disorder ( manic episode ) were r and omised to 12 weeks ' double-blind treatment with quetiapine ( flexibly dosed up to 800 mg/day ) , placebo , or haloperidol ( up to 8 mg/day ) . The primary efficacy outcome variable was change from baseline to Day 21 in Young Mania Rating Scale ( YMRS ) score . RESULTS YMRS score improved with quetiapine at Day 21 ( -12.29 versus -8.32 for placebo ; P Haloperidol also showed an advantage over placebo at Days 21 and 84 ( P significant difference in efficacy measures between quetiapine and haloperidol groups at any assessment except Day 21 . The only common adverse event with quetiapine was somnolence ( 12.7 % ) . Extrapyramidal symptoms ( EPS ) , including akathisia , occurred at 59.6 % with haloperidol , 12.7 % with quetiapine , 15.8 % with placebo . Most quetiapine responders ( 84 % ) received a dose of 400 - 800 mg/day . CONCLUSIONS Quetiapine was effective and well tolerated . The efficacy and tolerability profile of haloperidol ( including its propensity for EPS ) supported study validity",
"Background : In an earlier 21-day , placebo-controlled trial , ziprasidone was efficacious in improving symptoms of mania and was well tolerated . To confirm these results , a similarly design ed 21-day trial was conducted . Methods : In patients with bipolar I disorder , manic or mixed , were r and omized to ziprasidone ( 40 to 80 mg BID ) or placebo . Efficacy rating scales were derived from the Schedule for Affective Disorders and Schizophrenia-Change Bipolar Scale ( SADS-CB ) . SADS-CB-derived Mania Rating Scale ( MRS ) total score was the primary efficacy parameter . Secondary SADS-CB-derived efficacy parameters included Manic Syndrome and Behavior and Ideation Subscales , Hamilton Depression Rating Scale ( HAM-D ) , and the Montgomery Asberg Depression Rating Scale ( MADRS ) . The Clinical Global Impression-Severity Scale ( CGI-S ) , the Global Assessment of Functioning ( GAF ) , and the Positive and Negative Syndrome Scale ( PANSS ) were also assessed . Results : Sixty-five placebo and 137 ziprasidone patients were evaluable for efficacy . Baseline-to-endpoint mean changes in MRS scores were −11.1 for ziprasidone and −5.6 for placebo ( all patients , last observation carried forward [ LOCF ] ; P 0.01 ) . Ziprasidone produced significantly greater improvements in Manic Syndrome ( P ≤ 0.01 ) and Behavior and Ideation Subscales ( P ≤ 0.001 ) , CGI-S score , ( P ≤ 0.001 ) , PANSS Total ( P ≤ 0.01 ) and Positive Subscale ( P ≤ 0.001 ) scores , and GAF ( P ≤ 0.001 ) . With ziprasidone , significant improvements were observed from Day 2 onward for MRS and CGI-S at all time points except Day 4 for MRS . Treatment-related discontinuations due to adverse events were 5.8 % for ziprasidone and 1.5 % for placebo ( P = 0.20 ) . Conclusions : Ziprasidone was well tolerated , rapidly efficacious , and superior to placebo in improving symptoms and global illness severity in these in patients with acute bipolar mania , both manic and mixed episodes",
"OBJECTIVE There is a major unmet need for effective options in the treatment of bipolar depression . METHOD Five hundred forty-two out patients with bipolar I ( N=360 ) or II ( N=182 ) disorder experiencing a major depressive episode ( DSM-IV ) were r and omly assigned to 8 weeks of quetiapine ( 600 or 300 mg/day ) or placebo . The primary efficacy measure was mean change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale total score . Additional efficacy assessment s included the Hamilton Depression Rating Scale , Clinical Global Impression of severity and improvement , Hamilton Anxiety Rating Scale , Pittsburgh Sleep Quality Index , and Quality of Life Enjoyment and Satisfaction Question naire . RESULTS Quetiapine at either dose demonstrated statistically significant improvement in Montgomery-Asberg Depression Rating Scale total scores compared with placebo from week 1 onward . The proportions of patients meeting response criteria ( > or = 50 % Montgomery-Asberg Depression Rating Scale score improvement ) at the final assessment in the groups taking 600 and 300 mg/day of quetiapine were 58.2 % and 57.6 % , respectively , versus 36.1 % for placebo . The proportions of patients meeting remission criteria ( Montgomery-Asberg Depression Rating Scale quetiapine versus 28.4 % for placebo . Quetiapine at 600 and 300 mg/day significantly improved 9 of 10 and 8 of 10 Montgomery-Asberg Depression Rating Scale items , respectively , compared to placebo , including the core symptoms of depression . Treatment-emergent mania rates were low and similar for the quetiapine and placebo groups ( 3.2 % and 3.9 % , respectively ) . CONCLUSIONS Quetiapine monotherapy is efficacious and well tolerated for the treatment of bipolar depression ",
"OBJECTIVE The primary intent of this study was to compare the efficacy and safety of olanzapine and placebo in the treatment of acute mania . METHOD The design involved a r and om-assignment , double-blind , placebo-controlled parallel group study of 3 weeks ' duration . After a 2- to 4-day screening period , qualified patients were assigned to either olanzapine ( N = 70 ) or placebo ( N = 69 ) . Patients began double-blind therapy with either olanzapine , 10 mg , or placebo given once per day . After the first day of treatment , the daily dose could be adjusted upward or downward , as clinical ly indicated , by one capsule ( olanzapine , 5 mg/day ) within the allowed range of one to four capsules . The primary efficacy measure in the protocol was defined as a change from baseline to endpoint in total score on the Young Mania Rating Scale . Clinical response was defined a priori as a decrease of 50 % or more from baseline in Young Mania Rating Scale total score . RESULTS The olanzapine group experienced significantly greater mean improvement in Young Mania Rating Scale total score than the placebo group . On the basis of the clinical response criteria , significantly more olanzapine-treated patients ( 48.6 % ) responded than those assigned to placebo ( 24.2 % ) . Somnolence , dizziness , dry mouth , and weight gain occurred significantly more often with olanzapine . There were no statistically significant differences between the olanzapine-treated and placebo-treated patients with respect to measures of parkinsonism , akathisia , and dyskinesias . No discontinuations of treatment due to adverse events occurred in the olanzapine treatment group . CONCLUSIONS The results from this study suggest that compared with placebo , olanzapine has superior efficacy for the symptoms of acute mania",
"OBJECTIVE In a placebo-controlled , double-blind study , the authors investigated the efficacy and safety of olanzapine as monotherapy in relapse prevention in bipolar I disorder . METHOD Patients achieving symptomatic remission from a manic or mixed episode of bipolar I disorder ( Young Mania Rating Scale [ YMRS ] total score olanzapine were r and omly assigned to double-blind maintenance treatment with olanzapine ( N=225 ) or placebo ( N=136 ) for up to 48 weeks . The primary measure of efficacy was time to symptomatic relapse into any mood episode ( YMRS score > or = 15 , HAM-D score > or = 15 , or hospitalization ) . RESULTS Time to symptomatic relapse into any mood episode was significantly longer among patients receiving olanzapine ( a median of 174 days , compared with a median of 22 days in patients receiving placebo ) . Times to symptomatic relapse into manic , depressive , and mixed episodes were all significantly longer among patients receiving olanzapine than among patients receiving placebo . The relapse rate was significantly lower in the olanzapine group ( 46.7 % ) than in the placebo group ( 80.1 % ) . During olanzapine treatment , the most common emergent event was weight gain ; during the open-label phase , patients who received olanzapine gained a mean of 3.1 kg ( SD=3.4 ) . In double-blind treatment , placebo patients lost a mean of 2.0 kg ( SD=4.4 ) and patients who continued to take olanzapine gained an additional 1.0 kg ( SD=5.2 ) . CONCLUSIONS Compared to placebo , olanzapine delays relapse into subsequent mood episodes in bipolar I disorder patients who responded to open-label acute treatment with olanzapine for a manic or mixed episode",
"OBJECTIVE The effects of olanzapine and divalproex for the treatment of mania were compared in a large r and omized clinical trial . METHOD A 3-week , r and omized , double-blind trial compared flexibly dosed olanzapine ( 5 - 20 mg/day ) to divalproex ( 500 - 2500 mg/day in divided doses ) for the treatment of patients hospitalized for acute bipolar manic or mixed episodes . The Young Mania Rating Scale and the Hamilton Depression Rating Scale were used to quantify manic and depressive symptoms , respectively . Safety was assessed with several measures . RESULTS The protocol defined baseline-to-endpoint improvement in the mean total score on the Young Mania Rating Scale as the primary outcome variable . The mean Young Mania Rating Scale score decreased by 13.4 for patients treated with olanzapine ( N=125 ) and 10.4 for those treated with divalproex ( N=123 ) . A priori categorizations defined response and remission rates : 54.4 % of olanzapine-treated patients responded ( > or = 50 % reduction in Young Mania Rating Scale score ) , compared to 42.3 % of divalproex-treated patients ; 47.2 % of olanzapine-treated patients had remission of mania symptoms ( endpoint Young Mania Rating Scale divalproex-treated patients . The decrease in Hamilton depression scale score was similar in the two treatment groups . Completion rates for the 3-week study were similar in both groups . The most common treatment-emergent adverse events ( incidence > 10 % ) occurring more frequently during treatment with olanzapine were dry mouth , increased appetite , and somnolence . For divalproex , nausea was more frequently observed . The average weight gain with olanzapine treatment was 2.5 kg , compared to 0.9 kg with divalproex treatment . CONCLUSIONS The olanzapine treatment group had significantly greater mean improvement of mania ratings and a significantly greater proportion of patients achieving protocol -defined remission , compared with the divalproex treatment group . Significantly more weight gain and cases of dry mouth , increased appetite , and somnolence were reported with olanzapine , while more cases of nausea were reported with divalproex",
"Case reports and studies of other neuroleptics suggest the efficacy of risperidone in the treatment of mania . Forty-five in patients with DSM-IV mania were studied in a 28-day r and omized , controlled , double-blind trial of either 6 mg daily of risperidone , 10 mg daily of haloperidol , or 800 to 1200 mg daily of lithium . The patients in all three groups showed a similar improvement on the total score for all rating scales at day 28 ( Brief Psychiatric rating scale : lithium 9.1 , haloperidol 4.9 , risperidone 6.5 , F = 1.01 , df = 2 , p = 0.37 ; Mania rating scale : lithium 15.7 , haloperidol 10.2 , risperidone 12.4 , F = 1.07 , df = 2 , p = = 0.35 [ analysis of variance ] ) . The Global Assessment of Functioning and Clinical Global Impression data showed a similar pattern of improvement . This study suggests that risperidone is of equivalent efficacy to lithium and haloperidol in the management of acute mania . The extrapyramidal side effects of risperidone and haloperidol were not significantly different",
"OBJECTIVE The study assessed the efficacy and safety of risperidone as an adjunctive agent to mood stabilizers in the treatment of acute mania . METHOD This 3-week r and omized , double-blind , placebo-controlled study included 156 bipolar disorder patients with a current manic or mixed episode who received a mood stabilizer ( lithium or divalproex ) and placebo , risperidone , or haloperidol . The primary efficacy measure was the Young Mania Rating Scale . Other assessment s used the Brief Psychiatric Rating Scale , the Clinical Global Impression scale , and safety measures . RESULTS The trial was discontinued by 25 ( 49 % ) of the 51 placebo group patients , 18 ( 35 % ) of the 52 risperidone group patients , and 28 ( 53 % ) of the 53 haloperidol group patients . Mean modal doses were 3.8 mg/day ( SD=1.8 ) of risperidone and 6.2 mg/day ( SD=2.9 ) of haloperidol . Significantly greater reductions in Young Mania Rating Scale scores at endpoint and over time were seen in the risperidone group and in the haloperidol group , compared with the placebo group . Young Mania Rating Scale total scores improved with risperidone and with haloperidol both in patients with psychotic features and in those without psychotic features at baseline . Extrapyramidal Symptom Rating Scale total scores at endpoint were significantly higher in the haloperidol patients than in the placebo patients . Antiparkinsonian medications were received by 8 % , 17 % , and 38 % of patients in the placebo , risperidone , and haloperidol groups , respectively . CONCLUSIONS Risperidone plus a mood stabilizer was more efficacious than a mood stabilizer alone , and as efficacious as haloperidol plus a mood stabilizer , for the rapid control of manic symptoms and was well tolerated",
"BACKGROUND Despite the longer duration of the depressive phase in bipolar disorder and the frequent clinical use of antidepressants combined with antipsychotics or mood stabilizers , relatively few controlled studies have examined treatment strategies for bipolar depression . OBJECTIVE To examine the use of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression . DESIGN Double-blind , 8-week , r and omized controlled trial . SETTING Eighty-four sites ( inpatient and outpatient ) in 13 countries . Patients A total of 833 r and omized adults with bipolar I depression with a Montgomery-Asberg Depression Rating Scale ( MADRS ) score of at least 20 . Intervention Patients were r and omly assigned to receive placebo ( n = 377 ) ; olanzapine , 5 to 20 mg/d ( n = 370 ) ; or olanzapine-fluoxetine combination , 6 and 25 , 6 and 50 , or 12 and 50 mg/d ( n = 86 ) . MAIN OUTCOME MEASURE Changes in MADRS total scores using mixed-effects model repeated- measures analyses . RESULTS During all 8 study weeks , the olanzapine and olanzapine-fluoxetine groups showed statistically significant improvement in depressive symptoms vs the placebo group ( P olanzapine-fluoxetine group also showed statistically greater improvement than the olanzapine group at weeks 4 through 8 . At week 8 , MADRS total scores were lower than at baseline by 11.9 , 15.0 , and 18.5 points in the placebo , olanzapine , and olanzapine-fluoxetine groups , respectively . Remission criteria were met by 24.5 % ( 87/355 ) of the placebo group , 32.8 % ( 115/351 ) of the olanzapine group , and 48.8 % ( 40/82 ) of the olanzapine-fluoxetine group . Treatment-emergent mania ( Young Mania Rating Scale score or = 15 subsequently ) did not differ among groups ( placebo , 6.7 % [ 23/345 ] ; olanzapine , 5.7 % [ 19/335 ] ; and olanzapine-fluoxetine , 6.4 % [ 5/78 ] ) . Adverse events for olanzapine-fluoxetine therapy were similar to those for olanzapine therapy but also included higher rates of nausea and diarrhea . CONCLUSIONS Olanzapine is more effective than placebo , and combined olanzapine-fluoxetine is more effective than olanzapine and placebo in the treatment of bipolar I depression without increased risk of developing manic symptoms"
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QUESTIONS In female patients with locally advanced breast cancer ( labc ) and good response to neoadjuvant chemotherapy ( nact ) , including endocrine therapy , what is the role of breast-conserving surgery ( bcs ) compared with mastectomy?In female patients with labc , is radiotherapy ( rt ) indicated for those who have undergone mastectomy?does locoregional rt , compared with breast or chest wall rt alone , result in a higher survival rate and lower recurrence rates?is rt indicated for those achieving a pathologic complete response ( pcr ) to nact?In female patients with labc who receive nact , is the most appropriate axillary staging procedure sentinel lymph node biopsy ( slnb ) or axillary dissection ? Is slnb indicated before nact rather than at the time of surgery?How should female patients with labc that does not respond to initial nact be treated ? METHODS This guideline was developed by Cancer Care Ontario 's Program in Evidence -Based Care ( pebc ) and the Breast Cancer Disease Site Group ( dsg ) . A systematic review was prepared based on literature search es conducted using the medline and embase data bases for the period 1996 to December 11 , 2013 . Guidelines were located from that search and from the Web sites of major guideline organizations . The working group drafted recommendations based on the systemic review . The systematic review and recommendations were then circulated to the Breast Cancer dsg and the pebc Report Approval Panel for internal review ; the revised document underwent external review . The full three-part evidence series can be found on the Cancer Care Ontario Web site . RECOMMENDATIONS For most patients with labc , modified radical mastectomy should be considered the st and ard of care . For some patients with noninflammatory labc , bcs can be considered on a case-by-case basis when the surgeon deems that the disease can be fully resected and the patient expresses a strong preference for breast preservation . For patients with labc , rt after mastectomy is recommended . It is recommended that , after bcs or mastectomy , patients with labc receive locoregional rt encompassing the breast or chest wall and local node-bearing areas .It is recommended that postoperative rt remain the st and ard of care for patients with labc who achieve pcr to nact . It is recommended that axillary dissection remain the st and ard of care for axillary staging in labc , with the judicious use of slnb in patients who are advised of the limitations of the current data .Although slnb either before or after nact is technically feasible , the data are insufficient to make any recommendation about the optimal timing of slnb with respect to nact . Limited data suggest higher sentinel lymph node identification rates and lower false negative identification rates when slnb is conducted before nact ; however , those data must be balanced against the requirement for two operations if slnb is not performed at the time of resection of the main tumour . It is recommended that patients receiving neoadjuvant anthracycline-taxane-based therapy ( or other sequential regimens ) whose tumours do not respond to the initial agent or agents , or who experience disease progression , be expedited to the next agent or agents of the regimen . For patients who , in the opinion of the treating physician , fail to respond or progress on first-line nact , several therapeutic options can be considered , including second-line chemotherapy , hormonal therapy ( if appropriate ) , rt , or immediate surgery ( if technically feasible ) . Treatment should be individualized through discussion at a multidisciplinary case conference , considering tumour characteristics , patient factors and preferences , and risk of adverse effects . It is recommended that prospect i ve r and omized clinical trials be design ed for patients with labc who fail to respond to nact so that more definitive treatment recommendations can be developed
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"Introduction The Preoperative Chemotherapy in Primary Operable Breast Cancer ( POCOB ) study was design ed to compare preoperative with postoperative chemotherapy in patients with early breast cancer concerning breast conserving therapy ( BCT ) procedures , disease free survival ( DFS ) and overall survival ( OS ) . Methods Patients ( n = 698 ) with early breast cancer were enrolled between 1991 and 1999 and r and omized between preoperative versus postoperative chemotherapy ( four cycles of fluorouracil , epirubicin , and cyclophosphamide ) . Endpoints were BCT procedures , DFS , OS , and tumor response to preoperative chemotherapy . In addition , tumor tissue was collected for translational research and the following markers were examined : ER , PgR , HER2 , p21 , p53 , and bcl-2 expression . Results With a median follow-up of 10 years , there was no statistically significant difference between the two treatment arms for OS ( HR = 1.09 ; 95%CI 0.83–1.42 ; P = 0.54 ) , DFS ( HR = 1.12 ; 95%CI 0.90–1.39 ; P = 0.30 ) , or locoregional recurrences ( LRR , HR = 1.16 ; 95%CI 0.77–1.74 ) . Preoperative chemotherapy was associated with an increase in BCT rates . BCT in part feasible due to tumor downsizing after preoperative chemotherapy was not correlated with higher LRR or worse OS compared to BCT which was feasible without downsizing of the tumor . Using available tumor material , only tumor stage , nodal stage , and grade were independent prognostic factors for overall survival . Conclusions Preoperative chemotherapy does not result in a difference in OS or DFS compared to postoperative chemotherapy in patients with early breast cancer . Moreover , it increases BCT rates with no significant increase of LRR . This implies that preoperative chemotherapy is a safe procedure for patients with early breast cancer , even after a follow-up period of 10 years",
"OBJECTIVE To evaluate factors affecting sentinel lymph node ( SLN ) identification after neoadjuvant chemotherapy ( NAC ) in patients with initial node-positive breast cancer . BACKGROUND SLN surgery is increasingly used for nodal staging after NAC and optimal technique for SLN identification is important . METHODS The American College of Surgeons Oncology Group Z1071 prospect i ve trial enrolled clinical T0 - 4 , N1 - 2 , M0 breast cancer patients . After NAC , SLN surgery and axillary lymph node dissection ( ALND ) were planned . Multivariate logistic regression modeling assessing factors influencing SLN identification was performed . RESULTS Of 756 patients enrolled , 34 women withdrew , 21 were ineligible , 12 underwent ALND only , and 689 had SLN surgery attempted . At least 1 SLN was identified in 639 patients ( 92.7 % : 95 % CI : 90.5%-94.6 % ) . Among factors evaluated , mapping technique was the only factor found to impact SLN identification ; with use of blue dye alone increasing the likelihood of failure to identify the SLN relative to using radiolabeled colloid + /- blue dye ( P = 0.006 ; OR = 3.82 ; 95 % CI : 1.47 - 9.92 ) . The SLN identification rate was 78.6 % with blue dye alone ; 91.4 % with radiolabeled colloid and 93.8 % with dual mapping agents . Patient factors ( age , body mass index ) , tumor factors ( clinical T or N stage ) , pathologic nodal response to chemotherapy , site of tracer injection , and length of chemotherapy treatment did not significantly affect the SLN identification rate . CONCLUSIONS The SLN identification rate after NAC was higher when mapping was performed using radiolabeled colloid alone or with blue dye compared with blue dye alone . Optimal tracer use is important to ensure successful identification of SLN(s ) after NAC",
"PURPOSE This study was design ed to determine the effect of adding docetaxel ( T ) to preoperative doxorubicin and cyclophosphamide ( AC ) on breast cancer response rates and disease-free survival ( DFS ) and overall survival ( OS ) . PATIENTS AND METHODS Women with operable breast cancer ( N = 2,411 ) were r and omly assigned to receive preoperative AC followed by surgery , AC followed by T and surgery , or AC followed by surgery and then T. Tamoxifen was initiated concurrently with chemotherapy . Median time on study for 2,404 patients with follow-up was 77.9 months . RESULTS Addition of T to AC did not significantly impact DFS or OS . There were trends toward improved DFS with addition of T. The addition of T reduced the incidence of local recurrences as first events ( P = .0034 ) . Preoperative T , but not postoperative T , significantly improved DFS in patients who had a clinical partial response after AC ( hazard ratio [ HR ] = 0.71 ; 95 % CI , 0.55 to 0.91 ; P = .007 ) . Pathologic complete response , which was doubled by addition of preoperative T , was a significant predictor of OS regardless of treatment ( HR = 0.33 ; 95 % CI , 0.23 to 0.47 ; P Pathologic nodal status after chemotherapy was a significant predictor of OS ( P affect OS , slightly improved DFS , and decreased the incidence of local recurrences . The sample size of this study was not sufficient to yield significance for the moderate DFS improvement . Concurrent use of tamoxifen may have limited the impact of adding",
"PURPOSE The American College of Surgeons Oncology Group trial Z0011 was a prospect i ve , r and omized , multicenter trial comparing overall survival between patients with positive sentinel lymph nodes ( SLNs ) who did and did not undergo axillary lymph node dissection ( ALND ) . The current study compares complications associated with SLN dissection ( SLND ) plus ALND , versus SLND alone . PATIENTS AND METHODS From May 1999 to December 2004 , 891 patients were r and omly assigned to SLND + ALND ( n = 445 ) or SLND alone ( n = 446 ) . Information on wound infection , axillary seroma , paresthesia , brachial plexus injury ( BPI ) , and lymphedema was available for 821 patients . RESULTS Adverse surgical effects were reported in 70 % ( 278 of 399 ) of patients after SLND + ALND and 25 % ( 103 of 411 ) after SLND alone ( P + ALND group had more wound infections ( P seromas ( P paresthesias ( P lymphedema was reported subjectively by 13 % ( 37 of 288 ) of patients after SLND + ALND and 2 % ( six of 268 ) after SLND alone ( P lymphedema , assessed by arm measurements at 30 days ( P = .36 ) , 6 months ( P = .22 ) , and 1 year ( P = .078 ) , although close to the cutoff for significance at 1 year , was not significant . BPIs occurred in less than 1 % of patients . CONCLUSION In trial Z0011 , the use of SLND + ALND result ed in more wound infections , axillary seromas , and paresthesias than SLND alone . Lymphedema was more common after SLND + ALND but was significantly different only by subjective report . The use of SLND alone result ed in fewer complications",
"PURPOSE To evaluate the efficacy of irradiation of internal mammary nodes ( IMN ) on 10-year overall survival in breast cancer patients after mastectomy . METHODS AND PATIENTS This multicenter phase 3 study enrolled patients with positive axillary nodes ( pN+ ) or central /medial tumors with or without pN+ . Other inclusion criteria were age All patients received postoperative irradiation of the chest wall and supraclavicular nodes and were r and omly assigned to receive IMN irradiation or not . R and omization was stratified by tumor location ( medial/ central or lateral ) , axillary lymph node status , and adjuvant therapy ( chemotherapy vs no chemotherapy ) . The prescribed dose of irradiation to the target volumes was 50 Gy or equivalent . The first 5 intercostal spaces were included in the IMN target volume , and two-thirds of the dose ( 31.5 Gy ) was given by electrons . The primary outcome was overall survival at 10 years . Disease-free survival and toxicity were secondary outcomes . RESULTS T total of 1334 patients were analyzed after a median follow-up of 11.3 years among the survivors . No benefit of IMN irradiation on the overall survival could be demonstrated : the 10-year overall survival was 59.3 % in the IMN-nonirradiated group versus 62.6 % in the IMN-irradiated group ( P=.8 ) . According to stratification factors , we defined 6 subgroups ( medial/ central or lateral tumor , pN0 [ only for medial/ central ] or pN+ , and chemotherapy or not ) . In all these subgroups , IMN irradiation did not significantly improve overall survival . CONCLUSIONS In patients treated with 2-dimensional techniques , we failed to demonstrate a survival benefit for IMN irradiation . This study can not rule out a moderate benefit , especially with more modern , conformal techniques applied to a higher risk population",
"National Surgical Adjuvant Breast and Bowel Project ( NSABP ) Protocol B-18 was initiated in 1988 to determine whether four cycles of doxorubicin/cyclophosphamide given preoperatively improve survival and disease-free survival ( DFS ) when compared with the same chemotherapy given postoperatively . Secondary aims included the evaluation of preoperative chemotherapy in downstaging the primary breast tumor and involved axillary lymph nodes , the comparison of lumpectomy rates and rates of ipsilateral breast tumor recurrence ( IBTR ) in the two treatment groups , and the assessment of the correlation between primary tumor response and outcome . Initially published findings were based on a follow-up of 5 years ; this report up date s results through 9 years of follow-up . There continue to be no statistically significant overall differences in survival or DFS between the two treatment groups . Survival at 9 years is 70 % in the postoperative group and 69 % in the preoperative group ( P = .80 ) . DFS is 53 % in postoperative patients and 55 % in preoperative patients ( P = .50 ) . A statistically significant correlation persists between primary tumor response and outcome , and this correlation has become statistically stronger with longer follow-up . Patients assigned to preoperative chemotherapy received notably more lumpectomies than postoperative patients , especially among patients with tumors greater than 5 cm at study entry . Although the rate of IBTR was slightly higher in the preoperative group ( 10.7 % versus 7.6 % ) , this difference was not statistically significant . Marginally statistically significant treatment-by-age interactions appear to be emerging for survival and DFS , suggesting that younger patients may benefit from preoperative therapy , whereas the reverse may be true for older patients",
"BACKGROUND The optimum timing of sentinel-lymph-node biopsy for breast cancer patients treated with neoadjuvant chemotherapy is uncertain . The SENTINA ( SENTinel NeoAdjuvant ) study was design ed to evaluate a specific algorithm for timing of a st and ardised sentinel-lymph-node biopsy procedure in patients who undergo neoadjuvant chemotherapy . METHODS SENTINA is a four-arm , prospect i ve , multicentre cohort study undertaken at 103 institutions in Germany and Austria . Women with breast cancer who were scheduled for neoadjuvant chemotherapy were enrolled into the study . Patients with clinical ly node-negative disease ( cN0 ) underwent sentinel-lymph-node biopsy before neoadjuvant chemotherapy ( arm A ) . If the sentinel node was positive ( pN1 ) , a second sentinel-lymph-node biopsy procedure was done after neoadjuvant chemotherapy ( arm B ) . Women with clinical ly node-positive disease ( cN+ ) received neoadjuvant chemotherapy . Those who converted to clinical ly node-negative disease after chemotherapy ( ycN0 ; arm C ) were treated with sentinel-lymph-node biopsy and axillary dissection . Only patients whose clinical nodal status remained positive ( ycN1 ) underwent axillary dissection without sentinel-lymph-node biopsy ( arm D ) . The primary endpoint was accuracy ( false-negative rate ) of sentinel-lymph-node biopsy after neoadjuvant chemotherapy for patients who converted from cN1 to ycN0 disease during neoadjuvant chemotherapy ( arm C ) . Secondary endpoints included comparison of the detection rate of sentinel-lymph-node biopsy before and after neoadjuvant chemotherapy , and also the false-negative rate and detection rate of sentinel-lymph-node biopsy after removal of the sentinel lymph node . Analyses were done according to treatment received ( per protocol ) . FINDINGS Of 1737 patients who received treatment , 1022 women underwent sentinel-lymph-node biopsy before neoadjuvant chemotherapy ( arms A and B ) , with a detection rate of 99.1 % ( 95 % CI 98.3 - 99.6 ; 1013 of 1022 ) . In patients who converted after neoadjuvant chemotherapy from cN+ to ycN0 ( arm C ) , the detection rate was 80.1 % ( 95 % CI 76.6 - 83.2 ; 474 of 592 ) and false-negative rate was 14.2 % ( 95 % CI 9.9 - 19.4 ; 32 of 226 ) . The false-negative rate was 24.3 % ( 17 of 70 ) for women who had one node removed and 18.5 % ( 10 of 54 ) for those who had two sentinel nodes removed ( arm C ) . In patients who had a second sentinel-lymph-node biopsy procedure after neoadjuvant chemotherapy ( arm B ) , the detection rate was 60.8 % ( 95 % CI 55.6 - 65.9 ; 219 of 360 ) and the false-negative rate was 51.6 % ( 95 % CI 38.7 - 64.2 ; 33 of 64 ) . INTERPRETATION Sentinel-lymph-node biopsy is a reliable diagnostic method before neoadjuvant chemotherapy . After systemic treatment or early sentinel-lymph-node biopsy , the procedure has a lower detection rate and a higher false-negative rate compared with sentinel-lymph-node biopsy done before neoadjuvant chemotherapy . These limitations should be considered if biopsy is planned after neoadjuvant chemotherapy . FUNDING Brustkrebs Deutschl and , German Society for Senology , German Breast Group",
"BACKGROUND AND OBJECTIVES Locally advanced breast cancer ( LABC ) remains a major problem in developing countries . While trials utilizing neo-adjuvant chemotherapy demonstrate superior survival rates compared to historic controls , r and omized studies evaluating the precise role of neo-adjuvant chemotherapy in LABC are lacking . In the present trial , neo-adjuvant chemotherapy was compared against adjuvant chemotherapy to assess survival advantage in operable T4b N0 - 2 M0 breast cancer . METHODS A total of 101 women with operable LABC ( T4b N0 - 2 M0 ) were r and omized . In arm A , 50 patients received 3 cycles of CEF chemotherapy before and 3 cycles following surgery . In arm B , 51 patients had primary surgery followed by 6 cycles of CEF chemotherapy . In both arms , loco-regional radiotherapy was given after completion of CEF . RESULTS The response of primary tumor to neo-adjuvant chemotherapy was 66 % , complete response ( CR ) 14 % and partial response ( PR ) 52 % . Clinical nodal response occurred in 95 % of node positive patients . Only two ( 4 % ) patients had pathologic CR both in tumor and axilla . There was a significant ( P = 0.02 ) increase in incidence of pathologically negative nodes in arm A. At a median follow up of 25 months , there was no significant difference in overall and disease free survival ( DFS ) in both arms ( P = 0.42 and 0.18 ) . Patients showing a response to neo-adjuvant chemotherapy had better DFS ( P = 0.04 ) compared to those who had no response . CONCLUSIONS Early results of the study indicate no survival benefit with the inclusion of neo-adjuvant chemotherapy in LABC ( T4b N0 - 2 M0 ) . Neo-adjuvant chemotherapy result ed in significant down staging ; good responders had a better DFS compared to those who did not respond",
"The EORTC 22922/10925 trial r and omly compares irradiation or no irradiation of the internal mammary and medio supraclavicular ( IM-MS ) nodes for stage I-III breast cancer . We report on the characteristics of 4004 participating patients , aspects of quality assurance and compliance to protocol treatment . The actual population has intermediate-risk disease : 51.8 % stage II , 56 % positive axillary nodes . The allocated treatment was not followed in 3.2 % in the IM-MS irradiation arm versus 2 % in the no IM-MS irradiation arm . In the IM-MS arm , there were major deviations for dose in 0.8 % , surgery-to-radiotherapy time interval in 3.9 % and in overall treatment time in 0.9 % cases . Major deviations were found in 7.9 % patients in the IM-MS group and in 2 % patients in the no IM-MS group . In the final trial analysis , a sensitivity analysis should evaluate the subgroup of patients receiving an optimal treatment to verify the robustness of the results and the true impact of IM-MS irradiation",
"BACKGROUND Neoadjuvant chemotherapy improves overall survival and renders possible breast-conserving treatment in locally advanced breast cancer . It was necessary for this method to be evaluated in operable breast tumors too large to be treated immediately by conserving surgery . Initial results of this r and omized trial were published in Annals of Oncology ( 1991 ) . PATIENTS AND METHODS Women with T2 > 3 cm or T3 N0 - 1 M0 breast tumors were treated by either initial mastectomy followed by adjuvant chemotherapy , or neoadjuvant chemotherapy followed by adjusted locoregional treatment . Chemotherapy was the same in the two arms . The prognostic and predictive factors of response to chemotherapy were analyzed . RESULTS Conserving treatments were performed in 63 % at the end of neoadjuvant chemotherapy and this rate had decreased to 45 % at the median follow-up of 124 months . Survivals are identical in the two treatment groups . Initial clinical tumor size 40 % are predictive of tumor response to chemotherapy by uni- and multivariate analyses . For outcome prediction , c-erb-B2 > 0 % is the independent prognostic factor for overall and metastasis-free survivals . CONCLUSION Breast-conserving therapy can be performed in more than half of all cases without alteration of survival , despite a non-negligible rate of local recurrences",
"PURPOSE This phase II single-institution prospect i ve , nonr and omized trial investigates high-dose adjuvant chemotherapy and locoregional radiotherapy in patients with breast cancer . We compared the outcome of patients in this study treated with radiotherapy fields including the internal mammary nodes ( IMN ) to a group of patients who did not receive IMN irradiation . PATIENTS AND METHODS 100 patients with high-risk stage II-III breast cancer received doxorubicin-based adjuvant chemotherapy followed by high-dose chemotherapy , stem-cell support , and locoregional radiotherapy . The radiotherapy included electron-beam irradiation to the IMN . For 20 months during the study , no electron-beam facility was available and we were unable to deliver the IMN irradiation as planned to 33 patients . The remaining 67 patients ( 32 treated before and 35 treated after this period ) received IMN irradiation . Patients with receptor-positive tumors received tamoxifen for 5 years . RESULTS At a median follow-up of 77 months for all of the patients , disease-free survival ( DFS ) was significantly prolonged in patients receiving IMN radiation compared to those without IMN radiation ( 73 % v 52 % ; P = .02 ) . A trend was seen for overall survival ( OS ; 78 % v 64 % ; P = .08 ) . Cox regression multivariate analysis found IMN radiotherapy to be significant both for DFS and OS . Estrogen receptor positivity was also significant for DFS . There was no treatment related mortality . CONCLUSION In patients with high-risk stage II to III breast cancer , the inclusion of the IMN in the radiotherapy field was associated with a statistically significant increase in DFS and a borderline increase in OS",
"PURPOSE To determine the value of the intent to include internal mammary nodes ( IMNs ) in the radiation therapy ( RT ) volume for patients receiving adjuvant locoregional ( breast or chest wall plus axillary and supraclavicular fossa ) RT for breast cancer . METHODS AND MATERIAL S 2413 women with node-positive or T3/4N0 invasive breast cancer , treated with locoregional RT from 2001 to 2006 , were identified in a prospect ively maintained , population -based data base . Intent to include IMNs in RT volume was determined through review of patient charts and RT plans . Distant relapse free survival ( D-RFS ) , breast cancer-specific survival ( BCSS ) , and overall survival ( OS ) were compared between the two groups . Prespecified pN1 subgroup analyses were performed . RESULTS The median follow-up time was 6.2 years . Forty-one percent of study participants received IMN RT . The 5-year D-RFS for IMN inclusion and exclusion groups were 82 % vs. 82 % ( p = 0.82 ) , BCSS was 87 % vs. 87 % ( p = 0.81 ) , and OS was 85 % vs. 83 % ( p = 0.06 ) . In the pN1 subgroup , D-RFS was 90 % vs. 88 % ( p = 0.31 ) , BCSS was 94 % vs. 92 % ( p = 0.18 ) , and OS was 91 % vs. 88 % ( p = 0.01 ) . After potential confounding variables were controlled for , women who received IMN RT did not have significantly different D-RFS ( hazard ratio [ HR ] = 1.02 ( 95 % confidence interval [ CI ] , 0.84 - 1.24 ; p = 0.85 ) , BCSS ( HR = 0.98 ( 95 % CI , 0.79 - 1.22 ; p = 0.88 ) , or OS ( HR = 0.95 ; 95 % CI , 0.78 - 1.15 ; p = 0.57 ) . In the pN1 subgroup , IMN RT was associated with trends for improved survival that were not statistically significant : D-RFS ( HR = 0.87 ; 95 % CI , 0.63 - 1.22 ; p = 0.42 ) , BCSS ( HR = 0.85 ; 95 % CI , 0.57 - 1.25 ; p = 0.39 ) , and OS ( HR = 0.78 ; 95 % CI , 0.56 - 1.09 ; p = 0.14 ) . CONCLUSIONS After a median follow-up time of 6.2 years , although intentional IMN RT was not associated with a significant improvement in survival , this population -based study suggests that IMN RT may contribute to improved outcomes in selected patients with N1 disease",
"The purpose of this study is to compare the efficacy of weekly paclitaxel to every-3-week schedule in terms of pathologic response and toxicity which caused treatment delay in primary chemotherapy of breast cancer . After pretreatment of two cycles of cyclophosphamide/ pirarubicin/ fluorouracil ( cyclophosphamide 500 mg/m2 days 1 , 8 ; pirarubicin 35 mg/m2 days 1 , 8 ; 5-Fu 200 mg/m2 day ci day 1–28 , every 4 weeks ) , 219 women with histologically confirmed T1–3 N0–2 M0 invasive breast cancer , whose vertical diameters production of breast tumor reduced not more than 75 % , were r and omized to receive four cycles of Pq3wC ( arm A : paclitaxel 175 mg/m2 day 1 , carboplatin AUC 6 d1 , every 3 weeks ) or Pq1wC ( arm B : paclitaxel 60 mg/m2 days 1 , 8 , 15 , carboplatin AUC 6 day 1 for every 3 weeks ) before surgery , stratified by partial or no response ( stable disease and progression of disease ) evaluated by ultrasonography . Pathologic response of the primary tumor was assessed by using Miller and Payne grading system . We defined grade 4/5 as excellent response , grade 3/4/5 as response and treatment delay as paclitaxel administration being delayed at least 1 week because of toxicity in this study . 213 patients ( 2 cases with concurrent bilateral breast cancer ) were eligible for analysis , 109 patients with 110 lesions in arm A and 104 patients with 105 lesions in arm B. Patients in arm B had a higher excellent pathologic response rate and a higher pathologic response rate compared with patients in arm A ( 59.0 vs. 45.5 % , P = 0.046 and 86.7 vs. 71.8 % , P = 0.007 ) . Pathologic complete response ( pCR ) rate in breast alone was similar between two arms ( P = 0.733 ) , but there was a higher pCR rate in patients with partial response to two cycles of cyclophosphamide/pirarubicin/fluorouracil than those with no response ( 32.4 vs. 13.9 % , P = 0.001 ) . There was no treatment-related death , however more patients in arm B than in arm A experienced treatment delay caused by toxicity ( 60.6 vs. 11.9 % , P paclitaxel was more effective than 3 weeks schedule in terms of pathologic response to primary chemotherapy in breast cancer , and caused more treatment delay related to toxicity though well tolerant",
"For many years , loco-regional radiotherapy was the st and ard postoperative treatment for node positive breast cancer patients in Sweden . Because of encouraging results from trials of adjuvant chemotherapy in the mid 1970s , the Stockholm Breast Cancer Study Group decided to directly compare postoperative radiation ( RT ) with adjuvant CMF-type chemotherapy ( CT ) . Long-term results are presented from two r and omized trials of RT versus CT in pre- ( n = 547 ) and postmenopausal ( n = 679 ) patients , respectively , with node positive disease or a tumour diameter > 30 mm . RT substantially reduced loco-regional recurrences among both pre- and postmenopausal patients ( relative hazard RT versus CT : 0.67 and 0.43 , respectively ) . Among premenopausal patients distant metastases occurred less frequently in the CT group ( relative hazard : 1.68 , p > 0.001 ) result ing in an improved recurrence-free survival ( p = 0.04 ) . Overall survival was also better with CT ( cumulative survival at 15 years : 50 % and 44 % in the CT and RT groups , respectively ) but the difference was not statistically significant . Among the postmenopausal patients there were no substantial differences in terms of recurrence-free or overall survival between the treatment groups . The risk of a second primary malignancy , however , was doubled in the RT group ( p > 0.01 ) . The most pronounced excess concerned second lung cancers occurring after 10 years . The cumulative incidence at 20 years was estimated at 0.3 % and 3.7 % in the CT and RT groups , respectively . The trials illustrate the role of radiotherapy in preventing loco-regional recurrences among high-risk patients , as well as the need for systemic treatment to control the disease systemically",
"Abstract Introduction . The EORTC 22922/10925 trial investigated the potential survival benefit and toxicity of elective irradiation of the internal mammary and medial supraclavicular ( IM-MS ) nodes Accrual completed in January 2004 and first results are expected in 2012 . We present the toxicity reported until year 3 after treatment . Patients and methods . At each visit , toxicity was reported but severity was not grade d routinely . Toxicity rates and performance status ( PS ) changes at three years were compared by χ2 tests and logistic regression models in all the 3 866 of 4 004 patients eligible to the trial who received the allocated treatment . Results . Only lung ( fibrosis ; dyspnoea ; pneumonitis ; any lung toxicities ) ( 4.3 % vs. 1.3 % ; p not cardiac toxicity ( 0.3 % vs. 0.4 % ; p = 0.55 ) significantly increased with IM-MS treatment . No significant worsening of the PS was observed ( p = 0.79 ) , suggesting that treatment-related toxicity does not impair patient 's daily activities . Conclusions . IM-MS irradiation seems well tolerated and does not significantly impair WHO PS at three years . A follow-up period of at least 10 years is needed to determine whether cardiac toxicity is increased after radiotherapy",
"Rationale There is currently considerable variation in the use of radiation therapy ( RT ) in early-stage breast cancer . R and omized trials1 - 3 and a meta analysis 4 of patients receiving systemic therapy have shown that RT after mastectomy improves survival compared with mastectomy without RT . At the same time , r and omized trials have shown that breastconserving surgery ( BCS ) plus RT is equivalent to mastectomy.5 - 8 The RT in the BCS trials was generally restricted to the breast alone and most patients had node-negative breast cancer . Therefore , it is possible that adding regional RT may improve survival compared with breast-alone RT after BCS plus systemic therapy . Modern breast cancer treatments also involve more frequent use of anthracycline chemotherapy or combined chemohormonal therapy . Whether adding regional RT after anthracycline chemotherapy improves survival or further increases toxicity is not known . Extending the RT volume could possibly increase the risk of pneumonitis , lymphedema , and for patients with left-sided breast cancer , cardiac disease.9,10 The MA20 trial will determine the appropriate volume of RT for women treated with BCS and systemic therapy and will determine the effects of adding regional RT on survival and quality of life . Careful attention to RT technique is an important element of the MA20 trial as the survival benefit of postmastectomy RT in older r and omized trials using out date d techniques appears to have been Noneified by late cardiac mortality.11,12 Each patient has a review of the RT quality that considers the target volume included , normal tissues excluded , and dose homogeneity parameters . This review is conducted in real-time so that modifications to a patient ’s treatment to ensure compliance with the treatment protocol specifications can be made prior to the start of treatment . The National Cancer Institute of Canada Clinical Trials Group ( NCIC-CTG ) is piloting a Webbased , real-time review process",
"PURPOSE To evaluate whether preoperative neoadjuvant chemotherapy in patients with primary operable breast cancer results in better overall survival ( OS ) and relapse-free survival rates and whether preoperative chemotherapy permits more breast-conserving surgery procedures than postoperative chemotherapy . PATIENTS AND METHODS Six hundred ninety-eight breast cancer patients ( T1c , T2 , T3 , T4b , N0 to 1 , and M0 ) were enrolled onto a r and omized phase III trial that compared four cycles of fluorouracil , epirubicin , and cyclophosphamide administered preoperatively versus the same regimen administered postoperatively ( the first cycle administered within 36 hours after surgery ) . Patients were followed up for OS , progression-free survival ( PFS ) , and locoregional recurrence ( LRR ) . RESULTS At a median follow-up of 56 months , there was no significant difference in terms of OS ( hazards ratio , 1.16 ; P = .38 ) , PFS ( hazards ratio , 1.15 ; P = .27 ) , and time to LRR ( hazards ratio , 1.13 ; P = .61 ) . Fifty-seven patients ( 23 % ) were downstaged by the preoperative chemotherapy , whereas 14 patients ( 18 % ) underwent mastectomy and not the planned breast-conserving therapy . CONCLUSION The use of preoperative chemotherapy yields similar results in terms of PFS , OS , and locoregional control compared with conventional postoperative chemotherapy . In addition , preoperative chemotherapy enables more patients to be treated with breast-conserving surgery . Because preoperative chemotherapy does not improve disease outcome compared with postoperative chemotherapy , future trials should involve quality -of-life studies to investigate whether patients will benefit from this treatment modality",
"In 1984 the GBSG started a multicenter r and omized trial to compare the effectiveness of 6 cycles of cyclophosphamide , methotrexate and fluorouracil ( CMF ) with or without radiotherapy ( RT ) as adjuvant treatment in node-positive breast-cancer patients treated by mastectomy . During 5 years , 199 patients were r and omized . After a median follow-up of about 9 years , the treatment groups 6 x CMF and 6 x CMF + RT were compared regarding time to recurrence and death . As the first event of failure , we observed locoregional recurrence in 22 patients , distant metastases in 66 patients , a secondary malignancy in 9 patients and death without previous event in 5 patients . For event-free survival ( EFS ) , no significant difference was observed [ relative risk ( RR ) 6 x CMF + RT vs. 6 x CMF 0.82 , 95 % confidence interval ( CI ) 0.55 - 1.21 ] . Event-specific analysis showed a significant decreased risk after radiotherapy for locoregional recurrence . The risk for distant metastases was estimated as slightly decreased and the risk for secondary malignancy and for death without previous event was estimated as increased in treatment group 6 x CMF + RT in comparison with treatment group 6 x CMF , but these effects were not significant . For overall survival ( OS ) and breast-cancer-specific survival ( BCS ) , no significant treatment effect could be demonstrated . There is a beneficial effect of radiotherapy on locoregional recurrence . For EFS and BCS , a tendency in favour of radiotherapy is observed , but this is not significant ; for OS , no difference can be demonstrated , but the power of the study is too low to detect small treatment effects",
"BACKGROUND Among breast cancer patients , nonresponse to initial neoadjuvant chemotherapy is associated with unfavorable outcome . We compared the response of nonresponding patients who continued the same treatment with that of patients who switched to a well-tolerated non-cross-resistant regimen . METHODS Previously untreated breast cancer patients received two 3-week cycles of docetaxel at 75 mg/m(2 ) , doxorubicin at 50 mg/m(2 ) , and cyclophosphamide at 500 mg/m(2 ) per day ( TAC ) . Patients whose tumors did not decrease in size by at least 50 % were r and omly assigned to four additional cycles of TAC or to four cycles of vinorelbine at 25 mg/m(2 ) and capecitabine at 2000 mg/m(2 ) ( NX ) . The outcome was sonographic response , defined as a reduction in the product of the two largest perpendicular diameters by at least 50 % . A difference of 10 % or less in the sonographic response qualified as noninferiority of the NX treatment . Pathological complete response was defined as no invasive or in situ residual tumor masses in the breast and lymph nodes . Toxic effects were assessed . All statistical tests were two-sided . RESULTS Of 2090 patients enrolled in the GeparTrio study , 622 ( 29.8 % ) who did not respond to two initial cycles of TAC were r and omly assigned to an additional four cycles of TAC ( n = 321 ) or to four cycles of NX ( n = 301 ) . Sonographic response rate was 50.5 % for the TAC arm and 51.2 % for the NX arm . The difference of 0.7 % ( 95 % confidence interval = -7.1 % to 8.5 % ) demonstrated noninferiority of NX ( P = .008 ) . Similar numbers of patients in both arms received breast-conserving surgery ( 184 [ 57.3 % ] in the TAC arm vs 180 [ 59.8 % ] in the NX arm ) and had a pathological complete response ( 5.3 % vs 6.0 % ) . Fewer patients in the NX arm than in the TAC arm had hematologic toxic effects , mucositis , infections , and nail changes , but more had h and -foot syndrome and sensory neuropathy . CONCLUSION Pathological complete responses to both regimens were marginal . Among patients who did not respond to the initial neoadjuvant TAC treatment , similar efficacy but better tolerability was observed by switching to NX than continuing with TAC",
"IMPORTANCE Sentinel lymph node ( SLN ) surgery provides reliable nodal staging information with less morbidity than axillary lymph node dissection ( ALND ) for patients with clinical ly node-negative ( cN0 ) breast cancer . The application of SLN surgery for staging the axilla following chemotherapy for women who initially had node-positive cN1 breast cancer is unclear because of high false-negative results reported in previous studies . OBJECTIVE To determine the false-negative rate ( FNR ) for SLN surgery following chemotherapy in women initially presenting with biopsy-proven cN1 breast cancer . DESIGN , SETTING , AND PATIENTS The American College of Surgeons Oncology Group ( ACOSOG ) Z1071 trial enrolled women from 136 institutions from July 2009 to June 2011 who had clinical T0 through T4 , N1 through N2 , M0 breast cancer and received neoadjuvant chemotherapy . Following chemotherapy , patients underwent both SLN surgery and ALND . Sentinel lymph node surgery using both blue dye ( isosulfan blue or methylene blue ) and a radiolabeled colloid mapping agent was encouraged . MAIN OUTCOMES AND MEASURES The primary end point was the FNR of SLN surgery after chemotherapy in women who presented with cN1 disease . We evaluated the likelihood that the FNR in patients with 2 or more SLNs examined was greater than 10 % , the rate expected for women undergoing SLN surgery who present with cN0 disease . RESULTS Seven hundred fifty-six women were enrolled in the study . Of 663 evaluable patients with cN1 disease , 649 underwent chemotherapy followed by both SLN surgery and ALND . An SLN could not be identified in 46 patients ( 7.1 % ) . Only 1 SLN was excised in 78 patients ( 12.0 % ) . Of the remaining 525 patients with 2 or more SLNs removed , no cancer was identified in the axillary lymph nodes of 215 patients , yielding a pathological complete nodal response of 41.0 % ( 95 % CI , 36.7%-45.3 % ) . In 39 patients , cancer was not identified in the SLNs but was found in lymph nodes obtained with ALND , result ing in an FNR of 12.6 % ( 90 % Bayesian credible interval , 9.85%-16.05 % ) . CONCLUSIONS AND RELEVANCE Among women with cN1 breast cancer receiving neoadjuvant chemotherapy who had 2 or more SLNs examined , the FNR was not found to be 10 % or less . Given this FNR threshold , changes in approach and patient selection that result in greater sensitivity would be necessary to support the use of SLN surgery as an alternative to ALND . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00881361"
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41171900-06ff-11f0-808a-c43d1ab1c353
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Background Research suggests that individuals with musculoskeletal injury may have difficulty negotiating physical tasks when they are combined with cognitive loads . Objective Our objective was to conduct a systematic review to underst and the effects of increased cognitive dem and on movement patterns among individuals with musculoskeletal injuries . Methods A comprehensive search of PubMed , MEDLINE , the Cumulative Index for Nursing and Allied Health Literature ( CINAHL ) , and SPORTD iscus was conducted to find research reports that included a population that had previously experienced an ankle , knee , or low back injury , included an uninjured control group , and assessed a dual-task paradigm . Results Forty-five full-text research reports were assessed , of which 28 studies ( six ankle injury , nine knee injury , and 13 low back pain studies ) were included in the review . Included studies were assessed for method ological quality and the study design extracted for analysis including the participants , cognitive and physical tasks performed , as well as outcome measures ( e.g. , three-dimensional kinematics , center of pressure , etc . ) . All studies included were cross-sectional or case – control with method ological quality scores of 17.8 ± 2.2 out of a possible 22 . Twenty-five of the 28 studies found changes in motor performance with dual-task conditions compared with single tasks . Furthermore , 54 % of studies reported a significant group by task interaction effect , reporting at least one alteration in injured groups ’ motor performance under dual-task conditions when compared with an uninjured group . Conclusion The results of this systematic review indicate that motor performance is further impaired by placing a cognitive load on individuals in population s with musculoskeletal injury . More dem and ing tasks such as gait appear to be more affected in injured individuals than simple balance tasks . Future investigators may want to consider the difficulty of the tasks included as well as the impact of dual-task paradigms on rehabilitation programs
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[
"OBJECTIVE The aim of this study was to investigate the effect of a cognitive task on st and ing postural control of the injured and non-injured leg of athletes with chronic ankle instability . METHODS Postural stability was measured by center of pressure parameters while chronic ankle instability patients ( n = 8) r and omly performed single and double leg st and ing in isolation or concurrently with a digit-backward cognitive task . RESULTS After performing a concurrent cognitive task , anteroposterior sway significantly decreased in injured leg ( P center of pressure parameters between injured and non-injured legs . CONCLUSION The findings confirm the effect of a concurrent digit-backwards memory task on single leg st and ing balance in chronic ankle instability patients but the response to cognitive loading was not significantly different between the injured and non-injured legs",
"Study Design . Three factors mixed- design with 1 between-subject and 2 within-subject factors . Objective . To compare the main effects and interactions of postural and cognitive difficulty on quiet stance between subjects with and without nonspecific low back pain ( LBP ) . Summary of Background Data . The interference between postural control and cognitive tasks depends on factors such as sensorimotor/cognitive integrity . Changes in peripheral sensory and muscular systems as well as cognitive processes have been observed in LBP patients . It was hypothesized that the effect of cognitive task on postural performance might be different in subjects with nonspecific LBP as compared with healthy individuals . To the authors ’ knowledge this has not been investigated before . Methods . Postural stability was measured by center of pressure parameters while nonspecific LBP ( n = 22 ) and healthy ( n = 22 ) subjects r and omly performed quiet st and ing task with 3 levels of difficulty ( rigid-surface eyes open , rigid-surface eyes-closed , and foam-surface eyes-closed ) in isolation or concurrently with an easy or difficult digits backward cognitive task . Results . Subjects with nonspecific LBP had less postural sway than healthy subjects , while postural sway decreased with increase in the level of cognitive difficulty . Nonspecific LBP and healthy subjects had larger postural sway at more difficult sensory conditions such as rigid-surface eyes-closed and foam-surface eyes-closed . The response to dual-tasking was not significantly different between the 2 groups . Conclusion . The dual-tasking did not change the postural performance of nonspecific LBP subjects with low level of pain and disability differently compared to healthy subjects",
"Background Knee reinjury after ACL reconstruction is common and increases the risk of osteoarthritis . There is sparse evidence to guide return to sport ( RTS ) decisions in this population . Objectives To assess the relationship between knee reinjury after ACL reconstruction and ( 1 ) return to level I sports , ( 2 ) timing of RTS and ( 3 ) knee function prior to return . Methods 106 patients who participated in pivoting sports participated in this prospect i ve 2-year cohort study . Sports participation and knee reinjury were recorded monthly . Knee function was assessed with the Knee Outcome Survey — Activities of Daily Living Scale , global rating scale of function , and quadriceps strength and hop test symmetry . Pass RTS criteria were defined as scores > 90 on all tests , failure as failing any . Results Patients who returned to level I sports had a 4.32 ( p=0.048 ) times higher reinjury rate than those who did not . The reinjury rate was significantly reduced by 51 % for each month RTS was delayed until 9 months after surgery , after which no further risk reduction was observed . 38.2 % of those who failed RTS criteria suffered reinjuries versus 5.6 % of those who passed ( HR 0.16 , p=0.075 ) . More symmetrical quadriceps strength prior to return significantly reduced the knee reinjury rate . Conclusions Returning to level I sports after ACL reconstruction leads to a more than 4-fold increase in reinjury rates over 2 years . RTS 9 months or later after surgery and more symmetrical quadriceps strength prior to return substantially reduce the reinjury rate",
"Study Design . Prospect i ve assessment of return to work after low back pain . Objective . To determine which factors or combination of factors best predict recurrence of low back pain ( defined 4 different ways ) when returning to full-duty work . Summary of Background Data . Recurrent back pain is one of the more costly health problems facing industry today . Few systematic evaluations of the various factors suspected of exacerbating low back pain have been reported in the literature . Methods . A total of 206 workers who reported low back pain were evaluated as they returned to full-duty work . Five types of assessment s were performed including : 1 ) a low back kinematic functional assessment s , 2 ) evaluation of job physical dem and s , 3 ) psychosocial assessment of the job environment , 4 ) self-reported impairment including perception of symptoms and psychological measures , and 5 ) personal ( individual ) factors . One year after return to full duty workers were interviewed to assess who had a recurrence of low back pain according to 4 different definitions of low back pain ( symptom reports , medical visits , self-reported lost days , and employer-reported lost days due to back pain ) . Multiple logistic regression models were developed to assess the best combinations of predictors . Results . The most liberal definition of recurrence , recurrent symptoms , had a significantly greater recurrence rate at 58 % than all other outcome measures ( P = 0.0001 ) . The medical visit recurrence rate of 36 % was significantly greater than the more conservative lost time measures ( P = 0.0001 ) . The recurrence rate for self-reported lost time was 15 % , whereas the more conservative employer confirmed lost time measure was significantly lower at 10 % ( P = 0.0077 ) . Multivariate predictive models associated with the various recurrence definitions yielded sensitivities varying between 78 % and 80 % and specificity between 73 % and 80 % . Conclusion . Recurrence is greatly dependent on how one defines recurrence with symptom reporting yielding 5.5 times as many recurrences compared with employer confirmed lost time . In general , more quantitative measures of worker musculoskeletal function yielded the best predictions of recurrence when predicting the more restrictive definitions of recurrence ( employer confirmed lost time )",
"Examining postural control while simultaneously performing a cognitive , or suprapostural task , has shown a fairly consistent trend of improving postural control in young healthy adults and provides insight into postural control mechanisms used in everyday life . However , the role of attention driven by explicit verbal instructions while dual-tasking is less understood . Therefore , the purpose of this investigation is to determine the effects of explicit verbal instructions on the postural-suprapostural interactions among various domains of working memory . A total of 22 healthy young adults with a heterogeneous history of ankle sprains volunteered to participate ( age : 22.2±5.1 years ; n=10 history of ankle sprains , n=12 no history ) . Participants were asked to perform single-limb balance trials while performing three suprapostural tasks : backwards counting , r and om number generation , and the manikin test . In addition , each suprapostural task was completed under three conditions of instruction : no instructions , focus on the postural control task , focus on the suprapostural task . The results indicate a significant effect of instructions on postural control outcomes , with postural performance improving in the presence of instructions across all three cognitive tasks which each stress different aspects of working memory . Further , postural-suprapostural interactions appear to be related to the direction or focus of an individual 's attention as instructions to focus on the suprapostural task result ed in the greatest postural control improvements . Thus , attention driven by explicit verbal instructions influence postural-suprapostural interactions as measured by a temporal-spatial postural control outcome , time-to-boundary , regardless of the suprapostural task performed",
"PURPOSE To evaluate health-related quality of life ( HRQL ) in patients undergoing anterior cruciate ligament ( ACL ) reconstructive surgery by use of 2 procedures and to estimate the direct costs of surgery . METHODS We performed a 2-year r and omized , prospect i ve intervention study of 2 surgical ACL reconstruction techniques ( anatomic single bundle [ SB ] v double bundle [ DB ] ) . Fifty-five consecutive out patients , with a mean age of 30.88 years , were r and omized to SB or DB ACL reconstruction . The Medical Outcomes Study 36-item Short Form Health Survey ( SF-36 ) was used to measure HRQL ( primary outcome ) . ACL injuries were assessed by the International Knee Documentation Committee ( IKDC ) score ( secondary outcome ) . The use of medical re sources and their costs were evaluated . RESULTS We included 52 patients in the final analyses ( 23 in the SB group and 29 in the DB group ) . At baseline , there were no significant differences in study variables . At 2 years of follow-up , there were no significant differences in SF-36 and IKDC scores between groups . However , compared with baseline , the SF-36 physical function , physical role , bodily pain , social function , and emotional role scores were significantly better in the SB group ( P ( P = .047 ) . IKDC scores at 2 years improved significantly in the SB group ( P correlation between the SF-36 physical function , physical role , and bodily pain dimensions and the IKDC score at 2 years ( P were € 3,251 for the SB group and € 4,172 for the DB group . CONCLUSIONS HRQL and medical outcomes were similar between SB and DB ACL reconstruction techniques , 2 years after surgery . However , the SB technique was more cost-effective",
"Performing a cognitive task while balancing can result in either increased or decreased sway depending on the nature of the cognitive task , and is commonly used in pathologic population s to evaluate postural performance . A total of 39 participants were recruited into two groups : uninjured controls ( n=20 , age : 21.9±2.1 years , height : 175.0±11.2 cm , mass : 71.3±14.9 kg ) and chronic ankle instability ( n=19 , age : 22.1±5.6 years , height : 169.7±7.7 cm , mass : 72.9±17.3 kg ) . Participants were asked to perform one of three cognitive tasks while maintaining single limb balance . Cognitive tasks included backwards counting by 3 ( BC ) , the manikin test ( MAN ) , and r and om number generation ( RNG ) . Time-to-boundary minima , mean , and st and ard deviations were calculated and compared between groups as pre to post change scores . Effect sizes and 95 % confidence intervals were also calculated to test for group differences and the effect of task performance on sway . No significant main effects of Group or Group by Task interactions were identified ( p>0.05 ) . However , a significant multivariate main effect of Task was identified in BC ( p=0.001 , F(6 , 32)=4.804 ) and RNG ( p those with chronic ankle instability and uninjured controls have similar postural-suprapostural interactions across multiple cognitive task domains . Both the BC and RNG tasks result ed in less sway for all participants . Our results suggest that dual-task interference in the CAI population may not be present as previous research would suggest",
"Recurrence quantification analysis ( RQA ) , a nonlinear method of postural analysis , was used to explore the effects of dual-tasking on postural performance in people with nonspecific low back pain ( LBP ) compared with healthy participants . Postural performance was quantified by RQA % recurrence , % determinism , entropy and trend . People with nonspecific LBP ( n=22 ) and unimpaired individuals ( n=22 ) r and omly performed quiet st and ing tasks with three levels of difficulty ( rigid-surface eyes open , rigid-surface eyes closed and foam-surface eyes closed ) . These tasks were performed in isolation or concurrently with an easy or difficult cognitive task . Increasing postural difficulty was associated with higher % determinism , higher entropy and lower trend in anteroposterior ( AP ) and mediolateral ( ML ) directions in people with LBP and healthy participants . All RQA variables in the ML direction decreased as cognitive conditions became more difficult . Significant interactions between group and cognitive difficulty were shown for % recurrence , % determinism and trend in the AP direction . While healthy participants decreased % recurrence and trend by increasing the level of cognitive difficulty , the LBP patients did not . This preliminary study suggests that LBP may be one factor that modulates the posture-cognition interaction",
"Our study aim ed to evaluate the effect of cognitive challenge on double-leg postural control under visual and surface perturbations of patients with anterior cruciate ligament reconstruction ( ACLR ) cleared to return to sport . Double-leg stance postural control of 19 rehabilitated patients with ACLR ( age : 24.8 ± 6.7 years , time since surgery : 9.2 ± 1.6 months ) and 21 controls ( age : 24.9 ± 3.7 years ) was evaluated in eight r and omized situations combining two cognitive ( with and without silent backward counting in steps of seven ) , two visual ( eyes open , eyes closed ) and two surface ( stable support , foam support ) conditions . Sway area and sway path of the centre of foot pressure were measured during three 20-s recordings for each situation . Higher values indicated poorer postural control . Generally , postural control of patients with ACLR and controls was similar for sway area and sway path ( p > 0.05 ) . The lack of visual anchorage and the disturbance of the plantar input by the foam support increased sway area and sway path ( p cognitive task decreased sway area and sway path ( p Patients with ACLR who recently completed their rehabilitation have normalized postural control during double-leg stance tests . The use of a dual task paradigm under increased task complexity modified postural control , but in a similar way in patients with ACLR than in healthy controls . Double-leg stance tests , even under challenging conditions , are not sensitive enough to reveal postural control differences between rehabilitated patients with ACLR and controls"
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41171946-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND : Our previous review reported great variability in the incidence and prevalence of atrial fibrillation ( AF ) in non‐Western cohorts , especially from Asian countries ; in recent years , epidemiologic studies on AF have been increasingly reported from Asia . METHODS : The goal of this up date d systematic review was to present the current knowledge base of AF epidemiology in Asian countries since our previous review . We also explored AF incidence and the risk of stroke in AF by using a meta‐ analysis , with I2 testing the heterogeneity . Third , “ real‐world ” antithrombotic drug use for ischemic stroke ( IS ) prevention associated with AF was studied . RESULTS : A total of 58 articles from eight countries in Asia were included in the analysis . The summary annual incidence of AF was 5.38 ( 95 % CI , 4.53–6.24 ; I2 = 99.5 % ; n = 10 ) per 1,000 person‐years , and the IS annual risk in AF was 3.0 % ( 1.60%‐4.95 % ; I2 = 99.8 % ; n = 8) when meta‐ analysis was performed on hospital‐ and community‐based studies . Hospital‐ and community‐based AF prevalence ranged from 0.37 % to 3.56 % and 2.8 % to 15.8 % , respectively . IS prevalence in AF ranged from 1.9 % to 6.0 % and 0.36 % to 28.3 % in community‐ and hospital‐based studies . Warfarin use in Chinese subjects is relatively low ( 1.0%‐4.1 % ) compared with Japanese subjects ( 49.1%‐70.0 % ) in community‐based studies . The rate of warfarin use was The incidence and prevalence of AF have increased in recent years , although great variability still exists in Asian countries . Variability in annual IS risk in patients with AF was apparent between hospital‐ and community‐based studies . However , the rate of warfarin use was Asian countries
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"Background and Purpose — There is controversy on the relationship of the type of atrial fibrillation ( AF ) to stroke . Although several studies show that patients with paroxysmal AF ( PAF ) have a stroke risk similar to those with persistent or permanent AF , recent studies suggest that PAF is associated with a lower rate of stroke . Limited data on stroke risk associated with PAF are evident in Asian population s. Methods — The Registry Study of Atrial Fibrillation Patients in Fushimi-ku ( Fushimi AF Registry ) is a community-based survey of patients with AF in Fushimi-ku , Kyoto , Japan . Patients were categorized into 2 types of AF : PAF or sustained ( persistent or permanent ) AF . We compared clinical events between PAF ( n=1588 ) and sustained AF ( n=1716 ) . Results — Patients with PAF were younger , had less comorbidities , and received oral anticoagulants ( OAC ) less commonly . A lower risk of stroke/systemic embolism during follow-up period in the patients with PAF was consistently observed ( non-OAC users : hazard ratio , 0.45 ; 95 % confidence intervals , 0.27–0.75 ; P OAC users : hazard ratio , 0.59 ; 95 % confidence interval , 0.35–0.93 ; P=0.03 ) . The composite end point of stroke/systemic embolism/all-cause mortality was also lower in PAF , whether among OAC users ( hazard ratio , 0.77 ; 95 % confidence interval , 0.59–0.99 ; P=0.046 ) or non-OAC users ( hazard ratio , 0.59 ; 95 % confidence interval , 0.46–0.75 ; P lower stroke/systemic embolism risk . Conclusions — In this large cohort of Japanese patients with AF , PAF was independently associated with lower incidence of stroke/systemic embolism than sustained AF . This may aid decision making for anticoagulation , especially in those patients with AF with few stroke risk factors . Clinical Trial Registration — URL : http://www.umin.ac.jp/ctr/index.htm . Unique identifier : UMIN000005834",
"BACKGROUND There remains uncertainty about the risk of cardiovascular events in stable out patients with a history of myocardial infa rct ion ( MI ) , stroke , and atrial fibrillation in Japan . METHODS AND RESULTS In the Japan Thrombosis Registry for Atrial Fibrillation , Coronary , or Cerebrovascular Events ( J-TRACE ) , a nationwide prospect i ve cohort of stable out patients with a history of MI ( n=2,291 ) , stroke ( n=3,554 ) , and /or atrial fibrillation ( n=2,242 ) , 1-year follow-up data were available for 7,513 of 8,087 patients ( follow-up rate : 92.9 % ) . The primary endpoint ( death/MI/stroke ) was reported in 3.53 events per 100 person-years ( 95 % confidence interval [ CI ] : 3.11 - 3.99 ) within 1 year . The rates of all-cause death , death from stroke , and death from MI within 1 year were 1.35 ( 95%CI : 1.10 - 1.65 ) , 0.15 ( 95%CI : 0.08 - 0.27 ) , and 0.06 ( 95%CI : 0.02 - 0.14 ) per 100 person-years , respectively . The rate of non-fatal stroke was 1.85 ( 95%CI : 1.55 - 2.19 ) , while that of non-fatal MI was 0.33 ( 95%CI : 0.21 - 0.49 ) . The rate of non-fatal stroke was highest among stroke patients ( 2.95 ; 95%CI : 2.39 - 3.60 per 100 person-years ) , while that of non-fatal MI was similar across all disease categories . Investigator-decided serious non-fatal bleeding events occurred in 0.21 events ( 95%CI : 0.12 - 0.34 ) per 100 person-years . CONCLUSIONS In this large , nationwide Japanese registry , the highest stroke event rate was seen in patients with a history of stroke",
"Background and Purpose — Reported rates of oral anticoagulation ( OAC ) use have been low among Chinese patients with atrial fibrillation ( AF ) . With improved awareness , changing guidelines , this situation may be changing over time . We aim ed to explore the current status and time trends of OAC use in Beijing . Methods — We used the data set from the Chinese Atrial Fibrillation Registry ( CAFR ) , a prospect i ve , multicenter , hospital-based registry study involving 20 tertiary and 12 nontertiary hospitals in Beijing . A total of 11 496 patients with AF were enrolled from 2011 to 2014 . Results — Seven thous and nine hundred seventy-seven eligible patients were included in this ancillary study . The proportions of OAC use were 36.5 % ( 2268/6210 ) , 28.5 % ( 333/1168 ) , and 21.4 % ( 128/599 ) for patients with CHA2DS2-VASc scores ≥2 , 1 , and 0 , respectively . Persistent AF , history of stroke/transient ischemic attack/peripheral embolism , diabetes mellitus , higher body mass index , and tertiary hospital management were factors positively associated with OAC use , whereas older age , previous bleeding , hypercholesterolemia , and established coronary artery disease were factors negatively associated with OAC use . Among patients with CHADS2 scores ≥2 and CHA2DS2-VASc scores ≥2 , the proportion of OAC use increased from 31.3 % to 64.5 % and 30.2 % to 57.7 % , respectively , from 2011 to 2014 . Variation in OAC use was substantial among different hospitals . Conclusions — An improvement of OAC use among Chinese patients with AF in Beijing is observed in recent years although only 36.5 % of patients with CHA2DS2-VASc score ≥2 received OAC . However , variations between different hospitals were large , suggesting that better education and awareness are needed to improve efforts for stroke prevention among AF patients . Clinical Trial Registration — URL : http://www.chictr.org.cn/showproj.aspx?proj=5831 . Unique identifier : ChiCTR-OCH-13003729",
"BACKGROUND Although hyperuricemia has been reported to be a risk factor of stroke , the relationship between hyperuricemia and stroke in patients with atrial fibrillation ( AF ) remains uncertain . The goal of the present study was to investigate whether hyperuricemia could potentially refine clinical risk stratification in AF . METHODS This study used the \" National Health Insurance Research Data base \" in Taiwan . A total of 7601 AF patients who did not receive antiplatelet agents or oral anticoagulants were identified as the study population . Hyperuricemia was defined as having at least one episode of gout attack necessitating long-term treatment with uric acid-lowering agents . The association between hyperuricemia and ischemic stroke was analyzed . RESULTS During the follow up of 3.0±2.7 years , 1116 patients ( 14.7 % ) experienced ischemic stroke with an annual rate of around 4.9 % . Hyperuricemia significantly predicts stroke , with a hazard ratio ( HR ) of 1.280 after adjusting for CHA2DS2-VASc score and other comorbidities . Among the 376 patients with a CHA2DS2VASc score of 0 , hyperuricemia can further stratify them into 2 groups with different stroke rates ( 7.1 % versus 1.3 % , p=0.020 ) . The adjusted HR of hyperuricemia in predicting ischemic stroke diminished from 7.491 for patients with a CHA2DS2-VASc score of 0 to 1.659 for those with a score of 3 , and became insignificant for patients with a score ≥4 . CONCLUSIONS Hyperuricemia was a significant risk factor of stroke which could potentially refine the clinical risk stratification in AF . It deserves a prospect i ve trial to investigate whether it would change the current strategy for stroke preventions using oral anticoagulants ",
"A prospect i ve registry was made of all patients hospitalized with atrial fibrillation ( AF ) in the State of Qatar from 1991 to 2010 . Clinical characteristics , management , and outcomes were compared according to ethnicity ( Middle Eastern Arab vs South Asian ) . During this 20-year period , 2857 Arabs and 548 Asians were hospitalized for AF . Arabs were 9 years older and more likely to have hypertension , diabetes mellitus ( DM ) , chronic renal impairment , and dyslipidemia than the Asians . Valvular heart disease and acute coronary syndromes were more common among Asians , while congestive heart failure was more common in Arabs . The overall inhospital mortality was lower in Asians than that of Arabs , while stroke rates were comparable . There was an increase in the prevalence of DM and hypertension in both the groups in the latter years of the study period , but there was no change in mortality trends . Our findings underscore the need to study AF according to ethnicity",
"BACKGROUND Evidence regarding the relationship between different levels of alcohol consumption and the risk of atrial fibrillation ( AF ) is currently limited in Asian population s. METHODS AND RESULTS Between 1991 and 1995 , a total of 8,602 Japanese men and women aged 30 - 80 years took part in the first examination of the Circulatory Risk in Communities Study ( CIRCS ) , a population -based cohort study in Japanese communities . An interviewer obtained detailed information on weekly alcohol intake . During the follow-up period , the incidence of AF was ascertained from annual ECG records , the subject 's medical history of AF , and cardiovascular disease surveillance . The hazard ratios ( HRs ) of incident AF and the 95 % confidence intervals ( CIs ) relative to the never-drinking group were calculated with adjustment for potential confounding factors by using the Cox proportional hazard model . During a median follow-up period of 6.4 years , 296 incidents of AF occurred . A higher incidence of AF was observed among participants with an ethanol intake > 69g/day , compared with never-drinkers . Compared with the never-drinkers , the multivariable-adjusted HRs ( CIs ) of past , light ( 69g/day ) drinkers were 1.30 ( 0.68 - 2.49 ) , 0.89 ( 0.60 - 1.32 ) , 1.19 ( 0.73 - 1.95 ) , 1.36 ( 0.79 - 2.35 ) , and 2.90 ( 1.61 - 5.23 ) , respectively . CONCLUSIONS Heavy alcohol consumption is associated with a higher risk of AF",
"Background There is limited information on prevalent and incident atrial fibrillation in Chinese . We aim ed to investigate the prevalence , incidence , management and risks of atrial fibrillation in an elderly Chinese population . Methods In a population —based prospect i ve study in elderly ( ≥60 years ) Chinese , we performed cardiovascular health examinations including a 12-lead electrocardiogram at baseline in 3,922 participants and biennially during follow-up in 2,017 participants . We collected information on vital status during the whole follow-up period . Results The baseline prevalence of atrial fibrillation was 2.0 % ( n = 34 ) in 1718 men and 1.6 % ( n = 36 ) in 2204 women . During a median 3.8 years of follow-up , the incidence rate of atrial fibrillation ( n = 34 ) was 4.9 per 1000 person-years ( 95 % confidence interval [ CI ] , 3.4–6.9 ) . In univariate analysis , both the prevalence and incidence of atrial fibrillation were higher with age advancing ( P received anticoagulant therapy ( warfarin ) . These patients with atrial fibrillation , compared with those with sinus rhythm , had significantly higher risks of all-cause ( n = 261 , hazard ratio [ HR ] 1.87 , 95 % CI , 1.09–3.20 , P = 0.02 ) , cardiovascular ( n = 136 , HR 3.78 , 95 % CI 2.17–6.58 , P 0.0001 ) and stroke mortality ( n = 44 , HR 6.31 , 95 % CI 2.81–14.19 , P = 0.0003 ) . Conclusions Atrial fibrillation was relatively frequent in elderly Chinese , poorly managed and associated with higher risks of mortality",
"OBJECTIVE This study aim ed at the assessment of the clinical approach to atrial fibrillation ( AF ) in the older population and the consistency with the guidelines based on the records of the multicenter , prospect i ve AFTER ( Atrial Fibrillation in Turkey : Epidemiologic Registry ) study . PATIENTS AND METHODS 2242 consecutive patients admitted to the Cardiology Outpatient Clinics of 17 different tertiary Health Care Centers with at least one AF attack determined on electrocardiographic examination , were included in the study . Among the patients included in the study , 631 individuals aged 75 years and older were analyzed . RESULTS The mean age of the patients was determined as 80.3±4.2 years . The most frequent type of AF in geriatric population was the persistent-permanent type with a percentage of 88 % . 60 % of the patients with AF were female . Hypertension was the most common co-morbidity in patients with AF ( 76 % ) . While in 16 % of patients a history of stroke , transient ischemic attack or systemic thromboembolism was present , a history of bleeding was present in 14 % of the patients . 37 % of the patients were on warfarin treatment and 60 % of the patients were on aspirin treatment . In 38 % of the patients who were on oral anticoagulant treatment , INR level was in the effective range . CONCLUSIONS The rate of anticoagulant use in the elderly with AF was 37 % and considering the reason of this situation was the medication not being prescribed by the physician , one should pay more attention particularly in the field of treatment",
"Background & objectives : Morphological abnormalities in 12-lead electrocardiograms ( ECGs ) are seen in subgroups of healthy individuals like athletes and air-force personnel . As these population s may not truly represent healthy individuals , we assessed morphological abnormalities in ECG in healthy volunteers participating in phase I studies , who are screened to exclude associated conditions . Methods : ECGs from 62 phase I studies analyzed in a central ECG laboratory were pooled . A single drug-free baseline ECG from each subject was review ed by experienced cardiologists . ECG intervals were measured on five consecutive beats and morphological abnormalities identified using st and ard guidelines . Results : Morphological abnormalities were detected in 25.5 per cent of 3978 healthy volunteers ( 2495 males , 1483 females ; aged 18 - 76 yr ) ; the presence was higher in males ( 29.3 % vs. 19.2 % in females ; P Rhythm abnormalities were the commonest ( 11.5 % ) followed by conduction abnormalities ( 5.9 % ) , axis deviation ( 4 % ) , ST-T wave changes ( 3.1 % ) and chamber enlargement ( 1.4 % ) . Incomplete right bundle branch block ( RBBB ) , short PR interval and right ventricular hypertrophy were common in young subjects ( atrial fibrillation , first degree atrioventricular block , complete RBBB and left anterior fascicular block were more prevalent in elderly subjects ( > 65 yr ) . Prolonged PR interval , RBBB and intraventricular conduction defects were more common in males while sinus tachycardia , short PR interval and non-specific T wave changes were more frequent in females . Interpretation & Conclusions : Morphological abnormalities in ECG are commonly seen in healthy volunteers participating in phase I studies ; and vary with age and gender . Further studies are required to determine whether these abnormalities persist or if some of these disappear on follow up",
"Background Only a few population -based cohort studies have investigated the impact of atrial fibrillation ( AF ) on stroke in Japan . Methods A total of 10 929 participants ( 4147 men and 6782 women ) were included in this population -based prospect i ve cohort study . Baseline data , including electrocardiograms ( ECGs ) to ascertain AF status , were obtained from April 1992 through July 1995 in 12 areas in Japan . Cox proportional hazards models were used to analyze the association of AF with stroke . Results A total of 54 participants had AF ( 0.49 % ) . The mean follow-up period was 10.7 years , during which 405 strokes were identified ; 12 of these occurred in participants with AF . The crude incidence of stroke in participants with and without AF was 14.9 and 4.5 per 1000 person-years in men , respectively , and 39.3 and 2.7 per 1000 person-years in women . After adjusting for geographical area , sex , age , smoking status , drinking status , obesity , hypertension , dyslipidemia , and diabetes mellitus , the hazard ratios ( 95 % confidence interval ) of AF in all participants and in male and female participants were 4.11 ( 2.28–7.41 ) , 2.12 ( 0.77–5.84 ) , and 10.6 ( 5.01–22.4 ) , respectively . The population attributable fraction ( PAF ) of stroke caused by AF was 2.2 % ; the PAFs were 1.0 % and 3.6 % in men and women , respectively . Conclusions The present Japanese population -based prospect i ve cohort study showed that AF is a major risk factor for stroke , especially in women",
"OBJECTIVE To assess the risk of first-ever ischemic stroke in younger patients with atrial fibrillation ( AF ) who have none of the CHA2DS2-VASc ( congestive heart failure , hypertension , age ≥75 years , diabetes mellitus , previous stroke/transient ischemic attack , vascular disease , age 65 - 74 years , sex category [ female sex ] ) risk factors ( excluding female sex ) by using the National Health Insurance research data base in Taiwan . PATIENTS AND METHODS From 22,842,778 insured people , we identified 24,612 hospitalized patients with newly diagnosed AF between January 1 , 2002 , and December 31 , 2004 , as the AF group and r and omly selected 98,448 age- and sex-matched persons without AF as the non-AF group . Both groups were followed up until December 31 , 2010 , to estimate ischemic stroke incidences in relation to other stroke risk factors . RESULTS During a follow-up period of 89,468 person-years , the stroke rate was higher in patients with AF than in those without AF ( 5.79 per 100 person-years vs 2.25 per 100 person-years ) . The higher prevalence of CHA2DS2-VASc comorbidities ( heart failure , hypertension , diabetes , coronary artery disease , and peripheral artery disease ) in patients with AF further increased the stroke risk . In 790 patients with AF aged 30 to 55 years who had none of the CHA2DS2-VASc comorbidities at baseline and retained a \" low risk , \" that is , those with a CHA2DS2-VASc score of 0 in men and 1 in women during follow-up , the stroke rate remained considerably higher than that in their non-AF counterparts ( 1.00 per 100 person-years vs 0.25 per 100 person-years ) , with a sex-adjusted hazard ratio of 4.09 ( 95 % CI , 2.97 - 5.62 ) . CONCLUSION This study finds an increased risk of stroke in younger patients with AF who are not recommended for prevention of thromboembolism by current guidelines . Better stroke risk stratification tools are needed to prioritize younger patients with AF for thromboprophylactic therapy in this population",
"OBJECTIVE In healthy persons , cardiovascular risk is the result of multiple interacting risk associates including demographic , clinical , genetic and environmental factors . Several non-invasive tools such as echocardiography , ultrasonography and electrocardiography as well as new biochemical markers were shown to be applicable to predict cardiovascular events . However , implementation of all of these tools has not been tested before . The aim of the study was to evaluate the independent predictors of major adverse cardiovascular events in a prospect i ve population based study , with the use of bioempedance analysis , echocardiography , ultrasonography and ECG . PATIENTS AND METHODS The baseline measurements were conducted on 2230 participants ( 1427 women , 803 men with a mean age of 49 ± 15 ) . The follow-up was done 36 months after the baseline admission via telephone call . Major adverse event was defined as mortality or myocardial infa rct ion or stroke . RESULTS Follow-up data was possible in 1495 participants ( 65 % ) . During the follow-up of 36 months ( 4485 patient years ) , 42 major adverse events occurred ( 0.03 % ) . Among them , 16 were death ( 1 stroke , 2 cancer , 13 cardiac related ) , 12 were stroke and 14 were myocardial infa rct ion . Age , body mass index and atrial fibrillation were independent predictors of major adverse events ; AF being the most powerful ( Odds ratio 10.46 ; 95 % confidence interval [ 1.73 - 63.14 ] ; p = 0.010 ) . CONCLUSIONS Age , lower body mass index and atrial fibrillation were independent predictors of major cardiovascular events in our cohort",
"Objectives Atrial fibrillation ( AF ) is the most common sustained arrhythmia encountered in clinical practice with major public health impact mainly due to the increased risk of stroke . The recent Global Burden of Disease Study reported a lack of prevalence data from India . Our goal was to conduct a pilot study to evaluate the feasibility of assessing AF prevalence and stroke prophylaxis in an urban Indian community . Methods A screening camp was conducted in Nagpur , India , that evaluated adults aged ≥18 years . We collected demographics , recorded blood pressure , height , weight and the 12-lead electrocardiogram ( ECG ) . The presence of diabetes and hypertension was recorded by self-reported history . Patients diagnosed with AF were evaluated further to assess aetiology and management . Results Of the total 4077 r and omly selected , community-dwelling adults studied , 0.196 % ( eight patients ) were found to have AF . Mean age of the population was 43.9±14.8 , and 44.5 % were female . The mean age of the patients with AF was 60.5±15.8 years ( five females ) . Rheumatic heart disease was found in five patients with AF . Three patients had history of stroke ( 37.5 % ) and one had peripheral arterial thrombosis . Three patients were on warfarin , but without routine international normalised ratio ( INR ) monitoring . One patient was on aspirin . Five patients were on β-blockers and one on both β-blocker and digoxin . Conclusions The prevalence of AF was low compared with other regions of the world and stroke prophylaxis was underused . A larger study is needed to confirm these findings . This study demonstrates that larger evaluations would be feasible using the community-based techniques employed here",
"Background : Most studies on atrial fibrillation ( AF ) epidemiology , treatment , and outcomes have included mainly Caucasians patients . The world literature on AF in other ethnicities is very limited particularly in the elderly . Aims : The aim of this study was to compare the clinical characteristics , treatment and outcome of elderly and younger patients hospitalized with AF in a Middle-Eastern country and examine the trends of AF etiologies over a 20-year period . Methods : A retrospective analysis of a prospect i ve registry of all patients hospitalized with AF in Qatar from 1991 through 2010 was made . Patients were divided into three groups ; group 1 : patients ≦50 years old , group 2 : patients between 51 and 70 years old , and group 3 : patients > 70 years old . Clinical characteristics , management , and outcomes of AF patients were compared according to age . Results : Between the year 1991 and the end of 2010 , a total 3848 consecutive patients were admitted with AF . One thous and three hundred and forty-five patients were ≦50 years , 1759 were between 51 and 70 years and 744 patients were > 70 years old . Elderly patients were more likely to have hypertension and chronic renal impairment . There was a higher prevalence of associated coronary artery disease and aortic stenosis in elderly patients with a lower left ventricular ejection fraction than the younger age groups . A lower use of anticoagulation in the elderly group was observed but there was no underuse of other evidence -based medications . The older AF patients had significantly higher in-hospital mortality and stroke rates with no significant changes in mortality trends over the 20 years of study . An increasing trend of the associated acute coronary syndromes , hypertension and diabetes mellitus prevalence was observed in the elderly group . Conclusion : Anticoagulation remains underutilized in elderly patients with AF despite proven efficacy and increasing trends of cardiovascular comorbidities . The current study underscores the urgent need for prospect i ve studies to investigate warfarin contraindications , relative warfarin efficacy and bleeding risks in our region to help guide healthcare providers in warfarin prescribing in this frail patient population and consequently reduce the risk of AF-related disabling strokes and mortality ",
"OBJECTIVE To investigate prevalence of atrial fibrillation ( AF ) in Uygur and Han elderly population s in Xinjiang Uygur autonomous region ( Xinjiang ) . METHODS Epidemiological survey was conducted among the residents selected through stratified r and om cluster sampling in the southern , northern and eastern Xinjiang . RESULTS The overall AF prevalence among Uygur and Han elderly people was 3.56 % . The crude prevalence of AF was 2.91 % among Uygur elderly people and 4.13 % among Han elderly people . The sex specific prevalence of AF were 3.19 % and 2.61 % among Uygur males and females respectively , and 5.01 % and 3.31 % among Han males and females respectively . The prevalence of valvular AF among Uygur ethnic group was higher than that in Han ethnic group ; the prevalence of non-valvular and isolated AF in Han ethnic group were higher than those in Uygur ethnic group . The compliance of aspirin and β-blocker medication among Han ethnic group was better than that in Uygur ethnic group . The compliance of warfarin medication was poor in both Uygur ethnic group and Han ethnic group . The prevalence of ischemic stroke were 8.82 % and 0.98 % in Uygur elderly people with or without AF . The prevalence of ischemic stroke were 6.08 % and 0.70 % in Han elderly people with or without AF . CONCLUSION The prevalence of AF in elderly people in Xinjiang is similar to the results from other domestic studies , the prevalence of AF in Han elderly people was higher than that in Uygur elderly peoples",
"BACKGROUND AND AIM Atrial fibrillation ( AF ) is an important cardiovascular disease in the elderly . The association between hyperuricemia and AF is unclear . Therefore , we aim ed to investigate the prospect i ve relationship between uric acid and development of AF in a nationally representative cohort of elderly people . METHODS AND RESULTS A total of 1485 elderly people ( age ≥ 65 yrs ) from the Elderly Nutrition and Health Survey in Taiwan ( 1999 - 2000 ) were without AF on \" electrocardiography \" at baseline . Incident AF events ( International Classification of Diseases , Ninth Revision , Clinical Modification , ICD-9-CM : 427.31 ) were identified using data from the National Health Insurance Data set . Hyperuricemia was defined as levels of uric acid > 7.0 mg/dL in men and 6.0 mg/dL in women . A Cox proportional hazards model was used to evaluate the association between hyperuricemia and incident AF . The follow-up period was from 1999 to 2000 to 2008 . During the follow-up period ( median : 9.16 yrs ) , 90 AF events occurred ( 44 in men and 46 in women ) . Older age , elevated systolic blood pressure , being an ex-smoker , and high uric acid were positively associated with incident AF . Hyperuricemia was positively associated with incident AF in normotensive ( age-adjusted hazard ratio ( HR ) : 2.65 and 95 % confidence intervals : 1.05 - 6.69 ) , but not in ( 1.20:0.74 - 1.94 ) hypertensive individuals ( systolic blood pressure ≥130 or diastolic blood pressure ≥85 or using hypertensive medicine ) . A significant association between hyperuricemia and AF ( 3.78 ; 1.24 - 11.59 ) remained after adjusting for other potential confounders among normotensive older persons . CONCLUSION Hyperuricemia is associated with the development of AF in elderly people with normal blood pressure",
"BACKGROUND Although various kinds of cardiovascular risk factors have been reported to be associated with atrial fibrillation ( AF ) , the relationship between serum uric acid level and AF has not been fully examined . METHODS AND RESULTS Data were collected from a single hospital-based cohort in the Shinken Data base 2004 - 2008 ( n=11,123 ) , and consisted of serum uric acid level for 7,155 patients . The association between serum uric acid level and AF prevalence was evaluated on logistic regression . Uric acid significantly increased the crude AF prevalence in both men and women ( both , P odds ratio ( OR ) and 95 % confidence interval ( 95%CI ) in the highest tertile compared with the lowest one were 3.368 ( 2.478 - 4.578 ) and 1.408 ( 1.169 - 1.695 ) in women and men , respectively . Uric acid was also significantly associated with other various cardiovascular risk factors for AF . Even after the multivariate model was adjusted using these variables , the effect of uric acid on AF was independent in women ( OR , 1.888 ; 95%CI : 1.278 - 2.790 ) , but not in men . CONCLUSIONS Reflecting the composite of various cardiovascular risk factors , serum uric acid level was apparently associated with AF prevalence . The independent association in women might imply some sex-specific mechanisms . The results should be confirmed in prospect i ve studies",
"BACKGROUND Tobacco smoking is a well-known risk factor for cardiovascular disease , but controversial results have been reported regarding its relationship with atrial fibrillation ( AF ) . Moreover , no study on the relationship between smoking and AF has yet been undertaken in a Japanese context . METHODS AND RESULTS We used data from the Shinken Data base 2004 - 2011 ( men/women , n=10,714/6,803 , respectively ) , which included all new patients attending the Cardiovascular Institute between June 2004 and March 2012 . AF was diagnosed in 1,698 and 598 men and women , respectively . In men , smokers were more prevalent in the AF than in the non-AF group ( 54.5 % vs. 44.7 % ) , whereas in women the prevalence of smokers was similar between AF and non-AF groups ( 14.4 % vs. 15.4 % ) . This discrepancy between the sexes seems to derive from a characteristic distribution pattern of smoking habit in women . After adjustment for various cofactors , smoking was independently associated with AF ( odds ratio 1.54 ; 95 % confidence interval 1.35 - 1.75 ; P with AF without a significant interaction between sex categories among Japanese patients visiting a cardiovascular hospital . Further studies using a prospect i ve cohort design are required to confirm a causal link between smoking and AF in Japanese patients",
"BACKGROUND Much of the clinical epidemiology and treatment patterns for patients with atrial fibrillation ( AF ) are derived from Western population s. Limited data are available on antithrombotic therapy use over time and its impact on the stroke or bleeding events in newly diagnosed Chinese patients with AF . The present study investigates time trends in warfarin and aspirin use in China in relation to stroke and bleeding events in a Chinese population . METHODS We used a medical insurance data base involving > 10 million individuals for the years 2001 to 2012 in Yunnan , a southwestern province of China , and performed time-trend analysis on those with newly diagnosed AF . Cox proportional hazards time-varying exposures were used to determine the risk of stroke or bleeding events associated with antithrombotic therapy among patients with AF . RESULTS Among the r and omly sample d 471,446 participants , there were 1,237 patients with AF , including 921 newly diagnosed with AF , thus providing 4,859 person-years of experience ( 62 % men ; mean attained age , 70 years ) . The overall rate of antithrombotic therapy was 37.7 % ( 347 of 921 patients ) , with 4.1 % ( 38 of 921 ) on warfarin and 32.3 % ( 298 of 921 ) on aspirin . Antithrombotic therapy was not related to stroke/bleeding risk scores ( CHADS2 [ congestive heart failure , hypertension , age ≥ 75 years , diabetes , stroke ( doubled ) ] score , P = .522 ; CHA2DS2-VASc [ congestive heart failure , hypertension , age ≥ 75 years ( doubled ) , diabetes mellitus , stroke or transient ischemic attack ( doubled ) , vascular disease , age 65 to 74 years , and female sex ] score , P = .957 ; HAS-BLED [ hypertension , abnormal renal/liver function , stroke , bleeding history or predisposition , labile international normalized ratio , elderly ( > 65 years ) , drugs/alcohol concomitantly ] score , P = .095 ) . The use of antithrombotic drugs ( mainly aspirin ) increased in both women and men over time , with the rate of aspirin increasing from 4.0 % in 2007 to 46.1 % in 2012 in the former , and from 7.7 % in 2007 to 61.9 % in 2012 in the latter ( P for trend for both , the annual stroke rate was approximately 6 % and the annual major bleeding rate was about 1 % . Compared with nonantithrombotic therapy , the hazard ratio for ischemic stroke was 0.68 ( 95 % CI , 0.39 - 1.18 ) for aspirin and 1.39 ( 0.54 - 3.59 ) for warfarin . CONCLUSIONS Aspirin use increased among Chinese patients newly diagnosed with AF , with no relationship to the patient 's stroke or bleeding risk . Warfarin use was very low . Given the health-care burden of AF and its complications , our study has major implication s for health-care systems in non-Western countries , given the global burden of this common arrhythmia",
"OBJECTIVE To investigate the prevalence and distributing feature of atrial fibrillation ( AF ) in Xinjiang Kazaks adult population . METHODS Four-stage selected r and om sample s aged 30 - 89 years from Tacheng , Yili and Aletai were analyzed . An epidemical study of AF was performed including inquiring medical history , recording electrocardiogram and auscultation . RESULTS A total of 22 514 adults were surveyed . The prevalence of AF in Xinjiang Kazaks adult population was 0.37 % , which was increasing with aging . The prevalence was higher in men than in women ( 0.5 % vs 0.2 % , P valvular AF . Ischemic stroke was the most frequent type and the stroke rate in the patients with AF was significantly higher than that without AF ( 6.0 % vs 1.2 % , P Xinjiang Kazaks adult population is lower than the reported national prevalence but patients with AF in this population would not like to take the necessary medicine . Therefore , the control of AF need to be reinforced",
"Background Recent evidence suggests that there are ethnic variations in atrial fi brillation ( AF ) susceptibility and incidence following acute myocardial infa rct ion ( AMI ) . Objectives The aim of this study was to evaluate the incidence and predictors of AF in the setting of AMI in Middle Eastern Arab and South Asian patients and its impact on in-hospital morbidity and mortality . Methods A retrospective analysis of a prospect i ve registry of all patients hospitalized with AMI in the state of Qatar from 1991 through 2010 was made . Clinical characteristics and outcomes of AMI patients with and without AF were compared . Sub- analysis according to ethnicity was also performed . Results During the 20-year period ; a total of 12,881 patients were hospitalized with AMI . Of these 5028 were Arabs and 5985 were South Asians . A total of 227 had AF during hospitalization with an overall incidence of 1.8 % ( 156 Arabs ; incidence 3.1 % and 48 South Asians ; incidence 0.8 % ) . The mean age of AF patients was 65 years ( Arabs 69 , South Asians 54 ) . Patients with AF were signifi cantly older and had more cardiovascular co-morbidities than patients without AF , and were more likely to have non-ST elevation AMI on presentation . Patients with AF had signifi cantly higher in-hospital mortality rate ( 20.3 % versus 7.1 % ; P= 0.001 ) and stroke rates ( 1.8 % versus 0.3 % ; P= 0.001 ) when compared to patients without AF . Age was the only independent predictor of AF development in patients with AMI in our study . Conclusions Our study reports variability in the prevalence of AF among AMI patients according to ethnicity using a 20-year registry from a Middle Eastern country . Advancing age was the major independent predictor of AF in our AMI patients . Further prospect i ve studies are required evaluating optimal therapeutic approaches for these high-risk patients in order to reduce the high mortality observed",
"AIMS Change in NT-proBNP level is a common surrogate endpoint in early phase heart failure ( HF ) trials , but whether this endpoint is influenced by atrial fibrillation/flutter ( AFF ) is unclear . METHODS AND RESULTS This analysis included 1358 patients from the ASTRONAUT trial , which r and omized patients hospitalized for HF with EF ≤40 % to aliskiren or placebo in addition to st and ard care . Patients were stratified by presence of AFF on baseline ECG . NT-proBNP was measured longitudinally by a core laboratory at baseline , 1 month , 6 months , and 12 months . Compared with non-AFF patients , AFF patients experienced greater reduction from baseline in log-transformed NT-proBNP ( interaction P of aliskiren to lower NT-proBNP during follow-up differed by AFF status ( interaction P = 0.001 ) , with aliskiren lowering NT-proBNP more than placebo among non-AFF patients only . After adjustment , baseline AFF was not associated with mortality or HF hospitalization at 12 months ( all P ≥ 0.152 ) . CONCLUSION In this hospitalized HF cohort , AFF status did not influence post-discharge NT-proBNP trajectory or clinical outcomes after adjustment for patient characteristics . Aliskiren lowered follow-up NT-proBNP levels in patients without AFF , but had no influence among patients with AFF . This study generates the hypothesis that the ability of a HF trial to meet an NT-proBNP defined endpoint may be influenced by the prevalence of AFF in the population . Because aliskiren did not improve outcomes in patients without AFF , this analysis suggests changes in NT-proBNP induced by investigational therapies may be dissociated from clinical effects"
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41171982-06ff-11f0-808a-c43d1ab1c353
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AIM To review outcomes of surgical and antibiotic management of acute appendicitis . METHODS 11 prospect i ve studies comparing surgical versus antibiotic management of acute appendicitis over a 21-year period were review ed . RESULTS Antibiotic management is successful in most cases of uncomplicated acute appendicitis . The need for crossover in management and recurrent appendicitis were low among all studies . For those patients who ultimately required surgery , no increased complications were observed . CONCLUSION The decision to use antibiotics to treat acute appendicitis should be held to the same st and ards of diagnostic rigor as surgical management . Antibiotics may be safely recommended in patients with high surgical risk , such as the elderly or those with multiple comorbidities
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"BACKGROUND For decades , urgent operation has been considered the only appropriate management of acute appendicitis in children . The purpose of this study was to investigate the feasibility of nonoperative management of uncomplicated acute appendicitis in children . STUDY DESIGN A prospect i ve nonr and omized clinical trial of children with uncomplicated acute appendicitis comparing nonoperative management with urgent appendectomy was performed . The primary result was 30-day success rate of nonoperative management . Secondary outcomes included comparisons of disability days , missed school days , hospital length of stay , and measures of quality of life and health care satisfaction . RESULTS Seventy-seven patients were enrolled during October 2012 to October 2013 ; 30 chose nonoperative management and 47 chose surgery . There were no significant differences in demographic or clinical characteristics . The immediate and 30-day success rates of nonoperative management were 93 % ( 28 of 30 ) and 90 % ( 27 of 30 ) . There was no evidence of progression of appendicitis to rupture at the time of surgery in the 3 patients for whom nonoperative management failed . Compared with the surgery group , the nonoperative group had fewer disability days ( 3 vs 17 days ; p returned to school more quickly ( 3 vs 5 days ; p = 0.008 ) , and exhibited higher quality of life scores in both the child ( 93 vs 88 ; p = 0.01 ) and the parent ( 96 vs 90 ; p = 0.03 ) , but incurred a longer length of stay ( 38 vs 20 hours ; p Nonoperative management of uncomplicated acute appendicitis in children is feasible , with a high 30-day success rate and short-term benefits that include quicker recovery and improved quality of life scores . Additional follow-up will allow for determination of longer-term success rate , safety , and cost effectiveness",
"IMPORTANCE Current evidence suggests that nonoperative management of uncomplicated appendicitis is safe , but overall effectiveness is determined by combining medical outcomes with the patient 's and family 's perspective , goals , and expectations . OBJECTIVE To determine the effectiveness of patient choice in nonoperative vs surgical management of uncomplicated acute appendicitis in children . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve patient choice cohort study in patients aged 7 to 17 years with acute uncomplicated appendicitis presenting at a single pediatric tertiary acute care hospital from October 1 , 2012 , through March 6 , 2013 . Participating patients and families gave informed consent and chose between nonoperative management and urgent appendectomy . INTERVENTIONS Urgent appendectomy or nonoperative management entailing at least 24 hours of inpatient observation while receiving intravenous antibiotics and , on demonstrating improvement of symptoms , completion of 10 days of treatment with oral antibiotics . MAIN OUTCOMES AND MEASURES The primary outcome was the 1-year success rate of nonoperative management . Successful nonoperative management was defined as not undergoing an appendectomy . Secondary outcomes included comparisons of the rates of complicated appendicitis , disability days , and health care costs between nonoperative management and surgery . RESULTS A total of 102 patients were enrolled ; 65 patients /families chose appendectomy ( median age , 12 years ; interquartile range [ IQR ] , 9 - 13 years ; 45 male [ 69.2 % ] ) and 37 patients /families chose nonoperative management ( median age , 11 years ; IQR , 10 - 14 years ; 24 male [ 64.9 % ] ) . Baseline characteristics were similar between the groups . The success rate of nonoperative management was 89.2 % ( 95 % CI , 74.6%-97.0 % ) at 30 days ( 33 of 37 children ) and 75.7 % ( 95 % CI , 58.9%-88.2 % ) at 1 year ( 28 of 37 children ) . The incidence of complicated appendicitis was 2.7 % in the nonoperative group ( 1 of 37 children ) and 12.3 % in the surgery group ( 8 of 65 children ) ( P = .15 ) . After 1 year , children managed nonoperatively compared with the surgery group had fewer disability days ( median [ IQR ] , 8 [ 5 - 18 ] vs 21 [ 15 - 25 ] days , respectively ; P lower appendicitis-related health care costs ( median [ IQR ] , $ 4219 [ $ 2514-$7795 ] vs $ 5029 [ $ 4596-$5482 ] , respectively ; P = .01 ) . CONCLUSIONS AND RELEVANCE When chosen by the family , nonoperative management is an effective treatment strategy for children with uncomplicated acute appendicitis , incurring less morbidity and lower costs than surgery . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01718275",
"The Alvarado score was assessed as to its accuracy in the preoperative diagnosis of acute appendicitis . A series of 49 consecutive patients was studied prospect ively over a period of 9 months in two hospitals ( Gateshead and Sunderl and ) . The presence of a high score was found to be an easy and satisfactory aid to early diagnosis of appendicitis in children and men . However , the false-positive rate for appendicitis in women was unacceptably high",
"BACKGROUND In 2012 , a protocol for routine outpatient laparoscopic appendectomy for uncomplicated appendicitis was published reflecting high success , low morbidity , and significant cost savings . Despite this , national data reflect that the majority of laparoscopic appendectomies are performed with overnight admission . This study up date s our experience with outpatient appendectomy since our initial report , confirming the efficacy of this approach . METHODS In July 2010 , a prospect i ve protocol for outpatient laparoscopic appendectomy was adopted at our institution . Patients were dismissed from the postanesthesia recovery room or day surgery if they met predefined criteria for dismissal . Patients admitted to a hospital room as either full admission or observation status were considered failures of outpatient management . An institutional review board – approved retrospective review of patients undergoing laparoscopic appendectomy for uncomplicated appendicitis from July 2010 through December 2012 was performed to analyze success of outpatient management , postoperative morbidity and mortality , as well as readmission rates . RESULTS Three hundred forty-five patients underwent laparoscopic appendectomy for uncomplicated appendicitis during this time frame . There were 166 men and 179 women , with a mean age of 35 years . Three hundred five patients were managed as out patients , with a success rate of 88 % . Forty patients ( 12 % ) were admitted for preexisting comorbidities ( 15 patients ) , postoperative morbidity ( 6 patients ) , or lack of transportation or home support ( 19 patients ) . Twenty-three patients ( 6.6 % ) experienced postoperative morbidity . There were no mortalities . Four patients ( 1 % ) were readmitted for transient fever , nausea/vomiting , partial small bowel obstruction , and deep venous thrombosis . CONCLUSION Outpatient laparoscopic appendectomy can be performed with a high rate of success , a low morbidity , and a low readmission rate . This study reaffirms our original pilot study and should serve as the basis for a change in the st and ard of care for appendicitis . LEVEL OF EVIDENCE Therapeutic study , level",
"In a prospect i ve controlled study the effect of antibiotics as the only treatment in acute appendicitis was evaluated . Of 40 patients admitted with a duration of abdominal pain of less than 72 h , 20 received antibiotics intravenously for 2 days followed by oral treatment for 8 days and 20 considered as controls were r and omized to surgery . All patients treated conservatively were discharged within 2 days , except one who required surgery after 12 h because of peritonitis secondary to perforated appendicitis . Seven patients were readmitted within 1 year as a result of recurrent appendicitis and underwent surgery , when appendicitis was confirmed . The diagnostic accuracy within the operated group was 85 per cent . One patient had perforated appendicitis at operation . Antibiotic treatment in patients with acute appendicitis was as effective as surgery . The patients had less pain and required less analgesia , but the recurrence rate was high ",
"IMPORTANCE An increasing amount of evidence supports the use of antibiotics instead of surgery for treating patients with uncomplicated acute appendicitis . OBJECTIVE To compare antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis confirmed by computed tomography ( CT ) . DESIGN , SETTING , AND PARTICIPANTS The Appendicitis Acuta ( APPAC ) multicenter , open-label , noninferiority r and omized clinical trial was conducted from November 2009 until June 2012 in Finl and . The trial enrolled 530 patients aged 18 to 60 years with uncomplicated acute appendicitis confirmed by a CT scan . Patients were r and omly assigned to early appendectomy or antibiotic treatment with a 1-year follow-up period . INTERVENTIONS Patients r and omized to antibiotic therapy received intravenous ertapenem ( 1 g/d ) for 3 days followed by 7 days of oral levofloxacin ( 500 mg once daily ) and metronidazole ( 500 mg 3 times per day ) . Patients r and omized to the surgical treatment group were assigned to undergo st and ard open appendectomy . MAIN OUTCOMES AND MEASURES The primary end point for the surgical intervention was the successful completion of an appendectomy . The primary end point for antibiotic-treated patients was discharge from the hospital without the need for surgery and no recurrent appendicitis during a 1-year follow-up period . RESULTS There were 273 patients in the surgical group and 257 in the antibiotic group . Of 273 patients in the surgical group , all but 1 underwent successful appendectomy , result ing in a success rate of 99.6 % ( 95 % CI , 98.0 % to 100.0 % ) . In the antibiotic group , 70 patients ( 27.3 % ; 95 % CI , 22.0 % to 33.2 % ) underwent appendectomy within 1 year of initial presentation for appendicitis . Of the 256 patients available for follow-up in the antibiotic group , 186 ( 72.7 % ; 95 % CI , 66.8 % to 78.0 % ) did not require surgery . The intention-to-treat analysis yielded a difference in treatment efficacy between groups of -27.0 % ( 95 % CI , -31.6 % to ∞ ) ( P = .89 ) . Given the prespecified noninferiority margin of 24 % , we were unable to demonstrate noninferiority of antibiotic treatment relative to surgery . Of the 70 patients r and omized to antibiotic treatment who subsequently underwent appendectomy , 58 ( 82.9 % ; 95 % CI , 72.0 % to 90.8 % ) had uncomplicated appendicitis , 7 ( 10.0 % ; 95 % CI , 4.1 % to 19.5 % ) had complicated acute appendicitis , and 5 ( 7.1 % ; 95 % CI , 2.4 % to 15.9 % ) did not have appendicitis but received appendectomy for suspected recurrence . There were no intra-abdominal abscesses or other major complications associated with delayed appendectomy in patients r and omized to antibiotic treatment . CONCLUSIONS AND RELEVANCE Among patients with CT-proven , uncomplicated appendicitis , antibiotic treatment did not meet the prespecified criterion for noninferiority compared with appendectomy . Most patients r and omized to antibiotic treatment for uncomplicated appendicitis did not require appendectomy during the 1-year follow-up period , and those who required appendectomy did not experience significant complications . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01022567",
"Background and Objectives : Studies suggest that computed tomography and ultrasonography can effectively diagnose and rule out appendicitis , safely reducing negative appendectomies ( NAs ) ; however , some within the surgical community remain reluctant to add imaging to clinical evaluation of patients with suspected appendicitis . The Surgical Care and Outcomes Assessment Program ( SCOAP ) is a physician-led quality initiative that monitors performance by benchmarking processes of care and outcomes . Since 2006 , accurate diagnosis of appendicitis has been a priority for SCOAP . The objective of this study was to evaluate the association between imaging and NA in the general community . Methods : Data were collected prospect ively for consecutive appendectomy patients ( age > 15 years ) at nearly 60 hospitals . SCOAP data are obtained directly from clinical records , including radiological , operative , and pathological reports . Multivariate logistic regression models were used to examine the association between imaging and NA . Tests for trends over time were also conducted . Results : Among 19,327 patients ( 47.9 % female ) who underwent appendectomy , 5.4 % had NA . Among patients who were imaged , frequency of NA was 4.5 % , whereas among those who were not imaged , it was 15.4 % ( P men ( 3 % vs 10 % , P and for women of reproductive age ( 6.9 % vs 24.7 % , P NA for patients not imaged were 3.7 times the odds for those who received imaging ( 95 % CI : 3.0–4.4 ) . Among SCOAP hospitals , use of imaging increased and NA decreased significantly over time ; frequency of perforation was unchanged . Conclusions : Patients who were not imaged during workup for suspected appendicitis had more than 3 times the odds of NA as those who were imaged . Routine imaging in the evaluation of patients suspected to have appendicitis can safely reduce unnecessary operations . Programs such as SCOAP improve care through peer-led , benchmarked practice change",
"BACKGROUND In this prospect i ve study , operative and nonoperative management of acute appendicitis were evaluated regarding their safety and cost effectiveness . METHODS Two hundred ninety patients presenting to our Emergency Department between March 2005 and March 2006 with acute appendicitis were included in this prospect i ve study . Nonoperative medical therapy was performed in 107 patients ( Group 1 ) , and 183 patients were treated surgically ( Group 2 ) . Routine follow-up controls were done on the 10th day , at the 3rd and 6th months and at the first year after discharge in Group 1 . Both groups were compared regarding age , gender , mean hospital stay , modified Alvarado score , morbidity , mortality , and cost effectiveness . RESULTS The male/female ratio of Groups 1 and 2 were 65/42 ( mean age : 30.98+/-1.30 ) and 125/58 ( mean age : 26.25+/-0.79 ) , respectively . In Group 1 , 19 patients were operated . Operation indications were resistance to therapy , patient 's request , and operation in another hospital . Although the mean hospital stay of Group 1 was statistically significantly longer than Group 2 , the mean cost of the therapy was $ 559 in Group 2 and $ 433 in Group 1 . Morbidity rates were similar , with no mortality in either group . CONCLUSION With its high success rate and cost effectiveness , medical treatment seems to be a good alternative to the gold st and ard therapy of surgery in management of acute appendicitis",
"The editors of the Journal of Gastrointestinal Surgery as well as the SSAT Board of Directors have retracted the article Malik , A.A. & Bari , S.U. Conservative management of acute appendicitis . J Gastrointest . Surg 13 , 966–970 ( 2009 ) since significant portions of the article were published earlier in the following articles : Eriksson , S. & Granstrom , L. R and omized controlled trial of appendectomy versus antibiotic therapy for acute appendicitis . Br J Surg 82 , 166–169 ( 1995 ) . Horton , M.D. , Counter , S.F. , Florence , M.G. & Hart , M.J. A prospect i ve trial of computed tomography and ultrasonography for diagnosing appendicitis in the atypical patient . Am J Surg 179 , 379–381 ( 2000 )",
"OBJECTIVE Laparoscopic appendectomy for acute appendicitis has become increasingly used over the past decade . The objective of this trend analysis is to assess whether clinical outcomes after laparoscopic appendectomy have improved over the past 12 years . METHODS This analysis is based on the prospect i ve data base of the Swiss Association of Laparoscopic and Thoracoscopic Surgery . All patients undergoing emergency laparoscopic appendectomy for acute appendicitis from 1995 to 2006 were included . The following outcomes were assessed for each of the 12 years : conversion rates , intraoperative complications , surgical postoperative complications , general postoperative complications , rate of reoperations , and length of hospital stay . Unadjusted and risk-adjusted multivariable analyses were performed . Statistical significance was set at a level of P Data from 7446 patients undergoing laparoscopic appendectomy for acute appendicitis were prospect ively collected . Over the period of observation , the conversion rate decreased significantly from 2.2 % to 1.2 % ( P(trend ) intraoperative complications ( from 3.1 % to 0.7 % ; P(trend ) surgical postoperative complications ( from 6.1 % to 1.9 % ; P(trend ) general postoperative complications ( from 4.9 % to 1.5 % ; P(trend ) rates of reoperations ( from 3.4 % to 0.7 % ; P(trend ) Average postoperative length of hospital stay also significantly decreased from 4.9 to 3.5 days ( P(trend ) intraoperative complications , surgical and general postoperative complications , conversion rates , rates of reoperations , and average length of hospital stay have significantly decreased over the past decade in patients undergoing surgery for acute appendicitis . The present trend analysis is the first one in the literature encompassing more than a decade and reporting clinical outcomes after laparoscopic appendectomy for acute appendicitis , which represents an important quality control",
"PURPOSE Although many patients receive antibiotic therapy for uncomplicated appendicitis , the relatively high treatment failure and recurrence rates are problematic . We assumed that patients with appendicitis and appendiceal diameters ≤ 10 mm , have better outcomes . The purpose of this prospect i ve non-r and omized study was to assess the outcomes of antibiotic therapy in patients with uncomplicated appendicitis and appendiceal diameters ≤ 10 mm . METHODS Over 2 years , we enrolled 119 patients who initially received antibiotic therapy . The failure of antibiotic therapy was defined as the need for appendectomy and true appendicitis . Peritonitis was defined as either complicated appendicitis or intra-abdominal abscess postoperatively . We evaluated the rates of treatment failure , peritonitis , and recurrence . RESULTS Nine patients ( 7.6 % ) failed to respond to initial antibiotic therapy , and 6 had true appendicitis after subsequent surgery . Two patients had complicated appendicitis ( peritonitis ) , but no patient displayed intra-abdominal abscess postoperatively . During a median follow-up period months of 14 months , 14 patients ( 12.7 % ) experienced recurrence . CONCLUSIONS Antibiotic therapy without surgery may be a safe treatment for uncomplicated appendicitis in select patients with appendiceal diameters ≤ 10 mm"
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RATIONALE Many types of pain assessment are available to research ers carrying out clinical trials in chronic pelvic pain ( CPP ) , ranging from a single-item scale to multidimensional inventories . AIM Our objective was to investigate which assessment s of pain are more commonly used in clinical trials on CPP . METHOD We have review ed articles published between 1991 and 2014 . A total of 74 studies out of 1299 original research articles review ed met the selection criteria by containing at least one method of pain assessment . The selected studies were classified according to the dimensions of pain evaluated , the type of scale and the descriptors used . RESULTS The instruments most frequently used were single-item VAS and Biberoglu and Behrman pain score , while multidimensional inventories were used in few studies . The results of clinical studies in CPP are more frequently based on one-dimensional measurements . Valuable results from clinical studies in CPP might have been omitted because of incomplete outcome measurements . CONCLUSION We believe the authors of clinical studies should report their results in a comprehensive way including in the outcomes of the measurement of one-dimensional and multidimensional pain characteristics
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"An open-label r and omized pilot study was conducted to evaluate the efficacy and acceptability of 6 months treatment with leuprolide in a 3-monthly versus a monthly i.m . depot injection for the relief of chronic pelvic pain in women with endometriosis . A total of 30 women aged 18 - 38 years were allocated to the 3-monthly depot arm ( n = 15 ) or to the monthly depot arm ( n = 15 ) after laparoscopic diagnosis of pelvic endometriosis . Mean ( SD ) deep dyspareunia scores according to a 0 - 3 point verbal rating scale decreased from 1.8 ( 0.9 ) at baseline to 1.3 ( 0.7 ) at the end of treatment in the 3-monthly depot group and from 2.1 ( 1.2 ) to 1.3 ( 0.7 ) in the monthly depot group . Corresponding values in non-menstrual pain scores fell from 2.1 ( 0.6 ) to 1.1 ( 0.3 ) , and from 2.1 ( 0.8 ) to 1.2 ( 0.4 ) respectively , without statistically significant differences between the groups . Serum luteinizing hormone ( LH ) and 17 beta-oestradiol concentrations were significantly suppressed at 12 and 24 weeks compared with baseline values , without differences between the groups . The monthly depot caused a slightly more marked inhibition of serum follicle stimulating hormone ( FSH ) levels with respect to the 3-monthly preparation . Mean ( SD ) endometriosis scores at baseline and at 6-month follow-up laparoscopy were respectively 32.8 ( 25.1 ) and 12.2 ( 9.3 ) in the 3-monthly depot group and 29.0 ( 22.7 ) and 13.1 ( 15.3 ) in the monthly depot group ( paired t-test , P Mean percentage decrease in lumbar spine bone mineral density was 5.2 % in the former and 4.9 % in the latter subjects . In the 3-monthly depot group , 13 women grade d the tolerability of their treatment schedule as \" good ' compared with seven in the monthly depot group ( chi 2 = 5.40 , P = 0.02 )",
"Background : Prior study has shown that right paracolic adhesions are found in 90 % of patients with chronic pelvic pain and less frequently in pain-free patients . We set out to determine whether paracolic adhesiolysis will reduce site-specific pain . Methods : This was a prospect i ve , r and omized trial of right paracolic adhesiolysis at the time of diagnostic and operative laparoscopy for chronic pelvic pain . Twenty-five patients with a diagnosis of chronic pelvic pain were r and omized to either undergo or withhold lysis of right paracolic adhesions at the time of operative laparoscopy . Results : Right paracolic adhesions were found in 100 % of our patients . For all subjects , there was a significant reduction of right and left lower quadrant pain ( P right paracolic adhesiolysis had significantly greater right pelvic pain reduction than those who did not ( P=0.014 ) . There was no difference in the reduction of left or mid pelvic pain between the treatment and control groups . Conclusions : Right paracolic adhesiolysis reduces short-term site-specific tenderness in patients with chronic pelvic pain . Patients who would benefit from diagnostic or operative laparoscopy are likely to benefit further from paracolic adhesiolysis",
"OBJECTIVE To compare the efficacy and safety of SC depot medroxyprogesterone acetate ( DMPA-SC 104 ) with that of leuprolide acetate in treatment of endometriosis . DESIGN Phase 3 , multicenter , r and omized , evaluator-blinded , comparator-controlled trial . SETTING Clinical trial sites in Canada and United States . PATIENT(S ) Two hundred seventy-four women with surgically diagnosed endometriosis . INTERVENTION(S ) Intramuscular injections of DMPA-SC ( 104 mg ) or leuprolide acetate ( 11.25 mg ) , given every 3 months for 6 months , with 12 months of posttreatment follow-up . MAIN OUTCOME MEASURE(S ) Reduction in five endometriosis symptoms or signs ( dysmenorrhea , dyspareunia , pelvic pain , pelvic tenderness , pelvic in duration ) ; change in bone mineral density ( BMD ) , hypoestrogenic symptoms , bleeding , and weight . RESULT ( S ) The depot medroxyprogesterone acetate given SC was statistically equivalent to leuprolide in reducing four of five endometriosis symptoms or signs at the end of treatment ( month 6 ) and in reducing all five symptoms after 12 months ' follow-up ( month 18 ) . Patients in the DMPA-SC 104 group showed significantly less BMD loss than did leuprolide patients at month 6 , with scores returning to baseline at 12 months ' follow-up . No statistically significant differences in median weight changes were observed between groups . Compared with leuprolide , DMPA-SC 104 was associated with fewer hypoestrogenic symptoms but more irregular bleeding . CONCLUSION ( S ) Efficacy of DMPA-SC 104 was equivalent to that of leuprolide for reducing endometriosis-associated pain , with less impact on BMD and fewer hypoestrogenic side effects but more bleeding",
"The effect of treatment with danazol was evaluated with respect to expectant management after laparoscopic conservative surgery . All patients conservatively operated at laparoscopy for stage III-IV endometriosis from July 1994 to October 1996 were requested to enter the study . Patients who underwent surgery for recurrent endometriosis were excluded from the study , as well as patients who had taken hormonal therapies before laparoscopy . Informed consent was obtained from 77 women who were r and omized after surgery to treatment with danazol 600 mg daily for 3 months ( n = 36 ) or to expectant management ( n = 41 ) . All patients were regularly followed up every 6 months for evaluation of fertility , recurrence of pain symptoms and disease . During the follow-up , six ( 55 % ) of the 11 infertile women allocated to danazol and eight ( 50 % ) of the 16 given no treatment became pregnant ( not significant ) . Moderate/severe pelvic pain recurred during follow-up in seven ( 23 % ) of the 31 women with pelvic pain allocated to the danazol group and nine ( 31 % ) of the 29 allocated to no treatment ; the respective cumulative pain recurrence rates at 12 months were 26 and 34 % ( log rank test , not significant ) . Three women ( 8.3 % ) treated with danazol and six ( 15 % ) who received no treatment had disease recurrence as demonstrated by gynaecological examination and /or pelvic ultrasonography ( not significant ) . Our results do not demonstrate a significant advantage of 3 month danazol therapy after laparoscopic surgery for stage III-IV endometriosis with respect to postoperative expectant management",
"OBJECTIVE There are fundamental differences between the administration of medications and the application of manual procedures , such as those used by chiropractors . The objective of this study was to gather preliminary information on how to address these differences in the design of a multisite , r and omized placebo-controlled trial of chiropractic care for women with chronic pelvic pain ( CPP ) . DESIGN Pilot study for a multisite , r and omized , placebo-controlled clinical trial . SETTING Three chiropractic research clinics in the midwest United States . SUBJECTS Thirty-nine ( 39 ) women with CPP of at least 6 months ' duration , diagnosed by board-certified gynecologists . INTERVENTIONS The active intervention consisted of the chiropractic technique , lumbar spine flexion-distraction , combined with manual Trigger Point Therapy . The placebo intervention consisted of a sham chiropractic procedure performed with an instrument combined with effleurage ( light massage ) . OUTCOME MEASURES The primary outcome measure was the change in the Pain Disability Index ( PDI ) from baseline to the end of treatment ( 6 weeks ) , assessed by group and site . If the change score was in the same direction at all sites , the results were to be combined to estimate treatment effect size . RESULTS Patient characteristics were similar to those of patients with CPP in other studies . Recruitment methods , particularly in respect to the eligibility criteria and screening protocol s , would require modification in order to recruit an adequate sample for the planned r and omized controlled trial . Clinicians followed st and ardized procedures with apparently minimal deviation , patients in both groups were satisfied with their care and blinding appeared to be successful . PDI change scores were not consistent across sites and so results were not combined and overall treatment effect sizes were not estimated . CONCLUSIONS The technical and personnel re sources required to achieve adequate st and ardization of procedures at multiple sites may make a placebo-controlled trial unfeasible , given our current lack of knowledge about the active agent in manual chiropractic procedures",
"Summary BACKGROUND : The aim of this study was to compare the efficacy and side effects of gabapentin , amitriptyline , and their combination in women with chronic pelvic pain . METHODS : In this open-label , prospect i ve , r and omized trial , 56 women with chronic pelvic pain were investigated with a two-year follow-up at the Vienna Medical University Hospital . If pain intensity assessed by a visual analog scale ( VAS ) was 5 or more ( 0 , no pain ; 10 , maximal pain ) , despite analgesic therapy using the nonopioid drug metamizol together with weak opioids , patients were r and omized to receive gabapentin ( n = 20 ) , amitriptyline ( n = 20 ) , or a combination of both drugs ( n = 16 ) . Doses of gabapentin and amitriptyline were increased to maximum daily doses of 3600 mg and 150 mg , respectively , until sufficient pain relief or the occurrence of side effects . VAS and side effects were evaluated before treatment and at 1 , 3 , 6 , 12 and 24 months afterwards . RESULTS : All patients experienced significant pain relief during the observation period . However , after 6 , 12 and 24 months , pain relief was significantly better in patients receiving gabapentin either alone or in combination with amitriptyline than in patients receiving monotherapy with amitriptyline ( gabapentin : 0 months , 7.7 ± 1.5 ; 6 months , 1.6 ± 0.9 ; 12 months , 1.5 ± 0.9 ; 24 months , 1.9 ± 0.9 ; amitriptyline : 0 months , 7.3 ± 1.5 ; 6 months , 2.2 ± 1.6 ; 12 months , 2.2 ± 1.6 ; 24 months ; 3.4 ± 0.9 ; amitriptyline-gabapentin : 0 months , 7.6 ± 0.8 ; 6 months , 1.3 ± 0.9 ; 12 months , 1.7 ± 1.0 ; 24 months , 2.3 ± 0.9 ) . Side effects were lower in the gabapentin group than in the two other groups , the difference reaching statistical significance after three months ( P : Gabapentin alone or in combination with amitriptyline is better than amitriptyline alone in the treatment of female chronic pelvic pain . ZusammenfassungEINLEITUNG : Gegenst and der Studie war der Vergleich der Wirksamkeit und Verträglichkeit von Gabapentin bzw . Amitriptylin allein mit der Kombination der beiden Medikamente bei chronischen Unterbauchschmerzen ( chronic pelvic pain , CPP ) . METHOD EN : 56 weibliche Patientinnen mit chronischen Unterbauschmerzen wurden bei der prospektiven , r and omisierten Open-label-Studie mit einem 2-jährigem Follow-up an der Schmerzambulanz der Universitätsklinik Wien , Österreich , eingeschlossen . Wenn die Schmerzintensität trotz analgetischer Therapie mit dem Nichtopioid Metamizol und einem schwachen Opioid gemessen auf der visuellen Analogskala ( VAS ) bei 5 oder darüber lag ( 0 , kein Schmerz ; 10 , schlimmster vorstellbarer Schmerz ) , wurden die Patientinnen r and omisiert einem der drei Beh and lungsarme zugeteilt ( Gabapentin , n = 20 ; Amitriptylin , n = 20 , oder beides , n = 16 ) . Die Medikamentengaben von Gabapentin bzw . Amitriptylin wurden auf eine tägliche Dosis von 3600 mg bzw . 150 mg gesteigert , bis eine suffiziente Schmerzerleichterung erreicht war oder unerwünschte Nebenwirkungen auftraten . VAS-Werte wurde vor Beginn der Beh and lung und 1 , 3 , 6 , 12 und 24 Monate danach erhoben . ERGEBNISSE : Alle Patientinnen erfuhren während des Beobachtungszeitraumes eine signifikante Schmerzreduktion . Dennoch war die Schmerzreduktion bei Patientinnen , die Gabapentin allein oder in Kombination mit Amitriptylin erhalten hatten , signifikant höher als unter Monotherapie mit Amitriptylin ( Gabapentin : 0 , 7,7 ± 1,5 ; 6 , 1,6 ± 0,9 ; 12 , 1,5 ± 0,9 ; 24 , 1,9 ± 0,9 ; Amitriptylin : 0 , 7,3 ± 1,5 ; 6 , 2,2 ± 1,6 ; 12 , 2,2 ± 1,6 ; 24 , 3,4 ± 0,9 ; Amitriptylin-Gabapentin : 0 , 7,6 ± 0,8 ; 6 , 1,3 ± 0,9 ; 12 , 1,7 ± 1,0 ; 24 , 2,3 ± 0,9 ) . Unerwünschte Nebenwirkungen traten signifikant seltener in der Gabapentin-Gruppe auf als in den beiden and eren Gruppen ( P Gabapentin die Beh and lung von chronischen Unterbauchschmerzen bei ambulanten Patientinnen verbessert",
"Following identification of the proportion of pelvic congestion among symptomatic patients complaining of chronic pelvic pain , and in a totally asymptomatic group of patients requesting tubal ligation , the efficiency of goserelin acetate versus medroxyprogesterone acetate was compared objective ly using pelvic venogram scores , and subjectively by symptom resolution , improvement of psychological status and sexual functioning in a prospect i ve r and omized trial in 47 patients with pure pelvic congestion syndrome . Patients received either goserelin acetate ( 3.6 mg/month for 6 months ) or medroxyprogesterone acetate ( MPA ; 30 mg/day for 6 months ) . Among patients with chronic pelvic pain , those with pure pelvic congestion were mostly parous , had the most severe pelvic signs and symptom scores , lowest rates of sexual functioning , and higher states of anxiety and depression as compared with others . At 1 year after treatment , goserelin remained superior to MPA in terms of pelvic venographic improvement as an objective measure . In alleviation of signs and symptomatology , improvement of sexual functioning and reduction of anxiety and depressive states as subjective measures , goserelin acetate achieved a statistically significant advantage ( P = 0.0001 ) compared with MPA",
"OBJECTIVE To examine the effect on pain and quality of life for women with all stages of endometriosis undergoing laparoscopic surgery compared with placebo surgery . DESIGN A r and omized , blinded , crossover study . SETTING A tertiary referral unit in a district general hospital . PATIENT(S ) Thirty-nine women with histologically proven endometriosis completed the 12-month study . INTERVENTION(S ) Women were r and omized to receive initially either a diagnostic procedure ( the delayed surgical group ) or full excisional surgery ( the immediate surgery group ) . After 6 months , repeat laparoscopy was performed , with removal of any pathology present . MAIN OUTCOME MEASURE(S ) The end points were changes from baseline values of visual analogue pain scores , vali date d quality -of-life instruments ( EQ-5D and SF-12 ) , and sexual activity question naire scores . Patients and assessors of outcomes were blinded to the treatment-group assignment . RESULT ( S ) Significantly more of the 39 women operated on according to protocol reported symptomatic improvement after excisional surgery than after placebo : 16 of 20 ( 80 % ) vs. 6 of 19 ( 32 % ) ; chi(2)(1 ) = 9.3 . Other aspects of quality of life were also significantly improved 6 months after excisional surgery but not after placebo . Progression of disease at second surgery was demonstrated for women having only an initial diagnostic procedure in 45 % of cases , with disease remaining static in 33 % and improving in 22 % of cases . Nonresponsiveness to surgery was reported in 20 % of cases . CONCLUSION ( S ) Laparoscopic excision of endometriosis is more effective than placebo at reducing pain and improving quality of life . Surgery is associated with a 30 % placebo response rate that is not dependent on severity of disease . Approximately 20 % of women do not report an improvement after surgery for endometriosis",
"Objectives : To determine if low-dose estrogen replacement can be added to GnRH agonist therapy after three months to reduce hypoestrogenic symptoms while allowing continued relief of pain in patients with endometriosis . Material s and Methods : Thirteen women with endometriosis and pain were treated with six months of leuprolide acetate in a prospect i ve , r and omized double-blind placebo controlled study . After three months of therapy , six subjects initiated oral estradiol 1 mg daily , and seven received an identical placebo . Results : Dysmenorrhea improved in both groups , and dyspareunia significantly improved in the GnRH agonist plus placebo group . The mean pain scores of the oral estrogen group tended to be higher than the placebo group , and hot flushes tended to be less severe with estrogen treatment . However , differences observed between the study and placebo groups did not reach statistical significance . Conclusion : In a prospect i ve , r and omized study , low-dose estrogen replacement increases endometriosis-related pain during GnRH agonist therapy . The study was terminated after the first 13 subjects due to the concerning trend toward recurrent symptoms in women who received oral estradiol during GnRH agonist therapy for endometriosis-related pain . With the trend toward increasing pain with estrogen add-back therapy , a larger study would not seem to be justifiable",
"OBJECTIVE To evaluate the efficacy and tolerability of a contraceptive vaginal ring and transdermal patch in the treatment of endometriosis-associated pain . DESIGN Patient preference cohort study . SETTING Academic center . PATIENT(S ) Two-hundred and seven women with recurrent moderate or severe pelvic pain after conservative surgery for symptomatic endometriosis . INTERVENTION(S ) Continuous , 12-month treatment with a vaginal ring supplying 15 mcg of ethinyl E and 120 mcg of etonogestrel per day or a transdermal system delivering 20 mcg of ethinyl E and 150 mcg norelgestromin per day . MAIN OUTCOME MEASURE(S ) Satisfaction with treatment . RESULT ( S ) One-hundred and twenty-three women preferred the ring , and 84 preferred the patch . Forty-four ring users ( 36 % ) and 51 patch users ( 61 % ) withdrew . Thirty-six of 79 subjects ( 46 % ) in the ring group and 14 of 33 ( 42 % ) in the patch group shifted from continuous to cyclic use because of irregular bleeding . Pain symptoms were reduced by both treatments , with the ring being more effective than the patch in patients with rectovaginal lesions . According to an intention-to-treat analysis , 88 of 123 ring users ( 72 % ) and 40 of 84 patch users ( 48 % ) were satisfied with the treatment received . CONCLUSION ( S ) Patients who preferred the ring were significantly more likely to be satisfied and to comply with treatment than those who chose the patch . Both systems were associated with poor bleeding control when used continuously",
"BACKGROUND Endometriosis is associated with an inflammatory response . Hence infliximab , an anti-TNF-α monoclonal antibody , might relieve pain . METHODS A r and omized placebo-controlled trial was design ed with 21 women with severe pain and a rectovaginal nodule of at least 1 cm . After 1 month of observation , three infusions of infliximab ( 5 mg/kg ) or placebo were given . Surgery was performed 3 months later and follow-up continued for 6 months . The primary end-point was pain ( dysmenorrhea , deep dyspareunia and non-menstrual pain ) rated at each visit by the clinician and on a daily basis by the patient who in addition scored pain by visual analog pain scale and analgesia intake . Secondary end-points included the volume of the endometriotic nodule , pelvic tenderness and the visual appearance of endometriotic lesions at laparoscopy . RESULTS Pain severity decreased during the treatment by 30 % in both the placebo ( P infliximab was observed for any of the outcome measures . After surgery , pain scores decreased in both groups to less than 20 % of the initial value . CONCLUSIONS Infliximab appears not to affect pain associated with deep endometriosis . Treatment is associated with an important placebo effect . After surgery , pain decreases to less than 20 % . Trials registration number Clinical Trials.gov : NCT00604864",
"OBJECTIVE To evaluate postoperative long-term cyclic and continuous administration of combined oral contraceptive ( OC ) pills in preventing endometriosis-related pain recurrence . DESIGN Prospect i ve , r and omized , controlled trial . SETTING Tertiary care university hospital . PATIENT(S ) Three hundred eleven women who underwent laparoscopic excision for symptomatic ovarian endometrioma . INTERVENTION(S ) Patients were r and omly divided into three groups : nonuser group receiving no therapy , and cyclic user group and continuous user group receiving low-dose , monophasic OC pills for 24 months in either cyclic or continuous administration . MAIN OUTCOME MEASURE(S ) Presence and intensity of dysmenorrhea , dyspareunia , and chronic pelvic pain were assessed by a 10-point visual analogue scale ( VAS ) at 6 , 12 , 18 , and 24 months postoperatively . RESULT ( S ) A significant reduction in recurrence rate and VAS scores for dysmenorrhea was evident in the continuous users versus the other groups at 6 months , and in cyclic users versus nonusers at 18 months postoperatively . No significant differences in recurrence rate and VAS scores for dyspareunia and chronic pelvic pain were demonstrated among the groups . The increase of VAS scores from 6 - 24 months during the study period for dysmenorrhea , dyspareunia , and chronic pelvic pain was significantly higher in nonusers than in the other groups . CONCLUSION ( S ) Long-term postoperative use of OC pills can reduce the frequency and the severity of recurrent endometriosis-related dysmenorrhea",
"OBJECTIVE To assess the effect of a new progestin progestogen only pill ( desogestrel ) versus an oral contraceptive in the treatment of recurrent endometriosis . STUDY DESIGN A r and omized prospect i ve clinical study . A group of women with endometriosis ( n=40 ) who showed recurrent dysmenorrhea and /or pelvic pain after conservative surgery , and did not desire a pregnancy . Continuous treatment for 6 months with desogestrel ( 75 microg/d ) ( n=20 ) versus a combined oral contraceptive ( ethinyl estradiol 20 microg plus desogestrel 150 microg ) ( n=20 ) was performed . RESULTS A significant improvement of both pelvic pain and dysmenorrhea was observed following each type of treatment ( P desogestrel progestogen only pill was associated with a breakthrough bleeding in 20 % patients , while a significant body weight increase was observed in 15 % after oral contraceptive . CONCLUSIONS Both desogestrel and an oral estro-progestinic were effective , safe and low cost therapy of pain symptoms after endoscopic surgery for endometriosis , the former showing an impact on breakthrough bleeding , the later an incidence on body weight increase",
"OBJECTIVE To investigate the role of adjuvant treatment with gonadotropin-releasing-hormone agonist ( GnRHa ) following conservative surgical treatment of endometriosis . STUDY DESIGN Sixty patients in the reproductive age ( mean age 28.6 years ) , with symptomatic stages III and IV endometriosis following laparoscopic surgery and without previous hormonal treatment were enrolled in a prospect i ve , r and omized , controlled trial to compare the effects of 3-month treatment with triptorelin depot-3.75 i.m . ( 30 patients ) versus expectant management using placebo injection ( 30 patients ) . RESULTS Six patients ( one in triptorelin group and five in placebo group ) were lost at follow-up , the remaining 54 were suitable for analysis . Pelvic pain persistence or recurrence , endometrioma relapses and pregnancy rate were evaluated during a 5-year follow-up . The results of 29 cases treated with triptorelin and 25 that received placebo did not show significant differences in pain recurrence ( P=1 , RR=0.94 , 95 % CI=0.57 - 1.55 ) , endometrioma relapse ( P=0.67 , RR=1.29 , 95 % CI=0.66 - 2.50 ) , and pregnancy rate in infertile women ( P=0.80 , RR=0.81 , 95 % CI=0.37 - 1.80 ) . Curves of time of pain recurrence and pregnancy during 5-year follow-up did not show significant differences between the two groups ( P=0.79 and P=0.51 , respectively , using Mantel-Haenzsel logrank test ) . CONCLUSION Triptorelin treatment after operative laparoscopy for stage III/IV endometriosis does not appear to be superior to expectant management in terms of prevention of symptoms recurrence and endometrioma relapse , and has no influence on pregnancy rate in endometriosis-associated infertility ",
"BACKGROUND Dienogest is a selective progestin that has been investigated in a clinical trial programme for the treatment of endometriosis . The current non-inferiority trial compared the efficacy and safety of dienogest against leuprolide acetate ( LA ) for treating the pain associated with endometriosis . METHODS Patients with confirmed endometriosis were r and omized to treatment with dienogest ( 2 mg/day , orally ) or LA ( 3.75 mg , depot i.m . injection , every 4 weeks ) for 24 weeks . The primary efficacy variable was absolute change in pelvic pain from baseline to end of treatment , assessed by visual analogue scale ( VAS ) . Safety variables included adverse event profile , laboratory parameters , bone mineral density ( BMD ) , bone markers and bleeding patterns . RESULTS A total of 252 women were r and omized to treatment with dienogest ( n = 124 ) or LA ( n = 128 ) ; 87.9 and 93.8 % of the respective groups completed the trial . Absolute reductions in VAS score from baseline to Week 24 were 47.5 mm with dienogest and 46.0 mm with LA , demonstrating the equivalence of dienogest relative to LA . Hypoestrogenic effects ( e.g. hot flushes ) were reported less frequently in the dienogest group . As expected , bleeding episodes were suppressed less with dienogest than with LA . Changes in mean lumbar BMD between screening and final visit were + 0.25 % with dienogest and -4.04 % with LA subgroups ( P = 0.0003 ) . Markers of bone resorption increased with LA but not dienogest . CONCLUSIONS Dienogest 2 mg/day orally demonstrated equivalent efficacy to depot LA at st and ard dose in relieving the pain associated with endometriosis , although offering advantages in safety and tolerability",
"OBJECTIVE To evaluate the effectiveness of a levonorgestrel-releasing IUD as therapy for endometriosis of the rectovaginal septum . DESIGN Prospect i ve therapeutic non-r and omized , self-controlled clinical trial analyzing changes in pain symptoms and size of lesions induced by the levonorgestrel-releasing IUD over 12 months . SETTING Tertiary referral center for treatment of deep endometriosis . PATIENT(S ) Eleven symptomatic patients with rectovaginal endometriosis . INTERVENTION(S ) A levonorgestrel-releasing IUD was inserted and maintained for 12 months . MAIN OUTCOME MEASURE(S ) Severity of dysmenorrhea , pelvic pain , and deep dyspareunia were assessed before insertion of the IUD and throughout treatment . The size of rectovaginal endometriotic lesions were evaluated by using transrectal and transvaginal ultrasonography . RESULT ( S ) Dysmenorrhea , pelvic pain , and deep dyspareunia greatly improved and the size of the endometriotic lesions was significantly reduced by treatment . CONCLUSION ( S ) Insertion of a levonorgestrel-releasing IUD alleviates pain and reduces the size of lesions in patients with endometriosis of the rectovaginal septum",
"OBJECTIVE To compare the effect of a GnRH-agonist , triptorelin , versus placebo on the symptoms of endometriosis . DESIGN A prospect i ve , r and omized , double-blind study of 6 months of treatment followed by 12 months of follow-up . SETTING Departments of Obstetrics and Gynecology at two universities and one general hospital . PATIENT(S ) Forty-nine women with symptoms of laparoscopically verified endometriosis . INTERVENTION(S ) Triptorelin depot or placebo was given every 4 weeks . Clinical evaluation , including the Duration Intensity Behavior Scale and Visual Analogue Scale for pain , was performed before the injections and up to 12 months after treatment . A control laparoscopy was performed 4 - 6 weeks after the last injection . MAIN OUTCOME MEASURE(S ) Quantitation of pain . RESULT ( S ) Twenty-four patients had active treatment and 25 received placebo . Pain symptoms according to both scales were significantly more reduced after 2 months of triptorelin treatment compared to placebo . The extent of endometriotic lesions was reduced 50 % during triptorelin treatment and increased 17 % during placebo . The average area of endometriotic lesions was reduced 45 % during triptorelin treatment but was unchanged during placebo . Side effects , mainly hot flushes , were experienced by 80 % of the actively treated group but also by 33 % of patients in the placebo group . Because of recurrent symptoms , only five patients could be observed for 12 months after completion of treatment . CONCLUSION ( S ) Triptorelin reduces endometriotic lesions and pain to a significantly higher degree than placebo",
"Background When aromatase inhibitors are used to treat premenopausal women with endometriosis , additional drugs should be used to effectively down-regulate gonadal estrogen bio synthesis . This r and omized prospect i ve open-label study compared the efficacy in treating pain symptoms and the tolerability of letrozole combined with either norethisterone acetate or triptorelin . Methods Women with pain symptoms caused by rectovaginal endometriosis were treated with letrozole ( 2.5 mg/day ) and were r and omized to also receive either oral norethisterone acetate ( 2.5 mg/day ; group N ) or intramuscular injection of triptorelin ( 11.25 mg every 3 months ; group T ) . The scheduled length of treatment was 6 months . A visual analogue scale and a multidimensional categorical rating scale were used to assess the severity of pain symptoms . The volume of the endometriotic nodules was estimated by ultrasonography using virtual organ computer-aided analysis . Adverse effects of treatment were recorded . Results A total of 35 women were r and omized between the two treatment protocol s. Significantly more patients in group N rated their treatment as satisfactory or very satisfactory ( 64.7 % ) as compared to group T ( 22.2 % ; p = 0.028 ) . The intensity of both non-menstrual pelvic pain and deep dyspareunia significantly decreased during treatment in both study groups , though no statistically meaningful difference between the two groups was apparent . Reduction in the volume of endometriotic nodules was significantly greater in group T than in group N. Interruption of treatment due to adverse effects significantly differed between the groups , with 8 women in group T ( 44.4 % ) and 1 woman in group N ( 5.9 % ) interrupting treatment ( p = 0.018 ) . Similarly , 14 women included in group T ( 77.8 % ) and 6 women included in group N ( 35.3 % ) experienced adverse effects of treatment ( p = 0.018 ) . During treatment , mineral bone density significantly decreased in group T but not in group N. Conclusions Aromatase inhibitors reduce the intensity of endometriosis-related pain symptoms . Combining letrozole with oral norethisterone acetate was associated with a lower incidence of adverse effects and a lower discontinuation rate than combining letrozole with triptorelin",
"PURPOSE In this r and omized , double-blind , placebo controlled phase 2 study we investigated tanezumab , a humanized monoclonal antibody that specifically inhibits nerve growth factor as a treatment for interstitial cystitis pain . MATERIAL S AND METHODS Patients with interstitial cystitis received a single intravenous dose of 200 μg/kg tanezumab or placebo . Patients recorded daily pain scores ( on an 11-point numerical rating scale ) 7 days before attending study visits and completed a urinary symptom diary for 3 of those days . Patients also completed the Interstitial Cystitis Symptom Index question naire and a global response assessment . The primary end point was change in average daily numerical rating scale pain score from baseline to week 6 . Secondary end points included global response assessment , Interstitial Cystitis Symptom Index score , micturition and urgency episode frequency per 24 hours , and mean voided volume per micturition . The incidence of adverse events was also assessed . RESULTS A total of 34 patients received tanezumab and 30 received placebo . At week 6 tanezumab produced a significant reduction from baseline in average daily pain score vs placebo ( treatment difference [ LS mean , 90 % CI ] was -1.4 [ -2.2 , -0.5 ] ) . A significantly higher proportion of patients on tanezumab responded as improved in the global response assessment and tanezumab also significantly reduced urgency episode frequency vs placebo . Tanezumab had no significant effect on Interstitial Cystitis Symptom Index score , micturition frequency or mean voided volume per micturition . The most common adverse events were headache ( tanezumab 20.6 % , placebo 16.7 % ) and paresthesia ( tanezumab 17.6 % , placebo 3.3 % ) . CONCLUSIONS Tanezumab has shown preliminary efficacy in the treatment of pain associated with interstitial cystitis",
"OBJECTIVE To evaluate the effectiveness for the outcomes of endometriosis-related pain and quality of life of conservative surgery plus placebo compared with conservative surgery plus hormonal suppression treatment or dietary therapy . DESIGN R and omized comparative trial . SETTING University hospital . PATIENT(S ) Two hundred twenty-two consecutive women who underwent conservative pelvic surgery for symptomatic endometriosis stage III-IV ( r-AFS ) . INTERVENTION(S ) Six months of placebo ( n = 110 ) versus GnRH-a ( tryptorelin or leuprorelin , 3.75 mg every 28 days ) ( n = 39 ) or continuous estroprogestin ( ethynilestradiol , 0.03 mg plus gestoden , 0.75 mg ) ( n = 38 ) versus dietary therapy ( vitamins , minerals salts , lactic ferments , fish oil ) ( n = 35 ) . MAIN OUTCOME MEASURE(S ) Painful symptoms ( visual analogue scale score ) and quality -of-life endometriosis-related symptoms ( SF-36 score ) at 12 months ' follow-up . RESULT ( S ) Patients treated with postoperative hormonal suppression therapy showed less visual analogue scale scores for dysmenorrhoea than patients of the other groups . Hormonal suppression therapy and dietary supplementation were equally effective in reducing nonmenstrual pelvic pain . Surgery plus placebo showed significative decrease in dyspareunia scores . Postoperative medical and dietary therapy allowed a better quality of life than placebo . CONCLUSION ( S ) Postoperative hormonal suppression treatment or dietary therapy are more effective than surgery plus placebo to obtain relief of pain associated with endometriosis stage III-IV and improvement of quality of life",
"PURPOSE Interstitial cystitis is a severe debilitating bladder disease characterized by unrelenting pelvic pain and urinary frequency . A prospect i ve , double-blind , placebo controlled study of the use of intravesical bacillus Calmette-Guerin ( BCG ) in the treatment of interstitial cystitis was recently completed with a mean followup of 8 months . Results demonstrated a 60 % BCG response rate , compared to a 27 % placebo response rate . We now report the long-term followup results of those patients who received intravesical BCG . MATERIAL S AND METHODS Subjects r and omized to receive BCG were followed at routine intervals with question naires and voiding diaries identical to those in the blinded study . Adverse events were closely monitored in the treatment and followup phases of the study . Subject baseline values were compared to followup data . RESULTS Of the BCG responders mean followup was 27 months ( range 24 to 33 ) , and 8 of 9 ( 89 % ) continue to have an excellent response in all parameters measured . The global interstitial cystitis survey improved 70 % , daily voids decreased 31 % , nocturia improved 54 % , mean voided volume increased 61 % , pelvic pain decreased 81 % , vaginal pain decreased 71 % , urgency decreased 71 % and dysuria decreased 82 % . Overall well-being improved 54 % and the R and -36 quality of life survey overall improved 64 % . In 86 % of the patients ( 6 of 7 ) dyspareunia resolved . Of the initial BCG nonresponders there was no significant difference in interstitial cystitis symptomatology from baseline to last followup , suggesting that BCG does not worsen interstitial cystitis symptoms . No long-term adverse events from BCG were noted . CONCLUSIONS Intravesical Tice BCG is safe , effective and durable in the treatment of interstitial cystitis . Of those patients who received only 6 weekly treatments and responded favorably 89 % continue to have an excellent response with followup ranging from 24 to 33 months",
"BACKGROUND The objective of this multicentre r and omized , controlled clinical trial was to compare the efficacy of a levonorgestrel-releasing intrauterine system ( LNG-IUS ) and a depot-GnRH-analogue in the control of endometriosis-related pain over a period of six months . METHODS Eighty-two women , 18 to 40 years of age ( mean 30 years ) , with endometriosis , dysmenorrhoea and /or CPP , were r and omized using a computer-generated system of sealed envelopes into either LNG-IUS ( n = 39 ) or GnRH analogue ( n = 43 ) treatment groups at three university centres . Daily scores of endometriosis-associated CPP were evaluated using the Visual Analogue Scale ( VAS ) , daily bleeding score was calculated from bleeding calendars , and improvement in quality of life was evaluated using the Psychological General Well-Being Index Question naire ( PGWBI ) . The pain score diary was based on the VAS in which women recorded the occurrence and intensity of pain on a daily basis . A monthly score was calculated from the result of the sum of the daily scores divided by the number of days in each observation period . RESULTS CPP decreased significantly from the first month throughout the six months of therapy with both forms of treatment and there was no difference between the groups ( P > 0.999 ) . In both treatment groups , women with stage III and IV endometriosis showed a more rapid improvement in the VAS pain score than women with stage I and II of the disease ( P LNG-IUS users had a higher bleeding score than GnRH-analogue users at all time points of observation with 34 % and 71 % of patients in the LNG-IUS and GnRH-analogue groups , respectively , reporting no bleeding during the first treatment month , and 70 % and 98 % reporting no bleeding during the sixth month . No difference was observed between groups with reference to improvement in quality of life . CONCLUSIONS Both , the LNG-IUS and the GnRH-analogue were effective in the treatment of CPP-associated endometriosis , although no differences were observed between the two treatments . Among the additional advantages of the LNG-IUS is the fact that it does not provoke hypoestrogenism and that it requires only one medical intervention for its introduction every 5 years . This device could therefore become the treatment of choice for CPP-associated endometriosis in women who do not wish to conceive",
"PURPOSE We examined the safety and the efficacy of a combination of intravesical and oral pentosan polysulfate sodium in comparison to only oral pentosan polysulfate sodium in treating interstitial cystitis . MATERIAL S AND METHODS A total of 41 females diagnosed with interstitial cystitis were r and omized to receive a combination of intravesical pentosan polysulfate sodium plus oral pentosan polysulfate sodium ( 21 in treatment group ) or intravesical placebo plus oral pentosan polysulfate sodium ( 20 in placebo group ) for 6 weeks . All subjects continued to receive oral pentosan polysulfate sodium for another 12 weeks . The primary outcome was the change in the O'Leary-Sant Interstitial Cystitis Symptoms/Problem Index from baseline to week 6 , 12 , and 18 . Other outcomes included : the changes in Pelvic Pain and Urgency Frequency question naire , Health Related Quality of Life index : SF-36 , pain scale , urgency scale , voiding log , patient global assessment , and sexual function scales . RESULTS The change in the total score of O'Leary-Sant Interstitial Cystitis Symptoms/Problems Index from baseline to week 12 among the treatment group ( median -12 or approximately a 46 % reduction ) was significantly greater compared to the placebo group ( median -5.5 or approximately a 24 % reduction , p = 0.04 ) . At week 18 the treatment group showed statistically significant improvement in all Health Related Quality of Life domains compared to the baseline ( p Health Related Quality of Life domains , ( p adverse events between treated and placebo groups . CONCLUSIONS The use of intravesical pentosan polysulfate sodium simultaneously with oral pentosan polysulfate sodium is a safe and effective therapeutic option . These findings will open a new option for patients with interstitial cystitis to reduce their severely devastating symptoms and to improve their quality of life and well-being",
"OBJECTIVE To compare efficacy of the levonorgestrel-releasing intrauterine system ( LNG-IUS ; Mirena ) with depot GnRH analogue ( GnRH-a ; gosareline acetate ; Zoladex ) on endometriosis-related chronic pelvic pain ( CPP ) in patients with severe endometriosis during 12 months . DESIGN Prospect i ve , r and omized , controlled study . SETTING The reproductive endocrinology unit of a tertiary , research and education hospital . PATIENT(S ) Forty women with severe endometriosis ( revised The American Fertility Society [ AFS ] classification > 40 ) and endometriosis-related CPP and control groups were enrolled in the study . INTERVENTION(S ) The patients were treated with either LNG-IUS ( n = 20 ) or GnRH-a ( n = 20 ) . The GnRH-a dose was repeated every 4 weeks for 24 weeks . MAIN OUTCOME MEASURE(S ) Scores of CPP were evaluated using a visual analogue scale ( VAS ) and total endometriosis severity profile ( TESP ) . RESULT ( S ) The TESP score decreased in the LNG-IUS group at first , third , and sixth month follow-up visits , whereas at the 12th month follow-up visit , the TESP scores were increased to values similar to pretreatment values . Although the VAS score had no significant alteration during the follow-up period in the LNG-IUS group , the GnRH-a group showed a significant decrease in the VAS score and TESP score at the end of 1 year . The LNG-IUS treatment showed a lower patient satisfaction . CONCLUSION ( S ) Both treatment modalities showed comparable effectiveness in the treatment of CPP-related endometriosis",
"OBJECTIVE : To evaluate whether 6 months of raloxifene was effective in treatment of chronic pelvic pain in women with endometriosis . METHODS : Women with chronic pelvic pain and no endometriosis treatment for 6 months underwent laparoscopy for excision of all lesions . Those with biopsy-proven endometriosis were r and omly allocated to raloxifene ( 180 mg ) or placebo daily . A second laparoscopy was performed at 2 years , or earlier , if pain returned . Return of pain was defined as 2 months of pain equal to or more severe than that at study entry . Menstrual cycles and adverse events were recorded . The log rank test was used to compare the time to return of pain by drug group . Analyses were done as intent-to-treat . RESULTS : A total of 127 of 158 women underwent surgery . Of these , 93 had biopsy-confirmed endometriosis and were r and omly assigned to study treatment . Menstrual cycle length , pelvic pain severity , quality of life , bone mineral density , and adverse events did not differ between treatment groups . The Data Safety Monitoring Committee terminated the study early when the raloxifene group experienced pain ( P=.03 ) and had second surgery ( P=.016 ) significantly sooner than the placebo group . Interestingly , biopsy-proven endometriosis was not associated with return of pain ( P=.6 ) . CONCLUSION : Raloxifene significantly shortened the time to return of chronic pelvic pain . Because recurrence of endometriosis lesions did not correlate with return of pain , other factors are implicated in pelvic pain . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www.cliicaltrials.gov , NCT00001848 LEVEL OF EVIDENCE :",
"OBJECTIVE The aim of the study was to determine the efficacy of static magnetic field therapy for the treatment of chronic pelvic pain ( CPP ) by measuring changes in pain relief and disability . STUDY DESIGN Thirty-two patients with CPP completed 2 weeks and 19 patients completed 4 weeks of r and omized double-blind placebo-controlled treatment at a gynecology clinic . Active ( 500 G ) or placebo magnets were applied to abdominal trigger points for 24 hour per day . The McGill Pain Question naire , Pain Disability Index , and Clinical Global Impressions Scale were outcome measures . RESULTS Patients receiving active magnets who completed 4 weeks of double-blind treatment had significantly lower Pain Disability Index ( P .05 ) , Clinical Global Impressions-Severity ( P , and Clinical Global Impressions-Improvement ( P .01 ) scores than those receiving placebo magnets , but were more likely to correctly identify their treatment ( P disability and may reduce pain when active magnets are worn continuously for 4 weeks in patients with CPP , but blinding efficacy is compromised",
"OBJECTIVE To compare reduction of pain following laparoscopy after ablation or excision of endometriosis . DESIGN A prospect i ve , r and omized , double-blind study . SETTING Endometriosis and pelvic pain clinic at a university teaching hospital . PATIENT(S ) Women of reproductive age presenting with pelvic pain and visually proved endometriosis . INTERVENTION(S ) Subjects completed a question naire rating their various pains using visual analogue scales ( VASs ) . After visual identification subjects were assigned r and omly to treatment with ablation or excision by supervised training gynecologists as primary surgeon . Follow-up question naires at 3 , 6 , 9 , and 12 months documented pain levels . MAIN OUTCOME MEASURE(S ) Change in overall pain VAS score at 12 months after operation . RESULT ( S ) There was no significant difference in reduction in overall pain VAS scores at 12 months when comparing ablation and excision . CONCLUSION ( S ) This study has not been able to demonstrate a significant difference in pain reduction between ablation and excisional treatments . Nonsignificant trends suggest that a larger study may find a difference in outcomes looking at dyspareunia or dyschezia",
"OBJECTIVE To evaluate the efficacy and safety of a cyclooxygenase (COX)-2 specific inhibitors versus placebo in the treatment of endometriosis-associated pelvic pain . STUDY DESIGN A group of women ( n = 28 ) with pelvic pain after conservative surgery for symptomatic endometriosis ( Stage I and II ) were enrolled at the Department of Pediatric , Obstetrics and Reproductive Medicine of University of Siena . A treatment with a COX-2 specific inhibitors ( rofecoxib , 25 mg per day ) ( n = 16 ) or placebo ( n = 12 ) was given for 6 months . Pelvic pain quantification with a clinical evaluation , including Visual Analogue Scale ( VAS ) for pain , was performed before and up to 6 months after treatment . RESULTS A significant improvement of both pelvic pain and dyspareunia was observed after a 6 months persisting since the end of the treatment ( P efficacy of rofecoxib was higher than placebo and no recurrence occurred , while in the placebo-treatment a 16 % ( 2/12 ) occurred . No significant side effects have been found with the use of rofecoxib . CONCLUSIONS The use of COX-2 specific inhibitors was effective , safe and low cost therapy in the management of pelvic pain associated to endometriosis and might be also proposed in early stage of endometriosis",
"OBJECTIVE To determine the difference between two laparoscopic methods for the management of endometriomas with regard to recurrence of signs and symptoms and pregnancy rate . DESIGN Prospect i ve , r and omized clinical trial . SETTING Infertility and gynecologic endoscopy units of two medical university hospitals . PATIENT(S ) One hundred patients with endometriomas who had either infertility or pelvic pain . INTERVENTION(S ) Patients were r and omly divided into two groups ; one group underwent cystectomy ( group 1 ) , and fenestration and coagulation were performed for the other ( group 2 ) . MAIN OUTCOME MEASURE(S ) A comparison of recurrence of signs and symptoms of endometriomas and pregnancy rates in two groups . RESULT ( S ) Fifty-two patients were studied in group 1 and 48 in group 2 . The recurrence of symptoms , such as pelvic pain and dysmenorrhea , was 15.8 % in group 1 and 56.7 % in group 2 after 2 years . The rate of reoperation was 5.8 % in group 1 and 22.9 % in group 2 and these differences were statistically significant . The cumulative pregnancy rate was significantly higher in group 1 ( 59.4 % ) than in group 2 ( 23.3 % ) at 1-year follow-up . CONCLUSION ( S ) Laparoscopic cystectomy of endometriomas is a better choice than fenestration and coagulation because the former technique leads to a lower recurrence of signs and symptoms and a lower rate of reoperation and a higher cumulative pregnancy rate than the latter",
"OBJECTIVE The aim of the study was to examine whether acupuncture is an effective additional pain treatment for endometriosis . STUDY DESIGN One hundred and one women aged 20 - 40 years participated and were r and omised into two groups , each receiving two units of 10 acupuncture treatments , twice a week over a period of five weeks . Group 1 ( n = 47 ) received verum-acupuncture during the first series , and group 2 ( n = 54 ) received non-specific acupuncture . After the first unit of 10 treatments , an observation period of at least two menstruation cycles was set , followed by a second unit , according to a cross-over design . Prior to the study ( during a two-week run-in period ) the patients ' actual pain intensity was surveyed . Throughout the study period , participants were asked to keep a ' pain protocol ' , in which they defined and recorded their pain according to the 10-point visual analogue scale ( VAS ) . RESULTS Eighty-three out of a total of 101 patients finished the study . Group 1 showed a significant reduction of pain intensity after the first 10 treatments . In comparison , group 2 showed significant pain relief only after the cross-over . CONCLUSION Acupuncture treatment on specific acupuncture points appears to be an effective pain treatment for endometriosis , but this has to be confirmed in further study",
"One hundred six patients with chronic pelvic pain were r and omly allocated to one of two treatment groups . In the st and ard-approach group , organic causes of pelvic pain were excluded first and diagnostic laparoscopy was routinely performed . If no somatic cause could be found , attention was given to other causes such as psychological disturbances . In the second group an integrated approach was chosen . From the beginning equal attention was devoted to somatic , psychological , dietary , environmental , and physiotherapeutic factors . In this group , laparoscopy was not routinely performed . Both groups were similar with respect to clinical characteristics of the patients and the severity of their pain as assessed by various pain parameters . Postcoital pain was reported by 27 % of the patients . Twenty percent of the patients had had negative sexual experiences such as childhood sexual abuse or rape . Evaluation of the pain 1 year after the institution of treatment revealed that the integrated approach improved pelvic pain significantly more often than the st and ard approach for three out of four pain parameters ( P pain . It is concluded that equal attention to both organic and other causative factors from the beginning of therapy is more likely to result in a reduction of pelvic pain than is a st and ard approach",
"OBJECTIVE To assess the efficacy of two laparoscopic methods for the management of endometriomas with regard to pain relief , pregnancy rate , and disease recurrence . DESIGN Prospect i ve , r and omized clinical trial . SETTING Tertiary care hospital . PATIENT(S ) Sixty-four patients with advanced stages of endometriosis . INTERVENTION(S ) Patients were r and omly allocated at the time of laparoscopy to undergo either cystectomy of the endometrioma ( group 1 ) or drainage of the endometrioma and bipolar coagulation of the inner lining ( group 2 ) . MAIN OUTCOME MEASURE(S ) Pain relief and pregnancy rate . RESULT ( S ) Thirty-two patients were enrolled in each group . The 24-month cumulative recurrence rates of dysmenorrhea , deep dyspareunia , and nonmenstrual pelvic pain were lower in group 1 than in group 2 ( dysmenorrhea : 15.8 % versus 52.9 % ; deep dyspareunia : 20 % versus 75 % ; nonmenstrual pelvic pain : 10 % versus 52.9 % ) . The median interval between the operation and the recurrence of moderate to severe pelvic pain was longer in group 1 than in group 2 ( 19 months [ range , 13.5 - 24 months ] versus 9.5 months [ range , 3 - 20 months ] ) . The 24-month cumulative pregnancy rate was higher in group 1 than in group 2 ( 66.7 % versus 23.5 % ) . CONCLUSION ( S ) For the treatment of ovarian endometriomas , a better outcome with a similar rate of complications is achieved with laparoscopic cystectomy than with drainage and coagulation",
"PURPOSE We compared intravesical bacillus Calmette-Guerin ( BCG ) to placebo instillations in patients with treatment refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC , and reported at least moderate pain and frequency for a minimum of 6 months before study entry , were r and omized to 6 weekly double-blinded intravesical instillations of either BCG or placebo , and then followed for a total of 34 weeks . The primary outcome was a patient reported global response assessment at week 34 , supplemented with medications for IC during weeks 31 to 34 . Secondary outcomes included a 24-hour voiding diary , pain , urgency , vali date d IC symptom indexes and adverse events . The target sample size was 260 participants , design ed to detect a difference in response rates between placebo and BCG of 30 % and 50 % , respectively . RESULTS A total of 265 participants were r and omized and 17 ( 6 % ) patients withdrew from study . The response rates for the primary outcome were 12 % for placebo and 21 % for BCG ( p = 0.062 ) . Small improvements were observed for all secondary outcomes , some more so with BCG , but these differences were of borderline statistical significance . Although a large number of adverse events were reported in the BCG arm , there was no statistically significant difference between the treatment arms in overall adverse event rates . CONCLUSIONS Although the BCG safety profile was acceptable , the response rate for the primary outcome was low . Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive",
"OBJECTIVE To determine the efficacy of GnRH analogue plus add-back therapy compared with GnRH analogue alone and estroprogestin in patients with relapse of endometriosis-associated pain . DESIGN R and omized , controlled study . SETTING University hospital . PATIENT(S ) One hundred thirty-three women with relapse of endometriosis-related pain after previous endometriosis surgery . INTERVENTION(S ) Forty-six women were treated with GnRH analogue plus add-back therapy , 44 women were given GnRH analogue alone , and 43 women received estroprogestin , for 12 months . MAIN OUTCOME MEASURE(S ) Pain evaluation by a visual analogue scale , quality of life in treated patients according to the SF-36 question naire , and occurrence of adverse effects , including bone mass density loss , at pretreatment , after 6 months of treatment , at the end of treatment ( 12 months ) , and 6 months after discontinuation of treatment . RESULT ( S ) Patients treated either with GnRH analogue alone or GnRH analogue plus add-back therapy showed a higher reduction of pelvic pain , dysmenorrhea , and dyspareunia than patients treated with oral contraceptive , whereas patients treated with add-back therapy showed a better quality of life , as assessed with the SF-36 question naire , and adverse effects rate than the other two groups . CONCLUSION ( S ) Add-back therapy allows the treatment of women with relapse of endometriosis-associated pain for a longer period , with reduced bone mineral density loss , good control of pain symptoms , and better patient quality of life compared with GnRH analogue alone or oral contraceptive",
"OBJECTIVE To evaluate the efficacy of laparoscopic resection of the uterosacral ligaments in women with endometriosis and predominantly midline dysmenorrhea . DESIGN R and omized controlled trial . SETTING Two academic departments . One hundred eighty patients undergoing operative laparoscopy as first-line therapy for stage I to IV symptomatic endometriosis . INTERVENTION(S ) Operative laparoscopy including uterosacral ligament resection or conservative surgery alone . MAIN OUTCOME MEASURE(S ) Proportion of women with recurrence of moderate or severe dysmenorrhea 1 year after surgery . RESULT ( S ) No complications occurred . Among the patients who were evaluable 1 year after operative laparoscopy , 23 of 78 ( 29 % ) women who had uterosacral ligament resection and 21 of 78 ( 27 % ) women who had conservative surgery only reported recurrent dysmenorrhea . The corresponding numbers of patients at 3 years were 21 of 59 ( 36 % ) women and 18 of 57 ( 32 % ) women , respectively . Time to recurrence was similar in the two groups . Pain was substantially reduced , and patients in both groups experienced similar and significant improvements in health-related quality of life , psychiatric profile , and sexual satisfaction . Overall , 68 of 90 ( 75 % ) patients in the uterosacral ligament resection group and 67 of 90 ( 74 % ) patients in the conservative surgery group were satisfied at 1 year . CONCLUSION ( S ) Addition of uterosacral ligament resection to conservative laparoscopic surgery for endometriosis did not reduce the medium- or long-term frequency and severity of recurrence of dysmenorrhea",
"OBJECTIVE To establish the use of aromatase inhibitors as a therapeutic option for endometriosis . DESIGN Prospect i ve open-label Food and Drug Administration phase 2 trial with Institutional Review Board approval . SETTING Outpatient tertiary care centers . PATIENT(S ) Fifteen premenopausal patients with documented refractory endometriosis and chronic pelvic pain . INTERVENTION(S ) After a 1-month washout of endometriosis hormone therapies , women took 1 mg anastrazole ( Arimidex ; AstraZeneca , Wilmington , DE ) and one tablet of 20 microg ethinyl estradiol/0.1 mg levonorgestrel ( Alesse ; Wyeth , Madison , NJ ) daily for 6 months . MAIN OUTCOME MEASURE(S ) An analog pain scale recorded pelvic pain in daily diaries and surveys at baseline and after each treatment month . Side effects , blood counts , liver and renal function tests , cholesterol levels , and bone density were monitored . RESULT ( S ) Fourteen of 15 patients achieved significant pain reduction . Median pain scores decreased 55 % after 6 months , while mean pain scores decreased 40 % . Pain reduction comparing each treatment month to baseline achieved statistical significance . Average pain scores began dropping after only 1 treatment month and continued decreasing each additional month . No organ system experienced adverse effects . Estradiol levels were suppressed during treatment . Side effects were mild and improved over time . CONCLUSION ( S ) Fourteen of 15 patients with refractory endometriosis achieved significant pain relief using anastrazole and 20 microg ethinyl estradiol/0.1 mg levonorgestrel with minimal side effects . This treatment for endometriosis is a promising new modality that warrants further investigation",
"OBJECTIVE To assess and compare the laparoscopic uterine nerve ablation ( LUNA ) and the vaginal uterosacral ligament resection ( VUSR ) in postmenopausal women with chronic pelvic pain ( CPP ) . STUDY DESIGN Eighty postmenopausal women with intractable and severe midline CPP were r and omized to undergo LUNA or VUSR . Costs of two surgical procedures were assesses . Cure rate , severity of CPP , and deep dyspareunia were also evaluated after 6 and 12 months from surgery . RESULTS The mean cost of LUNA result ed significantly higher in comparison with VURS ( 2078+/-637 versus 1497+/-297 , P cure rate was not significantly different between the two groups at 6 ( 33/40 , 82.5 % versus 35/40 , 87.5 % for groups A and B , respectively ; P=0.530 ; RR 0.94 , 95 % CI 0.78 - 1.13 ) , and 12 months ( 27/36 , 75.0 % versus 28/38 , 73.7 % , for groups A and B , respectively ; P=0.901 ; RR 0.90 , 95 % CI 0.78 - 1.33 ) of follow-up . At same times , a significant ( P severity of CPP and deep dyspareunia was observed in both groups with no difference between them . CONCLUSIONS Both LUNA and VUSR are equally effective surgical treatments in postmenopausal women with central CPP but VUNR is significantly cheaper than LUNA",
"Objective Although written emotional disclosure has potential as a stress management intervention for people with health problems , the main ( group ) effects of disclosure in medical population s are limited . This study sought to identify individual difference moderators of the effects of written disclosure among women with chronic pelvic pain . Methods In a prospect i ve , r and omized trial , 48 women with chronic pelvic pain completed 3 individual difference measures and then wrote for 3 days about stressful consequences of their pain ( disclosure ) or positive events ( control ) . Health status was assessed at baseline and 2 months after writing . Results Main effect group comparisons indicated that disclosure writing result ed in significantly lower evaluative pain intensity ratings than control writing at follow-up , but there were no main effects on other outcome variables ( sensory or affective pain , disability , affect ) . Three baseline individual difference measures , however , significantly moderated group effects . Compared with control writing , disclosure led to less disability among women with higher baseline ambivalence over emotional expression or higher catastrophizing , and to increased positive affect among women with higher baseline negative affect . Ambivalence , but not catastrophizing , was independent of negative affect in its moderation effect . Conclusion Although the main effects of writing about the stress of pelvic pain are limited , women with higher baseline ambivalence about emotional expression or negative affect appear to respond more positively to this intervention",
"STUDY OBJECTIVE To evaluate continuous ( CON ) compared with cyclic ( CYC ) administration of combined oral estroprogestins for 6 months after laparoscopic excision of ovarian endometriomas associated with pain . DESIGN Multicenter , prospect i ve , r and omized trial ( Canadian Task Force classification I ) . SETTING Tertiary care university hospitals . PATIENTS Fifty-seven women aged 18 to 40 years with ovarian endometriomas associated with moderate to severe pelvic pain who underwent laparoscopic excision of the disease . INTERVENTIONS Patients were r and omized to receive postoperative estroprogestins for 6 months , administered as either a CON or CYC regimen . MEASUREMENTS AND MAIN RESULTS At 3 , 6 , 12 , and 24 months postoperatively , patients were evaluated for recurrence of endometriomas ( defined as cysts > 3 cm in greatest diameter ) using ultrasonography , for recurrence of pain using a visual analog scale , and for patient satisfaction . After a minimum follow-up of 12 months ( mean , 22 months ) , at intent-to-treat analysis , no endometrioma recurrence was observed in the CON group , whereas there was recurrence in 1 patient ( 4 % ) in the CYC group . Pain recurred in 5 and 9 patients , respectively ( 17 % vs 32 % ; p = .23 ) . Compared with pretreatment values , pain scores improved in both groups , with no significant difference between the 2 groups . Most patients in both groups were either satisfied or very satisfied , with no significant difference between treatment groups . However , compared with the CYC group , significantly more patients in the CON group experienced moderate to severe adverse effects , and therapy was discontinued ( 41 % vs 14 % ; p = .03 ) . CONCLUSIONS Although both regimens were equally effective insofar as postoperative pain and recurrence of endometrioma , when compared with the CYC regimen , the CON regimen seems to be associated with significantly more adverse effects and discontinuation rates",
"OBJECTIVE To compare the efficacy of leuprolide and continuous oral contraceptives in the treatment of endometriosis-associated pain . DESIGN Prospect i ve , r and omized , double-blind controlled trial . SETTING Academic medical centers in Rochester , New York , and Boston , Massachusetts . PATIENT(S ) Forty-seven women with endometriosis-associated pelvic pain . INTERVENTION(S ) Forty-eight weeks of either depot leuprolide , 11.25 mg IM every 12 weeks with hormonal add-back using norethindrone acetate 5 mg orally , daily ; or a generic monophasic oral contraceptive ( 1 mg norethindrone + 35 mg ethinyl estradiol ) given daily . MAIN OUTCOME MEASURE(S ) Biberoglu and Behrman ( B&B ) pain scores , numerical rating scores ( NRS ) , Beck Depression Inventory ( BDI ) , and Index of Sexual Satisfaction ( ISS ) . RESULT ( S ) Based on enrollment of 47 women r and omized to continuous oral contraceptives and to leuprolide , there were statistically significant declines in B&B , NRS , and BDI scores from baseline in both groups . There were no significant differences , however , in the extent of reduction in these measures between the groups . CONCLUSION ( S ) Leuprolide and continuous oral contraceptives appear to be equally effective in the treatment of endometriosis-associated pelvic pain",
"To present single institution open-label experience with intravesical liposomes ( LPs ) , a mucosal protective agent , in patients with interstitial cystitis/painful bladder syndrome ( IC/PBS ) and to assess the safety and efficacy on IC/PBS symptoms . A total of 17 symptomatic IC/PBS patients were treated with intravesical LPs ( 80mg/40mL distilled water ) once a week for 4 weeks ( n=12 ) or twice a week treatment for 4 weeks ( n=5 ) . The primary outcome was the change in the O'Leary-Sant Symptom/Problem score and O'Leary-Sant total Score from baseline to Week 4 and Week 8 . Other outcome measurements included the changes in pain scale , urgency scale , voiding log , and patient global assessment . Both weekly and biweekly LP instillation regiments were well tolerated . The incidence of urinary incontinence , retention , or unanticipated adverse changes was not noted at any dose either during the treatment or at the 4-week follow-up . The O'Leary-Sant Symptom/Problem score , O'Leary-Sant total Score , and pain score were significantly improved from baseline at both dose regimens with added benefit with the biweekly regimen . Intravesical LPs treatment is safe and its efficacy has sustained duration . Furthermore large-scale , placebo-controlled studies are warranted to assess the efficacy for this promising new treatment for IC/PBS",
"BACKGROUND A clinical study compared efficacy and safety of depot medroxyprogesterone acetate ( DMPA ) with leuprolide for endometriosis-associated pain . METHODS This multicentre , 18 month , evaluator-blinded , comparator-controlled trial r and omized 300 women with laparoscopically diagnosed endometriosis to 6 month treatment with subcutaneous injection of 104 mg/0.65 ml DMPA ( DMPA-SC 104 ) every 3 months or leuprolide ( 3.75 mg monthly or 11.25 mg every 3 months ) , with 12 months post-treatment follow-up . Endpoints included patient response to treatment in five signs/symptoms ( dysmenorrhoea , dyspareunia , pelvic pain , pelvic tenderness , in duration ) and changes in bone mineral density ( BMD ) and productivity at 6 and 18 months . RESULTS DMPA-SC 104 and leuprolide produced equivalent ( P pain categories and significant ( P composite score at months 6 and 18 . At month 6 , reductions in total hip and lumbar spine BMD were significantly less ( P DMPA-SC 104 versus leuprolide . BMD returned to pre-treatment levels 12 months post-treatment in the DMPA-SC 104 but not the leuprolide group . Total productivity also significantly ( P DMPA-SC 104 reduces endometriosis-associated pain as effectively as leuprolide and improves productivity with significantly less BMD decline",
"OBJECTIVE Aim of our study was to evaluate the effectiveness of the association between N-Palmitoylethanolamine and transpolydatin in the management of chronic pelvic pain related to EMS . STUDY DESIGN This was a r and omized , double-blind , parallel-group , placebo-controlled clinical trial involving 61 subjects , su bmi tted to a first line laparoscopic conservative surgery , who were r and omized into 3 groups receiving : group A ( n=21 ) the association N-Palmitoylethanolamine-transpolydatin 400 mg + 40 mg twice a day for 3 months ; group B ( n=20 ) the placebo for 3 months ; group C ( n=20 ) a single course of Celecoxib 200 mg twice a day for 7 consecutive days . Assessment s of the severity of pelvic endometriosis ( pelvic pain , dysmenorrhoea and dyspareunia ) were recorded before and after treatment on a question naire and a 10-point VAS . Differences between groups were verified with Kruskal-Wallis ANOVA for non-parametric multiple comparisons . RESULTS A marked decrease in dysmenorrhoea , dyspareunia and pelvic pain was observed in all groups , and the association between N-Palmitoylethanolamine and transpolydatin result ed to be more effective than placebo ( P Celecoxib result ed in a decrease in pelvic pain more effective either than the association N-Palmitoylethanolamine and transpolydatin or placebo . CONCLUSION These preliminary results show that the association between micronized N-Palmitoylethanolamine and transpolydatin is effective in the management of pelvic pain related to endometriosis after laparoscopy . Additionally , this association seems to be safe , shows an optimal control of pain and can be used in patients who are unable to receive other therapies",
"OBJECTIVES Chronic pelvic pain is a common source of disability among women in the western world . Here we report that 3 months of Mensendieck somatocognitive intervention in chronic pelvic pain patients was followed by continued improvements of outcomes at 1-year follow-up in a r and omized , controlled study design . METHODS Forty women with chronic pelvic pain unexplained by pelvic pathology were r and omly assigned to 2 groups : ( 1 ) st and ard gynecologic treatment and ( 2 ) gynecologic treatment plus somatocognitive therapy aim ed at reducing physical pain by changing posture , movement , and respiration patterns . A st and ardized Mensendieck test ( SMT ) of motor function ( assessing posture , movement , gait , sitting posture , and respiration ) , a self-rating question naire assessing psychologic distress and general well-being ( GHQ-30 ) and a visual analog score of pain ( VAS ) were obtained before , after 90 days of treatment and 1 year after inclusion . RESULTS Patients treated by st and ard gynecologic treatment/supervision did not improve significantly at 1-year follow-up in any of the test modalities . By contrast , those who in addition received somatocognitive therapy had improved scores for all motor functions and pain , as well as GHQ-30 scores for coping , and anxiety-insomnia-distress . CONCLUSION Mensendieck somatocognitive therapy combined with st and ard gynecologic care improves psychologic distress , pain experience , and motor functions of women with chronic pelvic pain better than gynecologic treatment alone . The effect lasted and even further improvement occurred 9 months after treatment",
"The efficacy of antidepressants as analgesics for a range of chronic pain problems is well documented . However , a controlled trial of an antidepressant for women with chronic pelvic pain has not yet been published . We r and omized 23 women from a general gynecology clinic to either double-blind sertraline or placebo . Measures of psychological function , pain , and functional disability were taken at baseline and 6 weeks . After a 2-week washout , the groups were crossed-over and the same measures were done over the next 6 weeks . There were no significant improvements in pain or functional disability noted on sertraline compared to placebo . Studies involving larger sample s of patients are needed to confirm these findings",
"OBJECTIVE : To estimate whether botulinum toxin type A is more effective than placebo at reducing pain and pelvic floor pressure in women with chronic pelvic pain and pelvic floor muscle spasm . METHODS : This study was a double-blinded , r and omized , placebo-controlled trial . All participants presented with chronic pelvic pain of more than 2 years duration and evidence of pelvic floor muscle spasm . Thirty women had 80 units of botulinum toxin type A injected into the pelvic floor muscles , and 30 women received saline . Dysmenorrhea , dyspareunia , dyschezia , and nonmenstrual pelvic pain were assessed by visual analog scale ( VAS ) at baseline and then monthly for 6 months . Pelvic floor pressures were measured by vaginal manometry . RESULTS : There was significant change from baseline in the botulinum toxin type A group for dyspareunia ( VAS score 66 versus 12 ; χ2=25.78 , P and nonmenstrual pelvic pain ( VAS score 51 versus 22 ; χ2=16.98 , P=.009 ) . In the placebo group only dyspareunia was significantly reduced from baseline ( 64 versus 27 ; χ2=2.98 , P=.043 ) . There was a significant reduction in pelvic floor pressure ( centimeters of H2O ) in the botulinum toxin type A group from baseline ( 49 versus 32 ; χ2=39.53 , P the placebo group also having lower pelvic floor muscle pressures ( 44 versus 39 ; χ2=19.85 , P=.003 ) . CONCLUSION : Objective reduction of pelvic floor spasm reduces some types of pelvic pain . Botulinum toxin type A reduces pressure in the pelvic floor muscles more than placebo . Botulinum toxin type A may be a useful agent in women with pelvic floor muscle spasm and chronic pelvic pain who do not respond to conservative physical therapy . Clinical Trial Registration : Australian Clinical Trials Registry , http://www.actr.org.au/ , ACTRN012605000515695 LEVEL OF EVIDENCE :",
"OBJECTIVE To assess the longer term efficacy of laparoscopic laser surgery in the treatment of painful pelvic endometriosis and to observe the natural history of the disease at second-look laparoscopy in a control group . DESIGN One-year follow-up of a prospect i ve , r and omized , double-blind controlled trial . SETTING A referral center for the laparoscopic laser treatment of endometriosis . PATIENT(S ) Sixty-three patients with pelvic pain and minimal to moderate endometriosis . INTERVENTION(S ) After the 6-month follow-up visit , the r and omization code was broken , and follow-up was continued to 1 year . Symptomatic patients were offered second-look laser laparoscopy . MAIN OUTCOME MEASURE(S ) Continued symptom relief at 1 year after treatment and findings at second-look laparoscopy in symptomatic controls . RESULT ( S ) Symptom relief continued at 1 year in 90 % of those who initially responded . All symptomatic controls had a second-look procedure , with 7 ( 29 % ) showing disease progression , 7 ( 29 % ) showing disease regression , and 10 ( 42 % ) having static disease . CONCLUSION ( S ) The benefits of laser laparoscopy for painful pelvic endometriosis are continued in the majority of patients at 1 year . Untreated painful endometriosis will progress or remain static in the majority of patients but will spontaneously improve in others",
"Background and Objectives : The purpose of this study was to assess the long-term efficacy of laparoscopic laser surgery in the treatment of painful pelvic endometriosis . Methods : We conducted a long-term follow-up of 56 patients who had participated in a r and omized , double-blind controlled study at a tertiary referral center for the laparoscopic treatment of endometriosis . The patients had pelvic pain , minimal-to-moderate endometriosis , and underwent laser laparoscopy . We asked patients whether they had now achieved satisfactory symptom relief or whether they had received any further medical intervention for their endometriosis . The main outcome measure was continued symptom relief after treatment and subsequent medical history . Results : Of the original 56 patients , we were able to contact 38 ( 67.9 % ) . The mean ( range ) time since operation was 73 months . Painful symptoms had recurred in 28/38 ( 73.7 % ) patients at some point since their operation . The median ( range ) time for recurrence was 19.7 ( 5 - 60 ) months . At the time of follow-up , satisfactory symptom relief was reported in 21/38 ( 55.3 % ) patients . The remaining 17/38 ( 44.7 % ) patients continued to experience painful symptoms , and eight eventually had a hysterectomy . Conclusions : This study suggests that operative laparoscopy can have long-term benefits for the majority of women with pelvic pain due to endometriosis , but because of the small numbers , this study lacks the power to demonstrate this conclusively",
"OBJECTIVE To evaluate whether persistence of pelvic pain after excision of endometriosis was associated with adenomyosis as defined by a thickened uterine junctional zone ( JZ ) on magnetic resonance ( MR ) imaging . DESIGN Prospect i ve clinical trial . SETTING Government research hospital . PATIENT(S ) Fifty-three women with chronic pelvic pain . INTERVENTION(S ) Preoperative MR imaging to measure uterine JZ thickness , surgical excision , and pathologic diagnosis of endometriosis . Those with biopsy-proven endometriosis were r and omized to raloxifene or placebo . Visual analog scale ( VAS ) was used to rate dysmenorrhea and nonmenstrual pain severity before surgery and 3 months later . MAIN OUTCOME MEASURE(S ) Comparison of JZ thickness and pain severity before and 3 months after surgery in women with endometriosis controlling for medical treatment . RESULT ( S ) Forty of the 53 patients had biopsy-proven endometriosis , and 6 of these 40 women with endometriosis had a thickened JZ . Overall , dysmenorrhea at 3 months was positively correlated with preoperative JZ thickness ( r = 0.47 , P=.01 ) . Dysmenorrhea pain severity showed no significant decrease in those patients whose JZ measured > or=11 mm compared with those with JZ VAS decreased 4.3 + /- 0.6 ) , or > or=8 and VAS decreased 4.8 + /- 1.3 ) . Nonmenstrual pain severity was correlated with JZ thickness ( r = 0.51 , P=.004 ) at 3 months with a significant decrease in nonmenstrual pain only in women with a JZ dysmenorrhea and nonmenstrual pain reduction and thinner JZ remained after controlling for medical treatment . CONCLUSION ( S ) Following surgical excision of endometriosis , chronic pelvic pain was significantly more likely to persist with JZ thickness > 11 mm on preoperative MR imaging . This suggests that myometrial JZ abnormalities or adenomyosis may contribute to chronic pelvic pain in women with endometriosis",
"This article reports the findings of a population -based study in New Zeal and that investigated comparative well-being , comorbidity , and the impact of chronic pelvic pain ( CPP ) on activities . Chronic pelvic pain was defined as lower abdominal pain that is associated with neither the menstrual cycle nor sexual activity . A postal question naire was administered to a r and om sample result ing in a study group of 1,160 . The negative impact of CPP on women 's general well-being is significant . They were more likely than women without CPP to have other long-st and ing illnesses , other unspecified conditions involving pain or fatigue , and sleep patterns were more seriously disturbed . Pain restricted their activities . Comparisons with the limited data available from other studies are made",
"OBJECTIVE To assess the efficacy , safety , and effect on bone mineral density of a 3-month course of retreatment with intranasal nafarelin acetate for recurrent symptoms of endometriosis . DESIGN Multicenter , open-label , nonr and omized clinical trial . SETTING Eleven hospital-based and private practice s. PATIENT(S ) Thirty-six women with endometriosis symptoms recurring after 3 or 6 months of treatment with nafarelin . INTERVENTION(S ) Nasal nafarelin 200 micrograms twice daily for 3 months . MAIN OUTCOME MEASURE(S ) Assessment s for dysmenorrhea , dyspareunia , pelvic pain , tenderness , and in duration . Measurement of bone mineral density of the lumbar spine . RESULT ( S ) Improvements from admission to the end of retreatment were significant for dysmenorrhea , pelvic pain , tenderness , in duration , and dyspareunia . Three months after retreatment ended , mean symptom scores for dysmenorrhea and pelvic tenderness , although worse than at the end of retreatment , were still significantly better than scores at admission . Mean bone mineral density 3 months after retreatment was 0.56 % lower than before retreatment and 1.94 % lower than before initial treatment . CONCLUSION ( S ) Three-month nafarelin retreatment for recurrent endometriosis symptoms was effective and safe",
"OBJECTIVE Our purpose was to evaluate the efficacy and safety of depot medroxyprogesterone acetate versus an oral contraceptive combined with very-low-dose danazol in the long-term treatment of pelvic pain in women with endometriosis . STUDY DESIGN Eighty patients with endometriosis and moderate or severe pelvic pain were r and omized to treatment for 1 year with intramuscular depot medroxyprogesterone acetate 150 mg every 3 months or a cyclic monophasic oral contraceptive ( ethinyl estradiol 0.02 mg , desogestrel 0.15 mg ) combined with oral danazol 50 mg a day for 21 days of each 28-day cycle . The women were asked to grade the degree of their satisfaction at the end of therapy . Variations in severity of symptoms during treatment were determined by a 10 cm visual analog and a 0- to 3-point verbal rating scale . RESULTS Twenty nine of 40 subjects ( 72.5 % ) in the depot medroxyprogesterone acetate group were satisfied after 1 year of therapy compared with 23 of 40 ( 57.5 % ) in the oral contraceptive plus danazol group ( chi 2(1 ) = 1.37 , p = 0.24 , odds ratio 1.95 , 95 % confidence interval 0.76 to 4.97 ) . A significant decrease was observed in all symptom scores in both study groups . At 1-year assessment dysmenorrhea was significantly greater in women allocated to oral contraceptive plus danazol . CONCLUSION Depot medroxyprogesterone acetate seems to be an effective , safe , and convenient low-cost treatment for pelvic pain associated with endometriosis . However , women should be carefully counseled regarding menstrual changes and the potential prolonged delay in the return of ovulation",
"BACKGROUND We hypothesised that the orally-active alpha(2)-adrenoceptor agonist lofexidine hydrochloride would ameliorate chronic pelvic pain in women . METHODS A r and omized placebo-controlled parallel group trial was undertaken in the University Hospital Gynaecology Clinic . Women with pelvic pain of at least 6 months duration were eligible , and were r and omized using a sealed envelope system to receive up to 600 mg lofexidine hydrochloride twice daily over 8 weeks or placebo . Outcome measures were summary and daily diary visual analog scales for pain ( VAS ) and a 5 point self rating scale . RESULTS 9/19 women r and omized to lofexidine completed the study compared to 14/20 of those r and omized to placebo . Intention-to-treat analysis showed that 4/19 in the lofexidine group achieved 50 % or greater reduction in VAS compared with 8/20 in the placebo group ( OR 2.5 , 95 % CI 0.6 - -10.3 ) . Summary and diary VAS were closely correlated . CONCLUSIONS Within the limits of a small study with power to detect only a substantial effect , we conclude that lofexidine hydrochloride is not effective for the treatment of chronic pelvic pain",
"OBJECTIVE This is a r and omized clinical trial comparing estroprogestin ( E/P ) pill given for 12 months vs. gonadotrophin releasing hormone agonist ( GNRHa ) given for 4 months followed by E/P pill treatment for 8 months in the relief of endometriosis-related pelvic pain . METHODS Eligible for the study were women with laparoscopically confirmed endometriosis and pelvic pain lasting 3 - 12 months after diagnosis . Eligible women were r and omly assigned to treatment with E/P pill ( gestroden 0.75 mg and ethynlestradiol 0.03 mg ) for 12 months ( 47 patients ) vs. tryptorelin 3.75 mg slow release every 28 days for 4 months followed by E/P pill for 8 months ( 55 patients ) . RESULTS At baseline , dysmenorrhea was reported in 46 women allocated to E/P pill only ( 97.9 % ) , and in all the 55 women allocated to GNRHa+E/P pill . The corresponding value at the 12 months follow-up visit was 14 subjects ( 35.9 % ) and 16 subjects ( 34.8 % ) . The baseline median values of the multidimensional and analog scale were for dysmenorrhea 4 and 6 in the EP only and 3 and 6 in the GNRHa+E/P group . The corresponding value at the 12 months follow-up visit were 2 and 6 and 0 and 5 . Non-menstrual pain was reported , respectively , at baseline and 12 month visit by 46 ( 97.9 % ) and 15 ( 38.5 % ) subjects in the E/P pill group and 49 ( 89.1 % ) and 17 ( 37.0 % ) of the GNRHa+E/P pill one . The baseline median values of the multidimensional and analog scale were for non-menstrual pain 3 and 5 in the E/P only and 2 and 6 in the GNRHa+E/P group . The corresponding values at the 12 month follow-up visit were 0 and 4 and 0 and 4 . These differences between the two groups were not statistically significant . CONCLUSIONS 1 year after r and omization , the two treatment schedules show similar relief of pelvic pain in women with endometriosis",
"The most effective therapy for endometriosis is a matter for debate . The aim of the present r and omized study was to evaluate the efficacy of low doses of danazol on recurrence of pelvic pain in patients with moderate or severe endometriosis , who had undergone laparoscopic surgery and 6 months of gonadotrophin-releasing hormone analogue ( GnRHa ) therapy . After surgery , 28 patients with moderate or severe endometriosis underwent therapy for 6 months with GnRHa i. m. every 4 weeks . They were then r and omized into two groups : group A ( 14 subjects ) was treated with 100 mg/day danazol for 6 months ; group B ( 14 subjects , control ) did not receive any type of therapy . After 12 months of treatment , group A had a significantly ( P pain score than group B. There was no significant difference between the groups in oestrogen concentrations , bone mineral density or side-effects . The results suggest that low-dose danazol therapy reduces recurrence of pelvic pain in patients with moderate or severe endometriosis , treated surgically , and has few or no metabolic side-effects",
"This study aims to determine whether the levonorgestrel-releasing intrauterine system can influence American Society for Reproductive Medicine endometriosis staging scores , as assessed through second-look laparoscopies , and to compare the results with those obtained with a GnRH agonist . Both treatments reduced the extent of pelvic endometriotic lesions in patients with chronic pelvic pain",
"OBJECTIVE To examine whether long-term administration of dienogest following gonadotropin-releasing hormone agonist ( GnRH-a ) therapy would prolong the relief of pelvic pain while reducing the amount of irregular uterine bleeding . STUDY DESIGN This was a prospect i ve , non-r and omized clinical trial . Among the patients suffering from chronic pelvic pain associated with recurrent endometriosis , Group G ( n=38 ) received GnRH-a for 4 - 6 months and then dienogest ( 1 mg/day ) for 12 months . The dose of dienogest was increased to 1.5 or 2 mg/day when a patient had uncontrollable uterine bleeding { n=15 (39%)}. Group D ( n=33 ) received only dienogest ( 2 mg/day ) for 12 months . Pelvic pain was assessed using a visual analog scale ( VAS ) . Uterine bleeding was semi-quantified using a pictorial blood loss assessment chart ( PBAC ) . RESULTS In Group G , GnRH-a significantly reduced the VAS score for pelvic pain , and alleviation was maintained during the 12-month therapy with dienogest . There was no significant difference in pain reduction between Group G and Group D. The PBAC score during the first 6 months on dienogest was significantly smaller in Group G than in Group D. CONCLUSION Treatment with a GnRH-a followed by long-term dienogest therapy maintains the relief of endometriosis-associated pelvic pain achieved with GnRH-a therapy for at least 12 months . This regimen reduces the amount of irregular uterine bleeding that often occurs during the early phase of dienogest therapy",
"Objective To determine the effectiveness of laparoscopic uterine nerve ablation ( LUNA ) for chronic pelvic pain in women with endometriosis and women with no laparoscopic evidence of endometriosis",
"Background . To assess whether hormonal treatment of endometriosis improves quality of life for women with endometriosis",
"To compare treatment efficacy and safety parameters a total of 55 premenopausal women with histologically proven endometriosis ( stage II-IV ) were r and omized to receive the LHRH-analogue depot triptorelin ( n = 30 ) or the steroid danazol ( n = 25 ) for a total of 24 weeks . Immediately after cessation of the endocrine therapy a second-look operation was performed . Four as well as 24 weeks after the end of treatment patients were seen for re-evaluation of clinical symptoms and safety parameters . Estradiol suppression was significantly more pronounced with triptorelin , while the free and rogenic index rose with danazol . Both substances were equally effective in reducing endometriotic implants ( 58 % and 51 % , respectively ) . Dysmenorrhea was absent at the end of medical therapy in both treatment groups . Dyspareunia and pelvic pain decreased at least by 50 % . Red blood count , thrombocytes , liver enzymes and the atherogenic index rose with danazol , while the urinary calcium/creatinine ratio showed a marked elevation with triptorelin . Adverse effects were mainly due to the hypoestrogenism of the LHRH analogue and the and rogenic/anabolic properties of the steroid . Triptorelin and danazol are equally effective in treating endometriosis . Therefore , choice of treatment should be based on the patient 's medical history and the pharmacological profile of each substance",
"OBJECTIVE To evaluate the efficacy and safety of cyproterone acetate versus an oral contraceptive in the treatment of endometriosis-associated recurrent pelvic pain . DESIGN R and omized controlled trial . SETTING Academic center . PATIENT(S ) Ninety women with recurrent moderate or severe pelvic pain after conservative surgery for symptomatic endometriosis . INTERVENTION(S ) Six months of continuous treatment with oral cyproterone acetate , 12.5 mg/d , or an oral contraceptive containing ethinyl estradiol , 0.02 mg , and desogestrel , 0.15 mg . MAIN OUTCOME MEASURE(S ) Degree of satisfaction with therapy . RESULT ( S ) Six patients in the cyproterone acetate arm and nine in the oral contraceptive arm withdrew because of side effects ( n = 9 ) , treatment inefficacy ( n = 4 ) , or loss to follow-up ( n = 2 ) . At 6 months , dysmenorrhea , deep dyspareunia , and nonmenstrual pelvic pain scores were substantially reduced , and significant improvements were observed in health-related quality -of-life , psychiatric profile , and sexual satisfaction ; no major between-group differences were seen . Subjective and metabolic side effects were limited . According to an intention-to-treat analysis , 33 of 45 ( 73 % ) of patients in the cyproterone acetate group and 30 of 45 ( 67 % ) in the oral contraceptive group were satisfied with the treatment received . CONCLUSIONS Both cyproterone acetate and a continuous monophasic oral contraceptive were effective , safe , and inexpensive therapy for recurrent pain after conservative surgery for endometriosis",
"BACKGROUND Implanon has been reported to be effective in the treatment of dysmenorrhea . We compared the therapeutic efficacies of depot medroxyprogesterone acetate ( DMPA ) and Implanon with regard to pain relief in women with endometriosis . STUDY DESIGN In a clinical research center at a university hospital , 41 patients with dysmenorrhea , nonmenstrual pelvic pain and dyspareunia associated with histologically proven endometriosis were included in an open , prospect i ve , r and omized , controlled clinical trial . Twenty-one women were assigned by computer-generated r and omization to receive Implanon , and 20 women to receive DMPA . As main outcome measures of this pilot study , we evaluated pain improvement quantified according to visual analog scale score , side effects , vaginal bleeding patterns , withdrawal rate and overall degree of satisfaction . RESULTS During a follow-up period of 1 year , we ascertained a clear improvement in pain intensity for both treatment options . After 6 months , the average decrease in pain was 68 % in the Implanon group and 53 % in the DMPA group . The side-effects profile and the overall degree of satisfaction after study termination were comparable for both treatment options . CONCLUSION Concerning pain relief , the therapeutic efficacy of the contraceptive implant Implanon is not inferior to that of DMPA in symptomatic endometriosis",
"& NA ; Melatonin reduced pain scores and analgesic use , and improved sleep quality in endometriosis‐associated chronic pelvic pain . Melatonin modulates the secretion of brain‐derived neurotrophic factor independently of its analgesic effect in endometriosis . & NA ; Endometriosis‐associated chronic pelvic pain ( EACPP ) presents with an intense inflammatory reaction . Melatonin has emerged as an important analgesic , antioxidant , and antiinflammatory agent . This trial investigates the effects of melatonin compared with a placebo on EACPP , brain‐derived neurotrophic factor ( BDNF ) level , and sleep quality . Forty females , aged 18 to 45 years , were r and omized into the placebo ( n = 20 ) or melatonin ( 10 mg ) ( n = 20 ) treatment groups for a period of 8 weeks . There was a significant interaction ( time vs group ) regarding the main outcomes of the pain scores as indexed by the visual analogue scale on daily pain , dysmenorrhea , dysuria , and dyschezia ( analysis of variance , P with placebo , the treatment reduced daily pain scores by 39.80 % ( 95 % confidence interval [ CI ] 12.88–43.01 % ) and dysmenorrhea by 38.01 % ( 95 % CI 15.96–49.15 % ) . Melatonin improved sleep quality , reduced the risk of using an analgesic by 80 % , and reduced BNDF levels independently of its effect on pain . This study provides additional evidence regarding the analgesic effects of melatonin on EACPP and melatonin ’s ability to improve sleep quality . Additionally , the study revealed that melatonin modulates the secretion of BDNF and pain through distinct mechanisms"
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OBJECTIVES The objective of our review was to systematic ally assess available evidence on the effectiveness , safety and efficiency of a spring sensor-irrigated contact force ( CF ) catheter ( THERMOCOOL SMARTTOUCH Catheter ( ST ) ) for percutaneous ablation of paroxysmal or persistent atrial fibrillation ( AF ) , compared with other ablation catheters , or with the ST with the operator blinded to CF data . DESIGN Systematic literature review and meta- analysis . BACKGROUND Emerging evidence suggests improved clinical outcomes of AF ablation using CF-sensing catheters ; however , review s to date have included data from multiple , distinct CF technologies . METHODS We conducted a systematic review and meta- analysis of published studies comparing the use of ST versus other ablation catheters for the treatment of AF . A comprehensive search of electronic and manual sources was conducted . The primary endpoint was freedom from recurrent atrial tachyarrhythmia ( AT ) at 12 months . Procedural and safety data were also analysed . RESULTS Thirty-four studies enrolling 5004 patients were eligible . The use of ST was associated with increased odds of freedom from AT at 12 months ( 71.0%vs60.8 % ; OR 1.454 , 95 % CI 1.12 to 1.88 , p=0.004 ) over the comparator group , and the effect size was most evident in paroxysmal AF patients ( 75.6%vs64.7 % ; OR 1.560 , 95 % CI 1.09 to 2.24 , p=0.015 ) . Procedure and fluoroscopy times were shorter with ST ( p=0.05 and p reduction in procedure time is estimated at 15.5 min ( 9.0 % ) , and fluoroscopy time 4.8 min ( 18.7 % ) . Complication rates , including cardiac tamponade , did not differ between groups . CONCLUSIONS Compared with the use of other catheters , AF ablation using the CF-sensing ST catheter for AF is associated with improved success rates , shorter procedure and fluoroscopy times and similar safety profile
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"Aims Contact force ( CF ) catheters provide catheter-tissue contact information to improve outcome of pulmonary vein isolation ( PVI ) in paroxysmal atrial fibrillation ( PAF ) . We evaluated different target-CF values for achievement of the additional endpoint of an unexcitable ablation line . Methods A total of 106 patients undergoing PVI were r and omized into three groups ( G ) ( G1 : target-CF 15 g , G2 : target-CF 10 g , G3 : CF concealed from operator ) . The PVI encircling line was divided into predefined sections . Excitable tissue along the PVI-line identified by high output pacing ( 10 V , 2 ms ) was targeted for further ablation . Results Mean average CF was 17.4 ± 4.7 g ( G1 ) vs. 12.3 ± 6.0 g ( G2 ) vs. 11.1 ± 6.5 g ( G 3 ) ( p 0.001 ) . Primary unexcitable ablation lines were found in 38.6 , 19.4 and 5.7 % ( G1 , G2 , G3 respectively ; G1 vs. G2 p Additional radiofrequency (RF)-energy to achieve unexcitability was lowest in G1 ( 3.6 ± 3.1 kJ vs. 8.6 ± 7.2 kJ ( G2 ) and 10.4 ± 6.7 ( G3 ) , p ≤ 0.001 , G2 vs. G3 ns ) with accordingly lowest additional RF applications in G1 ( 3.0 ± 2.6 vs. 7.0 ± 5.4 in G2 and 8.4 ± 4.0 in G3 ; G1 vs. G2 and G3 , p . Single procedure success was 81.9 vs. 73.5 vs. 71.4 % ( G 1 , 2 and 3 , p = 0.6 ) during 437 ± 254 day follow-up . Conclusion Higher tip-to-tissue CF during PVI facilitates the achievement of an unexcitable ablation line , requiring less additional RF-energy",
"Aims We have recently shown that a contact force (CF)-guided ablation protocol respecting region-specific criteria of lesion contiguity and lesion depth ( ' CLOSE ' protocol ) is associated with high incidence of acute durable pulmonary vein ( PV ) isolation ( PVI ) and a high single-procedure arrhythmia-free survival at 1 year . In the present study , we compared efficiency , safety , and efficacy of ' CLOSE'-guided PVI to conventional CF-guided PVI ( CONV-CF ) . Methods and results Fifty consecutive paroxysmal atrial fibrillation ( AF ) patients underwent PV encircling using a CF-sensing catheter targeting an interlesion distance ( ILD ) ≤6 mm and ablation index ( AI ) ≥400 and ≥550 at posterior and anterior wall ( ' CLOSE ' group ) . Results were compared to the last 50 patients undergoing ' CONV-CF ' . All patients underwent adenosine testing after PVI . Arrhythmia recurrence was defined as any atrial tachyarrhythmia ( ATA ) > 30 s on Holter at 3 , 6 , and 12 months . Clinical characteristics did not differ . Contact force variability was comparable in between both groups ( proportion of applications with intermittent contact 2 % in ' CLOSE ' vs. 1 % in CONV-CF , P = 0.67 ) . In the ' CLOSE ' group , procedure time and radiofrequency ( RF ) time per circle were shorter ( respectively 149 ± 33 min vs. 192 ± 42 min , P incidence of adenosine-proof isolation was higher ( 97 % vs. 82 % , P . No complications were observed in the ' CLOSE ' group , one tamponade in the ' CONV-CF ' group . At 12 months , single-procedure freedom from ATA was 94 % in ' CLOSE ' vs. 80 % in ' CONV-CF ' group ( P of reconnections at repeat were associated with either ILD > 6 mm and /or AI ' CLOSE'-guided PVI improves procedural and 1 year outcome in CF-guided PVI while shortening procedure time . Improvement can not be explained by differences in CF variability and is most likely due to the strict application of criteria for contiguity and ablation index . A r and omized controlled trial is needed to exclude the possible contribution of a learning curve",
"Introduction Comparative data of early recurrence rates of atrial fibrillation ( ERAF ) following second-generation cryoballoon ( CB-G2 ) and radiofrequency current ( RFC ) ablation for pulmonary vein isolation ( PVI ) in paroxysmal AF ( PAF ) are rare . We r and omized PAF patients into either PVI with CB-G2 ( group 1 ) or PVI with a combined RFC-approach applying contact force ( CF ) with the endpoint of unexcitability ( group 2 ) to investigate ERAF . Methods and results In group 1 ( n = 30 ) , CB-G2-PVI was performed . After CF-PVI in group 2 ( n = 30 ) , bipolar pacing on the ablation line and additional ablation until unexcitability was conducted . Follow-up included 48 h of in-hospital monitoring followed by 5-day Holter ECGs 1 , 2 , 3 , 6 , 12 months postablation to evaluate ERAF . Acute PVI was reached in 100 % of group 2 and in 99 % of group 1 . Shorter procedure duration s ( 98.0 ± 21.9 vs. 114.3 ± 18.7 min , P extended fluoroscopy times ( 15.4 ± 3.9 vs. 10.0 ± 4.3 min , P Ten non-severe complications occurred ( 6 vs. 4 in group 1 and 2 , P = 0.73 ) . In group 2 , five patients suffered from ERAF vs. seven patients in group 1 ( P = 0.67 ) . The time until the occurrence of ERAF was shorter in group 2 ( 1 day ( q1-q3 : 1 - 4.5 ) ) when compared with group 1 ( 22 ( q1-q3 : 6 - 54 ) days , P = 0.025 ) . Conclusion ERAF rates were equal among groups ; however , they occurred earlier in the initial phase after RFC ablation when compared with CB-G2 . PVI utilizing cryoablation is associated with shorter procedure duration s but extended fluoroscopy time while being similarly secure",
"BACKGROUND Pulmonary vein isolation ( PVI ) is a well-established treatment of atrial fibrillation ( AF ) , with contact force (CF)-sensing catheters joining 3-dimensional mapping systems and image integration as technological advancements over the last decade . OBJECTIVE The purpose of this study was to analyze trends in radiation exposure for AF ablation over the last 12 years at our center . METHODS We review ed prospect ively collected data of 2344 consecutive PVI procedures for either paroxysmal or persistent AF between January 2004 and December 2015 . During this period , all cases used 3-dimensional mapping systems , with 8 software and 2 hardware up grade s. Primary endpoints were fluoroscopy time , absorbed dose ( Air Kerma in mGy ) , and effective dose ( mSv ) . RESULTS In total , 1914 patients underwent initial PVI , and 430 patients underwent redo PVI using radiofrequency energy . Fluoroscopy time , and absorbed and effective doses significantly and progressively decreased over the 12-year period for initial PVI as follows : 2004 - 2006 : 61 ± 27 minutes ; 2007 - 2009 : 46 ± 14 minutes , 1365 ± 1369 mGy , 11.3 ± 12.5 mSv ; 2010 - 2012 : 31 ± 11 , 464 ± 339 mGy , 9.0 ± 10.4 mSv ; and 2013 - 2015 : 17 ± 9 minutes , 304 ± 758 mGy , 5.5 ± 6.7 mSv . CF-sensing catheters were used for 357/508 PVI only cases between 2014 and 2015 . Fluoroscopy times ( 11 ± 5 vs 21 ± 8 minutes ; P and absorbed dose ( 200 ± 524 vs 470 ± 1326 mGy ; P = .004 ) were significantly shorter with this catheter . CONCLUSION Radiation exposure has dramatically decreased over the last decade for PVI and is related to operator experience , annual case volume , technology evolution , and more recently CF-sensing catheters . This has significant implication s for both patient and operator long-term risk",
"BACKGROUND Contact force ( CF ) information may improve the safety and efficacy of ablation for paroxysmal atrial fibrillation ( PAF ) . OBJECTIVE The purpose of this study was to assess the impact of CF data on ablation for PAF . METHODS Patients undergoing first-time PAF ablation were r and omized at 7 UK centers to ablation with ( CF-on ) or without ( CF-off ) CF data available to the operator , using the same ablation catheter and mapping system . An ablation CF of 5 - 40 g was targeted . Pulmonary vein ( PV ) reconnection was assessed with adenosine at 60 minutes . Follow-up for arrhythmia recurrence was for 1 year with 7-day Holter recordings at 6 and 12 months . RESULTS One hundred seventeen patients were studied ( 59 CF-on , 58 CF-off ) . In the CF-on group , a reduction in acute PV reconnection rates ( 22 % vs 32 % , P = .03 ) but no significant difference in 1-year success rates off antiarrhythmic drugs ( 49 % vs 52 % , P = .9 ) was observed . There was no difference in major complication rates : 2 of 59 ( 3 % ) CF-on , 3 of 58 ( 5 % ) CF-off ( P = .7 ) . Procedural and fluoroscopy times were not significantly different ( P>.5 ) . Overall mean CFs per ablation were not different between groups ( 13.4 [9.1 - 19.6]g CF-on , 13.4 [7.4 - 22.4]g CF-off , P = .5 ) , but a greater proportion of readings in the CF-on group were in the target range ( 80 % vs 68 % , P acute PV reconnection but not improved 1-year success rates , procedural and fluoroscopy times , or complication rates . There was a reduction in extremes of CF , above and below the study target range , suggesting greater CF control during ablation",
"BACKGROUND Contact force ( CF ) monitoring could be useful in accomplishing circumferential pulmonary vein ( PV ) isolation ( CPVI ) for atrial fibrillation ( AF ) . OBJECTIVE The purpose of this study was to compare procedure parameters and outcomes between CF-guided and non-guided CPVI . METHODS Thirty-eight consecutive AF patients ( mean age 60 ± 11 years , 28 paroxysmal AF ) undergoing CPVI were r and omized to non-CF-guided ( n = 19 ) and CF-guided ( n = 19 ) groups . CPVI was performed with the ThermoCool SmartTouch catheter in both groups . The end-point was bidirectional block between the left atrium ( LA ) and PV . In the CF group , CF was kept between 10 and 20 g during CPVI , whereas in the non-CF group , all CF information was blanked . Radiofrequency energy at 30 W in the anterior and 25 W in the posterior LA wall was applied for 20 - 25 seconds at each point . RESULTS CPVI was successfully accomplished without any major complications in both groups . Mean CF in the non-CF and CF groups were 5.9 ± 4.5 g and 11.1 ± 4.3 g , respectively , for left-side CPVI , and 9.8 ± 6.6 g and 12.1 ± 4.8 g , respectively , for right-side CPVI ( both P The procedure and fluoroscopy times for CPVI in the non-CF and CF groups were 96 ± 39 minutes and 59 ± 16 minutes , respectively ( P respectively . Total number of residual conduction gaps was 6.3 ± 3.0 in the non-CF group and 2.8 ± 1.9 in the CF group ( P free from any atrial tachyarrhythmias ( P = .34 ) . CONCLUSION CF-guided CPVI is effective in reducing procedure time and additional touch-up ablation and may improve long-term outcome ",
"Background The aim of this study was to evaluate the impact of contact force ( CF ) visualization on the incidence of low and high CF during left atrial ( LA ) mapping and pulmonary vein isolation ( PVI ) . Methods CF was assessed in 70 patients who underwent PVI . Three highly experienced operators performed all procedures . The operators were blinded to CF in group A ( 35 patients ) , and CF was displayed in group B ( 35 patients ) . In group B , optimal CF was defined as mean CF between 10 and 39 g , and operators attempted to acquire points and ablate within this range . Results A total of 8401 mapping points were analyzed during LA mapping ( group A : 4104 , group B : 4297 ) . Low CF , CF was significantly lower ( 7.7 vs. 12.2 g , P PVI was successfully achieved in all patients . There were significant site-dependent CF differences between the two groups . Optimal CF was achieved in significantly more applications in group B ( P in atrial fibrillation ( AF ) recurrence rates after a minimum follow-up of 1 year between the two groups in this cohort ( P = 0.24 ) . No significant peri-procedural complications occurred in either group . Conclusions CF visualization can assist in avoiding both low and high CF , which may have the potential to improve lesion formation and patient safety profile . In this study , CF-guided ablation did not affect AF recurrence",
"Purpose We prospect ively investigated the differences in pulmonary vein reconnections ( PVRs ) and clinical outcomes between contact force (CF)-guided and conventional circumferential PV isolation ( CPVI ) of atrial fibrillation ( AF ) . Methods One hundred twenty consecutive AF patients ( 63 ± 10 years ; 88 males ) undergoing an initial CPVI were r and omized to ablation with a target CF of 20 g ( CF group ; n = 60 ) or that with operators blinded to the CF information ( blind group ; n = 60 ) . Results The CF group had fewer PVRs ( 0.67 ± 0.91/patient vs. 1.16 ± 1.16/patient ; P = 0.007 ) , a lower incidence of persistent PVRs ( 13.2 vs. 41.2 % ; P shorter procedural time for the CPVI ( 50 vs. 56 min ; P = 0.019 ) than the blind group . The mean CF was higher in the CF group than the blind group ( 18.0 vs. 16.1 g ; P the mean CF was a negative predictor of PVRs along the P-RPVs and A-LPVs in the blind group ( odds ratios , 0.728 and 0.786 ; P , the arrhythmia-free survival rate at 12 months was 89.9 % in the CF group and 88.2 % in the blind group , respectively ( P = 0.624 ) . Conclusions CF-guided CPVI can reduce PVRs and the procedural time and be particularly beneficial along regions where a relatively low CF tends to be applied : the P-RPVs and A-LPVs . The comparable clinical outcomes may be due to the learning curve effect obtained by the CF-guided technique and repeated provocation of dormant PV conduction",
"Background . There are little comparative data on catheter ablation of paroxysmal atrial fibrillation ( AF ) using the contact force radiofrequency ( CF-RF ) catheter versus the second-generation cryoballoon ( CB2 ) . Methods and results . This is a single center , retrospective , nonr and omized study of 98 patients with symptomatic , drug-refractory paroxysmal AF who underwent their first PVI ablation using either the CB2 ( n = 40 ) or CF-RF ( n = 58 ) . The mean age was 60 years with 63 % men , a mean LA size of 42 mm . The procedure duration ( 74 ± 17 versus 120 ± 49 minutes p CB2 group ; the fluoroscopy time ( 14 ± 17 versus 16 ± 5 minutes , p = 0.45 ) was similar . Complete PVI was achieved in 96 % of patients with RF-CF and 98 % with CB2 . Phrenic nerve palsies ( 2 transient and 1 persistent ) occurred exclusively in the CB2 group and 1 severe , nonlethal complication ( pericardial tamponade ) occurred in the CF-RF group . At 24-month follow-up , the success rate , defined as freedom from AF/atrial tachycardia ( AT ) after a single procedure without antiarrhythmic drug , was comparable in CF-RF group and CB2 group ( 65.5 % versus 67 % , resp . , log rank p = 0.54 ) . Conclusion . Both the CB2 and the RF-CF ablation appeared safe ; the success rate at 2 years was comparable between both technologies",
"Aims : Late recovery of ablated tissue leading to reconnection of pulmonary veins remains common following radiofrequency catheter ablation for AF . Ablation Index ( AI ) , a novel ablation quality marker , incorporates contact force ( CF ) , time , and power in a weighted formula . We hypothesized that prospect i ve use of our previously published derived AI targets would result in better outcomes when compared to CF‐guided ablation . Methods : Eighty‐nine consecutive drug‐refractory AF patients ( 49 % paroxysmal ) underwent AI‐guided ablation ( AI‐group ) . AI targets were 550 for anterior/roof and 400 for posterior/inferior left atrial segments . Procedural and clinical outcomes of these patients were compared to 89 propensity‐matched controls who underwent CF‐guided ablation ( CF‐group ) . All 178 procedures were otherwise similar , and both groups were followed‐up for 12 months . The last 25 patients from each group underwent analysis of all VisiTags ™ for ablation duration , CF , Force‐Time Integral , and impedance drop . Results : First‐pass pulmonary vein isolation ( PVI ) was more frequent in AI‐group than in CF‐group ( 173 [ 97 % ] vs. 149 [ 84 % ] circles , P 0.001 ) , and acute PV reconnection was lower ( 11 [ 6 % ] vs. 24 [ 13 % ] circles , P = 0.02 ) . Mean PVI ablation time was similar ( AI‐group : 42 ± 9 vs. CF‐group : 45 ± 14 minutes , P = 0.14 ) . Median impedance drop for AI‐group was significantly higher than in CF‐group ( 13.7 [ 9‐19 ] Ω vs. 8.8 [ 5.2‐13 ] Ω , P Two major complications occurred in CF‐group and none in AI‐group . Atrial tachyarrhythmia recurrence was significantly lower in AI‐group ( 15 of 89 [ 17 % ] ) than in CF‐group ( 33 of 89 [ 37 % ] , P = 0.002 ) . Conclusion : AI‐guided ablation is associated with significant improvements in the incidence of acute PV reconnection and atrial tachyarrhythmia recurrence rate compared to CF‐guided ablation , potentially due to creation of better quality lesions as suggested by greater impedance drop",
"BACKGROUND Catheter-based contact force sensing ( CFS ) technology gives detailed information regarding contact between the catheter tip and myocardium . This may result in more effective ablation procedures . The primary objective of this study was comparison of remote robotic navigation ( RRN ) and Manual CFS ablation . The secondary objective was to compare CFS with non-CFS ablation for both navigation modes . METHODS Prospect i ve registries of consecutive cases undergoing their first ablation for persistent atrial fibrillation ( AF ) from six hospitals in the United Kingdom and South Africa were analyzed : 50 Manual/CFS and 50 RRN/CFS cases were included . Historical control non-CFS ablation patients were matched by propensity score , giving a total 200 patient cohort . RESULTS RRN/CFS was associated with improved single procedure 1-year success rates ( 64 % vs 36 % , P = 0.01 ) and shorter fluoroscopy times ( 41 % reduction , P procedure times ( P = 0.8 ) . The mean contact force was higher in RRN/CFS than Manual/CFS cases ( 16 [ 15 - 18 g ] vs 13 [ 12 - 15 g ] , respectively , P = 0.003 ) . Compared with non-CFS historical controls , CFS cases had higher 1-year success rates for RRN ( 64 % vs 36 % , P = 0.01 ) , but not Manual ablation ( 36 % vs 38 % , P = 1 ) . Procedure times were reduced for CFS cases ( 20 % , P fluoroscopy times ( Manual : 43 % , RRN 83 % , P rates of major or minor complications for either comparison ( P > 0.5 ) . CONCLUSIONS A combination of RRN and CFS is associated with improved success rates at 1 year and fluoroscopy times for persistent AF ablation , compared with Manual ablation and non-CFS RRN ablation",
"BACKGROUND Catheter ablation is important for treatment of paroxysmal atrial fibrillation ( PAF ) . Limited animal and human studies suggest a correlation between electrode-tissue contact and radiofrequency lesion generation . OBJECTIVES The study sought to assess the safety and effectiveness of an irrigated , contact force (CF)-sensing catheter in the treatment of drug refractory symptomatic PAF . METHODS A prospect i ve , multicenter , nonr and omized study was conducted . Enrollment criteria included : ≥3 symptomatic episodes of PAF within 6 months of enrollment and failure of ≥1 antiarrhythmic drug ( Class I to IV ) . Ablation included pulmonary vein isolation with confirmed entrance block as procedural endpoint . RESULTS A total of 172 patients were enrolled at 21 sites , where 161 patients had a study catheter inserted and 160 patients underwent radiofrequency application . Procedural-related serious adverse events occurring within 7 days of the procedure included tamponade ( n = 4 ) , pericarditis ( n = 3 ) , heart block ( n = 1 , prior to radiofrequency application ) , and vascular access complications ( n = 4 ) . By Kaplan-Meier analyses , 12-month freedom from atrial fibrillation/atrial flutter/atrial tachycardia recurrence was 72.5 % . The average CF per procedure was 17.9 ± 9.4 g. When the CF employed was between investigator selected working ranges ≥80 % of the time during therapy , outcomes were 4.25 times more likely to be successful ( p = 0.0054 ; 95 % confidence interval : 1.53 to 11.79 ) . CONCLUSIONS The SMART-AF trial demonstrated that this irrigated CF-sensing catheter is safe and effective for the treatment of drug refractory symptomatic PAF , with no unanticipated device-related adverse events . The increased percent of time within investigator-targeted CF ranges correlates with increased freedom from arrhythmia recurrence . Stable CF during radiofrequency application increases the likelihood of 12-month success . ( THERMOCOOL ® SMARTTOUCH ® Catheter for Treatment of Symptomatic Paroxysmal Atrial Fibrillation ; NCT01385202 )",
"Purpose Arrhythmia recurrence following pulmonary vein isolation ( PVI ) occurs predominantly due to the reconnection of previously isolated pulmonary veins ( PVs ) . The prognostic implication s of detection and treatment of acute PV reconnection are not well understood . We aim to examine the prognostic significance of acute PV reconnection on arrhythmia recurrence at 1 year following PVI . Methods This prospect i ve study included 44 patients ( 22 men , 60 ± 7 years ) who underwent index PVI procedure for treatment of atrial fibrillation ( AF ) . Acute PV reconnection and /or dormant PV conduction were assessed sequentially in response to a 30-min waiting period , intravenous isoproterenol infusion and /or adenosine . All cases of acute PV reconnection and /or dormant conduction were successfully targeted with additional ablation . Results Freedom from AF at 1 year was 75 % ( 83.3 % in paroxysmal and 65 % in persistent AF , p = ns ) . Acute PV reconnection and /or dormant conduction were evident in 16 of 44 patients ( 36.3 % ) . AF recurrence was documented in eight of 16 patients with , but only in three of 28 patients without acute reconnection ( p = 0.009 ) . Three patients underwent a redo procedure , all from the group of patients with acute PV reconnection . In a multivariate model , acute PV reconnection was a strong independent predictor of arrhythmia recurrence ( hazards ratio [ HR ] , 6.36 ; 95 % confidence interval [ CI ] , 1.12–31.6 ) . Conclusion Identification of acute PV reconnection , even when successfully targeted , is a strong predictor of arrhythmia recurrence following PVI",
"INTRODUCTION The additional benefit of contact force ( CF ) technology during pulmonary vein isolation ( PVI ) for paroxysmal atrial fibrillation ( AF ) to improve mid-term clinical outcome is unclear . METHODS AND RESULTS Eligible patients with symptomatic paroxysmal AF were enrolled in this prospect i ve trial , comparing circular antral catheter ablation ( guided by Carto 3 System , Biosense Webster ) using either a new open-irrigated CF catheter ( SmartTouch Thermocool , Biosense Webster ) ( CF group ) or a non-CF open-irrigated catheter ( EZ Steer Thermocool , Biosense Webster ) ( control group ) . Overall , 30 patients were enrolled in each group , with a st and ardized 12-month follow-up , free of antiarrhythmic therapy . Demographic , cardiovascular and anatomic characteristics were similar in both groups . Though complete PVI was eventually achieved in all cases in both groups , success using an exclusive anatomic approach was 80.0 % in CF group versus 36.7 % in control group ( P fluoroscopy exposure ( P radiofrequency time ( P = 0.01 ) . The incidence rates of AF recurrence were 10.5 % ( 95 % CI , 1.38 - 22.4 ) in the CF group , and 35.9 % ( 95 % CI , 12.4 - 59.4 ) in the control group ( log rank test , P = 0.04 ) . After adjustment on potential confounders , the use of CF catheter was found to be associated with a lower AF recurrence ( OR 0.18 , 95 % CI 0.04 - 0.94 , P = 0.04 ) . CONCLUSION Our findings suggest a potential benefit of real-time CF sensing technology , in reducing AF recurrence during the first year after PVI",
"AIM To investigate the impact of using computed tomography ( CT ) and contact force ( CF ) technology on recurrence of atrial tachyarrhythmia after atrial fibrillation ( AF ) ablation . METHODS This non-r and omized study included 2 groups of patients . All patients had symptomatic recurrent paroxysmal or persistent AF and were treated with at least 1 anti arrhythmic medication or intolerant to medication . The first group included 33 patients who underwent circumferential pulmonary veins isolation ( PVI ) for AF during 2012 and 2013 guided by CT image integration ( Cartomerge , Biosense Webster , Diamond Bar , CA , United States ) of left atrium and pulmonary veins into an electroanatomic mapping ( EAM ) system ( CT group ) using st and ard irrigated radiofrequency catheter ( ThermoCool , Carto , Biosense Webster , Diamond Bar , CA , United States ) or irrigated catheter with integrated CF sensor ( Smart Touch , Carto , Biosense Webster , Diamond Bar , CA , United States ) . The second group included immediately preceding 32 patients who had circumferential PVI by st and ard irrigated catheter ( ThermoCool ) using only EAM ( Carto ) system ( EAM group ) . Linear lesions were performed according to the discretion of operator . RESULTS Sex , age , and persistent AF were not different between groups . PVI was achieved in all patients in both groups . Linear ablations including cavo-tricuspid isthmus and or roof line ablation were not different between groups . Free of atrial tachyarrhythmia during follow-up of 24 mo was significantly higher among CT group compared to EAM group ( 81 % vs 55 % ; respectively ; P = 0.027 ) . When 11 patients from CT group who had ablation using Smart Touch catheter were excluded , the difference between CT group and EAM became non significant ( 73 % vs 55 % ; respectively ; P = 0.16 ) . Sub analysis of CT group showed that patients who had ablation using Smart Touch catheter tend to be more free of atrial tachyarrhythmia compared to patients who had ablation using st and ard irrigated catheter during follow-up ( 100 % vs 73 % ; respectively ; P = 0.07 ) . Major complications ( pericardial effusion , cerebrovascular accident/transient ischemic attack , vascular access injury requiring intervention ) did not occurred in both groups . CONCLUSION These preliminary results suggest that CT image integration and CF technology may reduce the recurrence of atrial tachyarrhythmia after catheter ablation for AF",
"AIMS In the setting of paroxysmal atrial fibrillation ( AF ) , there are no available data comparing the mid-term outcome of patients undergoing pulmonary vein isolation ( PVI ) catheter ablation using contact-force (CF)-guided radiofrequency ( RF ) vs. second-generation balloon cryotherapy . METHODS AND RESULTS Prospect i ve single-centre evaluation , carried out from March 2011 to February 2013 , comparing CF radiofrequency ( Thermocool ( ® ) SmartTouch ™ , Biosense Webster , Inc. ) ( CF group ) with cryoballoon ablation ( A rct ic Front Advance ™ 28 mm cryoballoon , Medtronic , Inc. ) ( CB group ) , in regards to procedural safety and efficacy , as well as recurrence at 12 months . Overall , 150 consecutive patients were enrolled ( 75 in each group ) . The characteristics of patients of both the groups were similar ( 61.2 ± 9.9 years , women 25.3 % , mean AF duration 4.1 ± 4.0 years , mean CHA2DS2-VASc score 1.4 ± 1.3 , mean HAS-BLED 1.4 ± 0.6 ) . Duration of the procedure was significantly lower in the CF group ( 110.7 ± 32.5 vs. 134.5 ± 48.3 min , P = 0.001 ) , with a lower duration of fluoroscopy ( 21.5 ± 8.5 vs. 25.3 ± 9.9 min , P = 0.017 ) and X-ray exposure ( 4748 ± 2411 cGy cm² vs. 7734 ± 5361 cGy cm² , P = 0.001 ) . In contrast , no significant difference was found regarding significant procedural complication ( 2.7 vs. 1.3 % in CF and CB groups , respectively ; P = 0.56 ) , and PVI was eventually achieved in all cases . At 12 months , AF recurrence occurred in 11 patients ( 14.7 % ) in the CB group and in 9 patients ( 12.0 % ) in the CF group ( HR = 1.20 95 % CI 0.50 - 2.90 ; log rank P = 0.682 ) . CONCLUSIONS Our preliminary findings suggest that CF-guided radiofrequency and cryotherapy present very similar performances in the setting of paroxysmal AF catheter ablation",
"BACKGROUND The impact of contact force ( CF ) monitoring in pulmonary vein ( PV ) isolation after a circumferential anatomic ablation ( CAA ) is unknown . We analyze the usefulness of CF monitoring in acute PV isolation and procedure parameters using a CAA . METHODS Fifty patients with paroxysmal atrial fibrillation were r and omized into CF-on ( CF > 10 grams ; n = 25 ) or CF-off ( CF blinded ; n = 25 ) groups . We performed a first round of CAA with a ThermoCool ( ® ) SmartTouch ( ® ) catheter blinded to the LASSO ( ® ) catheter ( Biosense Webster , Diamond Bar , CA , USA ) , with radiofrequency ( RF ) lesions tagged with the VisiTag ( ™ ) Module . After the CAA , each PV was review ed with the LASSO ( ® ) catheter recording the segments with gaps . RESULTS All the PVs were isolated with a CAA in 20 patients of the CF-on versus eight of the CF-off ( P = 0.001 ) . Of the 45 segments with gaps in the left PVs , 38 were from the CF-off ( P = 0.0001 ) . Of the eight segments with gaps in the right PVs , seven were from the CF-off ( P = 0.06 ) . The CF in the left PVs was higher in the CF-on ( 16.3 ± 3.2 grams vs 10.5 ± 4.3 grams ; P = 0.0001 ) and similar in the right PVs ( 17.6 ± 3.6 grams vs 15.2 ± 5.3 grams ; P = 0.08 ) . All of the gaps were closed with additional RF LASSO ( ® ) -guided touch-up . Procedure and fluoroscopy times were shorter in the CF-on ( 139 ± 24 minutes vs 157 ± 32 minutes and 20 ± 6 minutes vs 24 ± 7 minutes ; both P = 0.039 ) . At 12 months the patients free of AF recurrence was 84 % CF-on versus 75 % CF-off ( log-rank P = 0.4 ) [ corrected ] . CONCLUSIONS In paroxysmal atrial fibrillation , a CAA guided by CF reduces PV gaps and shortens the procedure parameters at the expense of the left PVs",
"Abstract Objective : To investigate the effect of the operator knowing the real-time contact force ( CF ) on the efficacy of pulmonary vein antrum isolation ( PVAI ) . Methods : Fifty patients with paroxysmal atrial fibrillation ( AF ) or short lasting persistent AF were r and omized to CF guided PVAI ( n = 25 ) or conventional PVAI ( n = 25 ) . In the CF guided group , CF between 10 and 40 g was aim ed at . Efficacy of PVAI was measured as reduction in AF burden ( AFB ) and time to AF recurrence detected by implantable cardiac monitor ( ICM ) , inserted three months before PVAI . Blanking period was three months and follow-up 12 months . Results : All pulmonary veins were isolated in the CF guided group and all but one in the conventional group . Mean CF was 25 g in the CF guided group and 24 g in the conventional group ( p = 0.75 ) . Compared to pre-ablation , median [ IQR ] relative reduction in AFB 3–12 months after ablation was 100 [99–100]% in the CF guided group ( p AF recurrence in the CF guided group and 13 ( 52 % ) in the conventional group ( p = 0.21 , log-rank test ) . CF differed between operators . When adjusted for operator by regression analysis , patients without recurrent AF had lower proportion of ablation time with CF No complications occurred . Conclusions : Operator knowledge of real-time CF had no significant effect on AFB reduction or time to AF recurrence . Larger trials should be done to study benefit of real-time CF",
"BACKGROUND Impact of contact force sensing ( CFS ) on ablation of persistent atrial fibrillation ( PeAF ) is unknown . OBJECTIVE The purpose of the TOUCH AF ( Therapeutic Outcomes Using Contact force H and ling during Ablation of Persistent Atrial Fibrillation ) r and omized trial was to compare CFS-guided ablation to a CFS-blinded strategy . METHODS Patients ( n = 128 ) undergoing first-time ablation for persistent AF were r and omized to a CFS-guided vs CFS-blinded strategy . In the CFS-guided procedure , operators visualized real-time force data . In the blinded procedure , force data were hidden . Wide antral pulmonary vein isolation plus a roof line were performed . Patients were followed at 3 , 6 , 9 , and 12 months with clinical visit , ECG , and 48-hour Holter monitoring . The primary endpoint was cumulative radiofrequency ( RF ) time for all procedures . Atrial arrhythmia > 30 seconds after 3 months was a recurrence . RESULTS PeAF was continuous for 26 weeks ( interquartile range [ IQR ] 13 - 52 ) , and left atrial size was 45 ± 5 mm . Force in the CFS-blinded and CFS-guided arms was 12 g [ IQR 6 - 20 ] and 14 g [ IQR 9 - 20 ] ( P = .10 ) , respectively . Total RF time did not differ between CFS-guided and CFS-blinded groups ( 49 ± 14 min vs 50 ± 20 min , respectively ; P = .70 ) . Single procedure freedom from atrial arrhythmia was 60 % in the CFS-guided arm and 63 % in the CFS-blinded arm off drugs . Lesions with gaps were associated with significantly less force ( 11.4 g [ IQR 6 - 19 ] vs 13.2 g [ IQR 8 - 20 ] , respectively ; P = .0007 ) and less force-time integral ( 174 gs [ IQR 91 - 330 ] vs 210 gs [ IQR 113 - 388 ] , respectively ; P ) . CONCLUSION CFS-guided ablation result ed in no difference to RF time or 12-month outcome . Lower force/force-time integral was associated with significantly more gaps"
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BACKGROUND Panic disorder is common in the general population . It is often associated with other psychiatric disorders , such as drug dependence , major depression , bipolar disorder , social phobia , specific phobia and generalised anxiety disorder . Azapirones are a class of drugs used as anxiolytics . They are associated with less drowsiness , psychomotor impairment , alcohol potentiation and potential for addiction or abuse than benzodiazepines . However , azapirones are not widely used in the treatment of panic disorder and evidence for their efficacy is unclear . It is important to find out if azapirones are effective and acceptable in the treatment of panic disorder . OBJECTIVES To assess the effects of azapirones on panic disorder in adults , specifically:1 . to determine the efficacy of azapirones in alleviating symptoms of panic disorder , with or without agoraphobia , in comparison with placebo;2 . to review the acceptability of azapirones in panic disorder , with or without agoraphobia , in comparison with placebo ; and 3 . to investigate adverse effects of azapirones in panic disorder with or without agoraphobia , including general prevalence of adverse effects , compared with placebo . SEARCH METHODS We search ed the Cochrane Depression Anxiety and Neurosis Group Trials Specialised Register ( CCDANCTR , search date : 10th January 2014 ) , which includes relevant r and omised controlled trials from The Cochrane Library ( all years ) , MEDLINE ( 1950- ) , EMBASE ( 1974- ) , and PsycINFO ( 1967- ) . SELECTION CRITERIA R and omised controlled trials that compared azapirones with placebo for panic disorder in adults . DATA COLLECTION AND ANALYSIS Three review authors independently identified studies , assessed trial quality and extracted data . We contacted study authors for additional information . MAIN RESULTS Three studies involving 170 participants compared the azapirone buspirone with placebo . No study provided enough usable information on our primary efficacy outcome ( response ) . For our primary acceptability outcome , moderate- quality evidence indicated that azapirones had lower acceptability than placebo : risk ratio ( RR ) for dropouts for any reason 2.13 ( 95 % confidence interval ( CI ) 1.11 to 4.07 ; 3 studies , 170 participants . Evidence for secondary efficacy outcomes were of low quality . Results on efficacy between azapirone and placebo in terms of agoraphobia ( st and ardised mean difference ( SMD ) -0.01 , 95 % CI -0.56 to 0.53 ; 1 study , 52 participants ) , general anxiety ( mean difference ( MD ) -2.20 , 95 % CI -5.45 to 1.06 ; 2 studies , 115 participants ) and depression ( MD -1.80 , 95 % CI -5.60 to 2.00 ; 1 study , 52 participants ) were uncertain . None of the studies provided information for the assessment of allocation concealment or sequence generation . Conflicts of interest were not explicitly expressed . The risk of attrition bias was rated high for all three studies . Information on adverse effects other than dropouts for any reason was insufficient to include in the analyses . AUTHORS ' CONCLUSIONS The efficacy of azapirones is uncertain due to the lack of meta-analysable data for the primary outcome and low- quality evidence for secondary efficacy outcomes . A small amount of moderate- quality evidence suggested that the acceptability of azapirones for panic disorder was lower than for placebo . However , only trials of one azapirone ( namely buspirone ) were included in this review ; this , combined with the small sample size , limits our conclusions . If further research is to be conducted , studies with larger sample sizes , with different azapirones and with less risk of bias are necessary to draw firm conclusions regarding azapirones for panic disorder
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"Recent animal models suggest that disturbances in serotonin type-1A receptor ( 5-HT1AR ) function may contribute to chronic anxiety , although it is not clear at all whether such models constitute relevant models for panic disorder ( PD ) in humans . The selective 5-HT1AR radiolig and [18F]trans-4-fluoro-N-2-[4-(2-methoxyphenyl)piperazin-1-yl]ethyl]-N-(2-pyridyl)cyclohexanecarboxamide ( FCWAY ) permits in vivo assessment of central 5-HT1AR binding using positron emission tomography ( PET ) . We studied 16 unmedicated symptomatic out patients with PD and 15 matched healthy controls . Seven patients had an additional diagnosis of a current major depressive episode , however PD was the primary diagnosis . A 120 min PET study of 5-HT1AR binding was acquired using a GE Advance scanner in three-dimensional mode . Using quantitative PET image analysis , regional values were obtained for [18F]-FCWAY volume of distribution ( DV ) , corrected for plasma protein binding , and K1 , the delivery rate of [18F]-FCWAY from plasma to tissue . MRI scanning was performed using a GE Signa Scanner ( 3.0 Tesla ) to provide an anatomical framework for image analysis and partial volume correction of PET data . PD patients showed lower DV in the anterior cingulate ( t = 4.3 ; p DVs did not differ between PD patients and PD patients with comorbid depression , whereas both patient groups differed significantly from controls . These results provide for the first time in vivo evidence for the involvement of 5-HT1ARs in the pathophysiology of PD",
"CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions . OBJECTIVE To explore whether the association between funding and conclusions in r and omized drug trials reflects treatment effects or adverse events . DESIGN Observational study of 370 r and omized drug trials included in meta-analyses from Cochrane review s selected from the Cochrane Library , May 2001 . From a r and om sample of 167 Cochrane review s , 25 contained eligible meta-analyses ( assessed a binary outcome ; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment ) . The primary binary outcome from each meta- analysis was considered the primary outcome for all trials included in each meta- analysis . The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect , adverse events , and additional confounding factors ( method ological quality , control intervention , sample size , publication year , and place of publication ) . MAIN OUTCOME MEASURE Conclusions in trials , classified into whether the experimental drug was recommended as the treatment of choice or not . RESULTS The experimental drug was recommended as treatment of choice in 16 % of trials funded by nonprofit organizations , 30 % of trials not reporting funding , 35 % of trials funded by both nonprofit and for-profit organizations , and 51 % of trials funded by for-profit organizations ( P funding , treatment effect , and double blinding were the only significant predictors of conclusions . Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice ( odds ratio , 5.3 ; 95 % confidence interval , 2.0 - 14.4 ) compared with trials funded by nonprofit organizations . This association did not appear to reflect treatment effect or adverse events . CONCLUSIONS Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results . Readers should carefully evaluate whether conclusions in r and omized trials are supported by data",
" Two groups of 12 out patients each ( six men and six women ) with generalized anxiety disorder , participated in this study . Each patient was treated single-blind with placebo during the first 7 days ( baseline ) , followed by a double-blind drug treatment period of 4 consecutive weeks ( active ) and ending again with 7 days single-blind placebo treatment ( washout ) . One group received buspirone 5 mg three times a day in the first week and continued with 10 mg in the morning , 5 mg in the afternoon , and 5 mg in the evening during the second , third , and fourth weeks . The other group received diazepam 5 mg three times a day in all 4 weeks . On the evening of the seventh day of each treatment week the Hamilton Rating Scale for Anxiety and the Symptom Check List ( 90 items ) were applied to assess the therapeutic effects , followed by an on-the-road driving test that started 1.5 hours after the last drug or placebo intake . The test consisted of operating an instrumented vehicle over a 100 kilometer highway circuit while attempting to maintain a constant speed and a steady lateral position within the right traffic lane . Two patients in the diazepam group were unable to complete their test after the first and second treatment week , respectively , because of serious sedative reactions . Both buspirone and diazepam were equally effective in reducing overall anxiety symptoms . The specific profiles showed that buspirone also reduced concomitant depressive symptoms and symptoms of interpersonal sensitivity and anger-hostility . In contrast , diazepam was found to be slightly more effective in reducing somatic symptoms and to positively affect sleep disturbances . Moreover , abrupt discontinuation of diazepam result ed in a relapse of psychic anxiety symptoms comparable with the placebo-baseline level and a partial relapse of somatic anxiety symptoms . Chronic treatment with buspirone had no significant effects on lateral position and speed control . In contrast , diazepam significantly impaired control of lateral position in the first 3 weeks of treatment . There was no significant impairment in the fourth treatment week and the placebo-washout week . Speed control was significantly impaired only in the first week . The relevance of the trend toward decreasing performance impairment during chronic treatment remains to be established",
"BACKGROUND The change of psychopathological dimensions during treatment of panic disorder is attracting increasing interest . METHODS A population of subjects experiencing panic disorder with agoraphobia is evaluated with the French version of the factor structure of the Symptom Checklist 90 R ( SCL 90 R ) . Two groups of patients are compared : a group receiving cognitive behaviour therapy ( CBT ) combined with buspirone and a group receiving cognitive behaviour therapy combined with placebo . RESULTS Comparative analysis of pre- and post-test changes between both groups completing treatment showed that the combination cognitive behaviour therapy plus buspirone provided better results than those in patients who had received cognitive behaviour therapy plus placebo . This difference between treatments did not persist at the 1-year follow-up , since , while results had been effectively maintained in the CBT plus buspirone group , the CBT plus placebo group continued to improve significantly for the target dimensions of treatment . CONCLUSIONS Psychopathological dimensions on the SCL 90 R show that combination of buspirone and cognitive behaviour therapy accelerates the behaviour modification process only in the short term",
"The efficacy of buspirone for panic disorder was tested in 60 patients who met Diagnostic and Statistical Manual of Mental Disorders ( 3rd ed . ) criteria for panic disorder or agoraphobia with panic attacks . Patients were r and omly assigned to treatment with buspirone ( mean dose 29.5 mg/day ) , imipramine ( mean dose 140 mg/day ) , or placebo , and treated for 8 weeks after a 4- to 7-day placebo lead-in period . Patients with 4 or fewer attacks per month and those without attacks at the baseline visit were excluded from panic frequency comparisons . Both buspirone and imipramine tended to be better than placebo on total number of panic attacks , global psychopathology , and the Hamilton Anxiety rating scale , but end point differences among treatments were not statistically significant . At the end of the study , 25 % of the buspirone patients were panic-free , as were 7 % of the imipramine patients and 14 % of the placebo patients ; again , these differences were not statistically significant . The results of this study were inconclusive , partly because of the relatively small number of patients ( 10 - 11 ) completing the study in each treatment group , and partly because of a robust placebo response in this population . Possible reasons for this high placebo response are discussed , as well as suggestions for changes in study design for future studies",
"OBJECTIVE Recently , pharmacological treatment guidelines for panic disorder have changed as newer treatment options have become available . The authors examined how the use of psychotropic drugs has shifted over the course of 10 years to determine if prescribing patterns have changed to reflect these revised treatment guidelines . METHOD A total of 443 patients with panic disorder were enrolled in the Harvard/Brown Anxiety Research Project , a prospect i ve longitudinal study of anxiety disorders . These patients were interviewed over the course of 10 years to examine their use of psychotropic medications . RESULTS Despite efforts aim ed at increasing the use of selective serotonin reuptake inhibitors ( SSRIs ) in patients with panic disorder ( e.g. , APA 's practice guideline for panic disorder , Food and Drug Administration approval of particular SSRIs for the treatment of panic disorder ) , only a modest increase in their use was found . Treatment patterns for psychotropic drugs appear to have remained stable over the past decade , with benzodiazepines being the most commonly used medication for panic disorder . In comparison , SSRI use throughout the follow-up period has remained low . Patients using an SSRI did not have a more favorable clinical course than those using a benzodiazepine , nor were there significantly better rates of remission in patients using SSRIs and benzodiazepines concomitantly . CONCLUSIONS These results highlight a gap between pharmacological treatment guidelines and actual delivery of care in that recommendations to use SSRIs to treat panic disorder are not being followed . Factors potentially associated with promoting and ignoring treatment recommendations are discussed",
"Proper evaluation of anxiolytic therapy , involving the possible use of rating scales as well as the physician 's skill in observation and communication , is essential in identifying the most appropriate treatment for a given patient and facilitating the management of therapy . These issues are discussed herein , using the clinical trials of buspirone , a new , nonsedating antianxiety agent , as a model for the process of drug selection",
" Thirty-six patients with generalised anxiety disorder , panic disorder or agoraphobia with panic attacks , diagnosed by DSM-III criteria , were treated with a new non-benzodiazepine anti-anxiety drug , buspirone , and with diazepam and placebo , in a cross-over design . Each patient took buspirone , diazepam and placebo for one week each in flexible dosage and balanced order . Ratings of symptomatology using the Comprehensive Psychopathological Rating Scale were made after each week 's treatment and a sub-scale used for measuring anxiety change alone was used separately . There was no overall difference in efficacy between the drugs , but when the scores for individual symptoms were analysed , diazepam was significantly superior to the other treatments for the symptom of muscle tension only . The results suggest that the common practice of giving short-term therapy with tranquilising drugs for anxiety in primary care is pharmacologically suspect",
"Sixty-five in patients of a psychosomatic hospital in the Federal Republic of Germany with the diagnosis of anxiety neurosis ( n = 31 ) or neurotic depression ( n = 34 ) as defined by the International Classification of Disease ( ICD-9 ) , were r and omized to a 4-week course of ipsapirone at 7.5 mg t.i.d . or placebo in a prospect i ve , double-blind clinical trial to assess safety , tolerability , and efficacy . This article reports the efficacy results for those patients with the diagnosis of neurotic depression . The primary efficacy variable for patients with neurotic depression was the change from baseline in the Hamilton Rating Scale for Depression ( HAM-D ) at 4 weeks of treatment . Considering all of the r and omized patients with neurotic depression ( n = 34 , the intent-to-treat population ) , the mean change from baseline in the HAM-D at Week 4 ( observed cases ) was -13.13 + /- 6.06 ( n = 16 ) for the ipsapirone group , and -3.19 + /- 5.99 ( n = 16 ) for the placebo group ( p less than .001 ) . A parallel analysis of the change from baseline in the Core Depression score of the HAM-D ( defined as the sum of items 1 , 2 , 3 , 7 , and 8) also showed a significant treatment difference ( p less than .01 ) . Results were similar for the intent-to-treat population , last observation carried forward . Safety and tolerability were evaluated for all study patients independent of diagnosis . Treatment-emergent events ( n = 65 ) were reported by 76 percent of patients treated with ipsapirone ( n = 33 ) and by 38 percent of patients treated with placebo ( n = 32 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"In this double-blind study , 56 adult psychoneurotic out patients with a primary diagnosis of anxiety neurosis were r and omly assigned to receive buspirone ( N = 18 ) , diazepam ( N = 20 ) , or placebo ( N = 18 ) over a four-week period . A battery of tests administered weekly indicated that buspirone , a new agent not chemically related to any currently marketed drugs , was as effective an antianxiety agent as diazepam and produced no more and perhaps fewer side effects . Buspirone showed excellent antidepressant effects as well . If further studies confirm the authors ' findings and determine that buspirone does not result in tolerance and addiction , it would be more advantageous than the benzodiazepines in the treatment of anxiety",
"Blunted neuroendocrine and physiological responses to the selective 5-HT(1A ) receptor agonist , ipsapirone , have been observed in patients with panic disorder and /or agoraphobia ( PDA ) . In order to examine whether this hyporesponsiveness to ipsapirone is modified by pharmacological or non-pharmacological therapeutic interventions , challenges with an oral dose of ipsapirone ( 0.3 mg/kg ) and placebo were performed in patients with PDA before and after 10 weeks of treatment with clomipramine , aerobic exercise and placebo . Before treatment , administration of ipsapirone was followed by significant increases of cortisol , anxiety and other psychopathological symptoms in comparison to the placebo challenge . In addition , a significant decrease of body temperature was observed . After the 10-week treatment period , the psychological responses to ipsapirone were significantly reduced in the clomipramine and the exercise group . In contrast , there was a non-significant trend towards higher cortisol responses after clomipramine and exercise treatment . The hypothermic response to ipsapirone was significantly reduced by clomipramine treatment . In conclusion , our results demonstrate that effective treatment of panic disorder has divergent effects on the psychological , neuroendocrine and temperature responses to ipsapirone",
"Abstract This article reports the initial results of a prospect i ve study on the prevalence of psychiatric disorders in the Dutch population aged 18–64 . The objectives and the design of the study are described elsewhere in this issue . A total of 7076 people were interviewed in person in 1996 . The presence of the following disorders was determined by means of the CIDI : mood disorders , anxiety disorders , eating disorders , schizophrenia and other non-affective psychoses , and substance use disorders . Psychiatric disorders were found to be quite common . Some 41.2 % of the adult population under 65 had experienced at least one DSM-III-R disorder in their lifetime , among them 23.3 % within the preceding year . No gender differences were found in overall morbidity . Depression , anxiety , and alcohol abuse and dependence were most prevalent , and there was a high degree of comorbidity between them . The prevalence rate encountered for schizophrenia was lower ( 0.4 % lifetime ) than generally presumed . A comparison with findings from other countries is made . Relevant determinants of psychiatric morbidity were analysed",
"Reduced 5-HT1A-receptor responsiveness has been reported in patients with panic disorder(PD ) and /or agoraphobia ( PDA ) . Although many of these patients are regular smokers , it has not been examined whether psychological or neurobiological effects induced by the selective 5-HT1A-receptor agonist , ipsapirone , are affected by the smoking status of the patients .In order to clarify this question neuroendocrine challenges with oral doses of ipsapirone ( 0.3 mg/kg ) and placebo were performed in 39 patients with PDA , and results were compared between patients who smoked ( > 10 cigarettes per day , n = 17 ) and patients who had been non-smokers for at least two years ( n = 22 ) . Patients who were smokers ( but did not smoke during the challenge procedure ) had significantly reduced baseline concentrations of cortisol and a significantly lower body temperature . In comparison to placebo , administration of ipsapirone was associated with significant increases of various psychological symptoms and plasma cortisol concentrations . The subgroup of PD patients who were smokers showed significantly higher cortisol responses to ipsapirone than non-smokers . In conclusion , smoking status has to be taken into account when assessing the responsiveness of 5-HT1A receptors in patients with psychiatric disorders . The prevention of smoking during challenge sessions might not be the ideal approach in heavy smokers , since sudden abstinence from smoking is likely to affect neurobiological and possibly psychological responses to ipsapirone",
"There is a need for safe effective alternatives to benzodiazepines in the treatment of panic disorder . Buspirone , a new nonbenzodiazepine anxiolytic , is compared to imipramine and placebo in the treatment of panic disorder in an 8 week double-blind controlled study of 52 r and omly assigned patients . Weekly assessment s were made using the Hamilton Anxiety Scale , the Sheehan Clinician Rated Anxiety Scale , the Sheehan Patient Rated Anxiety Scale , the Phobia Scale , the Disability Scale , the Hamilton Depression Scale , the Montgomery Asberg Depression Scale , the Investigator Rated Global Improvement Scale and the Patient Rated Global Improvement Scale . Preliminary results of repeated measures Anovas are reported . Imipramine was superior to placebo on many of the outcome measures . Imipramine was superior to buspirone on the Patient Rated Global Improvement Scale and on the Investigator Rated Global Improvement Scale , but not on other measures . Although buspirone appeared to be more effective than placebo , differences were not statistically significant . Some buspirone patients did very well compared to others , suggesting a possible bimodal distribution of response . Patients on buspirone had fewer and less disruptive side effects than those on imipramine",
"Two double-blind studies are described in which buspirone was compared with placebo and diazepam ( Study A ) or clorazepate ( Study B ) in out patients with moderate to severe anxiety . Results , assessed on the Hamilton Rating Scales for Depression and Anxiety , the SCL-56 , the Profile of Mood States , and the Covi and Raskin scales , indicated that buspirone consistently relieved both anxiety and associated depression . In Study B , trends in favor of buspirone were seen on several SCL-56 items and the Hamilton somatic factor ; significant differences in this direction were found for several POMS items . Sedation was seen less often with buspirone than either diazepam or clorazepate",
"& NA ; Forty patients over 65 years of age with anxiety symptoms due to an anxiety state ( N = 20 ) or secondary to neurotic depression ( N = 20 ) took part in a double‐blind , placebo‐controlled trial conducted in a primary care practice . All patients were receiving concomitant drug therapy for chronic medical conditions ; 70 % were receiving two or more nonpsychotropic drugs in addition to the study medication . Patients were r and omly assigned to treatment with buspirone 5‐30 mg/day or placebo for 4 weeks , with clinical evaluations made weekly . One buspironetreated and two placebo‐treated patients discontinued treatment after 2 weeks because of lack of efficacy . Buspirone treatment result ed in significantly greater ( p ≤ 0.05 ) improvement on the Hamilton Rating Scale for Anxiety , Hamilton Rating Scale for Depression , and Clinical Global Impression assessment than did placebo . Mild adverse experiences were reported by five buspirone‐treated and nine placebotreated patients . Buspirone ( mean dose , 18 mg/day ) proved equally effective for elderly patients suffering anxiety states or neurotic depression at doses similar to those used in younger patients , and was well tolerated by elderly patients receiving treatment for other chronic medical conditions",
"The selective 5-HT1A receptor lig and ipsapirone ( IPS ) induces hypothermia in humans . To explore 5-HT1A receptor-mediated thermoregulation in depression , 24 subjects ( 12 patients with unipolar depression and 12 individually matched controls ) received 0.3 mg/kg IPS or placebo in r and om order . Compared with controls , the depressed patients exhibited significantly attenuated hypothermic responses to IPS . The impaired hypothermic response following 5-HT1A receptor activation in unipolar depression could have result ed from subsensitivity of the ( presynaptic ) 5-HT1A receptor and /or related effector mechanisms , thus supporting the hypothesis that altered serotonergic activity may be present in affective disorders . Future studies of the hypothermic response to direct-acting 5-HT1A lig and s , such as IPS should facilitate the assessment of 5-HT receptor function in various affective disorders and its involvement in psychotropic drug effects",
"BACKGROUND Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings . In this study , we examine the association between industry funding and the statistical significance of results in recently published medical and surgical trials . METHODS We examined a consecutive series of 332 r and omized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals . Each eligible study was independently review ed for method ological quality using a 21-point index with 5 domains : r and omization , outcomes , eligibility criteria , interventions and statistical issues . Our primary analysis included studies that explicitly identified the primary outcome and reported it as statistically significant . For studies that did not explicitly identify a primary outcome , we defined a \" positive \" study as one with at least 1 statistically significant outcome measure . We used multivariable regression analysis to determine whether there was an association between reported industry funding and trial results , while controlling for study quality and sample size . RESULTS Among the 332 r and omized trials , there were 158 drug trials , 87 surgical trials and 87 trials of other therapies . In 122 ( 37 % ) of the trials , authors declared industry funding . An unadjusted analysis of this sample of trials revealed that industry funding was associated with a statistically significant result in favour of the new industry product ( odds ratio [ OR ] 1.9 , 95 % confidence interval [ CI ] 1.3 - 3.5 ) . The association remained significant after adjustment for study quality and sample size ( adjusted OR 1.8 , 95 % CI 1.1 - 3.0 ) . There was a nonsignificant difference between surgical trials ( OR 8.0 , 95 % CI 1.1 - 53.2 ) and drug trials ( OR 1.6 , 95 % CI 1.1 - 2.8 ) , both of which were likely to have a pro-industry result ( relative OR 5.0 , 95 % CI 0.7 - 37.5 , p = 0.14 ) . INTERPRETATION Industry-funded trials are more likely to be associated with statistically significant pro-industry findings , both in medical trials and surgical interventions",
"BACKGROUND This multicentre study compared a 16-week buspirone treatment with placebo in patients presenting with panic disorder with agoraphobia and also receiving cognitive behaviour therapy ( CBT ) . METHOD Double-blind testing was maintained until week 68 , but not tested ; 91 patients were included ; 14 placebo-responders excluded ; 77 patients r and omised ; 48 reached week 16 and 41 reached week 68 . RESULTS At week 16 , within-group analysis showed significant improvements in agoraphobia , panic attacks , and depression in both groups . Generalised anxiety improved only in CBT+buspirone . Between-group comparisons showed buspirone to have an effect on generalised anxiety and agoraphobia . Changes in degree of agoraphobia and depression were correlated in subjects on CBT+buspirone only . A significantly higher proportion of women , and of subjects showing high avoidance dropped out . Positive expectations regarding medication predicted success in both groups . At week 68 , improvement was retained without significant buspirone effect . CONCLUSION Buspirone enhanced the effects of cognitive behaviour therapy on generalised anxiety and agoraphobia in the short term",
"To explore 5-HT1A receptor responsivity in panic disorder ( PD ) , hypothermic , neuroendocrine and behavioral responses to the selective partial 5-HT1A receptor agonist ipsapirone ( IPS ) were investigated in patients with primary PD and healthy controls . Fourteen patients and matched controls received a single oral dose of 0.3 mg/kg IPS or placebo under double-blind , r and om-assignment conditions . IPS induced hypothermia and corticotropin (ACTH)/cortisol release but had only minimal effects on behavior . Compared with controls , the patients with PD exhibited significantly attenuated thermoregulatory and neuroendocrine responses to IPS . Although the healthy subjects reported increased drowsiness and the PD patients rated themselves more nervous and less calm following administration of IPS , no consistent changes in ratings of anxiety or panic symptoms were recorded . The impaired hypothermic and ACTH/cortisol responses following 5-HT1A receptor activation reflects subsensitivity of both the pre- and post-synaptic 5-HT1A receptor-effector system , thus supporting the hypothesis that a 5-HT1A receptor-related serotonergic dysfunction may be linked to the pathophysiology of PD . Future studies of 5-HT1A receptor-effector complex function in conjunction with assessment of the responsivity of other subtypes ( e.g. 5-HT2 , 5-HT3 ) should promote the evaluation of 5-HT system integrity in anxiety disorders and its involvement in anxiolytic drug effects",
"& NA ; Sixty patients being treated for anxiety in a primary care facility received ( double‐blind ) buspirone , the benzodiazepine drug clobazam , or placebo for 3 weeks . The mean daily dose at the end of treatment was 23 mg for buspirone and 21 mg for clobazam . Patients were assessed weekly using the Hamilton Rating Scale for Anxiety and Clinical Global Impression scale . Both active treatments produced significant improvement in anxiety symptoms compared with placebo as early as the first week of treatment , and there was progressive improvement over the subsequent 2 weeks . Response to buspirone was equally favorable in anxious patients who experienced depressive symptomatology",
" Sixty-two chronically agoraphobic patients completed a controlled study to assess the effects of 1 ) imipramine up to 200 mg/day ( mean = 130 mg/day ) , 2 ) 12 weekly therapist-assisted in vivo exposure sessions ( flooding ) , and 3 ) imipramine plus flooding . The control group received systematic therapeutic instructions for self-directed in vivo exposure ( programmed practice ) . Clinical measures of global severity , phobia , panic , anxiety , depression , and behavioral performance tests were administered before treatment and at Weeks 4 , 8 , and 12 of treatment . Results revealed significant improvement in all groups on all measures over the course of treatment ; almost a third of the control patients showed marked improvement . Imipramine had significant effects on improvement of phobias and markedly increased clinical response rates in patients receiving 150 - 200 mg/day . Less chronicity and severity of condition also predicted better clinical outcome . Flooding had limited effects above and beyond programmed practice , and no imipramine-flooding interactions effects were found",
"As much information as possible should be obtained in clinical trials to assess possible interactions between test drugs and concomitant medications prescribed for other medical indications . Side effect profiles were compared in patients taking buspirone , mean = 20 mg/day ; diazepam , 20 mg/day ; clorazepate , 23 mg/day ; and placebo , with or without concomitant medications . Approximately 1,000 anxious patients were included in the analysis ; 700 received buspirone . The use of a variety of common medications did not affect the side effect profile in the buspirone , clorazepate , and placebo groups , but did increase the incidence of side effects in the diazepam group . The increased incidence of sedation noted with diazepam and clorazepate , however , was not due to concomitant medication",
"OBJECTIVE Patients with generalized anxiety disorder ( N=107 ) who had been long-term benzodiazepine users ( average duration of use=8.5 years ) were enrolled in a benzodiazepine discontinuation program that assessed the effectiveness of concomitant imipramine ( 180 mg/day ) and buspirone ( 38 mg/day ) compared to placebo in facilitating benzodiazepine discontinuation . METHOD After a benzodiazepine stabilization period taking either diazepam , lorazepam , or alprazolam , patients were treated for 4 weeks with imipramine , buspirone , or placebo under double-blind conditions while benzodiazepine intake was kept stable ( treatment phase ) . Patients then entered a 4 - 6 week benzodiazepine taper and a 5-week posttaper phase with imipramine , buspirone , and placebo treatment being continued until 3 weeks into the posttaper phase , at which time all patients were switched to placebo for 2 weeks . Benzodiazepine plasma levels were assayed weekly . Benzodiazepine-free status was assessed 3 and 12 months posttaper . RESULTS Study subjects were long-term benzodiazepine users with an average of three unsuccessful prior taper attempts . The success rate of the taper in this study was significantly higher for patients who received imipramine ( 82.6 % ) , and nonsignificantly higher for patients who received buspirone ( 67.9 % ) , than for patients who received placebo ( 37.5 % ) . The imipramine effect remained highly significant even after the analysis adjusted for three other independent predictors of taper success : benzodiazepine dose , level of anxious symptoms at baseline , and duration of benzodiazepine therapy . CONCLUSIONS Management of benzodiazepine discontinuation can be facilitated significantly by co-prescribing imipramine before and during the benzodiazepine taper . Daily benzodiazepine dose , severity of baseline symptoms of anxiety and depression , and duration of benzodiazepine use were additional significant predictors of successful taper outcome",
"This report presents results from an international multicenter trial of the safety of buspirone in the treatment of anxiety disorders for periods up to one year , if needed ; 424 patients were treated for six months , and 264 patients completed a full year of treatment . Chronic use of buspirone for up to 52 weeks was associated with emergence of no new or unexpected side effects that were not previously reported during shorter periods of treatment . Most patients were successfully managed on daily doses ranging from 15 to 30 mg/day . When buspirone therapy was abruptly discontinued after more than six months of therapy , assessment s of patients yielded no evidence of a withdrawal syndrome or unusual events . Although long-term anxiolytic drug therapy is not generally recommended , this open study provides evidence of the potential usefulness of buspirone when used for up to one year . As a general guideline , when an anxiolytic agent is used for several months or longer to treat chronic anxiety , the need for drug therapy should be reevaluated periodically",
" Buspirone was compared with imipramine and placebo in the treatment of panic disorder in an 8-week , double-blind controlled study of 52 r and omly assigned patients . The side effect profile of buspirone was less disruptive than that of imipramine . Buspirone was not significantly superior to placebo in its antipanic or anxiolytic effects in panic disorder patients"
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41171a72-06ff-11f0-808a-c43d1ab1c353
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Attention-deficit/hyperactivity disorder ( ADHD ) frequently co-occurs with intellectual disability in children , and may further compromise learning . Methylpheni date is a first-line treatment for ADHD , however no previous meta- analysis has evaluated its overall efficacy for ADHD in children with comorbid intellectual disability ( ID ) or borderline intellectual functioning . The PubMed / MEDLINE , Cochrane CENTRAL and ScienceDirect data bases were systematic ally search ed from inception through 2018/7/15 for clinical studies that investigated the effects of methylpheni date in children with ADHD and ID . A r and om-effects model meta- analysis was used for data synthesis . Eight studies ( average Jadad score = 2.5 ) enrolling 242 participants receiving methylpheni date and 181 participants receiving placebo were included . The meta- analysis showed that methylpheni date led to a significant improvement in ADHD symptoms relative to placebo ( Hedges ’ g = 0.878 , p methylpheni date and overall improvement in ADHD severity ( slope = 1.334 , p drop-out rate [ odds ratio ( OR ) = 1.679 , p = 0.260 ] or rate of treatment discontinuation due to adverse events ( OR = 4.815 , p = 0.053 ) between subjects receiving methylpheni date and those taking placebos . Our study suggests that methylpheni date retains its efficacy in children with ADHD and borderline intellectual functioning or ID
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"OBJECTIVE To determine response of low-IQ children with attention deficit hyperactivity disorder ( ADHD ) symptoms to methylpheni date ( MPH ) . METHODS An aggregated analysis was conducted in 90 children with low IQ who received the same dose regimen of MPH in three independent , placebo-controlled studies . Active drug and placebo were given from 2 to 4 weeks each . Outcome measures included teacher and parent ratings on st and ardized behavior scales ( mean n = 84 ) , performance on computer-controlled cognitive-motor tests ( n = 62 ) , and measures of cardiovascular response ( n = 85 ) . RESULTS Both teachers and parents rated the children consistently as being improved on subscales assessing attention , overactivity , and conduct problems . Some 44 % of the subjects showed at least a 30 % reduction compared with placebo on teacher ratings . MPH improved accuracy on several cognitive tests , response speed was increased on some , and seat activity declined for one of three tests ; heart rate was mildly increased ( 3.9 beats/minute ) with MPH . Analyses of IQ and mental age as moderator variables suggested that lower functional level ( especially lower IQ ) may be associated with a less favorable response to MPH . CONCLUSIONS Children with low IQ and ADHD clearly respond to MPH , but their rate of beneficial response appears to be well under that of normal-IQ children and more varied . Different attentional mechanisms may moderate response to psychostimulants",
"A double-blind , placebo-controlled , crossover study of methylpheni date ( 0.4 mg/kgday ) and different doses of fenfluramine ( 1.0 , 1.5 , or 2.0 mg/g/day ) in children with mental retardation or borderline IQ and ADHD was conducted . Parents , teachers , examiners , and physicians rated the children . There were relatively few significant drug effects by condition . When the optimal fenfluramine dose for each child was compared with placebo and methylpheni date , significant improvements occurred for fenfluramine on several parent and teacher subscales ; teachers rated the children as somewhat improved with methylpheni date . The highest dose of fenfluramine produced more behavior compliance but apparently at the cost of cognitive efficiency . Most side effects ( drowsiness , dizziness , anorexia ) occurred with fenfluramine . Both drugs appear to be effective treatments for children with ADHD and mental retardation , although there is a possible neurotoxic action with fenfluramine . We recommend a gradual phase-in of fenfluramine dosage , up to 1.5 mg/kg/day , for most children",
"BACKGROUND Previous studies have demonstrated the short-term efficacy of pharmacotherapy and behavior therapy for attention-deficit/hyperactivity disorder ( ADHD ) , but no longer-term ( i.e. , > 4 months ) investigations have compared these 2 treatments or their combination . METHODS A group of 579 children with ADHD Combined Type , aged 7 to 9.9 years , were assigned to 14 months of medication management ( titration followed by monthly visits ) ; intensive behavioral treatment ( parent , school , and child components , with therapist involvement gradually reduced over time ) ; the two combined ; or st and ard community care ( treatments by community providers ) . Outcomes were assessed in multiple domains before and during treatment and at treatment end point ( with the combined treatment and medication management groups continuing medication at all assessment points ) . Data were analyzed through intent-to-treat r and om-effects regression procedures . RESULTS All 4 groups showed sizable reductions in symptoms over time , with significant differences among them in degrees of change . For most ADHD symptoms , children in the combined treatment and medication management groups showed significantly greater improvement than those given intensive behavioral treatment and community care . Combined and medication management treatments did not differ significantly on any direct comparisons , but in several instances ( oppositional/aggressive symptoms , internalizing symptoms , teacher-rated social skills , parent-child relations , and reading achievement ) combined treatment proved superior to intensive behavioral treatment and /or community care while medication management did not . Study medication strategies were superior to community care treatments , despite the fact that two thirds of community-treated subjects received medication during the study period . CONCLUSIONS For ADHD symptoms , our carefully crafted medication management was superior to behavioral treatment and to routine community care that included medication . Our combined treatment did not yield significantly greater benefits than medication management for core ADHD symptoms , but may have provided modest advantages for non-ADHD symptom and positive functioning outcomes",
"The author describes and emphasizes the value of a symptom and behavior rating checklist for teachers ' use in drug studies with children . Factor analysis of the scale produced five factors that gave reliable subscales over a one-month period . A treatment study of dextroamphetamine with a group of children having learning and /or behavior disorders showed significant changes in all factors compared with a placebo group in a double-blind study",
"Each of 28 nonautistic children with attention-deficit hyperactivity disorder and mental retardation received placebo , methylpheni date ( 0.4 mg/kg/day ) , and fenfluramine ( gradually increased to 1.5 mg/kg/day ) for 4 weeks each in a double-blind , crossover design . Teacher ratings indicated significant improvements with both active drugs on subscales design ated as Conduct Problem , Hyperactivity , and Irritability , but methylpheni date alone produced improvements on an Inattention subscale . Parent ratings indicated significant improvements with both drugs on subscales labeled Hyperactivity , Motor Excess , and Conduct Problem . Fenfluramine alone caused improved parent ratings on Irritability and Inappropriate Speech , and on Conners ' Abbreviated Symptom Question naire . Unlike a previous study , subgroup analyses failed to show a significantly better clinical response to methylpheni date for subjects with higher mental ages , although children with higher IQs responded better than those with IQs less than 45 . The active drugs had contrasting effects on heart rate and blood pressure . Fenfluramine caused significant weight reductions relative to both placebo and methylpheni date . These findings suggest that both methylpheni date and fenfluramine have useful , but somewhat different , clinical effects in certain children with attention-deficit hyperactivity disorder and mental retardation",
"BACKGROUND Attention deficit hyperactivity disorder is increased in children with intellectual disability . Previous research has suggested stimulants are less effective than in typically developing children but no studies have titrated medication for individual optimal dosing or tested the effects for longer than 4 weeks . METHOD One hundred and twenty two drug-free children aged 7 - 15 with hyperkinetic disorder and IQ 30 - 69 were recruited to a double-blind , placebo-controlled trial that r and omized participants using minimization by probability , stratified by referral source and IQ level in a one to one ratio . Methylpheni date was compared with placebo . Dose titration comprised at least 1 week each of low ( 0.5 mg/kg/day ) , medium ( 1.0 mg/kg/day ) and high dose ( 1.5 mg/kg/day ) . Parent and teacher Attention deficit hyperactivity disorder ( ADHD ) index of the Conners Rating Scale-Short Version at 16 weeks provided the primary outcome measures . Clinical response was determined with the Clinical Global Impressions scale ( CGI-I ) . Adverse effects were evaluated by a parent-rated question naire , weight , pulse and blood pressure . Analyses were by intention to treat . TRIAL REGISTRATION IS RCT N 68384912 . RESULTS Methylpheni date was superior to placebo with effect sizes of 0.39 [ 95 % confidence intervals ( CIs ) 0.09 , 0.70 ] and 0.52 ( 95 % CIs 0.23 , 0.82 ) for the parent and teacher Conners ADHD index . Four ( 7 % ) children on placebo versus 24 ( 40 % ) of those on methylpheni date were judged improved or much improved on the CGI . IQ and autistic symptoms did not affect treatment efficacy . Active medication was associated with sleep difficulty , loss of appetite and weight loss but there were no significant differences in pulse or blood pressure . CONCLUSIONS Optimal dosing of methylpheni date is practical and effective in some children with hyperkinetic disorder and intellectual disability . Adverse effects typical of methylpheni date were seen and medication use may require close monitoring in this vulnerable group",
"OBJECTIVE This was a double-blind , placebo-controlled , crossover design study of the safety and efficacy of methylpheni date ( MPH ) in 11 preschool children ( aged 4.0 - 5.11 years ) with developmental disabilities and attention-deficit hyperactivity disorder ( ADHD ) . METHOD MPH doses of 0.3 and 0.6 mg/kg per dose and a placebo were given . Drug response was evaluated via teacher-completed behavior checklists and clinic-based observations of activity level , attention , and compliance to adult requests . A side effects checklist was also completed by teachers and parents . RESULTS Significant improvement on teacher ratings of hyperactivity and inattention as well as clinic-based observations of activity level and compliance were associated with MPH . Eight of 11 preschool children were medication responders ( based on a minimum 40 % decrease between placebo and one drug condition on either the teacher-rated Conners Hyperactivity Index or the Hyperactive-Distractible subscale of the Preschool Behavior Question naire ) . Five children exhibited significant adverse drug side effects such as severe social withdrawal , increased crying , and irritability , especially at the higher dose ( 0.6 mg/kg ) . CONCLUSIONS Results suggest that preschool children with developmental disabilities and ADHD respond to MPH at rates similar to those of school-age children with mental retardation and ADHD . However , this population appears to be especially susceptible to adverse drug side effects",
"Attentional deficits and hyperactivity frequently are major problems for fra(X ) boys . This study evaluated the effectiveness of 2 stimulant medications , methylpheni date and dextroamphetamine compared to placebo in 15 children ( 13 males , 2 females ) with the fra(X ) syndrome . A double-blind crossover design was used with outcome measures which included parent and teacher behavior checklists , a controlled observation period , continuous performance tasks and an actometer measure of movement . When the children were treated with methylpheni date only , improvement was seen in socialization skills and attention span according to teacher checklists . Ten children were clinical ly considered responders and treatment was continued after the study was completed",
"Ten children with IQs ranging from 48 to 77 who were living at home and attending special education programs in public schools were involved in an outpatient , double-blind , active drug and placebo cross-over study using methylpheni date . These children were considered to have symptoms of the attention deficit disorder as well as being mentally retarded . Five of the 10 children responded positively to active medication as measured by improvement in the Conners ' rating forms for parents and teachers . We concluded that retarded children with high activity levels and attention disorders are positively affected by stimulant medication but that careful and controlled observational and behavioral assessment is required on an individual basis",
"Stimulant medication efficacy was evaluated in 14 children with attention-deficit hyperactivity disorder and IQs of 48 to 74 in a double-blind crossover study of two methylpheni date doses and placebo . Dependent measures included behavioral ratings , work output , measures of learning , attention and impulsivity , and direct observation of peer social interactions . Nine children ( 64 % ) were methylpheni date -responders , based upon the Conners Hyperactivity Index . Significant gains in on-task behavior and attentional skills were noted with methylpheni date in comparison to placebo . No improvement on measures of learning or social interactions were observed . Results extend and replicate previous research conducted by the authors",
"Twelve children with IQ scores of 50 to 74 ( educable mental retardation ) who met rigorous diagnostic criteria for attention deficit hyperactivity disorder participated in a double-blind crossover study of the efficacy of two doses of methylpheni date compared with placebo . Dependent measures included behavioral ratings , classroom work output , laboratory measures of attention and learning , and direct observations of social behavior . Improvement with medication on the Conners Hyperactivity Index was observed in 75 % of subjects . Significant increases in work output , on-task behavior , and attentional skills were associated with methylpheni date . However , gains in measures of attention were not associated with improvement in learning , as measured by a paired associate learning task . Additionally , no significant increases in appropriate social interactions during free play were associated with methylpheni date . The results suggest that mentally retarded children with attention deficit hyperactivity disorder respond to methylpheni date at similar rates and in similar domains to that of the nonretarded population",
"BACKGROUND The effectiveness of psychostimulants , primarily methylpheni date ( MPH ) , in the treatment of Attention Deficit Hyperactivity Disorder ( ADHD ) in the general population of typically growing children and adolescents is well established through many R and omised Controlled Trials ( RCTs ) . AIMS AND METHODS We carried out a systematic review of all the RCTs in people with intellectual disabilities ( ID ) that assessed effectiveness of MPH on the core ADHD symptoms . OUTCOMES AND RESULTS We included 15 papers from 13 studies that were all on children and adolescents with ID ( 315 participants were on MPH and placebo respectively ) , 12 of which used a cross over design , and one used a parallel design . On average around 40 - 50 % responded to MPH in the ID group whereas around 70 - 80 % response rate is reported among the non-ID children . Because of the heterogeneity of the outcome data it was not possible to carry out a meta- analysis . Significant adverse events included sleep difficulties and poor appetite along with weight loss and also irritability , social withdrawal and increased motor activities including tic . CONCLUSIONS AND IMPLEMENTATION On the basis of the poor quality evidence that is available , it seems that MPH may be effective in some but not all children and adolescents with ID and ADHD"
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41171aae-06ff-11f0-808a-c43d1ab1c353
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Background Food products containing non-nutritive sweeteners ( NNSs ) instead of sugar have become increasingly popular in the last decades . Their appeal is obviously related to their calorie-free sweet taste . However , with the dramatic increase in their consumption , it is reasonable and timely to evaluate their potential health benefits and , more importantly , potential adverse effects . The main aim of this scoping review was to map the evidence about health outcomes possibly associated with regular NNS consumption by examining the extent , range , and nature of research activity in this area . Methods We systematic ally search ed Ovid MEDLINE , EMBASE and the Cochrane CENTRAL data bases for studies on NNSs ( artificial sweeteners or natural , non-caloric sweeteners , either used individually or in combination ) using text terms with appropriate truncation and relevant indexing terms . All human studies investigating any health outcomes of a NNS intervention or exposure were eligible for inclusion . No studies were excluded based on language , study design or method ological quality . Data for each health outcome were summarized in tabular form and were discussed narratively . Results Finally , we included 372 studies in our scoping review , comprising 15 systematic review s , 155 r and omized controlled trials ( RCTs ) , 23 non-r and omized controlled trials , 57 cohort studies , 52 case-control studies , 28 cross sectional studies and 42 case series/case reports . In healthy subjects , appetite and short term food intake , risk of cancer , risk of diabetes , risk of dental caries , weight gain and risk of obesity are the most investigated health outcomes . Overall there is no conclusive evidence for beneficial and harmful effects on those outcomes . Numerous health outcomes including headaches , depression , behavioral and cognitive effects , neurological effects , risk of preterm delivery , cardiovascular effects or risk of chronic kidney disease were investigated in fewer studies and further research is needed . In subjects with diabetes and hypertension , the evidence regarding health outcomes of NNS use is also inconsistent . Conclusions This scoping review identifies the needs for future research to address the numerous evidence gaps related to health effects of NNSs use . It also specifies the research questions and areas where a systematic review with meta-analyses is required for the proper evaluation of health outcomes associated to regular NNSs consumption
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"CONTEXT Caffeine acutely increases blood pressure , but the association between habitual consumption of caffeinated beverages and incident hypertension is uncertain . OBJECTIVE To examine the association between caffeine intake and incident hypertension in women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study conducted in the Nurses ' Health Studies ( NHSs ) I and II of 155,594 US women free from physician-diagnosed hypertension followed up over 12 years ( 1990 - 1991 to 2002 - 2003 question naires ) . Caffeine intake and possible confounders were ascertained from regularly administered question naires . We also tested the associations with types of caffeinated beverages . MAIN OUTCOME MEASURE Incident physician-diagnosed hypertension . RESULTS During follow-up , 19,541 incident cases of physician-diagnosed hypertension were reported in NHS I and 13,536 in NHS II . In both cohorts , no linear association between caffeine consumption and risk of incident hypertension was observed after multivariate adjustment ( NHS I , P for trend = .29 ; NHS II , P for trend = .53 ) . Using categorical analysis , an inverse U-shaped association between caffeine consumption and incident hypertension was found . Compared with participants in the lowest quintile of caffeine consumption , those in the third quintile had a 13 % and 12 % increased risk of hypertension , respectively ( 95 % confidence interval in NHS I , 8%-18 % ; in NHS II , 6%-18 % ) . When study ing individual classes of caffeinated beverages , habitual coffee consumption was not associated with increased risk of hypertension . By contrast , consumption of cola beverages was associated with an increased risk of hypertension , independent of whether it was sugared or diet cola ( P for trend incident hypertension was found . Even though habitual coffee consumption was not associated with an increased risk of hypertension , consumption of sugared or diet cola was associated with it . Further research to eluci date the role of cola beverages in hypertension is warranted",
"BACKGROUND Despite safety reports of the artificial sweetener aspartame , health-related concerns remain . OBJECTIVE We prospect ively evaluated whether the consumption of aspartame- and sugar-containing soda is associated with risk of hematopoetic cancers . DESIGN We repeatedly assessed diet in the Nurses ' Health Study ( NHS ) and Health Professionals Follow-Up Study ( HPFS ) . Over 22 y , we identified 1324 non-Hodgkin lymphomas ( NHLs ) , 285 multiple myelomas , and 339 leukemias . We calculated incidence RRs and 95 % CIs by using Cox proportional hazards models . RESULTS When the 2 cohorts were combined , there was no significant association between soda intake and risks of NHL and multiple myeloma . However , in men , ≥1 daily serving of diet soda increased risks of NHL ( RR : 1.31 ; 95 % CI : 1.01 , 1.72 ) and multiple myeloma ( RR : 2.02 ; 95 % CI : 1.20 , 3.40 ) in comparison with men who did not consume diet soda . We observed no increased risks of NHL and multiple myeloma in women . We also observed an unexpected elevated risk of NHL ( RR : 1.66 ; 95 % CI : 1.10 , 2.51 ) with a higher consumption of regular , sugar-sweetened soda in men but not in women . In contrast , when sexes were analyzed separately with limited power , neither regular nor diet soda increased risk of leukemia but were associated with increased leukemia risk when data for men and women were combined ( RR for consumption of ≥1 serving of diet soda/d when the 2 cohorts were pooled : 1.42 ; 95 % CI : 1.00 , 2.02 ) . CONCLUSION Although our findings preserve the possibility of a detrimental effect of a constituent of diet soda , such as aspartame , on select cancers , the inconsistent sex effects and occurrence of an apparent cancer risk in individuals who consume regular soda do not permit the ruling out of chance as an explanation",
"BACKGROUND It has been extensively shown , mainly in US population s , that sugar-sweetened beverages ( SSBs ) are associated with increased risk of type 2 diabetes ( T2D ) , but less is known about the effects of artificially sweetened beverages ( ASBs ) . OBJECTIVE We evaluated the association between self-reported SSB , ASB , and 100 % fruit juice consumption and T2D risk over 14 y of follow-up in the French prospect i ve Etude Epidémiologique auprès des femmes de la Mutuelle Générale de l'Education Nationale-European Prospect i ve Investigation into Cancer and Nutrition cohort . DESIGN A total of 66,118 women were followed from 1993 , and 1369 incident cases of T2D were diagnosed during the follow-up . Cox regression models were used to estimate HRs and 95 % CIs for T2D risk . RESULTS The average consumption of sweetened beverages in consumers was 328 and 568 mL/wk for SSBs and ASBs , respectively . Compared with nonconsumers , women in the highest quartiles of SSB and ASB consumers were at increased risk of T2D with HRs ( 95 % CIs ) of 1.34 ( 1.05 , 1.71 ) and 2.21 ( 1.56 , 3.14 ) for women who consumed > 359 and > 603 mL/wk of SSBs and ASBs , respectively . Strong positive trends in T2D risk were also observed across quartiles of consumption for both types of beverage ( P = 0.0088 and P BMI , although there was still a strong significant independent effect . No association was observed for 100 % fruit juice consumption . CONCLUSIONS Both SSB consumption and ASB consumption were associated with increased T2D risk . We can not rule out that factors other than ASB consumption that we did not control for are responsible for the association with diabetes , and r and omized trials are required to prove a causal link between ASB consumption and T2D",
"Safety of long-term administration of 75 mg/kg of aspartame per day was evaluated with the use of a r and omized , double-blind , placebo-controlled , parallel-group design in 108 male and female volunteers aged 18 to 62 years . Subjects received either aspartame or placebo in capsule form three times daily for 24 weeks . No persistent changes over time were noted in either group in vital signs ; body weight ; results of st and ard laboratory tests ; fasting blood levels of aspartame 's constituent amino acids ( aspartic acid and phenylalanine ) , other amino acids , and methanol ; or blood formate levels and 24-hour urinary excretion of formate . There also were no statistically significant differences between groups in the number of subjects experiencing symptoms or in the number of symptoms per subject . These results further document the safety of the long-term consumption of aspartame at doses equivalent to the amount of aspartame in approximately 10 L of beverage per day",
"The long-term physiological effects of refined carbohydrates on appetite and mood remain unclear . Reported effects when subjects are not blind may be due to expectations and have rarely been studied for more than 24 h. The present study compared the effects of supplementary soft drinks added to the diet over 4 weeks on dietary intake , mood and BMI in normal-weight women ( n 133 ) . Subjects were categorised as ' watchers ' or ' non-watchers ' of what they ate then received sucrose or artificially sweetened drinks ( 4 x 250 ml per d ) . Expectancies were varied by labelling drinks ' sugar ' or ' diet ' in a counter-balanced design . Sucrose supplements provided 1800 kJ per d and sweetener supplements provided 67 kJ per d. Food intake was measured with a 7 d diary and mood with ten single Likert scales . By 4 weeks , sucrose supplements significantly reduced total carbohydrate intake ( F(1,129 ) = 53.81 ; P fat ( F(2,250 ) = 33.33 ; P protein intake ( F(2,250 ) = 28.04 ; P sweetener supplements . Mean daily energy intake increased by just under 1000 kJ compared with baseline ( t ( 67 df ) = 3.82 ; P sucrose to gain weight . There were no effects on appetite or mood . Neither dietary restraint status as measured by the Dutch Eating Behaviour Question naire nor the expectancy procedure had effects . Expectancies influenced mood only during baseline week . It is concluded that sucrose satiates , rather than stimulates , appetite or negative mood in normal-weight subjects",
"BACKGROUND The consumption of beverages that contain sugar is associated with overweight , possibly because liquid sugars do not lead to a sense of satiety , so the consumption of other foods is not reduced . However , data are lacking to show that the replacement of sugar-containing beverages with noncaloric beverages diminishes weight gain . METHODS We conducted an 18-month trial involving 641 primarily normal-weight children from 4 years 10 months to 11 years 11 months of age . Participants were r and omly assigned to receive 250 ml ( 8 oz ) per day of a sugar-free , artificially sweetened beverage ( sugar-free group ) or a similar sugar-containing beverage that provided 104 kcal ( sugar group ) . Beverages were distributed through schools . At 18 months , 26 % of the children had stopped consuming the beverages ; the data from children who did not complete the study were imputed . RESULTS The z score for the body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) increased on average by 0.02 SD units in the sugar-free group and by 0.15 SD units in the sugar group ; the 95 % confidence interval ( CI ) of the difference was -0.21 to -0.05 . Weight increased by 6.35 kg in the sugar-free group as compared with 7.37 kg in the sugar group ( 95 % CI for the difference , -1.54 to -0.48 ) . The skinfold-thickness measurements , waist-to-height ratio , and fat mass also increased significantly less in the sugar-free group . Adverse events were minor . When we combined measurements at 18 months in 136 children who had discontinued the study with those in 477 children who completed the study , the BMI z score increased by 0.06 SD units in the sugar-free group and by 0.12 SD units in the sugar group ( P=0.06 ) . CONCLUSIONS Masked replacement of sugar-containing beverages with noncaloric beverages reduced weight gain and fat accumulation in normal-weight children . ( Funded by the Netherl and s Organization for Health Research and Development and others ; DRINK Clinical Trials.gov number , NCT00893529 . )",
" We conducted a population -based case-control study of patients with bladder cancer and of controls drawn r and omly from the general population of Metropolitan Nagoya and interviewed both groups . The incidence rates of bladder cancer were 2.42 and 7.05/100,000 for females and males , respectively . The analysis , based on 293 patients and 589 controls who were frequency matched for age , sex , and residence , provided the following major findings . Age-adjusted relative risks of 1.89 ( 1.15 - 3.10 ) and 3.53 ( 1.71 - 7.27 ) were found in male and female cigarette smokers , respectively . Significant relative risk was also found in males who drank cocoa . Elevated risk with a dose-response relationship was observed among women who used hair dye and who smoke , but this risk was insignificant , with the disappearance of a dose-response relationship , when it was adjusted for smoking . Age- and smoking-adjusted relative risk of coffee drinking was insignificant with no dose-response relationship . Relative risk of artificial sweetener use was below 1 with adjustment for age and smoking . Intake of alcoholic beverages and cola was insignificantly associated . Reduced risk of significance was suggested for the intake of black tea and matcha ( powdered green tea ) in females and of fruit juice in males",
"BACKGROUND Increased intake of sugar-sweetened beverages and fruit juice has been associated with overweight in children . OBJECTIVE This study prospect ively assessed beverage consumption patterns and their relationship with weight status in a cohort of children born at different risk for obesity . METHODS AND PROCEDURES Participants were children born at low risk ( n = 27 ) or high risk ( n = 22 ) for obesity based on maternal prepregnancy BMI ( kg/m(2 ) ) . Daily beverage consumption was generated from 3-day food records from children aged 3 - 6 years and coded into seven beverage categories ( milk , fruit juice , fruit drinks , caloric and non-caloric soda , soft drinks including and excluding fruit juice ) . Child anthropometric measures were assessed yearly . RESULTS High-risk children consumed a greater percentage of daily calories from beverages at age 3 , more fruit juice at ages 3 and 4 , more soft drinks ( including fruit juice ) at ages 3 - 5 , and more soda at age 6 compared to low-risk children . Longitudinal analyses showed that a greater 3-year increase in soda intake was associated with an increased change in waist circumference , whereas a greater increase in milk intake was associated with a reduced change in waist circumference . There was no significant association between change in intake from any of the beverage categories and change in BMI z-score across analyses . DISCUSSION Children 's familial predisposition to obesity may differentially affect their beverage consumption patterns . Future research should examine the extent to which dietary factors may play a role in pediatric body fat deposition over time",
"The objective of the study was to compare the modification of fasting blood glucose in adults with diabetes mellitus type 2 after intake of regular soda and diet soda . We conducted a r and omized clinical trial in clinics of Instituto Mexicano del Seguro Social in Querétaro , México . We included 80 patients with diabetes ( mean weight 74.2 + /- 13.66 , BMI 30.5 + /- 4.305 , waist 98.2 + /- 12.9 and time evolution of diabetes 3.8 + /- 3.009 ) who were asked to come with fasting for 8 hours and without taking any medicine before testing . They were divided into two groups of 40 subjects , to whom was measured fasting blood glucose after the ingestion of 200 ml of diet soda ( with aspartame and acesulfame potassium ) or regular soda ( without sweetener ) we measure glucose at 10 , 15 and 30 minutes . For statistical analysis performed we used Student 's t-test for dependent and independent sample s , and paired t-test , and chi square test ( chi2 ) . Capillary glucose levels at 10 minutes were -34.52 and -25.41 % , at 15 minutes -48.8 and -36.2 % and at 30 minutes 57.75 and 43.6 % of absolute and relative differences , with p = 0.000 . In conclusion , according to the observations , diet soda does n't increased blood glucose levels , with a significant difference in fasting decreased at 30 minutes",
"The effects of sugar-sweetened ( SSB ) and non-nutritive sweetened ( NSB ) beverages on the regulation of appetite , energy intake and body weight regulation remain controversial . Using a behavioral choice paradigm , we sought to determine the effects of consuming a SSB or NSB on appetite and the reinforcing value of sweet relative to salty/savory snack foods . In a r and omized crossover study , 21 healthy weight adults consumed 360 ml of SSB ( sucrose ; 31 g ) or NSB ( sucralose ; 4 g ) with a st and ardized meal . Hedonic ratings for the sweet and salty/savory snack foods used for the reinforcement task were assessed prior to the start of the study . Satiety and the desire to eat foods with a specific taste profile were assessed before and every 30 min post-meal for 4 h. The relative reinforcing value of the snack foods was assessed using a computer-based choice task ( operant responding with concurrent schedules of reinforcement ) 4 h post-meal . Hedonic ratings did not differ between the most highly liked sweet and salty/savory snack foods . Beverage type did not influence measures of satiety or the desire to eat foods with a specific taste . However , sweet snacks were more ( p NSB than after a SSB . In conclusion , this is the first study to demonstrate that NSB can increase the motivation to gain access to sweet snacks relative to salty/savory snack foods later in the day",
"Limited evidence exists for an association between maternal diet during pregnancy and offspring bone health . In a prospect i ve study , we examined the association between dietary patterns in mid-pregnancy and offspring forearm fractures . In total , 101,042 pregnancies were recruited to the Danish National Birth Cohort ( DNBC ) during 1996–2002 . Maternal diet was collected by a food frequency question naire . Associations were analyzed between seven dietary patterns extracted by principal component analysis and offspring first occurrence of any forearm fracture diagnosis , extracted from the Danish National Patient Register , between time of birth and end of follow-up ( 53,922 ) . In multivariable Cox regression models , offspring of mothers in the fourth vs. first quintile of the Western pattern had a significant increased risk ( Hazard ratio , 95 % confidence interval : 1.11 , 1.01–1.23 ) of fractures , and there was a borderline significant positive trend ( p = 0.06 ) . The other dietary patterns showed no associations and neither did supplementary analyses of macro- and micronutrients or single food groups , except for the intake of artificially sweetened soft drinks , which was positively associated with offspring forearm fractures ( p = 0.02 ) . In the large prospect i ve DNBC high mid-pregnancy consumption of Western diet and artificially sweetened soft drinks , respectively , indicated positive associations with offspring forearm fractures , which provides interesting hypotheses for future research",
"BACKGROUND Consumption of caffeinated beverages such as coffee and tea has been associated with a lower risk of type 2 diabetes ( T2D ) . Paradoxically , short-term metabolic studies have shown that caffeine impairs postpr and ial glycemic control . OBJECTIVE The objective was to prospect ively examine the association of caffeinated compared with caffeine-free beverages , including coffee , tea , sugar-sweetened beverages ( SSBs ) , and carbonated artificially sweetened beverages ( ASBs ) , with T2D risk . DESIGN We prospect ively observed 74,749 women from the Nurses ' Health Study ( NHS , 1984 - 2008 ) and 39,059 men from the Health Professionals Follow-Up Study ( HPFS , 1986 - 2008 ) who were free of diabetes , cardiovascular diseases , and cancer at baseline . RESULTS We documented 7370 incident cases of T2D during 24 y of follow-up in the NHS and 2865 new cases during 22 y of follow-up in the HPFS . After major lifestyle and dietary risk factors were controlled for , caffeinated and caffeine-free SSB intake was significantly associated with a higher risk of T2D in the NHS ( RR per serving : 13 % for caffeinated SSBs , 11 % for caffeine-free SSBs ; P caffeine-free ASB intake in NHS participants was associated with a higher risk of T2D ( RR : 6 % per serving ; P caffeinated and decaffeinated coffee was associated with a lower risk of T2D [ RR per serving : 8 % for both caffeinated and decaffeinated coffee in the NHS ( P decaffeinated coffee in the HPFS ( P caffeinated tea was associated with a lower T2D risk among NHS participants ( RR per serving : 5 % ; P SSB intake was associated with a higher risk of T2D , and coffee intake was associated with a lower risk of T2D",
"BACKGROUND Sugar-sweetened soft drinks have been linked to a number of adverse health outcomes such as high weight gain . Therefore , artificially sweetened soft drinks are often promoted as an alternative . However , the safety of artificial sweeteners has been disputed , and consequences of high intakes of artificial sweeteners for pregnant women have been minimally addressed . OBJECTIVE We examined the association between intakes of sugar-sweetened and artificially sweetened soft drinks and preterm delivery . DESIGN We conducted prospect i ve cohort analyses of 59,334 women from the Danish National Birth Cohort ( 1996 - 2002 ) . Soft drink intake was assessed in midpregnancy by using a food-frequency question naire . Preterm delivery ( lt 37 wk ) was the primary outcome measure . Covariate information was assessed by telephone interviews . RESULTS There was an association between intake of artificially sweetened carbonated and noncarbonated soft drinks and an increased risk of preterm delivery ( P for trend : le 0.001 , both variables ) . In comparison with women with no intake of artificially sweetened carbonated soft drinks , the adjusted odds ratio for women who consumed ge 1 serving of artificially sweetened carbonated soft drinks/d was 1.38 ( 95 % CI : 1.15 , 1.65 ) . The corresponding odds ratio for women who consumed ge 4 servings of artificially sweetened carbonated soft drinks/d was 1.78 ( 95 % CI : 1.19 , 2.66 ) . The association was observed for normal-weight and overweight women . A stronger increase in risk was observed for early preterm and moderately preterm delivery than with late-preterm delivery . No association was observed for sugar-sweetened carbonated soft drinks ( P for trend : 0.29 ) or for sugar-sweetened noncarbonated soft drinks ( P for trend : 0.93 ) . CONCLUSIONS Daily intake of artificially sweetened soft drinks may increase the risk of preterm delivery . Further studies are needed to reject or confirm these findings",
"BACKGROUND Artificially sweetened ( AS ) and sugar-sweetened ( SS ) beverages are commonly consumed during pregnancy . A recent Danish study reported that the daily intake of an AS beverage was associated with an increased risk of preterm delivery . OBJECTIVE We examined the intake of AS and SS beverages in pregnant women to replicate the Danish study and observe whether AS intake is indeed associated with preterm delivery . DESIGN This was a prospect i ve study of 60,761 pregnant women in the Norwegian Mother and Child Cohort Study . Intakes of carbonated and noncarbonated AS and SS beverages and use of artificial sweeteners in hot drinks were assessed by a self-reported food-frequency question naire in midpregnancy . Preterm delivery was the primary outcome , and data were obtained from the Norwegian Medical Birth Registry . RESULTS Intakes of both AS and SS beverages increased with increasing BMI and energy intake and were higher in women with less education , in daily smokers , and in single women . A high intake of AS beverages was associated with preterm delivery ; the adjusted OR for those drinking > 1 serving/d was 1.11 ( 95 % CI : 1.00 , 1.24 ) . Drinking > 1 serving of SS beverages per day was also associated with an increased risk of preterm delivery ( adjusted OR : 1.25 ; 95 % CI : 1.08 , 1.45 ) . The trend tests were positive for both beverage types . CONCLUSION This study suggests that a high intake of both AS and SS beverages is associated with an increased risk of preterm delivery",
"Background : Substituting sweeteners with non-nutritive sweeteners ( NNS ) may aid in glycaemic control and body weight management . Limited studies have investigated energy compensation , glycaemic and insulinaemic responses to artificial and natural NNS . Objectives : This study compared the effects of consuming NNS ( artificial versus natural ) and sucrose ( 65 g ) on energy intake , blood glucose and insulin responses . Methods : Thirty healthy male subjects took part in this r and omised , crossover study with four treatments : aspartame- , monk fruit- , stevia- and sucrose-sweetened beverages . On each test day , participants were asked to consume a st and ardised breakfast in the morning , and they were provided with test beverage as a preload in mid-morning and ad libitum lunch was provided an hour after test beverage consumption . Blood glucose and insulin concentrations were measured every 15 min within the first hour of preload consumption and every 30 min for the subsequent 2 h. Participants left the study site 3 h after preload consumption and completed a food diary for the rest of the day . Results : Ad libitum lunch intake was significantly higher for the NNS treatments compared with sucrose ( P=0.010 ) . The energy ' saved ' from replacing sucrose with NNS was fully compensated for at subsequent meals ; hence , no difference in total daily energy intake was found between the treatments ( P=0.831 ) . The sucrose-sweetened beverage led to large spikes in blood glucose and insulin responses within the first hour , whereas these responses were higher for all three NNS beverages following the test lunch . Thus , there were no differences in total area under the curve ( AUC ) for glucose ( P=0.960 ) and insulin ( P=0.216 ) over 3 h between the four test beverages . Conclusions : The consumption of calorie-free beverages sweetened with artificial and natural NNS have minimal influences on total daily energy intake , postpr and ial glucose and insulin compared with a sucrose-sweetened beverage",
"To examine whether artificial sweeteners aid in the control of long-term food intake and body weight , we gave free-living , normal-weight subjects 1150 g soda sweetened with aspartame ( APM ) or high-fructose corn syrup ( HFCS ) per day . Relative to when no soda was given , drinking APM-sweetened soda for 3 wk significantly reduced calorie intake of both females ( n = 9 ) and males ( n = 21 ) and decreased the body weight of males but not of females . However , drinking HFCS-sweetened soda for 3 wk significantly increased the calorie intake and body weight of both sexes . Ingesting either type of soda reduced intake of sugar from the diet without affecting intake of other nutrients . Drinking large volumes of APM-sweetened soda , in contrast to drinking HFCS-sweetened soda , reduces sugar intake and thus may facilitate the control of calorie intake and body weight",
"This study investigated whether the addition of the high-intensity sweetener aspartame to a multidisciplinary weight-control program would improve weight loss and long-term control of body weight . One hundred sixty-three obese women were r and omly assigned to consume or to abstain from aspartame-sweetened foods and beverages during 16 wk of a 19-wk weight-reduction program ( active weight loss ) , a 1-y maintenance program , and a 2-y follow-up period . Women in both treatment groups lost approximately 10 % of initial body weight ( 10 kg ) during active weight loss . Among women assigned to the aspartame-treatment group , aspartame intake was positively correlated with percentage weight loss during active weight loss ( r = 0.32 , P regain of initial body weight after 71 and 175 wk , respectively , whereas those in the no-aspartame group gained an average of 5.4 % ( 5.4 kg ) and 9.4 % ( 9.4 kg ) , respectively . The aspartame group lost significantly more weight overall ( P = 0.028 ) and regained significantly less weight during maintenance and follow-up ( P = 0.046 ) than did the no-aspartame group . Percentage weight losses at 71 and 175 wk were also positively correlated with exercise ( r = 0.32 , P eating control ( r = 0.37 , P aspartame may facilitate the long-term maintenance of reduced body weight",
"Using a within-subjects design , we gave over-weight and normal-weight subjects a 500-mL drink of fructose , glucose , or aspartame diluted in lemon-flavored water or plain water in a r and omized fashion at about weekly intervals . Food intake was assessed at a buffet lunch that began 38 min after the preload was completed . Blood was drawn throughout and assayed for concentrations of glucose , insulin , glucagon , and free fatty acid . When subjects drank the fructose preload , they subsequently ate fewer overall calories and fewer grams of fat than when they drank any of the other preloads . The aspartame load did not stimulate intake beyond the plain-water control . The effects of the oxidation of fructose as a possible mechanism for the reduction in food intake is discussed . The effects of insulin in stimulating intake are also discussed",
"This study evaluated the feasibility of a home-based intervention to reduce sugar-sweetened beverage intake and television viewing among children . Lower income parents of overweight children aged 5 - 12 years ( n = 40 ) were r and omized to a home environment intervention to reduce television viewing with locking devices and displace availability of sugar-sweetened beverages with home delivery of non-caloric beverages ( n = 25 ) , or to a no-intervention control group ( n = 15 ) for 6 months . Data were collected at baseline and 6 months . After 6 months , television viewing hours per day was significantly lower in the intervention group compared with the control group ( 1.7 [ SE = .02 ] vs. 2.6 [ SE = .25 ] hours/day , respectively , P Sugar-sweetened beverage intake was marginally significantly lower among intervention group compared to control group children ( 0.21 [ SE = .09 ] vs. 0.45 [ SE = .10 ] , respectively , P Body mass index ( BMI ) z-score was not significantly lower among intervention compared to control children . Among a lower income sample of children , a home-based intervention reduced television viewing , but not sugar-sweetened beverage intake or BMI z-score",
"BACKGROUND Previous studies have linked full-calorie sugar-sweetened beverages ( SSBs ) with greater weight gain and an increased risk of type 2 diabetes . OBJECTIVE We prospect ively examined the association between consumption of SSBs and the risk of coronary heart disease ( CHD ) in women . DESIGN Women ( n = 88,520 ) from the Nurses ' Health Study aged 34 - 59 y , without previously diagnosed coronary heart disease ( CHD ) , stroke , or diabetes in 1980 , were followed from 1980 to 2004 . Consumption of SSBs was derived from 7 repeated food-frequency question naires administered between 1980 and 2002 . Relative risks ( RRs ) for CHD were calculated by using Cox proportional hazards models and adjusted for known cardiovascular disease risk factors . RESULTS During 24 y of follow-up , we ascertained 3105 incident cases of CHD ( nonfatal myocardial infa rct ion and fatal CHD ) . After st and ard and dietary risk factors were adjusted for , the RRs ( and 95 % CIs ) of CHD according to categories of cumulative average of SSB consumption ( or = 2 servings/d ) were 1.0 , 0.96 ( 0.87 , 1.06 ) , 1.04 ( 0.95 , 1.14 ) , 1.23 ( 1.06 , 1.43 ) , and 1.35 ( 1.07 , 1.69 ) ( P for trend Artificially sweetened beverages were not associated with CHD . CONCLUSION Regular consumption of SSBs is associated with a higher risk of CHD in women , even after other unhealthful lifestyle or dietary factors are accounted for",
"OBJECTIVES To examine the relationship between diet soda ( DS ) intake ( DSI ) and long-term waist circumference ( WC ) change ( ΔWC ) in the biethnic San Antonio Longitudinal Study of Aging ( SALSA ) . DESIGN Prospect i ve cohort study . SETTING San Antonio , Texas , neighborhoods . PARTICIPANTS SALSA examined 749 Mexican-American and European-American individuals aged 65 and older at baseline ( baseline , 1992 - 96 ) ; 474 ( 79.1 % ) survivors completed follow-up 1 ( FU1 , 2000 - 01 ) , 413 ( 73.4 % ) completed FU2 ( 2001 - 03 ) , and 375 ( 71.0 % ) completed FU3 ( 2003 - 04 ) . Participants completed a mean of 2.64 follow-up intervals , for 9.4 total follow-up years . MEASUREMENTS DSI , WC , height , and weight were measured at outset and at the conclusion of each interval : baseline , FU1 , FU2 , and FU3 . RESULTS Adjusted for initial WC , demographic characteristics , physical activity , diabetes mellitus , and smoking , mean interval ΔWC of DS users ( 2.11 cm , 95 % confidence interval ( CI ) = 1.45 - 2.76 cm ) was almost triple that of nonusers ( 0.77 cm , 95 % CI = 0.29 - 1.23 cm ) ( P .001 ) . Adjusted interval ΔWCs were 0.77 cm ( 95 % CI = 0.29 - 1.23 cm ) for nonusers , 1.76 cm ( 95 % CI = 0.96 - 2.57 cm ) for occasional users , and 3.04 cm ( 95 % CI = 1.82 - 4.26 cm ) for daily users ( P = .002 for trend ) . This translates to ΔWCs of 0.80 inches for nonusers , 1.83 inches for occasional users , and 3.16 for daily users over the total SALSA follow-up . In subanalyses stratified for selected covariates , ΔWC point estimates were consistently higher in DS users . CONCLUSION In a striking dose-response relationship , increasing DSI was associated with escalating abdominal obesity , a potential pathway for cardiometabolic risk in this aging population",
"BACKGROUND Consumption of liquid calories from beverages has increased in parallel with the obesity epidemic in the US population , but their causal relation remains unclear . OBJECTIVE The objective of this study was to examine how changes in beverage consumption affect weight change among adults . DESIGN This was a prospect i ve study of 810 adults participating in the PREMIER trial , an 18-mo r and omized , controlled , behavioral intervention trial . Measurements ( weight , height , and 24-h dietary recall ) were made at baseline , 6 mo , and 18 mo . RESULTS Baseline mean intake of liquid calories was 356 kcal/d ( 19 % of total energy intake ) . After potential confounders and intervention assignment were controlled for , a reduction in liquid calorie intake of 100 kcal/d was associated with a weight loss of 0.25 kg ( 95 % CI : 0.11 , 0.39 ; P liquid calorie intake had a stronger effect than did a reduction in solid calorie intake on weight loss . Of the individual beverages , only intake of sugar-sweetened beverages ( SSBs ) was significantly associated with weight change . A reduction in SSB intake of 1 serving/d was associated with a weight loss of 0.49 kg ( 95 % CI : 0.11 , 0.82 ; P = 0.006 ) at 6 mo and of 0.65 kg ( 95 % CI : 0.22 , 1.09 ; P = 0.003 ) at 18 mo . CONCLUSIONS These data support recommendations to limit liquid calorie intake among adults and to reduce SSB consumption as a means to accomplish weight loss or avoid excess weight gain . This trial was registered at clinical trials.gov as NCT00000616",
"The food and beverage industry has been increasingly replacing sugar with non-nutritive sweeteners in their sweetened products to control or reduce total calories . Research comparing the effect of nutritive and non-nutritive sweeteners on emotional state of participants exposed to acute stressors is still limited . This study aim ed to determine the effect of drinking tea sweetened with either a nutritive sweetener ( sugar ) or a non-nutritive sweetener ( sucralose or stevia ) on emotional state , in terms of calmness and pleasantness , of participants exposed to an acute stressor . Effects of acute stress on sweetness intensity and overall liking of tea beverages were also determined . Results showed that the possibility of tea-induced calmness , calculated as the difference between calmness ratings after and before drinking a tea sample , was established on stress session in the sugar-sweetened tea . Overall liking , but not the sweetness intensity , of the sugar-sweetened tea was affected by acute stress . In conclusion , this study provides empirical evidence that the consumption of tea sweetened with nutritive sweetener , but not with non-nutritive sweetener , has calming effect on consumers with acute stress , suggesting that this effect may not be due to the sweet taste of sugar , but due to the caloric nature of the sweetener",
"Weight change over a 1-year period was examined in a highly homogeneous group of 78,694 women ages 50 - 69 enrolled in a prospect i ve mortality study . Artificial sweetener usage increased with relative weight and decreased with age . Users were significantly more likely than nonusers to gain weight , regardless of initial weight . Average weight gains or losses by artificial sweetener users differed by less than 2 pounds from gains or losses among nonusers . These results were not explicable by differences in food consumption patterns . The data do not support the hypothesis that long-term artificial sweetener use either helps weight loss or prevents weight gain",
"Objective : The objective of this study was to evaluate and compare the efficacy of combined sucrose and non-nutritive sucking ( NNS ) for analgesia in newborn infants undergoing heel-stick procedures . Study Design : This r and omized control trial was conducted in the neonatal intensive care unit of a tertiary care hospital over a period of 1 year . One hundred and eighty full-term neonates with birth weight > 2200 g and age > 24 h were r and omized to one of four interventions administered 2 min before the procedure : 2 ml of 30 % sucrose ( group I , n=45 ) or NNS ( group II , n=45 ) or both ( group III , n=45 ) or none ( group IV , n=45 ) . Primary outcome was composite score based on Premature Infant Pain Profile ( PIPP ) score . Result : Baseline variables were comparable among the groups . Median ( interquartile range ) PIPP score was 3 ( 2 to 4 ) in group III as compared with 7 ( 6.5 to 8) in group I , 9 ( 7 to 11 ) in group II and 13 ( 10.5 to 15 ) in group IV . Group III had significant decrease in the median PIPP score compared with other groups ( P=0.000 ) . Median PIPP score also decreased significantly with any intervention as compared with no intervention ( P=0.000 ) . Conclusion : Sucrose and /or NNS are effective in providing analgesia in full-term neonates undergoing heel-stick procedures , with the combined intervention being more effective compared with any single intervention",
"OBJECTIVE : To examine the long-term relationship between changes in water and beverage intake and weight change . SUBJECTS : Prospect i ve cohort studies of 50 013 women aged 40–64 years in the Nurses ’ Health Study ( NHS , 1986–2006 ) , 52 987 women aged 27–44 years in the NHS II ( 1991–2007 ) and 21 988 men aged 40–64 years in the Health Professionals Follow-up Study ( 1986–2006 ) without obesity and chronic diseases at baseline . MEASURES : We assessed the association of weight change within each 4-year interval , with changes in beverage intakes and other lifestyle behaviors during the same period . Multivariate linear regression with robust variance and accounting for within-person repeated measures were used to evaluate the association . Results across the three cohorts were pooled by an inverse-variance-weighted meta- analysis . RESULTS : Participants gained an average of 1.45 kg ( 5th to 95th percentile : −1.87 to 5.46 ) within each 4-year period . After controlling for age , baseline body mass index and changes in other lifestyle behaviors ( diet , smoking habits , exercise , alcohol , sleep duration , TV watching ) , each 1 cup per day increment of water intake was inversely associated with weight gain within each 4-year period ( −0.13 kg ; 95 % confidence interval ( CI ) : −0.17 to −0.08 ) . The associations for other beverages were : sugar-sweetened beverages ( SSBs ) ( 0.36 kg ; 95 % CI : 0.24–0.48 ) , fruit juice ( 0.22 kg ; 95 % CI : 0.15–0.28 ) , coffee ( −0.14 kg ; 95 % CI : −0.19 to −0.09 ) , tea ( −0.03 kg ; 95 % CI : −0.05 to −0.01 ) , diet beverages ( −0.10 kg ; 95 % CI : −0.14 to −0.06 ) , low-fat milk ( 0.02 kg ; 95 % CI : −0.04 to 0.09 ) and whole milk ( 0.02 kg ; 95 % CI : −0.06 to 0.10 ) . We estimated that replacement of 1 serving per day of SSBs by 1 cup per day of water was associated with 0.49 kg ( 95 % CI : 0.32–0.65 ) less weight gain over each 4-year period , and the replacement estimate of fruit juices by water was 0.35 kg ( 95 % CI : 0.23–0.46 ) . Substitution of SSBs or fruit juices by other beverages ( coffee , tea , diet beverages , low-fat and whole milk ) were all significantly and inversely associated with weight gain . CONCLUSION : Our results suggest that increasing water intake in place of SSBs or fruit juices is associated with lower long-term weight gain",
"Background Non-nutritive sweeteners ( NNS ) , especially in form of diet soda , have been linked to metabolic derangements ( e.g. obesity and diabetes ) in epidemiologic studies . We aim ed to test acute metabolic effects of NNS in isolation ( water or seltzer ) and in diet sodas . Methods We conducted a four-period , cross-over study at the National Institutes of Health Clinical Center ( Bethesda , Maryl and ) . Thirty healthy adults consumed 355 mL water with 0 mg , 68 mg , 170 mg , and 250 mg sucralose , and 31 individuals consumed 355 mL caffeine-free Diet Rite Cola ™ , Diet Mountain Dew ™ ( 18 mg sucralose , 18 mg acesulfame-potassium , 57 mg aspartame ) , and seltzer water with NNS ( 68 mg sucralose and 41 mg acesulfame-potassium , equivalent to Diet Rite Cola ™ ) in r and omized order , prior to oral glucose tolerance tests . Blood sample s were collected serially for 130 min . Measures included GLP-1 , GIP , glucose , insulin , C-peptide , glucose absorption , gastric emptying , and subjective hunger and satiety ratings . Results Diet sodas augmented active GLP-1 ( Diet Rite Cola ™ vs. seltzer water , AUC , p = 0.039 ; Diet Mountain Dew ™ vs. seltzer water , AUC , p = 0.07 ) , but gastric emptying and satiety were unaffected . Insulin concentrations were nominally higher following all NNS conditions without altering glycemia . Sucralose alone ( at any concentration ) did not affect metabolic outcomes . Conclusions Diet sodas but not NNS in water augmented GLP-1 responses to oral glucose . Whether the trends toward higher insulin concentrations after NNS are of clinical importance remains to be determined . Our findings emphasize the need to test metabolic effects of NNS after chronic consumption . Trial registration The data for this manuscript were gathered from clinical trial # NCT01200940",
"To examine whether ingestion of aspartame is associated with headaches , we conducted a double-blind crossover study using volunteers with self-identified headaches after using aspartame . Of the 32 subjects r and omized to receive aspartame ( approximately 30 mg/kg/d ) and placebo in a two-treatment , four-period crossover design , 18 completed the full protocol , seven completed part of the protocol before withdrawing due to adverse effects , three withdrew for other reasons , two were lost to follow-up , one was withdrawn due to noncompliance , and one withdrew and gave no reason . Each experimental period was 7 days long . Subjects reported headaches on 33 % of the days during aspartame treatment , compared with 24 % on placebo treatment ( p = 0.04 ) . Subjects who were “ very sure ” prior to the study that aspartame triggered some of their headaches reported larger treatment differences ( aspartame = 0.37 headache-days , placebo = 0.18 headache-days ; p ( aspartame = 0.29 headache-days , placebo = 0.22 headache-days ; p = 0.51 ) or \" not sure \" ( aspartame = 0.33 headache-days , placebo = 0.39 headache-days ; p = 0.51 ) . There was no significant treatment difference in the length or intensity of headaches or in the occurrence of side effects associated with the headaches . This experiment provides evidence that , among individuals with self-reported headaches after ingestion of aspartame , a subset of this group report more headaches when tested under controlled conditions . It appears that some people are particularly susceptible to headaches caused by aspartame and may want to limit their consumption",
"BACKGROUND The consumption of sucrose-sweetened soft drinks ( SSSDs ) has been associated with obesity , the metabolic syndrome , and cardiovascular disorders in observational and short-term intervention studies . Too few long-term intervention studies in humans have examined the effects of soft drinks . OBJECTIVE We compared the effects of SSSDs with those of isocaloric milk and a noncaloric soft drink on changes in total fat mass and ectopic fat deposition ( in liver and muscle tissue ) . DESIGN Overweight subjects ( n = 47 ) were r and omly assigned to 4 different test drinks ( 1 L/d for 6 mo ) : SSSD ( regular cola ) , isocaloric semiskim milk , aspartame-sweetened diet cola , and water . The amount of intrahepatic fat and intramyocellular fat was measured with (1)H-magnetic resonance spectroscopy . Other endpoints were fat mass , fat distribution ( dual-energy X-ray absorptiometry and magnetic resonance imaging ) , and metabolic risk factors . RESULTS The relative changes between baseline and the end of 6-mo intervention were significantly higher in the regular cola group than in the 3 other groups for liver fat ( 132 - 143 % , sex-adjusted mean ; P skeletal muscle fat ( 117 - 221 % ; P visceral fat ( 24 - 31 % ; P blood triglycerides ( 32 % ; P total cholesterol ( 11 % ; P Total fat mass was not significantly different between the 4 beverage groups . Milk and diet cola reduced systolic blood pressure by 10 - 15 % compared with regular cola ( P diet cola had effects similar to those of water . CONCLUSION Daily intake of SSSDs for 6 mo increases ectopic fat accumulation and lipids compared with milk , diet cola , and water . Thus , daily intake of SSSDs is likely to enhance the risk of cardiovascular and metabolic diseases . This trial is registered at clinical trials.gov as NCT00777647",
"Sweetened beverages , coffee , and tea are the most consumed non-alcoholic beverages and may have important health consequences . We prospect ively evaluated the consumption of various types of beverages assessed in 1995–1996 in relation to self-reported depression diagnosis after 2000 among 263,923 participants of the NIH-AARP Diet and Health Study . Odds ratios ( OR ) and 95 % confidence intervals ( CI ) were derived from multivariate logistic regressions . The OR ( 95 % CI ) comparing ≥4 cans/cups per day with none were 1.30 ( 95%CI : 1.17–1.44 ) for soft drinks , 1.38 ( 1.15–1.65 ) for fruit drinks , and 0.91 ( 0.84–0.98 ) for coffee ( all P for trend iced-tea and hot tea . In stratified analyses by drinkers of primarily diet versus regular beverages , the ORs were 1.31 ( 1.16–1.47 ) for diet versus 1.22 ( 1.03–1.45 ) for regular soft drinks , 1.51 ( 1.18–1.92 ) for diet versus 1.08 ( 0.79–1.46 ) for regular fruit drinks , and 1.25 ( 1.10–1.41 ) for diet versus 0.94 ( 0.83–1.08 ) for regular sweetened iced-tea . Finally , compared to nondrinkers , drinking coffee or tea without any sweetener was associated with a lower risk for depression , adding artificial sweeteners , but not sugar or honey , was associated with higher risks . Frequent consumption of sweetened beverages , especially diet drinks , may increase depression risk among older adults , whereas coffee consumption may lower the risk",
"BACKGROUND There is a lack of appetite studies in free-living subjects supplying the habitual diet with either sucrose or artificially sweetened beverages and foods . Furthermore , the focus of artificial sweeteners has only been on the energy intake ( EI ) side of the energy-balance equation . The data are from a subgroup from a 10-wk study , which was previously published . OBJECTIVE The objective was to investigate changes in EI and energy expenditure ( EE ) as possible reasons for the changes in body weight during 10 wk of supplementation of either sucrose or artificial sweeteners in overweight subjects . DESIGN Supplements of sucrose-sweetened beverages and foods ( 2 g/kg body weight ; n = 12 ) or similar amounts containing artificial sweeteners ( n = 10 ) were given single-blind in a 10-wk parallel design . Beverages accounted for 80 % and solid foods for 20 % by weight of the supplements . The rest of the diet was free choice . Indirect 24-h whole-body calorimetry was performed at weeks 0 and 10 . At week 0 the diet was a weight-maintaining st and ardized diet . At week 10 the diet consisted of the supplements and ad libitum choice of foods . Visual analog scales were used to record appetite . RESULTS Body weight increased in the sucrose group and decreased in the sweetener group during the intervention . The sucrose group had a 3.3-MJ higher EI but felt less full and had higher ratings of prospect i ve food consumption than did the sweetener group at week 10 . Basal metabolic rate was increased in the sucrose group , whereas 24-h EE was increased in both groups at week 10 . Energy balance in the sucrose group was more positive than in the sweetener group at the stay at week 10 . CONCLUSION The changes in body weight in the 2 groups during the 10-wk intervention seem to be attributable to changes in EI rather than to changes in EE",
"Television viewing ( TVV ) is considered a contributing factor to the development of childhood obesity yet it is unclear whether obesity results , in part , from increased energy intake during TVV . The objective of this study was to determine the effect of TVV on food intake ( FI ) of boys at a meal and its effect on caloric compensation at the test meal after a premeal glucose drink . On four separate mornings and in r and om order , boys received equally sweetened preloads containing Splenda sucralose or glucose [ 1.0 g/kg body weight ( BW ) ] in 250 mL of water 2 h after a st and ard breakfast . Food intake from a pizza meal was measured 30 min later with or without TVV . Both preload treatment ( p FI ( kcal ) . TVV increased lunchtime FI by an average of 228 kcal . Glucose suppressed FI in the no TVV condition compared with control , but the effect was not statistically significant during TVV . Body composition and subjective appetite scores were positively associated with FI at the test lunch . In conclusion , TVV while eating a meal contributes to increased energy intake by delaying normal mealtime satiation and reducing satiety signals from previously consumed foods",
"Purpose Consumption of sugar-reformulated products ( commercially available foods and beverages that have been reduced in sugar content through reformulation ) is a potential strategy for lowering sugar intake at a population level . The impact of sugar-reformulated products on body weight , energy balance ( EB ) dynamics and cardiovascular disease risk indicators has yet to be established . The REFORMulated foods ( REFORM ) study examined the impact of an 8-week sugar-reformulated product exchange on body weight , EB dynamics , blood pressure , arterial stiffness , glycemia and lipemia . Methods A r and omized , controlled , double-blind , crossover dietary intervention study was performed with fifty healthy normal to overweight men and women ( age 32.0 ± 9.8 year , BMI 23.5 ± 3.0 kg/m2 ) who were r and omly assigned to consume either regular sugar or sugar-reduced foods and beverages for 8 weeks , separated by 4-week washout period . Body weight , energy intake ( EI ) , energy expenditure and vascular markers were assessed at baseline and after both interventions . Results We found that carbohydrate ( P total sugars ( P extrinsic sugars ( P 0.001 ) ( % EI ) were lower , whereas fat ( P = 0.001 ) and protein ( P = 0.038 ) intakes ( % EI ) were higher on the sugar-reduced than the regular diet . No effects on body weight , blood pressure , arterial stiffness , fasting glycemia or lipemia were observed . Conclusions Consumption of sugar-reduced products , as part of a blinded dietary exchange for an 8-week period , result ed in a significant reduction in sugar intake . Body weight did not change significantly , which we propose was due to energy compensation",
"CONTEXT Sugar-sweetened beverages like soft drinks and fruit punches contain large amounts of readily absorbable sugars and may contribute to weight gain and an increased risk of type 2 diabetes , but these relationships have been minimally addressed in adults . OBJECTIVE To examine the association between consumption of sugar-sweetened beverages and weight change and risk of type 2 diabetes in women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort analyses conducted from 1991 to 1999 among women in the Nurses ' Health Study II . The diabetes analysis included 91,249 women free of diabetes and other major chronic diseases at baseline in 1991 . The weight change analysis included 51,603 women for whom complete dietary information and body weight were ascertained in 1991 , 1995 , and 1999 . We identified 741 incident cases of confirmed type 2 diabetes during 716,300 person-years of follow-up . MAIN OUTCOME MEASURES Weight gain and incidence of type 2 diabetes . RESULTS Those with stable consumption patterns had no difference in weight gain , but weight gain over a 4-year period was highest among women who increased their sugar-sweetened soft drink consumption from 1 or fewer drinks per week to 1 or more drinks per day ( multivariate-adjusted means , 4.69 kg for 1991 to 1995 and 4.20 kg for 1995 to 1999 ) and was smallest among women who decreased their intake ( 1.34 and 0.15 kg for the 2 periods , respectively ) after adjusting for lifestyle and dietary confounders . Increased consumption of fruit punch was also associated with greater weight gain compared with decreased consumption . After adjustment for potential confounders , women consuming 1 or more sugar-sweetened soft drinks per day had a relative risk [ RR ] of type 2 diabetes of 1.83 ( 95 % confidence interval [ CI ] , 1.42 - 2.36 ; P fruit punch was associated with increased diabetes risk ( RR for > or = 1 drink per day compared with sugar-sweetened beverages is associated with a greater magnitude of weight gain and an increased risk for development of type 2 diabetes in women , possibly by providing excessive calories and large amounts of rapidly absorbable sugars",
"Aspartame administered in capsules ( i.e. , without tasting ) 1 h before a meal significantly reduces the amount eaten in that meal . In the present study 36 young men and women were divided into 3 groups of 12 to receive aspartame ( 400 mg ) or placebo ( 400 mg starch ) on separate occasions either 5 min ( Group A ) , 30 min ( Group B ) or 60 min ( Group C ) before beginning an ad lib test meal . Compared with placebo , aspartame reduced food intake in Group C ( by 18.5 % , p aspartame on premeal ratings of hunger , desire to eat or fullness for any of the groups . These results confirm a postingestive inhibitory action of aspartame on appetite , which may involve the amplification of the satiating effects of food . The lack of effect of aspartame administered at the shorter intervals before eating suggests a postgastric or even postabsorptive mechanism of action . This observation is also important in its implication s for the possible therapeutic exploitation of the anorexic effect of capsulated aspartame",
"OBJECTIVE : Dietary factors , independent of total energy , may be important in promoting obesity . We examined prospect ively the relationship between baseline diet composition and weight gain among adult men and women from southeastern New Engl and . DESIGN : The prospect i ve association of nutrient consumption and weight change was examined in a r and omly selected cohort examined four years apart . SUBJECTS : Adults aged 18 through 64 years from two communities in Southeastern New Engl and were r and omly selected for the study after being interviewed in their homes . The present investigation is based on a subgroup of 465 individuals who completed a food-frequency question naire in 1986 or 1987 and were reinterviewed four years later . STATISTICAL ANALYSES : Multiple regression analyses were used to determine the association of weight change with different nutrients and food groups after adjusting for age , smoking status , baseline body mass index , physical activity level , and total energy . RESULTS : Total energy was positively associated with weight gain and age was inversely associated with weight gain . None of the nutrients or food groups were significantly related to weight gain . CONCLUSIONS : These findings indicate that weight gain increased with increasing baseline total energy intake , particularly in the young . Future research is required to determine ways of decreasing energy intake in younger individuals",
"PURPOSE To compare the effect on in vivo plaque pH of rinsing with an aqueous solution of sucralose ( alone or in combination with maltodextrin or maltodextrin and dextrose ) to the effect of rinsing with an aqueous solution of sucrose . MATERIAL S AND METHODS Each solution ( four in total ) had a sweetness equivalent to two teaspoons of sucrose in 6 oz . of water . The four test solutions were administered r and omly over four test visits ( one solution per visit ) to 10 subjects presenting 2-day resting plaque . Before , and at specified time intervals over 60 minutes following the rinse , in vivo plaque pH was monitored at six design ated sites using a Beckman 3500 digital pH meter . Data were analyzed by ANOVA . RESULTS The mean pH minimum for the sucralose rinse ( 6.56 ) was significantly higher than the sucralose/maltodextrin ( SM ) , sucralose/maltodextrin/dextrose ( SMD ) , and sucrose rinses ( 6.15 , 5.84 , and 5.29 , respectively ) . The mean delta pH ( difference between resting and minimum pH ) for the sucralose rinse ( 0.45 ) was significantly lower when compared to the SM ( 0.79 ) , SMD ( 1.14 ) , and sucrose ( 1.69 ) rinses . The differences seen in mean pH minimum and mean delta pH for the SM and SMD groups vs. the sucrose group were also statistically significant . Mean areas under the pH vs. time curve for the sucralose , SM and SMD rinses were all significantly less compared to the sucrose rinse . Rinsing with aqueous solutions of sucralose , or of sucralose in combination with maltodextrin and /or dextrose ( commercially available formulations , of sucralose ) was less acidogenic than rinsing with a sucrose solution of equivalent sweetness",
"Consumption of sugar-sweetened beverages has been shown , largely in American population s , to increase type 2 diabetes incidence . We aim ed to evaluate the association of consumption of sweet beverages ( juices and nectars , sugar-sweetened soft drinks and artificially sweetened soft drinks ) with type 2 diabetes incidence in European adults . We established a case – cohort study including 12,403 incident type 2 diabetes cases and a stratified subcohort of 16,154 participants selected from eight European cohorts participating in the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) study . After exclusions , the final sample size included 11,684 incident cases and a subcohort of 15,374 participants . Cox proportional hazards regression models ( modified for the case – cohort design ) and r and om-effects meta-analyses were used to estimate the association between sweet beverage consumption ( obtained from vali date d dietary question naires ) and type 2 diabetes incidence . In adjusted models , one 336 g ( 12 oz ) daily increment in sugar-sweetened and artificially sweetened soft drink consumption was associated with HRs for type 2 diabetes of 1.22 ( 95 % CI 1.09 , 1.38 ) and 1.52 ( 95 % CI 1.26 , 1.83 ) , respectively . After further adjustment for energy intake and BMI , the association of sugar-sweetened soft drinks with type 2 diabetes persisted ( HR 1.18 , 95 % CI 1.06 , 1.32 ) , but the association of artificially sweetened soft drinks became statistically not significant ( HR 1.11 , 95 % CI 0.95 , 1.31 ) . Juice and nectar consumption was not associated with type 2 diabetes incidence . This study corroborates the association between increased incidence of type 2 diabetes and high consumption of sugar-sweetened soft drinks in European adults",
"OBJECTIVE To examine the effect of a single high oral dose of the novel noncaloric sweetener sucralose on short-term glucose homeostasis in patients with IDDM or NIDDM . RESEARCH DESIGN AND METHODS A total of 13 IDDM and 13 NIDDM patients with glycosylated hemoglobin levels completed this double-blind cross-over study . After an overnight fast , patients were administered opaque capsules containing either 1,000 mg sucralose or cellulose placebo , followed by a st and ardized 360-kcal liquid breakfast . Plasma glucose and serum C-peptide levels were measured over the next 4 h. RESULTS Regardless of the type of diabetes , areas under the curves for changes of plasma glucose and serum C-peptide levels after sucralose administration were not significantly different from those after placebo . During test meals with sucralose , one episode of symptomatic hypoglycemia occurred in each of three IDDM patients , but these episodes were not considered the result of sucralose administration . CONCLUSIONS The present results support the conclusion that sucralose consumption does not adversely affect short-term blood glucose control in patients with diabetes",
"BACKGROUND Little is understood about the effect of increased consumption of low-calorie sweeteners in diet beverages on dietary patterns and energy intake . OBJECTIVE We investigated whether energy intakes and dietary patterns were different in subjects who were r and omly assigned to substitute caloric beverages with either water or diet beverages ( DBs ) . DESIGN Participants from the Choose Healthy Options Consciously Everyday r and omized clinical trial ( a 6-mo , 3-arm study ) were included in the analysis [ water groups : n = 106 ( 94 % women ) ; DB group : n = 104 ( 82 % women ) ] . For energy , macronutrient , and food and beverage intakes , we investigated the main effects of time , treatment , and the treatment-by-time interaction by using mixed models . RESULTS Overall , the macronutrient composition changed in both groups without significant differences between groups over time . Both groups reduced absolute intakes of total daily energy , carbohydrates , fat , protein , saturated fat , total sugar , added sugar , and other carbohydrates . The DB group decreased energy from all beverages more than the water group did only at month 3 ( P-group-by-time grain intake at month 3 and a greater increase in fruit and vegetable intake at month 6 ( P-group-by-time dessert intake than the water group did at month 6 ( P-group-by-time changes in energy intakes and dietary patterns . The DB group showed decreases in most caloric beverages and specifically reduced more desserts than the water group did . Our study does not provide evidence to suggest that a short-term consumption of DBs , compared with water , increases preferences for sweet foods and beverages . This trial was registered at clinical trials.gov as NCT01017783",
"Background / Objective : The sweet-taste receptor ( T1r2+T1r3 ) is expressed by enteroendocrine L-cells throughout the gastrointestinal tract . Application of sucralose ( a non-calorific , non-metabolisable sweetener ) to L-cells in vitro stimulates glucagon-like peptide (GLP)-1 secretion , an effect that is inhibited with co-administration of a T1r2+T1r3 inhibitor . We conducted a r and omised , single-blinded , crossover study in eight healthy subjects to investigate whether oral ingestion of sucralose could stimulate L-cell-derived GLP-1 and peptide YY ( PYY ) release in vivo . Methods : Fasted subjects were studied on 4 study days in r and om order . Subjects consumed 50 ml of either water , sucralose ( 0.083 % w/v ) , a non-sweet , glucose-polymer matched for sweetness with sucralose addition ( 50 % w/v maltodextrin+0.083 % sucralose ) or a modified sham-feeding protocol ( MSF = oral stimulation ) of sucralose ( 0.083 % w/v ) . Appetite ratings and plasma GLP-1 , PYY , insulin and glucose were measured at regular time points for 120 min . At 120 min , energy intake at a buffet meal was measured . Results : Sucralose ingestion did not increase plasma GLP-1 or PYY . MSF of sucralose did not elicit a cephalic phase response for insulin or GLP-1 . Maltodextrin ingestion significantly increased insulin and glucose compared with water ( P Appetite ratings and energy intake were similar for all groups . Conclusions : At this dose , oral ingestion of sucralose does not increase plasma GLP-1 or PYY concentrations and hence , does not reduce appetite in healthy subjects . Oral stimulation with sucralose had no effect on GLP-1 , insulin or appetite",
"The antihypertensive effect of crude stevioside obtained from the leaves of Stevia rebaudiana ( Bertoni ) Bertoni ( Compositae ) on previously untreated mild hypertensive patients was examined . Patients with essential hypertension were su bmi tted to a placebo phase for 4 weeks . The volunteers selected in this phase were r and omly assigned to receive either capsules containing placebo during 24 weeks or crude stevioside 3.75 mg/kg/day ( 7 weeks ) , 7.5 mg/kg/day ( 11 weeks ) and 15.0 mg/kg/day ( 6 weeks ) . All capsules were prescribed twice a daily ( b.i.d . ) , i.e. before lunch and before dinner . After the placebo phase and after each dose of crude stevioside , body mass index , electrocardiogram and laboratory tests were performed . During the investigation blood pressure ( BP ) was measured biweekly and the remaining data were collected at the end of each stevioside dose step . All adverse events were prospect ively recorded but no major adverse clinical effects were observed during the trial . Systolic and diastolic BP decreased ( p crude stevioside , but a similar effect was observed in the placebo group . Therefore , crude stevioside up to 15.0 mg/kg/day did not show an antihypertensive effect . Moreover , the results suggest that oral crude stevioside is safe and supports the well-established tolerability during long term use as a sweetener in Brazil",
"OBJECTIVE To examine the effects of non-alcoholic beverage and caffeine consumption on all-cause mortality in older adults . METHODS The Leisure World Cohort Study is a prospect i ve study of residents of a California retirement community . A baseline postal health survey included details on coffee , tea , milk , soft drink , and chocolate consumption . Participants were followed for 23 years ( 1981 - 2004 ) . Risk ratios ( RRs ) of death were calculated using Cox regression for 8644 women and 4980 men ( median age at entry , 74 years ) and adjusted for age , gender , and multiple potential confounders . RESULTS Caffeine consumption exhibited a U-shaped mortality curve . Moderate caffeine consumers had a significantly reduced risk of death ( multivariable-adjusted RR=0.94 , 95 % CI : 0.89 , 0.99 for 100 - 199 mg/day and RR=0.90 , 95 % CI : 0.85 , 0.94 for 200 - 399 mg/day compared with those consuming artificially sweetened ( but not sugar-sweetened ) soft drink ( cola and other ) had an 8 % increased risk ( 95 % CI : 1.01 - 1.16 ) . Neither milk nor tea had a significant effect on mortality after multivariable adjustment . CONCLUSIONS Moderate caffeine consumption appeared beneficial in reducing risk of death . Attenuation in the observed associations between mortality and intake of tea and milk with adjustment for potential confounders suggests that such consumption identifies those with other mortality-associated lifestyle and health risks . The increased death risk with consumption of artificially sweetened , but not sugar-sweetened , soft drinks suggests an effect of the sweetener rather than other components of the soft drinks , although residual confounding remains a possibility",
"Background The importance of exchanging sucrose for artificial sweeteners on risk factors for developing diabetes and cardiovascular diseases is not yet clear . Objective To investigate the effects of a diet high in sucrose versus a diet high in artificial sweeteners on fasting and postpr and ial metabolic profiles after 10 weeks . Design Healthy overweight subjects were r and omised to consume drinks and foods sweetened with either sucrose ( ∼2 g/kg body weight ) ( n = 12 ) or artificial sweeteners ( n = 11 ) as supplements to their usual diet . Supplements were similar on the two diets and consisted of beverages ( ∼80 weight% ) and solid foods ( yoghurts , marmalade , ice cream , stewed fruits ) . The rest of the diet was free of choice and ad libitum . Before ( week 0 ) and after the intervention ( week 10 ) fasting blood sample s were drawn and in week 10 , postpr and ial blood was sample d during an 8-hour meal test ( breakfast and lunch ) . Results After 10 weeks postpr and ial glucose , insulin , lactate , triglyceride , leptin , glucagon , and GLP-1 were all significantly higher in the sucrose compared with the sweetener group . After adjusting for differences in body weight changes and fasting values ( week 10 ) , postpr and ial glucose , lactate , insulin , GIP , and GLP-1 were significantly higher and after further adjusting for differences in energy and sucrose intake , postpr and ial lactate , insulin , GIP , and GLP-1 levels were still significantly higher on the sucrose-rich diet . Conclusion A sucrose-rich diet consumed for 10 weeks result ed in significant elevations of postpr and ial glycaemia , insulinemia , and lipidemia compared to a diet rich in artificial sweeteners in slightly overweight healthy subjects",
"Background — Increased consumption of sugar-sweetened beverages ( SSBs ) has been associated with an elevated risk of obesity , metabolic syndrome , and type II diabetes mellitus . However , the effects of SSB consumption on blood pressure ( BP ) are uncertain . The objective of this study was to determine the relationship between changes in SSB consumption and changes in BP among adults . Methods and Results — This was a prospect i ve analysis of 810 adults who participated in the PREMIER Study ( an 18-month behavioral intervention trial ) . BP and dietary intake ( by two 24-hour recalls ) were measured at baseline and at 6 and 18 months . Mixed-effects models were applied to estimate the changes in BP in responding to changes in SSB consumption . At baseline , mean SSB intake was 0.9±1.0 servings per day ( 10.5±11.9 fl oz/d ) , and mean systolic BP/diastolic BP was 134.9±9.6/84.8±4.2 mm Hg . After potential confounders were controlled for , a reduction in SSB of 1 serving per day was associated with a 1.8-mm Hg ( 95 % confidence interval , 1.2 to 2.4 ) reduction in systolic BP and 1.1-mm Hg ( 95 % confidence interval , 0.7 to 1.4 ) reduction in diastolic BP over 18 months . After additional adjustment for weight change over the same period , a reduction in SSB intake was still significantly associated with reductions in systolic and diastolic BPs ( P . Reduced intake of sugars was also significantly associated with reduced BP . No association was found for diet beverage consumption or caffeine intake and BP . These findings suggest that sugars may be the nutrients that contribute to the observed association between SSB and BP . Conclusions — Reduced consumption of SSB and sugars was significantly associated with reduced BP . Reducing SSB and sugar consumption may be an important dietary strategy to lower BP . Clinical Trial Registration — URL : http:// clinical trials.gov . Unique identifier : NCT00000616",
"BACKGROUND The rising prevalence of obesity in children has been linked in part to the consumption of sugar-sweetened drinks . Our aim was to examine this relation . METHODS We enrolled 548 ethnically diverse schoolchildren ( age 11.7 years , SD 0.8 ) from public schools in four Massachusetts communities , and studied them prospect ively for 19 months from October , 1995 , to May , 1997 . We examined the association between baseline and change in consumption of sugar-sweetened drinks ( the independent variables ) , and difference in measures of obesity , with linear and logistic regression analyses adjusted for potentially confounding variables and clustering of results within schools . FINDINGS For each additional serving of sugar-sweetened drink consumed , both body mass index ( BMI ) ( mean 0.24 kg/m2 ; 95 % CI 0.10 - 0.39 ; p=0.03 ) and frequency of obesity ( odds ratio 1.60 ; 95 % CI 1.14 - 2.24 ; p=0.02 ) increased after adjustment for anthropometric , demographic , dietary , and lifestyle variables . Baseline consumption of sugar-sweetened drinks was also independently associated with change in BMI ( mean 0.18 kg/m2 for each daily serving ; 95 % CI 0.09 - 0.27 ; p=0.02 ) . INTERPRETATION Consumption of sugar-sweetened drinks is associated with obesity in children",
"Summary Objective The aim of this study was to examine differences in rates of non‐caloric beverage adoption by participants classified as sweet likers ( SLs ) or sweet dislikers ( measured using a behavioural tasting task ) . Methods Data are a sub‐ study from a 6‐month , three‐group , r and omized weight loss trial ( CHOICE ) ( body mass index 36.3 ± 5.8 kg m−2 , 84 % female , aged 42.2 ± 10.9 years , 53 % African‐American ) comparing the replacement of caloric beverages with either non‐caloric sweetened beverages ( diet ) or water ( water ) compared with a control group . This sub‐ study , which included participants within the water ( n = 106 ) and diet ( n = 103 ) groups only , examined whether SLs ( n = 33 water ; n = 37 diet ) varied in their adherence to caloric beverage recommendations compared with sweet dislikers ( n = 73 water ; n = 76 diet ) over the 6‐month study . Results Diet intake and sweet‐liking data collected on 190 ( 3 months ) and 169 participants ( 6 months ) were used for analysis . The interaction between SL status and beverage group ( diet vs. water ) approached significance ( P = 0.06 ) at 3 months but not 6 months . Caloric beverage intake ( % energy ) at 3 months was significantly higher in SLs within the water group ( 9.7 ± 1.4 % ) compared with SLs in the diet group ( 5.4 ± 1.0 % , P = 0.03 ) . Conclusions Results suggest that SL status may affect the rate in reduction of caloric beverages when water is the recommended substitution . Future studies should explore tailoring beverage recommendations to tasting profile",
"BACKGROUND A high incidence of dental caries and dental erosion associated with frequent consumption of soft drinks has been reported . The purpose of this study was to evaluate the pH response of dental plaque to a regular , diet and high energy drink . METHODOLOGY Twenty subjects were recruited for this study . All subjects were between the ages of 20 and 25 and had at least four restored tooth surfaces present . The subjects were asked to refrain from brushing for 48 hours prior to the study . At baseline , plaque pH was measured from four separate locations using harvesting method . Subjects were asked to swish with 15 ml of the respective soft drink for 1 minute . Plaque pH was measured at the four design ated tooth sites at 5 , 10 and 20 minutes intervals . Subjects then repeated the experiment using the other two soft drinks . RESULTS pH was minimum for regular soft drink ( 2.65 ± 0.026 ) followed by high energy drink ( 3.39 ± 0.026 ) and diet soft drink ( 3.78 ± 0.006 ) . The maximum drop in plaque pH was seen with regular soft drink followed by high energy drink and diet soft drink . CONCLUSION Regular soft drink possesses a greater acid challenge potential on enamel than diet and high energy soft drinks . However , in this clinical trial , the pH associated with either soft drink did not reach the critical pH which is expected for enamel demineralization and dissolution",
"Introduction Low-calorie sweetener use for weight control has come under increasing scrutiny as obesity , especially abdominal obesity , remain entrenched despite substantial low-calorie sweetener use . We evaluated whether chronic low-calorie sweetener use is a risk factor for abdominal obesity . Participants and Methods We used 8268 anthropometric measurements and 3096 food diary records with detailed information on low-calorie sweetener consumption in all food products , from 1454 participants ( 741 men , 713 women ) in the Baltimore Longitudinal Study of Aging collected from 1984 to 2012 with median follow-up of 10 years ( range : 0–28 years ) . At baseline , 785 were low-calorie sweetener non-users ( 51.7 % men ) and 669 participants were low-calorie sweetener users ( 50.1 % men ) . Time-varying low-calorie sweetener use was operationalized as the proportion of visits since baseline at which low-calorie sweetener use was reported . We used marginal structural models to determine the association between baseline and time-varying low-calorie sweetener use with longitudinal outcomes —body mass index , waist circumference , obesity and abdominal obesity — with outcome status assessed at the visit following low-calorie sweetener ascertainment to minimize the potential for reverse causality . All models were adjusted for year of visit , age , sex , age by sex interaction , race , current smoking status , dietary intake ( caffeine , fructose , protein , carbohydrate , and fat ) , physical activity , diabetes status , and Dietary Approaches to Stop Hypertension score as confounders . Results With median follow-up of 10 years , low-calorie sweetener users had 0.80 kg/m2 higher body mass index ( 95 % confidence interval [ CI ] , 0.17–1.44 ) , 2.6 cm larger waist circumference ( 95 % CI , 0.71–4.39 ) , 36.7 % higher prevalence ( prevalence ratio = 1.37 ; 95 % CI , 1.10–1.69 ) and 53 % higher incidence ( hazard ratio = 1.53 ; 95 % CI 1.10–2.12 ) of abdominal obesity than low-calorie sweetener non-users . Conclusions Low-calorie sweetener use is independently associated with heavier relative weight , a larger waist , and a higher prevalence and incidence of abdominal obesity suggesting that low-calorie sweetener use may not be an effective means of weight control",
"Stevioside is present in the plant Stevia rebaudiana Bertoni ( SrB ) . Extracts of SrB have been used for the treatment of diabetes in , for example , Brazil , although a positive effect on glucose metabolism has not been unequivocally demonstrated . We studied the acute effects of stevioside in type 2 diabetic patients . We hypothesize that supplementation with stevioside to a test meal causes a reduction in postpr and ial blood glucose . Twelve type 2 diabetic patients were included in an acute , paired cross-over study . A st and ard test meal was supplemented with either 1 g of stevioside or 1 g of maize starch ( control ) . Blood sample s were drawn at 30 minutes before and for 240 minutes after ingestion of the test meal . Compared to control , stevioside reduced the incremental area under the glucose response curve by 18 % ( P = .013 ) . The insulinogenic index ( AUC(i , insulin)/AUC(i , glucose ) ) was increased by approximately 40 % by stevioside compared to control ( P Stevioside tended to decrease glucagon levels , while it did not significantly alter the area under the insulin , glucagon-like peptide 1 , and glucose-dependent insulinotropic polypeptide curves . In conclusion , stevioside reduces postpr and ial blood glucose levels in type 2 diabetic patients , indicating beneficial effects on the glucose metabolism . Stevioside may be advantageous in the treatment of type 2 diabetes",
"Background : In a few animal experiments , aspartame has been linked to hematopoietic and brain cancers . Most animal studies have found no increase in the risk of these or other cancers . Data on humans are sparse for either cancer . Concern lingers regarding this widely used artificial sweetener . Objective : We investigated prospect ively whether aspartame consumption is associated with the risk of hematopoietic cancers or gliomas ( malignant brain cancer ) . Methods : We examined 285,079 men and 188,905 women ages 50 to 71 years in the NIH-AARP Diet and Health Study cohort . Daily aspartame intake was derived from responses to a baseline self-administered food frequency question naire that queried consumption of four aspartame-containing beverages ( soda , fruit drinks , sweetened iced tea , and aspartame added to hot coffee and tea ) during the past year . Histologically confirmed incident cancers were identified from eight state cancer registries . Multivariable-adjusted relative risks ( RR ) and 95 % confidence intervals ( CI ) were estimated using Cox proportional hazards regression that adjusted for age , sex , ethnicity , body mass index , and history of diabetes . Results : During over 5 years of follow-up ( 1995 - 2000 ) , 1,888 hematopoietic cancers and 315 malignant gliomas were ascertained . Higher levels of aspartame intake were not associated with the risk of overall hematopoietic cancer ( RR for ≥600 mg/d , 0.98 ; 95 % CI , 0.76 - 1.27 ) , glioma ( RR for ≥400 mg/d , 0.73 ; 95 % CI , 0.46 - 1.15 ; P for inverse linear trend = 0.05 ) , or their subtypes in men and women . Conclusions : Our findings do not support the hypothesis that aspartame increases hematopoietic or brain cancer risk . ( Cancer Epidemiol Biomarkers Prev 2006;15(9):1654–9",
"In two experiments , 2 - 5-year-old children 's responsiveness to caloric density cues was examined . In a preloading protocol , consumption of fixed volumes of drinks ( 205 ml in Experiment 1 ; 150 ml in Experiment 2 ) , sweetened with sucrose , aspartame , aspartame plus low glucose maltodextrin , or a water control , was followed by ad lib consumption from among a variety of foods . Caloric drinks had about 90 kcal in Experiment 1 , 65 kcal in Experiment 2 . The delay interval between the preload and the ad lib consumption was 0 , 30 or 60 minutes . In Experiment 1 , 24 4- and 5-year-old children participated in only one delay interval , while in Experiment 2 , all 20 2- and 3-year-old children were seen in all conditions . Results revealed evidence of caloric compensation , but no evidence of preload x time delay interaction . In both experiments , aspartame also produced a significant suppression of intake relative to water , primarily due to the pattern at 30 min following the preload . Across conditions , the suppression following aspartame was usually significantly less than that produced by the caloric sweet drinks , providing evidence for postingestive effects . In Experiment 1 , suppression of intake was related to the children 's preferences for the foods , not to macronutrient content ; consumption of nonpreferred foods was most suppressed . Consumption of sweetened drinks as long as 1 hour prior to eating suppressed food intake , and this common feeding practice may also reduce dietary variety",
" During the years 1979 to 1981 a population -based case-control study of bladder cancer including papillomas was performed in Greater Copenhagen . After exclusions some 388 patients ( 290 males ; 98 females ) and an age- and sex-matched group of 787 controls ( 592 males ; 195 females ) remained for analysis . Controls were selected at r and om from the general population of the study area . All persons were interviewed concerning use of artificial sweeteners in addition to their exposure to a number of other known or suspected risk factors for bladder cancer . Fifty-five male bladder cancer patients ( 19.4 % ) and 150 controls ( 25.7 % ) had at some time used artificial sweeteners regularly . Among females 27.1 % of cases and 25.9 % of controls regularly used sweeteners . In neither sex was the relative risk significantly increased in users compared with non-users of artificial sweeteners . The relative risk of 0.78 in the two sexes combined was not significantly different from 1.0 ( 95 % C.I. : 0.58 - 1.05 ) . There was no indication of a regular increase in risk with increasing daily consumption of table-top sweeteners nor was there any indication of an increase in risk with a duration of regular use of artificial sweeteners . Taking into account a possible latency period between first regular use and bladder cancer development did not change the finding of an absence of association between use of artificial sweeteners and the risk of bladder cancer . Neither saccharine nor cyclamate users had an increased risk of bladder cancer . This population -based case-control investigation provides further evidence that it is highly unlikely that the consumption of artificial sweeteners has contributed to current bladder cancer rates in man",
"BACKGROUND Sugar-sweetened beverages are risk factors for type 2 diabetes ; however , the role of artificially sweetened beverages is unclear . OBJECTIVE The objective was to examine the associations of sugar- and artificially sweetened beverages with incident type 2 diabetes . DESIGN An analysis of healthy men ( n = 40,389 ) from the Health Professionals Follow-Up Study , a prospect i ve cohort study , was performed . Cumulatively averaged intakes of sugar-sweetened ( sodas , fruit punches , lemonades , fruit drinks ) and artificially sweetened ( diet sodas , diet drinks ) beverages from food-frequency question naires were tested for associations with type 2 diabetes by using Cox regression . RESULTS There were 2680 cases over 20 y of follow-up . After age adjustment , the hazard ratio ( HR ) for the comparison of the top with the bottom quartile of sugar-sweetened beverage intake was 1.25 ( 95 % CI : 1.11 , 1.39 ; P for trend high triglycerides at baseline , high blood pressure , diuretics , pre-enrollment weight change , dieting , total energy , and body mass index , the HR was 1.24 ( 95 % CI : 1.09 , 1.40 ; P for trend artificially sweetened beverages was significantly associated with type 2 diabetes in the age-adjusted analysis ( HR : 1.91 ; 95 % CI : 1.72 , 2.11 ; P for trend of sugar-sweetened beverage with 1 cup ( ≈237 mL ) of coffee was associated with a risk reduction of 17 % . CONCLUSION Sugar-sweetened beverage consumption is associated with a significantly elevated risk of type 2 diabetes , whereas the association between artificially sweetened beverages and type 2 diabetes was largely explained by health status , pre-enrollment weight change , dieting , and body mass index",
"Twelve normal subjects and 10 subjects with non-insulin-dependent diabetes mellitus were given , in r and om order at intervals of ≥ 1 wk , three drinks of the same beverage : one unsweetened , one sweetened with 400 mg aspartame , and one sweetened with 135 mg saccharin . The amount of sweetener approximated that in 1 L of sugar-free soft drink . Plasma glucose , insulin , and glucagon were measured for 3 h after ingestion of the test beverage . Plasma glucose declined slightly throughout the test period , probably due to fasting , with no differences between the three treatments . Neither sweetener affected peak insulin levels in subjects with or without diabetes . Analysis of area under the curve showed that mean insulin levels were statistically significantly higher after aspartame than after saccharin or unsweetened beverage in normal subjects only , but the magnitude of the difference was small and unlikely to be of physiological importance in the absence of differences in glucose levels . Furthermore , the differences could largely be accounted for by a decrease in insulin values after both unsweetened beverage and saccharin , with no change from baseline after aspartame . Glucagon levels showed time-to-time variation but no overall differences . We conclude that ingestion of aspartame- or saccharin-sweetened beverages by fasting subjects , with or without diabetes , did not affect blood glucose homeostasis ",
"Background : The influence of artificial sweeteners on metabolic diseases is controversial . Artificially sweetened beverages have been associated with an increased risk of type 2 diabetes ( T2D ) but biases and reverse causation have been suspected to have influenced the observed association . In addition , it has been suggested that investigation into the relationship between the frequency and duration of the consumption of packet or tablet artificial sweeteners and T2D risk is necessary . Methods : We used data from 61,440 women in the prospect i ve E3N-European Prospect i ve Investigation into Cancer and Nutrition study , conducted between 1993 and 2011 . We estimated hazards ratios ( HRs ) and 95 % CIs of T2D risk associated with both the frequency and the duration of use of artificial sweeteners consumed in packets or tablets . Results : Compared to “ never or rare ” consumers of artificial sweeteners , those using them “ always or almost always ” had an increased risk of T2D ( HR = 1.83 [ 95 % CI 1.66 - 2.02 ] in the multivariate model [ MM ] , HR = 1.33 [ 95 % CI 1.20 - 1.47 ] when further adjusted for body mass index , BMI ) . Women consuming artificial sweeteners in packets or tablets for more than 10 years also had an increased risk of T2D compared to never or rare users ( HR = 2.10 [ 95 % CI 1.83 - 2.40 ] in the MM and HR = 1.15 [ 95 % CI 1.00 - 1.33 ] when adjusted for BMI , respectively ) . Conclusions : Our data suggest that both a higher frequency and a longer consumption of artificial sweeteners in packets or tablets was associated with T2D risk , independently of major T2D risk factors , but partially mediated by adiposity . A pre caution ary principle should be applied to the promotion of these products that are still largely recommended as healthy sugar substitutes",
"In a study of the impact of aspartame , fat , and carbohydrate on appetite , we monitored blood glucose continuously for 431 ( SE 16 ) min . Ten healthy males ( 19 - 31 years ) participated in three time-blinded visits . As blood glucose was monitored , appetite ratings were scored at r and omized times . On the first meal initiation , volunteers consumed one of three isovolumetric drinks ( aspartame , 1 MJ simple carbohydrate , and 1 MJ high-fat ; r and omized order ) . High-fat and high-carbohydrate foods were available ad libitum subsequently . Blood glucose patterns following the carbohydrate drink ( + 1.78 ( SE 0.28 ) mmol/l in 38 ( SE 3 ) min ) and high-fat drink ( + 0.83 ( SE 0.28 ) mmol/l in 49 ( SE 6 ) min ) were predictive of the next intermeal interval ( R 0.64 and R 0.97 respectively ) . Aspartame ingestion was followed by blood glucose declines ( 40 % of subjects ) , increases ( 20 % ) , or stability ( 40 % ) . These patterns were related to the volunteers ' perception of sweetness of the drink ( R 0.81 , P = 0.014 ) , and were predictive of subsequent intakes ( R -0.71 , P = 0.048 ) . For all drinks combined , declines in blood glucose and meal initiation were significantly associated ( chi 2 16.8 , P duration of blood glucose responses and intermeal intervals correlated significantly ( R 0.715 , P = 0.0001 ) , and sweetness perception correlated negatively with hunger suppression ( R -0.471 , P = 0.015 ) . Effects of fat , carbohydrate , and aspartame on meal initiation , meal size , and intermeal interval relate to blood glucose patterns . Varied blood glucose responses after aspartame support the controversy over its effects , and may relate to sweetness perception",
"OBJECTIVE To investigate the effect of 3-months ' daily administration of high doses of sucralose , a non-nutritive sweetener , on glycemic control in subjects with type 2 diabetes . DESIGN A multicenter , double-blind , placebo-controlled , r and omized study , consisting of a 6-week screening phase , a 13-week test phase , and a 4-week follow-up phase . SUBJECTS/ SETTING Subjects with type 2 diabetes ( age range 31 to 70 years ) entered the test phase of this study ; 128 subjects completed the study . The subjects were recruited from 5 medical centers across the United States and were , on average , obese . INTERVENTION Subjects were r and omly assigned to receive either placebo ( cellulose ) capsules ( n=69 ) or 667 mg encapsulated sucralose ( n=67 ) daily for the 13-week test phase . All subjects blindly received placebo capsules during the last 4 weeks of the screening phase and for the entire 4-week follow-up phase . MAIN OUTCOME MEASURES Glycated hemoglobin ( HbA1c ) , fasting plasma glucose , and fasting serum C-peptide were measured approximately every 2 weeks to evaluate blood glucose homeostasis . Data were analyzed by analysis of variance using repeated measures . RESULTS There were no significant differences between the sucralose and placebo groups in HbA1c , fasting plasma glucose , or fasting serum C-peptide changes from baseline . There were no clinical ly meaningful differences between the groups in any safety measure . CONCLUSIONS This study demonstrated that , similar to cellulose , sucralose consumption for 3 months at doses of 7.5 mg/kg/day , which is approximately three times the estimated maximum intake , had no effect on glucose homeostasis in individuals with type 2 diabetes . Additionally , this study showed that sucralose was as well-tolerated by the study subjects as was the placebo",
"In the Mediterranean region of France where bladder cancer mortality and incidence are high , a case-control study with 219 male incident cases and 794 r and omized , male population -controls was carried out in 1987–89 to investigate bladder cancer risk factors and more specifically , regional factors . A stepwise logistic regression was applied to the data . This investigation confirms the role of tobacco and of certain occupational exposures in bladder carcinogenesis . There was a significant dose-response relationship with lifelong coffee drinking and alcohol consumption ; however the risk estimates were only significantly elevated for the heaviest drinkers . The intake of saccharin was not associated with risk of bladder cancer . Infrequent consumption of carrots , spinach , and marrows conferred an increased risk , suggesting a protective effect of vitamin A. Finally , this investigation results in some new hypotheses . The study of residences and birthplaces has revealed a lower risk for those who have lived in a non-Mediterranean area and a higher risk for those born in a Mediterranean area . These features might be explained by some Mediterranean dietary habits , such as a high consumption of spices ( odds ratio = 3.64 , 95 percent confidence interval=2.21–5.98 )",
"Despite some reports that aspartame (APM)-sweetened beverages may increase subjective appetite , previously we demonstrated that drinking 280 ml of an APM-sweetened soft drink ( 170 mg APM ) had no effect on appetite , and 560 ml of the same soft drink ( 340 mg APM ) reduced appetite . The present study examined this appetite reduction to determine its cause . Eighteen normal weight young adult males received five treatments ( beverage preloads ) at 1100 h in a r and omized order , one per week : 280 ml of carbonated mineral water ( CMW ) ( control ) , 560 ml of CMW , 280 ml of CMW with 340 mg of encapsulated APM , 280 ml of CMW sweetened with 340 mg APM , 560 ml of an APM-sweetened soft drink ( 340 mg APM ) . Subjective hunger and food appeal were measured from 0930 a.m. to 1230 h , and food intake from a buffet lunch offered at 1205 h was measured . Treatment had no effect on food intake or macronutrient selection . Both 560 ml of CMW or soft drink suppressed appetite , although 280 ml of APM-sweetened mineral water significantly increased subjective appetite relative to the control . Encapsulated APM had no effect on appetite . Therefore , appetite reduction following consumption of an APM-sweetened drink is likely due to drink volume and not the APM content . In addition , consuming APM-sweetened CMW produces a short-term increase in subjective appetite",
"This study compared the effects of equal volumes of sugar-rich and sugar-free beverages on feelings of hunger and fullness and the ad libitum consumption of a palatable , fat-rich snack . Eleven healthy males consumed equal volumes ( 375 mL ) of three drinks ( sugar-rich cola , sugar-free cola , mineral water ) in r and om order on separate mornings . After 20 min , the subjects were able to snack freely on potato crisps during the next 90 min . Each subject 's individual bowl of potato crisps was covertly replenished at 15 min intervals while the subjects were completing appetite and mood ratings . After the 110 min experimental period , the subjects ' ad libitum food intake from a buffet-style lunch was covertly recorded . On leaving the laboratory , the subjects filled in a weighed food dairy for the rest of the day . The equal-volume preloads initially decreased hunger to a similar degree and potato crisp intake during the first 15 min interval was not significantly different among the three preloads . On average , total energy intakes from the crisps and lunch were not significantly different among the preloads , and by the end of the day , total energy intakes were similar for the three test conditions . Therefore , the low-calorie/low-sugar drinks did not facilitate a reduced energy intake by the lean , non-dieting male subjects",
"A case-control study of diet and bladder cancer was conducted during 1979 - 1982 in Edmonton , Calgary , Toronto , and Kingston , Canada . A total of 826 histologically verified cancer cases were individually matched by age , sex , and area of residence to 792 r and omly selected population controls . Subjects were interviewed concerning their histories of exposure to a number of dietary factors , including table-top artificial sweeteners , low calorie foods and drinks , beverages containing caffeine or ethanol , and certain other food items . Also , subjects provided information on their past medical , occupational , and residential histories , in addition to their exposures to tobacco and other life-style factors . For the analysis , conditional logistic regression methods were used . Under adjustment for cumulative lifetime amount of cigarette smoking , the dietary factors , with little exception , were not associated with significant alteration of risk for bladder cancer . In particular , ever regular use of artificial sweeteners did not appear to be associated with increased risk , either among men ( odds ratio = 0.95 , p = 0.70 ) or among women ( odds ratio = 1.15 , p = 0.53 ) . However , daily intake of cholesterol , calculated from reported frequencies of consumption of nine relevant food items , suggested a mild increase in risk ; the odds ratio estimate of trend was 1.07/100 mg average daily intake ( i.e. , 1.07(5.5 ) = 1.45 for 550 mg cholesterol per day , as might be consumed in one egg ; p = 0.009 ) . A history of diabetes mellitus of onset after age 20 years also seemed to be associated with increased risk of bladder cancer ( odds ratio = 1.65 , p = 0.019 ) , but this increase did not appear to be the result of use of insulin or other medications , or use of artificial sweeteners or low calorie foods . Thus , this study tends to confirm reports of a lack of association between use of artificial sweeteners and subsequent risk of bladder cancer",
"BACKGROUND Consumption of sugar-sweetened beverages may cause excessive weight gain . We aim ed to assess the effect on weight gain of an intervention that included the provision of noncaloric beverages at home for overweight and obese adolescents . METHODS We r and omly assigned 224 overweight and obese adolescents who regularly consumed sugar-sweetened beverages to experimental and control groups . The experimental group received a 1-year intervention design ed to decrease consumption of sugar-sweetened beverages , with follow-up for an additional year without intervention . We hypothesized that the experimental group would gain weight at a slower rate than the control group . RESULTS Retention rates were 97 % at 1 year and 93 % at 2 years . Reported consumption of sugar-sweetened beverages was similar at baseline in the experimental and control groups ( 1.7 servings per day ) , declined to nearly 0 in the experimental group at 1 year , and remained lower in the experimental group than in the control group at 2 years . The primary outcome , the change in mean body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) at 2 years , did not differ significantly between the two groups ( change in experimental group minus change in control group , -0.3 ; P=0.46 ) . At 1 year , however , there were significant between-group differences for changes in BMI ( -0.57 , P=0.045 ) and weight ( -1.9 kg , P=0.04 ) . We found evidence of effect modification according to ethnic group at 1 year ( P=0.04 ) and 2 years ( P=0.01 ) . In a prespecified analysis according to ethnic group , among Hispanic participants ( 27 in the experimental group and 19 in the control group ) , there was a significant between-group difference in the change in BMI at 1 year ( -1.79 , P=0.007 ) and 2 years ( -2.35 , P=0.01 ) , but not among non-Hispanic participants ( P>0.35 at years 1 and 2 ) . The change in body fat as a percentage of total weight did not differ significantly between groups at 2 years ( -0.5 % , P=0.40 ) . There were no adverse events related to study participation . CONCLUSIONS Among overweight and obese adolescents , the increase in BMI was smaller in the experimental group than in the control group after a 1-year intervention design ed to reduce consumption of sugar-sweetened beverages , but not at the 2-year follow-up ( the prespecified primary outcome ) . ( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; Clinical Trials.gov number , NCT00381160 . )",
"OBJECTIVE . The role of sugar-sweetened beverages ( SSBs ) in promoting obesity is controversial . Observational data link SSB consumption with excessive weight gain ; however , r and omized , controlled trials are lacking and necessary to resolve the debate . We conducted a pilot study to examine the effect of decreasing SSB consumption on body weight . METHODS . We r and omly assigned 103 adolescents aged 13 to 18 years who regularly consumed SSBs to intervention and control groups . The intervention , 25 weeks in duration , relied largely on home deliveries of noncaloric beverages to displace SSBs and thereby decrease consumption . Change in SSB consumption was the main process measure , and change in body mass index ( BMI ) was the primary end point . RESULTS . All of the r and omly assigned subjects completed the study . Consumption of SSBs decreased by 82 % in the intervention group and did not change in the control group . Change in BMI , adjusted for gender and age , was 0.07 ± 0.14 kg/m2 ( mean ± SE ) for the intervention group and 0.21 ± 0.15 kg/m2 for the control group . The net difference , −0.14 ± 0.21 kg/m2 , was not significant overall . However , baseline BMI was a significant effect modifier . Among the subjects in the upper baseline- BMI tertile , BMI change differed significantly between the intervention ( −0.63 ± 0.23 kg/m2 ) and control ( + 0.12 ± 0.26 kg/m2 ) groups , a net effect of −0.75 ± 0.34 kg/m2 . The interaction between weight change and baseline BMI was not attributable to baseline consumption of SSBs . CONCLUSIONS . A simple environmental intervention almost completely eliminated SSB consumption in a diverse group of adolescents . The beneficial effect on body weight of reducing SSB consumption increased with increasing baseline body weight , offering additional support for American Academy of Pediatrics guidelines to limit SSB consumption",
" Sixty-two subjects having either insulin-dependent or non-insulin-dependent diabetes completed a r and omized , double-blind study comparing effects of aspartame or a placebo on blood glucose control . Twenty-nine subjects consumed 2.7 g aspartame per day for 18 wk , given as aspartame-containing capsules with meals , while 33 subjects took identical appearing placebo capsules . After 18 wk , no changes were seen in fasting or 2-h postpr and ial blood glucose levels or glycohemoglobin levels in either the aspartame- or placebo-treated groups . Adverse reactions were no more common in the group taking aspartame . We conclude that use of aspartame as a low-calorie sweetener does not adversely affect glycemic control of persons with diabetes",
"The effect of daily mouthrinses on dental plaque accumulation and on salivary mutans streptococci was investigated in 200 children . The utilized solutions were : a placebo solution composed of mentholated deionized water ( group I ) ; 0.12 % chlorhexidine gluconate associated to 0.05 % sodium fluoride ( group II ) ; 0.2 % chlorhexidine digluconate ( group III ) , and 0.5 % stevioside mixed with 0.05 % sodium fluoride , with pH 3.4 ( group IV ) . In order to verify the effect on plaque formation , the accumulation of plaque was assessed by means of the Löe12 index , at the beginning and at the end of the experiment , whereas the quantification of cariogenic streptococci was accomplished on three saliva sample s collected at 3 different moments : before the first mouthrinse , 24 hours after the first mouthrinse and 1 week after the last mouthrinse . The mouthrinsing routine was carried out on a daily basis during 4 weeks . Five milliliters of solution were rinsed during 1 minute . The results revealed 4.10 , 26.75 , 41.20 , and 5.91 % of reduction in plaque accumulation for groups I , II , III , and IV , respectively . Comparisons between the groups as to plaque reduction revealed that groups II and III were significantly different from groups I ( control ) and IV ( p accepted by children and , as the solution utilized by group II , caused mild dental pigmentation . There were no statistically significant differences as to the levels of mutans streptococci , probably due to the low initial levels observed in each one of the four groups",
"OBJECTIVES . The intent of this study was to evaluate whether small changes in diet and physical activity , as promoted by the America on the Move initiative , could prevent excessive weight gain in overweight children . METHODS . In this family-intervention study , the America on the Move small-changes approach for weight-gain prevention was evaluated in families with at least 1 child ( 7–14 years old ) who was overweight or at risk for overweight . These children were the primary target of the intervention , and parents were the secondary target . Families were r and omly assigned to either the America on the Move group ( n = 100 ) or the self-monitor – only group ( n = 92 ) . Families who were assigned to the America on the Move group were asked to make 2 small lifestyle changes : ( 1 ) to walk an additional 2000 steps per day above baseline as measured by pedometers and ( 2 ) to eliminate 420 kJ/day ( 100 kcal/day ) from their typical diet by replacing dietary sugar with a noncaloric sweetener . Families who were assigned to the self-monitor group were asked to use pedometers to record physical activity but were not asked to change their diet or physical activity level . RESULTS . During a 6-month period , both groups of children showed significant decreases in BMI for age . However , the America on the Move group compared with the self-monitor group had a significantly higher percentage of target children who maintained or reduced their BMI for age and , consistently , a significantly lower percentage who increased their BMI for age . There was no significant weight gain during the 6-month intervention in parents of either group . CONCLUSIONS . The small-changes approach advocated by America on the Move could be useful for addressing childhood obesity by preventing excess weight gain in families",
"A study was design ed to determine the effect of the consumption of the nutritive sweetener aspartame on non-insulin-dependent diabetics . Forty-three adult diabetics between the ages of 21 and 70 completed a 90-day study ; all were diabetics whose conditions were managed by diet and /or hypoglycemic agents . Participants in the blind study were instructed to continue their usual diet and to take two capsules of an assigned preparation three times daily with meals , either the aspartame or the placebo . The 1.8 g of aspartame administered is approximately three times the expected daily consumption of aspartame if used as a sweetener to replace sugar . Throughout the study subjects were examined for ( 1 ) symptoms of intolerance , ( 2 ) fasting plasma phenylalanine levels exceeding 4 mg/100 ml , and ( 3 ) deterioration of diabetic control . At the conclusion of the study subjects exhibited no symptoms that could be traced to the administration of aspartame or the placebo , and diabetic control was unaffected by the chronic administration of these substances . Aspartame seems to be well tolerated by non-insulin-dependent diabetics",
"Objective : To investigate the influence of ingestion of beverages with sucrose or with intense sweeteners on food intake ( FI ) and on hunger ratings in before and after a month of daily consumption of beverages . Design : Experimental study . Setting : Department of Physiology , University Hospital , Dijon , France . Subjects : In all , 12 men and 12 women , aged 20–25 y. Interventions : Four beverages contained either sucrose ( E+:100 g/l , 1672 kJ ) or intense sweeteners ( E− : None energy content ) and were flavoured with either orange ( O ) or raspberry ( R ) . FI was measured in the lab during two 2-consecutive-day periods , carried out on 2 successive weeks ( session 1 ) . The subjects drank 2 l of either E+ or E− beverages on the first day of both weekly periods , according to a balanced r and omised design . E+ was paired with O for 50 % of subjects and with R for the other 50 % . Subjects were then habituated over a 4-week period to both beverages , consuming 1 l of E+ beverage on odd days and 1 l of E– drink on even days . After this period , the measurements of session 1 were repeated ( session 2 , weeks 7–8 ) . Finally , FI was measured for two more 2-day periods ( weeks 9–10 ) after the association between flavour and energy content was reversed ( session 3 ) . Results : The E– drinks were less palatable than the E+ drinks . Besides , we observed that FI was not reduced in response to a liquid extra caloric load and there was no change in hunger ratings after the beverages in any of the sessions . Conclusion : Ingestion of caloric beverages induced a positive energy balance and the continuous exposure phase to these beverages over 1 month did not improve FI adaptation in response to the extra energy provided by the beverages . Sponsorship : This study was sponsored by SEV , Bourg la Reine , France ; the French Ministère de la Recherche et de la Technologie ( Programme AGROBIO-Aliments Demain ) and the Regional Council of Burgundy ( Dijon , France )",
"PURPOSE Despite the presence or absence of artificial sweeteners in cola drinks , both regular and diet soft drinks still contain phosphoric and citric acid , which contributes to the total acidic challenge potential on enamel . The purpose of this study was to assess the plaque pH , in vivo , after a substrate challenge of diet and regular soft drinks . METHODS Seventeen subjects were recruited for this study . All subjects were between the ages of 12 and 15 and had at least 4 restored tooth surfaces present . The subjects were given consent by their parents and were asked to refrain from brushing for 48 hours prior to the study . At baseline , plaque pH was measured from 4 separate locations using touch electrode methodology . Each subject was then r and omly assigned to one of two groups . The first group was exposed to regular Coke followed by Diet Coke , while the second group was exposed to Diet Coke followed by regular Coke . Subjects were asked to swish with 15 ml of the respective soft drink for one minute . Plaque pH was measured at the 4 design ated tooth sites at 5- , 10- and 20-minute intervals . Subjects then repeated the experiment using the other soft drink . RESULTS The results showed that regular Coke had significantly more acidic plaque pH values at the 5- , 10- and 20-minute intervals compared to Diet Coke , ( P = mean pH at 5 minutes for Coke and Diet Coke was 5.5 + /- 0.5 and 6.0 + /- 0.7 , respectively . At 10 minutes , the pH for Coke and Diet Coke was 5.6 + /- 0.6 and 6.2 + /- 0.7 , respectively . The pH at 20 minutes for Coke and Diet Coke was 5.7 + /- 0.7 and 6.5 + /- 0.5 , respectively . CONCLUSIONS These data suggest that regular Coke possesses a greater acid challenge potential on enamel than Diet Coke . However , in this clinical trial , the pH associated with either soft drink did not reach the critical pH which is expected for enamel demineralization and dissolution",
"The purpose of this investigation was twofold : ( 1 ) to examine the role of low- to moderate-intensity , short- duration physical activity on subjective appetite and ( 2 ) to identify the role of and associations between ventilation threshold ( VeT ) and energy intake at a pizza lunch 30 min after glucose and whey protein drinks in normal weight boys . In 14 boys ( age : 12.5+/-0.4 years ) subjective appetite was measured before and after a 12 min walking protocol design ed to determine physical fitness based on the VeT. On a separate occasion food intake ( FI ) and subjective appetite were measured in response to sweetened preloads of either a SPLENDA Sucralose control , glucose or whey protein made up to 250 ml with water , given in r and om order to each boy , 2h after a st and ardized breakfast . Subjective average appetite and prospect i ve food consumption scores increased after physical activity . VeT was positively associated with FI at a pizza lunch consumed 30 min after glucose and whey protein drinks . Glucose and whey protein reduced FI similarly at lunch compared with control . In conclusion , appetite is increased by low- to moderate-intensity , short- duration physical activity and FI following glucose and protein preloads is positively associated with fitness levels in boys",
"Abstract Purpose The aim of the study was to assess associations between intake of combined soft drinks ( sugar sweetened and artificially sweetened ) and fruit and vegetable juices and the risk of hepatocellular carcinoma ( HCC ) , intrahepatic bile duct ( IHBC ) and biliary tract cancers ( GBTC ) using data from the European Prospect i ve Investigation into Cancer and Nutrition cohort of 477,206 participants from 10 European countries . Methods After 11.4 years of follow-up , 191 HCC , 66 IHBC and 236 GBTC cases were identified . Hazard ratios and 95 % confidence intervals ( HR ; 95 % CI ) were estimated with Cox regression models with multivariable adjustment ( baseline total energy intake , alcohol consumption and intake pattern , body mass index , physical activity , level of educational attainment and self-reported diabetes status ) . Results No risk associations were observed for IHBC or GBTC . Combined soft drinks consumption of > 6 servings/week was positively associated with HCC risk : HR 1.83 ; 95 % CI 1.11–3.02 , ptrend = 0.01 versus non-consumers . In sub-group analyses available for 91 % of the cohort artificially sweetened soft drinks increased HCC risk by 6 % per 1 serving increment ( HR 1.06 , 95 % CI 1.03–1.09 , ncases = 101 ) ; for sugar-sweetened soft drinks , this association was None ( HR 1.00 , 95 % CI 0.95–1.06 ; ncases = 127 , pheterogeneity = 0.07 ) . Juice consumption was not associated with HCC risk , except at very low intakes ( combined soft drinks is positively associated with HCC , but a differential association between sugar and artificially sweetened can not be discounted . This study provides some insight into possible associations of HCC with sugary drinks intake . Further exploration in other setting s is required",
"BACKGROUND Obesity in adolescence has been increasing in the past several decades . Beverage habits among adolescents include increased consumption of sugar-sweetened beverages and decreased consumption of milk . OBJECTIVE This study aim ed to examine the association between beverage consumption and 5-y body weight change in 2294 adolescents . DESIGN Project EAT ( Eating Among Teens ) is a 5-y longitudinal study of eating patterns among adolescents . Surveys were completed in 1998 - 1999 ( time 1 ) and in 2003 - 2004 ( time 2 ) . Multivariable linear regression was used to examine the association between beverage consumption at time 2 and change in body mass index from time 1 to time 2 , with adjustments for age , socioeconomic status , race , cohort , physical activity , sedentary behavior , coffee , tea , time 1 body mass index , and beverage variables . RESULTS In prospect i ve analyses , consumption of beverages was not associated with weight gain , except for consumption of low-calorie soft drinks ( positive association , P = 0.002 ) and white milk ( inverse association , P = 0.03 ) , but these associations did not appear to be a monotonic linear dose-response relation . The positive association with low-calorie soft drinks was no longer present after adjustment for dieting and parental weight-related concerns , which suggests that the use of low-calorie soft drinks is a marker for more general dietary behaviors and weight concerns . CONCLUSIONS We showed no association between sugar-sweetened beverage consumption , juice consumption , and adolescent weight gain over a 5-y period . A direct association between diet beverages and weight gain appeared to be explained by dieting practice s. Adolescents who consumed little or no white milk gained significantly more weight than their peers who consumed white milk . Future research that examines beverage habits and weight among adolescents should address portion sizes , adolescent maturation , and dieting behaviors",
"Exercise is known to cause physiological changes that could affect the impact of nutrients on appetite control . This study was design ed to assess the effect of drinks containing either sucrose or high-intensity sweeteners on food intake following exercise . Using a repeated- measures design , three drink conditions were employed : plain water ( W ) , a low-energy drink sweetened with artificial sweeteners aspartame and acesulfame-K ( L ) , and a high-energy , sucrose-sweetened drink ( H ) . Following a period of challenging exercise ( 70 % VO2 max for 50 min ) , subjects consumed freely from a particular drink before being offered a test meal at which energy and nutrient intakes were measured . The degree of pleasantness ( palatability ) of the drinks was also measured before and after exercise . At the test meal , energy intake following the artificially sweetened ( L ) drink was significantly greater than after water and the sucrose ( H ) drinks ( p artificially sweetened ( L ) drink , the high-energy ( H ) drink suppressed intake by approximately the energy contained in the drink itself . However , there was no difference between the water ( W ) and the sucrose ( H ) drink on test meal energy intake . When the net effects were compared ( i.e. , drink + test meal energy intake ) , total energy intake was significantly lower after the water ( W ) drink compared with the two sweet ( L and H ) drinks . The exercise period brought about changes in the perceived pleasantness of the water , but had no effect on either of the sweet drinks . The remarkably precise energy compensation demonstrated after the higher energy sucrose drink suggests that exercise may prime the system to respond sensitively to nutritional manipulations . The results may also have implication s for the effect on short-term appetite control of different types of drinks used to quench thirst during and after exercise",
"INTRODUCTION Recently has been documented that the consumption of sweetened non-caloric beverages has increased as an option to weight control , however r and omized control trials have demonstrated a modest weight loss . OBJECTIVE To evaluate the effect of reducing consumption of beverage with caloric and non-caloric sweeteners on weight , body composition and blood pressure in young Mexican adults . METHODS In an experimental study 148 nursing students were r and omly assigned to one of 3 groups : 1 ) no sweetened beverages were permitted , only plain water , tea or coffee without sugar ; 2 ) consumption of beverages with non-caloric sweeteners was allowed ; and 3 ) no restriction of sweetened beverages was imposed . All groups were given individualized isocaloric diets monitored by a 24-hour record of consumption and food frequency question naire and blood pressure , weight , waist circumference and body composition by tetrapolar bioelectric impedance were taken at the beginning of the study and three and six months later . RESULTS Differences between groups were found in body mass index at 3 months that decrease in group 1 and 2 and increase in group 3 ( -1.75 vs.-0.61 vs.0.54 % of change , p waist circumference ( -4.07 vs.-1.23 vs. 0.62 % of change , p sugar consumption ( -62.0 vs.-54.61 vs.11.08 % of change , p caloric and non-caloric sweetened beverages contributes to signifi ca nt body mass index loss and waist circumference",
"Steviol glycosides , isolated from the plant Stevia rebaudiana ( Bertoni ) Bertoni , have been used as safe sweetening agents for more than 30 years . Beneficial effects of high doses of steviol glycosides on hyperglycemia and hypertension have been previously described when these abnormalities are present . This study was design ed to evaluate the effects of steviol glycosides on blood glucose and on blood pressure ( BP ) in 3 groups of individuals . This was a r and omized , double-blind , placebo-controlled , long-term study in three groups of patients : Group 1 : subjects with Type 1 diabetes ; Group 2 : subjects with Type 2 diabetes ; and Group 3 : subjects without diabetes and with normal/low-normal BP levels . The subjects in each group were r and omly allocated to active treatment ( the steviol glycoside stevioside : 250 mg t.d.s . ) or to placebo treatment and followed-up for 3 months . Post-treatment systolic BP , diastolic BP , glucose and glycated hemoglobin ( HbA1c ) were not significantly different from baseline measurements , except for the placebo Type 1 diabetics group where a significant difference was observed for systolic BP and glucose . No side effects were observed in the two treatment groups . This study shows that oral steviol glycosides , taken as sweetener are well tolerated and have no pharmacological effect",
"Rebaudioside A and stevioside are steviol glycosides extracted from the plant Stevia rebaudiana Bertoni and are used in several countries as food and beverage sweeteners . This r and omized , double-blind trial evaluated the hemodynamic effects of 4weeks consumption of 1000mg/day rebaudioside A vs. placebo in 100 individuals with normal and low-normal systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) . Subjects were predominantly female ( 76 % , rebaudioside A and 82 % , placebo ) with a mean age of approximately 41 ( range 18 - 73 ) years . At baseline , mean resting , seated SBP/DBP was 110.0/70.3mmHg and 110.7/71.2mmHg for the rebaudioside A and placebo groups , respectively . Compared with placebo , rebaudioside A did not significantly alter resting , seated SBP , DBP , mean arterial pressure ( MAP ) , heart rate ( HR ) or 24-h ambulatory blood pressures responses . These results indicate that consumption of as much as 1000mg/day of rebaudioside A produced no clinical ly important changes in blood pressure in healthy adults with normal and low-normal blood pressure",
" Among the subjects enrolled in the American Cancer Society Cancer Prevention Study II , a large nation-wide prospect i ve study , 282 died from multiple myeloma ( MM ) during the first 4 years of follow-up . These were divided into incident cases who were initially free from disease and prevalent cases who reported MM or related symptoms at the time of enrollment . For each case , 4 controls matched for age , sex , ethnic group and residence were r and omly selected . Previous history of diabetes [ odds ratio ( OR ) = 2.0 ] and employment as farmer ( OR = 2.7 ) were the risk factors consistently suggested by the results of the analysis . The risk associated with farming showed a linear trend with duration of exposure . Pesticide or herbicide exposure was not a risk factor per se but , when combined with farming , it increased the OR to 4.3 . Low education , occupational exposure to dyes , and employment in a bank , on the railroad or as a maid were also suggested risk factors , but either they were not statistically significant or they were based on small numbers of exposed subjects . No association between MM and asbestos exposure was observed",
"OBJECTIVE To compare the efficacy of non-nutritive sweetened beverages ( NNS ) or water for weight loss during a 12-week behavioral weight loss treatment program . METHODS An equivalence trial design with water or NNS beverages as the main factor in a prospect i ve r and omized trial among 303 men and women was employed . All participants participated in a behavioral weight loss treatment program . The results of the weight loss phase ( 12 weeks ) of an ongoing trial ( 1 year ) that is also evaluating the effects of these two treatments on weight loss maintenance were reported . RESULTS The two treatments were not equivalent with the NNS beverage treatment group losing significantly more weight compared to the water group ( 5.95 kg versus 4.09 kg ; P NNS beverage group reported significantly greater reductions in subjective feelings of hunger than those in the water group during 12 weeks . CONCLUSION These results show that water is not superior to NNS beverages for weight loss during a comprehensive behavioral weight loss program",
"Consumers often turn to non-caloric sweeteners ( NCS ) as a means of promoting a healthy body weight . However , several studies have now linked their long-term use to increased weight gain , raising the question of whether these products produce unintended psychological , physiological , or behavioral changes that have implication s for weight management goals . In the following , we present the results of three experiments bearing on this issue , testing whether NCS-consumption influences how individuals think about and respond to food . Participants in each of our three experiments were r and omly assigned to consume a sugar-sweetened beverage , an unsweetened beverage , or a beverage sweetened with NCS . We then measured their cognition ( Experiment 1 ) , product choice ( Experiment 2 ) , and subjective responses to a sugar-sweetened food ( Experiment 3 ) . Results revealed that consuming NCS-sweetened beverages influences psychological processes in ways that - over time - may increase calorie intake",
"To determine the effect of chewing sugar-free gum on caries incidence , the authors conducted a r and omized clinical study . A total of 1,402 children in Puerto Rico , in grade s 5 through 7 at baseline , completed the study . They were r and omized by classroom into a control group or chewing gum group ; those in the gum group were instructed to chew sugar-free gum for 20 minutes after each of three meals a day . Clinical and radiographic evaluations were performed at baseline and after two and three years . The results show that all subjects and high-risk subjects , respectively , in the gum group developed 7.9 percent and 11.0 percent fewer decayed , missing or filled surfaces than subjects in the control group . Based on these findings , the authors concluded that chewing sorbitol-based sugar-free gum after eating significantly reduces the incidence of dental caries",
"Objective The present study evaluated weight loss and compliance outcomes for overweight adolescents assigned to one of two dietary interventions differing in the type of snacks allowed . Methods The study was a 12-week , controlled clinical trial , among otherwise healthy but overweight ( body mass index ≥95th percentile ) 11-year-old to 15-year-old girls who were r and omly assigned to either a 1,500 kcal/day free-snack program or a 1,500 kcal/day restricted-snack program . All subjects were counseled to consume three servings of dairy products per day , and were provided with a 500 mg calcium supplement as well . Subjects in the free-snack group could choose any 150-calorie item as one of their two daily snacks , including regular soda if desired ; however , subjects in the restricted-snack group were limited to diet soda . Results Thirty-two adolescent girls completed the 12-week intervention . Both diets were equally effective in achieving a modest amount of weight loss , and were equally acceptable to the subjects . Significant decreases in weight , body mass index , anthropometric measures , total cholesterol and triglycerides were observed . Conclusions A 1,500 kcal/day diet allowing for a free snack of 150 calories was equally as effective as a more restricted snack policy in achieving a modest amount of weight loss among overweight 11-year-old to 15-year-old girls . In addition , results suggest that some soda may be included in a teen weight control diet , as long as caloric intake is maintained at recommended levels , and care is taken to achieve adequate intake of essential nutrients . Calcium intake among subjects was low at baseline , and , although it increased during the study ( due to supplementation ) , further efforts to increase consumption of naturally calcium-rich and calcium-fortified foods and beverages are needed",
"BACKGROUND A population of over 12,000 mature subjects participated in a longitudinal study ( 8 years ) of nutrition and health ( the Su . Vi . Max Study ) . In this context , a specific cross-sectional study was carried out in a r and omly selected sub population . AIM To identify anthropometric , nutritional and biochemical correlates of spontaneous use of ' light ' foods and drinks in a free-living population . DESIGN Men ( n = 2299 ) and women ( n = 1979 ) , 45 - 60 years , reported their food intakes over six non-consecutive days . Consumers of low-fat and low-sugar foods and drinks , and artificial sweeteners , were compared with non-consumers . RESULTS Users of low-sugar products were heavier than non-users ; female consumers of low-fat products , but not males , had higher body weight and BMI than non-consumers . Users of low-sugar products had higher triacylglycerols and glycaemia than non-users while biochemical parameters were not different in users and non-users of low-fat products . Use of low-sugar products led to increased diet density of a few micronutrients , including cholesterol . Low-fat product selection was associated with increased intake of most micronutrients , both in absolute value and in density . CONCLUSIONS In mature adults , selection of fat-reduced products was associated with improved quality of the diet , while anthropometric and biological parameters appeared less favourable in consumers of low-sugar products vs. non-consumers . The longitudinal follow-up of the cohort in future years will help determine cause- and -effect relationships among these parameters",
"AIMS Stevioside is a natural plant glycoside isolated from the plant Stevia rebaudiana which has been commercialized as a sweetener in Japan for more than 20 years . Previous animal studies have shown that stevioside has an antihypertensive effect . This study was to design ed to evaluate the effect of stevioside in human hypertension . METHODS A multicentre , r and omized , double-blind , placebo-controlled study was undertaken . This study group consisted of 106 Chinese hypertensive subjects with diastolic blood pressure between 95 and 110 mmHg and ages ranging from 28 to 75 years with 60 subjects ( men 34 , women 26 ; mean + /- s.d . , 54.1+/-3.8 years ) allocated to active treatment and 46 ( men 19 , women 27 ; mean + /- s.d . , 53.7+/-4.1 years ) to placebo treatment . Each subject was given capsules containing stevioside ( 250 mg ) or placebo thrice daily and followed-up at monthly intervals for 1 year . RESULTS After 3 months , the systolic and diastolic blood pressure of the stevioside group decreased significantly ( systolic : 166.0+/-9.4 - 152.6+/-6.8 mmHg ; diastolic : 104.7 + /- 5.2 - 90.3+/-3.6 mmHg , P Blood biochemistry parameters including lipid and glucose showed no significant changes . No significant adverse effect was observed and quality of life assessment showed no deterioration . CONCLUSIONS This study shows that oral stevioside is a well tolerated and effective modality that may be considered as an alternative or supplementary therapy for patients with hypertension",
"Brain cancer incidence rates in the United States have been increasing in both adults ( 1 ) and children ( 2 ) . The possibility that aspartame , a widely ingested artificial sweetener , may be a cause of brain cancer in humans was suggested in a recent report by Olney et al. ( 3 ) . From a descriptive analysis of national cancer data , they noted increased brain cancer incidence rates in the United States that coincided with the introduction of aspartame into food stuffs in the early 1980s . As part of a population -based case– control study of environmental and nutritional risk factors for pediatric brain tumor occurrence , we collected data on aspartame consumption before the date of diagnosis for case patients ( or a comparable reference date for control subjects ) from the biologic mothers of study children by in-person interview . The methodology for the study has been published previously ( 4 ) . Briefly , case patients were 19 years of age or older and were diagnosed with a primary brain tumor between 1984 and 1991 in 19 West Coast counties of the United States . Control subjects were recruited using r and om-digit dialing and were frequency-matched by age at diagnosis , year of birth , sex , and study site . We present data on aspartame consumption among the subset of participants from the Los Angeles and San Francisco sites where questions on aspartame consumption were added to the original question naire midway through the interviews . Our analysis of the child ’s exposure was conducted on 56 case patients and 94 control subjects who were born in 1981 or later ( to correspond with the U.S. Food and Drug Administration [ FDA ] approval of aspartame ) . We also evaluated brain tumor risk in relation to mother ’s consumption of aspartame during pregnancy and breast-feeding for 49 case patients and 90 control subjects who were in utero in 1981 or later . We calculated odds ratios ( ORs ) and 95 % confidence intervals and adjusted for the frequency-matched variables with the use of unconditional logistic regression . Additional adjustment for known or suspected risk factors ( maternal vitamin use , cured meat consumption , passive smoke exposure , x-ray exposure , head injury , and family history of brain cancer ) did not change our results . Case children were no more likely than control children to consume foods containing aspartame , either from all sources of aspartame combined ( OR 4 1.1 ) or from diet drinks ( OR 4 0.9 ) ( Table 1 ) . There was no suggestion of a dose – response relation based on age at first consumption , number of years of consumption , or frequency of consumption . We observed no elevated brain tumor risk to the child from maternal consumption of aspartame during pregnancy nor did we find elevated risks during any trimester of pregnancy or during breast-feeding ( Table 2 ) . Additionally , we found no evidence for an aspartame – brain tumor association when the analysis was stratified by histologic subgroups ( astroglial , primitive neuroectodermal , or all others ) . These findings are not consistent with an aspartame – brain cancer relation , although our study sample was small and the confidence intervals of our risk estimates are relatively wide . Recall bias is unlikely to have affected these results , or we would expect to see elevations in risk ; however , it is conceivable that exposure misclassification that was r and omly distributed between case patients and control subjects could have masked a true effect , if the true effect was weak . We are aware of no other epidemiologic studies that have evaluated brain cancer risk from aspartame consumption . There have been numerous studies ( 5 - 8 ) related to the potential neurotoxic effects of aspartame . However , few experimental or biochemical reports related to the carcinogenicity of aspartame are in the scientific literature . Before approval of aspartame for human consumption , the FDA and an FDA appointed public board of inquiry review ed several studies to determine if aspartame can induce brain neoplasms in mice or rats . The mice studies were negative , but interpretation of two of the three rat studies differed initially between the FDA and its board of inquiry . These differences were resolved , and the FDA commissioner concluded that aspartame did not contribute to brain tumor formation in rats ( 7 - 10 ) . A subsequent rat study also found no association between aspartame and brain tumor occurrence ( 11 ) . Because some dietary constituents can be nitrosated in the stomach to form potentially carcinogenic N-nitroso compounds ( 12 ) , Shephard et al. ( 13 ) evaluated the mutagenic activity of aspartame after nitrosation . They observed only a weak mutagenic effect of nitrosated aspartame at concentrations considerably higher than normal human intake levels . On the basis of the kinetics of nitrosation of mutagenic intermediates , Shephard et al. concluded that the terminal amino group of aspartame , not the amide function , was primarily nitrosated . It would be nitrosation of the amide function , not the terminal amino group , that could produce a potential brain carcinogen , based on the ability of the related nitrosoureas to induce brain tumors in laboratory animals ( 14 ) . Thus , our review revealed little biologic or experimental evidence that aspartame is likely to act as a human brain carcinogen",
"OBJECTIVE The increase in consumption of sugar-added beverages over recent decades may be partly responsible for the obesity epidemic among U.S. adolescents . Our aim was to evaluate the relationship between BMI changes and intakes of sugar-added beverages , milk , fruit juices , and diet soda . RESEARCH METHODS AND PROCEDURES Our prospect i ve cohort study included > 10,000 boys and girls participating in the U.S. Growing Up Today Study . The participants were 9 to 14 years old in 1996 and completed question naires in 1996 , 1997 , and 1998 . We analyzed change in BMI ( kilograms per meter squared ) over two 1-year periods among children who completed annual food frequency question naires assessing typical past year intakes . We studied beverage intakes during the year corresponding to each BMI change , and in separate models , we studied 1-year changes in beverage intakes , adjusting for prior year intakes . Models included all beverages simultaneously ; further models adjusted for total energy intake . RESULTS Consumption of sugar-added beverages was associated with small BMI gains during the corresponding year ( boys : + 0.03 kg/m2 per daily serving , p = 0.04 ; girls : + 0.02 kg/m2 , p = 0.096 ) . In models not assuming a linear dose-response trend , girls who drank 1 serving/d of sugar-added beverages gained more weight ( + 0.068 , p = 0.02 ) than girls drinking none , as did girls drinking 2 servings/d ( + 0.09 , p = 0.06 ) or 3 + servings/d ( + 0.08 , p = 0.06 ) . Analyses of year-to-year change in beverage intakes provided generally similar findings ; boys who increased consumption of sugar-added beverages from the prior year experienced weight gain ( + 0.04 kg/m2 per additional daily serving , p = 0.01 ) . Children who increased intakes by 2 or more servings/d from the prior year gained weight ( boys : + 0.14 , p = 0.01 ; girls + 0.10 , p = 0.046 ) . Further adjusting our models for total energy intake substantially reduced the estimated effects , which were no longer significant . DISCUSSION Consumption of sugar-added beverages may contribute to weight gain among adolescents , probably due to their contribution to total energy intake , because adjustment for calories greatly attenuated the estimated associations",
"Given the potential use of a low-calorie sweetener during weight reduction , a toxicity study of chronic aspartame ingestion was conducted . Particular attention was given to possible long-term effects of aspartame on the fuel hormonal alterations characteristically caused by weight reduction . As a group mean age was 19.3 yr , body weight was 164.6 lb , and mean height was 65.4 in . Subjects were an average of 33 % in excess of ideal body weight . The aspartame dose was 2.7 g/day and was compared on a double-blind r and omized basis with a lactose placebo . Both material s were given in gelatin capsules . An average of 6.9 + /- 1.5 lb was lost by the aspartame group during the 13-wk study on a calculated 1,000-calorie diet . The placebo group lost 4.5 + /- 1.2 lb ( no significant difference between the two groups ) . After an overnight fast , reductions in glucose and immunoreactive insulin were seen in both groups , while rising trends in immunoreactive glucagon were observed . These changes are all characteristic of calorie restriction . In no instance was there a detectable effect of the ingested aspartame . No meaningful effect of weight reduction or aspartame was seen on plasma triglyceride and cholesterol , nor on any other parameter of hematologic , hepatic , or renal function that was measured . Similarly , side effects were equally distributed between asparatame and placebo",
"OBJECTIVE . The obesity epidemic in the United States continues to increase . Because obesity tends to track over time , the increase in overweight among young children is of significant concern . A number of eating patterns have been associated with overweight among preschool-aged children . Recently , 100 % fruit juice and sweetened fruit drinks have received considerable attention as potential sources of high-energy beverages that could be related to the prevalence of obesity among young children . Our aim was to evaluate the beverage intake among preschool children who participated in the National Health and Nutrition Examination Survey 1999–2002 and investigate associations between types and amounts of beverages consumed and weight status in preschool-aged children . METHODS . We performed a secondary analysis of the data from the National Health and Nutrition Examination Survey 1999–2002 , which is a continuous , cross-sectional survey of a nationally representative sample of the noninstitutionalized population of the United State . It included the collection of parent reported demographic descriptors , a 24-hour dietary recall , a measure of physical activity , and a st and ardized physical examination . The 24-hour dietary recall was obtained in person by a trained interviewer and reflected the foods and beverages that were consumed by the participant the previous day . The National Health and Nutrition Examination Survey food groups were classified on the basis of the US Department of Agriculture 's Food and Nutrient Data base for Dietary Studies . We review ed the main food descriptors used and classified all beverages listed . One hundred percent fruit juice was classified as only beverages that contained 100 % fruit juice , without sweetener . Fruit drinks included any sweetened fruit juice , fruit-flavored drink ( natural or artificial ) , or drink that contained fruit juice in part . Milk included any type of cow milk and then was subcategorized by percentage of milk fat . Any sweetened soft drink , caffeinated or uncaffeinated , was categorized as soda . Diet drinks included any fruit drink , tea , or soda that was sweetened by low-calorie sweetener . Several beverages were removed from the analysis because of low frequency of consumption among the sample . Water was not included in the analysis because it is not part of the US Department of Agriculture 's Food and Nutrient Data base categories . For the purpose s of this analysis , the beverages were converted and reported as ounces , rather than grams , as reported by the National Health and Nutrition Examination Survey , to make it more clinical ly relevant . The child 's BMI percentile for age and gender were calculated on the basis of Centers for Disease Control and Prevention criteria and used to identify children 's weight status as underweight ( , at risk for overweight ( 85 % to . Because of the small number of children in the underweight category , they were included in the normal-weight category for this analysis . Data were analyzed using SUDAAN 9.0.1 statistical software programs . SUDAAN allows for improved accuracy and validity of results by calculating test statistics for the stratified , multistage probability design of the National Health and Nutrition Examination Survey . Sample weights were applied to all analyses to account for unequal probability of selection from oversampling low-income children and black and Mexican American children . Descriptive and χ2 analyses and analysis of covariance , adjusting for age , gender , ethnicity , household income , energy intake , and physical activity , were conducted . RESULTS . All children who were aged 2 to 5 years were identified ( N = 1572 ) . Those with missing data were removed from additional analysis , result ing in a final sample of 1160 preschool children . Of the 1160 children analyzed , 579 ( 49.9 % ) were male . White children represented 35 % , black children represented 28.3 % , and Hispanic children represented 36.7 % of the sample . Twenty-four percent of the children were overweight or at risk for overweight ( BMI ≥85 % ) , and 10.7 % were overweight ( BMI ≥95 % ) . There were no statistically significant differences in BMI between boys and girls or among the ethnicities . Overweight children tended to be older ( mean age : 3.83 years ) compared with the normal-weight children ( mean age : 3.48 years ) . Eighty-three percent of children drank milk , 48 % drank 100 % fruit juice , 44 % drank fruit drink , and 39 % drank soda . Whole milk was consumed by 46.5 % of the children , and 3.1 % and 5.5 % of the children consumed skim milk and 1 % milk , respectively . Preschool children consumed a mean total beverage volume of 26.93 oz/day , which included 12.32 oz of milk , 4.70 oz of 100 % fruit juice , 4.98 oz of fruit drinks , and 3.25 oz of soda . Weight status of the child had no association with the amount of total beverages , milk , 100 % fruit juice , fruit drink , or soda consumed . There was no clinical ly significant association between the types of milk ( percentage of fat ) consumed and weight status . In analysis of covariance , daily total energy intake increased with increased consumption of milk , 100 % fruit juice , fruit drinks , and soda . However , there was not a statistically significant increase in BMI on the basis of quantity of milk , 100 % fruit juice , fruit drink , or soda consumed . CONCLUSIONS . On average , preschool children drank less milk than the 2005 Dietary Guidelines for Americans recommendation of 16 oz/day . Only 8.6 % drank low-fat or skim milk , as recommended for children who are older than 2 years . On average , preschool children drank total energy intake of the children but not with their BMI . Prospect ively study ing preschool children beyond 2 to 5 years of age , through their adiposity rebound ( ∼5.5–6 years ) to determine whether there is a trajectory increase in their BMI , may help to clarify the role of beverage consumption in total energy intake and weight status",
"The influence of dietary factors , in particular the intake of fat and beta‐carotene , on breast‐cancer risk was evaluated in a case‐control study including 1,486 breast cancer cases diagnosed over a 1 year period in Denmark . The control group was an age‐stratified r and om sample of 1,336 women from the general population . Data on usual diet prior to the breast cancer diagnosis were collected by self‐administered question naires of the semi‐quantitative food frequency type . A highly significant trend ( p fat intake , the RR for the highest quartile being 1.45 ( 95 % Cl 1.17‐1.80 ) compared with the lowest . However , information was not available to allow adjustment for the possible confounding effect of energy intake . The risk of breast cancer was not associated with consumption of vegetables rich in beta‐carotene , multi‐vitamin tablets or other dietary supplements , coffee , tea , sugar or artificial sweeteners",
"This study was design ed to ascertain whether individuals with mood disorders are particularly vulnerable to adverse effects of aspartame . Although the protocol required the recruitment of 40 patients with unipolar depression and a similar number of individuals without a psychiatric history , the project was halted by the Institutional Review Board after a total of 13 individuals had completed the study because of the severity of reactions within the group of patients with a history of depression . In a crossover design , subjects received aspartame 30 mg/kg/day or placebo for 7 days . Despite the small n , there was a significant difference between aspartame and placebo in number and severity of symptoms for patients with a history of depression , whereas for individuals without such a history there was not . We conclude that individuals with mood disorders are particularly sensitive to this artificial sweetener and its use in this population should be discouraged",
"The objective of this study was to determine whether sugarless chewing gums sweetened with different sweeteners differ in their ability to reduce an acidogenic response from a 10 percent sucrose-rinse challenge . Five commercially available chewing gums and two control regimens ( \" no gum \" or paraffin ) were tested using a plaque pH telemetry system . The gums were sweetened with sucrose , high-intensity sweeteners ( aspartame , saccharin , or acesulfame-K ) , or a polyol ( xylitol ) . Using a seven-period r and omized block design , eight adult panelists were challenged with a 10 percent sucrose solution and then r and omly used one of the test regimens during each of the seven test sessions . Each two-hour test session was divided into five periods : resting baseline ( five minutes ) ; sucrose rinse challenge ( two minutes ) ; postsucrose challenge ( ten minutes ) ; gum chewing ( ten minutes ) ; post gum chewing ( ninety-three minutes ) . The factors analyzed were : the area of the curve ( pH X Time ) below pH 5.5 , the minimum plaque pH attained , the changes in plaque pH over relevant intervals , and the length of time the plaque pH remained below pH 5.5 . The various response variables showed a similar pattern of statistically significant differences . All of the sugarless gums were effective in significantly increasing plaque pH and in reducing the area under the curve after the sucrose challenge compared with \" no gum \" treatment . No statistically significant differences were noted among the sugarless gums . The response to sucrose gum was intermediate between sugarless gums and \" no gum \" but was not statistically different from \" no gum \" or three of the sugarless gums . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The dietary intake of cyclamate was evaluated in the north-east of Spain in 1992 . In a r and om sample of the Catalan population consisting of 2450 people aged 6 - 75 years , two 24-h recalls at different seasons were collected ; the amount and type of all foods , drinks and drugs consumed were obtained and the total daily intake of cyclamate was expressed in mg/kg body weight ( bw ) , as the average of both 24-h recalls . Eighteen percent of the population consumed cyclamate , and the highest percentage was in men aged 35 - 44 years ( 33 % ) . Average daily intake of cyclamate was 0.44 mg/kg bw in the whole population and 2.44 mg/kg bw among consumers . Subjects following a diet reported highest intakes , especially diabetics , and only 0.16 % of the sample studied had levels above the Acceptable Daily Intake ( ADI ) . Among consumers , the intake of cyclamate was negatively correlated with Body Mass Index ( BMI ) . The results show the pattern of cyclamate intake in the Spanish population",
"A prospect i ve study of all patients with superficial bladder cancer diagnosed in Northern Alberta ( population 1.2 million ) from 1977 to 1983 was performed to establish patterns of recurrence . Of the 761 patients with all stages of bladder cancer at diagnosis , 642 were deemed to be free of disease after primary treatment consisting of transurethral resection , fulguration , or laser surgery . Follow-up of these patients showed that approximately two-thirds of first recurrences occur within 18 months of diagnosis and that more of these patients have died of unrelated causes ( n = 73 ) than of bladder cancer ( n = 34 ) . Censored disease-free interval comparisons showed that initial recurrences occurred sooner in patients with multifocal rather than unifocal disease and also sooner in females than in males . Known risk factors ( occupational exposure to chemicals and cigarette smoking ) and suspected risk factors ( coffee consumption and artificial sweetener use ) had no effect on disease-free interval and are not related to tumor multiplicity",
"This study explores whether the addition of aspartame-sweetened foods and beverages to a low fat , hypocaloric diet enhances compliance and result ing weight loss . Fifty-nine obese ( 130 - 225 % of ideal body weight ) , free living men and women were r and omly assigned to either a Balanced Deficit Diet ( BDD ) or a BDD supplemented with aspartame . Over a 12-week weight loss period , volunteers attended weekly support group meetings including behavior modification training and exercise instruction . Males achieved a clinical ly significant weight loss ( greater than 23 lb ) in both study groups , while females lost an average of 12.8 lb in the control group vs. 16.5 lb in the experimental group . In both treatment groups , sleep , general energy level , level of physical activity , and feeling of well-being showed clinical ly meaningful improvement . This study suggests possible advantages to supplementing a BDD with aspartame-sweetened foods as part of a multidisciplinary weight loss program . The small sample size prohibits definitive conclusions but does provide the protocol for a larger , outpatient clinical trial",
"BACKGROUND Bladder cancer is the second most incident malignancy among Lebanese men . The purpose of this study was to investigate potential risk factors associated with this observed high incidence . METHODS A case-control study ( 54 cases and 105 hospital-based controls ) was conducted in two major hospitals in Beirut . Cases were r and omly selected from patients diagnosed in the period of 2002 - 2008 . Controls were conveniently selected from the same setting s. Data were collected using interview question naire and blood analysis . Exposure data were collected using a structured face-to-face interview question naire . Blood sample s were collected to determine N-acetyltransferase1 ( NAT1 ) genotype by PCR-RFLP . Analyses revolved around univariate , bivariate and multivariate logistic regression , along with checks for effect modification . RESULTS The odds of having bladder cancer among smokers was 1.02 times significantly higher in cases vs. controls . The odds of exposure to occupational diesel or fuel combustion fumes were 4.1 times significantly higher in cases vs controls . The odds of prostate-related morbidity were 5.6 times significantly higher in cases vs controls . Cases and controls showed different clustering patterns of NAT1 alleles . No significant differences between cases and controls were found for consumption of alcohol , coffee , tea , or artificial sweeteners . CONCLUSIONS This is the first case-control study investigating bladder cancer risk factors in the Lebanese context . Results confirmed established risk factors in the literature , particularly smoking and occupational exposure to diesel . The herein observed associations should be used to develop appropriate prevention policies and intervention strategies , in order to control this alarming disease in Lebanon",
"To examine the eating behavior of preschool children offered chocolate-flavored or plain milk at lunch , food consumption by 135 children , aged 18 - 66 months , was measured . Four different menus were served six times during a 12-week period , each menu being presented twice with each of three test beverages , plain milk ( 18.1 kcal/oz ) , sucrose-sweetened chocolate milk ( 29.4 kcal/oz ) , or aspartame-sweetened chocolate milk ( 18.6 kcal/oz ) . The type of milk beverage served had no significant effect on the consumption of other food items offered at that meal . Subjects did drink significantly more chocolate milk than plain milk during all meals and consequently consumed significantly more energy during those meals in which sucrose-sweetened chocolate milk was served . A macronutrient analysis of lunch-time food intake for each menu revealed significant differences in protein , fat , and carbohydrate content among the four menus . Older children consumed significantly more milk and more energy per lunch-time meal than did younger preschoolers , but no other consistent age-related differences were observed . No significant gender differences were detected in any of the statistical analyses conducted . These findings suggest that young children do not reduce the intake of other food items at a meal to compensate for the increased energy intake that results from excessive sucrose-sweetened milk consumption . Aspartame-sweetened milk increases milk intake in small children without providing them with the additional calories of sucrose-sweetened milk",
"Chocolate milk increases milk consumption of children , but high sugar content raises health concerns . Interest in sugar reduction and parents ' preference for natural sweeteners necessitates further research on natural nonnutritive sweeteners . However , it is important to maintain consumer acceptability , especially for children , while reducing sugar in chocolate milk . The objectives of this study were to identify the sweetness intensity perception of stevia leaf ( STV ) and monk fruit ( MK ) extracts in skim chocolate milk ( SCM ) , to evaluate STV and MK as the sole or partial sweetener source for SCM for young adults ( 19 to 35 y ) and children ( 5 to 13 y ) , and to determine if information on natural nonnutritive sweeteners impacted parents ' acceptability of SCM . Power function and 2-alternative forced choice studies were used to determine the iso-sweetness of nonnutritive sweeteners to a sucrose control in SCM ( 51.4 g/L , SUC control ) . Young adults ( n = 131 ) evaluated 9 different SCM ( SUC control , STV , MK , STV : sucrose blends , or MK : sucrose blends ) in a completely r and omized 2-d test . Children ( n = 167 ) evaluated SUC control SCM and SCM with 39.7 g/L sucrose and 46 mg/L MK ( MK25 ) or 30 mg/L STV ( STV25 ) . Parents evaluated SUC control , MK25 , and STV25 in a balanced crossover design with a 40-d wait time between primed or unprimed ballots . Chocolate milks solely sweetened by nonnutritive sweeteners were less acceptable compared with SUC control by young adults . MK25 and STV25 were acceptable by young adults and children . The presentation of chocolate milk label information had different effects on parental acceptance . Traditional parents preferred sucrose sweetened SCM , and label conscious parents preferred SCM with natural nonnutritive sweeteners",
"SYNOPSIS Recently , three pilot studies have proposed that the addition of products containing aspartame to thediets of migraine headache sufferers may produce a significant increase in the frequency of theirmigraines . The present study was a controlled thirteen-week , double-blind , r and omized cross-over study comparing the effect of aspartame to that of a matched placebo on the frequency and intensity of migraineheadache . The results of this study indicated that the ingestion of aspartame by migraineurs caused asignificant increase in headache frequency for some subjects . The implication s of these findings and suggestions for further research are discussed",
"The aim of this study was to analyze the relationship between current dietary habits and dental caries in schoolchildren from an area of Spain on which the prevalence of caries was low . The results of an epidemiological study conducted on a r and om sample of 893 children from the cities of Girona and Figueres are presented . The method of dietary interview consisted of a food-frequency question naire . This showed a positive relationship between dental caries and consumption of ice cream , pastries , cakes , sliced bread , on the one h and , and sugar-free chewing gum and sugar-free c and ies , on the other . A protective effect of skimmed milk and artificial sweeteners was also observed . Results reflect the role of certain foods in caries development , but also the outcome of selective dietary counseling to high-risk children",
"The long-term effects of sucrose on appetite and mood remain unclear . Normal weight subjects compensate for sucrose added blind to the diet ( Reid et al. , 2007 ) . Overweight subjects , however , may differ . In a single-blind , between-subjects design , soft drinks ( 4x25cl per day ; 1800kJ sucrose sweetened versus 67kJ aspartame sweetened ) were added to the diet of overweight women ( n=53 , BMI 25 - 30 , age 20 - 55 ) for 4 weeks . A 7-day food diary gave measures of total energy , carbohydrate , protein , fat , and micronutrients . Mood and hunger were measured by ten single Likert scales rated daily at 11.00 , 14.00 , 16.00 , and 20.00 . Activity levels were measured by diary and pedometer . Baseline energy intake did not differ between groups . During the first week of the intervention energy intake increased slightly in the sucrose group , but not in the aspartame group , then decreased again , so by the final week intake again did not differ from the aspartame group . Compensation was not large enough to produce significant changes in the composition of the voluntary diet . There were no effects on hunger or mood . It is concluded that overweight women do not respond adversely to sucrose added blind to the diet , but compensate for it by reducing voluntary energy intake . Alternative explanations for the correlation between sugary soft drink intake and weight gain are discussed",
"BACKGROUND Concern about the carcinogenic potential of aspartame was raised after an increase in lymphomas and leukemia was reported in an animal study at doses similar to human exposure . Two prospect i ve cohort studies published after the report found inconsistent results for estimated aspartame intake , artificially sweetened beverage consumption , and risk of lymphoid neoplasms . OBJECTIVE The objective of this study was to examine associations of artificially and sugar-sweetened carbonated beverage consumption ( for comparison ) and aspartame intake with risk of non-Hodgkin lymphoma ( NHL ) overall and by major histologic subtype in the Cancer Prevention Study -II Nutrition Cohort . METHODS Among 100,442 adult men and women who provided information on diet and lifestyle factors in 1999 , 1196 NHL cases were verified during a 10-y follow-up period . Cox proportional hazards regression was used to estimate multivariable-adjusted RRs and 95 % CIs . RESULTS In women and men combined , there were no associations of consumption of ≥1 ( 355 mL ) servings/d of artificially ( RR : 0.92 ; 95 % CI : 0.73 , 1.17 ; P-trend : 0.14 ) or sugar- ( RR : 1.10 ; 95 % CI : 0.77 , 1.58 ; P-trend : 0.62 ) sweetened carbonated beverages with NHL risk , compared to no consumption ( P-heterogeneity by gender : 0.11 - 1.00 ) . Similarly , aspartame intake was not associated with NHL risk ( RR : 1.02 ; 95 % CI : 0.84 , 1.24 ; P-trend : 0.69 , top vs. bottom quintile ) . Associations with NHL subtype ( multiple myeloma , diffuse large B-cell lymphoma , chronic lymphocytic leukemia/small lymphocytic lymphoma , and follicular and other B-cell lymphoma ) were generally None . CONCLUSION These findings do not support associations of daily consumption of artificially or sugar-sweetened carbonated beverages , or aspartame , with NHL risk "
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41171af4-06ff-11f0-808a-c43d1ab1c353
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PURPOSE OF REVIEW The aim of this review is to summarize important publications in enhanced recovery during 2010 - 2011 and to highlight key themes . Specifically , we focus on up date d systematic review s of high- quality clinical trials of enhanced recovery in colorectal surgery , exemplar studies of enhanced recovery in other specialties , and exploration of which elements of the enhanced recovery package might be associated with improved patient outcome . RECENT FINDINGS An exp and ing evidence base of clinical trials and implementation evaluations supports the effectiveness of enhanced recovery programmes in improving outcome following major elective surgery . The majority of this literature derives from the study of patients undergoing colorectal surgery , but increasingly enhanced recovery is spreading to other surgical specialties . The combination of reduced length of hospital stay ( a surrogate for morbidity ) with no increase in readmissions to hospital suggests that morbidity is reduced with enhanced recovery . Inconsistency in morbidity reporting limits the value of pooling data between studies , but within study comparisons in general support this conclusion . Patients adhering to an enhanced recovery programme return to normal function faster than those following traditional care pathways . SUMMARY Enhanced recovery adoption is likely to continue to grow ( range of specialties and penetration within specialties ) . This progression is supported by the available published data
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[
"OBJECTIVES To study the impact of different adherence levels to the enhanced recovery after surgery ( ERAS ) protocol and the effect of various ERAS elements on outcomes following major surgery . DESIGN Single-center prospect i ve cohort study before and after reinforcement of an ERAS protocol . Comparisons were made both between and across periods using multivariate logistic regression . All clinical data ( 114 variables ) were prospect ively recorded . SETTING Ersta Hospital , Stockholm , Sweden . PATIENTS Nine hundred fifty-three consecutive patients with colorectal cancer : 464 patients treated in 2002 to 2004 and 489 in 2005 to 2007 . MAIN OUTCOME MEASURES The association between improved adherence to the ERAS protocol and the incidence of postoperative symptoms , complications , and length of stay following major colorectal cancer surgery was analyzed . RESULTS Following an overall increase in preoperative and perioperative adherence to the ERAS protocol from 43.3 % in 2002 to 2004 to 70.6 % in 2005 to 2007 , both postoperative complications ( odds ratio , 0.73 ; 95 % confidence interval , 0.55 - 0.98 ) and symptoms ( odds ratio , 0.53 ; 95 % confidence interval , 0.40 - 0.70 ) declined significantly . Restriction of intravenous fluid and use of a preoperative carbohydrate drink were major independent predictors . Across periods , the proportion of adverse postoperative outcomes ( 30-day morbidity , symptoms , and readmissions ) was significantly reduced with increasing adherence to the ERAS protocol ( > 70 % , > 80 % , and > 90 % ) compared with low ERAS adherence ( multimodal ERAS protocol is significantly associated with improved clinical outcomes following major colorectal cancer surgery , indicating a dose-response relationship",
"INTRODUCTION Colorectal surgery has been associated with a complication rate of 15 - 20 % and mean post-operative inpatient stays of 6 - 11 days . The principles of enhanced recovery after surgery ( ERAS ) are well established and have been developed to optimise peri-operative care and facilitate discharge . The purpose of this systematic review is to present an up date d review of peri-operative care in colorectal surgery from the available evidence and ERAS group recommendations . METHODS Systematic search es of the PubMed and Embase ™ data bases and the Cochrane library were conducted . A h and search of bibliographies of identified studies was conducted to identify any additional articles missed by the initial search strategy . RESULTS A total of 59 relevant studies were identified . These included six r and omised controlled trials and seven clinical controlled trials that fulfilled the inclusion criteria . These studies showed reductions in duration of inpatient stays in the ERAS groups compared with more traditional care as well as reductions in morbidity and mortality rates . CONCLUSIONS Review ing the data reveals that ERAS protocol s have a role in reducing post-operative morbidity and result in an accelerated recovery following colorectal surgery . Similarly , both primary and overall hospital stays are reduced significantly . However , the available evidence suggests that ERAS protocol s do not reduce hospital readmissions or mortality . These findings help to confirm that ERAS protocol s should now be implemented as the st and ard approach for peri-operative care in colorectal surgery",
"BACKGROUND AND PURPOSE Postoperative recovery of intestinal function , ability to ambulate , and effective pain management are main features to establish an effective fast-track surgery model . We investigated pain scores , ambulation rate , and recovery of intestinal function in a cohort of patients who were undergoing laparoscopic radical prostatectomy ( LRP ) . PATIENTS AND METHODS Fifty patients who underwent LRP in our institution were r and omized to receive either conventional or fast-track postoperative care . Postoperative intestinal function was quantified by clinical signs of intestinal motility . Ambulation data were collected by means of step-count devices . Pain scores were measured by a visual analog scale . Overall satisfaction and additional measures to describe patient satisfaction with the clinical course were used as quality -of-life variables . RESULTS Fast-track patients had significantly earlier propulsive intestinal motility without increased intestinal complications . Enforced mobilization led to a significantly shorter period to first deflation/defecation . Despite significantly increased ambulation rates in the fast-track group , these patients reported significantly less pain sentience during a significantly shorter hospital stay . Overall satisfaction was significantly higher in the fast-track cohort during the hospital stay . CONCLUSION With the implementation of fast-track concepts for LRP , patients can be discharged to home earlier with fewer complications , lower pain scores , and an overall higher satisfaction with life",
"Bilateral simultaneous total knee replacement ( TKR ) has been considered by some to be associated with increased morbidity and mortality . Our study analysed the outcome of 150 consecutive , but selected , bilateral simultaneous TKRs and compared them with that of 271 unilateral TKRs in a st and ardised fast-track setting . The procedures were performed between 2003 and 2009 . Apart from staying longer in hospital ( mean 4.7 days ( 2 to 16 ) versus 3.3 days ( 1 to 25 ) ) and requiring more blood transfusions , the outcome at three months and two years was similar or better in the bilateral simultaneous TKR group in regard to morbidity , mortality , satisfaction , the range of movement , pain , the use of a walking aid and the ability to return to work and to perform activities of daily living . Bilateral simultaneous TKR can therefore be performed as a fast-track procedure with excellent results",
"Background The aim of this trial was to compare the Enhanced Recovery After Surgery ( ERAS ) program with conventional perioperative management in patients who underwent radical resection for colorectal cancer . Methods A combination of evidence -based and consensus methodology was used to develop the ERAS protocol . Five hundred ninety-seven consecutive patients who underwent elective colorectal resection were r and omized to either the ERAS ( n = 299 ) or the control group ( n = 298 ) . Outcomes relating to nutrition and metabolism index , stress index , and recovery index were measured and recorded . Results Demographic and operative data were similar between the two groups . Patients in the ERAS group showed improved nutritional status when compared with those of the control group . On postoperative day ( POD ) 1 , the HOMA-IR ( insulin resistance index ) of the ERAS group was lower than that of the control group ( p The cortisol level of the control group was elevated on both POD 1 ( p = 0.007 ) and POD 5 ( p = 0.002 ) compared to the preoperative level . However , the cortisol level of the ERAS group was not increased until POD 5 ( p = 0.001 ) . Reduced levels of TNF-α , IL-1β , IL-6 , and IFN-γ in the ERAS group indicated less postoperative stress responses . In addition , ERAS was associated with accelerated recovery of gastrointestinal function . The postoperative length of stay ( p ERAS protocol attenuates the surgical stress response and accelerates postoperative recovery without compromising patient safety",
"OBJECTIVE To investigate the feasibility of a 48-hour postoperative stay program after colonic resection . SUMMARY BACKGROUND DATA Postoperative hospital stay after colonic resection is usually 6 to 12 days , with a complication rate of 10 % to 20 % . Limiting factors for early recovery include stress-induced organ dysfunction , paralytic ileus , pain , and fatigue . It has been hypothesized that an accelerated multimodal rehabilitation program with optimal pain relief , stress reduction with regional anesthesia , early enteral nutrition , and early mobilization may enhance recovery and reduce the complication rate . METHODS Sixty consecutive patients undergoing elective colonic resection were prospect ively studied using a well-defined postoperative care program including continuous thoracic epidural analgesia and enforced early mobilization and enteral nutrition , and a planned 48-hour postoperative hospital stay . Postoperative follow-up was scheduled at 8 and 30 days . RESULTS Median age was 74 years , with 20 patients in ASA group III-IV . Normal gastrointestinal function ( defecation ) occurred within 48 hours in 57 patients , and the median hospital stay was 2 days , with 32 patients staying 2 days after surgery . There were no cardiopulmonary complications . The readmission rate was 15 % , including two patients with anastomotic dehiscence ( one treated conservatively , one with colostomy ) ; other readmissions required only short-term observation . CONCLUSION A multimodal rehabilitation program may significantly reduce the postoperative hospital stay in high-risk patients undergoing colonic resection . Such a program may also reduce postoperative ileus and cardiopulmonary complications . These results may have important implication s for the care of patients after colonic surgery and in the future assessment of open versus laparoscopic colonic resection",
"OBJECTIVE To investigate if intrathecally administered morphine combined with a low-dose mode of total intravenous anaesthesia ( TIVA ) accelerates recovery after abdominal surgery as compared , to patient-controlled analgesia ( PCA ) combined with anaesthesia , based on volatile anaesthetics . STUDY DESIGN Fifty-three patients who were hysterectomised abdominally were r and omised to TIVA or PCA . Their per- and post-operative course was strictly monitored and their pain score was evaluated with a visual analogue scale at repeated time intervals . RESULTS Patients with TIVA had a significantly shorter stay on the post-operative ward , 180 (105 - 330)min , compared with the PCA group , 237 (120 - 1140)min ( p start of peroral fluid also differed significantly between groups , 4h ( 2 - 6 ) for TIVA versus 5h ( 2 - 24 ) for the PCA group ( p removal of the indwelling catheter took place significantly earlier in the TIVA group , 9h ( 5 - 23 ) versus 22h ( 17 - 24 ) in the PCA group ( p post-operative nausea in the TIVA group compared with the PCA group on the first post-operative day ( p length of stay was shorter , 2 days ( 1 - 3 ) compared with 3 days ( 1 - 6 ) for the TIVA group versus PCA ( p complications between groups . One patient in each group was re-admitted to hospital because of a vaginal cuff infection . CONCLUSION The TIVA per- and post-operative care was an advantage over PCA in most respects"
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41171b30-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Hypertension is a modifiable cardiovascular risk factor . Although it is established that low-dose thiazides reduce mortality as well as cardiovascular morbidity , the dose-related effect of thiazides in decreasing blood pressure has not been subject to a rigorous systematic review . It is not known whether individual drugs within the thiazide diuretic class differ in their blood pressure-lowering effects and adverse effects . OBJECTIVES To determine the dose-related decrease in systolic and /or diastolic blood pressure due to thiazide diuretics compared with placebo control in the treatment of patients with primary hypertension . Secondary outcomes included the dose-related adverse events leading to patient withdrawal and adverse biochemical effects on serum potassium , uric acid , creatinine , glucose and lipids . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL 2014 , Issue 1 ) , Ovid MEDLINE ( 1946 to February 2014 ) , Ovid EMBASE ( 1974 to February 2014 ) and Clinical Trials.gov . SELECTION CRITERIA We included double-blind , r and omized controlled trials ( RCTs ) comparing fixed-dose thiazide diuretic monotherapy with placebo for a duration of 3 to 12 weeks in the treatment of adult patients with primary hypertension . DATA COLLECTION AND ANALYSIS Two authors independently screened articles , assessed trial eligibility , extracted data and determined risk of bias . We combined data for continuous variables using a mean difference ( MD ) and for dichotomous outcomes we calculated the relative risk ratio ( RR ) with 95 % confidence interval ( CI ) . MAIN RESULTS We included 60 r and omized , double-blind trials that evaluated the dose-related trough blood pressure-lowering efficacy of six different thiazide diuretics in 11,282 participants treated for a mean duration of eight weeks . The mean age of the participants was 55 years and baseline blood pressure was 158/99 mmHg . Adequate blood pressure-lowering efficacy data were available for hydrochlorothiazide , chlorthalidone and indapamide . We judged 54 ( 90 % ) included trials to have unclear or high risk of bias , which impacted on our confidence in the results for some of our outcomes .In 33 trials with a baseline blood pressure of 155/100 mmHg , hydrochlorothiazide lowered blood pressure based on dose , with doses of 6.25 mg , 12.5 mg , 25 mg and 50 mg/day lowering blood pressure compared to placebo by 4 mmHg ( 95 % CI 2 to 6 , moderate- quality evidence ) /2 mmHg ( 95 % CI 1 to 4 , moderate- quality evidence ) , 6 mmHg ( 95 % CI 5 to 7 , high- quality evidence ) /3 mmHg ( 95 % CI 3 to 4 , high- quality evidence ) , 8 mmHg ( 95 % CI 7 to 9 , high- quality evidence ) /3 mmHg ( 95 % CI 3 to 4 , high- quality evidence ) and 11 mmHg ( 95 % CI 6 to 15 , low- quality evidence ) /5 mmHg ( 95 % CI 3 to 7 , low- quality evidence ) , respectively . Direct comparison of doses did not show evidence of dose dependence for blood pressure-lowering for any of the other thiazides for which RCT data were available : bendrofluazide , chlorthalidone , cyclopenthiazide , metolazone or indapamide . In seven trials with a baseline blood pressure of 163/88 mmHg , chlorthalidone at doses of 12.5 mg to 75 mg/day reduced average blood pressure compared to placebo by 12.0 mmHg ( 95 % CI 10 to 14 , low- quality evidence ) /4 mmHg ( 95 % CI 3 to 5 , low- quality evidence ) .In 10 trials with a baseline blood pressure of 161/98 mmHg , indapamide at doses of 1.0 mg to 5.0 mg/day reduced blood pressure compared to placebo by 9 mmHg ( 95 % CI 7 to 10 , low- quality evidence ) /4 ( 95 % CI 3 to 5 , low- quality evidence ) .We judged the maximal blood pressure-lowering effect of the different thiazides to be similar . Overall , thiazides reduced average blood pressure compared to placebo by 9 mmHg ( 95 % CI 9 to 10 , high- quality evidence ) /4 mmHg ( 95 % CI 3 to 4 , high- quality evidence ) .Thiazides as a class have a greater effect on systolic than on diastolic blood pressure , therefore thiazides lower pulse pressure by 4 mmHg to 6 mmHg , an amount that is greater than the 3 mmHg seen with angiotensin-converting enzyme ( ACE ) inhibitors , angiotensin receptor blockers ( ARBs ) and renin inhibitors , and the 2 mmHg seen with non-selective beta-blockers . This is based on an informal indirect comparison of results observed in other Cochrane review s on ACE inhibitors , ARBs and renin inhibitors compared with placebo , which used similar inclusion /exclusion criteria to the present review .Thiazides reduced potassium , increased uric acid and increased total cholesterol and triglycerides . These effects were dose-related and were least for hydrochlorothiazide . Chlorthalidone increased serum glucose but the evidence was unclear for other thiazides . There is a high risk of bias in the metabolic data . This review does not provide a good assessment of the adverse effects of these drugs because there was a high risk of bias in the reporting of withdrawals due to adverse effects . AUTHORS ' CONCLUSIONS This systematic review shows that hydrochlorothiazide has a dose-related blood pressure-lowering effect . The mean blood pressure-lowering effect over the dose range 6.25 mg , 12.5 mg , 25 mg and 50 mg/day is 4/2 mmHg , 6/3 mmHg , 8/3 mmHg and 11/5 mmHg , respectively . For other thiazide drugs , the lowest doses studied lowered blood pressure maximally and higher doses did not lower it more . Due to the greater effect on systolic than on diastolic blood pressure , thiazides lower pulse pressure by 4 mmHg to 6 mmHg . This exceeds the mean 3 mmHg pulse pressure reduction achieved by ACE inhibitors , ARBs and renin inhibitors , and the 2 mmHg pulse pressure reduction with non-selective beta-blockers as shown in other Cochrane review s , which compared these antihypertensive drug classes with placebo and used similar inclusion /exclusion criteria .Thiazides did not increase withdrawals due to adverse effects in these short-term trials but there is a high risk of bias for that outcome . Thiazides reduced potassium , increased uric acid and increased total cholesterol and triglycerides
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"A multicentre , r and omised , placebo-controlled parallel group study comparing various doses of the combination diltiazem SR ( DTZ SR)/hydrochlorothiazide ( HCTZ ) with the monotherapies was performed to delineate the optimal antihypertensive dosage of the two drug combinations . The study was carried out in 298 patients with mild to moderate essential hypertension ( stable supine diastolic blood pressure , DBP , greater than or equal to 95 and less than or equal to 110 mmHg ) . After a single-blind placebo lead-in period lasting 4 - 6 weeks to establish stable baseline BP , the patients were r and omised to receive either placebo ( n = 75 ) , HCTZ ( n = 76 ) , DTZ SR ( n = 72 ) , or the combination of DTZ SR/HCTZ ( n = 75 ) . There were three 4-week evaluation periods with forced escalation of therapy as follows : HCTZ ( 6.25 , 6.25 , 12.5 mg twice daily ) , DTZ SR ( 60 , 90 , 120 mg twice daily ) , and the combination of DTZ SR/HCTZ ( 60/6.25 , 90/6.25 , 120/12.5 mg twice daily ) . DTZ SR/HCTZ ( 120/12.5 mg ) produced statistically significantly greater reductions in supine DBP compared with each monotherapy and placebo . The lower doses of DTZ SR/HCTZ ( 60/6.25 mg and 90/6.25 mg ) produced statistically significantly greater supine DBP reductions compared with DTZ SR monotherapy and placebo , but not compared with HCTZ monotherapy . A comparison of reduction in supine DBP between evaluation periods demonstrated a dose-response relationship for the combination therapy in reducing BP over the dosage range studied . Adverse clinical and laboratory events were not significantly different between the therapies . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The effect of long-term treatment with indapamide in platelet alpha 2-adrenoceptors has been evaluated in 10 patients with essential hypertension , in a double-blind , cross-over study with placebo . After three months of therapy , indapamide significantly reduced mean blood pressure ( from 137 + /- 12 to 116 + /- 6 mm Hg , p less than 0.001 ) , whereas heart rate did not change ( from 72 + /- 8 to 73 + /- 7 beats/minute ) . At the same time , platelet alpha 2-adrenoceptor number increased ( from 168.2 + /- 48.4 to 256.8 + /- 14.5 fmol/mg protein , p less than 0.02 ) , whereas the dissociation constant did not change ( from 3.79 + /- 2.9 to 4.97 + /- 4.48 ) . The plasma norepinephrine level was significantly reduced after long-term treatment with indapamide ( from 275 + /- 118 to 210 + /- 56 pg/ml , p less than 0.02 ) . These results bring about an inhibition of norepinephrine release from sympathetic nerve endings with a likely secondary increase of the number of platelet alpha 2-adrenoceptors",
"1 . The anti-hypertensive actions of timolol and hydrochlorothiazide were analysed in a double-blind 2 x 2 factorial trial in twenty patients with essential hypertension . Each patient went through four phases of 8 weeks in r and omized order , receiving timolol alone , hydrochlorothiazide alone , timolol plus hydrochlorothiazide , and placebo . 2 . Supine mean arterial pressure fell from 119 mmHg in the placebo phase , to 110 mmHg during the thiazide phase , 106 mmHg during the timolol phase , and to 101 mmHg during the combined timolol plus hydrochlorothiazide phase . 3 . Factorial analysis revealed that the hypotensive actions of the beta-receptor-blocking drug and the diuretic were additive , without any synergism or antagonism . 4 . Plasma renin activity measured in ng 3 h-1 ml-1 rose from 5 - 02 in the placebo phase to 9 - 54 in the diuretic phase , but fell to 1 - 79 in the beta-receptor blockade . It was unchanged in the combined therapy phase , despite the greater drop in blood pressure . These results suggest that the fall in plasma renin activity during beta-receptor blockade is of little importance in the hypotensive action of beta-receptor-blocking drugs",
"In a double‐blind study , 28 patients having mild to moderate essential hypertension were r and omly assigned to a 6‐week regimen of ticrynafen , hydrochlorothiazide , or placebo . Blood pressure fell after ticrynafen and hydrochlorothiazide . Serum uric acid fell strikingly with ticrynafen whereas it rose with hydrochlorothiazide . Serum potassium declined very little with ticrynafen ; much less than with hydrochlorothiazide . Serum creatinine and blood urea nitrogen rose slightly more with ticrynafen than with hydrochlorothiazide . There were no clinical adverse effects to either of the medications . Ticrynafen appears to be an effective antihypertensive with a substantial hypouricemic effect",
"The antihypertensive effects of atenolol and hydrochlorothiazide were compared with placebo in a r and omized , double-blind crossover study , with the blood pressure responses related to sympathetic nervous system activity . Twelve patients with essential hypertension were given atenolol ( 100 mg ) , hydrochlorothiazide ( 50 mg ) , and placebo as single daily doses , each for 6 weeks . Mean supine , st and ing , and post-exercise blood pressures ( mm Hg ) on atenolol ( 155/94 , 152/95 , 177/93 , respectively ) and hydrochlorothiazide ( 154/99 , 150/103 , 172/96 ) were lower ( p less than 0.01 ) than corresponding placebo values ( 172/109 , 166/113 , 204/111 ) at 6 weeks . The role of the sympathetic nervous system in the antihypertensive actions of atenolol and hydrochlorothiazide was examined . The supine plasma norepinephrine on placebo was used as an index of sympathetic activity to categorize each patient 's \" adrenergic status . \" The six \" hyperadrenergic \" patients with high resting norepinephrine values ( mean , 302 pg/ml ) exhibited a greater ( p = 0.05 ) decrease in BP ( -30/-20 mm Hg ) on atenolol compared with the BP fall of -9/-11 mm Hg observed in the lower norepinephrine group ( mean , 211 pg/ml ) . Resting plasma norepinephrine values did not predict the BP fall on hydrochlorothiazide . The \" adrenergic status \" of each patient as measured by the plasma norepinephrine concentration tended to be relatively constant regardless of therapy or the state of activity . In this study , atenolol was an effective antihypertensive agent comparable to hydrochlorothiazide in potency . Adrenergic status tended to predict the BP response to atenolol and was a relatively constant feature of the patients in all treatment phases",
"Two hundred and eleven patients with mild or moderate hypertension , mean age 53.5 + /- 9.5 years ( range 24 - 70 ) were r and omised double-blind to treatment with either captopril 50 mg ( C50 ) , hydrochlorothiazide 25 mg ( HCTZ 25 ) , the fixed combination of captopril 50 mg and hydrochlorothiazide 25 mg ( C50/HCTZ 25 ) or placebo . Blood pressure , heart rate , body weight and side effects were assessed at the end of the run-in period on placebo and after 4 , 6 , 8 weeks treatment at the same time , 20 - 24 h after the last dosing . Routine biochemical examinations were carried out on all patients after the placebo period as well as after 4 and 8 weeks . Blood pressure significantly decreased in all groups , but the mean percentage change from baseline was highly statistically significant at 8 weeks , for C50 and C50/HCTZ 25 groups . The incidence of clinical side effects was low and not statistically different for the four groups with few specific adverse effects ( one transient alteration of taste in captopril group ) . No patient was withdrawn from the study due to side effects . A better anti-hypertensive efficacy was obtained with the fixed combination captopril 50 mg/hydrochlorothiazide 25 mg once daily compared to placebo or each component alone , and without any difference in side effects",
"BACKGROUND Most patients with hypertension require more than one agent to control blood pressure ( BP ) . The purpose of this study was to assess the efficacy and safety of the angiotensin II receptor blocker olmesartan medoxomil in combination with hydrochlorothiazide ( HCTZ ) . METHODS This was a r and omized , double-blind , factorial design study . After a placebo run-in period , eligible patients ( n = 502 ) with a baseline mean seated diastolic blood pressure ( SeDBP ) of 100 to 115 mm Hg were r and omized to one of 12 groups : placebo , olmesartan medoxomil monotherapy ( 10 , 20 , or 40 mg/day , HCTZ monotherapy ( 12.5 or 25 mg/day ) , or one of six groups of olmesartan medoxomil/HCTZ combination therapy . The primary endpoint was the change in mean trough SeDBP from baseline at week 8 . Statistical analyses were conducted to determine whether at least one combination produced a larger reduction in SeDBP at week 8 than the individual corresponding component doses , but did not compare BP reductions with different combination doses . RESULTS Olmesartan medoxomil plus HCTZ produced greater reductions in both SeDBP and seated systolic blood pressure ( SeSBP ) at week 8 than did monotherapy with either component . All olmesartan medoxomil/HCTZ combinations significantly reduced SeDBP and SeSBP compared with placebo in a dose-dependent manner . Reductions from baseline in mean trough SeSBP/SeDBP were 3.3/8.2 mm Hg , 20.1/16.4 mm Hg , and 26.8/21.9 mm Hg with placebo , olmesartan medoxomil/HCTZ 20/12.5 mg , and olmesartan medoxomil/HCTZ 40/25 mg , respectively . All treatments were well tolerated . CONCLUSIONS Olmesartan medoxomil/HCTZ combination therapy produced BP reductions of up to 26.8/21.9 mm Hg and was well tolerated",
"This placebo-controlled multifactorial design trial assessed the antihypertensive efficacy of nebivolol , a novel cardioselective beta 1-blocker with vasodilating properties , and hydrochlorothiazide monotherapy and in combination . After a 4-week placebo period , 240 white patients with a mean daytime ambulatory blood pressure of > or = 90 mm Hg were r and omized to receive either placebo , nebivolol ( 1 , 5 , or 10 mg ) , hydrochlorothiazide ( 12.5 or 25 mg ) , or one of the six possible combinations of nebivolol and hydrochlorothiazide for 12 weeks . A dose-related reduction in clinic and ambulatory blood pressure was demonstrated for each drug as monotherapy and for the two drugs in combination . Nebivolol , 5- and 10-mg doses , showed a larger effect than hydrochlorothiazide doses on clinic blood pressure and over the 24-h interval . Moreover , the combination doses had substantial antihypertensive effects that were sustained over the entire 24-h profile with a greater effect observed with the higher dose combinations . The reduction in ambulatory blood pressure was further substantiated by the reduction of blood pressure loads ( % of BP > 140/90 mm Hg awake and > 120/80 mm Hg asleep ) to as low as 11.5 % with 10 mg of nebivolol combined with 25 mg of hydrochlorothiazide . Nebivolol and hydrochlorothiazide were well tolerated . We provided evidence that nebivolol , given as monotherapy or in combination with low dose of hydrochlorothiazide , is effective in reducing clinic and 24-h ambulatory blood pressure in patients with ambulatory hypertension . The results provided further evidence for the use of ambulatory blood pressure monitoring and factorial design s when investigating new antihypertensive agents",
"Objective To establish the optimal dose of the perindopril/indapamide combination ( Per/Ind ) in the treatment of mild or moderate hypertension . Design This was a r and omized , double-blind , placebo-controlled , seven-way parallel-group , dose-ranging study , set in multicenter , outpatient offices/clinics in Europe and Canada . Patients A total of 438 patients aged between 18 and 75 years whose supine diastolic blood pressure was between 95 and 114 mmHg were r and omly assigned to an 8-week double-blind treatment with either placebo , Per 2/Ind 0.625 , Per 4/Ind 1.25 , Per 8/Ind 2.5 , Per 0/Ind 1.25 , Per 2/Ind 1.25 or Per 8/Ind 1.25 mg . Main outcome measures Systolic and diastolic blood pressure measured in the clinic approximately 24 h after dosing . Results There was a linear dose – response relationship ( P = 0.001 ) for doubling the dose of Per 2/Ind 0.625 mg up to Per 8/Ind 2.5 mg with a progressive fall in supine diastolic blood pressure ( −9.3 to −15.0 mmHg ) . Combining 1.25 mg Ind with increasing doses of Per ( 0 , 2 , 4 and 8 mg ) also showed a linear dose – response relationship ( P with supine diastolic blood pressure falling by −8.0 to −12.0 mmHg compared with a fall of −5.2 mmHg for the placebo group . Similar findings were noted for supine systolic blood pressure , st and ing blood pressure and ambulatory blood pressure . Hypokalemia was more common ( 9.7 % ) in the Per 8/Ind 2.5 mg group than in the groups receiving other doses ( 0–4.6 % ) . Conclusion The combinations of Per 2/Ind 0.625 mg and Per 4/Ind 1.25 mg were effective in reducing blood pressure without producing clinical ly important side effects",
"Background — Diuretics are recommended as first-line agents for the treatment of hypertension . This r and omized , double-blind , multicenter study assessed the long-term efficacy and safety of the direct renin inhibitor aliskiren in comparison with the diuretic hydrochlorothiazide in patients with essential hypertension . Methods and Results — After a 2- to 4-week placebo run-in , 1124 patients ( mean sitting diastolic blood pressure [ BP ] 95 to 109 mm Hg ) were r and omized to aliskiren 150 mg ( n=459 ) , hydrochlorothiazide 12.5 mg ( n=444 ) , or placebo ( n=221 ) once daily . Forced titration ( to aliskiren 300 mg or hydrochlorothiazide 25 mg ) occurred at week 3 ; at week 6 , patients receiving placebo were reassigned ( 1:1 ratio ) to aliskiren 300 mg or hydrochlorothiazide 25 mg . From week 12 , amlodipine 5 mg was added and titrated to 10 mg from week 18 for patients whose BP remained uncontrolled . Efficacy variables were analyzed for the intent-to-treat population with the use of the last observation carried forward method . BP reductions ( mean sitting systolic BP/mean sitting diastolic BP ) were significantly greater with aliskiren- versus hydrochlorothiazide-based treatment at week 26 ( −20.3/−14.2 versus −18.6/−13.0 mm Hg ; P for mean sitting diastolic BP ) . At the end of the monotherapy period ( week 12 ) , aliskiren 300 mg was superior to hydrochlorothiazide 25 mg in reducing BP ( −17.4/−12.2 versus −14.7/−10.3 mm H ; P rates were similar with aliskiren- ( 65.2 % ) and hydrochlorothiazide-based therapy ( 61.5 % ) . Hypokalemia was more frequent with hydrochlorothiazide-based therapy than aliskiren-based therapy ( 17.9 % versus 0.9 % ; P Aliskiren treatment , both as monotherapy and with optional addition of amlodipine , provided significantly greater BP reductions than the respective hydrochlorothiazide regimens . Aliskiren-based therapy was well tolerated . Direct renin inhibition with aliskiren therefore represents an effective option for the long-term treatment of essential hypertension",
"Considering the documented , potentially undesirable influence of various thiazide-type or loop diuretics on serum lipoproteins , we prospect ively investigated in 69 men(mean age ± SEM , 32 ± 1 years ) the metabolic effects of the new diuretic-antihypertensive compound indapamide . Compared to placebo , indapamide ( 2.5 mg/day ) given for 6 to 8 weeks lowered ( p ) blood pressure(supine values from 148/98 ± 3/2 to 137/93 ± 3/2 ) in 29 men with mild to moderate essential hypertension , but not in 40 healthy men . In both groups , significant ( p in body weight ( −0.8 kg ) and plasma potassium ( −0.6 mmol/L ) , and increases in plasma uric acid (= 20 % ) , renin activity (= 200 % ) , and aldosterone documented good compliance . There were no significant changes hi total cholesterol(in all subjects , from 208 ± 6 to 213 ± 6 mg/dl ) , low- or very low-density lipoprotein(VLDL ) cholesterol ( 127 ± 6 to 129 ± 6 and 21 ± 1 to 21 ± 2 respectively ) , high-density lipoprotein cholesterol ( 50 ± 1 to 51 ± 1 mg/dl ) , total triglycerides(Tg ) ( 108 ± 5 to 112 ± 6 mg/dl ) , VLDL-Tg , apoproteins Al and A2 , plasma glucose , epinephrine , norepinephrine , sodium , calcium , magnesium , and creatinine ; apoprotein B ( 84 ± 2 to 88 ± 3 mg/dl ) and plasma insulin after glucose loading dose tended to be increased minimally . The absence of distinct lipoprotein alterations after short-term indapamide treatment may be of clinical and epidemiological interest.(Hypertension 7 [ Suppl II ] : II-164–II-169 , 1985",
"In this issue , we answer three questions with respect to loss to follow-up in a clinical trial : How important is loss to follow-up ? How is loss to follow-up calculated ? How many patients can be lost to follow-up without mistrusting the results ? 1 . How important is loss to follow-up ? The simple answer to this question is “ very important ” because loss to follow-up can severely compromise a study 's validity . Incomplete follow-up biases the results when either : The dropout rates are different between study groups ; or The patients who drop out are different from those who do not drop out . Why do these situations make a difference ? Because in each situation , those lost to follow-up often have a different prognosis than those who complete the study . For example , patients who receive treatment for cervical myelopathy may not return for follow-up because they became asymptomatic and felt no need to return to see the surgeon . Conversely , some patients may not return because they had a particularly bad outcome ( worse pain or function ) or complication , or because they died . In either case , bias can affect the validity of the inferences drawn from the study . 2 . How is loss to follow-up calculated ? There is much confusion about how to determine the proportion of patients lost to follow-up . In order to correctly calculate the follow-up rate , one needs to know the denominator . In a r and omized controlled trial ( RCT ) , the denominator for each group is the number of patients who were r and omized , not the number who received the treatment . For example , suppose we have an RCT comparing two treatment groups , Group A and Group B. The investigators evaluate 178 patients and r and omize 120 ; 61 to Group A and 59 to Group B ( Fig 1 ) . Following the figure , we note that 49 patients received treatment A and 52 received treatment B. At the final follow-up 40 were analyzed in Group A and 41 in Group B. How many were considered lost to follow-up ? Many would consider the loss to follow-up rate to be 9 ( 18 % ) of 49 in treatment A and 11 ( 21 % ) of 52 in treatment B using as the denominator only those that were treated . However , the real proportion lost to follow-up must consider those who were r and omly assigned , even if they did not receive treatment . In the present example , this is calculated as 21 ( 34 % ) of 61 for treatment A and 18 ( 31 % ) of 59 for treatment B. Fig 1 Hypothetical example of patients lost to follow-up in a r and omized controlled trial . When calculating loss to follow-up in a retrospective cohort study , all individuals receiving treatment during the study period should be used as the denominator , not just those with complete data . For example , let 's say you want to compare decompression plus lumbar fusion with decompression alone in disc herniation and the data available are all patients receiving either treatment in the last 5 years ( N = 275 ) . However , the data base from which the data are obtained is incomplete and only 190 have the necessary data available . Since the investigators stated as part of the inclusion criteria that only those patients with complete data are included , they consider the follow-up to be 100 % ( 190/190 ) . This conclusion is wrong . The denominator should include all patients who underwent the surgery irrespective of completeness of data . The follow-up rate for this example is 69 % ( 190/275 ) . 3 . How many patients can be lost to follow-up without mistrusting the results ? Some have suggested that 20 % poses serious threats to validity 1 . This may be a good rule of thumb , but keep in mind that even small proportions of patients lost to follow-up can cause significant bias 2 . One way to determine if loss to follow-up can seriously affect results is to assume a worst-case scenario with the missing data and look to see if the results would change . Here is an example : Let 's assume a multicenter study enrolled 500 patients into each arm of a study comparing artificial disc replacement ( ADR ) with fusion , and the end point is adjacent segment disease ( ASD ) . The trial numbers are found in Fig 2 . Fig 2 Hypothetical example of the effect of loss to follow-up considering a worst-case scenario . ADR indicates artificial disc replacement ; ASD , adjacent segment disease . The proportion of patients with ASD in the ADR group is half as much versus the fusion group , 25 % ( 100/400 ) compared with 50 % ( 200/400 ) . If we assume that the 100 lost to follow-up in the ADR group had ASD and the 100 lost to follow-up in the fusion group did not , then the rate of ASD in each group would be 40 % ( 200/500 ) . In this case , adopting the worst-case scenario for the intervention group with respect to those lost to follow-up causes the results to change significantly from half the rate of ASD with ADR to the same rate . When this happens , loss to follow-up can threaten the internal validity of the trial . Only when the worst case does not change the inferences derived from the results is lost to follow-up not a problem",
"The study was to compare the effects of amlodipine ( calcium channel antagonist ) , chlorthalidone ( diuretic ) , and placebo in adults more than 50 years of age with stage 1 isolated systolic hypertension ( ISH ) . After a 4-week placebo run-in phase , 150 patients were r and omly assigned in a double-blind fashion to treatment with 5 mg of amlodipine ( n = 48 ) , 15 mg of chlorthalidone ( n = 50 ) , or placebo ( n = 52 ) . Patients who failed to meet the systolic blood pressure ( BP ) reduction goal by week 4 had their dose increased to 10 mg of amlodipine or 30 mg of chlorthalidone , and maintained at this increased dose for 12 weeks . Results showed a mean reduction ( mean + /- SD ) in sitting systolic BP from baseline to the last treatment visit of -14.6+/-12.2 mm Hg ( 95 % confidence interval [ CI ] -18.2 , -11.0 ) , -14.0+/-13.46 mm Hg ( 95 % CI -17.8 , -10.2 ) , and -3.4+/-11.83 mm Hg ( 95 % CI -6.7 , -0.1 ) for the amlodipine , chlorthalidone , and the placebo treatment groups , respectively . Both active treatments showed significantly greater reductions than the placebo group ( P amlodipine , 69 % of the chlorthalidone , and 25 % of the placebo-treated patients reached the protocol defined systolic BP goal ( P = .001 ) . Both active treatment groups showed a trend of better systolic BP response in older patients ( > or = 65 years ) . Secondary efficacy measures including pulse pressure , st and ing systolic , diastolic , and the 24-h ambulatory BP were also statistically significantly improved for both active treatments at the end of treatment , except for chlorthalidone in st and ing diastolic BP . Adverse events that occurred during the study were as expected and were well tolerated . The results of this study support the efficacy and safety of amlodipine and chlorthalidone for the treatment of stage 1 ISH during 20 weeks of treatment",
"OBJECTIVE To explore the sex-specific benefits and risks of treatment of stage 1 diastolic hypertension . METHODS Participants were African-American and white hypertensive men ( n = 557 ) and women ( n = 345 ) ( age range , 45 to 69 years ) with a diastolic blood pressure less than 100 mm Hg . Participants were r and omized to treatment with placebo , chlorthalidone ( 15 mg/d ) , acebutolol hydrochloride ( 400 mg/d ) , doxazosin mesylate ( 2 mg/d ) , amlodipine besylate ( 5 mg/d ) , or enalapril maleate ( 5 mg/d ) ; all were given nutritional-hygienic intervention . RESULTS After 4 years , women who were r and omized to lifestyle intervention only were less likely to be receiving step 1 therapy alone ( placebo ) than men who were r and omized to placebo therapy ( 46 % vs 66 % , respectively , P mean systolic blood pressure in both men and women who were assigned to treatment with active drugs compared with those participants who were receiving placebo therapy ; differences among treatments with active drugs were similar between men and women . Men experienced larger falls in their total and low-density lipoprotein cholesterol and triglyceride levels regardless of the treatment assignment than did women ; however , there were no significant sex-by-treatment interactions . Quality -of-life indexes were generally improved with active drug treatment compared with placebo therapy in both sexes ; there was a sex-by-treatment interaction for the general health index . The relative risk ( RR ) for combined clinical events was similar in women ( RR , 0.64 ; 95 % confidence interval [ CI ] , ( 0.36 to 1.16 ) and in men ( RR , 0.67 ; 95 % CI , 0.40 to 1.14 ) who were assigned to treatment with all active drugs combined , compared with those who were receiving placebo therapy . CONCLUSION In these exploratory analyses , men and women who were assigned to treatment with active drugs experienced greater and generally similar benefits from treatment than those participants who were assigned to lifestyle intervention only",
"Isolated systolic hypertension has a higher prevalence with age and an associated excess cardiovascular risk . The Systolic Hypertension in the Elderly Program ( SHEP ) was a r and omized , prospect i ve , double blind clinical trial to assess the efficacy and safety of a antihypertensive regimen based on low dose diuretic therapy in reducing the five year combined incidence of fatal and nonfatal stroke . SHEP demonstrated a significant 36 % reduction in stroke incidence . Also , 27 % reduction in coronary heart disease incidence and a 32 % reduction in major cardiovascular disease incidence were achieved . The benefits accrued to all subgroups identified based on baseline age , race , sex , blood pressure , serum cholesterol levels , and ECG abnormalities . A low-dose diuretic regimen should be the initial treatment of choice for most hypertensive patients , based on demonstrated reduction in risk for major cardiovascular events , its safety , acceptance by patients , and low cost",
"The effect of hydrochlorothiazide , propranolol , and enalapril on cognitive and motor function and quality of life ( QOL ) in hypertensive patients was studied . Patients > or = 55 years of age with asymptomatic essential hypertension were included in a r and omized , double-blind , placebo-controlled , crossover study . Subjects discontinued their previous antihypertensive agents and started hydrochlorothiazide 25 mg , extended-release propranolol hydrochloride 120 mg , enalapril maleate 10 mg , or placebo . One capsule was taken for three days and then the dosage was doubled for the remainder of a four-week period . Subsequent crossover treatments were begun without a washout period . In each treatment phase , a battery of psychometric tests was used to assess cognitive and motor function and quality of life ; all tests but one were self-administered via computer terminal . Pulse rate and blood pressure were recorded , and compliance was monitored by capsule count . Sixteen of 30 patients interviewed completed the trials ; one additional patient was evaluated after receiving all treatments except hydrochlorothiazide . Mean + /- S.D. age of the subjects was 66 + /- 6.1 years ; 10 were black and 7 white ; 9 were men . Except for the hydrochlorothiazide group , blood pressure in the active treatment groups did not differ significantly from placebo ; hydrochlorothiazide significantly reduced systolic but not diastolic blood pressure compared with placebo . Compared with placebo , hydrochlorothiazide was associated with fewer incorrect responses in a test of complex reaction time and with greater discriminant reaction time response rates ; otherwise , no difference between groups was noted in cognitive or motor performance . There were no significant differences between active treatments and placebo on individual QOL measures . ( ABSTRACT TRUNCATED AT 250 WORDS",
"One hundred seventy-one patients , 60 years of age or older with isolated systolic hypertension , were r and omly assigned to receive chlorthalidone 12.5 , 25.0 , or 50.0 mg or placebo once daily for 12 weeks . The majority of the patients receiving chlorthalidone 12.5 mg achieved therapeutic success with no clinical ly significant biochemical changes or side effects . The 50.0-mg dose level enhanced efficacy only minimally over the 25.0-mg dose level . Drug-related side effects were significantly more prevalent in the chlorthalidone 50.0-mg group than in the placebo group . The data suggest that most elderly patients with isolated systolic hypertension , regardless of the severity , could be treated effectively and safely with chlorthalidone 12.5 mg per day",
"A r and omised , placebo-controlled , double-blind crossover study was conducted in 14 patients with mild essential hypertension comparing different regimens of administration of the \" short-acting \" diuretic , chlorothiazide and the \" long-acting \" diuretic , chlorthalidone . There were 6 r and omised treatment phases each of 5 weeks duration . For blood pressure recorded both at the Clinic and at home the most prominent effects were seen with st and ing blood pressure , for which significant reductions of mean blood pressure compared to the placebo phase were observed with chlorthalidone 25 mg once daily ( -5 + /- 1 ( SE ) mm Hg - p less than 0.05 ) , chlorthalidone 50 mg once daily ( -7 + /- 1 mm Hg - p less than 0.01 ) and chlorothiazide 500 mg twice daily ( -4 + /- 1 mm Hg - p less than 0.05 ) . Blood pressure reductions with chlorothiazide 500 mg once daily and 1000 mg once daily were not significant . About half of the patients completing the trial could be described as \" non-responders \" . The observed biochemical changes ( reduced plasma potassium and chloride concentrations and increased plasma bicarbonate and urate concentrations ) were most marked in the phases with the most prominent blood pressure effects . The result support the suggestion that a sustained diuretic effect is desirable when diuretics are used in the treatment of hypertension . This can be obtained by selection of the appropriate dosage regimen for a particular diuretic , such as once daily administration for \" long-acting \" and twice daily for \" short-acting \" thiazide-type diuretics",
"Objective : This study compares the antihypertensive efficacy and tolerability of valsartan , a novel angiotensin II antagonist , given with hydrochlorothiazide ( HCTZ ) vs placebo or vs valsartan or HCTZ alone . Design : 871 adult out- patients with essential hypertension participated in this double-blind study . Patients were r and omised in equal number to receive either combination therapy of valsartan ( 80 mg or 160 mg ) and HCTZ ( 12.5 mg or 25 mg ) , or valsartan ( 80 mg or 160 mg ) or HCTZ ( 12.5 mg or 25 mg ) alone , or placebo . Patients were treated once daily for 8 weeks and assessed at 2 , 4 and 8 weeks after r and omisation . Main outcome measures : The primary efficacy variable was change from baseline in mean sitting diastolic blood pressure ( MSDBP ) at end-point . The secondary variable was change in mean sitting systolic blood pressure ( MSSBP ) from baseline to end-point . Results : All active treatments produced a statistically significant difference in MSDBP ( P placebo . similar results were obtained for mssbp . all combination regimens produced a statistically significantly greater reduction in msdpb and mssbp than the corresponding monotherapies . dizziness and headache were the most common treatment-related adverse experiences reported . hypokalaemia , associated with the use of thiazide diuretics , was more commonly reported in the higher dose hctz 25 mg groups . Conclusions : Valsartan 80 mg and 160 mg act additively with HCTZ 12.5 mg or 25 mg to lower MSDBP and MSSBP in patients with essential hypertension . The addition of HCTZ to valsartan 80 mg or 160 mg was well tolerated",
"The relationship of serum dopamine-beta-hydroxylase ( DBH ) , plasma renin activity ( PRA ) and urinary catecholamines ( IU catechols ) in various forms of essential hypertension ( EHT ) ( low , normal and high renin ) was evaluated . Eighty-four predominantly white , young ( 37 + / 8 years ( SD ) ) , mildly hypertensive patients ( diastolic pressure 93 + /- 4 mm Hg ( SD ) ) continued their regular diet and received no medications . Thirteen patients had low-renin , 64 had normal-renin , and seven had high-renin EHT . DBH , total IU catechols and urinary norepinephrine were not different between these renin subgroups . DBH was significantly lower in all hypertensives ( 55.6 + /- 36 IU ) and in the low-renin subgroup ( 46 + /- 30 IU ) compared with normal subjects ( 68 + /- 35 IU ) ( p less than 0.01 ) . However , the DBH range was so broad that an individual DBH value did not distinguish EHT from normals . After a baseline period , patients were r and omly assigned to receive chlorthali done 50 mg q.a.m . or placebo in a double-blind study . In the chlorthalidone group 1 month after therapy , the diastolic pressure decreased , PRA increased , and total IU catechols and urinary norepinephrine increased . Serum DBH did not change during diuretic therapy . A significant correlation could not be shown between pretreatment DBH and the changes in PRA and IU catechols before and after diuretics for all treated EHT patients . However , within the normal PRA EHT subgroup receiving chlorthalidone , the one-third of patients with lowest pretreatment DBH levels ( n = 10 ) were compared with the one-third of patients with the highest pretreatment DBH values ( n = 10 ) . The lower DBH patients showed significantly less change in PRA ( delta PRA = 2.9 + /- 1.8 ng/ml/hr ) compared with the higher DBH patients ( delta PRA = 8.2 + /- 1.6 ; P less than 0.05 ) . In some EHT patients , DBH levels may be related to PRA response to diuretic therapy",
"Objective To identify appropriate dosages of ramipril and hydrochlorothiazide ( HCT ) when given in combination once a day for the treatment of essential hypertension . Design A 2- or 4-week placebo run-in followed by 6-week , double-blind , parallel-group phase : 4 x 3 factorial ( 2.5 , 5 and 10 mg ramipril ; 12.5 and 25 mg HCT ; all six combinations ; placebo ) . Setting Office practice ( 21 centres ) . Patients and participants Patients with mild-to-moderate essential hypertension ( World Health Organization stage I — II ; supine diastolic blood pressure 100—115 mmHg in last 2 weeks of run-in ) : 581 enrolled , 534 r and omly assigned to double-blind therapy and 517 completed . Main outcome measures Reduction in supine and st and ing blood pressure . Results In pairwise comparisons , the combinations of 5 mg ramipril with 12.5 and 25 mg HCT and 10 mg ramipril with 12.5 mg HCT consistently produced significantly greater blood pressure reductions than their respective components . Response surface analyses were performed , and a stairstep model was constructed to characterize the shape of the dose-response surface . The combinations involving 5 and 10 mg ramipril with 12.5 and 25 mg HCT were again more effective than their components . Withdrawals and adverse effects were minimal for all treatments . A large drop in serum potassium was observed on 25 mg HCT , but not on combination therapy . Addition of ramipril appeared to reduce the hyperuricaemic effect of HCT . Conclusions Several dosage combinations of ramipril plus HCT produced significantly greater blood pressure reductions than the monotherapies at the same dosages . Overall , the combination of 5 mg ramipril and 25 mg HCT gave the best mean reduction . Combination therapy with ramipril plus HCT was safe and effective for patients with mild-to-moderate essential hypertension",
"Summary The presence of a possible correlation between changes in left ventricular mass of hypertensive patients and the degree of blood pressure reduction with different antihypertensive drugs has been investigated in 40 out patients by M-mode echocardiography . Ten of these , with blood pressure in normal limits with different antihypertensive treatment had their therapy changed in chlorthalidone 25 mg/day without any run-in ( Group A ) ; other 30 patients , with a previously uncontrolled blood pressure , after a 14 day run-in , were r and omly allocated to chlorthalidone 25 mg/day ( Group B ) , slow release nifedipine 20 mg/day ( Group C ) or placebo ( Group D ) . At the end of the eight week treatment period a further decrease in systolic blood pressure was observed in Group A without changes in ventricular mass ; an highly significant decrease in both systolic and diastolic blood pressure was observed in B and C but only patients on chlorthalidone changed their ventricular mass ; no change in both blood pressure and ventricular mass was observed on placebo . As changes in ventricular mass are not correlated with blood pressure reduction , we conclude that other , not well defined factors , apart from the decrease in duration and degree of left ventricular systolic wall tension , may be responsable for reversal of left ventricular hypertrophy",
"The combination of angiotensin converting enzyme ( ACE ) inhibitor and thiazide diuretic has advantages over monotherapy for the treatment of hypertension . Previous study design s have often been inadequate to demonstrate the details of interactions between these antihypertensive agents . This study used a modified 4 x 4 factorial r and omized , double-blind , placebo-controlled , parallel group design to study the efficacy of 17 different doses of fosinopril ( Fos ) , a phosphinic acid derived ACE inhibitor , and hydrochlorothiazide ( HCTZ ) in 550 patients with mild to moderate hypertension . Data from these variables were fit to quadratic response surface models ( QRSM ) using polynomial functions in the doses of the two components . Using QRSM , seated systolic ( SeSBP ) and diastolic blood pressure ( SeDBP ) responses at 8 weeks were predicted for actual doses and interpolated for intermediate doses not studied . Fos and HCTZ alone and in combination produced a dose-related reduction in SeSBP and SeDBP . Using 10 mg Fos + 12.5 mg HCTZ reduced the adjusted mean SeDBP 6.3 mm Hg and 20 mg Fos + 12.5 mg HCTZ lowered the same measure 9.1 mm Hg . Coadministration of Fos and HCTZ produced an additive antihypertensive effect . This study of combination agents for hypertension using a factorial design with QRSM accurately predicts dose responses and is a valuable clinical trial methodology",
"Objective In accordance with international recommendations on the need to decrease doses of antihypertensive drugs , a low-dose ( 1.5 mg ) sustained-release ( SR ) formulation of indapamide was developed to optimize the drug 's efficacy : safety ratio . The aim of this work was to evaluate the benefit of a low-dose diuretic by consolidating the efficacy and safety results of two clinical trials with a similar design . Patients and methods Clinical data were obtained in two European r and omized double-blind studies with 690 mild to moderate hypertensive patients ( 95 mmHg ≤ supine diastolic blood pressure ≤ 114 mmHg using a mercury sphygmomanometer ) treated respectively for 2 and 3 months , with a mean age of 53 and 57 years , 44 and 57 % males , mean supine diastolic blood pressure of 100.6 and 102.5 mmHg and mean supine systolic blood pressure of 161.0 and 164.5 mmHg . Results The first study , a dose-finding study with indapamide SR at 1.5 , 2 and 2.5 mg versus placebo and the immediate-release ( IR ) formulation of indapamide , showed that the 1.5 mg dosage of the new indapamide formulation had an improved antihypertensive efficacy : safety ratio . The second study confirmed the equivalence of blood pressure reductions with 1.5 mg indapamide SR and 2.5 mg indapamide IR , and better acceptability with 1.5 mg indapamide SR , particularly in the number of patients with serum potassium levels The long-term efficacy of 1.5 mg indapamide SR was observed through a 9-month open-treatment follow-up to the second study . Conclusion The 1.5 mg SR formulation of indapamide has an improved antihypertensive efficacy : safety ratio , which is in accordance with international recommendations for the use of low-dose antihypertensive drugs and diuretics in first-line therapy of hypertension",
"This study , carried out in three centers in the United States , investigated the antihypertensive effect of three dosages of indapamide in 87 patients with mild to moderate hypertension . The dosages studied were 1 mg , 2.5 mg , and 5 mg daily . A double-blind , parallel study design was used with a six-week placebo run-in period followed by an eight-week treatment period and a two-week follow-up period . Compared with placebo , all dosages caused a significant decrease ( P less than 0.05 ) in blood pressure , with an average decrease of approximately 6 mmHg diastolic and 13 mmHg systolic . The antihypertensive effect seemed to be fully manifest after six weeks of treatment . At all dosage levels , indapamide produced markedly greater therapeutic success rates than did the placebo . Success was defined as either a st and ing phase-5 diastolic blood pressure of less than 90 mmHg or a decrease by at least 10 mmHg from baseline . Although the decrease in mean serum potassium concentration was dose-related , the decrease was not clinical ly significant with any dose . A reduction in serum chloride and increases in serum uric acid and glucose were also observed . These changes were slight and did not cause the discontinuation of treatment for any patient . The most frequently observed side effects were mild to moderately severe dizziness , weakness , and headaches",
"OBJECTIVE Plasma renin activity was measured at baseline and 6 months in a trial of nonpharmacologic therapy of mild hypertension to determine whether plasma renin activity predicts the diastolic blood pressure ( DBP ) response to nonpharmacologic therapy . DESIGN , SETTING , AND PARTICIPANTS R and omized controlled trial of volunteers from the general community with mild hypertension ( DBP between 90 and 100 mm Hg ) , off all antihypertensive therapy at baseline , treated in special research clinics ( n = 593 ) . INTERVENTIONS Subjects were r and omly assigned to usual , weight loss , or low sodium/high potassium diet and then r and omly assigned to receive placebo , chlorthalidone , or atenolol . MAIN OUTCOME MEASURES Renin was analyzed as plasma renin activity and as a renin index ( logarithm of 24-hour urinary sodium excretion times logarithm of plasma renin activity ) ( 593 patients at baseline and 6 months ) to correct for varied sodium intakes . The DBP was measured using the r and om zero device . RESULTS Change in DBP at 6 months could be predicted from baseline plasma renin activity or renin index . The DBP was decreased after 6 months of therapy by 2 mm Hg for each unit increase in baseline plasma renin activity and by 0.16 mm Hg for each unit increase in baseline renin index . Patients in the highest renin index quartile had a greater DBP response to atenolol therapy , and patients in the lowest renin index quartile had a greater DBP response to chlorthalidone therapy . Weight loss diet achieved a greater reduction in DBP in patients with higher baseline renin index and had an additive effect on DBP response in both of the drug groups . Patients on a weight loss diet receiving placebo in the highest baseline renin index quartile had a reduction in DBP of 12.4 mm Hg , compared with 4.4 mm Hg in the lowest baseline renin index quartile ( P = .009 ) . A low sodium/high potassium diet had a lesser effect than a weight loss diet on pharmacologic therapy . As with the weight loss diet , patients on a low sodium/high potassium diet in the highest baseline renin index quartile had a greater reduction in DBP than patients in the lowest baseline renin index quartile . CONCLUSIONS These data suggest a significant relationship between baseline levels of plasma renin index and the likelihood of success of nonpharmacologic treatment of hypertension",
"We investigated serum glucose and insulin levels result ing from thiazide or thiazide-like diuretic administration and determined whether they were associated with serum or intracellular potassium or magnesium values . We also explored the role of obesity both alone and with thiazides on serum insulin and glucose . Hypertensive men were withdrawn from diuretics and repleted with oral potassium and magnesium and then r and omized to 2 months of treatment with ( 1 ) hydrochlorothiazide , ( 2 ) hydrochlorothiazide with oral potassium , ( 3 ) hydrochlorothiazide with oral potassium and magnesium ( 4 ) hydrochlorothiazide and triamterene , ( 5 ) chlorthalidone , or ( 6 ) placebo . Serum was available from 202 participants for insulin and glucose determinations . Mean fasting serum glucose and insulin did not change significantly after 2 months of r and omized therapy with the exception of participants r and omized to chlorthalidone , who had significant increases in both serum insulin and glucose ( P body mass index increased , there was a corresponding increase in serum insulin and to a lesser degree in serum glucose . Also , as body mass index increased , participants taking hydrochlorothiazide had a corresponding increase of serum insulin ( P serum insulin ( P magnesium with lower serum glucose ( P hypertensive men , treatment with 50 mg chlorthalidone increases glucose and insulin levels , whereas administration of 50 mg hydrochlorothiazide , with or without potassium and /or magnesium conserving strategies , does not . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Because obesity-associated hypertension has unique hemodynamic and hormonal profiles , certain classes of antihypertensive agents may be more effective than others as monotherapy . Thus , we compared the efficacy and safety of the angiotensin-converting enzyme inhibitor lisinopril and the diuretic hydrochlorothiazide in a 12-week , multicenter , double-blind trial in 232 obese patients with hypertension . Patients with an office diastolic pressure between 90 and 109 mm Hg were r and omized to treatment with daily doses of lisinopril ( 10 , 20 , or 40 mg ) , hydrochlorothiazide ( 12.5 , 25 , or 50 mg ) , or placebo . Mean body mass indexes were similar for all patients . At week 12 , lisinopril and hydrochlorothiazide effectively lowered office diastolic ( -8.3 and -7.7 versus -3.3 mm Hg , respectively ; P systolic ( -9.2 and -10.0 versus -4.6 mm Hg , respectively ; P pressures compared with placebo . Ambulatory blood pressure monitoring confirmed that lisinopril and hydrochlorothiazide effectively lowered 24-hour blood pressure compared with placebo ( P lisinopril had an office diastolic pressure Responses to therapies differed with both race and age . Neither treatment significantly affected insulin or lipid profiles ; however , plasma glucose increased significantly after 12 weeks of hydrochlorothiazide therapy compared with lisinopril ( + 0.31 versus -0.21 mmol/L ; P Hydrochlorothiazide also decreased serum potassium levels by 0.4 mmol/L from baseline . In conclusion , lisinopril was as effective as hydrochlorothiazide in treating obese patients with hypertension . Treatment with angiotensin-converting enzyme inhibitors may show greater efficacy as monotherapy at lower doses compared with thiazide diuretics , may have a more rapid rate of response , and may offer advantages in patients at high risk of metabolic disorders",
"The purpose of this study was to assess the safety and antihypertensive dose-response effects of irbesartan and hydrochlorothiazide ( HCTZ ) in patients with mild-to-moderate hypertension . After a 4- to 5-week single-blind placebo lead-in period , 683 patients with seated diastolic blood pressure ( SeDBP ) between 95 and 110 mm Hg were r and omized to receive once-daily dosing with one of 16 different double-blind , fixed combinations of irbesartan ( 0 , 37.5 , 100 , and 300 mg irbesartan ) and HCTZ ( 0 , 6.25 , 12.5 , and 25 mg HCTZ ) for 8 weeks . The primary efficacy variable was the change from baseline in trough SeDBP after 8 weeks of therapy . Data were analyzed by response surface modeling . At Week 8 , mean changes from baseline in trough SeDBP ( mm Hg ) ranged from -3.5 for placebo , -7.1 to -10.2 for the irbesartan monotherapy groups , -5.1 to -8.3 for the HCTZ monotherapy groups , and -8.1 to -15.0 for the combination groups . Irbesartan plus HCTZ produced additive reductions in both SeDBP and seated systolic BP , with at least one combination producing greater BP reduction than either drug alone ( P tolerated ; there were no treatment-related serious adverse events . Irbesartan tended to ameliorate the dose-related biochemical abnormalities associated with HCTZ alone . In conclusion , the combination of HCTZ in doses up to 25 mg with irbesartan , in doses up to 300 mg , is safe and produces dose-dependent reductions in BP",
"Twenty-nine subjects with mild to moderate essential hypertension completed this 13 week r and omized , double-blind , placebo-controlled study comparing the antihypertensive effects of nifedipine GITS ( N ) ( 30 - 60 mg/day ) , hydrochlorothiazide ( H ) ( 25 - 50 mg/day ) and placebo ( P ) . Nifedipine GITS is a new formulation design ed for once daily administration . N lowered blood pressure 15/10 mmHg ( p less than 0.0005/p less than 0.0001 ) , H 15/8 mmHg ( p less than 0.0005/p 0.05 ) , and P 4/0 mmHg ( p = NS ) . All patients required the larger dose of active drug to control BP . No drug affected the heart rate . For N , but not H , there was a positive correlation between age and the magnitude in reduction of SBP ( r = 0.79 ; p less than 0.005 ) , but not for DPB . N drug levels did not correlate with its antihypertensive effect . Epinephrine , norepinephrine , aldosterone , and plasma renin activity were not affected by N. No patients on N experienced immediate vasodilator side effects . N is a well tolerated and effective antihypertensive drug that can be given once daily . It does not cause reflex stimulation of the sympathetic nervous system",
"This multicenter , factorial- design trial assessed the safety and additive antihypertensive efficacy of a slow-release ( SR ) formulation of diltiazem hydrochloride given alone or in combination with hydrochlorothiazide for treatment of mild to moderate hypertension . After a 4- to 6-week placebo run-in period , 297 qualifying patients were r and omized to receive placebo , 1 of 4 doses of diltiazem SR monotherapy , 1 of 3 doses of hydrochlorothiazide monotherapy , or 1 of 12 possible combinations of diltiazem SR and hydrochlorothiazide for 6 weeks . A dose-related reduction in blood pressure was demonstrated for each drug as monotherapy and for the two drugs in combination . Absolute blood pressures of patients who received combination therapy were lower by an overall mean of 3.0 mm Hg diastolic and 8.0 mm Hg systolic vs diltiazem SR used alone and 3.5 mm Hg diastolic and 4.0 mm Hg systolic vs hydrochlorothiazide used alone . At the largest doses used , 50 % of patients achieved goal blood pressure while taking hydrochlorothiazide , 57 % while taking diltiazem SR , and 75 % while taking combination therapy . Combination therapy was well tolerated . This trial clearly demonstrates that diltiazem SR and hydrochlorothiazide have additive antihypertensive effects",
"A r and omized double-blind , crossover trial was carried out in twenty hypertensive patients to evaluate the hypotensive efficacy and safety of indapamide . Indapamide in doses of 2.5 mg per day in combination with other antihypertensive agents was as effective in reducing the blood pressure in hypertensive patients as one tablet of Moduretic ( 50 mg hydrochlorothiazide and 5 mg amiloride ) . Indapamide induced no changes in serum potassium or uric acid levels and there were no major side effects",
"Thirteen patients with mild hypertension ( untreated diastolic blood pressure of 95 to 114 mmHg ) received , in r and om order , three successive treatments of four weeks with placebo , spirapril ( 6 mg daily ) , or hydrochlorothiazide ( HCT2 ) ( 24 mg daily ) . At the end of each treatment , blood sample s for assessment of platelet aggregation and platelet release of platelet factor 4 ( PF4 ) and for assessment of fibrinolysis , estimated by tissue plasminogen activator ( t-PA ) , plasminogen activator inhibitor-type 1 ( PAI-1 ) , and euglob ulin clot lysis time ( ECLT ) , were taken , first at rest , then immediately after five to ten minutes of vigorous exercise , and finally after the subsequent hour of recovery rest . Platelet aggregation induced in vitro by adrenaline significantly decreased during treatment with HCT2 , the threshold rising to 10 μM as compared with 1.0 with placebo ( P for adenosine diphosphate ( ADP ) aggregation also rose , from 2 μM to 4 ( NS ) . The resting plasma PF4 value fell , although not significantly , during HCT2 treatment from the placebo value of 3.28 to 2.56 ng/mL. During spirapril treatment there was no change in the threshold of either adrenaline or ADP for aggregation of platelets sample d at rest , and the PF4 plasma levels showed no significant reductions at rest . However , during exercise PF4 showed an approximate doubling of the resting value irrespective of therapy . This exercise-induced increase in PF4 was significantly reduced by spirapril as compared with placebo ( P 0.05 ) . ECLT and t-PA did not shift significantly from the placebo level during either therapy . PAI-1 did not change during spirapril therapy , but during HCT2 treatment it fell , although not significantly , to 9.36 IU/mL from 15.91 with placebo ( NS ) . Spirapril and HCT2 did not produce any unwanted side effect on platelet function or fibrinolysis . HCT2 seems to decrease platelet activity at rest , whereas spirapril seems to some extent to decrease platelet activity at exercise",
"comparison of practolol mg/day , bendrofluazide 5 mg/day , and combined therapy of practolol with bendrofluazide has been carried out in 24 patients with sustained hypertension ( mean supine blood pressure I67/104 mmHg ) . The effect of treatment on the supine , erect , and post-exercise blood pressure was studied . After four weeks of therapy , each of the active treatments was significantly superior to treatment with placebo . There was a trendfor treatment with practolol alone to reduce the blood pressure more than bendrofluazide alone in all positions but this was not statistically significant after four weeks of treatment . The maximum reduction in supine blood pressure was achieved with combined therapy of practolol with bendrofluazide ( mean blood pressure I38 9/90o5 mmHg ) . The combined therapy was significantly superior to bendrofluazide alone in allpositions but was superior to practolol alone onlyfor supine and erect systolic blood pressures . The reductions in blood pressure achieved during the period on combined therapy were not significantly greater than the sum of the reductions obtained in the periods when the individual drugs were given separately . This study shows that practolol either alone or in combination with bendrofluazide is a useful addition to the range of antihypertensive drugs",
"Assessing the compliance of people over 60 years of age and older with an antihypertensive treatment regimen was a major objective of the Systolic Hypertension in the Elderly Program ( SHEP ) pilot study . The study r and omized 551 men and women over the age of 60 ( mean age = 72 years ) to a stepped care treatment that included chlorthalidone or placebo in a double-blind trial . Three measures of compliance to treatment protocol --pill count , self-report , and a urine chlorthalidone assay -- all indicated high levels of compliance in 80 to 90 % of participants at 3 months and 1 year after r and omization . Pill-taking compliance was similar in the active and placebo groups , although the rate of discontinuance from study medications at 1 year was higher in the placebo than in the active group . Compliance was high in all age categories , including those over age 80 . These data suggest that elderly patients can achieve high levels of compliance with antihypertensive medications",
"Summary Sixteen patients with essential hypertension completed a double blind factorial trial comparing the effects of indapamide ( 2.5 mg daily ) and pindolol ( 10 mg daily ) on blood pressure , heart rate , plasma renin activity and plasma aldosterone concentration . There were four r and omised test phases of eight weeks each during which patients received indapamide alone , pindolol alone , indapamide plus pindolol and no active treatment ( placebo ) . Blood pressure and heart rate were measured every two weeks . Supine mean arterial pressure fell from 117 mm Hg in the placebo phase to 111 mm Hg in the indapamide phase , 106 mm Hg in the pindolol phase and 103 mm Hg in the combined indapamide plus pindolol phase . Factorial analysis confirmed that the hypotensive effects of the two drugs were additive , without evidence of potentiation or antagonism . Indapamide caused significant reductions in plasma potassium and chloride , and increases in plasma bicarbonate and urate concentrations ; it also caused increases in plasma renin activity and aldosterone concentration . These changes are similar to those observed with thiazide diuretics",
"Background : Hydrochlorothiazide ( HCTZ ) is commonly used to treat black patients with hypertension . To avoid the metabolic disturbances associated with high‐dose HCTZ , blood pressure control may be achieved by combining low doses with another antihypertensive",
"OBJECTIVE --To determine the relevant dose of bendrofluazide for treating mild to moderate hypertension . DESIGN --Double blind parallel group trial of patients who were given placebo for six weeks and then r and omly allocated to various doses of bendrofluazide ( 1.25 , 2.5 , 5 , or 10 mg daily ) or placebo for 12 weeks . SETTING --General practice s in Zeal and , Denmark . PATIENTS --257 Patients with newly diagnosed or previously treated hypertension , aged 25 - 70 , who had a mean diastolic blood pressure of 100 - 120 mm Hg after receiving placebo for six weeks . MAIN OUTCOME MEASURES --Reduction in diastolic blood pressure and changes in biochemical variables ( potassium , urate , glucose , fructosamine , total cholesterol , apolipoprotein A I , apolipoprotein B , and triglyceride concentrations ) . RESULTS --All doses of bendrofluazide significantly reduced diastolic blood pressure to the same degree ( 10 - 11 mm Hg ) . Clear relations between dose and effect were shown for potassium , urate , glucose , total cholesterol , and apolipoprotein B concentrations . The 1.25 mg dose increased only urate concentrations , whereas the 10 mg dose affected all the above biochemical variables . CONCLUSION --The relevant range of doses of bendrofluazide to treat mild to moderate hypertension is 1.25 - 2.5 mg a day . Higher doses caused more pronounced adverse biochemical effects including adverse lipid effects . Previous trials with bendrofluazide have used too high doses",
"Summary The pharmacodynamic effects and acceptability of perindopril ( 4 mg daily ) and hydrochlorothiazide ( 25 mg daily ) given alone or in combination for 1 month were investigated in a double-blind , placebo controlled , parallel group study . The pharmacokinetics of perindopril and its active metabolite perindoprilat and the time course of angiotensin converting enzyme inhibition were studied for 72 h following the last dose of treatment in the two appropriate groups . Similar decreases in blood pressure were seen 24 h after the last dose of perindopril or hydrochlorothiazide ( 11/7 mm Hg supine ) given alone at these doses . The effect of these drugs given together was additive on diastolic blood pressure and synergistic on systolic blood pressure ( 24.5/12.6 mm Hg supine ) taking into account the placebo response . The significant increase in plasma renin activity produced by perindopril alone was potentiated by concurrent administration of hydrochlorothiazide . The formation of perindoprilat was slightly reduced in the group also receiving hydrochlorothiazide and there was a very small reduction in ACE inhibition in this group . Perindopril , whether given alone or in combination with hydrochlorothiazide , was well tolerated and produced no clinical ly significant change in routine haematology or serum biochemistry . The additive or synergistic effects of perindopril and hydrochlorothiazide on blood pressure must be due to their complementary physiological actions and not to a pharmacokinetic interaction",
"A multicenter study of chlorthalidone was performed to determine the relative antihypertensive efficacy and side effects of doses lower than those usually recommended for therapy . After a 4‐wk placebo control period 100 patients with mild hypertension were r and omly assigned doubleblind to 12.5‐ , 25‐ , 50‐ , or 75‐mg regimens of chlorthalidone or to placebo for 12 wk . The groups of patients taking 25 , 50 , and 75 mg had declines in blood pressure which were not significantly different from each other . Serum potassium decreased in the 50‐ and 75‐mg groups but not significantly in the 25‐mg group . We conclude that chlorthalidone , 25 mg daily , was at least as effective for hypertension as 50 and 75 mg with less perturbation of potassium . Use of smalter initial diuretic doses may provide equal efficacy with fewer side effects for many patients",
"We examined the biochemical changes and the efficacy of indapamide in the prevention of calcium stone recurrences . Seventy-five patients with calcium nephrolithiasis and hypercalciuria were r and omly assigned to three different therapies : diet and fluid ( group A ) , diet and fluid plus indapamide 2.5 mg/day ( group B ) . and diet and fluid plus indapamide 2.5 mg/day plus allopurinol 300 mg/day ( group C ) . Before treatment and after 6 , 12 , 24 , and 36 months of therapy , we evaluated blood pressure , serum and urine risk parameters ( including relative supersaturations of calcium oxalate . calcium phosphate and uric acid ) , stone rate , and the proportion of calculi-free patients . During the 3 years of treatment , urinary calcium greatly decreased in groups B and C. dropping to 50 % of the pretreatment values : urinary oxalate also significantly declined in group B ( - 24 % ) and group C ( -27 % ) . Relative supersaturations of calcium oxalate and calcium phosphate decreased to the same extent in groups B and C ( about one-half of the pretreatment value ) , and relative supersaturation of uric acid was particularly reduced in group C ( -65 % of the pretreatment value ) . The stone rate improved in all three groups ( p > 0.005 ) . but using actuarial analysis in the evaluation of calculi-free patients , indapamide , and indapamide plus allopurinol groups were found to have a significantly more favorable effect than diet and fluid treatment ( p > 0.02 ) , without any difference between the two drug groups . Because indapamide has fewer side effects than thiazide diuretics , we conclude that indapamide could be an interesting alternative to thiazides in the prevention of calcium stones in hypercalciuric patients",
"Two recent , multicenter , double-blind , placebo-controlled studies established the efficacy and safety of low-dose bisoprolol/hydrochlorothiazide ( HCTZ ) in patients with mild to moderate essential hypertension . Bisoprolol , a cardioselective beta-blocker , was used in a dose of 2.5 mg , 5 mg , or 10 mg . HCTZ was used at a dose of 6.25 mg . This low-dose compound was developed to minimize dose-related adverse effects . The addition of HCTZ to each of the doses of bisoprolol was compared with monotherapy and placebo . Results of both studies demonstrated that this once-a-day , low-dose option effectively reduced sitting diastolic and systolic blood pressure measured at the end of the 24-hour dosing period . Drug-related adverse effects , including those generally associated with traditional beta-blocker therapy , were infrequent in individuals who received the low-dose bisoprolol/HCTZ regimen . Dose-related side effects were minimized because of the low doses of the two agents used together . There were no significant changes in mean total cholesterol , triglycerides , or serum glucose with bisoprolol/HCTZ 6.25 mg therapy versus placebo ( analysis of variance statistical methods ) . The incidence of treatment-induced hypokalemia with bisoprolol/HCTZ 6.25 mg was not significant ; uric acid elevations were minimized , and the incidence of hyperuricemia was significantly ( P bisoprolol/HCTZ 6.25 mg than with 25 mg of HCTZ . Once-a-day dosing with the low-dose agent controlled ( defined as a sitting diastolic blood pressure or = 10 mmHg ) blood pressure in up to 80 % of patients for a full 24 hours after dosing . ( ABSTRACT TRUNCATED AT 250 WORDS",
"To determine whether the combination of nifedipine + chlorthalidone exerts an additive antihypertensive effect when compared with single-drug treatment , we studied 66 uncomplicated essential hypertensives , with diastolic blood pressure of greater than 100 and less than 115 mmHg . At the end of a 1-month washout placebo period , using a double-blind crossover design , the patients were r and omly allocated to nifedipine ( 20 mg twice a day ) , chlorthalidone ( 25 mg once a day ) , the two drugs combined at the same doses and the corresponding placebo . Compared with the r and omly allocated placebo , the three active treatments significantly reduced blood pressure without changing the heart rate or body weight . Both the absolute and percentage decreases in mean blood pressure induced by nifedipine and the combination compared with placebo were similar and significantly greater than those induced by chlorthalidone . Taken together , these data show that the combination of nifedipine + chlorthalidone does not exert any additive antihypertensive effect compared with nifedipine alone . This finding indicates that the combination of a dihydropyridine calcium antagonist + a thiazide diuretic is probably devoid of any particular clinical significance in the treatment of uncomplicated essential hypertensives",
"Thiazide diuretics are widely used in the drug treatment of hypertension but their dose-response curves for the antihypertensive and adverse metabolic effects differ . To characterize the lower end of the dose-response curve a double-blind , parallel group trial was performed as multicentre study in Sc and inavia . One hundred and eleven patients with newly diagnosed or previously treated mild to moderate hypertension ( untreated diastolic blood pressure of 95 - 115 mmHg after 4 weeks placebo ) were r and omly allocated to various doses of hydrochlorothiazide ( 3 , 6 , 12.5 or 25 mg ) or placebo for 6 weeks . Blood pressure and biochemical variables ( plasma renin activity , serum potassium , magnesium , urate , fasting glucose , total cholesterol , HDL-cholesterol , triglycerides and apolipoproteins A1 and B were measured . 12.5 mg hydrochlorothiazide had a borderline effect on blood pressure whilst 25 mg had a definite antihypertensive effect . Biochemical changes were seen in plasma renin activity , serum potassium and urate after the 12.5 and 25 mg dose . Three and 6 mg had no effect on blood pressure or metabolic parameters",
"Summary The dose response curve for 25 , 50 , 75 and 100 mg doses of chlorthalidone was studied in double blind fashion over an 8 week period in patients who presented with untreated mild hypertension . One hundred and thirty four patients completed this multicentre , family practice study . After 2 week 's medication , a decline in blood pressure was noted in all dosage groups and this was maximal by 4 weeks . At 8 weeks all doses of chlorthalidone induced a significant reduction in both systolic and diastolic blood pressures ( mean −18 and −10 mmHg respectively ) . Amongst the 4 dosage groups , no differences in response were noted result ing in a flat dose response curve . During the study , mean blood urea and serum uric acid rose whilst serum potassium fell , the urea and potassium being least affected in the 25 mg dosage group . As the dosage of chlorthalidone increased , so the tendency for abnormal laboratory values increased . Unwanted effects sought during the study were relatively few in number . No clear dose response relationship was evident although the positive responses in the 25 mg dosage group were less than in the higher dosages . These results suggest that 25 mg chlorthalidone is the optimum dosage for initiation of therapy in patients with mild to moderate hypertension . This dosage is associated with less adverse biochemical changes and unwanted effects than the higher dosages studied",
"Summary Men and women with isolated systolic hypertension who were at least 60 years of age were treated for 1 year with chlorthalidone ( 25–50 mg daily ) or matching placebo as the step I drug . Most patients reached goal blood pressure without requiring a step II drug . The blood pressure response was similar in all age , sex and race subgroups , with an overall difference between the r and omised groups of 17 mm Hg for systolic blood pressure ( p diastolic blood pressure ( p adverse effects were asymptomatic changes in the serum concentrations of potassium ( 0.5 mmol/L lower in the chlorthalidone group , p uric acid ( 0.9 mg/dl higher , p and creatinine ( 0.08 mg/dl higher , p=0.02 . Compliance was good , and more than 80 % of participants were still taking the study medications at the end of the year . RésuméLes hommes et les femmes porteurs d’une hypertension systolique isolée , âgés au moins de 60 ans , ont été traités , en première intention , pendant 1 an avec du chlorthalidone ( 25–50 mg par jour ) ou par le traitement placebo apparié . La plupart des malades ont atteint la pression sanguine recherchée sans qu’il soit nécessaire de passer au degré II du traitement médicamenteux . La réponse de la pression sanguine a été similaire dans tous les sous-groupes âge , sexe et race , avec une différence extrême entre les groupes tirés au sort de 17 mmHg pour la pression systolique ( p concentrations sériques de potassium ( moins 0,5 mmol/l dans le groupe chlorthalidone , ( p créatinine ( plus 0,08 mg/dl , p=0.02 ) . L’adhésion au traitement a été bonne , et plus de 80 % des participants continuaient de prendre leurs médicaments à la fin de l’année de traitement . ZusammenfassungMänner und Frauen mit einer isolierten systolischen Hypertonie , die mindestens 60 Jahre alt waren , wurden über ein Jahr mit Chlorthalidon ( 25–50 mg täglich ) oder gleichartigem Placebo als Pharmaka der ersten Stufe beh and elt . Die meisten Patienten erreichten den erwünschten Blutdruck , ohne daβ ein Medikament der zweiten Stufe erforderlich war . Die Blutdruck-Reaktion war in allen Alters- , Geschlechts-und Rassen-Untergruppen ähnlich mit einem Gesamtunterschied zwischen den r and omisierten Gruppen von 17 mmHg für den systolischen Blutdruck ( p Nebenwirkung best and in einer asymptomatischen Veränderung des Kalium in den Serumkonzentrationen ( 0,5 mmol/L niedriger in der Chlorthalidon-Gruppe , p Harnsäure ( 0,9 mg/dl höher , p 60 años de edad , se han tratado durante 1 año con clortalidona ( 25–50 mg diarios ) , o placebo de análogo aspecto , como fármaco de etapa I. La mayoría de los pacientes alcanzaron la presión deseada sin necesitar medicamento de etapa II . La respuesta tensional fue semejante en todos los grupos de edad , sexo y raza con una diferencia total entre los grupos aleatorizados de 17 mm Hg para la presion sistólica ( p clortalidona , p aceptación fue buena y más del 80 % de participantes todavía estaban tom and o las medicaciones en estudio al final del año . ResumoHomens e mulheres com hipertensão sistólica isolada e com idade mínima de 60 anos foram tratados por um ano com clortalidona ( 25 a 50 mg por dia ) ou placebo equivalente como drogas de primeira escolha . A maioria dos pacientes atingiu o nível de pressão sanguínea objetivado sem recorrerem a outras drogas . A reação da pressão sanguínea foi semelhante em todos os subgrupos , fossem por idade , sexo ou raça , com uma diferença global entre os grupos selecionados de 17 mmHg para a pressão sistólica ( p diastólica ( p assintomáticas nas concentrações de potássio no soro ( 0,5 mmol/L abaixo , no grupo com clortalidona , cortalidona , p ùrico ( 0,9 mg/dl acima , p clortalidone ( 25–50 mg al giorno ) o placebo , come farmaco di primo livello . La maggior parte dei pazienti normalizzarono la loro pressione arteriosa senza richiedere un farmaco di secondo livello . La risposta pressoria fu simile in tutti i sottogruppi di età , sesso e razza , con una differenza totale tra i gruppi r and omizzati di 17 mm Hg per la pressione sistolica ( p concentrazioni sieriche di potassio ( di 0,5 mmol/1 inferiore nel gruppo trattato con clortalidone , p acido urico ( di 0.9 mg/dl più alto , p creatinina ( di 0.08 mg/dl maggiore , p compliance fu buona e più dell’80 % dei partecipanti allo studio era ancora in trattamento alla fine dell’anno",
"In this study we compared the antihypertensive efficacy and tolerability of captopril at 25 mg twice daily , hydrochlorothiazide ( HCTZ ) , 12.5 mg twice daily and placebo in a multicentre , double-blind , r and omized study that included 152 essential hypertensive patients ( 77 males , 75 females , 87 WHO stage I , 65 WHO stage II , aged 69 + /- 4 years , mean + /- s.d . ) . Supine and st and ing blood pressure were similarly reduced by captopril and HCTZ ( P less than 0.01 for both compared with placebo ) . The heart rate did not change . Captopril ( 25 - 30 mg twice daily ) and HCTZ ( 12.5 mg twice daily ) , alone or in combination , maintained their antihypertensive effect during a 24-week single-blind follow-up study . During the follow-up , diastolic blood pressure remained less than 100 mmHg in seven essential hypertensives on placebo , in 45 on captopril and in 25 on HCTZ . Side effects were observed in seven essential hypertensives during placebo ( treatment withdrawn in two ) , in eight during HCTZ and in three during captopril . Serum potassium was reduced ( P less than 0.05 ) and uric acid was increased ( P less than 0.01 ) only during HCTZ . We conclude that captopril and HCTZ have similar antihypertensive efficacy in the elderly ; however , captopril appears to be better tolerated",
"Objective : To compare the antihypertensive efficacy of moexipril , a new angiotensin-converting enzyme ( ACE ) inhibitor , to treatment with hydrochlorothiazide ( HCTZ ) . Patients : Two hundred and one non-hospitalized male and female patients between 65 and 80 years of age with essential hypertension . Methods : This was a multicentre , placebo-controlled , double-blind study with a parallel group design . Subjects with a sitting diastolic blood pressure ( DBP ) ≥ 95 mmHg were r and omized to monotherapy with placebo , moexipril 7.5 mg o.d . , moexipril 15 mg o.d . or HCTZ 25 mg o.d . for 8 weeks . Results : Throughout the study period treatment with moexipril and HCTZ result ed in significant reductions of DBP compared with placebo , but there were no significant differences between the active treatment groups . At end point the adjusted mean reductions were 10.5 , 8.7 and 10.1 mmHg in the HCTZ , moexipril 7.5 mg and moexipril 15 mg groups , respectively , compared to 3.9 mmHg in the placebo group . Treatment with moexipril was associated with two cases of first dose hypotension and two cases of moderate and reversible increases in serum creatinine levels . Otherwise , both dosages of moexipril were well tolerated and the overall percentages of patients who had adverse experiences were smaller than in the placebo group . Conclusion : Moexipril is well tolerated and is at least as effective as HCTZ in elderly patients with essential hypertension",
"BACKGROUND The safety and effectiveness of different dosages and combinations of antihypertensive agents can be efficiently studied using a multifactorial trial design . In consultation with the Cardio-Renal Division of the Food and Drug Administration , we conducted a r and omized , double-blind , placebo-controlled , 3 x 4 factorial trial of bisoprolol , a beta 1-selective adrenergic blocking agent , and hydrochlorothiazide . METHODS A total of 512 patients with mild to moderate essential hypertension were r and omized to once-daily treatment with bisoprolol ( 0 , 2.5 , 10 , or 40 mg ) , hydrochlorothiazide ( 0 , 6.25 , or 25 mg ) , and all possible combinations . Diastolic and systolic blood pressures were monitored during this 12-week trial . RESULTS The effects of bisoprolol and hydrochlorothiazide were additive with respect to reductions in diastolic and systolic blood pressures over the dosage ranges studied . The addition of hydrochlorothiazide ( or bisoprolol ) to therapy with bisoprolol ( or hydrochlorothiazide ) produced an incremental reduction in blood pressure . Dosages of hydrochlorothiazide as low as 6.25 mg/d contributed a significant antihypertensive effect . A hydrochlorothiazide dosage of 6.25 mg/d produced significantly less hypokalemia and less of an increase in uric acid levels than a dosage of 25 mg/d . The low-dose combination of bisoprolol , 2.5 mg/d , and hydrochlorothiazide , 6.25 mg/d , reduced diastolic blood pressure to lower than 90 mm Hg in 61 % of patients and demonstrated a safety profile that compared favorably with that of placebo . CONCLUSIONS The utility of factorial design trials to characterize dose-response relationships and to test the potential interactions between various antihypertensive agents has been demonstrated . The combination of low dosages of bisoprolol and hydrochlorothiazide may be a rational alternative to conventional stepped-care therapy for the initial treatment of patients with mild to moderate hypertension",
"The Trial of Antihypertensives Interventions and Management ( T AIM ) was a multicenter double-blind placebo-controlled clinical trial of drug and diet combinations for the treatment of mild hypertension among 878 participants , ages 21 to 65 , 110 % to 160 % ideal weight , and with baseline diastolic blood pressure 90 to 100 mm Hg . The drugs used were placebo , chlorthalidone ( 25 mg/daily ) or atenolol ( 50 mg/daily ) . The diets studied were usual , weight loss , sodium reduction/potassium increase . Trial end points were 6-month diastolic blood pressure change , cardiovascular risk change , and quality of life change . Either drug combined with weight loss produced the greatest blood pressure reduction of 15 mm Hg , compared to 8 mm Hg on placebo/usual diet . Adding sodium restriction to either drug did not enhance blood pressure lowering effect . Drugs outperformed diet in terms of antihypertensive effect . However , those on placebo and assigned to weight reduction who lost more than 4.5 kg and those on sodium restriction who reduced sodium to less than 70 mEq daily lowered blood pressure to a similar extent as those on either of the two drugs alone . Cardiovascular risk at 6 months relative to baseline ranged from 0.85 in weight loss/atenolol subgroup to 1.04 in the usual diet/chlorthalidone subgroup . Blacks were more responsive to chlorthalidone plus weight loss and whites to atenolol plus weight loss . Quality of life , as measured by scales of distress and well-being , was favorably affected by weight reduction . Although there were few side effects of the drugs and most patients improved on most parameters , sexual complaints were worsened among those on chlorthalidone and usual diet compared to placebo . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND Angiotensin II acts at the cellular level through specific angiotensin II subtype I , AT-1 receptors . Losartan is the first of a new class of antihypertensive agents that specifically block angiotensin II at AT-1 receptors . By acting on complementary and different pharmacologic mechanisms , the concomitant use of low doses of hydrochlorothiazide with losartan may offer an additive antihypertensive activity with fewer adverse experiences . METHODS This double-blind study evaluated losartan concomitantly administered with hydrochlorothiazide as initial therapy in 703 patients with essential hypertension . RESULTS The greatest reduction in blood pressure was observed in the 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide group ( 17.2 mm Hg in sitting systolic blood pressure and 13.2 mm Hg in sitting diastolic blood pressure [ P losartan potassium and 12.5 mg of hydrochlorothiazide had an excellent or good antihypertensive response ( sitting diastolic blood pressure or = 90 mm Hg with a reduction of 10 mm Hg or more ) . Peak ( 6 hours after dosing ) and trough placebo-adjusted ratios for the losartan-hydrochlorothiazide groups ranged from 62 % to 85 % , indicating that there was a smooth reduction in sitting diastolic blood pressure that was sustained over 24 hours . The most common clinical adverse experiences ( > or = 4 % ) that occurred with an incidence slightly greater than that reported by the placebo-treated patients were headache , asthenia or fatigue , dizziness , sinusitis , and upper respiratory infection . CONCLUSION The concomitant administration of losartan potassium , 50 mg , with 12.5 mg of hydrochlorothiazide once daily produced an additive reduction in trough sitting systolic and diastolic blood pressure and was well tolerated",
"The antihypertensive effect of once and twice daily hydrochlorothiazide administration was compared in 24 ambulatory patients with essential hypertension . Hydrochlorothiazide 100 mg daily taken as a single morning dose or as a twice daily divided dose was administered to 24 previously diagnosed hypertensive patients in a double-blind cross-over fashion for 12 weeks . No patient received other antihypertensive agents or medications known to influence blood pressure . Sitting and st and ing blood pressure , weight , pulse , tablet count , and subjective complaints of side effects were obtained at study weeks 3 and 6 on each treatment schedule . There was no significant difference between the mean sitting systolic ( 133 and 131 mm Hg ) or diastolic ( 85 and 84 mm Hg ) blood pressure measurements at study weeks 3 and 6 for each treatment schedule . Comparison of st and ing mean systolic and diastolic blood pressure and mean arterial pressure produced similar results . Subjective complaints of medication side effects , including orthostasis or urinary frequency , did not differ between treatment schedules . This study suggests that hydrochlorothiazide may be effectively administered once daily for the treatment of hypertension",
"BACKGROUND Increased left ventricular mass ( LVM ) by echocardiography is associated with increased risk of cardiovascular disease . Thus , it is of interest to compare the effects of both pharmacological and nonpharmacological approaches to the treatment of hypertension on reduction of LVM . METHODS AND RESULTS Changes in LV structure were assessed by M-mode echocardiograms in a double-blind , placebo-controlled clinical trial of 844 mild hypertensive participants r and omized to nutritional-hygienic ( NH ) intervention plus placebo or NH plus one of five classes of antihypertensive agents : ( 1 ) diuretic ( chlorthalidone ) , ( 2 ) beta-blocker ( acebutolol ) , ( 3 ) alpha-antagonist ( doxazosin mesylate ) , ( 4 ) calcium antagonist ( amlodipine maleate ) , or ( 5 ) angiotensin-converting enzyme inhibitor ( enalapril maleate ) . Echocardiograms were performed at baseline , at 3 months , and annually for 4 years . Changes in blood pressure averaged 16/12 mm Hg in the active treatment groups and 9/9 mm Hg in the NH only group . All groups showed significant decreases ( 10 % to 15 % ) in LVM from baseline that appeared at 3 months and continued for 48 months . The chlorthalidone group experienced the greatest decrease at each follow-up visit ( average decrease , 34 g ) , although the differences from other groups were modest ( average decrease among 5 other groups , 24 to 27 g ) . Participants r and omized to NH intervention only had mean changes in LVM similar to those in the participants r and omized to NH intervention plus pharmacological treatment . The greatest difference between groups was seen at 12 months , with mean decreases ranging from 35 g ( chlorthalidone group ) to 17 g ( acebutolol group ) ( P = .001 comparing all groups ) . Within-group analysis showed that changes in weight , urinary sodium excretion , and systolic BP were moderately correlated with changes in LVM , being statistically significant in most analyses . CONCLUSIONS NH intervention with emphasis on weight loss and reduction of dietary sodium is as effective as NH intervention plus pharmacological treatment in reducing echocardiographically determined LVM , despite a smaller decrease in blood pressure in the NH intervention only group . A possible exception is that the addition of diuretic ( chlorthalidone ) may have a modest additional effect on reducing LVM",
"The 4 year prospect i ve trial on the effectiveness of the antihypertensive treatment was performed in 100 mild hypertensive patients of the aged , the average age being 76.1 years . Dropouts during the drug-off control period were 9 cases . The matched pair group was selected by the age , sex , and blood pressure . Forty-four drug treated cases and 47 placebo treated cases were comparable in blood pressure as well as in laboratory data . Cerebrovascular and cardiac complications were observed in 4 cases or 10.5 % in the drug group , and in 9 cases or 22.0 % in the placebo group . When 8 cases of blood pressure elevation over 200/110 mmHg in the placebo group were added to the cardiovascular complications , dropouts in placebo group reached 41.5 % , and this showed the significant difference . Other complications were observed in 12 cases or 31.6 % in the drug group and in 17 cases or 41.5 % in the placebo group . Major complications were cancers , infections , and bone or joint diseases . Blood pressure was decreased from 171/87 to 151/80 in the drug group , and the average decrease was 20/7 mmHg in 4 year period . No significant changes in hematocrit , serum protein , urea nitrogen , uric acid , sodium , and potassium were observed during the trial period . The present study suggested that antihypertensive treatment was effective in the aged with mild hypertension , and that careful follow up was needed not only for cardiovascular complications but also for general health condition",
"Aim : To review the efficacy and safety of losartan and hydrochlorothiazide compared to losartan alone , hydrochlorothiazide alone or placebo in the treatment of mild to moderate hypertension in a clinical trial Patients and methods : A r and omly allocated , placebo-controlled , double-blind parallel study was performed in 40 clinical centers throughout the United States . A total of 703 males and females aged 18–75 years with a sitting diastolic blood pressure of 95–115 mmHg entered the trial and 604 completed the 12-week protocol . The participants were r and omly assigned to concomitant therapy once a day with : ( 1 ) 50 mg losartan and 6.25 mg hydrochlorothiazide , ( 2 ) 50 mg losartan and 12.5 mg hydrochlorothiazide , ( 3 ) 50 mg losartan alone , ( 4 ) 12.5 mg hydrochlorothiazide alone or ( 5 ) placebo . All participants were followed for 12 weeks Results : At baseline , mean trough sitting diastolic blood pressure was 100.9 - 101.7 mmHg , with no significant difference between treatment groups . Sitting diastolic blood pressure fell 4.0 mmHg with placebo , 7.2 mmHg with 12.5 mg hydrochlorothiazide , 7.2 mmHg with 50 mg losartan , 9.3 mmHg with 50 mg losartan + 6.25 mg hydrochlorothiazide , and 13.2 mmHg with 50 mg losartan + 12.5 mg hydrochlorothiazide . The fall in mean trough sitting systolic blood pressure was 2.4 , 9.3 , 10.7 , 12.0 and 17.9 mmHg for the respective groups . After subtracting the placebo effect , the reductions in blood pressure induced by losartan and hydrochlorothiazide were additive for both sitting diastolic and systolic blood pressures and approximately equaled the reduction seen with the combination of losartan and hydrochlorothiazide . There were no significant differences in adverse events between treatment groups Conclusions : The concomitant administration of 50 mg losartan + 12.5 mg hydrochlorothiazide produced additive falls in sitting diastolic and systolic blood pressures which were greater than that achieved with either drug alone . On the basis of the adverse effects reported , the combination was well",
"A blood lipid-lipoprotein elevating effect of the diuretics hydrochlorothiazide and chlorthalidone in mildly hypertensive men has been established by a cross-over , r and omized controlled trial , confirming previous clinical observations . Compared to baseline , plasma total cholesterol increased 6 % and 8 % and triglycerides 17 % and 15 % under treatment with hydrochlorothiazide and chlorthalidone , respectively . A cholesterol-lowering diet largely prevents this increase . Because these effects may be long-lasting and may cancel part of the potential benefit of blood pressure control in mildly hypertensive patients , with thiazide diuretics attention should be given to prescription of a cholesterol-lowering diet and to periodic monitoring of blood lipid levels . Different antihypertensive agents might be considered in patients with elevated blood lipid levels . Other antihypertensive agents currently in use need to be studied for potential effects on lipid metabolism",
"STUDY OBJECTIVES To compare the efficacy of combination therapy with sustained-release diltiazem and hydrochlorothiazide ( DTZ SR-HCTZ ) with that of monotherapy with DTZ SR , HCTZ , or placebo in the treatment of essential hypertension ; and to determine whether the addition of a diuretic to diltiazem at apparent optimum doses of each agent significantly enhances their antihypertensive effects . DESIGN Multicenter , r and omized , double-blind , placebo-controlled , parallel-group trial with a 6-week treatment phase . SETTING Private and university-based clinics . PATIENTS AND PARTICIPANTS Subjects of either sex , ranging in age from 18 - 70 years , with a diagnosis of stable essential hypertension made from two consecutive weekly mean supine diastolic blood pressure ( DBP ) readings of 95 mm Hg or above to 110 mm Hg or less that varied 7 mm Hg or less after 4 - 6 weeks in the baseline phase . Of the patients enrolled , 298 met the inclusion criteria . INTERVENTIONS Combination therapy with DTZ SR-HCTZ 120 mg-12.5 mg , or monotherapy with DTZ SR 120 mg or HCTZ 12.5 mg , or placebo was administered twice daily . MEASUREMENTS AND MAIN RESULTS Combination therapy with DTZ SR-HCTZ lowered both supine DBP and SBP significantly ( p DBP and SBP significantly more than either monotherapy . During a 12-hour in-clinic monitoring period spanning a dosing interval , both the combination and DTZ SR therapies maintained efficacy , whereas the antihypertensive effects of HCTZ dissipated after 8 hours . Treatment-related adverse events for the combination and HCTZ were similar but slightly greater than those for DTZ SR and placebo . CONCLUSIONS The addition of a diuretic to sustained-release diltiazem produced an enhanced antihypertensive effect compared with monotherapy with either individual agent",
"During a 12-week , multicenter study to evaluate the efficacy and safety of lisinopril and hydrochlorothiazide ( HCTZ ) for the treatment of obesity-related hypertension , ambulatory blood pressure ( ABP ) monitoring was performed both at baseline and at study completion in 124 patients . Patients were r and omized to three groups : placebo , lisinopril ( 10 , 20 , or 40 mg/day ) , or HCTZ ( 12.5 , 25 , or 50 mg/day ) . All groups were matched with regard to sex , race , age , body mass index , and waist/hip ratio . The primary analysis of ABP data revealed that both lisinopril and HCTZ effectively lowered mean 24-h systolic ( SBP ) and diastolic ( DBP ) blood pressure compared with placebo , ( mean change from baseline SBP/DBP : -12.0/-8.2 , -10.6/-5.5 , and -0.3/-0.5 mm Hg , respectively ) ; however , lisinopril lowered DBP better than HCTZ ( P responded better to lisinopril than HCTZ ( -11.9/-7.3 v -6.6/-3.5 mm Hg , respectively ) , whereas women responded well to both drugs . White patients responded better to lisinopril than HCTZ , whereas black patients showed a significant response to HCTZ only . Response to treatment was also influenced by patient classification of 24-h blood pressure profiles , ie , \" dipper \" or \" nondipper . \" Overall , the majority of obese hypertensives were nondippers . Nondippers ( n = 82 ) responded well to both drugs ( -10.4/-6.9 v -12.5/-5.7 mm Hg , P lisinopril ( -11.7/ -9.4 mm Hg , P HCTZ ) , but not HCTZ ( -5.6/-4.1 mm Hg , P = NS v placebo ) . Results of 24-h ABP data show that both lisinopril and HCTZ are effective therapies for obesity-related hypertension and that response to treatment is influenced by sex , race , and dipper/nondipper status",
"A factorial design method was applied in this multicentre trial of the angiotensin-converting enzyme inhibitor quinapril hydrochloride ( Accupril ) in combination with the diuretic hydrochlorothiazide ( HCTZ ) to assess the additive effects of the combination versus monotherapy , to characterise the dose-response relationship of each drug in the presence of the other and to determine if quinapril would attenuate the hypokalemic effect of HCTZ . Following a two to four week placebo-baseline period , 460 qualifying patients with a DBP > or = 100 mmHg and were r and omised to an eight week double-blind phase with one of 16 parallel treatments : placebo , one of three doses of quinapril monotherapy , one of three doses of HCTZ monotherapy or one of nine possible corresponding combinations of quinapril and HCTZ . Mean reductions in sitting SBP/DBP at trough with combination therapy ranged from 7.8 mmHg/7.2 mmHg to 19.6 mmHg/15.1 mmHg ( n = 458 ) . Results of the response surface analyses indicate that the effects of the two drugs were additive and that the maximum antihypertensive effect of quinapril in combination with HCTZ within the doses studied is achieved approximately at a dose of 26 mg quinapril and 25 mg HCTZ . The degree of attenuation of the hypokalemic effect of HCTZ was directly related to the dose of quinapril . At 40 mg quinapril , the HCTZ dose-related decreases of serum potassium were not apparent and overall hypokalemic effects were attenuated by quinapril . Thus , the combination of quinapril and HCTZ given once daily provided additive antihypertensive effects of predictable degrees and the addition of quinapril attenuated the hypokalemic effect of HCTZ",
"BACKGROUND African Americans with hypertension , particularly those with more severe blood pressure elevations , are generally less responsive to monotherapy from any antihypertensive class . These patients usually require treatment with drugs from > or = 2 antihypertensive classes to achieve adequate blood pressure control . OBJECTIVE The purpose of this study was to assess the antihypertensive efficacy and safety of losartan alone and in combination with hydrochlorothiazide ( HCTZ ) in African American adults with mild to moderate hypertension . METHODS In this 12-week , multicenter , double-blind , r and omized , parallel-group , placebo-controlled study , African American patients were r and omized in a 3:3:1 ratio to I of 3 treatment groups : placebo , losartan monotherapy ( 50 to 150 mg ) , or losartan plus HCTZ ( 50/0 to 50/12.5 to 100/25 mg ) . Doses were titrated at weeks 4 and 8 if sitting diastolic blood pressure ( SiDBP ) was > or = 90 mm Hg . Safety was assessed by determining the incidence of clinical and laboratory Adverse events and evaluating mean changes in pulse , body weight , electrocardiographic parameters , and laboratory test results . RESULTS A total of 440 patients were r and omized-188 to placebo , 193 to losartan monotherapy , and 59 to losartan/HCTZ ; 391 completed the study . At week 12 , the response rate with losartan monotherapy was 45.8 % , with a significant ( P mean SiDBP by 6.6 mm Hg compared with placebo ; the response rate with placebo was 27.2 % , with a mean SiDBP reduction of 3.9 mm Hg . Sitting systolic blood pressure ( SiSBP ) was significantly lowered with losartan monotherapy , by 6.4 mm Hg , compared with placebo ( reduction of 2.3 mm Hg ) . The response rate with losartan/ HCTZ was 62.7 % , with reductions in SiSBP and SiDBP of 16.8 mm Hg and 10.8 mm Hg , respectively ( P adverse events was comparable in the 3 treatment groups . CONCLUSIONS The results of this study suggest that in African American patients , losartan monotherapy was significantly more effective than placebo in lowering SiSBP and SiDBP . Moreover , the losartan/ HCTZ combination regimen result ed in significant and clinical ly meaningful additional reductions in SiSBP and SiDBP compared with losartan monotherapy or placebo . Losartan monotherapy and the losartan/HCTZ regimens were generally as well tolerated as placebo",
"Introduction : Blood pressure ( BP ) levels , beat-to-beat blood pressure variability , dynamic cerebral autoregulation and cardiac baroreceptor sensitivity are frequently abnormal following acute stroke and are associated with an adverse short- and long-term prognosis . Thiazide diuretics are effective antihypertensive agents in preventing primary and secondary stroke , but their hypotensive and cerebral autoregulatory effects in the immediate post-stroke period have not been studied . Methods : Thirty-seven hypertensive neuroradiologically proven ischaemic stroke patients were r and omized in a double-blind , placebo controlled , parallel group study to bendrofluazide 2.5 mg daily or matching placebo , within 96 h of stroke onset , for a 7-day period . Casual and non-invasive beat-to-beat arterial BP levels , cerebral blood flow velocity , ECG and transcutaneous carbon dioxide levels were measured within 70 ± 20 h of cerebral infa rct ion and again 7 days later . Dynamic cerebral autoregulatory indices , pulse interval , BP variability and cardiac baroreceptor sensitivity were also calculated . Results : Small , non-significant falls were seen in casual and beat-to-beat BP levels over the 7-day period in both active and placebo-treated patients with no differences between treatments . No significant changes were seen in dynamic cerebral autoregulation or in cardiac baroreceptor sensitivity during the follow-up in either group . Conclusion : Following acute ischaemic stroke , the st and ard dose of bendrofluazide at 2.5 mg daily in this study sample did not lower systemic BP levels over the subsequent 7-day period . There was no evidence that bendrofluazide significantly altered cerebral autoregulation or improved cardiac baroreceptor sensitivity post-ictus . Bendrofluazide appears to be an ineffective hypotensive agent at the st and ard dosage in the initial post-stroke period",
"Twenty-two white men and two white women with uncomplicated essential hypertension participated in a r and omized double-blind trial comparing placebo with alpha-methyldopa ( 750 mg/d orally ) and chlorothiazide ( 450 mg/d orally ) , alone or in combination . There were no significant differences in blood pressures as measured with the patients lying down ; however , with the patients st and ing the systolic , diastolic and mean arterial blood pressures were significantly lower ( P alpha-methyldopa or the combination product . The higher the blood pressure before treatment , the greater the fall with treatment . Adverse effects were infrequent",
"Summary In a multicentre , double-blind , crossover , placebo-controlled study , the antihypertensive effect of labetalol 100 mg and chlorthalidone 10 mg , given alone or in combination , has been assessed in 32 hypertensive patients . The combination had a greater effect in reducing blood pressure than did its separate components . This was particularly evident after exercise . Heart rate increased during chlorthalidone therapy , decreased during labetalol therapy , and a summation effect was observed during treatment with the combination . In most cases additivity was observed , as no interaction between the single components was observed , except for heart rate after exercise , and for diastolic blood pressure in the upright position . No interaction was observed either in the biochemical indices or in the clinical side-effects",
"To determine dose‐effect and concentration‐effect relationships in hypertension for pinacidil and hydrochlorothiazide when given alone and together , we conducted a r and omized , double‐blind , 4 × 3 factorial , modified fixed‐dose multicenter trial . Three hundred and eighty‐four patients with essential hypertension ( supine diastolic blood pressure , 95 to 110 mm Hg ) were assigned to one of 12 groups that received all combinations of four doses of pinacidil ( 0 , 12.5 , 25 , and 37.5 mg , b.i.d . ) with three doses of hydrochlorothiazide ( 0 , 12.5 , and 25 mg , b.i.d . ) . Significant dose‐ and concentration‐effect relationships were seen for pinacidil and hydrochlorothiazide on diastolic blood pressure . For pinacidil , dose‐ and concentration‐effect relationships were steeper after the dose than before the dose . A significant interaction with hydrochlorothiazide was noted such that , when combined with 12.5 mg hydrochlorothiazide , 12.5 mg pinacidil had near‐maximal effects on blood pressure at both peak and trough . Edema occurred in 47 % of those who received 37.5 mg pinacidil monotherapy ( 19 % discontinued ) . The administration of 12.5 mg pinacidil with 12.5 mg hydrochlorothiazide appears to be optimal for efficacy and safety",
"In a joint Veterans Administration-National Heart , Lung , and Blood Institute study of mild hypertension , 1,012 men and women , 21 to 50 years of age and with diastolic pressure from 85 to 105 mm Hg , were r and omized into two double-blind treatment groups . Subjects in the active group received chlorthalidone or chlorthalidone plus reserpine , while the other subjects received matching placebo tablets . After one year of treatment , the chlorthalidone group had increases of 10.0 + /- 1.8 ( SE ) mg/dL in total cholesterol level , 9.8 + /- 5.2 mg/dL in triglyceride level , and 12.6 + /- 3.4 mg/dL in low-density lipoprotein-cholesterol level above the changes in the placebo group . There was no difference in high-density lipoprotein changes between the two groups ( 0.1 + /- 0.8 mg/dL ) . The possible net effect on risk of increasing lipid values while lowering pressure in the long-term treatment of mild hypertension with thiazides or related diuretics must be further evaluated",
"Indapamide ( Lozol ) , an indoline antihypertensive drug with diuretic and vasodilating activities , was evaluated in 195 patients with mild to moderate essential hypertension ( sitting DBP between 95 and 110 mmHg ) in a multicentre , r and omised , double-blind , parallel-group design trial . A four week single-blind placebo wash-out period was followed by an eight week double-blind period . Patients were r and omised to indapamide 1.25 mg/day or to placebo . The primary efficacy endpoint was the mean change in sitting DBP from baseline to week 8 . Ninety patients in the placebo group ( 93 % ) and 82 patients ( 84 % ) in the indapamide group completed the eight weeks of double-blind therapy . Indapamide produced a mean ( SE ) decrease in sitting DBP of 7.4 ( 0.63 ) mmHg ( from 100.1 to 92.8 mmHg ) compared with a decrease of 3.6 ( 0.75 ) mmHg ( from 99.6 to 95.8 mmHg ) produced by placebo ( p Indapamide and placebo also produced mean decreases in st and ing DBP of 6.8 ( 0.75 ) and 2.8 ( 0.77 ) mmHg , respectively ( p = 0.0002 ) , in sitting SBP of 11.1 ( 1.18 ) and 3.2 ( 1.35 ) mmHg , respectively ( p = 0.0001 ) and in st and ing SBP of 11.4 ( 1.29 ) and 4.0 ( 1.43 ) mmHg , respectively ( P = 0.0002 ) . Reduction in BP of > or = 10 mmHg or to a DBP of indapamide ( 46.6 % ) compared with placebo ( 23.7 % ) treated patients . During the eight week double-blind treatment period , incidence rates for all adverse experiences and for drug-related adverse experiences were similar between the two treatment groups . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The object of this study was to determine the clinical ly relevant dose of bendrofluazide for the treatment of arterial hypertension . A material of 257 male and female subjects , age 25 - 70 years , with sitting diastolic blood pressures between 100 - 120 mmHg after six weeks of placebo treatment participated in this r and omized , double-blind placebo-controlled parallel group study . The patients were treated with either 0 , 1.25 , 2.5 , 5.0 or 10 mg bendrofluazide daily for 12 weeks . Blood pressure was measured with a r and om zero sphygmomanometer and a Tricuff . Compliance was checked by tablet counts . The mean decreases in diastolic blood pressure were 3.5 , 9.8 , 10.8 , 10.1 and 10.8 mmHg in the five treatment groups respectively . The heart rates were unchanged in all groups . Dose-effect relations were demonstrated for potassium , urate , glucose , cholesterol and apolipoprotein B. The lowest dose of bendrofluazide , 1.25 mg , affected only urate , whereas all of the mentioned biochemical variables were affected by the highest dose of 10 mg . It can be concluded that the optimal dose of bendrofluazide for aterial hypertension is 1.25 mg daily . Increase in the dose beyond this level only results in more pronounced adverse biochemical effects including the lipid-metabolism and subjective adverse events",
"Unlike some thiazide diuretics , indapamide -- a non-thiazide chlorosulphonamide derivative -- has been shown to have a magnesium-sparing effect in normotensive subjects . This effect has not been studied in hypertensive subjects . In a r and omised double-blind trial indapamide 2,5 mg and placebo were given daily to a group of elderly patients with mild hypertension , with and without supplemental magnesium chloride . Blood pressure and serum and red blood cell cations were measured . The significant antihypertensive effect of indapamide was confirmed . There was no effect of indapamide on serum and red cell magnesium concentrations compared with placebo , both with and without magnesium supplementation . Indapamide induced hypokalaemia with a shift of sodium into the red cells . In this group of elderly hypertensive subjects indapamide induced potassium but not magnesium loss",
"The antihypertensive effect and safety of fosinopril and hydrochlorothiazide combined were compared with each drug singly and placebo in a controlled manner . After a 4- to 5-week placebo lead-in period , 67 mild to moderate essential hypertensive patients ( seated diastolic blood pressure £ 95 and £ 110 mm Hg ) were r and omized in a double-blind fashion into four parallel treatment groups : 20 mg fosinopril plus 12.5 mg hydrochlorothiazide , 20 mg fosinopril , 12.5 mg hydrochlorothiazide , and placebo during 8 weeks . Patients were seen biweekly . Sitting diastolic blood pressure was the outcome variable defining therapeutic response . The efficacy of fosinopril plus hydrochlorothiazide as a combined therapy was superior to any single drug ( P hypertension . Mean adjusted systolic/diastolic blood pressure decrements at week 8 were −18.8/−13.7 , −12.9/−11.8 , −8.5/−9.3 , and −2.11−6.9 mm Hg for the fosinopril plus hydrochlorothiazide , fosinopril , hydrochlorothiazide , and placebo groups , respectively . Clinical adverse events and laboratory changes documented throughout the study were similar to placebo and were mild in severity in all groups",
"Thiazide diuretics are known to raise total and LDL cholesterol . To assess whether chlorthalidone affected levels of putatively atherogenic small , dense LDL ( LDL 3 ) , we conducted a 12 week double blind r and omized , placebo controlled clinical trial in 34 nonsmoking men aged 35 to 57 years with mild hypertension ( DBP 90 to 104 mm Hg ) . Our a priori hypothesis that chlorthalidone raised LDL 3 levels was not confirmed . However , the fall in LDL 3 ( P = .03 ) and total cholesterol ( P = .08 ) associated with weight loss was attenuated by chlorthalidone . Since weight loss is commonly prescribed during the clinical management of hypertensives with concomitant hypercholesterolemia , consideration should be given to the attenuating effect of chlorthalidone on cholesterol reduction in the management of these patients",
"BACKGROUND To attain goal blood pressure ( BP ) , many hypertensive patients require combination antihypertensive therapy . Thiazide diuretic/beta-blocker regimens lower BP , and clinical studies indicate that they reduce the risk for cardiovascular consequences of hypertension . Fixed-dose combination tablets can simplify multidrug treatment regimens . METHODS This multicenter , r and omized , double-blind , placebo-controlled , unbalanced factorial study ( N = 1571 ) was design ed to determine whether hydrochlorothiazide ( HCT ) and extended release ( ER ) metoprolol both contribute to an antihypertensive effect . Hypertensive adults with sitting diastolic BP ( SiDBP ) 95 to 114 mm Hg and systolic BP ( SiSBP ) received one of three hydrochlorothiazide doses ( 6.25 mg , 12.5 mg , or 25 mg ) , one of four ER-metoprolol doses ( 25 mg , 50 mg , 100 mg , 200 mg ) , or one of nine of the combinations or placebo for 8 weeks . RESULTS Blood pressure decreased with all combinations ( P Reductions with placebo were 5.3 ( SiDBP ) and 4.2 mm Hg ( SiSBP ) . Both active agents contributed to the combination effect ( P = .0015 for SiDBP ; P = .0006 for SiSBP ) . Several low-dose combinations were approximately as effective as high doses of the individual agents ( differences within 1 to 2.5 mm Hg ) . The adverse event discontinuation rate was 2.9 % . Serum potassium decreased and uric acid increased with increasing doses of HCT . CONCLUSIONS Extended-release metoprolol/hydrochlorothiazide is an effective antihypertensive combination that offers additive antihypertensive contributions from both components",
"The objective of this study was to evaluate the safety and efficacy of indapamide 1.25 mg once daily as monotherapy in elderly patients ( 65 years and older ) with mild to moderate essential hypertension . Two hundred and seventy-nine ( 279 ) elderly patients were enrolled in a washout period , during which patients received single-blind placebo for 4 weeks . Patients demonstrating supine diastolic pressures between 95 mm Hg and 114 mm Hg at the end of the 4-week placebo washout period were entered into the 8-week double-blind treatment period . Two hundred and four ( 204 ) patients qualified for the study and were r and omized to the double-blind treatment ; 103 patients received indapamide 1.25 mg and 101 patients received placebo for 8 weeks . Overall , 177 patients ( 92 indapamide and 85 placebo ) completed the study . The primary efficacy criterion was the mean change in supine diastolic blood pressure ( DBP ) from double-blind baseline to the end of 8 weeks of therapy . By week 8 of the double-blind treatment period , indapamide 1.25 mg produced a statistically significant ( P = 0.0037 ) decrease in supine DBP of 8.2 mm Hg compared to a decrease of 5.3 mm Hg produced in the placebo group . Additionally , indapamide 1.25 mg was statistically ( P = 0.0028 ) more effective than placebo in reducing supine systolic BP ( SBP ) ( −10.1 vs −4.2 mm Hg ) . The incidence of drug-related adverse events during the double-blind treatment period was similar between the two treatment groups . A low dose of indapamide , 1.25 mg , given once daily for 8 weeks was effective as monotherapy with respect to BP reduction in an elderly population with mild to moderate hypertension . Indapamide 1.25 mg was safe and generally well tolerated in this elderly patient population",
"BACKGROUND Losartan , an angiotensin II receptor antagonist , has been shown to decrease serum uric acid and to increase urinary excretion of uric acid . METHODS To determine if this effect can increase the risk of acute urate nephropathy , 63 hypertensive patients with thiazide-induced asymptomatic hyperuricemia ( serum uric acid 7.0 to 12.0 mg/dl ) were r and omized double-blind to losartan 50 mg every day ( q.d . ) , losartan 50 mg plus hydrochlorothiazide ( HCTZ ) 50 mg q.d . , HCTZ 50 mg q.d . , or placebo for three weeks . To potentiate the risk of crystal formation , patients received a 2 g/kg protein diet one day prior to each clinic visit on days 0 ( baseline ) , 1 , 7 , and 21 . RESULTS Adverse events typically associated with acute urate nephropathy , for example , flank pain , hematuria , or increased blood urea nitrogen/creatinine , were not reported . Uric acid excretion and urine pH increased four and six hours after losartan on day 1 compared with day 0 . Dihydrogen urate , the primary risk factor for crystal formation , decreased at four and six hours on day 1 compared with day 0 associated with the concurrent rise in urine pH. Day 7 and 21 changes , compared with day 0 , in uric acid excretion rate , urine pH , and dihydrogen urate with losartan were comparable to day 1 results but were not statistically significant . Serum uric acid was significantly reduced after 21 days of therapy with losartan . CONCLUSION Losartan decreased serum uric acid and increased uric acid excretion without increasing urinary dihydrogen urate , the primary risk factor for acute urate nephropathy , during 21 days of dosing in hypertensive patients with thiazide-induced hyperuricemia",
"The possible beneficial or adverse effects of long-term diuretic use in the elderly were evaluated in 60 males ( mean age 80.0 years ) and 17 females ( mean age 84.3 years ) . All subjects were found to have no obvious need for diuretics when initially assessed and were not receiving concurrent digoxin therapy . Residents were r and omly allocated to placebo or active groups with stratification for prior hypertension or congestive heart failure ( CHF ) and they were followed for one year in a double-blind design . Mean BP , heart rate and weight at one year were similar to baseline values in both groups . Six active and two placebo subjects developed CHF and two other placebo subjects had a return of BP to hypertensive levels . Serum creatinine , cholesterol , potassium and BUN were significantly improved at one year in the placebo group . Chronic diuretic use did not alter appreciably the occurrence of CHF or hypertension in this elderly population and may not be necessary",
"A double-blind study carried out on volunteer patienls with medium to severe grade II hypertension , did not show any slatistically significant difference between treatment with Baycaron 25 mg daily and hydrochlorothiazide 50 mg daily",
"In a double-blind , crossover study , five white men with mild-to-moderate hypertension received placebo and fixed doses of atenolol , metoprolol , chlorthalidone , verapamil , and the combination of atenolol and chlorthalidone in a quasi-r and om order . Daily dosages were : atenolol , 100 mg ; metoprolol , 200 mg ; chlorthalidone , 50 mg ; verapamil , 240 mg ; and the same doses of atenolol and chlorthalidone in combination . St and ard office and daytime ambulatory blood pressures were assessed at the end of each month-long trial . Atenolol , metoprolol , chlorthalidone , and verapamil controlled office blood pressure with similar reductions . Verapamil did not lower ambulatory blood pressure at this dose ( which is lower than is now commonly used ) , but reductions in ambulatory blood pressure were similar for atenolol , metoprolol , and chlorthalidone . The combination of atenolol and chlorthalidone maintained blood pressure control more effectively than the single drug treatments in both office and ambulatory setting s , and the combined hypotensive effects were additive . However , reductions in the office due to the combination appeared to overestimate hypotensive effectiveness in the ambulatory setting . This study suggests that the effectiveness of commonly prescribed antihypertensive regimens varies according to setting as well as drug , and that assessment of treatment effectiveness can be improved by automated ambulatory blood pressure monitoring",
"A double-blind , placebo controlled , crossover trial of 20 and 40 mg of xipamid once daily in the treatment of mild to moderate hypertension is reported and some of the difficulties and pitfalls of multicentre trials of this type are described . 2 Both doses were significantly more effective in reducing the blood pressure than the placebo and neither was superior to the other . Both produced some potassium loss . Xipamid acted for at least 22 h and was effective in up to 83 % of the patients . 3 Further trials are suggested to investigate the activity of a lower dose than 20 mg",
"BACKGROUND Characteristics such as age and race are often cited as determinants of the response of blood pressure to specific antihypertensive agents , but this clinical ly important issue has not been examined in sufficiently large trials , involving all st and ard treatments , to determine the effect of such factors . METHODS In a r and omized , double-blind study at 15 clinics , we assigned 1292 men with diastolic blood pressures of 95 to 109 mm Hg , after a placebo washout period , to receive placebo or one of six drugs : hydrochlorothiazide ( 12.5 to 50 mg per day ) , atenolol ( 25 to 100 mg per day ) , captopril ( 25 to 100 mg per day ) , clonidine ( 0.2 to 0.6 mg per day ) , a sustained-release preparation of diltiazem ( 120 to 360 mg per day ) , or prazosin ( 4 to 20 mg per day ) . The drug doses were titrated to a goal of less than 90 mm Hg for maximal diastolic pressure , and the patients continued to receive therapy for at least one year . RESULTS The mean ( + /- SD ) age of the r and omized patients was 59 + /- 10 years , and 48 percent were black . The average blood pressure at base line was 152 + /- 14/99 + /- 3 mm Hg . Diltiazem therapy had the highest rate of success : 59 percent of the treated patients had reached the blood-pressure goal at the end of the titration phase and had a diastolic blood pressure of less than 95 mm Hg at one year . Atenolol was successful by this definition in 51 percent of the patients , clonidine in 50 percent , hydrochlorothiazide in 46 percent , captopril in 42 percent , and prazosin in 42 percent ; all these agents were superior to placebo ( success rate , 25 percent ) . Diltiazem ranked first for younger blacks ( ) and older blacks ( > or = 60 years ) , among whom the success rate was 64 percent , captopril for younger whites ( success rate , 55 percent ) , and atenolol for older whites ( 68 percent ) . Drug intolerance was more frequent with clonidine ( 14 percent ) and prazosin ( 12 percent ) than with the other drugs . CONCLUSIONS Among men , race and age have an important effect on the response to single-drug therapy for hypertension . In addition to cost and quality of life , these factors should be considered in the initial choice of a drug",
"Atenolol was compared with five other beta-blockers and a thiazide diuretic in a r and omised cross-over trial of once-daily treatment of essential hypertension . Atenolol was significantly better at reducing resting and exercise blood pressures at 24 hours than any of the other drugs and had a low incidence of side effects . Both timolol and acebutolol had a significant hypotensive effect at 24 hours and a low incidence of side effects , suggesting that further increases in dosage might be effective and well tolerated . Labetalol proved ineffective when given once daily , and the high incidence of side effects , equalled only by pindolol , would probably prohibit further increases in dosage . Bendrofluazide was equal or superior to all the beta-blockers except atenolol at reducing resting blood pressure , and its cheapness still makes it an agent of first choice in mild or moderate essential hypertension",
"Abstract . A 2‐year double‐blind trial design ed for study ing the separate and combined effects of bendroflumethiazide ( BFTZ ) and cyclical administration of 17β‐estradiol + estriol/norethisterone ( E/N ) on coronary risk factors and bone mineral loss ( reported elsewhere ) was undertaken . Serum lipids , fasting blood glucose , body weight and blood pressure were measured every 3 months in 97 normal women in their early menopause . All participants received a supplement of 500 mg calcium and were r and omized to one of the following treatment groups : 1 ) placebo ( P ) + P ( n = 33 ) ; 2 ) P + E/N ( n = 21 ) ; 3 ) BFTZ + E/N ( n = 22 ) ; and 4 ) BFTZ + P ( n = 21 )",
"A r and omized double-blind crossover trial of labetalol , bendrofluazide and placebo was carried out in 18 patients with mild to moderate hypertension . The reduction in blood pressure observed with labetalol and bendrofluazide was similar . The plasma levels of labetalol showed a significant correlation with changes in blood pressure ( r = 0.07 ; P less than 0.021 ) ; and plasma level determinations of this drug may be of value in the management of patients who receive antihypertensive agents",
"Objectives Aliskiren is a novel , orally active renin inhibitor . Its antihypertensive efficacy and safety , alone and in combination with hydrochlorothiazide ( HCTZ ) , were investigated in an 8-week , double-blind , placebo-controlled trial in hypertensive patients . The effects of these treatments on plasma renin activity ( PRA ) were also assessed . Methods A total of 2776 patients aged ≥ 18 years with mean sitting diastolic blood pressure ( MSDBP ) 95–109 mmHg were r and omized to receive once-daily treatment with aliskiren ( 75 , 150 or 300 mg ) , HCTZ ( 6.25 , 12.5 or 25 mg ) , the combination of aliskiren and HCTZ , or placebo , in a factorial design . The primary endpoint was the change in MSDBP from baseline to week 8 . PRA was assessed at these timepoints at selected study centers . Results Aliskiren monotherapy was superior to placebo ( P reducing MSDBP and mean sitting systolic blood pressure ( MSSBP ) . Combination treatment was superior to both component monotherapies in reducing BP ( maximum MSSBP/MSDBP reduction of 21.2/14.3 mmHg from baseline with aliskiren/HCTZ 300/25 mg ) , and result ed in more responders ( patients with MSDBP . Aliskiren monotherapy reduced PRA by up to 65 % from baseline . Although HCTZ monotherapy increased PRA by up to 72 % , PRA decreased in all of the combination therapy groups . All active treatments were well tolerated . Conclusions Aliskiren monotherapy demonstrated significant BP lowering , and its effect was considerably greater when combined with HCTZ . Renin inhibition with aliskiren neutralized the compensatory rise in PRA induced by HCTZ ",
"Fifty-five patients with mild to moderate , renal or essential hypertension were admitted to a double blind cross-over trial of 18 weeks , involving treatment periods with placebo , the thiazide bendrofluazide ( 15 mg daily ) and the beta blocker atenolol ( 600 mg daily ) . Compared to the placebo period ( 190/117 mm Hg ) the hypotensive effect of atenolol ( -24/16 mm Hg ) was more pronounced than the hypotensive effect of bendrofluazide ( -17/6 mm Hg ) . Arguments in favor of initiating antihypertensive drug therapy with beta blocker were its more powerful hypotensive effect , the quicker onset of its action , less metabolic disturbance , decreased frequency of complaints and patient 's preference . On thiazides body weight and the frequency of swollen ankles decreased . Plasma renin concentration was not found to have a strong predicting power for the hypotensive effect of atenolol or bendrofluazide but low renin patients showed a more pronounced blood pressure decrease on bendrofluazide and high renin patients , especially essential hypertensives , on atenolol . While these points can be a guide to therapy today , the preference of one drug over the other must eventually be based on their relative efficacy in decreasing morbidity and mortality from the hypertensive disease",
"In a double-blind trail in 22 patients with mild to moderate essential hypertension , indapamide was compared with chlorathiazide and placebo . Dosage levels were set at 5 mg . indapamide and 500 mg . chlorothiazide daily , for 5 days out of 7 , and patients were treated alternately , in r and om sequence , with each drug for a month over a 3-month period . Blood pressure readings and blood chemistry investigations were carried out before and after each treatment period and a careful history was kept of subjective symptoms and patients ' tolerance of therapy . The results show that both active treatments produced drops in systolic and diastolic pressures , but were only statisically significant and different from placebo in the case of indapamide . Indapamide also produce much greater subjective improvement ( 74 % ) in patients with functional symptoms compared with chlorothiazide ( 15 % ) . In an overall assessment , indapamide produced an excellent to good response to treatment in 57 % of patients . Comparable responses for chlorotiazide and placebo were 25 % and 20 % respectivlely . Using patients as their own controls to compare the relative effectiveness of the three periods of treatment , indapamide was shown to be more effective than placebo in 65 % of cases and more effective han chlorothiazide in 60 % . Although patient tolerance of indapamide was slightly better , both drugs were well accepted and no significant changes from baseline levels were noted in any of the laboratory parameters investigated",
"Arterial compliance , assessed by the ratio of stroke volume to pulse pressure , and baroreceptor sensitivity ( Oxford method ) , were determined in ten patients with essential hypertension , treated with placebo or indapamide ( 2.5 mg/day ) , in a cross-over , single blind study . After three months of therapy , mean arterial pressure was significantly reduced from 127 + /- 10 to 118 + /- 9 mmHg , ( P less than 0.001 ) , as was total peripheral vascular resistance ( from 3017 + /- 561 to 2457 + /- 614 dyne/sec/cm-5/m2 , P less than 0.001 ) . Significant increases occurred in cardiac index ( 3.47 + /- 0.55 to 4.03 + /- 0.86 l/min/m2 , P less than 0.01 ) , baroreceptor sensitivity assessed with phenylephrine ( from 11.69 + /- 7.9 to 15.0 + /- 9.1 msec/mmHg , P less than 0.01 ) or with nitroglycerine ( from 4.77 + /- 1.6 to 7.11 + /- 2.7 msec/mmHg , P less than 0.01 ) and arterial compliance ( from 1.27 + /- 0.42 to 1.55 + /- 0.57 , P less than 0.01 ) . A significant direct correlation was found between arterial compliance and baroreceptor sensitivity assessed during induced increase and reduction of BP , both during placebo ( r = 0.88 , P less than 0.001 and r = 0.77 , P less than 0.01 , respectively ) and during active therapy ( r = 0.94 , P less than 0.001 and r = 0.92 , P less than 0.001 , respectively ) . These results support the conclusion that chronic treatment with indapamide enhances arterial compliances and reduces the heart load and blood vessel stress . The same effect could explain the enhancement of baroreceptor sensitivity promoted by the drug",
"Benazepril hydrochloride is a new angiotensin‐converting enzyme inhibitor . In a multicenter study , 206 patients with mild to moderate hypertension were r and omized to receive benazepril at a dose of 2 , 5 , 10 , or 20 mg , hydrochlorothiazide , 25 mg , or placebo once daily for 4 weeks . The 20 mg dosage of benazepril lowered blood pressure to a degree equal to that of 25 mg hydrochlorothiazide : −12.217.7 mm Hg and −13.4/−7.5 mm Hg , respectively . Hydrochlorothiazide proved to be more effective in black subjects . At lower dosage levels of benazepril ( 2 , 5 , and 10 mg ) , blood pressure reduction was not significantly different from that with placebo . In those patients who failed to achieve goal diastolic blood pressure of hydrochlorothiazide ( 25 mg/day ) to benazepril , hydrochlorothiazide , or placebo produced a substantial additional decrease in blood pressure over a 2‐week period . No definite adverse effects on hématologie measurements , serum biochemistry test results , or urinalyses were noted . Subjective adverse experiences were common in all groups but except in three or possibly four instances were not considered causally related to the study drug",
"AIM To compare the efficacy of indapamide ( 1.25 mg daily ) and low-salt diet ( essential hypertensive patients with inadequate BP response to perindopril . DESIGN AND METHODS R and omized double-blind , double-dummy , crossover design . The r and omized treatments were indapamide 1.25 mg daily , sodium chloride 80 mmol daily , the combination of indapamide and sodium chloride and placebo . All patients received perindopril 4 mg daily and maintained a low-sodium diet . RESULTS 19 patients entered and 17 completed the study . Prior to r and omization , average clinic sitting blood pressure was 162/101 mm Hg and average 24-h urine sodium excretion was 157 mmol/day . Compared to the phase in which patients received perindopril with sodium repletion , clinic and ambulatory BPs were significantly reduced ( p BP than dietary sodium restriction , and in combination their effects were additive . The effect of indapamide on ambulatory BP persisted throughout 24 h , but the effect of the low-salt diet was predominantly observed during waking hours . CONCLUSIONS In hypertensives with BP resistant to the angiotensin converting enzyme ( ACE ) inhibitor perindopril , the diuretic indapamide had greater additional efficacy and longer duration of action than dietary sodium restriction . In combination they had additive effects on BP",
"In accordance with international recommendations on the need to decrease doses of antihypertensive drugs , a low-dose ( 1.5 mg ) sustained-release form of indapamide was developed so as to optimize the safety/efficacy ratio , while maintaining a once-daily administration . The new formulation ensures that the active ingredient release occurs in a sustained manner over 24 hours , with mean concentrations close to the maximal concentration over a prolonged period , while avoiding peak plasma concentrations . Clinical data were obtained mainly through two European multicenter , r and omized , double-blind trials , totalling 690 patients . Firstly , the antihypertensive efficacy ' of the new indapamide 1.5 mg form was demonstrated by measuring blood pressure 24 hours after the last drug intake , using a mercury sphygmomanometer ; the equivalence of its antihypertensive efficacy with the immediate-release form of indapamide 2.5 mg was then verified . Biochemical safety data showed better acceptability with indapamide 1.5 mg with in particular a reduction of more than 50 % of the number of patients with kalemia clinical safety data confirmed the good acceptability observed with the 2.5 mg immediate-release form of indapamide since many years , especially regarding glucose and lipid neutrality . In conclusion , the 1.5 mg sustained-release form of indapamide has an improved antihypertensive efficacy/safety ratio which is in accordance with international recommendations for the usage of low doses of antihypertensive drugs and diuretics in the first-line treatment of hypertension",
"1 The hypotensive effect of single daily dosing with atenolol 100 mg and chlorthalidone 25 mg given alone or in combination has been assessed in a double-blind , crossover , placebo controlled trial in fifteen hypertensive patients . 2 Average lying blood pressures were : Placebo 155.4/103.9 mm Hg , atenolol 134.6/85.8 mm Hg , chlorthalidone 139.5/90.1 mm Hg , combination 127.7/82.5 mm Hg . 3 The effect of the combination therapy in reducing lying diastolic pressure compared with placebo ( a fall of 21.4 mm Hg ) was significantly less than the 31.9 mm Hg fall predicted from the sum of the individual effects ( P = 0.01 ) . 4 Observations on blood pressure at rest and under mental , isometric and bicycle ergometer stress were made pre-dose and post-dose for a 12 h period at the end of the last treatment period . 5 Lying blood pressure declined from the zero hour ( pre-dose ) reading on all treatments to a low at 15.00 - -18.00 h and then rose again . 6 The rise in systolic blood pressure after isometric exercise and mental stress was of a similar magnitude with all four treatment regimes . 7 Atenolol , alone and in combination with chlorthalidone , reduced the blood pressure and the pulse rate increase on exercise 2 h post-dose when compared with readings 24 h post-dose . 8 Once daily dosing with a combination of atenolol and chlorthalidone produced a fall in supine blood pressure over a 24 h period but the effect on exercise induced changes was not uniform over this period",
"We r and omised ambulatory men with diastolic blood pressure ( BP ) 95 - 109 mmHg without anti-hypertensive medication to single drug treatment with either hydrochlorothiazide 12.5 - 50 mg/day , atenolol 25 - 100 mg/day , captopril 25 - 100 mg/day , clonidine 0.2 - 0.6 mg/day , diltiazem-SR 120 - 360 mg/day , prazosin 4 - 20 mg/day or placebo in a double-blind prospect i ve trial . The assigned drug was titrated to a goal BP of goal BP were rer and omised to an alternative single active drug . Non-responders to the second drug received the first drug in combination with the second . Of the 102 non-responders to both drugs who qualified for the combination , 59 ( 57.8 % ) responded . The combination pairs that included a diuretic achieved diastolic goal BP in 69 % and adverse drug reactions were in combinations containing prazosin ; three of these six were hypotensive reactions . We conclude that two single drugs of insufficient efficacy to control BP individually have a high probability of achieving goal BP when combined , especially if the combination contains a diuretic",
"BACKGROUND Reducing systolic blood pressure ( BP ) is of major benefit to patients with isolated systolic hypertension , but lowering normal diastolic BP may be harmful in terms of cardiovascular risk . Effects of different drugs on systolic BP , diastolic BP , and pulse pressure are therefore of interest . METHODS The NatriliX SR versus C and Esartan and amLodipine in the reduction of systoLic blood prEssure in hyperteNsive patienTs study ( X-CELLENT ) was a r and omized , double-blind , placebo-controlled study comparing the effects of three drugs on these BP components . Patients with systolic-diastolic or isolated systolic hypertension ( n = 1758 ) received indapamide ( 1.5 mg ) sustained release ( SR ) , c and esartan ( 8 mg ) , amlodipine ( 5 mg ) , or placebo once daily for 12 weeks . RESULTS Compared to placebo all active treatments reduced all BP components significantly ( P patients with isolated systolic hypertension ( n = 388 ) , the three treatments significantly reduced systolic BP , but only indapamide SR did not change diastolic BP and thus reduced pulse pressure significantly relative to placebo ( P = .005 ) . In an ancillary study using ambulatory BP monitoring ( n = 576 ) , all three treatments significantly reduced BP components during 24 h relative to placebo . Changes in systolic BP and pulse pressure were similar with the three treatments , but the reduction in diastolic BP was significantly smaller , and therefore more favorable , with indapamide SR compared with c and esartan ( P = .039 ) . In patients with isolated systolic hypertension ( n = 106 ) , indapamide SR reduced 24-h systolic BP significantly more than amlodipine ( P = .037 ) , and only indapamide SR reduced 24-h pulse pressure significantly relative to placebo ( P = .03 ) . All three drugs were well tolerated . CONCLUSIONS This distinctive BP-lowering profile of indapamide SR seems highly beneficial when compared to the either of c and esartan or amlodipine",
"BACKGROUND Increasing concern over long-term drug treatment of mild hypertension has stimulated several studies of weight reduction . Phase I of the Trial of Antihypertensive Interventions and Management demonstrated a short-term effect of weight loss on blood pressure control in overweight persons with mild hypertension , who were either taking placebo or taking low-dose monotherapy . Phase II investigates the long-term benefit of weight loss on the ability to maintain blood pressure control . METHODS From 10148 community-based screenees , 587 persons ( 5.8 % ) , aged 21 to 65 years , entered a multicenter , r and omized drug ( double-blind , placebo-controlled ) and diet trial . Participants had a diastolic blood pressure between 90 and 100 mm Hg and were at 110 % to 160 % of their ideal weight . They were r and omized to a usual diet ( n = 296 ) or to a weight loss diet ( n = 291 ) and within each diet group to placebo , chlorthalidone , 25 mg/d , or atenolol , 50 mg/d . Treatment failure was defined as using additional antihypertensive medications if diastolic blood pressure rose above 90 mm Hg according to protocol -specified criteria . RESULTS At baseline , mean diastolic blood pressure was 93 mm Hg ; systolic blood pressure , 143 mm Hg ; weight , 88 kg ; percent ideal weight , 137 % ; age , 48 years ; 56 % were men ; and 33 % were black . Mean follow-up was 4.5 years . There was a net loss of 2 to 3 kg with weight loss diet compared with usual diet over most of the follow-up period . The 5-year incidence of treatment failure was 56.7 per 100 participants with usual diet and 49.8 per 100 with weight loss . Long-term weight loss decreased failure of blood pressure control for those receiving placebo or low-dose diuretic or beta-blocker by 23 % . The results were similar in direction in each drug group . CONCLUSIONS The Trial of Antihypertensive Interventions and Management demonstrated that weight reduction is an effective long-term therapy for maintaining blood pressure in the normal range when used as monotherapy or in combination with either thiazide diuretics or beta-blockers . Consequently , weight loss should be recommended for the management of obese individuals with mild hypertension",
"The effects of the ACE inhibitor spirapril and of hydrochlorothiazide on left ventricular diastolic function were studied . Thirteen patients with mild to moderate essential hypertension completed this r and omized , double-blinded , placebo-controlled , crossover study . After a three-week run-in period the patients entered three periods lasting four weeks each , wherein they were treated with placebo , spirapril , or hydrochlorothiazide . Blood pressure , hemodynamic variables ( stroke volume , heart rate , cardiac output , index of contractility , and systemic vascular resistance ) , echocardiography ( left ventricular mass ) , and Doppler-derived atrial to early (A/E)-ratio velocity time integrals ( VTI ) were measured at the end of each of the four periods . Spirapril lowered the A/E-ratio VTIs ( 0.57 , 0.12 - 1.00 ) ( P A/E-ratio VTI in those patients with elevated values . The hemodynamic variables , left ventricular mass , and end-systolic wall stress were unchanged during all three treatments . There were no significant changes in mean blood pressure during the treatment periods . These results indicate that spirapril lowers A/E ratio within four weeks in patients with mild to moderate essential hypertension . It thereby seems able to improve left ventricular diastolic function . The effect is not dependent upon changes in hemodynamic variables , blood pressure , left ventricular mass , or end-systolic wall stress",
"The efficacy of low dosages of diuretics was evaluated in two studies . In one , 62 ( 48 % ) of 130 patients became normotensive with 2.5 mg/day of metolazone . In the other , 28 ( 49 % ) of 57 patients became normotensive with 25 mg of chlorthalidone , compared with 12 ( 22 % ) of 55 patients given placebo . There was a marked variation in blood pressure response and the occurrence of hypokalemia ( less than 3.5 mEq/L of potassium ) from center to center and within patient groups in both studies . The mean decrease in serum potassium was between 0.5 and 0.6 mEq/L in the metolazone group and 0.44 mEq/L in the chlorthalidone-treated patients . This degree of hypokalemia is only slightly less than that noted when larger dosages of thiazide diuretics are used ( 0.6 to 0.7 mEq/L ) . It is concluded that 2.5 mg/day of metolazone or 25 mg/day of chlorthalidone are effective antihypertensive agents but that blood pressure lowering may be inconsistent at these dosage levels . It is reasonable , therefore , to begin diuretic therapy with low dosages , but larger dosages ( 5 mg of metolazone or 50 mg of chlorthalidone ) should be tried before adding another drug or concluding that diuretic therapy is ineffective if an acceptable blood pressure response is not obtained . The degree of hypokalemia that occurs at lower-dose therapy is variable but may be of less clinical significance than that noted with higher dosages of diuretics in some patients . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE To assess the efficacy and safety of several combinations of benazepril , an angiotensin-converting enzyme inhibitor , and hydrochlorothiazide , as compared with placebo , in the treatment of patients with essential hypertension . DESIGN A 6-week , r and omized , double-blind , parallel study conducted at 24 centers . A placebo run-in period of 1 to 4 weeks preceded the double-blind phase . PARTICIPANTS AND SETTING Male and female out patients , aged 18 years and older , were eligible to participate if their sitting diastolic blood pressure was between 95 and 114 mm Hg at the last two consecutive visits during the placebo phase . Among the 334 patients who entered the double-blind phase , 17 % were aged 65 years or older and 26 % were black . Eleven patients withdrew because of adverse experiences , including two patients receiving placebo . INTERVENTIONS Patients received placebo ; benazepril , 20 mg ; hydrochlorothiazide , 25 mg ; or combination therapy with benazepril/hydrochlorothiazide , 5/6.25 mg , 10/12.5 mg , 20/25 mg , 20/6.25 mg , or 5/25 mg , once daily for 6 weeks . MAIN OUTCOME MEASURES The mean change from baseline in sitting diastolic blood pressure at end point ( last postr and omization measurement carried forward ) in the double-blind phase . Combination therapy with benazepril/hydrochlorothiazide , 20/25 mg , was compared with benazepril , 20 mg alone , and hydrochlorothiazide , 25 mg alone . Sitting systolic blood pressure and the effect of race and age on treatment efficacy were also evaluated . RESULTS Compared with placebo , all benazepril/hydrochlorothiazide combinations produced statistically significant reductions from baseline in sitting diastolic and systolic blood pressures at study end point . In the benazepril/hydrochlorothiazide , 20/25 mg , group , the adjusted mean changes in sitting diastolic blood pressure at end point were statistically significantly greater than those in the monotherapy treatment groups ( benazepril , 20 mg , P hydrochlorothiazide , 25 mg , P tolerated . Decreases in mean serum potassium level with hydrochlorothiazide monotherapy were reduced or eliminated with combination therapy . CONCLUSION Benazepril in combination with hydrochlorothiazide , including a low-dose combination of 5/6.25 mg , is effective in reducing sitting diastolic and systolic blood pressure in patients with hypertension",
"BACKGROUND One third of patients treated for hypertension attain adequate blood pressure ( BP ) control , and multidrug regimens are often required . Given the lifelong nature of hypertension , there is a need to evaluate the long-term efficacy and tolerability of higher doses of combination anti-hypertensive therapies . OBJECTIVE This study investigated the efficacy and tolerability of valsartan ( VAL ) or hydrochlorothiazide (HCTZ)-monotherapy and higher-dose combinations in patients with essential hypertension . METHODS The first part of this study was an 8-week , multicenter , r and omized , double-blind , placebo controlled , parallel-group trial . Patients with essential hypertension ( mean sitting diastolic BP [ MSDBP ] , > or = 95 mm Hg and were r and omized to 1 of 8 treatment groups : VAL 160 or 320 mg ; HCTZ 12.5 or 25 mg ; VAL/HCTZ 160/12.5 , 320/12.5 , or 320/25 mg ; or placebo . Mean changes in MSDBP and mean sitting systolic BP ( MSSBP ) were analyzed at the 8-week core study end point . VAL/HCTZ 320/12.5 and 320/25 mg were further investigated in a 54-week , open-label extension . Response was defined as MSDBP or = 10 mm Hg decrease compared to baseline . Control was defined as MSDBP Tolerability was assessed by monitoring adverse events at r and omization and all subsequent study visits and regular evaluation of hematology and blood chemistry . RESULTS A total of 1346 patients were r and omized into the 8-week core study ( 734 men , 612 women ; 924 white , 291 black , 23 Asian , 108 other ; mean age , 52.7 years ; mean weight , 92.6 kg ) . All active treatments were associated with significantly reduced MSSBP and MSDBP during the core 8-week study , with each monotherapy significantly contributing to the overall effect of combination therapy ( VAL and HCTZ , P reductions in MSSBP and MSDBP compared with the monotherapies and placebo ( all , P mean reduction in MSSBP/MSDBP with VAL/HCTZ 320/25 mg was 24.7/16.6 mm Hg , compared with 5.9/7.0 mm Hg with placebo . The reduction in MSSBP was significantly greater with VAL/HCTZ 320/25 mg compared with VAL/HCTZ 160/12.5 mg ( P Rates of response and BP control were significantly higher in the groups that received combination treatment compared with those that received monotherapy . The incidence of hypokalemia was lower with VAL/HCTZ combinations ( 1.8%-6.1 % ) than with HCTZ monotherapies ( 7.1%-13.3 % ) . The majority of adverse events in the core study were of mild to moderate severity . The efficacy and tolerability of VAL/HCTZ combinations were maintained during the extension ( 797 patients ) . CONCLUSIONS In this study population , combination therapies with VAL/HCTZ were associated with significantly greater BP reductions compared with either monotherapy , were well tolerated , and were associated with less hypokalemia than HCTZ alone",
"A low dose ( 1.25 mg ) of indapamide ( Lozol , Rhône-Poulenc Rorer Pharmaceuticals , Collegeville , PA ) was evaluated in 222 elderly patients ( > or = 50 years ) with mild to moderate essential hypertension in a multicenter , r and omized , double-blind , parallel-group clinical trial . A 4-week single-blind placebo washout period was followed by an 8-week double-blind treatment period . Patients were r and omized to receive indapamide 1.25 mg/day or to receive placebo . The primary efficacy variable was the mean change in sitting diastolic blood pressure from baseline to week 8 . Eighty-one patients in the indapamide group ( 73 % ) and 87 patients in the placebo group ( 78 % ) completed the 8 weeks of double-blind therapy . Therapy with 1.25 mg of indapamide produced greater reductions compared with placebo in sitting diastolic blood pressure after 8 weeks of therapy , with statistical significance ( P ( sitting systolic blood pressure , st and ing systolic and diastolic blood pressures , and > or = 10 mm Hg decrease or final value of sitting diastolic blood pressure ) also showed superior ( P indapamide group compared with placebo after 8 weeks of double-blind treatment . During the 8-week double-blind treatment period , incidence rates for all adverse events and for drug-related adverse events were similar between the two treatment groups . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Previous studies indicate that low dose bendrofluazide ( 1.25 mg/day ) has no deleterious effect on insulin sensitivity in contrast to conventional doses . To evaluate the antihypertensive effect of 1.25 mg bendrofluazide across 24 h , we studied 12 subjects in a r and omized , double blind , cross-over trial , comprising 8 weeks of either 1.25 mg/day bendrofluazide or placebo . Twenty-four-hour blood pressure averages were significantly lower after bendrofluazide compared with placebo ( systolic 125 + /- 4 v 136 + /- 3 mm Hg , P Trough : peak ratios were 0.67 + /- 0.07 for systolic and 0.72 + /- 0.15 for diastolic blood pressure reduction . In conclusion , 1.25 mg bendrofluazide daily produced a useful antihypertensive effect across the full 24-h period",
"Ninety four patients with mild hypertension ( average supine diastolic blood pressure ( phase V ) 95 - 110 mm Hg ) were allocated at r and om to receive restriction of dietary sodium ( maximum allowed 70 mmol(mEq)/24 h ) or a normal diet . In addition , they received in r and om order 25 mg chlorthalidone , 200 mg metoprolol ( slow release ) , and a fixed combination of these two drugs . Each drug treatment was given for four weeks and alternated with four weeks of placebo . Forty four patients were allocated to sodium restriction ( group 1 ) and 50 to normal diet ( group 2 ) . The mean 24 hour urinary sodium excretion in group 1 was 74 ( SD 31 ) mmol(mEq)/24 h , and in group 2 132 ( 51 ) mmol/24 h. Compared with the screening blood pressure the average decrement of the supine blood pressure in group 1 was 16.0/8.6 mm Hg with placebo , 21.7/11.5 mm Hg with the diuretic , 28.5/17.8 mm Hg with the beta blocker , and 28.9/18.4 mm Hg with the combined agent ; in group 2 these values were 13.3/6.1 , 20.3/9.7 , 21.3/12.9 , and 29.4/16.8 mm Hg , respectively . There was a sharp decrease of the average potassium concentration during chlorthalidone and combination treatment periods ( average value 3.3 mmol(mEq)/1 ) . These results suggest that moderate salt restriction used as sole treatment has a limited though demonstrable blood pressure lowering effect but that when it is used as an adjuvant to beta blocker treatment its value is greatly enhanced",
"Guanfacine , 1 to 3 mg/day , and clonidine , 0.1 to 0.3 mg twice a day , were compared in a 24‐week double‐blind , r and omized , parallel study of 42 patients with hypertension that was inadequately treated by chlorthalidone , 25 mg/day . Mean reduction of blood pressure was 18/9 mm Hg after guanfacine and 14/8 mm Hg after clonidine . To determine the incidence of rebound hypertension , subjects were hospitalized for 7 days during chlorthalidone therapy for collection of baseline data and once again immediately after abrupt withdrawal of the α‐agonist after 24 weeks of dosing . Although blood pressure and heart rate rose significantly in both groups , the changes after clonidine withdrawal were greater and occurred earlier ( day 2 ) than those after guanfacine withdrawal ( day 4 ) . Forty percent of the subjects receiving guanfacine and 64 % of subjects receiving clonidine had diastolic blood pressure elevations ≥10 mm Hg from baseline . There were increases in urinary norepinephrine levels in both groups after drug withdrawal , but these correlated poorly with blood pressure rise . Side effects after guanfacine were much the same as those after clonidine . Guanfacine taken once a day provides an effective and safe alternative to clonidine in the management of essential hypertension",
"A r and omized , double-blind , placebo-controlled , parallel-group multicenter study was conducted to evaluate the antihypertensive efficacy and safety of 8-week treatment with one of three fixed-dose combinations — losartan 50 mg plus hydrochlorothiazide 12.5 mg , losartan 50 mg plus hydrochlorothiazide 6.25 mg , or losartan 25 mg plus hydrochlorothiazide 6.25 mg — in comparison with those of hydrochlorothiazide 12.5 mg alone , losartan 50 mg alone , or placebo in Japanese patients with essential hypertension . Significant reductions in sitting diastolic blood pressure ( DBP ) and systolic blood pressure ( SBP ) were seen in all three combination groups compared with the placebo group ( each p DBP and SBP were observed in the losartan 50 mg plus hydrochlorothiazide 12.5 mg group ( 12.7 and 18.0 mmHg , respectively ) . The reductions in the losartan 50 mg plus hydrochlorothiazide 12.5 mg group were significantly greater ( each p incidences of clinical and laboratory drug-related adverse events between any of the combination groups and the placebo group . All combination groups showed improved hypokalemia and hyperuricemia compared to the hydrochlorothiazide 12.5 mg group . These results demonstrated that once-daily , fixed-dose combination therapy with losartan 50 mg plus hydrochlorothiazide 12.5 mg is well tolerated and more efficacious in lowering DBP and SBP than monotherapy in Japanese hypertensive patients",
"BACKGROUND Recent surveys reveal continuing deficiencies in the awareness , treatment , and control of hypertension . In many cases , failure to achieve blood pressure targets may be attributable to the use of antihypertensive monotherapy . OBJECTIVES This study was undertaken to identify combinations of telmisartan , a new oral angiotensin II type 1-receptor antagonist , and hydrochlorothiazide ( HCTZ ) that might provide greater antihypertensive efficacy than monotherapy with either agent in the treatment of mild to moderate hypertension . It also examined the dose-response surface for the 2 drugs alone and in combination . METHODS This was a multicenter , r and omized , double-blind , placebo-controlled , parallel-group study that employed all cells of a 4 x 5 factorial design . After a 4-week , single-blind , placebo run-in period , men and women between 18 and 80 years of age with mild to moderate hypertension ( defined as mean supine diastolic blood pressure [ DBP ] between 95 and 114 mm Hg during the last 2 weeks of the placebo run-in period and systolic blood pressure [ SBP ] between 114 and 200 mm Hg immediately before r and omization ) were eligible to enter the 8-week , double-blind , double-dummy treatment period . Study comparisons were between once-daily telmisartan monotherapy ( 20 , 40 , 80 , or 160 mg ) , HCTZ monotherapy ( 6.25 , 12.5 , or 25 mg ) , 12 combinations of these telmisartan/HCTZ doses , and placebo . The focus was on 2 combinations : telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg . The primary efficacy variable was change in supine trough DBP from baseline to the last evaluable measurement during double-blind treatment . Plasma renin activity and safety parameters , including treatment-emergent adverse events , physical findings , electrocardiograms , and serum electrolyte levels ( which are known to increase with HCTZ treatment ) , were also assessed . RESULTS Of 1293 patients screened , 818 ( 63.3 % ) were enrolled at 47 centers . Of these 818 , 749 ( 91.6 % ) completed the study . The intent-to-treat population ( r and omized with > or = 1 postr and omization blood pressure measurement ) consisted of 807 patients ( 98.7 % ) . Telmisartan 80 mg/HCTZ 12.5 mg significantly decreased mean supine trough SBP/DBP by 23.9/14.9 mm Hg , a benefit of 8.5/3.4 mm Hg compared with telmisartan 80 mg and of 17.0/7.6 mm Hg compared with HCTZ 12.5 mg ( both comparisons , P Telmisartan 40 mg/HCTZ 12.5 mg significantly reduced mean supine SBP by 18.8 mm Hg , a benefit of 6.6 mm Hg compared with telmisartan 40 mg and 11.9 mm Hg compared with HCTZ 12.5 mg ( both , P mean supine DBP by 12.6 mm Hg , a benefit of 5.3 mm Hg compared with HCTZ 12.5 mg ( P telmisartan 40 mg . Telmisartan 80 mg/HCTZ 12.5 mg was significantly more effective than telmisartan 40 mg/HCTZ 12.5 mg in reducing mean supine DBP and SBP ( both , P antihypertensive efficacy of the combination of telmisartan and HCTZ . All regimens were well tolerated . CONCLUSIONS Once-daily telmisartan 80 mg/HCTZ 12.5 mg was effective and well tolerated when used to reduce SBP and DBP in patients with mild to moderate hypertension . In addition to enhancing efficacy , this combination protected against potassium depletion , a common side effect of thiazide monotherapy",
"1 . A within-patient r and omized double-blind crossover study was performed on mechanisms of action of bendrofluazide in mild essential hypertension . Significant reductions in lying , st and ing and post-exercise blood pressure were seen after both 3 days and 10 weeks treatment with bendrofluazide ( 10 mg daily ) . 2 . Plasma levels of 6-oxo-prostagl and in F1 alpha , the chemical hydrolysis product of prostacyclin , were significantly increased by both 3 days and 10 weeks therapy with bendrofluazide . This raises the possibility that thiazides may reduce peripheral resistance by increasing prostacyclin bio synthesis",
"A within‐patient r and omized , double‐blind , crossover study was performed to investigate mechanisms of action of bendroflumethiazide in mild essential hypertension . Significant reductions in lying , st and ing , and postexercise blood pressure were seen after both 3 days and 10 wk treatment with bendroflumethiazide 10 mg daily . Plasma levels of 6‐oxo‐PGF1α , the chemical hydrolysis product of prostacyclin , were increased by both 3 days and 10 wk therapy with bendroflumethiazide . This raises the possibility that thiazides may reduce peripheral resistance by increasing prostacyclin bio synthesis",
"The antihypertensive efficacy of a 1.5-mg sustained-release formulation ( SR 1.5 ) of indapamide , a diuretic related to thiazide , has been pointed out by using conventional sphygmomanometric measurement 24 h after dosing in clinic , in two large European r and omized , double-blind , controlled studies ( 2 and 3 months ) . One of these studies was then extended to 12 months , as a complementary open study . Quality -controlled ambulatory blood pressure monitoring ( ABPM ) data for a total of 216 patients from these studies are presented , including subgroups of hypertensives and responders . Indapamide SR 1.5 achieves an adequate 24-h blood pressure control by significantly reducing the 24-h , diurnal , and nocturnal blood pressures versus baseline , confirming the sphygmomanometric data . The benefit at 2 and 3 months is maintained at 1 year , which confirms the long-term efficacy of SR 1.5 mg . The trough-to-peak ratio -- not previously calculated for a diuretic according to international guidelines --meets Food and Drug Administration requirements and confirms the 24-h efficacy of indapamide SR 1.5",
"This 30-center , r and omized , double-blind , placebo-controlled , parallel-group study was design ed to ( 1 ) establish that 6.25 mg of hydrochlorothiazide ( HCTZ ) given once daily with 5 mg of bisoprolol fumarate can contribute to antihypertensive effectiveness in patients with stage I and stage II ( mild to moderate ) systemic hypertension ; and ( 2 ) assess whether this formulation was more effective or possessed a safety advantage over st and ard monotherapy with bisoprolol or 25 mg of HCTZ . Results showed that HCTZ 6.25 mg contributed significantly to the antihypertensive effectiveness of bisoprolol 5 mg . Bisoprolol 5 mg/HCTZ 6.25 mg ( B5/H6.25 ) produced significantly greater mean reductions from baseline in sitting systolic and diastolic blood pressure ( -15.8 mm Hg/-12.6 mm Hg ) than bisoprolol 5 mg alone ( -10.0 mm Hg/-10.5 mm Hg ) and HCTZ 25 mg alone ( -10.2 mm Hg/-8.5 mm Hg ) . A 73 % response rate was achieved with the low-dose formulation compared with 61 % for the bisoprolol 5 mg ( B5 ) group and 47 % for the HCTZ 25 mg ( H25 ) group . B5/H6.25 was found to be significantly more effective than B5 or H25 in all subgroups of patients , regardless of gender , race , age , or smoking history . Antihypertensive effects were maintained during the 24-hour dosing interval . The incremental effectiveness of B5/H6.25 was not accompanied by an increase in the frequency or severity of adverse experiences ; the incidence of adverse experiences in the B5/H6.25 group was comparable to that in the placebo group . B5/H6.25 was shown to provide safety advantages over H25 , as shown by less hypokalemia ( < 1 % with B5/H6.25 versus 6.5 % with H25 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"The hypotensive and hormonal effects of the angiotensin converting enzyme ( ACE ) inhibitor enalapril ( 10 mg twice daily ) were compared with those of hydrochlorothiazide ( 25 mg twice daily ) , with the two drugs in combination and with placebo in 21 patients with essential hypertension . For each patient there were four r and omised double-blind treatment phases , each of four weeks ' duration , which comprised a 2 X 2 factorial experiment . All blood pressure parameters were reduced in the three active treatment phases compared to placebo ( p less than 0.001 ) . Supine mean blood pressures were 119 mmHg ( placebo ) , 113 mmHg ( hydrochlorothiazide ) , 108 mmHg ( enalapril ) , and 98 mmHg ( hydrochlorothiazide plus enalapril ) ( SEM 3 mmHg , ANOVA ) . Enalapril and hydrochlorothiazide were equally effective and well tolerated and their hypotensive effects were additive . Enalapril increased plasma renin activity ( PRA ) , reduced plasma angiotensin II ( AII ) and aldosterone concentrations , and reduced ACE activity , whereas hydrochlorothiazide increased PRA , plasma AII , and aldosterone concentrations without altering ACE activity . With combination treatment the effects of enalapril on PRA and plasma AII concentrations were potentiated whereas those on plasma aldosterone concentration and ACE activity were additive . Atrial natriuretic factor plasma concentration in the placebo phase was 92 pg/ml and increased to 145 pg/ml in the hydrochlorothiazide phase ( p less than 0.001 , SEM 13 pg/ml ) , but there was no significant change in either the enalapril or combination phases",
"The effects of nebivolol , a new beta-blocker with vasodilating properties , and hydrochlorothiazide ( HCTZ ) as monotherapies and in combination on BP and plasma lipids , lipoproteins and apolipoproteins were compared with placebo in a parallel 3 x 4 factorial design study . After an eight week wash-out period , 240 patients with primary hypertension were r and omised to receive either placebo , nebivolol 1 , 5 or 10 mg , HCTZ 12.5 or 25 mg or one of the six possible combinations of nebivolol and HCTZ . Twenty patients were assigned to each of the 12 parallel groups . After 12 weeks of treatment , there was a significant dose-related reduction in BP among all active treatment groups . Apart from a slight and isolated increase in triglycerides with HCTZ 12.5 mg , lipid , lipoprotein and apolipoprotein levels as well as lipoprotein and apolipoprotein ratios were not significantly modified by 12 week active treatments when compared with placebo treatment . The results of this multifactorial study with 12 small sample size groups , suggest that nebivolol as monotherapy and in combination with HCTZ does not cause deleterious effects on the lipid profile",
"The antihypertensive effect of indapamide ( 2.5 mg/day ) was compared to that obtained with a placebo in a controlled trial carried out by 11 physicians in their private practice . Thirty-one patients with uncomplicated essential hypertension were included . After a run-in period of 3 weeks without any treatment , either indapamide ( n = 16 ) or a placebo ( n = 15 ) were administered for 8 weeks in double-blind fashion . Blood pressure decreased in both groups . In patients treated with indapamide , systolic pressure was significantly lower than in those given the placebo at 3 out of the 4 follow-up visits ; diastolic pressure , however , was significantly lower only at the end of the trial . Both the active drug and the placebo were well tolerated . No significant change in body weight , plasma potassium and uric acid occurred during the study in either group of patients . It appears therefore that indapamide , at a dose which apparently has no major diuretic effect , may be useful for practitioners in managing patients with mild to moderate hypertension",
"The effects of timolol ( 10 mg thrice daily ) and hydrochlorothiazide ( 50 mg/day ) have been compared in a double-blind factorial trial in 20 patients with essential hypertension . There were four r and omised test phases of 8 weeks each during which patients received timolol alone , hydrochlorothiazide alone , timolol plus hydrochlorothiazide , and no treatment ( placebo ) . Blood-pressure was measured weekly , alternately at the outpatient clinic and at the patient 's home . Supine mean arterial pressure fell from 119 mm Hg in the placebo phase to 110 mm Hg in the hydrochlorothiazide phase , 106 mm Hg in the timolol phase , and 101 mm Hg in the combined timolol plus hydrochlorothiazide phase . Factorial analysis revealed that these effects of the two drugs were additive without any potentiation or antagonism . Mean plasma-renin activity ( P.R.A. ) was 5 - 02 ng/ml/3 h in the placebo phase falling to 1 - 79 in the timolol phase and rising to 9 - 54 in the diuretic phase , but remaining unchanged in the combined treatment phase ( 5 - 40 ng/ml/3 h ) . The data suggest that the hypotensive action of timolol is not dependent on the concomitant fall in P.R.A. The methods described provide a valuable tool for quantitating the effects of a given drug , and hence a valid basis for objective comparison",
"To assess the duration of antihypertensive effect of a single daily dose of the short‐acting diuretic hydrochlorothiazide , a double‐blind crossover study was performed in 11 patients previously well controlled with diuretics . Each patient received hydrochlorothiazide 100 mg in the morning for 12 wk and blood pressures were recorded 4 times daily ( 8 A.M. , 12 noon , 4 A.M. , and 8 P.M. ) on 3 separate visits . The crossover design also included a 12‐wk placebo period either preceding or following active therapy . Blood pressure control was excellent and sustained throughout the day in all patients studied , indicating that a single daily dose of hydrochlorothiazide is a suitable regimen for hypertension therapy . The use of a placebo period before initiating the trial and during the active part of the trial confirmed the observation that patients who have been adequately treated for long periods will maintain lowered blood pressure for a variable period after stopping therapy",
"To evaluate whether the combination of nifedipine with chlorthalidone exerts an additive antihypertensive effect when compared to single-drug treatment , 66 uncomplicated essential hypertensives , whose diastolic blood pressure was > 100 and placebo period , received , according to a r and omized , double-blind , crossover design , nifedipine ( 20 mg b.i.d . ) , chlorthalidone ( 25 mg o.d . ) , the two drugs combined at the same doses , and the corresponding placebo . When compared to the r and omized placebo the three active treatments significantly ( p blood pressure without changing heart rate and body weight . However , blood prssure values were similarly reduced under nifedipine and the combination and were significantly lower ( p chlorthalidone . Moreover , the percentage of responders and normalized patients under nifedipine and the two drugs combined were similar and significantly ( normalized , p chlorthalidone . Under chlorthalidone and its combination with nifedipine , plasma potassium tended to decrease and blood glucose and serum uric acid were significantly ( p nifedipine with chlorthalidone does not exert any additive antihypertensive effect when compared to nifedipine alone and that this combination increases both blood glucose and serum uric acid . Taken together these findings indicate that the combination of a dihydropyridine calcium antagonist with a thiazide diuretic is devoid of any clinical significance in the treatment of uncomplicated essential hypertensives",
"Two multicenter , double-blind , r and omized studies were performed to determine the antihypertensive efficacy and effects on laboratory values of a new , shorter-acting formulation of metolazone in patients with mild to moderate hypertension . After baseline placebo-control periods , 105 patients were r and omly assigned to receive single daily doses of either placebo or 0.5 , 1.0 , or 2.0 mg of the new formulation of metolazone for six weeks in one study , and 164 patients were r and omized to receive 0.5 , 1.0 , or 2.0 mg of the new formulation of metolazone or 2.5 mg of the older , long-acting metolazone in the other . Mean blood pressure reductions in all three metolazone groups were statistically and clinical ly significant . Blood pressures of 51 % to 58 % of patients in the 0.5-mg metolazone group were controlled ( diastolic blood pressure less than 90 or a fall of greater than or equal to 10 mmHg from baseline ) . Reductions in mean serum potassium levels were dose-related . We conclude that 0.5 mg of metolazone is safe and effective therapy for hypertension ; it will significantly reduce systolic and diastolic blood pressure and minimizes changes in laboratory test values",
"The echocardiographic predictors of ventricular arrhythmias are reported for the Hypertension Arrhythmia Reduction Trial . Men with mild hypertension were withdrawn from their diuretic therapy and repleted with 40 mEq/day of oral potassium and 20 mEq/day of oral magnesium for 1 month . M-mode echocardiography and 24-hour continuous ambulatory electrocardiography were performed on 123 men , mean age 62 years . Forty-eight men ( 39 % ) had echocardiographic evidence of left ventricular ( LV ) hypertrophy defined as an LV mass index greater than 134 g/m2 and this finding was not related to the presence of LV hypertrophy on electrocardiogram or to age . Men who had echocardiographic LV hypertrophy were more likely than men without echocardiographic LV hypertrophy to have greater than or equal to 30 ventricular premature complexes (VPCs)/hr ( odds ratio = 2.7 ; 95 % confidence interval = 0.9 , 8.0 ) , multiform extrasystoles ( odds ratio = 1.7 ; confidence interval = 0.8 , 3.7 ) , episodes of ventricular tachycardia ( odds ratio = 2.3 ; confidence interval = 0.7 , 7.1 ) and the combination of frequent ( greater than or equal to 30 VPCs/hr ) or complex ( ventricular couplets , multiform extrasystoles or episodes of ventricular tachycardia ) ventricular arrhythmia ( odds ratio = 1.7 ; confidence interval = 0.8 , 3.5 ) . Similar associations between echocardiographic LV hypertrophy and ventricular arrhythmias were observed on 24-hour tracings obtained on entry to the study ( before electrolyte repletion ) in the 96 men who were taking diuretics at this time . The combination of a frequent or complex arrhythmia was also more common in men aged 60 to 70 compared to men aged 35 to 59 ( odds ratio = 3.4 ; confidence interval = 1.4 , 8.2 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
"Objective To compare with placebo the efficacies of once-daily administrations of lacidipine and hydrochlorothiazide separately and in combination to elderly patients with systolic hypertension . Design and methods Nineteen elderly subjects ( five men and 14 women , median age 71 years , range 62–79 years ) participated in the study , which had a r and omized double-blind crossover design . For each subject there were four treatment phases , each of duration 4 weeks . The initial treatments in each phase were 2 mg lacidipine once a day and 25 mg hydrochlorothiazide once a day , separately and in combination , and placebo . Doses of each agent could be doubled after 2 weeks in each phase if the patient 's goal systolic blood pressure had not been achieved . The numbers of subjects administered the higher dose of each treatment were 13 for placebo , 14 for lacidipine , 11 for hydrochlorothiazide and eight for lacidipine plus hydrochlorothiazide . Results End-of-phase mean clinic blood pressures were 164/85 mmHg with placebo , 159/82 mmHg with lacidipine , 157/84 mmHg with hydrochlorothiazide and 152/82 mmHg with lacidipine plus hydrochlorothiazide . Systolic blood pressure was significantly reduced during all active treatment phases compared with placebo and that for the lacidipine plus hydrochlorothiazide phase was also significantly less than those for both of the other active treatment phases . There was no difference between sitting and st and ing blood pressure for any phase . Factorial analysis of the main effects of treatment indicated that the effects of lacidipine and hydrochlorothiazide on clinic blood pressure were additive and also that heart rate was higher when hydrochlorothiazide had been administered . Ambulatory blood pressure monitoring confirmed the pattern of the responses of blood pressure and showed that administration of hydrochlorothiazide had a significantly greater effect on systolic blood pressure and a longer duration of action than did administration of lacidipine . There was no difference in the frequency of adverse effects among any of the phases . Conclusions In treating elderly systolic hypertensives the diuretic hydrochlorothiazide is a more effective antihypertensive agent with a longer duration of action than is the calcium channel antagonist lacidipine . In combination the effects of these two drugs on blood pressure are additive",
"OBJECTIVE To investigate the patterns of electrolyte abnormalities result ing from thiazide administration and whether they cause ventricular arrhythmias , and to help resolve the controversy over whether clinicians should routinely prescribe potassium-conserving therapy to all patients treated with thiazides . DESIGN Double-blind , r and omized controlled trial . PARTICIPANTS A total of 233 hypertensive men aged 35 to 70 years . INTERVENTIONS Participants were withdrawn from prior diuretic treatment and were replenished with oral potassium chloride and magnesium oxide . They were then r and omized to 2 months of treatment with ( 1 ) hydrochlorothiazide ; ( 2 ) hydrochlorothiazide with oral potassium ; ( 3 ) hydrochlorothiazide with oral potassium and magnesium ; ( 4 ) hydrochlorothiazide and triamterene ; ( 5 ) chlorthalidone ; or ( 6 ) placebo . MAIN OUTCOME MEASURES Ventricular arrhythmias on 24-hour Holter monitoring and serum and intracellular potassium and magnesium levels . RESULTS Of the 233 participants , 212 ( 91 % ) completed the study . Serum potassium levels were 0.4 mmol/L lower in the hydrochlorothiazide group than in the placebo group ( P less than 0.01 ) , and this mean difference was not affected by supplementation with potassium , with potassium and magnesium , or with triamterene . However , the supplements did prevent the occasional occurrence of marked hypokalemia ; all 12 of the men who developed serum potassium levels of 3.0 mmol/L or less were among the 90 who received diuretics without supplementation ( P less than 0.01 ) . Similarly , the overall proportion of men with ventricular arrhythmias was not affected by r and omized treatment , but there was a twofold increase in the proportion with arrhythmias among the 12 men with serum potassium levels of 3.0 mmol/L or less ( P = .02 ) . Serum magnesium and intracellular potassium and magnesium levels were not reduced by hydrochlorothiazide , nor were they related to ventricular arrhythmias . CONCLUSIONS In the majority of hypertensive patients , treatment with 50 mg/d of hydrochlorothiazide does not cause marked hypokalemia or ventricular arrhythmias . However , because some individuals will develop hypokalemia after starting diuretic therapy , serum potassium levels should be monitored and potassium-sparing strategies should be used when indicated",
"OBJECTIVE To test the antihypertensive and metabolic effects of lisinopril , 10 mg/d ( L ) ; hydrochlorothiazide , 12.5 and 25 mg/d ( H12.5 and H25 ) ; and its combination with lisinopril ( L/H12.5 and L/H25 ) against placebo in patients with mild to moderate ( stage I and stage II ) hypertension . DESIGN Multicenter , double-blind , placebo-controlled outpatient study of 12 weeks ' duration . PATIENTS After 4 weeks of single-blind placebo treatment , 505 patients whose sitting diastolic blood pressure was 100 to 114 mm Hg were r and omized into the study --467 patients completed it ( placebo , 71 ; L , 80 ; H12.5 , 79 ; H25 , 77 ; L/H12.5 , 79 ; and L/H25 , 81 ) . The patients were seen in the clinic every 2 weeks , where measurements of their sitting and upright blood pressure and heart rate were taken 24 + /- 2 hours after drug administration . Complete blood cell counts with differential cell counts , blood chemistry studies , urinalyses , and electrocardiograms were done at baseline and during the study . Roentgenograms were done once at baseline . RESULTS Compared with placebo , all drug regimens decreased sitting and upright blood pressure ( P sitting and upright heart rate . The greatest effect was obtained with the combinations of L/H12.5 and L/H25 . There was no difference between L/H12.5 and L/H25 or between H12.5 and H25 . There were no serious clinical side effects except cough , which was slightly higher with L , L/H12.5 , and L/H25 . The only metabolic side effects were in serum potassium level , which was lower with H25 ( P serum glucose level , which was higher with H25 and L/H25 ( P L , H12.5 , H25 , L/H12.5 , and L/H25 was effective and well tolerated ; ( 2 ) the best results were achieved with L/H12.5 and L/H25 ; ( 3 ) lower doses of hydrochlorothiazide either alone or in combination with lisinopril were equipotent with higher doses and were free of metabolic side effects",
"In a double-blind study , thirty patients having mild to moderate essential hypertension were r and omly assigned to a six week regimen of either tienilic acid , hydrochlorothiazide , or placebo . Blood pressure was significantly reduced with tienilic acid and hydrochlorothiazide although more so with tienilic acid . Serum uric acid declined strikingly with tienilic acid and increased significantly with hydrochlorothiazide . Serum potassium declined slightly with tienilic acid but more so with hydrochlorothiazide . Serum creatinine and blood urea nitrogen increased slightly more with tienilic acid than with hydrochlorothiazide . There were no clinical adverse effects to any of the medications during this study . Twenty-four months of continuous administration of tienilic acid revealed maintenance of blood pressure effect , but with slight increases in blood urea nitrogen , serum creatinine and uric acid and slight decreases in serum potassium as compared to six weeks administration . Tienilic acid appears to be a useful new antihypertensive agent . The hypouricaemic effect is profound and strongly suggests the need for continuing evaluation of this compound because of its unique combination of diuretic , antihypertensive and hypouricaemic properties",
"In a double-blind , placebo-controlled , crossover study in 16 hypertensives , 4 weeks of 50 mg hydrochlorothiazide twice daily , caused significant elevations in total plasma cholesterol , high density lipoprotein (HDL)-cholesterol , low density lipoprotein (LDL)-cholesterol , very low density lipoprotein (VLDL)-cholesterol and triglycerides . Significant elevations in fasting plasma glucose and in plasma insulin were observed , but no correlation between individual lipid elevations and either glucose or insulin elevations was apparent . The metabolic effects developed within 2 weeks , and dissipated within 4 weeks . Changes induced within 4 weeks of treatment with hydrochlorothiazide were unaltered at 6 months . Hydrochlorothiazide induces elevation of all lipoprotein cholesterol fractions and VLDL-triglyceride . However , as the important ratio between LDL- and HDL-cholesterol is unchanged , coronary risk may be unchanged",
"& NA ; This study compared the effects of beta‐blockers differing in degree of central nervous system penetration on Type A behavior and cardiovascular reactivity to mental stress . Forty‐six male hypertensives were assigned r and omly to receive either highly lipophilic and nonselective propranolol , hydrophilic and cardioselective atenolol , the diuretic hydrochlorothiazide , or placebo . Subjects were administered parallel forms of the Structured Interview ( SI ) and performed mental arithmetic and a cognitive task prior to and after 6 weeks of therapy . Results indicated that diuretic and placebo subjects ( subsequently combined into a single control group ) did not differ and that both beta‐blockers reduced heart rate but not blood pressure reactivity to mental stress ( p less than 0.02 ) , an effect that was strongest during the mental arithmetic test . Analysis of SI components indicated a reduction only in explosive speech for beta‐blockers versus controls ( p less than 0.05 ) . For global SI classifications , seven out of 12 subjects ( 58 % ) receiving propranolol , three of 12 ( 25 % ) receiving atenolol , and four of 22 control subjects ( 18 % ) became less Type A ( p less than 0.05 ) . These data do not replicate results of a prior study obtained with atenolol and suggest that only a subset of hypertensive individuals show reduced Type A behavior with propranolol . Central nervous system mechanisms may be important in producing these effects",
"The objective of this study was to determine which of the common groups of antihypertensive drugs is most effective at lowering systolic blood pressure ( SBP ) in elderly patients with previously untreated hypertension and the percentage of patients controlled with single or sequential monotherapy . Subjects were recruited from patients attending other outpatient clinics and entered into the study if their SBP was more than 150 mm Hg after three visits . Patients were given a low and high dose of each of the main classes of drugs or placebo for 1 month each . The study was a balanced , r and omized crossover design with five periods : placebo ; angiotensin converting enzyme inhibitors ; beta-blocking drugs ; calcium-blocking drugs ; and thiazide diuretics . Blood pressure ( BP ) was measured 24 to 26 h after the previous dose . A question naire for side effects was administered at each visit . Seventy-four patients entered the study . beta-Blockers could not be used in 15 patients because of asthma or bronchospasm and these had two placebo periods . There were 9 of 66 patients on P , 9 of 46 on beta-blockers , 4 of 65 on calcium-blocking drugs , 4 of 65 on diuretic , and 1 of 62 patients on ACE inhibitors who did not progress to the higher dose because of side effects . Decreases in SBP compared to r and omized placebo were calcium-blocking drugs 15 mm Hg = diuretic 13 mm Hg > ACE inhibitors 8 mm Hg = beta-blockers 5 mm Hg . Blood pressure decrease correlated with placebo BP ( P target SBP ( Angiotensin converting enzyme inhibitors , calcium-blocking drugs , and diuretics had no more side effects than placebo . Patients on beta-blockers had more side effects and the well-being score was reduced . Diuretics and calcium-blocking drugs are more effective in elderly patients at lowering SBP pressure . beta-Blockers were relatively ineffective , were frequently contraindicated , and had more side effects . Monotherapy achieved control in only a small number of patients . In elderly people with essential hypertension , therapy should be instituted with diuretics or calcium-blocking drugs , but combination therapy will usually be required to achieve goal",
"The antihypertensive effects of low doses of hydrochlorothiazide have not been examined in black African hypertensive patients although hydrochlorothiazide is commonly used as first-line therapy . The antihypertensive effects of hydrochlorothiazide in a daily dose of 6.25 , 12.5 , 25 and 50 mg were examined in 19 black Zimbabwean hypertensive patients in a double-blind , r and om order , placebo-controlled , cross-over trial . The mean systolic blood pressure on placebo was 170.2 mmHg ( 95 % CI + /- 9.0 mmHg ) and on daily doses of hydrochlorothiazide decreased to : 161.1 mmHg ( 95 % CI + 10.0 mmHg ) on 6.25 mg ; 156.6 mmHg ( 95 % CI + /- 8.6 mmHg ) on 12.5 mg ; 154.9 mmHg ( 95 % CI + /- 8.5 mmHg ) on 25 mg and 149.1 mmHg ( 95 % CI + /- 9.2 mmHg ) on 50 mg . The mean diastolic blood pressure on placebo was 101.4 mmHg ( 95 % CI + /- 5.0 mmHg ) and decreased to : 98.0 mmHg ( 95 % CI + /- 5.7 mmHg ) on 6.25 mg ; 96.1 mmHg ( 95 % CI + /- 4.5 mmHg ) on 12.5 mg ; 93.6 mmHg ( 95 % CI + /- 5.3 mmHg ) on 25 mg and 90.5 mmHg ( 95 % CI + /- 3.9 mmHg ) on 50 mg . Hydrochlorothiazide in doses of 25 mg and 50 mg decreased systolic and diastolic blood pressure and the 12.5 mg dose decreased systolic blood pressure significantly more than placebo . We conclude that in this population maximum antihypertensive effect is not seen with the lower doses of hydrochlorothiazide and 25 mg is an appropriate starting dose for most patients",
"The antihypertensive characteristics of the angiotensin-converting enzyme inhibitor moexipril were evaluated in 413 patients with baseline sitting diastolic blood pressures between 95 and 114 mm Hg . The study was double blind , with patients r and omized to placebo or to differing doses of moexipril alone or in combination with a low dose of hydrochlorothiazide . Compared with placebo , moexipril 3.75 mg daily was not different , but single daily doses of 7.5 , 15 , and 30 mg were significantly more effective ( as measured at trough , approximately 24 h after dosing ) in decreasing the diastolic blood pressuring during an 8-week treatment period . The dose – response relationship indicated that no additional blood-pressure-lowering effect occurred above 15 mg daily . Hydrochlorothiazide 12.5 mg was not significantly more effective than placebo , but the combinations of the diuretic with moexipril doses of 3.75 , 7.5 , and 15 mg all produced significant antihypertensive actions . Interestingly , the 3.75-mg moexipril-hydrochlorothiazide combination was equally as efficacious as the higher doses . The combinations were all more effective than their respective moexipril and hydrochlorothiazide monotherapies . There were no meaningful laboratory changes except for decreased potassium concentrations in the patients on diuretic alone ; this effect was attenuated in the low-dose moexipril combination . Only 14 of the 413 patients who entered the double-blind study period ( 3 % ) discontinued treatment because of adverse experiences . Thus , moexipril is a well-tolerated drug that has clear antihypertensive efficacy as a single agent in once-daily doses of 7.5–30 mg . When combined with hydrochlorothiazide 12.5 mg , it is effective in daily doses as low as 3.75 mg",
"The antihypertensive effect of captopril , metoprolol , and hydrochlorothiazide was compared in 23 non-insulin-dependent ( NIDDM ) diabetic patients less than or equal to 75 years of age , with borderline to moderate primary hypertension . In a double blind , placebo-controlled cross-over trial the patients were treated with 25 to 50 mg captopril , 50 to 100 mg metoprolol , 12.5 to 25 mg hydrochlorothiazide , and placebo , each given twice daily for 8 weeks . Antidiabetic treatment remained unchanged during the study . After receiving placebo for a 4 week run-in period , arterial blood pressure was 168/101 + /- 93/10 ( mean + /- SEM ) mm Hg . Diastolic blood pressure was lowered significantly during all active treatment periods compared to the placebo value of 97 + /- 2 mm Hg : captopril , 92 + /- 1 mm Hg ; metoprolol , 90 + /- 1 mm Hg ; hydrochlorothiazide , 91 + /- 1 mm Hg . Metabolic variables were not significantly altered by captopril and metoprolol , while hydrochlorothiazide treatment increased hemoglobin A1c from 7.5 + /- 0.3 to 8.2 + /- 0.4 % ( P less than .001 ) , decreased high-density lipoprotein-cholesterol from 1.19 + /- 0.08 to 1.10 + /- 0.06 mmol/L ( P less than .05 ) . Glomerular filtration rate , urinary albumin excretion , orthostatic blood pressure response , and digital systolic blood pressure in the lower limb remained unchanged during the active treatment periods . The frequency of subjective adverse effects was acceptable during active treatment and not significantly different compared to placebo . We conclude that antihypertensive treatment for 8 weeks with captopril or metoprolol in NIDDM patients is well-tolerated and causes no deterioration in metabolic control and kidney function , while hydrochlorothiazide causes a slight deterioration in glycemic control and lipid profile",
"本態性高血圧に対する利尿降圧剤 tripamide 1日15～60mg単独投与の有用性を60歳以上の老年者33例 ( 平均年齢65.9歳 ) と59歳以下の壮年者59例 ( 平均年齢50.0歳 ) に於て二重盲検法により検討した.降圧効果 ( 20/10mmHgまたは平均血圧13mmHg以上下降 ) は老年者で84.8 % , 壮年者で59.3%で , 老年者の降圧効果が有意に高いことを認めた ( p<0.05 ) . しかし降圧幅は老年者で32.0/13.2mmHg , 壮年者で26.9/11.2mmHgであり , 有意差を認めず , 老年者で過度の降圧を来さないことを示唆した.臨床検査のうち , 血液学検査では両年齢群とも有意の変動を認めず , 血液濃縮は見られなかった. 生化学検査では老年者では血清Cl , アルカリフォスファターゼの低下と尿素窒素 , 尿酸の上昇を , 壮年者では血清Clの低下と総コレステロール , Ca , 尿酸 , 尿素窒素の上昇を認めた. 血清Na , K , 空腹時血糖値には両年齢群とも変化を認めなかった. 心胸比は老年者で減少した. これらの変化は有意差を認めたものの正常範囲内の変化であり臨床的意義は少ないと思われる.副作用は壮年者で5例8%に認められたが , 老年者では認められなかった. 副作用に臨床検査値の異常変化例を含めると壮年者で9例15 % , 老年者で4例12%でいずれも有意差は見られなかった.従って有用性 ( 有用以上 ) は , 老年者で78.8 % , 壮年者で52.5%と有意差を認め ( p<0.05 ) , 利尿降圧剤 tripamide",
"In a double blind placebo controlled r and omised parallel study the antihypertensive activity and adverse biochemical effects of three doses of cyclopenthiazide were evaluated in patients with mild essential hypertension that had been recently diagnosed or was being treated with a single drug . After a four week placebo washout period 53 patients with diastolic blood pressures between 90 - 110 mm Hg were r and omly assigned to 50 , 125 , or 500 micrograms cyclopenthiazide or matching placebo for an eight week period of treatment . Blood pressure was measured in the patients ' homes by the same observer every two weeks . Serum urea , electrolytes , urate , and creatinine concentrations and 24 hour urinary sodium excretion were monitored every four weeks and serum magnesium concentration and plasma renin activity at the end of the washout and treatment periods . After eight weeks of treatment systolic and diastolic blood pressures were significantly reduced in patients taking 125 and 500 micrograms cyclopenthiazide when compared with those taking placebo . The decrement in serum potassium concentration ( 0.6 mmol/l ) and increase in serum urate concentration 0.06 mmol/l ) were greatest with the 500 micrograms dose , the increase in serum urate concentration alone being significant . No change in serum magnesium concentration or 24 hour urinary sodium excretion was noted with any dose of cyclopenthiazide . Only the 500 micrograms dose of cyclopenthiazide significantly increased the mean plasma renin activity ( 1.8 ( 95 % confidence interval 0.2 to 3.4)-5.4 ( 3.9 to 6.8 ) nmol angiotensin I/l/h ) ; the other doses like the placebo had no effect . Cyclopenthiazide 125 micrograms , a dose lower than is currently marketed , produced a similar hypotensive response to 500 micrograms of the drug without up setting the biochemical profile",
"This study was design ed as a multicenter , double-blind , placebo-controlled , parallel-group , prospect ively r and omized study comparing , after a 4-week placebo run-in phase , moxonidine 0.4 mg once daily ( o.d . ) , hydrochlorothiazide 25 mg o.d . , and the combination of the two with placebo . A total of 160 patients were analyzed in an intent-to-treat analysis . Moxonidine 0.4 mg o.d . was effective in significantly lowering blood pressure in this group of mild-to-moderate hypertensive patients in comparison with placebo . The efficacy and the side-effect profile of moxonidine were comparable to those of the first-line antihypertensive agent hydrochlorothiazide . The combination of moxonidine and hydrochlorothiazide in the same dosage as a monotherapy improves efficacy significantly without additive effects on the safety profile . Response rate after monotherapies was calculated with 70.3 and 70.0 % , respectively , after combination treatment in 87.8 % of all patients in the treatment group . The trial gives support to a recommended dosage regimen of moxonidine 0.4 mg o.d . This profile of moxonidine is highly comparable to a st and ard first-line antihypertensive drug such as hydrochlorothiazide , without sacrificing tolerance and safety for increased efficacy , in combination with hydrochlorothiazide",
"The Systolic Hypertension in the Elderly Program ( SHEP ) is a r and omized , blinded test of the efficacy of antihypertensive drug treatment . In a large feasibility trial , 551 men and women who had isolated systolic hypertension and were at least 60 years old received chlorthalidone ( 25 to 50 mg/day ) or matching placebo as the step I drug . After 1 year , 83 % of the chlorthalidone group and 80 % of the placebo group were still taking SHEP medications . Of those still taking chlorthalidone , 88 % had reached goal blood pressure ( BP ) without requiring a step II drug , and most had responded to the lower dose ( 25 mg/day ) . The BP response was similar in all age , sex and race subgroups , with an overall mean difference between r and omized groups of 17 mm Hg for systolic BP ( p less than 0.001 ) and 6 mm Hg for diastolic BP ( p less than 0.001 ) . The only common adverse effects were asymptomatic changes in the serum levels of potassium ( 0.5 mEq/liter lower in the chlorthalidone group , p less than 0.001 ) , uric acid ( 0.9 mg/dl higher , p less than 0.001 ) and creatinine ( 0.08 mg/dl higher , p = 0.02 ) . This study indicates that chlorthalidone is effective for lowering BP in elderly patients with systolic hypertension and sets the stage for a larger trial of the effects of such treatment on the incidence of cardiovascular disease",
"In this multicenter , placebo-controlled , double-blind , 4 x 3 factorial design study , 1,162 patients r and omized into 12 parallel groups received either placebo ( n = 97 ) , cilazapril ( CLZ 0.5 , 5 , or 10 mg ; n = 288 total ) , hydrochlorothiazide ( HCTZ 12.5 or 25 mg ; n = 198 total ) , or one of the six possible combinations of the two drugs ( n = 579 total ) given orally once daily for 4 weeks . The mean decrease from baseline in predose ( i.e. , 24 h postdose ) sitting diastolic blood pressure ( SDBP ) was statistically significantly ( p Synergistic antihypertensive effects were noted for the 5/12.5 mg CLZ/HCTZ combination therapy . The normalization ( SDBP CLZ/HCTZ combination was essentially additive with respect to the component monotherapies . The tolerability profile of the CLZ/HCTZ combination was similar to its respective components and comparable to placebo . The CLZ/HCTZ group reported low serum potassium ( K+ ) and high serum uric acid less frequently than the HCTZ group . Therefore , the CLZ/HCTZ combination ( 5 mg/12.5 mg ) is an option for hypertensive patients not responding to single drug CLZ therapy",
"119 elderly , hypertensive patients were followed-up for 1 year and 48 for 2 years in a double-blind , r and omised , controlled trial in which they received either placebo or 25 - 50 mg hydrochlorothiazide and 50 - 100 mg of triamterene daily . Half of the active treatment group also received 250 mg to 2 g methyldopa daily . After 2 years the active treatment group had an average increase in fasting blood-sugar of 9.6 mg/dl compared with an average fall of 3.1 mg in the placebo group ( p less than 0.001 ) . Blood-glucose rose by an average of 26.6 mg/dl in the active group when determined 1 hour after 50 g oral glucose and decreased by an average of 5.3 mg/dl in patients who had been on placebo for two years ( p less than 0.05 ) . The hyperglycaemic effect of diuretics appeared to be related to potassium loss since , in both groups , impairment of glucose tolerance was most marked in those in whom the serum-potassium decreased over the 2 years"
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41171b6c-06ff-11f0-808a-c43d1ab1c353
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Background Behaviour problems are common in young children with autism spectrum disorder ( ASD ) . There are many different tools used to measure behavior problems but little is known about their validity for the population . Objectives To evaluate the measurement properties of behaviour problems tools used in evaluation of intervention or observational research studies with children with ASD up to the age of six years . Methods Behaviour measurement tools were identified as part of a larger , two stage , systematic review . First , sixteen major electronic data bases , as well as grey literature and research registers were search ed , and tools used listed and categorized . Second , using method ological filters , we search ed for articles examining the measurement properties of the tools in use with young children with ASD in ERIC , MEDLINE , EMBASE , CINAHL , and PsycINFO . The quality of these papers was then evaluated using the COSMIN checklist . Results We identified twelve tools which had been used to measure behaviour problems in young children with ASD , and fifteen studies which investigated the measurement properties of six of these tools . There was no evidence available for the remaining six tools . Two question naires were found to be the most robust in their measurement properties , the Child Behavior Checklist and the Home Situations Question naire — Pervasive Developmental Disorders version . Conclusions We found patchy evidence on reliability and validity , for only a few of the tools used to measure behaviour problems in young children with ASD . More systematic research is required on measurement properties of tools for use in this population , in particular to establish responsiveness to change which is essential in measurement of outcomes of intervention . PROSPERO Registration Number
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"OBJECTIVE A consumer-oriented efficacy assessment in clinical trials should measure changes in chief complaint and consumer request ( symptoms of most concern to patient/caregiver ) , which may be diluted in change scores of multisymptom scales . METHOD In the Research Units on Pediatric Psychopharmacology ( RUPP ) Autism Network 8-week double-blind trial of risperidone versus placebo , the chief concerns of parents were collected at 0 , 4 , and 8 weeks ( endpoint ) , in addition to st and ardized primary measures . Blinded clinical judges rated change from baseline to 4 and 8 weeks on a 9-point scale ( 1 = normalized , 5 = unchanged , 9 = disastrous ) ; 94 participants had usable data . RESULTS The most common symptoms identified by parents were tantrums , aggression , and hyperactivity . Interrater reliability was excellent . Mean ratings at endpoint were 2.8 + /- 1.2 on risperidone and 4.5 + /- 1.3 on placebo ( p Clinical Global Impression-Improvement and Aberrant Behavior Checklist Irritability subscale ( primary dimensional measure ) . Effect size d was 1.4 , compared to 1.2 on the Aberrant Behavior Checklist Irritability subscale . Effect sizes varied twofold by symptom category , largest for self-injury ( 2.11 ) and tantrums ( 1.95 ) . CONCLUSIONS Risperidone was superior to placebo in reducing symptoms of most concern to parents of autistic children with irritable behavior . Rating individualized participant-chosen target symptoms seems a reliable , sensitive , efficient , and consumer-friendly way to assess treatment effect and might have clinical application",
"This study evaluated the effectiveness of low intensity behavioral treatment ( on average 6.5h per week ) supplementing preschool services in 3 - 6-year-old children with autism spectrum disorder and severe to mild intellectual disability . Treatment was implemented in preschools ( i.e. , daycare centers ) and a discrete trial teaching approach was used . Twelve children in the treatment group were compared to 22 children receiving regular intervention . At pre-treatment , both groups did not differ on chronological age , developmental age , diagnosis and level of adaptive skills . Eight months into treatment , children receiving behavioral treatment displayed significantly higher developmental ages and made more gains in adaptive skills than children from the control group . No significant differences between groups were found on autistic symptom severity and emotional and behavioral problems",
"Twenty children with autism , ages 3 to 6 years , were r and omly assigned to massage therapy and reading attention control groups . Parents in the massage therapy group were trained by a massage therapist to massage their children for 15 minutes prior to bedtime every night for 1 month and the parents of the attention control group read Dr. Seuss stories to their children on the same time schedule . Conners Teacher and Parent scales , classroom and playground observations , and sleep diaries were used to assess the effects of therapy on various behaviors , including hyperactivity , stereotypical and off-task behavior , and sleep problems . Results suggested that the children in the massage group exhibited less stereotypic behavior and showed more on-task and social relatedness behavior during play observations at school , and they experienced fewer sleep problems at home",
"Objectives For the measurement of patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields",
"Previously , we adapted the Home Situations Question naire to measure behavioral non-compliance in everyday setting s in children with pervasive developmental disorders . In this study , we further revised this instrument for use in autism spectrum disorder and examined its psychometric properties ( referred to as the Home Situations Question naire-Autism Spectrum Disorder ) . To cover a broader range of situations and improve reliability , we prepared seven new items describing situations in which children with autism spectrum disorder might display non-compliance . Parents completed ratings of 242 children with autism spectrum disorder with accompanying disruptive behaviors ( ages 4–14 years ) participating in one of two r and omized clinical trials . Results from an exploratory factor analysis indicated that the Home Situations Question naire-Autism Spectrum Disorder consists of two 12-item factors : Socially Inflexible ( α = 0.84 ) and Dem and Specific ( α = 0.89 ) . One-to-two-week test – retest reliability was statistically significant for all scored items and also for subscale totals . The pattern of correspondence between the Home Situations Question naire-Autism Spectrum Disorder and parent-rated problem behavior , clinician-rated repetitive behavior , adaptive behavior , and IQ provided evidence for concurrent and divergent validity of the Home Situations Question naire-Autism Spectrum Disorder . Overall , the results suggest that the Home Situations Question naire-Autism Spectrum Disorder is an adequate measure for assessing non-compliance in a variety of situations in this population , and use of its two subscales will likely provide a more refined interpretation of ratings",
" An intervention group ( n=23 ) of preschool children with autism was identified on the basis of parent preference for early intensive behavioral intervention and a comparison group ( n=21 ) identified as receiving treatment as usual . Prospect i ve assessment was undertaken before treatment , after 1 year of treatment , and again after 2 years . Groups did not differ on assessment s at baseline but after 2 years , robust differences favoring intensive behavioral intervention were observed on measures of intelligence , language , daily living skills , positive social behavior , and a statistical measure of best outcome for individual children . Measures of parental well-being , obtained at the same three time points , produced no evidence that behavioral intervention created increased problems for either mothers or fathers of children receiving it",
"Goal attainment scaling ( GAS ) holds promise as an idiographic approach for measuring outcomes of psychosocial interventions in community setting s. GAS has been criticized for untested assumptions of scaling level ( i.e. , interval or ordinal ) , inter-individual equivalence and comparability , and reliability of coding across different behavioral observation methods . We tested assumptions of e quality between GAS descriptions for outcome measurement in a r and omized trial ( i.e. , measurability , equidistance , level of difficulty , comparability of behavior sample s collected from teachers vs. research ers and live vs. videotape ) . Results suggest GAS descriptions can be evaluated for equivalency , that teacher collected behavior sample s are representative , and that varied sources of behavior sample s can be reliably coded . GAS is a promising measurement approach . Recommendations are provided to ensure method ological quality",
"The Nova Scotia early intensive behavior intervention model -NS EIBI ( Bryson et al. , 2007 ) for children with autistic spectrum disorders was design ed to be feasible and sustainable in community setting s. It combines parent training and naturalistic one-to-one behavior intervention employing Pivotal Response Treatment - PRT ( R. Koegel & Koegel , 2006 ) . We followed 45 children ( 33 males , mean baseline age = 50 months ) for 12months . Mean gains of 14.9 and 19.5 months were observed on expressive and receptive language measures , respectively , for children with an IQ of 50 or more at baseline versus 6.1 and 8.4 months for children with IQs less than 50 . Behavior problems decreased significantly over the 1-year treatment for both groups , but autism symptoms decreased only for those with an IQ of 50 or more",
"Young children with pervasive developmental disorder were r and omly assigned to intensive treatment or parent training . The intensive treatment group ( 7 with autism , 8 with pervasive developmental disorder not otherwise specified -- NOS ) averaged 24.52 hours per week of individual treatment for one year , gradually reducing hours over the next 1 to 2 years . The parent training group ( 7 with autism , 6 with pervasive developmental disorder NOS ) received 3 to 9 months of parent training . The groups appeared similar at intake on all measures ; however , at follow-up the intensive treatment group outperformed the parent training group on measures of intelligence , visual-spatial skills , language , and academics , though not adaptive functioning or behavior problems . Children with pervasive developmental disorder NOS may have gained more than those with autism",
"The Behavior Problems Inventory ( BPI-01 ) is a 52-item respondent-based behavior rating instrument for self-injurious , stereotypic , and aggressive/destructive behavior in mental retardation and other developmental disabilities . Items are rated on a frequency scale and a severity scale . The BPI-01 was administered by interviewing direct care staff of 432 r and omly selected residents from a developmental center between the ages of 14 to 91 years . For 73 % of those selected , at least one problem was endorsed on the BPI-01 . A total of 43 % showed self-injury , 54 % stereotyped behavior , and 38 % aggressive/destructive behavior . Confirmatory factor analysis and item-total correlations supported the three a priori factors . Analyses of variance ( ANOVA ) showed that of the variables age , sex , and level of mental retardation , only the latter had a significant effect on the BPI-01 total score , the SIB subscale score , and the Stereotyped Behavior subscale score . Aggression/destruction was not significantly related to any of the three variables . Individuals with a diagnosis of pervasive developmental disorder had higher scores on all three subscales than those without , whereas residents with a diagnosis of stereotyped movement disorder had higher Stereotyped Behavior scale scores than those without . The BPI-01 was found to be a reliable ( retest reliability , internal consistency , and between-interviewer-agreement ) and valid ( factor and criterion validity ) behavior rating instrument for problem behaviors in mental retardation and developmental disabilities with a variety of potentially useful applications . Strengths and limitations of the instrument are discussed",
"Aim : To determine the effect of parent education on adaptive behaviour , autism symptoms and cognitive/ language skills of young children with autistic disorder . Method : A r and omised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample . Two rural and two metropolitan regions were r and omly allocated to intervention groups ( n = 70 ) or control ( n = 35 ) . Parents from autism assessment services in the intervention regions were r and omly allocated to parent education and behaviour management ( n = 35 ) or parent education and counselling ( n = 35 ) . Results : Parent education and behaviour management result ed in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour . Parent education and behaviour management was superior to parent education and counselling . We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children",
"IMPORTANCE Disruptive behavior is common in children with autism spectrum disorder . Behavioral interventions are used to treat disruptive behavior but have not been evaluated in large-scale r and omized trials . OBJECTIVE To evaluate the efficacy of parent training for children with autism spectrum disorder and disruptive behavior . DESIGN , SETTING , AND PARTICIPANTS This 24-week r and omized trial compared parent training ( n = 89 ) to parent education ( n = 91 ) at 6 centers ( Emory University , Indiana University , Ohio State University , University of Pittsburgh , University of Rochester , Yale University ) . We screened 267 children ; 180 children ( aged 3 - 7 years ) with autism spectrum disorder and disruptive behaviors were r and omly assigned ( 86 % white , 88 % male ) between September 2010 and February 2014 . INTERVENTIONS Parent training ( 11 core , 2 optional sessions ; 2 telephone boosters ; 2 home visits ) provided specific strategies to manage disruptive behavior . Parent education ( 12 core sessions , 1 home visit ) provided information about autism but no behavior management strategies . MAIN OUTCOMES AND MEASURES Parents rated disruptive behavior and noncompliance on co- primary outcomes : the Aberrant Behavior Checklist-Irritability subscale ( range , 0 - 45 ) and the Home Situations Question naire-Autism Spectrum Disorder ( range , 0 - 9 ) . On both measures , higher scores indicate greater severity and a 25 % reduction indicates clinical improvement . A clinician blind to treatment assignment rated the Improvement scale of the Clinical Global Impression ( range , 1 - 7 ) , a secondary outcome , with a positive response less than 3 . RESULTS At week 24 , the Aberrant Behavior Checklist-Irritability subscale declined 47.7 % in parent training ( from 23.7 to 12.4 ) compared with 31.8 % for parent education ( 23.9 to 16.3 ) ( treatment effect , -3.9 ; 95 % CI , -6.2 to -1.7 ; P 0.62 ) . The Home Situations Question naire-Autism Spectrum Disorder declined 55 % ( from 4.0 to 1.8 ) compared with 34.2 % in parent education ( 3.8 to 2.5 ) ( treatment effect , -0.7 ; 95 % CI , -1.1 to -0.3 ; P with a positive response on the Clinical Global Impression-Improvement scale were 68.5 % for parent training vs 39.6 % for parent education ( P For children with autism spectrum disorder , a 24-week parent training program was superior to parent education for reducing disruptive behavior on parent-reported outcomes , although the clinical significance of the improvement is unclear . The rate of positive response judged by a blinded clinician was greater for parent training vs parent education . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01233414",
" Guidance on effective interventions for disruptive behavior in young children with autism spectrum disorders ( ASDs ) is limited . We present feasibility and initial efficacy data on a structured parent training program for 16 children ( ages 3–6 ) with ASD and disruptive behavior . The 6-month intervention included 11 Core and up to 2 Optional sessions . The program was acceptable to parents as evidence d by an attendance rate of 84 % for Core sessions . Fourteen of 16 families completed the treatment . An independent clinician rated 14 of 16 subjects as much improved or very much improved at Week 24 . Using last observation carried forward , the parent-rated Aberrant Behavior Checklist-Irritability subscale decreased 54 % from 16.00 ( SD = 9.21 ) to 7.38 ( SD = 6.15 )",
"INTRODUCTION There is debate about the type and intensity of early childhood intervention that is most helpful for children with developmental problems . The aim of the study was to determine whether a home-based programme provided over 12 months result ed in sustained improvement in development and behaviour 12 months after the intervention ceased . The characteristics of the children and families who benefited most from the intervention were also studied . METHOD R and omized controlled trial . Participants A total of 59 children , aged 3 - 5 years , attending two early childhood intervention centres in Melbourne , Australia . Intervention Half of the subjects received an additional home-based programme consisting of 40 weekly visits . MAIN OUTCOME MEASURES Bayley Scales of Infant Development and Wechsler Preschool and Primary Scale of Intelligence Revised , Preschool Behaviour Checklist , Bayley Behaviour Rating Scale and Behaviour Screening Question naire . All tests administered pre-intervention , following the intervention and 12 months later . Secondary outcome measures Family stress , support and empowerment . RESULTS Fifty-four children completed the assessment s 12 months after conclusion of the intervention . Compared with the control group , improvement in aspects of cognitive development in the children who received the extra intervention was sustained 1 year later ( P= 0.007 ) while significant behavioural differences post intervention were not . Analyses of the data by the Reliable Change Index indicated improvement of clinical significance occurred in non-verbal areas . In contrast to the control group who deteriorated , language skills in the intervention group remained stable . Improvements were significantly associated with higher stress in the families . CONCLUSION Improvements following the provision of a home-based programme to preschool children with developmental disabilities were sustained 1 year later . Children from highly stressed families appeared to benefit most , reinforcing the importance of involving families in early childhood intervention programmes",
"This study examined the measurement tools and target symptoms/skills used to assess treatment response during Autism Spectrum Disorder ( ASD ) intervention trials from 2001 through 2010 . Data from 195 prospect i ve trials were analyzed . There were 289 unique measurement tools , of which 61.6 % were used only once , and 20.8 % were investigator- design ed . Only three tools were used in more than 2 % of the studies , and none were used in more than 7 % of studies . Studies investigated an average of 11.4 tool-symptom combinations per trial , with as many as 45 in one study . These results represent a lack of consistency in outcome measurements in ASD intervention trials . These findings highlight the need to set guidelines for appropriate outcome measurement in the ASD field"
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41171ba8-06ff-11f0-808a-c43d1ab1c353
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Objective To estimate the cost-effectiveness of Tobacco , Exercise and Diet Messages ( TEXT ME ) , a text message-based intervention that provides advice , motivation , information and support to improve health-related behaviours . Methods A lifetime Markov model was used to estimate major vascular events ( myocardial infa rct ions and strokes ) avoided , quality -adjusted life years ( QALYs ) gained , costs to the health system and the incremental cost per QALY gained . The model was informed by data from a r and omised controlled trial of TEXT ME , with evidence from systematic review s and meta-analyses used to estimate the effects of changes in risk factors on the risk of major vascular events . Expected costs and health outcomes were estimated with uncertainty surrounding these characterised using probabilistic sensitivity analysis and a number of scenario analyses . Results For a target population of 50 000 patients with documented coronary heart disease , the intervention is expected to lead to 563 fewer myocardial infa rct ions , 361 fewer strokes and 1143 additional QALYs . TEXT ME is expected to lead to an overall saving of $ 10.56 million for the health system over the patients ’ lifetimes . The intervention can therefore be considered cost-saving and health-improving . Neither parameter nor structural uncertainty had a significant impact on the conclusion that TEXT ME is cost-effective . Conclusions The provision of TEXT ME is predicted to lead to better health outcomes and an overall saving in costs for the health system . Trial registration number anzctr.org.au identifier : ACTRN12611000161921
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"Background Although supporting lifestyle change is an effective way of preventing further events in people with cardiovascular disease , providing access to such interventions is a major challenge . This study aims to investigate whether simple reminders about behaviour change sent via mobile phone text message decrease cardiovascular risk . Methods and analysis R and omised controlled trial with 6 months of follow-up to evaluate the feasibility , acceptability and effect on cardiovascular risk of repeated lifestyle reminders sent via mobile phone text messages compared to usual care . A total of 720 patients with coronary artery disease will be r and omised to either st and ard care or the TEXT ME intervention . The intervention group will receive multiple weekly text messages that provide information , motivation , support to quit smoking ( if relevant ) and recommendations for healthy diets and exercise . The primary end point is a change in plasma low-density lipoprotein cholesterol at 6 months . Secondary end points include a change in systolic blood pressure , smoking status , quality of life , medication adherence , waist circumference , physical activity levels , nutritional status and mood at 6 months . Process outcomes related to acceptability and feasibility of TEXT ME will also be collected . Ethics and dissemination Primary ethics approval was received from Western Sydney Local Health Network Human Research Ethics Committee — Westmead . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences . Clinical trials registration number ACTRN12611000161921",
"Background : Supporting lifestyle change is an effective way of preventing recurrent events in people with cardiovascular disease ( CVD ) . However , there is a need to develop innovative strategies that increase access to programmes for individuals at high risk of CVD . This study aim ed to develop a bank of text messages design ed to provide advice , motivation , and support for decreasing cardiovascular risk . Design : Iterative development process with mixed methods Methods : An initial bank of 120 text messages was drafted based on behaviour change techniques , guidelines , and input from clinicians and public health experts . A question naire was then administered to participants ( n = 53 ) for evaluation of message content , usefulness , and language . To test the process of delivery , a pilot study was conducted using a specifically design ed computer programme that delivered messages to multiple mobile phones according to a pre-specified schedule . Data were collected regarding message timing , delivery , and usefulness . Results : In the qualitative question naire , 92 % of participants found the messages easy to underst and and 86 % found the messages contained useful information . Positive feedback was also obtained from the pilot study . Based on these results , together with suggestions provided , several messages were reworded and an additional 44 were written . The need for semi-personalization was also identified and a r and om set of 103 individualized messages was created . Conclusions : A final bank of 137 mobile telephone text messages design ed to support behaviour change and decrease cardiovascular risk have been developed through a multistep iterative process . This provides a scientific approach for future developers of health-related text messages",
"Objectives A policy model is a model that can evaluate the effectiveness and cost-effectiveness of interventions and inform policy decisions . In this study , we introduce a cardiovascular disease ( CVD ) policy model which can be used to model remaining life expectancy including a measure of socioeconomic deprivation as an independent risk factor for CVD . Design A state transition model was developed using the Scottish Heart Health Extended Cohort ( SHHEC ) linked to Scottish morbidity and death records . Individuals start in a CVD-free state and can transit to three CVD event states plus a non-CVD death state . Individuals who have a non-fatal first event are then followed up until death . Taking a competing risk approach , the cause-specific hazards of a first event are modelled using parametric survival analysis . Survival following a first non-fatal event is also modelled parametrically . We assessed discrimination , validation and calibration of our model . Results Our model achieved a good level of discrimination in each component ( c-statistics for men (women)—non-fatal coronary heart disease ( CHD ) : 0.70 ( 0.74 ) , non-fatal cerebrovascular disease ( CBVD ) : 0.73 ( 0.76 ) , fatal CVD : 0.77 ( 0.80 ) , fatal non-CVD : 0.74 ( 0.72 ) , survival after non-fatal CHD : 0.68 ( 0.67 ) and survival after non-fatal CBVD : 0.65 ( 0.66 ) ) . In general , our model predictions were comparable with observed event rates for a Scottish r and omised statin trial population which has an overlapping follow-up period with SHHEC . After applying a calibration factor , our predictions of life expectancy closely match those published in recent national life tables . Conclusions Our model can be used to estimate the impact of primary prevention interventions on life expectancy and can assess the impact of interventions on inequalities",
"Background : Psychological morbidity after an acute myocardial infa rct ion ( AMI ) is known to be common , but can be addressed by appropriate rehabilitation . The area in which this research was conducted experiences high rates of deprivation and of coronary heart disease and limited access to hospital-based rehabilitation . Responding to concern about psychological needs of AMI patients , a self-help package was introduced and evaluated alongside st and ard hospital-based cardiac rehabilitation . Aims : To evaluate the impact of a home-based self-help package ( the Heart Manual ) , alongside existing cardiac rehabilitation provision , on psychological morbidity and health status after AMI . A secondary aim was to assess the suitability of the Heart Manual for older patients aged over 80 years . Methods : A controlled observational study , comparing two cohorts of patients discharged from hospital after AMI . The intervention group was given the self-help package in addition to st and ard care . The control group received st and ard care alone . Outcome measures used were the Hospital Anxiety and Depression Scale and the EuroQol . Results : The intervention group showed significant improvement in anxiety and depression scores after 3 months and nonsignificant improvement in general health status . Patients who attended hospital-based rehabilitation classes , and those aged over 80 years , also benefited from the intervention . Conclusion : A home-based self-help rehabilitation package is an effective tool alongside hospital-based rehabilitation classes and can be given to all age groups",
"IMPORTANCE Little is known about adoption of healthy lifestyle behaviors among individuals with a coronary heart disease ( CHD ) or stroke event in communities across a range of countries worldwide . OBJECTIVE To examine the prevalence of avoidance or cessation of smoking , eating a healthy diet , and undertaking regular physical activities by individuals with a CHD or stroke event . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve Urban Rural Epidemiology ( PURE ) was a large , prospect i ve cohort study that used an epidemiological survey of 153,996 adults , aged 35 to 70 years , from 628 urban and rural communities in 3 high-income countries ( HIC ) , 7 upper-middle-income countries ( UMIC ) , 3 lower-middle-income countries ( LMIC ) , and 4 low-income countries ( LIC ) , who were enrolled between January 2003 and December 2009 . MAIN OUTCOME MEASURES Smoking status ( current , former , never ) , level of exercise ( low , 3000 MET-min/wk ) , and diet ( classified by the Food Frequency Question naire and defined using the Alternative Healthy Eating Index ) . RESULTS Among 7519 individuals with self-reported CHD ( past event : median , 5.0 [ interquartile range { IQR } , 2.0 - 10.0 ] years ago ) or stroke ( past event : median , 4.0 [ IQR , 2.0 - 8.0 ] years ago ) , 18.5 % ( 95 % CI , 17.6%-19.4 % ) continued to smoke ; only 35.1 % ( 95 % CI , 29.6%-41.0 % ) undertook high levels of work- or leisure-related physical activity , and 39.0 % ( 95 % CI , 30.0%-48.7 % ) had healthy diets ; 14.3 % ( 95 % CI , 11.7%-17.3 % ) did not undertake any of the 3 healthy lifestyle behaviors and 4.3 % ( 95 % CI , 3.1%-5.8 % ) had all 3 . Overall , 52.5 % ( 95 % CI , 50.7%-54.3 % ) quit smoking ( by income country classification : 74.9 % [ 95 % CI , 71.1%-78.6 % ] in HIC ; 56.5 % [ 95 % CI , 53.4%-58.6 % ] in UMIC ; 42.6 % [ 95 % CI , 39.6%-45.6 % ] in LMIC ; and 38.1 % [ 95 % CI , 33.1%-43.2 % ] in LIC ) . Levels of physical activity increased with increasing country income but this trend was not statistically significant . The lowest prevalence of eating healthy diets was in LIC ( 25.8 % ; 95 % CI , 13.0%-44.8 % ) compared with LMIC ( 43.2 % ; 95 % CI , 30.0%-57.4 % ) , UMIC ( 45.1 % , 95 % CI , 30.9%-60.1 % ) , and HIC ( 43.4 % , 95 % CI , 21.0%-68.7 % ) . CONCLUSION AND RELEVANCE Among a sample of patients with a CHD or stroke event from countries with varying income levels , the prevalence of healthy lifestyle behaviors was low , with even lower levels in poorer countries",
"Summary Background The main associations of body-mass index ( BMI ) with overall and cause-specific mortality can best be assessed by long-term prospect i ve follow-up of large numbers of people . The Prospect i ve Studies Collaboration aim ed to investigate these associations by sharing data from many studies . Methods Collaborative analyses were undertaken of baseline BMI versus mortality in 57 prospect i ve studies with 894 576 participants , mostly in western Europe and North America ( 61 % [ n=541 452 ] male , mean recruitment age 46 [ SD 11 ] years , median recruitment year 1979 [ IQR 1975–85 ] , mean BMI 25 [ SD 4 ] kg/m2 ) . The analyses were adjusted for age , sex , smoking status , and study . To limit reverse causality , the first 5 years of follow-up were excluded , leaving 66 552 deaths of known cause during a mean of 8 ( SD 6 ) further years of follow-up ( mean age at death 67 [ SD 10 ] years ) : 30 416 vascular ; 2070 diabetic , renal or hepatic ; 22 592 neoplastic ; 3770 respiratory ; 7704 other . Findings In both sexes , mortality was lowest at about 22·5–25 kg/m2 . Above this range , positive associations were recorded for several specific causes and inverse associations for none , the absolute excess risks for higher BMI and smoking were roughly additive , and each 5 kg/m2 higher BMI was on average associated with about 30 % higher overall mortality ( hazard ratio per 5 kg/m2 [ HR ] 1·29 [ 95 % CI 1·27–1·32 ] ) : 40 % for vascular mortality ( HR 1·41 [ 1·37–1·45 ] ) ; 60–120 % for diabetic , renal , and hepatic mortality ( HRs 2·16 [ 1·89–2·46 ] , 1·59 [ 1·27–1·99 ] , and 1·82 [ 1·59–2·09 ] , respectively ) ; 10 % for neoplastic mortality ( HR 1·10 [ 1·06–1·15 ] ) ; and 20 % for respiratory and for all other mortality ( HRs 1·20 [ 1·07–1·34 ] and 1·20 [ 1·16–1·25 ] , respectively ) . Below the range 22·5–25 kg/m2 , BMI was associated inversely with overall mortality , mainly because of strong inverse associations with respiratory disease and lung cancer . These inverse associations were much stronger for smokers than for non-smokers , despite cigarette consumption per smoker varying little with BMI . Interpretation Although other anthropometric measures ( eg , waist circumference , waist-to-hip ratio ) could well add extra information to BMI , and BMI to them , BMI is in itself a strong predictor of overall mortality both above and below the apparent optimum of about 22·5–25 kg/m2 . The progressive excess mortality above this range is due mainly to vascular disease and is probably largely causal . At 30–35 kg/m2 , median survival is reduced by 2–4 years ; at 40–45 kg/m2 , it is reduced by 8–10 years ( which is comparable with the effects of smoking ) . The definite excess mortality below 22·5 kg/m2 is due mainly to smoking-related diseases , and is not fully explained . Funding UK Medical Research Council , British Heart Foundation , Cancer Research UK , EU BIOMED programme , US National Institute on Aging , and Clinical Trial Service Unit ( Oxford , UK )",
"Introduction Many studies have now demonstrated the efficacy of text messaging in positively changing behaviours . We aim ed to identify features and factors that explain the effectiveness of a successful text messaging program in terms of user engagement , perceived usefulness , behavior change and program delivery preferences . Methods Mixed methods qualitative design combining four data sources ; ( i ) analytic data extracted directly from the software system , ( ii ) participant survey , ( iii ) focus groups to identify barriers and enablers to implementation and mechanisms of effect and ( iv ) recruitment screening logs and text message responses to examine engagement . This evaluation was conducted within the TEXT ME trial — a parallel design , single-blind r and omized controlled trial ( RCT ) of 710 patients with coronary heart disease ( CHD ) . Qualitative data were interpreted using inductive thematic analysis . Results 307/352 ( 87 % response rate ) of recruited patients with CHD completed the program evaluation survey at six months and 25 participated in a focus group . Factors increasing engagement included ( i ) ability to save and share messages , ( ii ) having the support of providers and family , ( iii ) a feeling of support through participation in the program , ( iv ) the program being initiated close to the time of a cardiovascular event , ( v ) personalization of the messages , ( vi ) opportunity for initial face-to-face contact with a provider and ( vii ) that program and content was perceived to be from a credible source . Clear themes relating to program delivery were that diet and physical activity messages were most valued , four messages per week was ideal and most participants felt program duration should be provided for at least for six months or longer . Conclusions This study provides context and insight into the factors influencing consumer engagement with a text message program aim ed at improving health-related behavior . The study suggests program components that may enhance potential success but will require integration at the development stage to optimize up-scaling . Trial Registration Australia and New Zeal and Clinical Trials Registry , ACTRN12611000161921",
"IMPORTANCE Cardiovascular disease prevention , including lifestyle modification , is important but underutilized . Mobile health strategies could address this gap but lack evidence of therapeutic benefit . OBJECTIVE To examine the effect of a lifestyle-focused semipersonalized support program delivered by mobile phone text message on cardiovascular risk factors . DESIGN AND SETTING The Tobacco , Exercise and Diet Messages ( TEXT ME ) trial was a parallel-group , single-blind , r and omized clinical trial that recruited 710 patients ( mean age , 58 [ SD , 9.2 ] years ; 82 % men ; 53 % current smokers ) with proven coronary heart disease ( prior myocardial infa rct ion or proven angiographically ) between September 2011 and November 2013 from a large tertiary hospital in Sydney , Australia . INTERVENTIONS Patients in the intervention group ( n = 352 ) received 4 text messages per week for 6 months in addition to usual care . Text messages provided advice , motivational reminders , and support to change lifestyle behaviors . Patients in the control group ( n=358 ) received usual care . Messages for each participant were selected from a bank of messages according to baseline characteristics ( eg , smoking ) and delivered via an automated computerized message management system . The program was not interactive . MAIN OUTCOMES AND MEASURES The primary end point was low-density lipoprotein cholesterol ( LDL-C ) level at 6 months . Secondary end points included systolic blood pressure , body mass index ( BMI ) , physical activity , and smoking status . RESULTS At 6 months , levels of LDL-C were significantly lower in intervention participants , with concurrent reductions in systolic blood pressure and BMI , significant increases in physical activity , and a significant reduction in smoking . The majority reported the text messages to be useful ( 91 % ) , easy to underst and ( 97 % ) , and appropriate in frequency ( 86 % ) . [ table : see text ] . CONCLUSIONS AND RELEVANCE Among patients with coronary heart disease , the use of a lifestyle-focused text messaging service compared with usual care result ed in a modest improvement in LDL-C level and greater improvement in other cardiovascular disease risk factors . The duration of these effects and hence whether they result in improved clinical outcomes remain to be determined . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12611000161921",
"Background — Although preventive drug therapy is a priority after acute coronary syndrome , less is known about adherence to behavioral recommendations . The aim of this study was to examine the influence of adherence to behavioral recommendations in the short term on risk of cardiovascular events . Methods and Results — The study population included 18 809 patients from 41 countries enrolled in the Organization to Assess Strategies in Acute Ischemic Syndromes ( OASIS ) 5 r and omized clinical trial . At the 30-day follow-up , patients reported adherence to diet , physical activity , and smoking cessation . Cardiovascular events ( myocardial infa rct ion , stroke , cardiovascular death ) and all-cause mortality were documented to 6 months . About one third of smokers persisted in smoking . Adherence to neither diet nor exercise recommendations was reported by 28.5 % , adherence to either diet or exercise by 41.6 % , and adherence to both by 29.9 % . In contrast , 96.1 % of subjects reported antiplatelet use , 78.9 % reported statin use , and 72.4 % reported angiotensin-converting enzyme/angiotensin receptor blocker use . Quitting smoking was associated with a decreased risk of myocardial infa rct ion compared with persistent smoking ( odds ratio , 0.57 ; 95 % confidence interval , 0.36 to 0.89 ) . Diet and exercise adherence was associated with a decreased risk of myocardial infa rct ion compared with nonadherence ( odds ratio , 0.52 ; 95 % confidence interval , 0.4 to 0.69 ) . Patients who reported persistent smoking and nonadherence to diet and exercise had a 3.8-fold ( 95 % confidence interval , 2.5 to 5.9 ) increased risk of myocardial infa rct ion/stroke/death compared with never smokers who modified diet and exercise . Conclusions — Adherence to behavioral advice ( diet , exercise , and smoking cessation ) after acute coronary syndrome was associated with a substantially lower risk of recurrent cardiovascular events . These findings suggest that behavioral modification should be given priority similar to other preventive medications immediately after acute coronary syndrome . Clinical Trial Registration Information— URL : http:// clinical trials.gov/ct2/show/NCT00139815 . Unique identifier : NCT00139815"
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Purpose Infection is a concern after all orthopedic procedures , including shoulder surgery . This systematic review of literature aim ed to determine risk factors for infection as well as the availability and effectiveness of measures utilized to prevent infection after elective shoulder surgery . Methods An electronic data base search was performed using MEDLINE ( 1950–October 2017 ) , EMBASE ( 1980–October 2017 ) , CINAHL ( 1982–October 2017 ) , and the Cochrane data base to identify studies reporting a risk factor or preventive measure for infection after shoulder surgery . Results Fifty-one studies were eligible for inclusion . Risk factors identified for infection were male sex , the presence of hair , receiving an intra-articular cortisone injection within the 3 months prior to surgery , smoking , obesity , and several comorbidities . The only preventive measure with level I evidence was for the use of chlorhexidine wipes for cleansing the skin in the days prior to surgery and for the use of ChloraPrep or DuraPrep over povodine and iodine to prep the skin at the time of surgery . Level II – IV evidence was found for other infection prevention methods such as intravenous antibiotic prophylaxis . Conclusion There are many risk factors associated with developing an infection after elective shoulder surgery . Many preventive measures have been described which may decrease the risk of infection ; however , most lack a high level evidence to support them . The findings of this systematic review are clinical ly relevant as it has been shown that infection after shoulder surgery results in poor patient-reported outcomes and pose a significant financial burden . As surgeons the goal should be to prevent infections to avoid the morbidity for patients and the increased cost for society . Level of evidence IV systematic review of literature
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"Background Deep and superficial sternal wound infections ( DSWI & SWI ) following cardiac surgery increase morbidity , mortality and cost . Autologous platelet rich plasma ( PRP ) derived from the patient ’s own blood has been used in other surgical setting s to promote successful wound healing . The goal of this study was to analyze the addition of PRP using a rapid point of care bedside system to st and ard wound care in all patients undergoing sternotomy for cardiac surgical procedures . Methods Over a 7 year period , 2000 patients undergoing open cardiac operations requiring sternotomy were enrolled . One thous and patients received st and ard of care sternal closure . The other 1000 patients received st and ard of care sternal closure plus PRP applied to the sternum at the time of closure . The outcomes related to wound healing , infection , readmissions , and costs were analyzed . Results In the 2000 patients , there were more ventricular assist device implants/heart transplants and emergency operations in the PRP group ; otherwise there were no significant differences . The use of PRP reduced the incidence of DSWI from 2.0 to 0.6 % , SWI from 8.0 to 2.0 % , and the readmission rate from 4.0 to 0.8 % . The use of PRP reduced the costs associated with the development of deep and superficial wound complications from $ 1,256,960 to $ 593,791 . Conclusions The use of PRP decreases the incidence and costs of sternal wound complications following cardiac surgery . The routine use of platelet rich plasma should be considered for all patients undergoing sternotomy for cardiac surgical procedures .Trial registration Clinical trials.gov ( NCT00130377 ) for the data registry",
"BACKGROUND This investigation used age as a continuous variable to estimate implant survival and the risk of complications . METHODS Prospect ively collected data were used to analyze 5494 consecutive shoulder arthroplasties performed from 1970 to 2012 . Patients were a mean age of 67 years . The association between the age at the index procedure and the risk for each outcome was assessed using Cox regression and smoothing spline analysis . RESULTS Older age was associated with a decreased risk of revision surgery , revision for mechanical failure , and reoperation but with a higher risk for thromboembolic events . Reoperation rates also decreased in a linear fashion with older ages ( P risk of revision surgery decreased in a linear fashion between the ages of 40 and 85 , with a 3 % decreased risk of revision per 1-year increase in age ( P 65 years ( P risks of revision surgery . The risk of a revision surgery in a patient aged > 50 years was significantly decreased ( ~13 % reduction in risk for each year ; P decreased rates of infection ( P = .01 ) . CONCLUSIONS There is a strong association between older age and decreased rates of revision surgery and reoperation after shoulder arthroplasty , with a striking association with decreased rates of mechanical failure . These are important considerations when counseling younger patients regarding their risks",
"BACKGROUND Anatomic total shoulder arthroplasty ( TSA ) and reverse total shoulder arthroplasty ( RTSA ) are increasingly common procedures employed to treat arthritic conditions . Although TSA is a widely accepted procedure for glenohumeral arthritis with intact rotator cuff , concerns about RTSA persist because of variable complication rates and outcomes . METHODS This is a prospect i ve , case-control study comparing outcomes and complications after TSA and RTSA . The study included 47 patients undergoing TSA for glenohumeral arthritis and 53 patients undergoing RTSA for rotator cuff tear arthropathy . Average clinical follow-up was more than 2 years in both groups . Major complications included infection , periprosthetic fracture , instability , glenoid loosening , and need for revision surgery . Patient outcome measures included the American Shoulder and Elbow Surgeons score , pain visual analog scale score , and goniometer-measured range of motion . Plain radiographs were review ed to assess for degree of glenoid lucency in TSA and scapular notching in RTSA . RESULTS At 2 years , there were no differences in rate of major complications ( TSA , 15 % ; RTSA , 13 % ; P = .808 ) or revision surgeries ( TSA , 11 % ; RTSA , 9 % ) . Outcomes assessed by the American Shoulder and Elbow Surgeons score and visual analog scale were also similar between the 2 groups . TSA patients had greater external rotation than RTSA patients did ( 53 ° vs 38 ° ; P = .001 ) . Otherwise , forward flexion , abduction , and internal rotation were comparable in range of motion . CONCLUSIONS TSA and RTSA have similar complication rates , need for revision , patient-reported outcomes , and range of motion at 2 years of follow-up . The use of side-by-side cohorts in this study allows st and ardized comparison between these 2 shoulder arthroplasty procedures",
"HYPOTHESIS Deep infection after shoulder surgery is a rare but devastating problem . This study tested the hypothesis that the home application of a 2 % chlorhexidine gluconate cloth before shoulder surgery would be more efficacious than a st and ard shower of soap and water at decreasing the preoperative cutaneous levels of pathogenic bacteria on the shoulder . MATERIAL S AND METHODS This r and omized , prospect i ve study evaluated 100 consecutive patients undergoing shoulder surgery . Patients were r and omly assigned to use 2 % chlorhexidine gluconate-impregnated cloths ( treatment group ) or to shower with soap and water before surgery ( control group ) . Cutaneous cultures were taken from the patients ' shoulders in the preoperative holding area . Patients were monitored for 2 months postoperatively for clinical signs of infection . RESULTS In the treatment group vs the control group , the overall positive culture rate was 66 % vs 94 % ( P = .0008 ) , and the positive culture rate for coagulase-negative Staphylococcus was 30 % vs 70 % ( P = .0001 ) . The positive culture rate for Propionibacterium acnes was 46 % in the treatment group vs 58 % in the control group ( P = .32 ) . No infections occurred in any patients at a minimum of 2-months after surgery . DISCUSSION The use of the 2 % chlorhexidine cloth was effective at decreasing overall bacterial culture rates before shoulder surgery and was particularly effective at decreasing the quantity of coagulase-negative Staphylococcus , a known causative agent of postoperative shoulder infections . CONCLUSION Use of chlorhexidine impregnated cloths prior to shoulder surgery may be a useful adjunct to presently used infection prevention strategies",
"Background Few studies have analyzed the association between elevated BMI and complications after total shoulder arthroplasty ( TSA ) . Previous studies have not consistently arrived at the same conclusion regarding whether obesity is associated with a greater number of postoperative complications . We used a national surgical data base to compare the 30-day complication profile and hospitalization outcomes after primary TSA among patients in different BMI categories . Questions / purpose sWe asked : ( 1 ) Is obesity associated with an increased risk of complications within 30 days of primary TSA ? ( 2 ) Is obesity associated with increased operative time ? Methods The American College of Surgeons National Surgical Quality Improvement Program ® data base for 2006 to 2012 was queried to identify all patients who underwent a primary TSA for osteoarthritis of the shoulder . The ACS-NSQIP ® data base was selected for this study as it is a nationally representative data base that provides prospect ively collected perioperative data and a comprehensive patient medical profile . Exclusion criteria included revision TSA , infection , tumor , or fracture . We analyzed 4796 patients who underwent a primary TSA for osteoarthritis of the shoulder . Patients who underwent a TSA were divided in four BMI categories : normal ( 18.5–25 kg/m2 ) , overweight ( 25–30 kg/m2 ) , obesity Class 1 ( 30–35 kg/m2 ) , and obesity Class 2 or greater ( > 35 kg/m2 ) . Perioperative hospitalization data and 30-day postoperative complications were compared among different BMI classes . Differences in patient demographics , preoperative laboratory values , and preexisting patient comorbidities also were analyzed among different BMI groups , and multivariate analysis was used to adjust for any potential confounding variables . Results There was no association between BMI and 30-day complications after surgery ( normal as reference , overweight group relative risk : 0.57 [ 95 % CI , 0.30–1.06 ] , p = 0.076 ; obesity Class 1 relative risk : 0.52 [ 95 % CI , 0.26–1.03 ] , p = 0.061 ; obesity Class 2 or greater relative risk : 0.54 [ 95 % CI , 0.25–1.17 ] , p = 0.117 ) . However , greater BMI was associated with longer surgical times ( for normal BMI control group : 110 minutes , SD , 42 minutes ; overweight group : 115 minutes , SD , 46 minutes , mean difference to control : 5 minutes [ 95 % CI , −1 to 10 minutes ] , p = 0.096 ; obesity Class 1 : 120 minutes , SD , 43 minutes , mean difference : 10 minutes [ 95 % CI , 5–15 minutes ] , p surgical time increased for patients with greater BMI , the 30-day complications and perioperative hospitalization data after TSA were not different in patients with increased BMI levels . Obesity alone should not be a contraindication for TSA , and obese patients can expect similar incidences of postoperative complications . The preoperative medical optimization plan should be consistent with that of patients who are not obese who undergo TSA.Level of Evidence Level III , therapeutic study",
"PURPOSE To document the skin colonization and deep tissue inoculation rates associated with arthroscopic shoulder surgery and how these rates differ with procedural and demographic factors . METHODS We prospect ively recruited outpatient shoulder arthroscopy patients who agreed to participate and met the inclusion criteria from February 2013 to May 2014 . All patients received routine antibiotic prophylaxis intravenously . Initial cultures were obtained before the skin preparation by swabbing the skin at the 3 st and ard portal sites : posterior , anterosuperior , and anterolateral . The skin preparation used 4 % chlorhexidine scrub and 2 % chlorhexidine gluconate/70 % isopropyl alcohol paint applied to the entire shoulder . After completion of the arthroscopic procedure , a second culture was obtained through a cannula at the surgical site . All cultures were plated for 21 days using Brucella medium . RESULTS We enrolled 51 patients over a 15-month period . Cultures showed a 72.5 % Propionibacterium acnes superficial colonization rate : 46.1 % of female and 81.6 % of male patients ( P = .027 ) . We identified a deep culture-positive inoculation rate of 19.6 % , all with positive P acnes skin colonization . No correlation could be made concerning diagnosis , procedure , suture anchor use , age , or sex . CONCLUSIONS The rate of skin colonization with P acnes is high at arthroscopic portals , especially in men . Despite st and ard skin preparation and prophylactic antibiotics , the rate of deep tissue inoculation with P acnes in shoulder arthroscopy is much higher than the rate of infection reported in the literature . CLINICAL RELEVANCE Shoulder arthroscopy introduces a significant amount of P acnes into the deep tissues",
"BACKGROUND Although diabetes has been associated with increased perioperative morbidity and mortality after hip and knee arthroplasty , its impact on early postoperative outcomes after shoulder replacement remains relatively unexplored . The purpose of the study was to determine the association of diabetes with in-hospital death , complications , length of stay , non-homebound disposition , and cost in patients undergoing shoulder arthroplasty . METHODS By use of the Nationwide Inpatient Sample data base for the year 2011 , an estimated 66,485 patients having undergone shoulder arthroplasty were identified and separated into groups with ( 21 % ) and without ( 79 % ) diabetes mellitus . Comparisons of specific outcome measures between diabetic and nondiabetic cohorts were performed by bivariate and multivariable analyses with logistic regression modeling . RESULTS Diabetes mellitus was independently associated with in-hospital death , a number of perioperative complications , prolonged hospital stay , and increased non-homebound disposition after shoulder arthroplasty . The presence of diabetes was not associated with increased hospital cost . CONCLUSION Patients with preexisting diabetes are at higher risk for perioperative morbidity and mortality after shoulder arthroplasty . Future prospect i ve research should explore in more detail the relationship between diabetes and shoulder arthroplasty outcomes",
"Background and Objectives : This study reports our early experience with continuous cervical paravertebral block ( CCPVB ) using a stimulating catheter for the management of acute pain after shoulder surgery . Methods : This prospect i ve observational study presents 256 CCPVB for pain relief after 14 different shoulder operations . Surgery was performed under general anesthesia and blocks were placed prior to induction of general anesthesia ( n = 81 [ 32 % ] ) , after induction of general anesthesia ( n = 116 [ 45 % ] ) , or postoperatively in the recovery room ( n = 59 [ 23 % ] ) . A bolus dose of 30 mL of 0.5 % ropivacaine was followed by an infusion of 0.1 mL/kg/h of 0.2 % ropivacaine . Patient- or nurse-initiated bolus doses of 10 mL of the same drug were used for breakthrough pain and rescue analgesics were available . Postoperative pain , patient satisfaction , and motor function in different parts of the upper limb were evaluated immediately after surgery ( time 0 ) , and then 6 , 12 , 24 , 48 , 60 hours , and 14 days postoperatively . Results : An average of 2 ( range 1 - 7 ) attempts were needed to advance the catheter while still stimulating the nerve . Average postoperative pain ranged from 0.27 ± 1.04 cm to 0.78 ± 1.56 cm ( mean ± SD ) on a visual analog scale ( VAS ) ( 0 - 10 cm ) for the first 48 hours and 3.8 ± 2.1 cm and 3.5 ± 2.4 cm at 60 hours and 14 days , respectively . Patient satisfaction on a VAS of 0 to 5 was 4.19 ± 1.1 , 4.28 ± 1.01 , and 4.69 ± 1.05 at times 0 , 6 hours , and 14 days , respectively . Motor function returned to normal in the fingers within 24 hours and in the shoulder within 60 hours . Complications included Horner 's syndrome ( 40 % ) , dyspnea ( 8 % ) , superficial skin infection ( 5 % ) , posterior neck pain ( 22 % ) , subclavian artery puncture ( 1 % ) , contralateral epidural spread ( 4 % ) , and 8 % of the patients complained of an unpleasant “ dead feeling ” of the arm . Ninety-one percent of patients would request CCPVB again for future shoulder surgery . There was no evidence of nerve damage ",
"BACKGROUND To examine the rates and predictors of deep periprosthetic infections after shoulder hemiarthroplasty . METHODS We used prospect ively collected institutional registry data on all primary shoulder hemiarthroplasty patients from 1976 - 2008 . We estimated survival free of deep periprosthetic infections using Kaplan-Meier survival curves . Using univariate Cox regression analyses , we examined the association of patient-related factors ( age , sex , body mass index ) , comorbidity ( Deyo-Charlson index ) , American Society of Anesthesiologists grade , underlying diagnosis , and implant fixation with the risk of infection . RESULTS A total of 1,349 patients , with a mean age of 63 years ( SD , 16 years ) , 63 % of whom were women , underwent 1,431 primary shoulder hemiarthroplasties . Mean follow-up was 8 years ( SD , 7 years ) . Fourteen deep periprosthetic infections occurred during the follow-up , confirmed by medical record review . The most common organisms were Staphylococcus aureus , coagulase-negative Staphylococcus , and Propionibacterium acnes , each accounting for 3 cases ( 21 % each ) . The 5- , 10- , and 20-year prosthetic infection-free rates were 98.9 % ( 95 % confidence interval [ CI ] , 98.3%-99.5 % ) , 98.7 % ( 95 % CI , 98.1%-99.4 % ) , and 98.7 % ( 95 % CI , 98.1%-99.4 % ) , respectively . None of the factors evaluated were significantly associated with risk of prosthetic infection after primary shoulder hemiarthroplasty , except that an underlying diagnosis of trauma was associated with a significantly higher hazard ratio of 3.18 ( 95 % CI , 1.06 - 9.56 ) for infection compared with all other diagnoses ( P = .04 ) . A higher body mass index showed a non-statistically significant trend toward an association with higher hazard ( P = .13 ) . CONCLUSION The periprosthetic infection rate after shoulder hemiarthroplasty was low , estimated at 1.3 % at 20-year follow-up . An underlying diagnosis of trauma was associated with a higher risk of periprosthetic infection . These patients should be observed closely for development of infection",
"BACKGROUND In vitro , Propionibacterium acnes ( P acnes ) is highly susceptible to commonly used antibiotics and antiseptics , yet in vivo , it still causes postsurgical infections of the shoulder . We hypothesized that the local environment within the pilosebaceous gl and s protects P acnes and that incision of the skin transects these gl and s , exposing viable P acnes to the wound . METHODS Fifty consecutive patients undergoing open shoulder surgery were prospect ively studied . Prophylactic antibiotics were administered to all patients . Microbiologic swabs of the skin surface were taken before and after skin preparation with 70 % alcoholic chlorhexidine . The skin was incised , and a further swab and dermal biopsy specimen were taken . RESULTS P acnes was cultured in 21 of 50 prepreparation skin surface swabs ( 42 % ) , 7 of 50 postpreparation skin surface swabs ( 14 % ) , 26 of 50 dermal swabs ( 52 % ) , and 20 of 50 dermal biopsy specimens ( 40 % ) . There was a significantly higher incidence of P acnes growth from the skin surface ( P = .009 ) and dermis ( P = .01 ) of patients aged ≤50 years old and in the dermal biopsy specimens of patients undergoing revision surgery ( P = .01 ) and a trend toward increased incidence of P acnes in men . P acnes growth from a prepreparation skin surface swab had a sensitivity of 69 % , specificity of 88 % , positive predictive value of 86 % , and negative predictive value of 72 % at predicting subsequent P acnes growth from the dermal swab or biopsy specimen . CONCLUSIONS Viable P acnes persists within the skin dermis , despite st and ard antimicrobial pre caution s. These findings suggest that incising the skin is likely to lead to deep seeding of the surgical wound , which has implication s for the pathogenesis and prevention of postsurgical shoulder infections",
"Background A concern regarding reverse shoulder arthroplasty ( RSA ) is the possibly higher complication rate compared with conventional unconstrained shoulder arthroplasty . Questions / purpose sWe determined ( 1 ) the rate of instability and infection ; ( 2 ) whether diagnosis influenced instability and infection rates ; and ( 3 ) whether these complications affect ASES , Constant , and WOOS scores after RSA . Methods A prospect i ve data base , clinical charts , and radiographs of 284 patients who had undergone primary ( n = 212 patients ) or revision ( n = 72 patients ) RSA were review ed to identify patients whose postoperative course was complicated by instability or infection . Results The rate of instability was similar in patients with primary ( eleven of 212 [ 5 % ) ] and revision ( six of 72 [ 8 % ] ) reverse arthroplasty . The rate of infection was higher in the revision ( five of 72 [ 7 % ] ) than in the primary ( three of 212 [ 1 % ] ) group . Patients with an irreparable subscapularis tendon had a higher rate of instability ( 14 of 123 [ 12 % ] ) compared with patients with a repairable subscapularis tendon ( one of 161 [ less than 1 % ] ) . The fracture sequelae group had the highest rate of instability ( seven of 25 [ 28 % ] ) among diagnoses within the primary group . The rates of infection were similar between the diagnoses within the primary group . The improvements in the ASES score , the Constant score , and the WOOS score from preoperatively to postoperatively were better in the no instability/infection group as compared with the instability/infection group . Conclusions This information confirms the available literature allowing surgeons to give patients realistic expectations regarding the infection and instability rates after RSA.Level of Evidence Level III , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"To evaluate the effectiveness of closed wound drainage in shoulder surgery , 300 patients were enrolled in a prospect i ve r and omized study . Three operations were studied : rotator cuff repair , anterior reconstruction for instability , and arthroplasty . One hundred patients were included in each group . All patients were evaluated for wound hematoma , infection , variation in postoperative rehabilitation caused by wound problems , and length of hospital stay . No statistical difference was found between the patients whose wounds were drained and those whose wounds were not drained . This finding existed within each category . Our data do not support the routine use of closed wound drainage in elective shoulder surgery",
"BACKGROUND Management of periprosthetic infection after reverse shoulder arthroplasty ( RSA ) remains a challenge . Whereas the infection rate after RSA has improved , more information would be helpful to identify patient risk factors for infection after RSA . The purpose of this study was to evaluate risk factors for infection after RSA . METHODS We identified 301 primary RSAs with a minimum of 1-year follow-up in a prospect ively collected shoulder arthroplasty registry . We performed bivariate and multivariable logistic regression analyses to assess the association between patient demographic and clinical characteristics ( age , sex , smoking , diabetes , rheumatoid arthritis , body mass index , and history of prior failed hemiarthroplasty or total shoulder arthroplasty ) and periprosthetic infection after RSA . RESULTS There were 15 periprosthetic infections after RSA ( 5.0 % ) . Patients with a history of RSA for failed arthroplasty ( odds ratio , 5.75 ; 95 % confidence interval , 2.01 - 16.43 ; P = .001 ) and patients younger than 65 years had an increased risk for development of an infection ( odds ratio , 4.0 ; 95 % confidence interval , 1.21 - 15.35 ; P = .021 ) . History of smoking , diabetes , rheumatoid arthritis , or obesity did not contribute to an increased risk of infection after RSA . CONCLUSIONS This is the first study evaluating risk factors for infection after RSA while controlling for confounding variables with multivariable analysis . The greatest risk factors for infection after RSA were history of a prior failed arthroplasty and age younger than 65 years . Patients with these clinical characteristics should be counseled preoperatively about the increased risk for development of infection after RSA",
"Background Continuous interscalene block is the technique of choice for postoperative pain relief treatment after shoulder surgery . The authors prospect ively evaluated the modified lateral approach for the performance of the interscalene catheter block and monitored 700 patients for clinical efficacy and complications during the first 6 months after placement of the catheter . Methods A total of 700 adults scheduled to undergo elective shoulder surgery performed with an interscalene brachial plexus block through an interscalene catheter were included in this study . The interscalene brachial plexus block procedure was st and ardized for all patients . Difficulties in placement of the catheter , clinical efficacy of anesthesia and analgesia , patient satisfaction , and acute and chronic complications were recorded . Patients were observed daily for 5 days for any complications and were evaluated at 1 , 3 , and 6 months after surgery . Persistence of neurologic complication was investigated by electroneuromyography . Results A total of 700 adults completed the study . Easy placement of the catheter ( one attempt ) was achieved in 86 % of the patients . Resistance to thread the catheter was encountered in 6 % ; no major complications were observed during injection of the initial bolus . The success rate for anesthesia was 97 % . Postoperative analgesia was efficient in 99 % . The concentration and the rate of infusion of ropivacaine had to be increased in 31 patients ( 6 % ) . In five patients ( 0.7 % ) , signs of local infection around the puncture point were noted ; in one patient ( 0.1 % ) , a collection of pus was surgically drained . Patient satisfaction was 9.6 on a scale of 0–10 . Minor neurologic complications ( paresthesias , dysesthesias , pain not related to surgery ) were observed in 2.4 % , 0.3 % , and 0 % at 1 , 3 , and 6 months , respectively . At 1 month , three sulcus ulnaris syndromes , one carpal tunnel syndrome , and one complex regional pain syndrome were diagnosed . Two patients ( 0.2 % ) had sensory-motor deficit , which necessitated 19 and 28 weeks to recover . Electromyography was suggestive of partial axonotmesis . Conclusion The lateral modified approach provides good conditions for placement of the interscalene catheter . Anesthesia and analgesia performed through the catheter are efficient . The rates of infection and neurologic complications are low , and patient satisfaction is high",
"BACKGROUND To examine the rates and predictors of deep periprosthetic infections after primary total shoulder arthroplasty ( TSA ) . METHODS We used prospect ively collected data on all primary TSA patients from 1976 - 2008 at Mayo Clinic Medical Center . We estimated survival free of deep periprosthetic infections after primary TSA using Kaplan-Meier survival . Univariate and multivariable Cox regression was used to assess the association of patient-related factors ( age , gender , body mass index ) , comorbidity ( Deyo-Charlson index ) , American Society of Anesthesiologists class , implant fixation , and underlying diagnosis with risk of infection . RESULTS A total of 2,207 patients , with a mean age of 65 years ( SD , 12 years ) , 53 % of whom were women , underwent 2,588 primary TSAs . Mean follow-up was 7 years ( SD , 6 years ) , and the mean body mass index was 30 kg/m(2 ) ( SD , 6 kg/m(2 ) ) . The American Society of Anesthesiologists class was 1 or 2 in 61 % of cases . Thirty-two confirmed deep periprosthetic infections occurred during follow-up . In earlier years , Staphylococcus predominated ; in recent years , Propionibacterium acnes was almost as common . The 5- , 10- , and 20-year prosthetic infection-free rates were 99.3 % ( 95 % confidence interval [ CI ] , 98.9 - 99.6 ) , 98.5 % ( 95 % CI , 97.8 - 99.1 ) , and 97.2 % ( 95 % CI , 96.0 - 98.4 ) , respectively . On multivariable analysis , a male patient had a significantly higher risk of deep periprosthetic infection ( hazard ratio , 2.67 [ 95 % CI , 1.22 - 5.87 ] ; P = .01 ) and older age was associated with lower risk ( hazard ratio , 0.97 [ 95 % CI , 0.95 - 1.00 ] per year ; P = .05 ) . CONCLUSIONS The periprosthetic infection rate was low at 20-year follow-up . Male gender and younger age were significant risk factors for deep periprosthetic infections after TSA . Future studies should investigate whether differences in bone morphology , medical comorbidity , or other factors are underlying these associations",
"BACKGROUND Infection after shoulder surgery can have devastating consequences . Recent literature has implicated Propionibacterium acnes as a causative agent for postoperative shoulder infections . Axillary hair removal has been suggested as a method for infection prevention , although data quantifying its effect on the bacterial load around the shoulder are lacking . METHODS We clipped one r and omly selected axilla in 85 healthy male volunteers with commercially available surgical clippers . Aerobic and anaerobic culture specimens were taken from the clipped and unclipped axillae . Each shoulder was then prepared with 2 % chlorhexidine gluconate and 70 % isopropyl alcohol . Repeated culture specimens were then taken from both axillae . Cultures were held for 14 days and recorded with a semiquantitative system ( 0 - 4 points ) . Results were compared by the Wilcoxon signed rank test . RESULTS There was no difference in the burden of P. acnes between the clipped and unclipped axillae before or after surgical preparation ( P = .109 , P = .344 , respectively ) . There was a significantly greater bacterial burden in the clipped shoulder compared with the unclipped shoulder before preparation ( P total bacterial load and P. acnes load for both axillae after surgical preparation ( P total bacterial burden . A 2 % chlorhexidine gluconate surgical preparation is effective at removal of all bacteria and specifically P. acnes from the axilla",
"Background and Objectives : Large prospect i ve studies evaluating continuous interscalene block for shoulder surgery have thus far been limited to inpatient and university teaching practice s. Shoulder surgery is increasingly being performed on an outpatient basis . The aim of this case series was to prospect ively evaluate a large series of interscalene catheters for ambulatory shoulder surgery in a private practice setting . Methods : A single operator placed nonstimulating catheters using a combination of ultrasound and nerve stimulation . Following postanesthesia care unit ( PACU ) discharge , opioid‐like analgesic adjuvants other than tramadol were avoided unless patients experienced inadequate pain relief . All patients were assessed in the PACU , on the first postoperative morning , and at 3 weeks for catheter effectiveness and for acute and chronic complications . Pain scores and patient satisfaction were assessed in subgroups of 100 consecutive patients . Results : Three hundred patients were studied . The first attempt catheter success rate was 96 % . In all but 1 patient , ineffective catheters in the PACU were effectively reinserted . Thirteen patients experienced inadequate pain relief after leaving the PACU . Of these patients , 5 were rescued with additional ropivacaine , 3 had the catheter effectively reinserted , and 5 were managed with oral opioids . One patient required antibiotic treatment for catheter site infection . Neurological sequelae potentially attributable to the catheter were present in 3 patients at 3 weeks , and remained in 1 patient at 4 weeks . This patient 's symptoms resolved at 6 months . Conclusions : Continuous interscalene block for ambulatory shoulder surgery in a private practice setting had a high success rate , a low complication rate , and enabled the avoidance of the use of potent opioids in 98 % of patients",
"BACKGROUND Recent studies have identified Propionibacterium acnes as the causal organism in an increasing number of postoperative shoulder infections . Most reports have found a high rate of P acnes infection after open surgery , particularly shoulder arthroplasty . However , there are limited data regarding P acnes infections after shoulder arthroscopy . MATERIAL S AND METHODS We prospect ively collected data on all shoulder arthroscopies performed by the senior author from January 1 , 2009 , until April 1 , 2013 . Cultures were taken in all revision shoulder arthroscopy cases performed for pain , stiffness , or weakness . In addition , 2 cultures were taken from each of a cohort of 32 primary shoulder arthroscopy cases without concern for infection to determine the false-positive rate . RESULTS A total of 1,591 shoulder arthroscopies were performed during this period , 68 ( 4.3 % ) of which were revision procedures performed for pain , stiffness , or weakness . A total of 20 revision arthroscopies ( 29.4 % ) had positive culture findings , and 16 ( 23.5 % ) were positive for P acnes . In the control group , 1 patient ( 3.2 % ) had P acnes growth . CONCLUSIONS The rate of P acnes infection in patients undergoing revision shoulder arthroscopy is higher than previously published and should be considered in cases characterized by refractory postoperative pain and stiffness",
"Background Frozen shoulder has not previously been shown to be associated with infection . The present study set out to confirm the None hypothesis that there is no relationship between infection and frozen shoulder using two modern scientific methods , extended culture and polymerase chain reaction ( PCR ) for bacterial nucleic acids . Methods A prospect i ve cohort of 10 patients undergoing arthroscopic release for stage II idiopathic frozen shoulder had two biopsies of tissue taken from the affected shoulder joint capsule at the time of surgery , along with control biopsies of subdermal fat . The biopsies and controls were examined with extended culture and PCR for microbial nucleic acid . Results Eight of the 10 patients had positive findings on extended culture in their shoulder capsule and , in six of these , Propionibacterium acnes was present . Conclusions The findings mean that we must reject the None hypothesis that there is no relationship between infection and frozen shoulder . More studies are urgently needed to confirm or refute these findings . If they are confirmed , this could potentially lead to new and effective treatments for this common , painful and disabling condition . Could P. acnes be the Helicobacter of frozen shoulder",
"BACKGROUND Deep infection following shoulder surgery is a rare but devastating problem . The use of an effective skin-preparation solution may be an important step in preventing infection . The purpose s of the present study were to examine the native bacteria around the shoulder and to determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder . METHODS A prospect i ve study was undertaken to evaluate 150 consecutive patients undergoing shoulder surgery at one institution . Each shoulder was prepared with one of three r and omly selected solutions : ChloraPrep ( 2 % chlorhexidine gluconate and 70 % isopropyl alcohol ) , DuraPrep ( 0.7 % iodophor and 74 % isopropyl alcohol ) , or povidone-iodine scrub and paint ( 0.75 % iodine scrub and 1.0 % iodine paint ) . Aerobic and anaerobic cultures were obtained prior to skin preparation for the first twenty patients , to determine the native bacteria around the shoulder , and following skin preparation for all patients . RESULTS Coagulase-negative Staphylococcus and Propionibacterium acnes were the most commonly isolated organisms prior to skin preparation . The overall rate of positive cultures was 31 % in the povidone-iodine group , 19 % in the DuraPrep group , and 7 % in the ChloraPrep group . The positive culture rate for the ChloraPrep group was lower than that for the povidone-iodine group ( p ChloraPrep and DuraPrep were more effective than povidone-iodine in eliminating coagulase-negative Staphylococcus from the shoulder region ( p eliminate Propionibacterium acnes from the shoulder region . No infections occurred in any of the patients treated in this study at a minimum of ten months of follow-up . CONCLUSIONS ChloraPrep is more effective than DuraPrep and povidone-iodine at eliminating overall bacteria from the shoulder region . Both ChloraPrep and DuraPrep are more effective than povidone-iodine at eliminating coagulase-negative Staphylococcus from the shoulder"
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Introduction : There is limited literature on the impact of testing variables on the push‐out bond test ( POBT ) . This review identified design s of the POBT used in the endodontic literature and aim ed to determine which experimental variables may influence the push‐out bond strength ( POBS ) . Methods : A systematic review based on PRISMA guidelines was performed by search ing the PubMed , SCOPUS , and Cochrane library data bases using terms including push‐out and dislocation resistance and descriptions of endodontic material s. Test variables assessed included method of root preparation , timing of sectioning compared with filling , thickness , diameter and taper of sections , and plunger size and velocity . The POBS of 3 common material s ( gutta‐percha and AH Plus , mineral trioxide aggregate , and Biodentine ) were collected from investigations , and a comparison was attempted . Results : One hundred thirty‐three studies assessed the POBS of root‐filling material s , 68 assessed root repair cements/root‐end filling material s , and 16 assessed orifice barrier material s other than mineral trioxide aggregate . There was significant variation in all of the assessed variables , result ing in a large range of reported values for the POBS of the various material s. Because of this heterogeneity in study design , no further statistical analysis of the impact of the test variables on POBS was possible . Conclusions : There was considerable variation in the POBT design used in endodontic research . Greater st and ardization is required for future research as well as accurate reporting for all test variables to assess the impact of specific design variables on POBS . HIGHLIGHTSPOBT in endodontic research predicts the clinical behavior of endodontic material s . Great variability in POBT criteria compromises interpretation and clinical extrapolation . Greater st and ardization of the variables related to this test is required
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"AIM To analyse the influence of exposure of mineral trioxide aggregate ( MTA ) with and without calcium chloride ( CaCl2 ) to phosphate-buffered saline ( PBS ) on the push-out bond strength , over different experimental periods . METHODOLOGY One hundred and twenty dentine discs with st and ardized cavities were filled with MTA with and without 10 % CaCl2 . The specimens were r and omly divided as follows ( n = 30 ) : ( G1 ) MTA in contact with a moistened cotton pellet , ( G2 ) MTA immersed in PBS , ( G3 ) MTA + CaCl2 in contact with a moistened cotton pellet and ( G4 ) MTA + CaCl2 immersed in PBS . The sample s were stored for 3 , 28 and 60 days . The bond strengths were measured with the Instron Testing machine . Data were analysed using the three-way anova and Tukey test ( P of MTA with and without CaCl2 , exposed to PBS , had higher bond strength values in all study periods ( P addition of CaCl2 to MTA ( G1 × G3 ) evidence d significant differences in bond strength in the different periods ( P of MTA to PBS positively influenced the push-out bond strength , whereas the addition of CaCl2 had a negative influence",
"INTRODUCTION Calcium silicate-based sealers are known to have excellent sealing ability and bioactivities . They are typically recommended to be used in a single-cone ( SC ) technique . No studies have evaluated the effects of the thermoplastic obturation technique on the dentin interface of these sealers . The purpose of this study was to evaluate the push-out bond strengths of MTA Plus Sealer ( Avalon Biomed Inc , Bradenton , FL ) and EndoSequence BC Sealer ( BC ; Brasseler USA , Savannah , GA ) when they were used in a thermoplastic technique . METHODS Fifty single-rooted human extracted teeth were r and omly divided into 5 groups ( n = 10 ) , instrumented , and obturated with the SC technique or continuous wave ( CW ) technique : group 1 , BC-SC ; group 2 , BC-CW ; group 3 , MTA Plus-SC ; group 4 , MTA Plus-CW ; and group 5 , AH Plus ( Dentsply DeTrey , Konstanz , Germany)-CW . The roots were sectioned into 1.0-mm-thick slices , and bond strengths were measured using a st and ardized push-out test . The mode of failure was determined by visual inspection under magnification . RESULTS The MTA Plus-CW had statistically significant lower bond strengths than all other groups . The BC-SC group had statistically higher bond strengths than the MTA Plus-SC and AH Plus-CW groups . No significant differences were seen among the other groups . Modes of failure were predominately cohesive or mixed except for group 4 ( ie , MTA Plus-CW ) in which nearly half the specimens had no visible sealer . CONCLUSIONS BC and MTA Plus sealer showed favorable bond strengths when used in an SC technique . The CW obturation technique decreased the bond strengths of these sealers",
"AIM This study aim ed to evaluate the push-out bond strength of NeoMTA Plus ( NMTA ) , EndoSequence root repair material fast set putty ( ERRMF ) , biodentine ( BD ) , and ProRoot white mineral trioxide aggregate ( PMTA ) when used as perforation repair material s after exposure to 2.5 % sodium hypochlorite ( NaOCl ) during the early setting phase . MATERIAL S AND METHODS Horizontal midroot sections were prepared from single-rooted human teeth . Sections ( n = 144 ) were r and omly divided into four groups : PMTA , BD , NMTA , and ERRMF . Material s were condensed and allowed to set for 10 minutes . The groups were further divided into two subgroups . The NaOCl group included specimens that were immersed in 2.5 % NaOCl for 30 minutes , and the control group included specimens on which a wet cotton pellet was placed over the test material . After 48 hours , the highest force applied to the material s at the time of dislodgement was recorded . Slices were then examined under a digital microscope to evaluate the nature of the bond failure . The surfaces of two specimens from each subgroup were observed by scanning electron microscopy . Data were statistically analyzed with two-way and one-way analysis of variances , independent t-tests , and chi-square tests . The statistical significance was set at 0.05 . RESULTS In NaOCl-treated groups , PMTA showed a significantly higher push-out bond strength than the other three material s ( p = 0.00 ) . In the control groups , the bond strength of BD was significantly higher than that of PMTA , ERRMF , and NMTA ( p NaOCl treatment significantly increased the push-out bond strength of PMTA ( p = 0.00 ) and ERRMF ( p = 0.00 ) and significantly reduced the bond strength of BD ( p = 0.00 ) and NMTA ( p = 0.03 ) . None of the specimens showed an adhesive type of failure . The majority of the sample s exhibited a cohesive failure type . Morphological observations revealed that the surfaces exhibited cubic crystals . In ERRMF , the crystals were few in number . Sodium hypochlorite enhanced the crystallization of NMTA . CONCLUSION The push-out bond strengths of PMTA and ERRMF were significantly increased after exposure to 2.5 % NaOCl in the early setting phase , and those of BD and NMTA were significantly decreased . CLINICAL SIGNIFICANCE The results of the present study suggest that early exposure of NaOCl increase the push-out bond strength of PMTA and ERRMF . PMTA had the highest push-out values . Therefore , it would be a potentially useful perforation repair material for single visit endodontic treatment",
"AIM To evaluate the effect of prior application of several intracanal medicaments on the push-out bond strength of ProRoot MTA and Biodentine . METHODOLOGY Sixty freshly extracted maxillary anterior teeth were sectioned below the cementoenamel junction , and the root canals instrumented using rotary files . Thereafter , a parallel post drill was used to obtain a st and ardized root canal dimension . The roots were r and omly assigned into one of the following groups with respect to the intracanal medicament applied : group 1 : calcium hydroxide ( CH ) powder ( Merck , Darmstadt , Germany ) mixed with distilled water ; group 2 : a mixture of metronidazole , ciprofloxacin and minocycline ( triple antibiotic paste ) ; group 3 : a combination of amoxicillin and clavulanic acid ( Augmentin ; Champs Pharmacy , San Antonio , TX , USA ) ; group 4 : an antibiotic-corticoid compound paste ( Ledermix ; Riemser , Greifswald , Germany ) ; and group 5 : no medicament ( control ) . Following removal of medicaments with instrumentation and irrigation , the roots were cut into 1-mm-thick parallel transverse sections in a coronal-to-apical direction ( 5 slices/tooth ) . Thereafter , the specimens were divided into two subgroups according to the calcium silicate cement applied ( n = 30/group ) : ( i ) ProRoot MTA ( Dentsply Tulsa Dental , Tulsa , OK , USA ) and ( ii ) Biodentine ( Septodont , Saint-Maur-des-Fosses , France ) . A push-out test was performed , and the data were analysed statistically using two-way anova and Tukey 's post hoc test . RESULTS Regardless of the type of intracanal medicament used , Biodentine had significantly higher bond strength than MTA ( P push-out bond strength results were obtained in CH-treated dentine . Compared with other medicaments , this value was only significantly higher than that of Ledermix ( P similar debonding values ( P > 0.05 ) . CONCLUSIONS Biodentine had a higher bond strength to root canal dentine than ProRoot MTA . Prior CH in distilled water intracanal placement increased the dislodgment resistance of both calcium silicate cements",
"INTRODUCTION The aim of this study was to evaluate the effect of 3 different mixing methods on push-out bond strength of white tooth-colored mineral trioxide aggregate ( MTA ) . METHODS Sixty 2-mm-thick root sections were prepared from 60 single-rooted human teeth and filled with MTA . The sample s were r and omly divided into 3 groups ( n = 20 ) of MTA mixed by ultrasonic , trituration , or conventional methods and then allowed to set for 72 hours in a synthetic tissue fluid environment . Push-out bond strength values of the specimens were measured by a universal testing machine and examined under a stereomicroscope at × 4 to determine the nature of the bond failure . RESULTS The means of push-out bond strength values of white MTA in the ultrasonic , conventional , and trituration groups were 105.67 ± 12.79 , 118.95 ± 12.76 , and 99.60 ± 14.27 MPa , respectively . The differences between the 3 groups were not statistically significant . CONCLUSIONS On the basis of the results of this study , it can be concluded that different mixing methods have no significant effect on push-out bond strength of white MTA ",
"The present study evaluated the influence of 2 % chlorhexidine and 2.5 % sodium hypochlorite on the resin sealer/dentin interface bond strength of AH Plus/gutta-percha and Epiphany/Resilon . Seventy-two extracted bovine incisors were r and omly distributed into 6 groups according to irrigant and sealers : G(S+AH)=physiologic saline solution+AH Plus/gutta-percha ; G(S+Ep)=physiologic saline solution+Epiphany/Resilon ; G(H+AH)=2.5 % sodium hypochlorite (NaOCl)+AH Plus/gutta-percha ; G(H+Ep)=2.5 % NaOCl+Epiphany/Resilon ; G(C+AH)=2 % chlorhexidine (CHX)+AH Plus/gutta-percha ; and G(C+Ep)=2 % CHX+Epiphany/Resilon . After 7 days at 37 ° C and 100 % humidity , the roots were cut transversally on the long axis of the tooth in 0.8 mm (±0.09)-thick slices ; these slices were then subjected to the push-out test . Data were analyzed using a 2-way ANOVA and Tukey tests at 5 % significance . The AH Plus/gutta-percha groups showed significantly higher bond strength than the Epiphany/Resilon groups , regardless of the irrigant used ( p . Sodium hypochlorite adversely affected bond strength in the AH Plus group , whereas chlorhexidine did not influence the push-out bond strength of either sealer ( p ) . Two percent chlorhexidine did not adversely affect the bond strength of the sealers , whereas 2.5 % sodium hypochlorite solution damaged AH Plus/gutta-percha bond strength",
"Introduction : The aim of this in vitro study was to evaluate the bond strength of Photo-Activated Disinfection ( PAD ) system to dentin with different root canal sealers by using a push-out test design . Material s and Methods : A total of 30 extracted m and ibular premolar teeth with single and straight roots were used . The crowns were removed and the root canals were prepared by using ProTaper rotary files . The smear layer was removed and the roots were r and omly divided into two groups ( n = 15 ) according to the use of PAD system as the final disinfecting agent . Each group was then divided into 6 ( n = 5 ) subgroups and obturated with gutta-percha and 3 different root canal sealers . The groups were Group 1 : Sodium hypochlorite ( NaOCl ) + ethylenediaminetetraacetic acid (EDTA)-AH Plus sealer ; Group 2 : NaOCl + EDTA + PAD-AH Plus ; Group 3 : NaOCl + EDTA-Sealapex ; Group 4 : NaOCl + EDTA + PAD-Sealapex ; Group 5 : NaOCl + EDTA-mineral trioxide aggregate (MTA)-Fiallapex ; and Group 6 : NaOCl + EDTA + PAD-MTA-Fillapex . 1-mm thickness horizontal sections ( n : 5 × 4 = 20 ) were sliced for the push-out bond strength measurement . Results : Group 3 and 4 showed significantly lower bond strengths compared with all the other groups ( P that the PAD system adversely affected the bond strength of the MTA Fillapex root canal sealer",
"We have developed a visible-light curable urethane-acrylate/tripropylene glycol diacrylate ( UA/TPGDA ) oligomer to serve as a root canal sealer and a zinc oxide/thermoplastic polyurethane ( ZnO/TPU ) composite to serve as a root canal obturation material . The purpose of this study was to compare the push-out bond strengths of the following 8 groups of material s : ( 1 ) Tubliseal + gutta-percha ( TB/GP ) ; ( 2 ) Tubliseal + Resilon ( TB/R ) ; ( 3 ) Epiphany + gutta-percha ( EP/GP ) ; ( 4 ) Epiphany + Resilon ( EP/R ) ; ( 5 ) EndoREZ sealer + EndoREZ cone ( ES/EC ) ; ( 6 ) EndoREZ sealer + ZnO/TPU ( ES/PU ) ; ( 7 ) UA/TPGDA + EndoREZ cone ( UA/EC ) ; and ( 8) UA/TPGDA + ZnO/TPU ( UA/PU ) . Eighty 1-mm-thick root slices prepared from extracted human permanent molars were r and omly divided into 8 groups with 10 specimens in each group . Root slices were filled with the above obturation material s , and then push-out test was performed with a universal testing machine . The results showed that the UA/EC and UA/PU groups had significantly higher bond strengths than the other groups",
"Background : The purpose of this study was to compare the push-out bond strength of mineral trioxide aggregate ( MTA ) and calcium enriched mixture ( CEM ) as root end filling material s. Material s and Methods : A total of 40 root dentin slices ( 1 ± 0.2 mm ) were prepared from freshly extracted human maxillary central teeth and their lumens were enlarged to 1.3 mm . The slices were r and omly divided into two groups ( n = 20 ) . MTA and CEM cement were mixed according to manufacturer 's instruction and introduced into the lumens . The specimens were wrapped in pieces of wet gauze soaked in distilled water and incubated at 37 ° C for 3 days . The push-out bond strength was measured using a universal testing machine . The slices were then examined under a light microscope at ×10 magnification to determine the nature of bond failure . The data were analyzed using Mann-Whitney test ( P The mean push-out bond strength for CEM cement and MTA were 1.68 ± 0.9 and 5.94 ± 3.99 respectively . The difference was statistically significant ( P failure was predominantly of adhesive type in MTA group and cohesive type in CEM group . Conclusion : CEM cement showed significantly lower bond strength to the dentinal wall compared to MTA",
"To compare the effects of different chelating agents on the push-out bond strength of calcium silicate-based cements to the simulated root-end cavities . Root-end cavities were prepared on the roots of fifty extracted maxillary anterior teeth . The specimens were then r and omly divided into 5 groups ( n = 10 ) based on the final irrigation regimen : Group 1 : 17 % EDTA , Group 2 : 7 % maleic acid , Group 3 : QMix , Group 4 : 2.25 % peracetic acid ( PAA ) , Group 5 : 0.9 % saline . Then , the sample s from each group were subdivided into two groups ( n = 5 ) based on the apical filling material . In group 1 , root-end cavities of all sample s were filled with Biodentine and in group 2 , with MTA . Each sample was horizontally sectioned to produce two discs of ∼1 mm thick per specimen . The maximum load required for the dislodgement of 100 retrofillings was recorded . The specimens were examined under scanning electron microscope after debonding to assess the type of bond failure . Data were statistically analyzed using Kruskal Wallis and Mann Whitney U tests . Irrigation with saline result ed in higher bond strength compared to the other irrigants in the retro grade cavities obturated with MTA or Biodentine ( p .05 ) . EDTA and PAA groups showed higher dislodgement resistance values than the other test irrigants , when Biodentine was used as a filling . The type of irrigation solution influences the bond strength of the root-end fillings",
"Objective : This was an in vitro evaluation of push-out bond strength and surface microhardness of calcium silicate-based bio material s in coronal and apical root dentin . Material s and Methods : Ninety sections ( 2 mm thick ) of coronal and apical root dentin were obtained from roots of 60 extracted teeth ; the canals were enlarged to a st and ardized cavity diameter of 1.3 mm . Sections were r and omly divided into 6 groups ( n = 15 per group ) , and cavities were filled with Biodentine ™ , BioAggregate , or ProRoot mineral trioxide aggregate ( MTA ) , according to the manufacturers ' instructions . Push-out bond strength values were measured using a universal testing machine under a compressive load at a speed of 1 mm/min . Sample s were analyzed under a light microscope to determine the nature of bond failure . Ten sample s ( 2 mm thick ) were prepared for all the material s , and Vickers microhardness was determined using a digital hardness tester . Data were analyzed using one-way analysis of variance and Tukey-Kramer multiple comparison tests at a significance level of p higher bond strengths than BioAggregate ( 6.63 ; 10.09 MPa ) in coronal and apical root dentin , respectively ( p in coronal dentin . Bond failure was predominantly adhesive in Biodentine and ProRoot MTA , while BioAggregate showed predominantly mixed failure . ProRoot MTA ( 158.52 HV ) showed significantly higher microhardness and BioAggregate ( 68.79 HV ) showed the lowest hardness . Conclusion : Biodentine and ProRoot MTA showed higher bond strength and microhardness compared to BioAggregate",
"INTRODUCTION The aim of this study was to evaluate the quality and bond strength of three root filling techniques ( lateral compaction , continuous wave of condensation and Tagger 's Hybrid technique [ THT ] ) using micro-computed tomography ( CT ) images and push-out tests , respectively . MATERIAL S AND METHODS Thirty m and ibular incisors were prepared using the same protocol and r and omly divided into three groups ( n=10 ) : Lateral condensation technique ( LCT ) , continuous wave of condensation technique ( CWCT ) , and THT . All specimens were filled with Gutta-percha ( GP ) cones and AH Plus sealer . Five specimens of each group were r and omly chosen for micro-CT analysis and all of them were sectioned into 1 mm slices and subjected to push-out tests . RESULTS Micro-CT analysis revealed less empty spaces when GP was heated within the root canals in CWCT and THT when compared to LCT . Push-out tests showed that LCT and THT had a significantly higher displacement resistance ( P CWCT . Bond strength was lower in apical and middle thirds than in the coronal thirds . CONCLUSIONS It can be concluded that LCT and THT were associated with higher bond strengths to intraradicular dentine than CWCT . However , LCT was associated with more empty voids than the other techniques",
"Background . Further studies on the adhesion properties of MTA-based material s seem necessary due to their growing use in endodontic treatment . This research aim ed to assess the effect of retreatment on the bond strength of MTA-based ( MTA Fillapex ) and epoxy resin-based ( AH Plus ) sealers . Methods . ProTaper rotary files were applied to prepare the root canals of 80 human m and ibular premolars . Then , the roots were r and omly divided intotwo groups of A ( n=40 ) and B ( n=40 ) , which were obturated with gutta-percha and MTA Filla-pex and AH Plus sealer , respectively . In both groups , the teeth were r and omly subdivided into 2 subgroups . No retreatment was carried out in subgroups A1 and B1 , while subgroups A2 and B2 were retreated with rotary files and a solvent . Then , a push-out test was performed on four 2-mm slices of each tooth at a distance of 2 mm from the coronal surface after two weeks of incubation . Data were analyzed with two-way ANOVA and statistical significance was set at P mean bond strength values between the two sealers . Irrespective of the sealer type ( P=0.3 ) , no significant differences were revealed by comparing the mean bond strength values of the study subgroups . Furthermore , no statistically significant interaction ( P=0.5 ) was found between the treatment and sealer types . Conclusion . AH Plus sealer exhibited a higher bond strength compared to MTA Fillapex . Retreatment using rotary files and chloroform had no statistically significant effect on the bond strength of sealers evaluated in this study",
"Background The aim of the present study was to evaluate the time-dependent effectiveness of the intracanal medicaments used in pulp revascularization on the dislocation resistance of mineral trioxide aggregate ( MTA ) . Methods One hundred ninety-two extracted human maxillary incisor teeth were sectioned apically 12 mm below and coronally 2 mm above the cemento-enamel junction . Roots were enlarged to size 40 ( Protaper F4 ) . Next , Peeso reamers from # 1 to # 5 were used sequentially . Sodium hypochlorite ( 2.5 % ) , EDTA ( 17 % ) , and distilled water were used in final irrigation . The specimens were r and omly divided into four groups ( n = 48 ) : Group 1 , in which triple antibiotic paste ( TAP ) ( ciprofloxacin + metronidazole + minocycline ) was prepared and delivered into the canals using a lentulo spiral ; Group 2 , in which double antibiotic paste ( DAP ) ( ciprofloxacin + metronidazole ) was placed into the canals ; Group 3 , in which calcium hydroxide paste ( CH ) ( calcium hydroxide + distilled water ) was introduced into the roots ; and Group 4 ( control ) , in which no medicament was applied into the root canals . Then , the sample s were kept in saline solution for 2 , 4 , and 12 weeks , after which time 16 roots were selected r and omly from each group , representing the sample s of each time point . After removal of the medicaments , MTA was placed into the coronal third of the roots , and the sample s were incubated for 7 days . A push-out test was used to measure the dislocation resistance ( DR ) of MTA . The data were analyzed using a two-way ANOVA followed by Tukey ’s pairwise comparisons ( p = 0.05 ) . Results The time factor displayed a significant effect on the DR of MTA ( p smaller DR values after 12 weeks compared to after 1 week ( p significant unfavorable effect of TAP and DAP was observed as early as 2 weeks after the application , while 2 and 4 weeks after the application of CH there was no effect on the DR of MTA . No significant differences were found between the time points in the control group ( p > 0.05 ) . Conclusion The type and the intracanal duration of medicaments used for pulp revascularization should be chosen carefully to provide maximum antimicrobial effect while creating a favorable environment both for stem cell attachment and MTA adhesion ",
"Objective : Mineral trioxide aggregate ( MTA ) has been accepted as an appropriate root-end filling material in endodontic microsurgery because of setting ability in the wet environment . The aim of this study was to assess the bond strength of root-end placed MTA and Biodentine ( Septodont , Saint Maur des Fossés , France ) in the absence/presence of blood contamination . Material s and Methods : Forty-eight single-rooted maxillary incisors were used . subsequent to root-end resection and apical preparation using ultrasonic retro-tips , the specimens were r and omly separated into two groups according to the root-end filling material s : MTA ( Cerkamed Medical Company , Stalowa , Pol and ) or Biodentine . The specimens were then separated into two subgroups according to storage condition ( absence/presence of blood ) ( n = 12 ) . After obtaining 2.0 ± 0.1 mm slices , push-out tests were performed . Each slice was examined under a stereomicroscope to evaluate the failure mode . The data were analyzed using two-way analysis of variance and Tukey 's post hoc test for multiple comparisons . The failure modes were analyzed using the Chi-square test ( P = 0.05 ) . Results : The bond strength was significantly affected by the presence of blood contamination and root-end filling material type ( P bond strength than MTA ( P failure type was adhesive failure . According to the Chi-square test , there were no statistically significant differences among the groups ( P = 0.394 ) . Conclusions : Biodentine had better bond strength values compared to MTA , and the bond strength of both MTA and Biodentine as root-end filling material s was negatively affected by the presence of blood",
"INTRODUCTION The aim of this in vitro study was to evaluate the effect of various irrigants on the push-out bond strength of calcium-enriched mixture ( CEM ) cement and mineral trioxide aggregate ( MTA ) . METHODS AND MATERIAL S A total of 140 dentin disks with a thickness of 1.5±0.2 mm and lumen size of 1.3 mm , were r and omly divided into 12 groups ( n=10 ) and 4 control groups ( n=5 ) . The lumen of disks in groups 1 , 2 , 3 , 7 , 8 , 9 were filled with CEM and groups 4 , 5 , 6 , 10 , 11 , 12 were filled with MTA . Control groups were filled with CEM and MTA . Specimens were incubated at 37 ° C for one day in groups 1 to 6 and seven days in groups 7 to 12 . After incubation the sample s were divided into three subgroups ( n=10 ) that were either immersed for 30 min in 5.5 % sodium hypochlorite ( NaOCl ) , 2 % chlorhexidine ( CHX ) or saline solution . The push-out bond strength values were measured by using a universal testing machine . The nature of the failures were determined by light microscope . Data was analyzed using the three-way ANOVA to evaluate the effect of material type , different irrigants and time intervals . Post hoc Tukey 's test was used for two-by-two comparison of the groups . RESULTS CEM cement significantly showed a higher push-out bond strength in comparison with MTA ( P=0.001 ) . The elapse of time significantly increased the bond strength ( P=0.001 ) . There was no significant difference between the irrigants used in this study ( P=0.441 ) . Bond failure was predominantly of mixed type in MTA and of cohesive type in CEM sample s. CONCLUSION Based on this study , endodontic irrigants did not influence the push-out bond strength of MTA and CEM cement",
"Objective : This study compared the push-out bond strength of EndoSequence Root Repair Material ( ERRM ) and Bioaggregate ( BA ) , new bioceramic material s , to that of mineral trioxide aggregate ( MTA ) after incubation in phosphate-buffered saline ( PBS ) , a synthetic tissue fluid , for either 1 week or 2 months . Material s and Methods : One-hundred and twenty root sections were filled with ProRoot MTA , BA , or ERRM . Each tested material was then r and omly divided into two subgroups ( n = 20 ) : root sections were immersed in PBS for 1 week or 2 months . The bond strengths were measured using a universal testing machine . After that , the failure modes were examined with stereomicroscopy and scanning electron microscopy ( SEM ) . The push-out data and failure mode categories were analyzed by two-way ANOVA and chi-square tests , respectively . Results : The bond strength of ERRM was significantly higher than that of BA and MTA at both incubation periods . No significant difference was found between the bond strength of MTA and BA at either 1 week or 2 months . Increasing the incubation time to 2 months result ed in a significant increase in bond strength of all the material s. The failure mode was mainly mixed for MTA and BA , but cohesive for ERRM at both incubation periods . Conclusion : ERRM had significantly higher bond strength to root canal walls compared to MTA and BA . Increasing the incubation time significantly improved the bond strength and bioactive reaction products of all material",
"Background This study aim ed to assess the push-out bond strength of mineral trioxide aggregate ( MTA ) to root canal dentin after irrigation with Smear Clear in comparison with 2.5 % sodium hypochlorite ( NaOCl ) , 2 % chlorhexidine ( CHX ) and saline as commonly used root canal irrigants . Material and Methods The coronal and mid-root areas of maxillary anterior teeth were horizontally sectioned into one-millimeter thick slices . The root canal lumen of dentinal slices was dilated using a diamond bur with 1.3 mm diameter . After the application of MTA , the sample s were incubated in 100 % humidity for 10 minutes and were then r and omly divided into four groups ( n=20 ) and immersed in Smear Clear , 2.5 % NaOCl , 2 % CHX and saline for 30 minutes . No irrigant was used for the control group ( n=20 ) . A wet cotton pellet was placed on the sample s and after 48 hours of incubation , push-out bond strength was measured using a universal testing machine . The sample s were evaluated under a stereomicroscope to determine the mode of failure . One-way ANOVA was used to assess statistical differences among the groups . Results The control group showed the highest bond strength with significant differences with other groups ( P Smear Clear and NaOCl groups ( P bond strength to MTA was noted after irrigation with Smear Clear , CHX and NaOCl ( P>0.05 ) . Other pairwise comparisons showed no significant difference ( P>0.05 ) . Conclusions Irrigation with Smear Clear , CHX and NaOCl did not cause a significant change in bond strength of MTA to dentin . Key words : Root Canal Irrigants , push-out , Mineral Trioxide Aggregate , dentin",
"The purpose of this study was to evaluate the effects of ultrasonic and manual placement techniques on the push-out bond strength of Biodentine and MTA with and without calcium chloride . One hundred and twenty mid-root slices from forty freshly extracted single-rooted human m and ibular premolar teeth were instrumented and r and omly divided into six groups ( n=20 ) according to the filling material and placement technique applied , as follows : G1 : MTA-manual compaction , G2 : Biodentine-manual compaction , G3 : MTA+5 % CaCl2-manual compaction , G4 : MTA-ultrasonic activation , G5 : Biodentine-ultrasonic activation , G6 : MTA+5 % CaCl2-ultrasonic activation . The push-out bond strengths were measured using an Instron testing machine . Data were analyzed using twoway analysis of variance ( ANOVA ) with Bonferroni correction . The ultrasonic activation significantly enhanced the bond strength values of the material s. Biodentine presented higher bond strength values than that of MTA groups . The addition of CaCl2 to MTA did not improve the bond strength of the material",
"INTRODUCTION The aim of this study was to evaluate the effect of a range of alkaline pH values on the push-out strength of white mineral trioxide aggregate ( WMTA ) . METHODS The st and ardized lumens of root slices prepared from extracted single-rooted human teeth were filled with white ProRoot MTA . The specimens were then r and omly divided into 4 groups ( n = 20 ) and wrapped in pieces of gauze soaked in synthetic tissue fluid ( STF ) ( pH , 7.4 ) and STF buffered in potassium hydroxide at pH values of 8.4 , 9.4 , or 10.4 . The sample s were incubated for 3 days at 37 ° C . The push-out bond strengths were then measured by using a universal testing machine . Failure modes after the push-out test were examined under a light microscope at ×40 magnification . The data were analyzed by using one-way analysis of variance and Tukey post hoc tests . RESULTS The greatest ( 9.46 ± 0.63 MPa ) and lowest ( 5.68 ± 0.83 MPa ) mean push-out bond strengths were observed after exposure to pH values of 8.4 and 10.4 , respectively . There were significant differences between the groups ( P = .001 ) . The bond failure was adhesive for all experimental groups . CONCLUSIONS Push-out bond strength of WMTA could be influenced by different alkaline pH values",
"The bond strength of ActiV GP root canal filling system and gutta-percha/AH plus sealer when used after final rinse with different irrigation protocol s was evaluated in this study . Forty roots were r and omly divided into four groups ( n = 10 ) according to the final irrigation regimen : group 1 , 5 mL 17 % EDTA ; group 2 , 5 mL 17 % EDTA followed by 5 mL 2 % chlorhexidine gluconate ( CHX ) ; group 3 , 5 mL MTAD ; and group 4 , 5 mL MTAD followed by 5 mL 2 % CHX . Each group was further subdivided into two subgroups ( n = 5 ) : in subgroup a , the root canals were filled using warm gutta-percha and AH plus sealer , and in subgroup b , the root canals were filled using the ActiV GP obturation system . Two-millimeter thick horizontal sections from the coronal and midthirds of each root were sliced for the push-out bond strength measurement . EDTA/CHX/ActiV GP ( 2.46 + /- 1.02 MPa ) yielded significantly the highest mean bond strength value . The significantly lowest bond strength was recorded for EDTA/ActiV GP ( 1.12 + /- 0.72 MPa ) . It was concluded that the bond strength of ActiV GP was improved by using 2 % CHX in the final irrigation after 17 % EDTA , whereas CHX did not enhance the effect of MTAD on the bond strength of the material . The bond strength of gutta-percha/AH plus was adversely affected by MTAD and MTAD/CHX",
"Background The aim of this in vitro study was to examine and compare the effect of photodynamic therapy and solution containing nano particles Ag/ZnO on adhesion of endodontic sealers to dentinal walls of human root canal . Material and Methods Ninty single-rooted human teeth were selected and their clinical crown was cut from the cemento-enamel junction zone . Canals were prepared by RaCe rotary system and the smear layer was removed using 17 % EDTA and 5.25 % NaOCl . Sample s were r and omly divided into two groups of AH Plus and MTA Fillapex based on the sealer type and each group based on antimicrobial method was divided into two sub-groups of photodynamic therapy and polymer containing nano particles of Ag / ZnO and a control sub-group ( N = 15 ) . After obturation of canals with gutta-percha and sealers mentioned , the sample s were incubated for a week at a humidity of 95 % and 37 ° C and then 2 mm thick discs were prepared from the middle region of roots for Push-out test . The maximum failure force was recorded in newton and converted to MPa . Then , 3 r and om specimens of each subgroup were evaluated by scanning electron microscopy . Statistical analysis was performed by Two way ANOVA and ( P 1.63 ) and lowest ( 0.16 ± 0.075 ) push-out bond strength values were obtained in ( AH Plus-PDT ) and ( MTA Fillapex-Ag/ZnO ) respectively . Independent of antimicrobial method , AH Plus bond strength was significantly higher than the MTA Fillapex ( p , PDT increased the bond strength significantly ( p Conclusions Photodynamic therapy has a positive effect on the bond strength of AH Plus and MTA Fillapex sealers . Key words : AH Plus , MTA Fillapex , Nano particles , Photodynamic therapy , Push-out",
"INTRODUCTION The aim of this study was to evaluate the bond strength of various root canal sealers after various irrigation solutions and Er : YAG laser irradiation were used on root canal dentin . METHODS One hundred fifty freshly extracted human maxillary single-rooted teeth were used in this study . Teeth were sectioned transversally 4 mm below the cementoenamel junction . The root canal of each specimen was prepared using a tapered bur . Teeth were divided into 3 main groups by sealer ( AH Plus Jet [ Dentsply DeTrey , Konstanz , Germany ] , EndoSequence BC Sealer [ Brasseler , Savannah , GA ] , and Real Seal [ SybronEndo , Orange , CA ] ) and then divided into 5 subgroups by dentin treatment ( distilled water , calcium hydroxide , sodium hypochlorite , EDTA , and Er : YAG laser ) . The specimens were placed immediately at 37 ° C and 100 % humidity for 1 week . Then , the push-out test was applied . The maximum failure load was recorded in newtons and was used to calculate the push-out bond strength in MPa . Then , 3 r and om specimens from each group were examined under scanning electron microscopy . RESULTS The resin root canal sealers had higher push-out bond strength than the bioceramic sealer , and the differences were statistically significant ( P The EDTA and Er : YAG laser applications removed the smear layer and increased the bond strength . The highest adhesion was observed in EDTA groups when each sealer was evaluated in itself . CONCLUSIONS The bonding strength of root canal sealers is influenced by their properties and various dentin surface treatments . The scanning electron microscopic study showed that although the dentinal tubules were open , at the profile examination the sealers did not penetrate into the dentin canals in all specimens",
"Aim To evaluate the push-out bond strength of MTA Fillapex ( Angelus ) and compare it with ProRoot MTA ( Dentsply ) and AH Plus ( Dentsply ) . Design Thirty extracted single-rooted teeth were selected and prepared using a rotary system . The sample s were divided r and omly into three groups ( n = 10 ) and obturated , respectively , with : ( 1 ) AH Plus + gutta-percha ( DiaDent ) ; ( 2 ) MTA Fillapex + gutta-percha ; ( 3 ) ProRoot MTA . Each root was sectioned into 1-mm-thick slices and 30 sample s for each group were obtained . The sample s were subjected to push-out test . Failure modes were examined under 30 × magnification . The results were analysed statistically by one-way ANOVA and Tukey ’s test . Results Mean push-out bond strength values were ranked as follows : ProRoot MTA > AH Plus > MTA Fillapex . Statistically significant differences were found among all groups ( p Conclusion ProRoot MTA had the highest bond strength , whilst MTA Fillapex displayed the lowest values among the groups",
"Introduction : This in vitro study investigated the effect of adding 10 % calcium chloride ( CaCl2 ) on push out bond strength of calcium-enriched mixture ( CEM ) cement and mineral trioxide aggregate ( MTA ) to root canal dentin . Methods and Material s : A total of 120 root dentin slices with 2 mm thickness were prepared from sixty single-rooted human teeth . Dentinal discs were enlarged to achieve 1.3 mm diameter . The specimens were r and omly allocated into eight groups ( n=15 ) . Dentin discs were filled with either CEM cement or MTA with or without CaCl2 and the push out test was performed after 3 and 21 days . Data were analyzed with two-way ANOVA test . The level of significance was set at 0.05 . Results : There was an interaction effect amongst all groups ( P=0.028 ) . After 3 days , CEM cement showed a significantly lower bond strength than other groups ( P bond strength than CEM cement with or without CaCl2 ( P=0.001 ) . After 21 days , CEM cement with or without CaCl2 had no significant difference with other groups ( P>0.05 ) . However , the bond strength of MTA decreased when CaCl2 was added ( P=0.011 ) . Conclusion : The addition of 10 % CaCl2 increased the push out bond strength of CEM cement and improved it over time ; while , this substance aggravated this property for MTA",
"Background Proper bond strength to dentin is one of the properties of bio material s used for therapeutic purpose s such as repair of furcal perforations . The aim of the present study to evaluate the effects of different powder to liquid ratios of Calcium-enriched mixture ( CEM ) on the push-out bond strengths in simulated perforations in the furcal area and compare it with Mineral trioxide aggregate ( MTA ) . Material and Methods Furcal perforations , measuring 1.3 mm in diameter and 2 mm in height , were prepared in 120 m and ibular first molars . Then the sample s were r and omly assigned to two groups ( n=60 ) . MTA and CEM cement were used for the repair of perforations in groups 1 and 2 , respectively . Each group was divided into 3 subgroups based on the powder to liquid rations as follows : subgroup 1 ( W/P ) , 1:2 ; subgroup 2 , 1:3 ; and subgroup 3 , 1:4 . After mixing and placing the material s in the perforation area , the sample s were placed in closed containers at 37 ° C and 100 % relative humidity for one week . A universal testing machine was used to determine the bond strength values . After recording the st and ard deviations , data were analyzed with two-way ANOVA . Statistical significance was set at P MTA and CEM groups the highest push-out bond strength values were recorded in the third ( W/P : 1:4 ) and first ( W/P : 1:2 ) subgroups , respectively . There were significant differences in both groups between the ratios mentioned above and the other ratios ( P<0.05 ) . Conclusions Under the limitations of the present study , an increase in the powder-to-liquid ratio in CEM cement result ed in a decrease in bond strength , contrary to MTA . Key words : CEM , Perforation , Powder-to-liquid ratio , push-out bond strength , MTA",
"INTRODUCTION To analyze the push-out bond strength of Angelus WMTA ( Angelus Dental Products ) , a nano-modification of WMTA ( Kamal Asgar Research Center ) and Bioaggregate ( Innovative Bioceramix ) . METHODS Sixty 2-mm-thick root sections were prepared from 60 single-rooted human teeth . The dentin disks were r and omly divided into three groups ( n = 20 ) and filled with Angelus WMTA , Nano-WMTA , or Bioaggregate , respectively . Push-out bond strength values of the specimens were measured by a universal testing machine and examined under scanning electron microscope at × 40 magnification to determine the nature of the bond failure . The data were analyzed with a Kruskal-Wallis test . RESULTS The greatest mean for push-out bond strength ( 138.48 ± 11.43 MPa ) was observed for the nano-modification of WMTA . The values decreased to 110.73 ± 11.19 and 25.64 ± 5.27 MPa for Angelus WMTA and Bioaggregate , respectively . There were significant differences between the groups ( P cohesive failures . CONCLUSIONS It is concluded that the force needed for the displacement of the nano-modification of WMTA ( NWMTA ) was significantly higher than for Angelus WMTA and Bioaggregate",
"OBJECTIVE To evaluate the push-out bond strength of Biodentine ( BD ) in comparison with two available calcium silicate based material s , bioaggregate ( BA ) and ProRoot MTA ( WMTA ) . MATERIAL S AND METHODS One hundred and twenty-three Root dentin slices of freshly extracted single Rooted human teeth were r and omly divided into three groups ( n = 41 ) according to the used test material : WMTA , BA , BD . After canal space preparation , the filling material s were placed inside the lumen of the slices . After 72 hours , the maximum force applied to material s at the time of dislodgement was recorded and slices were then examined under a stereomicroscope at ×40 magnification to determine the nature of bond failure . Analysis of variance ( ANOVA ) test was used to compare means of push-out bond strength . Post-hoc test was then accomplished for multiple comparisons . Chi-square test was used to determine if there is significant association between the type of material and type of failure . RESULTS The mean push-out bond strength ± st and ard deviation in MPa values of WMTA , BA and BD were 23.26 ± 5.49 , 9.57 ± 3.45 , 21.86 ± 6.9 , respectively . There was no significant difference between the means of WMTA and BD ( p = 0.566 ) , but the mean of BA was significantly lower than those of WMTA and BD ( p = 0.000 ) . Under stereomicroscope , WMTA and BA showed a majority of mixed type of failure than cohesive failure , while BD showed the opposite . No adhesive failure was observed in any specimen . CONCLUSION The findings of the present study imply that the force needed for BD displacement is similar to WMTA and significantly higher than the force required to displace BA",
"The aim of this study was to evaluate the influence of tooth bleaching on the push-out bond strength of a composite resin based on dimethacrylates and silorane to cavities that involve both enamel and dentin . A total of 80 bovine incisors were sectioned on the buccal surface to obtain specimens ( 10 × 10 mm ) presenting enamel and dentin ( 1-mm thick each substrate ) . The specimens were r and omly distributed into eight groups ( n=10 ) , according to the bleaching protocol ( 1 - -none ; 2 - -10 % carbamide peroxide [ CP ] for 21 days , six hours each day ; 3 - -three applications of 35 % hydrogen peroxide [ HP ] in 15-minute sessions , one session every seven days for three weeks ; 4 - -10 % CP for 18 days , six hours each day + three applications of 35 % HP in 15-minute sessions , one session every seven days for three weeks ) and the restorative system applied ( Adper Single Bond 2 + Filtek Supreme ; Filtek Silorane adhesive and composite resin ) . After treatment , cavities were made ( 1.2-mm diameter on dentin ; 1.5-mm diameter on enamel ) with a diamond bur . At 24 hours after restoration , a push-out bond strength test was performed at a crosshead speed of 0.5 mm/min . The bleaching treatments did not significantly affect the bond strengths of either restorative system to enamel-dentin . Regardless of the bleaching treatment , the dimethacrylate-based resin system exhibited significantly higher bond strengths to enamel-dentin than did the silorane-based system ",
"INTRODUCTION Recently , it was shown that the biomineralization process promoted by the interaction of mineral trioxide aggregate ( MTA ) with dentin in phosphate-buffered saline ( PBS ) positively influenced the push-out bond strength of the cement . This study investigated if the use of a PBS intracanal dressing promotes the biomineralization process of MTA apical plugs using an ex vivo apexification model . METHODS White MTA was introduced into single-rooted teeth with st and ardized artificially created open apices to form 5-mm-thick apical plugs . The specimens were r and omly divided into the following three groups of 10 sample s each : group 1 : the remaining canal space was filled with PBS as an intracanal dressing ; group 2 : the root segments were introduced in plastic vials containing floral foams with 20 mL of PBS ; and group 3 : the root segments were placed in the floral foams with 20 mL of PBS and a PBS intracanal dressing was used . After 2 months , the sample s were processed for scanning electron microscopic observations . Data were analyzed by using the Kruskall-Wallis test . RESULTS In group 1 , the formation of an interfacial layer ( IL ) with intratubular mineralization ( ITM ) was more evident at the cervical third ; however , no mineralization was revealed at the apical third . In group 2 , there was no IL and /or ITM formation at the cervical third , but sample s denoted IL and ITM formation at the apical third . Group 3 displayed the formation of IL and ITM at the different levels . CONCLUSION It was concluded that the use of a PBS intracanal dressing promotes the biomineralization process at the inner side of MTA apical plugs",
"This study evaluated the retention characteristics of ProRoot mineral trioxide aggregate ( MTA ) , RetroMTA , Supra MTA , and Biodentine bio material s used to repair furcation perforations contaminated with blood . Furcal perforations measuring 1.3 mm in diameter and 2 mm in height were created in 96 m and ibular first molar teeth , which were then r and omly divided into the following two groups ( n = 48 ) : contaminated ( + ) or non-contaminated ( - ) with blood . The groups were subdivided into four groups ( n = 12 ) according to the material used ( ProRoot MTA , RetroMTA , Supra MTA , and Biodentine ) to seal the perforations . The sample s were allowed to set for 14 days and were then subjected to push-out testing . The results were analyzed using ANOVA , and the failure modes were examined using a surgical microscope . ProRoot MTA ( + /- ) and RetroMTA ( + /- ) exhibited superior bond strength values ; in addition , there were no significant differences among these groups ( P > 0.05 ) . Biodentine ( + ) showed intermediate values that were sometimes statistically similar to the ProRoot MTA ( + /- ) and RetroMTA ( + /- ) groups ( P > 0.05 ) and , at other times , the Biodentine ( - ) and Supra MTA ( + /- ) groups ( P > 0.05 ) . The lowest bond strength values were shown by the Biodentine ( - ) and Supra MTA groups ( P > 0.05 ) . \" Adhesive failure mode \" was the most frequently observed type for all tested material s. Blood contamination did not affect the dislocation resistance of material",
"The aim of this study was to evaluate the influence of drying protocol s ( DP ) on the apical sealing ( AS ) and on the bond strength ( BS ) of teeth filled with different sealers . The root canals of one hundred and fifty-six roots of maxillary canines were prepared with Reciproc rotary files ( R50 ) . The teeth were r and omly divided into four groups ( n = 39 ) , according to the DP : GI-paper points ; GII-70 % isopropyl alcohol + aspiration with NaviTip points ; GIII-95 % ethanol + paper points ; GIV-EndoVac + paper points . Each group was divided into subgroups , according to the sealer used : AH Plus , Sealapex and MTA Fillapex , using a single-cone technique . Evaluation of AS and BS was performed with fluid filtration ( FF ) and push-out ( PO ) methods , respectively . The PO test consisted of sectioning the roots , and subjecting a single slice from each third to testing and analysis for failure type . The data was su bmi tted to two-way and three-way variance analysis ( ANOVA ) and Tukey ( α = 5 % ) . The AS showed no drying protocol influence . The FF results revealed a statistically significant difference between MTA and Sealapex ( p The BS test values showed that there was no statistical significant difference among the canal thirds ( p > 0.05 ) , but that there was such a difference among the sealers ( p highest BS values among the sealers ; the highest BS results for the sealers occurred with the specimens used with isopropyl alcohol , compared with ethanol and EndoVac",
"INTRODUCTION The aim of this study was to evaluate the effect of calcium hydroxide ( CH ) and antibiotic pastes , including a mixture of metronidazole and ciprofloxacin , with and without minocycline or cefaclor , on the dislocation resistance of mineral trioxide aggregate ( MTA ) to root dentin . METHODS Eighty single-rooted human m and ibular premolars were selected . The teeth were prepared by using the ProTaper system . The prepared teeth were then instrumented to a # 6 Peeso reamer to obtain a st and ard internal diameter of 1.5 mm . The reamers were passed 1 mm beyond apex to simulate immature teeth . The specimens were then r and omly divided into a control group ( no intracanal medicament was used ) and 4 experimental groups that were treated with an intracanal medicament : CH , double antibiotic paste ( DAP ) with metronidazole and ciprofloxacin , triple antibiotic paste ( TAP ) with minocycline , or TAP with cefaclor ( n = 16 ) . After 3 weeks , the medicaments were removed , and approximately 3 mm of MTA was placed in the coronal third of the canals . A push-out test was used to measure the dislocation resistance between the root dentin and MTA . Data were analyzed by using one-way analysis of variance and Tukey post hoc tests . RESULTS The dislocation resistance values of the CH , TAP with minocycline , and TAP with cefaclor groups were similar to those of the control group ( P > .05 ) , whereas the DAP group had the lowest dislocation resistance when compared with the other groups ( P cohesive failures between root dentin and MTA . CONCLUSIONS The results of this study indicate that the application of DAP as an intracanal medicament reduced the dislocation resistance of MTA to root dentin",
"Objectives The objective of this study was to evaluate the bond strength of three root-end filling material s ( MTAA – MTA Angelus , MTAS – experimental MTA Sealer , and ZOE- zinc oxide and eugenol cement ) in retro grade preparations performed with different ultrasonic tips ( CVD , Trinity , and Satelec ) . Material s and method Ninety 2-mm root sections from single-rooted human teeth were used . The retro grade cavities were prepared by using the ultrasonic tips , coupled to a device for position st and ardization . The specimens were r and omly divided into nine groups : CVD MTAA ; CVD MTAS ; CVD ZOE ; Trinity MTAA ; Trinity MTAS ; Trinity ZOE ; Satelec MTAA ; Satelec MTAS ; Satelec ZOE . Each resin disc/dentin/root-end filling material was placed in the machine to perform the push-out test . The specimens were examined in a stereomicroscope to evaluate the type of failure . Data were su bmi tted to statistical analysis using ANOVA and Tukey tests ( α = 0.05 ) . Results The highest bond strength was observed for the CVD tip irrespective of the material used ( P 0.05 ) . MTAA and MTAS showed highest bond strength . The most common type of failure was adhesion between the filling material and dentin wall , except for ZOE , where mixed failure was predominant . Conclusions The CVD tip favored higher bond strength of the root-end filling material s. MTA Angelus and experimental MTAS presented bond strength to dentin prepared with ultrasonic tips . Clinical relevance Root-end preparation with the CVD tip positively influences the bond strength of root-end filling material s. MTA Angelus and experimental MTAS present bond strength to be used as root-end filling material",
"This study compared the push-out bond strength of mineral trioxide aggregate ( MTA ) and a new endodontic cement ( NEC ) as root-end filling material s in root-end cavities prepared by ultrasonic technique ( US ) or Er , Cr : YSGG laser ( L ) . Eighty single-rooted extracted human teeth were endodontically treated , apicectomised and r and omly divided into four following groups ( n = 20 ) : US/MTA , US/NEC , L/MTA and L/NEC . In US/MTA and US/NEC groups , root-end cavities were prepared with ultrasonic retrotip and filled with MTA and NEC , respectively . In L/MTA and L/NEC groups , root-end cavities were prepared using Er , Cr : YSGG laser and filled with MTA and NEC , respectively . Each root was cut apically to create a 2 mm-thick root slice for measurement of bond strength using a universal testing machine . Then , all slices were examined to determine the mode of bond failure . Data were analysed using two-way anova . Root-end filling material s showed significantly higher bond strength in root-end cavities prepared using ultrasonic technique ( US/MTA and US/NEC ) ( P bond strengths of MTA and NEC did not differ significantly . The failure modes were mainly adhesive for MTA , but cohesive for NEC . In conclusion , bond strengths of MTA and NEC to root-end cavities were comparable and higher in ultrasonically prepared cavities",
"AIM To characterize an experimental gutta-percha and niobium phosphate glass composite ( GNB ) applied with a thermoplastic technique to the root canals without sealer in a moist environment and to evaluate its micropush-out bond strength to root canal wall dentine . METHODOLOGY The root canals of sixty human m and ibular pre-molars were prepared using rotary NiTi instruments and irrigation with sodium hypochlorite and EDTA . The teeth were then r and omly divided into three groups according to the root filling material used : AH plus sealer and gutta-percha ( AH ) , EndoSequence BC gutta-percha without sealer ( GBC ) , and GNB without sealer . The root canals were filled with a single cone using warm vertical condensation . Push-out bond strengths associated with the filling material s in slices from middle root thirds was determined 30 days after root filling . The failure mode was analyzed with SEM . Analysis using EDX and SEM-EDS was carried out to verify the composition and distribution of the particles of the tested material s. Data were statistically analyzed by one-way anova and Tukey 's test ( P GNB groups had bond strengths of 2.83 ± 0.64 MPa and 2.68 ± 0.84 MPa , respectively , with no significant difference between them ( P > 0.05 ) . The GBC group had the lowest mean bond strength ( 1.34 ± 0.42 MPa ) , which was significantly different compared with the other groups ( P . Cohesive failures prevailed in the AH group , whereas failures were mixed in the GBC and GNB groups . The SEM-EDS analysis on the surface and in the bulk of GBC revealed only a superficial coating of bioceramic particles . Glass particles were detected both on the surface and in the bulk of GNB . CONCLUSIONS The experimental root filling composite ( GNB ) had an ability to adhere to root canal wall dentine equal to the current gold st and ard root filling with gutta-percha and sealer ( AH Plus )",
"The purpose of this study was to compare the micropush-out bond strength of Resilon to that of gutta-percha . Extracted human anterior teeth were used for evaluation . The crowns were removed and the root canals were instrumented with Gates Glidden drills and 0.06 Profile rotary files . Instrumentation was performed with 5.25 % sodium hypochlorite irrigation and a final rinse of 17 % EDTA . The teeth were r and omly divided into two groups . Gutta-percha group : obturation with gutta-percha and Kerr Pulp Canal Sealer EWT . Resilon group : obturation with Resilon points , Epiphany Primer , and Root Canal Sealant . The teeth were cut perpendicular to their long axis to obtain a series of 1.0 mm thick disks ( n = 15 per group ) . Micropush-out bond strengths to root canal dentin were measured . The results show that the mean bond strength to root canal dentin was significantly higher ( p Resilon/Epiphany group as compared to the gutta-percha/Kerr Pulp Canal Sealer EWT group",
"This study aim ed to investigate the effect of epigallocatechin-3-gallate ( EGCG ) from green tea extract on the push out bond strength of an epoxy resin sealer to root dentin . Seventy single root canal premolars were decoronated and instrumented . The roots were r and omly irrigated with different final irrigation protocol s ( n=16 ) : 17%EDTA ( EDTA ) , 17%EDTA followed by 2.5%NaOCl ( EDTA+NaOCl ) , 17%EDTA followed by 1 mg/mL EGCG ( EDTA+EGCG ) and 1 mg/mL EGCG ( EGCG ) . Other six root canals were received only 2.5%NaOCl as a control group . One root from each group ( n=1 ) was excluded and prepared for SEM investigation . All root canals were then obturated and horizontally sectioned to perform the push out test . EDTA+EGCG group had the highest bond strength ( p EGCG group showed higher bond strength than EDTA group ( p EGCG as a final irrigant significantly increased the push out bond strength of an epoxy resin sealer to root dentin ",
"INTRODUCTION The aim of this study was to evaluate the effect of smear layer removal on the push-out bond strength between radicular dentin and three calcium silicate cements ( CSC ) in comparison with gutta percha and sealer . METHODS Eighty human anterior extracted teeth were decoronated , cleaned and shaped to size 50/0.05 apically and r and omly divided into 2 major groups : ( A ) smear layer preserved , and ( B ) smear layer removed using irrigation with 17 % EDTA . Roots within each major group were further divided into 4 subgroups according to the obturation material used : ( 1 ) ProRoot MTA , ( 2 ) Biodentine , ( 3 ) Harvard MTA , ( 4 ) Gutta percha and AH-plus sealer . Obturated roots were stored in synthetic tissue fluid for 7 days to allow maximum setting of the root filling material s. Three 2-mm-thick slices were obtained from each root at different section levels ( coronal , middle , apical ) . The canal diameters and slice thickness were measured , and the adhesion surface area for each slice was calculated . Push-out bond strength test was carried out using a universal testing machine . The bond failure mode was assessed under an optical microscope at 40 × . RESULTS The mean push-out bond strength in groups 1A , 2A and 3A were 7.54 ( ±1.11 ) , 7.64 ( ±1.08 ) and 8.79 (±1.55)MPa respectively , while those for groups 1B , 2B and 3B were 6.58 ( ±1.13 ) , 6.47 ( ±1.08 ) , 7.71 (±1.81)MPa , respectively . In the gutta percha and sealer groups the push-out bond strength means were : 1.98 ( ±0.48 ) and 2.09 (±0.51)MPa in the preserved and removed smear layer groups respectively . The push-out strength values were significantly reduced when the smear layer was removed in the CSC groups ( P<0.05 ) while no significant difference was detected in the gutta percha and sealer groups . CONCLUSIONS Based on the conditions of this ex vivo study , it can be concluded that smear layer removal is detrimental to the bond strength between calcium silicate cements and dentin",
"AIM To assess the push-out bond strength of two new calcium silicate-based endodontic sealers in the root canals of extracted teeth . METHODOLOGY Thirty extracted single-rooted central incisors of similar sizes were selected r and omly and distributed to three groups ( n = 10 ) . All canals were instrumented using ProTaper rotary instruments to achieve tapered canal walls . Irrigation was performed using 5 mL 2.5 % NaOCl between each instrument , and the smear layer was removed using 5 mL 17 % EDTA . The canals were filled with three different sealers using a cold lateral compaction technique : group 1 : AH Plus + gutta-percha , group 2 : I Root SP + gutta-percha and group 3 : MTA Fillapex + gutta-percha . Three horizontal sections were prepared at a thickness of 1 mm ± 0.1 in the apical , middle and coronal parts of each root . The test specimens were subjected to the push-out test method using a Universal Test Machine ( Instron , Canton , MA , USA ) that carried 1-mm , 0.5-mm and 0.3-mm plungers for coronal , middle and apical specimens , respectively . The loading speed was 1 mm min(-1 ) . The push-out data were analysed by two-way analysis of variance ( anova ) and the post hoc Holm-Sidak test , with significance set at P was no significant difference between the sealers . In the middle and apical segments , there was no significant difference between I Root SP and AH Plus groups . However , the I Root SP and AH Plus had significantly higher bond strength values than the MTA Fillapex ( P , the bond strengths in the middle specimens and the apical specimens were higher compared with the bond strengths in the coronal specimens ( P differences between the bond strengths in the middle and apical specimens . CONCLUSION MTA Fillapex had the lowest push-out bond values to root dentine compared with other sealers",
"AIM The aim of the study was to evaluate the regional push-out bond strength of mineral trioxide aggregate ( MTA ) after exposure to sodium hypochlorite ( NaOCl ) , ethylenediaminetetraacetic ( EDTA ) , and peracetic acid ( PAA ) irrigation solutions . MATERIAL S AND METHODS 1-mm-thick longitudinal slabs of root dentin were obtained from freshly extracted human canine teeth ( n = 80 ) . Simulated root perforation defects , 1 mm in diameter , were prepared in the coronal , middle , and apical thirds of radicular dentin . Mineral trioxide aggregate was placed into the cavities , and the specimens were stored for 1 week at 37 ° C . Thereafter , the specimens were r and omly divided into four groups ( n = 20 ) according to the irrigation solution applied over the repair sites : Group 1 - 10 ml of 5.25 % NaOCl for 10 min ; Group 2 - 10 ml of 5.25 % NaOCl for 10 min , followed by 5 ml 17 % EDTA for 5 min ; Group 3 - 10 ml of 5.25 % NaOCl for 10 min , followed by application of 5 ml 1 % PAA for 5 min ; and Group 4-no irrigation . Push-out test was performed at a crosshead speed of 1 mm/min . Debonding values were compared statistically using two-way analysis of variance and Tukey tests ( P The push-out bond strength of MTA was not affected by the type of irrigation solution or location of the perforation defects ( both P the bond failure was predominantly adhesive . CONCLUSION Exposure of repaired root perforations to 5.25 % NaOCl , 17 % EDTA , or 1 % PAA does not alter the dislocation resistance of MTA at different locations of root dentin",
"This study evaluated the bond strength of mineral trioxide aggregate ( MTA ) to root canal dentin after the performance of various irrigation procedures to remove triple antibiotic paste ( TAP ) . A total of 56 single-rooted human m and ibular premolars were instrumented using a rotary system to size 40 and divided r and omly into a control group ( no intracanal dressing ) and three experimental groups ( TAP application for 28 days ) . TAP was then removed by rinsing with 10 mL 2.5 % NaOCl using three irrigation systems ( Vibringe sonic irrigation , CanalBrush , and syringe irrigation ) . The coronal and middle parts of root canals were then obturated with MTA . After storage for 1 week , each specimen was embedded in an acrylic block and sectioned horizontally ( 2-mm-thick slices ) at two levels ( coronal and middle ) . Bond strength of MTA to root canal dentin was assessed in 28 sample s per group via push-out test using a universal testing machine . Data from the four groups were compared using one-way analysis of variance . Tukey 's test was used for multiple comparisons . Push-out bond strength values were significantly higher in the control and Vibringe groups than in the CanalBrush and syringe irrigation groups ( p Vibringe irrigation system may increase the push-out bond strength of MTA compared with the use of the CanalBrush or syringe irrigation",
"The purpose of this in vitro study was to compare the bond strength of various obturation material s to root canal dentin by using a push-out test design . Twenty-five single-rooted extracted human teeth were used in this study . The crowns were removed , and root canal instrumentation was completed by using Endogel-coated 0.06 EndoSequence rotary files ( Brasseler , Savannah , GA ) and appropriate irrigation with 5.25 % NaOCl and a final rinse with 17 % EDTA . After instrumentation , the roots were r and omly divided into five single-matched cone obturation groups ( n = 5 roots/group ) , as follows : group 1 , gutta percha with Kerr EWT ( Kerr Corp , Romulus , MI ) ; group 2 , gutta percha with AH Plus ( Dentsply , DeTrey , Germany ) ; group 3 , Resilon ( Pentron Clinical Technologies , Wallingford , CT ) and Epiphany ( Pentron ) ; group 4 , Activ GP ( Brasseler ) obturation system ; and group 5 , EndoREZ obturation system ( Ultradent , South Jordan , UT ) . The obturated roots were cut perpendicular to the long access to create 1-mm thick slices from the apical , middle , and coronal thirds . The bond strength was measured for each test slice with a push-out testing machine . Statistical analysis was completed by using a two-way analysis of variance and the post hoc Tukeys test with significance set at p bond strength compared with all other groups . Also , groups 1 and 4 had significantly ( p bond strengths compared with groups 3 and 5",
"OBJECTIVE The aim was to evaluate the influence of Er , Cr : YSGG laser irradiation associated with different final irrigation protocol s on the bond strength of epoxy resin-based root canal sealer to root dentin , on the dentin/filling material interface and in the temperature variation during irradiation . METHODOLOGY Ninety-six maxillary canines were prepared with K3 rotary system up to # 45/0.02 instrument , irrigating with distilled water between files . The specimens were r and omly assigned to three groups-final irrigation ( distilled water , 1 % NaOCl , and 17 % EDTAC ) and four subgroups ( n = 8)-laser parameters ( non-irradiated , 2 W/20 Hz , 3 W/20 Hz , and 4 W/20 Hz ) . During irradiation , the temperatures were measured on the outer root dentin wall in the three thirds , and root apex . Canals were filled with lateral condensation of AHPlus sealer and gutta-percha cones . Two slices from each third were su bmi tted to a push-out test in Instron machine and the failure mode was analyzed . One slice from each third was analyzed by confocal laser microscopy to evaluate the percentage of the perimeter of the root canal cross-section with sealer tags and depth of tags . Data were analyzed by ANOVA , Kruskal-Wallis , and Tukey 's tests ( P RESULTS Er , Cr : YSGG laser irradiation increased sealer bond strength to dentin , regardless of the final irrigation . The highest values were obtained for 3 W ( 4.02 ± 1.32 ) and 4 W ( 4.18 ± 0.98 ) powers and different from the non-irradiated group ( 2.64 ± 0.58 ) ( P higher bond strength ( 4.01 ± 1.02 ) compared with distilled water ( 3.11 ± 1.09 ) and 1 % NaOCl ( 3.47 ± 1.18 ) ( P significantly higher bond strength than the apical third ( 3.04 ± 0.89 ) . There was a greater percentage of adhesive and mixed failure . In the groups irradiated with 3 W [ 21.1 ( 14.1 - 27.7 ) ] and 4 W [ 17.8 ( 11.9 - 23.7 ) ] , a greater depth of filling material tags was observed compared with the non-irradiated group [ 12.9 ( 9.0 - 20.0 ) ] . The greatest percentage of canal perimeter with sealer tags was observed in the irradiated groups , with no difference among them ( P > 0.05 ) . The temperature rise was proportional to the increase of laser power . CONCLUSIONS Er , Cr : YSGG laser irradiation increased the bond strength of an epoxy resin-based sealer to root dentin , with greater formation of sealer tags for all tested powers , especially when combined with 17 % EDTAC final irrigation ; temperature rise during irradiation remained below the critical threshold biologically accepted . Lasers Surg . Med . 48:985 - 994 , 2016 . © 2016 Wiley Periodicals ,",
"OBJECTIVES The aim of this study was to evaluate the effect of photon induced photoacoustic streaming ( PIPS ) technique in combination with EDTA on bond strength of gutta-percha/AH Plus and Resilon/RealSeal SE root canal fillings to root dentine . MATERIAL S AND METHODS Forty freshly extracted human maxillary anterior teeth with intact straight roots , were instrumented endodontically with rotating ProTaper instruments and r and omly divided into two experimental groups . In group 1 ( n = 20 ) , root canals were rinsed for 1 minute with 2 ml of 17 % EDTA . In group 2 ( n = 20 ) , Er : YAG laser , with a 14 mm long 400 μ diameter tapered PIPS tip , was used for 1 minute with 2 ml of 17 % EDTA . The laser parameters used were : 20 mJ per pulse , 15 Hz , 50 microsecond . In each experimental group , half of the root canals ( n = 10 ) were obturated with gutta-percha/AH Plus and other half ( n = 10 ) with Resilon/RealSeal SE . A micropush-out test was performed on sectiond specimens of the filled roots using a universal testing machine and resistance to failure plus failure modes were determined . RESULTS Both gutta-percha/AH Plus groups had higher bond strength to root dentin than the Resilon/RealSeal SE groups ( P bond strength of either gutta-percha/AH Plus , or Resilon/RealSeal SE ( P > 0.05 ) . CONCLUSION Within the limitations of this study , it was found that the application of the PIPS technique did not have an affect on the push-out bond strength of Resilon/RealSeal SE root canal filling to dentin nor on the gutta-percha/AH Plus . A significant difference in bond strength was noted between the two root canal filling material s. Lasers Surg . Med . 48:951 - 954 , 2016 . © 2016 Wiley Periodicals ,",
"AIM To compare the push-out bond strength exhibited by root fillings performed with either C-Point and Endosequence ® BC sealer ™ ( BC Sealer ) or gutta-percha and AH Plus ® after the instrumentation of oval canals with either the Self-Adjusting File ( SAF ) System or WaveOne ( WO ) reciprocating file . METHODOLOGY Eighty extracted premolars were selected and divided r and omly into the following four groups ( n = 20 ) : group 1 , SAF instrumentation and filling using gutta-percha and AH Plus sealer ; group 2 , SAF instrumentation and C-Point and BC sealer filling ; group 3 , WO instrumentation and filling using gutta-percha and AH Plus sealer ; and group 4 , WO instrumentation and filling with C-Point and BC sealer . Sodium hypochlorite ( 5.25 % ) and EDTA ( 17 % ) were used as irrigants for all groups . After the sealer was set completely , the teeth were prepared for micro push-out assessment using 1.0-mm-thick root slices . Loading was performed with a universal testing machine at a speed of 0.5 mm min(-1 ) . Two-way anova and Student 's t-test for pairwise comparisons were used to compare groups . RESULTS All specimens filled with C-Point and BC sealer were associated with significantly higher push-out bond strength compared with gutta-percha and AH Plus sealer ( P ) . The bond strength was higher for the coronal and apical sample s of the C-Point/BC sealer/SAF group ( 6.6 ± 0.3 and 3.2 ± 0.3 MPa ) versus those of the gutta-percha/AH Plus/WO group ( 4.8 ± 0.3 and 1.8 ± 0.3 MPa ) , by 38 % and by 80 % in the coronal and apical parts , respectively ( P P 0.0001 ) . Adhesive bond failure was more common in the WaveOne-instrumented group in general and in the buccal and lingual recesses in this group in particular . CONCLUSIONS In oval canals , the instrument used and the root filling material significantly affected the push-out values of root fillings . The highest value was recorded in oval root canals instrumented with the SAF System and filled with C-Point and BC sealer , whereas the lowest strength was noted in oval canals instrumented with WaveOne and filled with gutta-percha and AH Plus sealer",
"AIMS To evaluate the effect of plunger diameter on the push-out bond strength of different root filling material s to root canal dentine . METHODOLOGY Freshly extracted human incisors ( n=90 ) were decoronated , and the root canals were enlarged with post drills . Prepared roots were placed into a custom alignment apparatus to embed the roots vertically within self-curing acrylic resin . The specimens were r and omly assigned into three groups according to the root filling system used : gutta-percha/AH Plus ; Resilon/Epiphany ; and fibre-reinforced composite (FRC)/Duolink resin cement . After filling , the specimens were further subdivided according to the diameter of the plunger used to employ the debonding force : 0.75 , 1 and 1.25 mm . Intra-radicular bond strength was measured using the push-out test at a cross-head speed of 1 mm min(-1 ) . The data were analysed statistically using Kruskal-Wallis test with Bonferroni correction at P = 0.05 . RESULTS Regardless of the plunger diameter , FRC yielded the highest bond strength , followed by gutta-percha and Resilon , respectively ( P bond strength , but the differences were only significant in the FRC group , with the 1.25-mm plunger generating higher debonding values compared with that of its 0.75- and 1-mm versions ( P adhesive failures . Roots filled with FRC exhibited more cohesive failures than those of the other test groups . CONCLUSIONS Different plunger diameters are associated with significantly different intra-radicular push-out bond strengths of root filling systems"
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To date , the predominant mechanism underlying menstrual disturbances in exercising women supports an underlying energy deficiency-related aetiology , in which a failure to compensate dietary intake for the energy cost of exercise suppresses reproductive function . Increasing evidence demonstrates that energy deficiency plays a causal role in the induction of amenorrhoea in exercising women , and consistent with this mechanism are findings of glucoregulatory perturbations such as low triiodothyronine , reduced insulin secretion and elevated cortisol , growth hormone and ghrelin levels . The menstrual disturbance that may differ in its energetic characteristics and , perhaps in its and rogenic and ovarian steroid environment , is oligomenorrhoea . We conducted a systematic review of the literature to begin to underst and whether oligomenorrhoea in exercising women is a mild sub clinical phenotype of polycystic ovarian syndrome ( PCOS ) in which exercise is conferring beneficial effects in protecting women from the classic PCOS phenotype , or whether oligomenorrhoea is part of the spectrum of menstrual disturbances caused by an energy deficiency that is often reported in exercising women with menstrual disturbances . We included observational , r and omized controlled trials and cross-sectional studies that reported clinical , hormonal and metabolic profiles in exercising women with amenorrhoea or oligomenorrhoea and in women with PCOS . Previous studies examining the underlying mechanisms and consequences of exercise-associated menstrual disturbances have grouped exercising amenorrhoeic and oligomenorrhoeic women into a single group , and have relied primarily on self-reported menstrual history . Although scarce , the data available to date suggest that hyper and rogenism , such as that observed in PCOS , may likely be associated with oligomenorrhoea in exercising women , and may not always represent hypothalamic inhibition secondary to an energy deficiency . It is critical to closely examine the metabolic and endocrine status of women with menstrual disturbances because the treatment strategies for energy deficiency-related menstrual disturbances differ from that of disturbances traceable to hyper and rogenaemia . Further investigation is necessary to explore whether different endocrine aetiologies underly menstrual disturbances , particularly oligomenorrhoea , in physically active women
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"We performed a prospect i ve study of 28 initially untrained college women with documented ovulation and luteal adequacy to determine whether strenuous exercise spanning two menstrual cycles would induce menstrual disorders . To ascertain the influence , if any , that weight loss might exert , we r and omly assigned the subjects to weight-loss and weight-maintenance groups . Subjects were expected to run 4 miles ( 6.4 km ) per day , progressing to 10 miles ( 16.1 km ) per day by the fifth week , and to engage daily in 31/2 hours of moderate-intensity sports . The normalcy of the menstrual cycles during the period of exercise was judged independently according to clinical and hormonal criteria , the latter comprising serial measurements of gonadotropin and sex-steroid excretion . A higher percentage of abnormalities proved to be detectable by hormonal means ( P less than 0.02 ) . Only four subjects ( three in the weight-maintenance group ) had a normal menstrual cycle during training . In the weight-loss group , the number of women who had luteal abnormalities as compared with those who lost the surge in luteinizing hormone altered significantly over time , the latter occurring more frequently ( P less than 0.01 ) as training progressed . Within six months of termination of the study , all subjects were again experiencing normal menstrual cycles . We conclude that vigorous exercise , particularly if compounded by weight loss , can reversibly disturb reproductive function in women",
"We performed this study to access the changes in glucose tolerance over time in a group of women with polycystic ovary syndrome ( PCOS ) ( n = 71 ) and control women ( n = 23 ) with regular menstrual cycles and baseline normal glucose tolerance . Mean follow-up was between 2 and 3 yr for both groups ( PCOS 2.5 + /- 1.7 yr ; controls 2.9 + /- 2.1 yr ) . Based on World Health Organization glucose tolerance categories , there was no significant difference in the prevalence of glucose intolerance at follow-up in the PCOS group . In the PCOS group , 25 ( 37 % ) had impaired glucose tolerance ( IGT ) and seven ( 10 % ) had type 2 diabetes mellitus at baseline , compared with 30 ( 45 % ) and 10 ( 15 % ) , respectively , at follow-up . There were also no differences within groups ( PCOS or control ) or between groups ( PCOS vs. control ) in the oral glucose tolerance test-derived measure of insulin sensitivity , but in the women with PCOS who converted to either IGT or type 2 diabetes mellitus , there was a significant decrease ( P mean glycohemoglobin level was 6.1 + /- 0.9 % in women with PCOS vs. 5.3 + /- 0.7 % in the control women ( P conversion risk of 6 % to type 2 diabetes over approximately 3 yr , or 2 % per year . The effect of PCOS , given normal glucose tolerance ( NGT ) at baseline , is more pronounced with 16 % conversion to IGT per year . Our study supports that women with PCOS ( especially with NGT ) should be periodically rescreened for diabetes due to worsening glucose intolerance over time , but this interval may be over several years and not annually",
"We tested two hypotheses about the disruption of luteinizing hormone ( LH ) pulsatility in exercising women by assaying LH in blood sample s drawn at 10-min intervals over 24 h from nine young , habitually sedentary , regularly menstruating women on days 8 , 9 , or 10 of two menstrual cycles after 4 days of intense exercise [ E = 30 kcal.kg lean body mass (LBM)-1.day-1 at 70 % of aerobic capacity ] . To test the hypothesis that LH pulsatility is disrupted by low energy availability , we controlled the subjects ' dietary energy intakes ( I ) to set their energy availabilities ( A = I - E ) at 45 and 10 kcal.kg LBM-1.day-1 during the two trials . To test the hypothesis that LH pulsatility is disrupted by the stress of exercise , we compared the result ing LH pulsatilities to those previously reported in women with similar controlled energy availability who had not exercised . In the exercising women , low energy availability reduced LH pulse frequency by 10 % ( P LH pulse amplitude by 36 % ( P = 0.05 ) during waking and sleeping hours , but this reduction in LH pulse frequency was blunted by 60 % ( P = 0.03 ) compared with that in the previously studied nonexercising women whose low energy availability was caused by dietary restriction . The stress of exercise neither reduced LH pulse frequency nor increased LH pulse amplitude ( all P > 0.4 ) . During exercise , the proportion of energy derived from carbohydrate oxidation was reduced from 73 % while A = 45 kcal.kg LBM-1.day-1 to 49 % while A = 10 kcal.kg LBM-1.day-1 ( P LH pulsatility is disrupted by exercise stress and suggest that LH pulsatility in women depends on energy availability",
"Cross-sectional and short-term prospect i ve studies in humans support the concept that low energy availability , and not other factors associated with exercise , causes the development of exercise-induced reproductive dysfunction . To rigorously test this hypothesis , we performed a longitudinal study , examining the role of low energy availability on both the development and the reversal of exercise-induced amenorrhea , using a monkey model ( Macaca fascicularis ) . Eight adult female monkeys developed amenorrhea ( defined as absence of menses for at least 100 d , with low and unchanging concentrations of LH , FSH , E2 , and P4 ) after gradually increasing their daily exercise to 12.3 + /- 0.9 km/d of running over a 7- to 24-month period . Food intake remained constant during exercise training . To test whether amenorrhea is caused by low energy availability , four of the eight amenorrheic monkeys were provided with supplemental calories ( 138 - 181 % of calorie intake during amenorrhea ) while they maintained their daily training . All four monkeys exhibited increased reproductive hormone levels and reestablished ovulatory cycles , with recovery times for circulating gonadotropin levels ranging from 12 - 57 d from the initiation of supplemental feeding . The rapidity of recovery within the reproductive axis in a given monkey was directly related to the amount of energy that was consumed during the period of supplemental feeding ( r = -0.97 ; P plasma T3 concentrations , a marker of cellular energy availability , revealed a tight correlation between the changes in reproductive function and T3 levels , such that T3 significantly decreased ( 27 % ) with the induction and significantly increased ( 18 % ) with the reversal of amenorrhea ( P low energy availability plays a causal role in the development of exercise-induced amenorrhea",
"Cross-sectional studies suggest that women who have irregular menstrual cycles and hyper and rogenism may be at increased risk for cardiovascular disease ( CVD ) . However , prospect i ve data are lacking on the relationship between menstrual cycle irregularity and subsequent CVD risk . The objective of this study was to assess prospect ively the risk for coronary heart disease ( CHD ) and stroke associated with a history of irregular menstrual cycles . The study design was a prospect i ve cohort study of 82,439 female nurses who provided information in 1982 on prior menstrual regularity ( at ages 20 - 35 yr ) and were followed through 1996 for cardiovascular events . Incident reports of nonfatal myocardial infa rct ion , fatal CHD , and nonfatal and fatal stroke were made . Medical records were review ed for confirmation . During 14 yr ( 1,155,915 person-yr ) of follow-up , there were 1417 incident cases of CHD and 838 incident cases of stroke , including 471 cases of ischemic stroke . Compared with women reporting a history of very regular menstrual cycles , women reporting usually irregular or very irregular cycles had an increased risk for nonfatal or fatal CHD [ age-adjusted relative risks ( RR ) , 1.25 and 1.67 , respectively ; 95 % confidence intervals ( CI ) , 1.07 - 1.47 and 1.35 - 2.06 , respectively ] . Increased risks for CHD associated with prior cycle irregularity remained significant after adjustment for body mass index and several potential confounders . There was a nonsignificant increase in overall stroke risk ( RR , 1.30 ; 95 % CI = 0.97 - 1.74 ) and in ischemic stroke risk ( RR , 1.40 ; 95 % CI = 0.97 - 2.04 ) associated with very irregular cycles . Menstrual cycle irregularity may be a marker of metabolic abnormalities predisposing to increased risk for CVD",
"The notion of an oscillator or signal generator in the central nervous system that controls the rhythmic release of GnRH and , thereby , the pulsatile secretion of the gonadotropic hormones , originated in the finding of strikingly abrupt and rhythmic fluctuations in the concentration of LH in the plasma of ovariectomized monkeys . These oscillations had a period of about one hour when blood sample s were obtained at 10 to 20 minute intervals . I These surprising observations were presaged by reports of seemingly r and om , major fluctuations in plasma gonadotropin concentrations in gonadectomized monkeys \" and rats\"\"1 as well as in women . ' In these earlier studies the sampling intervals employed were never less than one hour and unable , therefore , to reveal the orderly , rhythmic events that occur with frequencies of one event per hour , or more . In the original study describing pulsatile LH secretion in ovariectomized monkeys the possibility was considered that the circhoral discharges of LH may be initiated by autoregulatory mechanisms involving long or short feedback loops , but the more likely view that these discharges were due to intermittent signals from the central nervous system unrelated to circulating LH levels that result ed in putative increments in GnRH release was favored . Nevertheless , the possible role of autoregulatory mechanisms in the control of pulsatile LH secretion was repeatedly considered,6 but finally laid to rest in the relatively recent past.7 Conversely , the view that each pulse of LH released from the pituitary gl and is the consequence of a bolus of GnRH secreted into the pituitary portal system has been unequivocally upheld by the demonstration of synchronous increments ofGnRH assessed in the pituitary portal circulation and of LH measured in sample s of peripheral blood obtained simultaneously.s , 9 In any case , the phenomenon of pulsatile gonadotropic hormone secretion was rapidly extended to most vertebrate species studied in this regard , including our own ,",
"The hormonal profiles of nested female patients ( n = 500 ) with self-reported symptoms typical of polycystic ovary syndrome ( PCOS ) , oligomenorrhea , and /or hirsutism and their r and omly selected controls ( n = 1026 ) at the age of 31 yr were analyzed in a general population -based Northern Finl and birth cohort 1966 to find out whether the symptomatic women also have the endocrine characteristics of PCOS and could be detected in a general population using simple questions . Higher medians of serum testosterone ( T ) ( 2.10 vs. 1.90 nmol/liter , P free and rogen index ( FAI ) ( 4.01 vs. 3.03 , P lower glucose/insulin ratio ( 91.1 x 10(8 ) vs. 94.9 x 10(8 ) , P = 0.048 ) and SHBG ( 52.4 vs. 60.7 nmol/liter , P cortisol and glucose levels between the cases and controls . Of all the women in the cohort , 10.2 % reported only oligomenorrhea and had biochemical findings similar to the whole case group . Those who reported only hirsutism ( 10.4 % ) were in between the case and control groups according to biochemical findings . The subjects who reported both oligomenorrhea and hirsutism ( 3.4 % ) had the highest T , LH , FAI , insulin , and glucose and the lowest SHBG and glucose/insulin ratio , compared with the case group and the groups with either symptom only indicating a dose-response manner in typical endocrine profile of PCOS by adding up symptoms . The levels of T and FAI were higher and SHBG lower in groups with overweight or obesity both at 14 and 31 yr , compared with groups with normal weight at 14 yr and overweight or obesity at 31 yr . In the group with normal weight at 14 and 31 yr and the group with overweight or obesity at 14 yr but normal weight at 31 yr , the levels of T and FAI were lowest and SHBG highest . T and FAI were higher and SHBG lower among the cases than the controls in groups stratified by weight development from adolescence to adulthood . In conclusion , this longitudinal study of a large , stable population indicates that women with self-reported symptoms of hirsutism and /or oligomenorrhea show endocrine characteristics of PCOS and can be detected in a general population using simple questions . These symptoms are markers of the underlying metabolic alterations possibly associated with increased health risks in later life",
"OBJECTIVE We tested the hypothesis that the three clinical phenotypes of polycystic ovary syndrome ( PCOS ) represent forms of the same metabolic disorder . DESIGN Prospect i ve cohort analysis . SETTING University-based tertiary care . PATIENT(S ) Three-hundred sixteen untreated consecutive women diagnosed as having PCOS . INTERVENTION(S ) None . MAIN OUTCOME MEASURE(S ) Each subject underwent an evaluation of ovulatory function , body habitus , acne , and hirsutism ; serum free and total testosterone ( T ) , 17-hydroxyprogesterone ( 17-HP ) , and DHEAS ; and fasting plasma glucose and insulin levels . Insulin resistance and beta-cell function were assessed using the homeostatic assessment model equation ( HOMA-IR and HOMA-beta-cell , respectively ) . RESULT ( S ) The Oligo+HA+Hirsutism phenotype was present in 48 % of subjects , Oligo+HA in 29 % , and Oligo+Hirsutism in 23 % . The three phenotypes did not differ in mean body mass index , waist-to-hip ratio , racial composition , degree of oligo-ovulation , prevalence of acne , or family history of hyper and rogenic symptomatology . However , subjects demonstrating the Oligo+HA+Hirsutism phenotype were the youngest and had the greatest degrees of hyper and rogenemia , hyperinsulinemia , and beta-cell function ; patients with the Oligo+Hirsutism phenotype where the oldest and had the mildest degrees of hyper and rogenemia , hyperinsulinemia , and beta-cell function . Subjects with the Oligo+HA phenotype demonstrated intermediate degrees of hyper and rogenemia and metabolic dysfunction . CONCLUSION ( S ) We conclude that the three clinical phenotypes of PCOS do not represent forms of the same metabolic disorder and may be the result of varying degrees of metabolic dysfunction ; greater degrees of beta-cell function and circulating insulin levels favored the development of hirsutism and frank hyper and rogenemia",
"CONTEXT Polycystic ovary syndrome ( PCOS ) is an endocrine disease closely related to several risk factors for cardiovascular disease . An impaired cardiopulmonary functional capacity was previously demonstrated in PCOS women . No data regarding the effects of a structured exercise training ( ET ) program on cardiopulmonary functional capacity in PCOS women are available . OBJECTIVE Our objective was to evaluate the effects of a 3-month ET program on cardiopulmonary functional capacity in young PCOS women . DESIGN AND SETTING A prospect i ve baseline-r and omized clinical study was conducted at the University \" Federico II \" of Naples , School of Medicine ( Italy ) . PATIENTS Ninety young overweight PCOS women were enrolled . MEAN OUTCOME MEASURES Ninety young PCOS women were r and omly subdivided into two groups , each composed of 45 subjects . The PCOS-T ( trained ) group underwent a 3-month structured ET program , whereas the PCOS-UnT ( untrained ) group did not . Hormonal and metabolic profiles and cardiopulmonary and exercise parameters were evaluated . RESULTS After 3-month ET , PCOS-T showed a significant improvement in peak oxygen consumption ( + 35.4 % ; P maximal workload ( + 37.2 % ; P body mass index ( -4.5 % ; P C-reactive protein ( -10 % ; P insulin sensitivity indexes . After 3 months , no changes were observed in PCOS-UnT. CONCLUSIONS A 3-month structured ET program improves cardiopulmonary functional capacity in young PCOS women",
"OBJECTIVE We performed this study as a pilot experiment to investigate the short term effects of two diets of varying composition on weight loss as the primary outcome in obese women with polycystic ovary syndrome ( PCOS ) seeking fertility . DESIGN R and omized clinical trial . SETTING Academic medical center . PATIENT(S ) Thirty-five obese women with PCOS . INTERVENTION(S ) We examined the effects of a 1-month dietary intervention on the PCOS phenotype . Participants were r and omized to one of two energy-restricted diets ; high protein ( HP : 30 % protein , 40 % carbohydrate , and 30 % fat ) or high carbohydrate ( HC : 15 % protein , 55 % carbohydrate , and 30 % fat ) . The fat content was held constant in both diets . MAIN OUTCOME MEASURE(S ) Primary - change in body weight ; Secondary - biometric , hormonal , lipid and lipoprotein , and markers of glucose homeostasis and energy metabolism . RESULT ( S ) Twenty-six women completed the study . Both the HP ( -3.7 + /- 1.9 kg ) and HC ( -4.4 + /- 1.5 kg ) diets result ed in significant weight loss , but there was no significant difference in mean weight loss between the two groups . There were also no differences between diets on a variety of measures including circulating and rogens , measures of glucose metabolism , and leptin . However , the effects of a hypocaloric diet per se on improving metabolic and reproductive abnormalities in a group of PCOS women were marked by a decline in circulating and rogens ( P=.03 ) , fasting and area under the curve ( AUC ) insulins ( P fasting and AUC leptin levels ( P menstrual bleeding during the trial ( 14 out of 26 patients ) . CONCLUSION ( S ) Those who completed the short-term hypocaloric diet had a significant weight loss and a significant improvement in their reproductive and metabolic abnormalities . There was no increased benefit to a high-protein diet . Future diet studies evaluating the ideal composition of a hypocaloric diet in women with PCOS will require a large study population , and will most likely require a multicenter trial",
"BACKGROUND Lifestyle modifications are successfully employed to treat obese and overweight women with polycystic ovary syndrome ( PCOS ) . The aims of the current pilot study were ( i ) to compare the efficacy on reproductive functions of a structured exercise training ( SET ) programme with a diet programme in obese PCOS patients and ( ii ) to study their clinical , hormonal and metabolic effects to eluci date potentially different mechanisms of action . METHODS Forty obese PCOS patients with anovulatory infertility underwent a SET programme ( SET group , n = 20 ) and a hypocaloric hyperproteic diet ( diet group , n = 20 ) . Clinical , hormonal and metabolic data were assessed at baseline , and at 12- and 24-week follow-ups . Primary endpoint was cumulative pregnancy rate . RESULTS The two groups had similar demographic , anthropometric and biochemical parameters . After intervention , a significant improvement in menstrual cycles and fertility was noted in both groups , with no differences between groups . The frequency of menses and the ovulation rate were significantly ( P SET group than in diet group but the increased cumulative pregnancy rate was not significant . Body weight , body mass index , waist circumference , insulin resistance indexes and serum levels of sex hormone-binding globulin , and rostenedione and dehydroepi and rosterone sulphate changed significantly ( P SET and diet interventions improve fertility in obese PCOS patients with anovulatory infertility . We hypothesize that in both interventions an improvement in insulin sensitivity is the pivotal factor involved in the restoration of ovarian function but potentially acting through different mechanisms"
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PURPOSE OF REVIEW Whether statins may prevent atrial fibrillation remains a subject of debate . An up date d systematic review of r and omized controlled trials with statins that collected data on the incidence or recurrence of atrial fibrillation was performed . RECENT FINDINGS Thirty-two published studies with 71 005 patients were included in the analysis . Overall , the use of statins was significantly associated with a decreased risk of atrial fibrillation compared with controls [ odds ratio ( OR ) 0.69 , 95 % confidence interval ( CI ) 0.57 - 0.83 , P statin therapy appeared highly significant for the prevention of postoperative atrial fibrillation ( homogeneous OR 0.37 , 95 % CI 0.28 - 0.51 , P prevention of new-onset atrial fibrillation ( OR 1.00 , 95 % CI 0.86 - 1.15 , P = 0.95 ) but was significant for secondary prevention of atrial fibrillation ( OR 0.57 , 95 % CI 0.36 - 0.91 , P = 0.02 with significant heterogeneity ) . There was no reduction in the risk of atrial fibrillation with more intensive vs. st and ard statin regimens ( OR 1.01 , 95 % CI 0.77 - 1.32 , P = 0.96 ) . SUMMARY The use of statins was significantly associated with a decreased risk of atrial fibrillation in patients with sinus rhythm . The highest benefit was seen for the prevention of postoperative atrial fibrillation and in secondary prevention of atrial fibrillation , with a heterogeneity that deserves further clarification
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"BACKGROUND Inflammation and oxidative stress are associated with atrial fibrillation ( AF ) . Statins have antioxidant and anti-inflammatory properties . We tested if atorvastatin reduced AF recurrence after DC cardioversion ( CV ) by modifying systemic oxidative stress and inflammation ( NCT00252967 ) . METHODS AND RESULTS In a r and omized , double-blinded , placebo-controlled trial , patients with atrial fibrillation/flutter ( AF ) were r and omized to receive either atorvastatin 80 mg ( n = 33 ) or placebo ( n = 31 ) before CV . Treatment was continued for 12 months or until AF recurred . Serum oxidative stress markers ( ratios of oxidized to reduced glutathione and cysteine , derivatives of reactive oxygen species , isoprostanes ) and inflammatory markers ( high-sensitivity C- reactive protein [ hs-CRP ] , interleukin-6 [ IL-6 ] , interleukin-1β[IL-1β ] , tumor necrosis factor alpha [ TNFα ] ) were measured at baseline and on follow-up . AF recurred in 22 ( 66.7 % ) of atorvastatin and 26 ( 83.9 % ) of placebo group ( P = 0.2 ) . The adjusted hazard ratio of having recurrence on atorvastatin versus on placebo was 0.99 ( 95 % CI : 0.98 - 1.01 , P = 0.3 ) . There was no significant difference in the time to recurrence using Kaplan-Meier survival estimates ( median [ IR ] : 29 [ 2 - 145 ] days versus 22 [ 7 - 70 ] days , P = 0.9 ) . Although no significant effect was seen on oxidative stress , 2 of 4 inflammatory markers , IL-6 ( adjusted OR : 0.59 , 95 % CI : 0.35 - 0.97 , P = 0.04 ) and hs-CRP ( adjusted OR : 0.59 , 95 % CI : 0.37 - 0.95 , P = 0.03 ) were significantly lowered with atorvastatin . Cholesterol levels significantly decreased with atorvastatin ( P = 0.03 ) . CONCLUSIONS High-dose atorvastatin did not reduce the recurrence of AF after CV . It reduced selective markers of inflammation without affecting systemic oxidative stress . Failure of atorvastatin to prevent AF recurrence may be due to its failure to affect oxidative stress",
"AIMS This ancillary analysis of the GISSI-HF data base aims at assessing the effect of rosuvastatin on the occurrence of atrial fibrillation ( AF ) in patients with chronic heart failure ( HF ) who were not in AF at study entry . METHODS AND RESULTS GISSI-HF was a double-blind , placebo-controlled trial testing n-3 PUFA and rosuvastatin vs. corresponding placebos in patients with chronic HF . Atrial fibrillation occurrence was defined as the presence of AF in the electrocardiogram ( ECG ) performed at each visit during the trial or AF as a cause of worsening HF or hospital admission or as an event during hospitalization . Among the 3690 patients ( 80.7 % ) without AF on their baseline ECG , 15.0 % developed AF during a median follow-up period of 3.7 years , 258 r and omized to rosuvastatin ( 13.9 % ) vs. 294 allocated to placebo ( 16.0 % ) . Although the difference was not significant at unadjusted analysis ( P = 0.097 ) and multivariable analysis adjusting for clinical variables ( P = 0.067 ) , it became significant after adjustment for clinical variables and laboratory examinations ( P = 0.039 ) , and for clinical variables , laboratory examinations , and background therapies ( P = 0.038 ) . CONCLUSION This study shows that there is some evidence of a beneficial effect of rosuvastatin in terms of reduction of AF occurrence in patients with HF . Larger population s are needed to provide a definite answer to the question . Clinical Trials.gov Identifier : NCT00336336",
"A study was performed to evaluate the extent to which the medical literature may be misleading as a result of selective publication of r and omized clinical trials ( RCTs ) with results showing a statistically significant treatment effect . Three hundred eighteen authors of published trials were asked whether they had participated in any unpublished RCTs . The 156 respondents reported 271 unpublished and 1041 published trials . Of the 178 completed unpublished RCTs with a trend specified , 26 ( 14 % ) favored the new therapy compared to 423 of 767 ( 55 % ) published reports ( p less than 0.001 ) . For trials that were completed but not published , the major reasons for nonpublication were \" negative \" results and lack of interest . From the data provided , it appears that nonpublication was primarily a result of failure to write up and su bmi t the trial results rather than rejection of su bmi tted manuscripts . The results of this study imply the existence of a publication bias of importance both to meta- analysis and the interpretation of statistically significant positive trials",
"CONTEXT Atrial fibrillation is a common , but potentially preventable , complication following coronary artery bypass graft ( CABG ) surgery . OBJECTIVES To assess the nature and consequences of atrial fibrillation after CABG surgery and to develop a comprehensive risk index that can better identify patients at risk for atrial fibrillation . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve observational study of 4657 patients undergoing CABG surgery between November 1996 and June 2000 at 70 centers located within 17 countries , selected using a systematic sampling technique . From a derivation cohort of 3093 patients , associations between predictor variables and postoperative atrial fibrillation were identified to develop a risk model , which was assessed in a validation cohort of 1564 patients . MAIN OUTCOME MEASURE New-onset atrial fibrillation after CABG surgery . RESULTS A total of 1503 patients ( 32.3 % ) developed atrial fibrillation after CABG surgery . Postoperative atrial fibrillation was associated with subsequent greater re source use as well as with cognitive changes , renal dysfunction , and infection . Among patients in the derivation cohort , risk factors associated with atrial fibrillation were advanced age ( odds ratio [ OR ] for 10-year increase , 1.75 ; 95 % confidence interval [ CI ] , 1.59 - 1.93 ) ; history of atrial fibrillation ( OR , 2.11 ; 95 % CI , 1.57 - 2.85 ) or chronic obstructive pulmonary disease ( OR , 1.43 ; 95 % CI , 1.09 - 1.87 ) ; valve surgery ( OR , 1.74 ; 95 % CI , 1.31 - 2.32 ) ; and postoperative withdrawal of a beta-blocker ( OR , 1.91 ; 95 % CI , 1.52 - 2.40 ) or an angiotensin-converting enzyme ( ACE ) inhibitor ( OR 1.69 ; 95 % CI , 1.38 - 2.08 ) . Conversely , reduced risk was associated with postoperative administration of beta-blockers ( OR , 0.32 ; 95 % CI , 0.22 - 0.46 ) , ACE inhibitors ( OR , 0.62 ; 95 % CI , 0.48 - 0.79 ) , potassium supplementation ( OR , 0.53 ; 95 % CI , 0.42 - 0.68 ) , and nonsteroidal anti-inflammatory drugs ( OR , 0.49 ; 95 % CI , 0.40 - 0.60 ) . The result ing multivariable risk index had adequate discriminative power with an area under the receiver operating characteristic ( ROC ) curve of 0.77 in the validation sample . Forty-three percent ( 640/1503 ) of patients who had atrial fibrillation after CABG surgery experienced more than 1 episode of atrial fibrillation . Predictors of recurrent atrial fibrillation included older age , history of congestive heart failure , left ventricular hypertrophy , aortic atherosclerosis , bicaval venous cannulation , withdrawal of ACE inhibitor or beta-blocker therapy , and use of amiodarone or digoxin ( area under the ROC curve of 0.66 ) . Patients with recurrent atrial fibrillation had longer hospital stays and experienced greater infectious , renal , and neurological complications than those with a single episode . CONCLUSIONS We have developed and vali date d models predicting the occurrence of atrial fibrillation after CABG surgery based on an analysis of a large multicenter international cohort . Our findings suggest that treatment with beta-blockers , ACE inhibitors , and /or nonsteroidal anti-inflammatory drugs may offer protection . Atrial fibrillation after CABG surgery is associated with important complications",
"Background — Recent clinical trials have suggested that intensive versus st and ard lipid-lowering therapy provides for additional benefit . Electron-beam computed tomography provides the opportunity to quantify the progression of coronary artery calcification ( CAC ) in serial measurements . Methods and Results — In a multicenter , r and omized , double-blind trial , 471 patients ( age 61±8 years ) who had no history of coronary artery disease and no evidence of high- grade coronary stenoses ( > 50 % diameter reduction ) were r and omized if they had ≥2 cardiovascular risk factors and moderate calcified coronary atherosclerosis as evidence d by a CAC score ≥30 . Patients were assigned to receive 80 mg or 10 mg of atorvastatin per day over 12 months . Progression of CAC volume scores could be analyzed in 366 patients . After pretreatment with 10 mg of atorvastatin for 4 weeks , 12 months of study medication reduced LDL cholesterol from 106±22 to 87±33 mg/dL in the group r and omized to receive 80 mg of atorvastatin ( P ) . The mean progression of CAC volume scores , corrected for the baseline CAC volume score , was 27 % ( 95 % CI 20.8 % to 33.1 % ) in the 80-mg atorvastatin group and 25 % ( 95 % CI 19.1 % to 30.8 % ) in the 10-mg atorvastatin group ( P=0.65 ) . CAC progression showed no relationship with on-treatment LDL cholesterol levels . Conclusions — We did not observe a relationship between on-treatment LDL cholesterol levels and the progression of calcified coronary atherosclerosis . Over a period of 12 months , intensive atorvastatin therapy was unable to attenuate CAC progression compared with st and ard atorvastatin therapy . The possibility remains that the time window was too short to demonstrate an effect",
"Background — Atrial fibrillation ( AF ) after cardiac surgery is associated with increased risk of complications , length of stay , and cost of care . Observational evidence suggests that patients who have undergone previous statin therapy have a lower incidence of postoperative AF . We tested this observation in a r and omized , controlled trial . Methods and Results — Two hundred patients undergoing elective cardiac surgery with cardiopulmonary bypass , without previous statin treatment or history of AF , were enrolled . Patients were r and omized to atorvastatin ( 40 mg/d , n=101 ) or placebo ( n=99 ) starting 7 days before operation . The primary end point was incidence of postoperative AF ; secondary end points were length of stay , 30-day major adverse cardiac and cerebrovascular events , and postoperative C-reactive protein ( CRP ) variations . Atorvastatin significantly reduced the incidence of AF versus placebo ( 35 % versus 57 % , P=0.003 ) . Accordingly , length of stay was longer in the placebo versus atorvastatin arm ( 6.9±1.4 versus 6.3±1.2 days , P=0.001 ) . Peak CRP levels were lower in patients without AF ( P=0.01 ) , irrespective of r and omization assignment . Multivariable analysis showed that atorvastatin treatment conferred a 61 % reduction in risk of AF ( odds ratio 0.39 , 95 % confidence interval 0.18 to 0.85 , P=0.017 ) , whereas high postoperative CRP levels were associated with increased risk ( odds ratio 2.0 , 95 % confidence interval 1.2 to 7.0 , P=0.01 ) . The incidence of major adverse cardiac and cerebrovascular events at 30 days was similar in the 2 arms . Conclusions — Treatment with atorvastatin 40 mg/d , initiated 7 days before surgery , significantly reduces the incidence of postoperative AF after elective cardiac surgery with cardiopulmonary bypass and shortens hospital stay . These results may influence practice patterns with regard to adjuvant pharmacological therapy before cardiac surgery",
"Background —The early response of C-reactive protein to initiation of a hydroxymethylglutaryl coenzyme A reductase inhibitor ( statin ) is not known . The purpose of this study was to determine the rate at which highly sensitive C-reactive protein ( hsCRP ) levels change after initiation of simvastatin and whether this occurs independently of the change in LDL cholesterol . Methods and Results —The study was a crossover , double-blind design including 40 subjects with elevated LDL cholesterol . Subjects were r and omly assigned to 1 of 2 groups : simvastatin 40 mg for 14 days , then placebo for 14 days , or placebo first , then simvastatin . Simvastatin decreased LDL cholesterol by 56±4 mg/dL ( P Baseline log(hsCRP ) levels were similar in the 2 groups . By day 14 , log(hsCRP ) was significantly lower in patients on simvastatin when compared with placebo ( P = 0.011 ) . Although there was no significant difference in fibrinogen levels , simvastatin produced a modest increase in log[lipoprotein(a ) ] ( P = 0.03 ) at days 7 and 14 . There were no relationships between the decrease in LDL cholesterol and the decrease in hsCRP . Conclusions —Simvastatin lowers hsCRP by 14 days , independent of its effect on LDL cholesterol . This rapid impact of a statin on hsCRP has potential implication s in the management of acute coronary syndromes",
"BACKGROUND High levels of asymmetric dimethylarginine ( ADMA ) are associated with an increased risk of early recurrence of atrial fibrillation ( AF ) after electrical cardioversion . We aim ed to investigate the effects of rosuvastatin on serum ADMA levels and early recurrence of AF following successful electrical cardioversion . METHODS A total of 64 patients with persistent AF , but without known heart disease , who underwent elective electrical cardioversion were r and omized to the rosuvastatin ( group I , n = 32 ) and control ( group II , n = 32 ) groups . The end point was the recurrence of AF during the 3 months of follow-up . RESULTS The baseline ADMA levels were not different between the two groups . At the end of follow-up , serum ADMA levels in group I decreased compared with the baseline levels , whereas no significant change occurred in group II . During the follow-up , five patients in group I ( 15.6 % ) and 13 in group II ( 40.6 % ) had AF recurrence ( P or = 65 years , left atrial diameter > 45 mm , and baseline ADMA levels > or = 2.0 micromol/l . Rosuvastatin was associated with a reduced risk of AF recurrence ( relative risk 0.35 , 95 % confidence interval 0.12 - 0.96 , P Rosuvastatin decreased the early recurrence of AF following successful electrical cardioversion with reduced ADMA levels",
"BACKGROUND Increasing evidence suggests that atrial fibrillation ( AF ) is an inflammatory disease . Statins is an anti-inflammatory agent . The present study was conducted to test the efficacy of atorvastatin in preventing paroxysmal AF or atrial high rate episodes ( AHEs ) in patients with bradyarrhythmias and implantation of an atrial-based or dual-chamber pacemaker . METHODS The effect of atorvastatin on time to the first attack of AF or AHE ( > or = 180 per minute and > or = 1 or 10 minutes ) , which was accurately detected by pacemaker interrogation , was evaluated in an open-label prospect i ve r and omized design for 1 year of follow-up . RESULTS Fifty-two patients ( 23 males , 70 + /- 13 years old ) were r and omized to the statin group ( atorvastatin 20 mg/d ) and 54 ( 25 males , 72 + /- 13 years old ) to the nonstatin group . Event-free survivals from AHE > or = 1 minute were not significantly different between the 2 groups ( log-rank P = .410 ) . However , patients in the nonstatin group were more likely to develop AHE > or = 10 minutes than those in the statin group ( log-rank P = .028 ) . Atrial high rate episode > or = 10 minutes occurred in 3 ( 5.8 % ) of 51 patients in the statin group after 1 year of follow-up , and 10 ( 19.2 % ) of 52 patients ( odds ratio 0.26 , P = .041 ) in the nonstatin group . The mean left atrial volume of the statin group was significantly lower than that of the nonstatin group at the end of follow-up ( 39.7 + /- 1.7 vs 43.7 + /- 1.9 mL , P AF ( > or = 10 minutes ) and left atrial enlargement in patients with bradyarrhythmias and implantation of a pacemaker",
"Objectives We investigated the effects of short-term use of atorvastatin on CD34+/VEGF-R2+/CD133+/CD45- endothelial progenitor cell ( EPC ) count after on-pump coronary artery bypass surgery ( CABG ) . Methods Between Feb-2010 and May-2010 , we r and omly assigned , in a placebo-controlled , double-blind study , 60 consecutive patients who underwent isolated , first-time CABG to receive either 14-day atorvastatin ( 40 mg/day ) or placebo preoperatively . Urgent CABG and recent myocardial infa rct ion were excluded . EPCs were quantified ( cells/μl ) by flow cytometric phenotyping obtained from venous blood sample s collected preoperatively ( T1 ) , 6-hours ( T2 ) , and on the 5th day postoperatively ( T3 ) . Levels of markers of inflammation and serum cardiac troponin I were also measured preoperatively and daily until day-5 after surgery . Results There were no differences in baseline risk factors including cholesterol profiles , and EuroSCORES between the groups . The composite primary end-point , favored statin group with higher amount of circulating , early EPC count ( cells/μl ) at all time points compared with placebo ( T1 , 2.30 ± 0.02 versus 1.58 ± 0.03 , p p rise were inversely correlated with EPC count , and were significantly lower in the statin group ( T1 , 0.8 ± 0.1 versus 2.2 ± 1.5 , p ± 4.1 , p was significantly lower in the statin group compared to placebo ( 3.3 % versus 23 % , p = 0.02 ) . Conclusions Short-term atorvastatin use increases circulating early EPCs both pre- and post-operatively and is associated with better preservation of sinus rhythm and reduced hsCRP levels . ( Clinical Trials.gov number , NCT01096875",
"AIMS Atrial fibrillation/flutter ( AF ) is the most common arrhythmia in older people . It associates with reduced exercise capacity , increased risk of stroke , and mortality . We aim ed to determine retrospectively whether pravastatin reduces the incidence of AF and whether any electrocardiographic measures or clinical conditions might be risk factors for its development . METHODS AND RESULTS The PROspect i ve Study of Pravastatin in the Elderly at Risk ( PROSPER ) was a r and omized , double-blind controlled trial that recruited 5804 individuals aged 70 - 82 years with a history of , or risk factors for , vascular disease . A total of 2891 were allocated to pravastatin and 2913 to placebo ; mean follow-up was 3.2 years . Electrocardiograms ( ECGs ) , which were recorded at baseline , annually thereafter , and at run-out , were processed by computer and review ed manually . In all , 264 of 2912 ( 9.1 % ) of the placebo group and 283 of 2888 ( 9.8 % ) of the pravastatin-treated group developed AF [ hazard ratio 1.08 ( 0.92,1.28 ) , P= 0.35 ) ] . Multivariate analysis showed that PR and QTc intervals , age , left ventricular hypertrophy , and ST-T abnormalities were related to development of AF after adjustment for many variables including alcohol consumption , which itself was univariately predictive of developing AF . Previous myocardial infa rct ion on the ECG was not a risk factor . A history of vascular disease was strongly linked with developing AF but not diabetes and hypertension . CONCLUSION Pravastatin does not reduce the incidence of AF in older people at risk of vascular disease , at least in the short-medium term . Risk factors for AF include older age , prolongation of PR or QTc intervals , left ventricular hypertrophy , and ST-T abnormalities on the ECG",
"Atrial fibrillation ( AF ) is one of the most common postoperative arrhythmias in patients who undergo coronary artery bypass grafting ( CABG ) . The aim of this study was to evaluate the effect of preoperative atorvastatin on postoperative atrial fibrillation following coronary artery bypass grafting with cardiopulmonary bypass ( CCABG ) . One hundred consecutive patients undergoing elective CCABG , without history of AF or previous statin treatment , were enrolled and r and omly assigned to a statin group ( atorvastatin 20 mg/d , n = 49 ) or a control group ( placebo , n = 51 ) starting 7 days preoperatively . The primary endpoint was the occurrence of postoperative AF . C-reactive protein ( CRP ) levels were assessed in all selected patients before surgery and every 24 hours postoperatively until discharge from hospital . Atorvastatin significantly reduced the incidence of postoperative AF and postoperative peak CRP level versus placebo ( 18 % versus 41 % , P = 0.017 ; 129.3 ± 24.3 mg/L versus 149.3 ± 32.5 mg/L , P better postoperative atrial fibrillation-free survival in the statin group ( χ(2 ) = 7.466 , P = 0.006 ) . Logistic regression analysis showed preoperative atorvastatin treatment was an independent factor associated with a significant reduction in postoperative AF ( OR = 0.235 , P = 0.007 ) , whereas high postoperative CRP levels were associated with increased risk ( OR = 2.421 , P = 0.015 ) . Preoperative atorvastatin administration may inhibit inflammatory reactions to prevent atrial fibrillation following coronary artery bypass grafting with cardiopulmonary bypass",
"Endothelial progenitor cells ( EPCs ) are a subtype of hematopoietic stem cells , which contribute to the repair of injured endothelium . Treatment with atorvastatin has been shown to increase EPC count in patients with coronary artery disease . Therefore , we investigated whether atorvastatin augments the number of EPCs after cardiopulmonary bypass ( CPB ) surgery . We conducted a r and omized double-blind , placebo-controlled , 2-way crossover trial in 50 patients undergoing elective coronary surgery . Patients received either 3-week treatment with atorvastatin or placebo . EPCs were quantitated by flow cytometric phenotyping on blood sample s. Levels of interleukin , IL-6 and IL-8 ; tumor necrosis factor α ; SDF-1α ; granulocyte colony-stimulating factor ; and vascular endothelial growth factor were determined at recruitment , preoperatively , post-CPB , and 6 , 12 , and 24 hours postoperatively . The atorvastatin group showed a significantly higher amount of EPCs both pre- and postoperatively compared with the placebo , with a > 4-fold increase compared with the baseline values . CPB induced an increase in all cytokines , but the levels of proinflammatory cytokines were significantly lower in the atorvastatin group ( P did not affect levels of SDF-1α , granulocyte colony-stimulating factor , and vascular endothelial growth factor . However , no correlation was found between plasma levels of any cytokine and number of EPCs , with the exception of SDF-1α . Pretreatment with atorvastatin significantly increases the amount of EPCs after CPB , by a mechanism independent of plasma levels of cytokines and cholesterol",
"BACKGROUND Lipid-lowering drugs , particularly statins , have anti-inflammatory and antioxidant properties that may prevent atrial fibrillation ( AF ) . This effect has not been investigated on new-onset AF in asymptomatic patients with aortic stenosis ( AS ) . METHODS Asymptomatic patients with mild-to-moderate AS ( n = 1,421 ) were r and omized ( 1:1 ) to double-blind simvastatin 40 mg and ezetimibe 10 mg combination or placebo and followed up for a mean of 4.3 years . The primary end point was the time to new-onset AF adjudicated by 12-lead electrocardiogram at a core laboratory reading center . Secondary outcomes were the correlates of new-onset AF with nonfatal nonhemorrhagic stroke and a combined end point of AS-related events . RESULTS During the course of the study , new-onset AF was detected in 85 ( 6 % ) patients ( 14.2/1,000 person-years of follow-up ) . At baseline , patients who developed AF were , compared with those remaining in sinus rhythm , older and had a higher left ventricular mass index a smaller aortic valve area index . Treatment with simvastatin and ezetimibe was not associated with less new-onset AF ( odds ratio 0.89 [ 95 % CI 0.57 - 1.97 ] , P = .717 ) . In contrast , age ( hazard ratio [ HR ] 1.07 [ 95 % CI 1.05 - 1.10 ] , P new-onset AF . The occurrence of new-onset AF was independently associated with 2-fold higher risk of AS-related outcomes ( HR 1.65 [ 95 % CI 1.02 - 2.66 ] , P = .04 ) and 4-fold higher risk of nonfatal nonhemorrhagic stroke ( HR 4.04 [ 95 % CI 1.18 - 13.82 ] , P = .03 ) . CONCLUSIONS Simvastatin and ezetimibe were not associated with less new-onset AF . Older age and greater left ventricular mass index were independent predictors of AF development . New-onset AF was associated with a worsening of prognosis",
"OBJECTIVE Myocardial disease without evidence of myocardial infa rct ion is a frequent complication after cardiac surgery during cardiopulmonary bypass . Statins might be protective , but their efficacy has not been established in r and omized trials . METHODS Two hundred patients undergoing coronary surgery were enrolled . They were r and omized to rosuvastatin ( 20 mg/d , n = 100 ) or placebo ( n = 100 ) starting 1 week before the operation . Troponin I , myoglobin , creatine kinase-MB mass , and high-sensitivity C-reactive protein were used as markers of myocardial injury , and their values were determined at baseline and at regular intervals after the operation . Electrocardiography and echocardiography were performed before and after the operation . RESULTS Myocardial disease was diagnosed when troponin I , myoglobin , and creatine kinase-MB mass values were above the upper normal limit without evidence of electrocardiographic changes , echocardiographic changes , or both . The percentages of marker level increase indicative of myocardial disease were determined in the placebo versus statin groups and were as follows : troponin I , 35 % versus 65 % ( P Peak postoperative values of troponin I ( 0.16 + /- 0.15 vs 0.32 + /- 0.26 ng/mL , P = .0008 ) , myoglobin ( 72.25 + /- 25 vs 98.31 + /- 31 ng/mL , P creatine kinase-MB mass ( 3.9 + /- 3.3 vs 9.3 + /- 8.1 ng/mL , P High-sensitivity C-reactive protein values were increased in 58 % of pretreated versus 88 % of the control patients ( 15.4 + /- 2.5 vs 17.2 + /- 3.4 mg/L , P myocardial disease was observed more frequently but significantly less in statin-pretreated patients . CONCLUSIONS Statin pretreatment reduces myocardial damage after coronary surgery and could improve both short- and long-term results",
"Objective : In this study , our aim was to evaluate the effect of a higher dose of atorvastatin on the recurrence rate of atrial fibrillation ( AF ) after electrical cardioversion ( EC ) in addition to antiarrhythmic therapy . Subjects and Methods : 48 patients with persistent AF were included in this study . The patients were r and omized to an atorvastatin 40-mg treatment group and a control group . Atorvastatin was started 3 weeks before EC and was continued for 2 months after EC . EC was performed using biphasic shocks after 3 weeks of treatment with the orally administered anticoagulant warfarin . Lipid and inflammatory parameters ( high-sensitivity C-reactive protein , white blood cell count and fibrinogen level ) were evaluated at the baseline and before EC . The endpoint of this study was electrocardiographically confirmed recurrence of AF of > 10 min . Results : There were no significant differences in baseline characteristics and lipid and inflammatory marker levels between the treatment and control groups . Total cholesterol and low-density lipoprotein levels were significantly decreased in patients taking atorvastatin for 2 months compared with baseline values ( 174 ± 31 vs. 129 ± 25 mg/dl , p = 0.001 , and 112 ± 23 vs. 62 ± 20 mg/dl , p = 0.001 , respectively ) , while no significant change occurred in control patients ( 168 ± 26 vs. 182 ± 29 mg/dl , p = 0.07 , and 99 ± 18 vs. 108 ± 26 mg/dl , p = 0.1 , respectively ) . At the end of the 2-month follow-up period , 9 patients ( 20.5 % ) experienced AF recurrence , and there was no significant difference in AF recurrence rate between the treatment and control groups ( 26 vs. 13 % ; p = 0.2 ) . Conclusion : Atorvastatin therapy prior to EC does not prevent the recurrence of arrhythmia in patients with persistent AF who are receiving antiarrhythmic therapy",
"BACKGROUND It is known that statins are effective in preventing atrial fibrillation ( AF ) in patients undergoing cardiac surgery . OBJECTIVE The purpose of this study was to evaluate the efficacy of statins in preventing AF recurrence following left atrial ablation . METHODS One hundred twenty-five patients who had no statin indication undergoing catheter ablation due to drug-refractory paroxysmal ( n = 90 ) or persistent ( n = 35 ) AF were r and omized in a prospect i ve , double-blind , placebo-controlled trial to receive 80 mg atorvastatin ( n = 62 ) or placebo ( n = 63 ) for 3 months . The primary endpoint was freedom from symptomatic AF at 3 months . Secondary endpoints included freedom from any atrial arrhythmia recurrence irrespective of symptoms , quality of life ( QoL ) , and reduction in C-reactive protein ( CRP ) . RESULTS At 3 months , 95 % of patients in the atorvastatin group were free of symptomatic AF compared with 93.5 % in the placebo group ( P = .75 ) . Similarly , 85 % of patients treated in the atorvastatin group remained free of any recurrent atrial arrhythmia vs 88 % of patients in the placebo group ( P = .37 ) . Mean CRP levels decreased in the atorvastatin group ( mean change -0.75 ± 3 , P = .02 ) and increased in the placebo group ( mean change 2.1 ± 19.9 , P = .48 ) . Mean QoL score improved significantly in both groups ( mean change 13.14 ± 18.2 in the atorvastatin group and 11.10 ± 17.7 in the placebo group , P = .53 ) . CONCLUSION In patients with no st and ard indication for statin therapy , treatment with atorvastatin 80 mg/day following AF ablation does not decrease the risk of AF recurrence in the first 3 months and should not be routinely administered to prevent periprocedural arrhythmias",
"BACKGROUND Atrial fibrillation ( AF ) after coronary artery bypass grafting ( CABG ) is still the most common postoperative arrhythmic complication . Previous studies report that patients undergoing preoperative statin therapy had a lower incidence of postoperative AF . This study aim ed to assess the effect of preoperative atorvastatin therapy on preventing AF following off-pump CABG in a r and omized , controlled trial . METHODS AND RESULTS The 140 consecutive patients undergoing elective off-pump CABG , without a history of AF or previous statin treatment , were enrolled and r and omly assigned to a statin ( atorvastatin 20 mg/day , n=71 ) or a control group ( placebo , n=69 ) starting 7 days preoperatively . The primary endpoint was the occurrence of postoperative AF ; secondary endpoints were major adverse in-hospital cardiac and cerebrovascular events and identification of variables predicting postoperative AF . Atorvastatin significantly reduced the incidence of postoperative AF and the postoperative peak C-reactive protein ( CRP ) level vs placebo ( 14 % vs 34 % , P=0.009 ; 126.5 + /-22.3 vs 145.2 + /-31.6 mg/L , P postoperative AF ( odds ratio ( OR ) 0.219 , P=0.005 ) , whereas a high postoperative CRP level was associated with increased risk ( OR 2.011 , P=0.013 ) . CONCLUSIONS Administration of atorvastatin 20 mg/day , initiated 1 week before elective off-pump CABG and continued in the postoperative period , significantly decreases postoperative AF",
"BACKGROUND Inflammation has been suggested as a factor in the initiation and maintenance of atrial fibrillation ( AF ) . Several observational studies have suggested that statins , presumably through their anti-inflammatory properties , decrease the risk of AF . METHODS We analyzed 2 large , r and omized trials , PROVE IT-TIMI 22 and phase Z of the A to Z trial , which compared lower- versus higher-intensity statin therapy to evaluate whether higher-intensity statin therapy lowered the risk of AF onset during the 2 years of follow-up . We hypothesized that higher-intensity statin therapy would decrease the risk of AF when compared to lower-intensity statin therapy . From each trial , patients experiencing the onset of AF during follow-up were identified from the adverse event reports . RESULTS Neither study showed a decreased AF risk with higher-dose statin . In PROVE IT-TIMI 22 , 2.9 % versus 3.3 % in the high- versus st and ard-dose statin therapy , respectively , experienced the onset of AF over 2 years ( OR 0.86 , 95 % CI 0.61 - 1.23 , P = .41 ) . In A to Z , rates were 1.6 % versus 0.99 % , respectively ( OR 1.58 , 95 % CI 0.92 - 2.70 , P = .096 ) . In both trials , C-reactive protein levels ( plasma or serum ) tended to be higher among patients experiencing the onset of AF . CONCLUSION Our r and omized comparison among 8659 patients found that higher-dose statin therapy did not reduce the short term incidence of AF among patients after acute coronary syndromes when compared with st and ard dose statin treatment",
"BACKGROUND While statins are increasingly used in cardiopulmonary bypass ( CPB ) , the anti-inflammatory effects of individual statins , within the context of various treatment regimes , need further examination . The present study evaluates the anti-inflammatory effectiveness of the short-term , preoperative and intensive postoperative use of pravastatin in CPB . METHOD Forty three patients undergoing CPB were enrolled in a r and omized , prospect i ve clinical study . One group ( n = 21 ) , received pravastatin , the other ( n = 22 ) did not . Patients in the pravastatin group received one dose of 40 mg per day for nine days , starting 48 hours before CPB , with an additional dose of 40 mg one hour after surgery . Plasma levels of selected inflammatory mediators were measured at baseline and tracked systematic ally . RESULTS Pravastatin reduced postoperative interleukin-6 ( IL-6 ) levels significantly at 24 and 48 hours , and at seven days . Mean + /- SD values , for treated versus untreated patients were : at 24 hours , 159.5 + /- 58.5 versus 251.2 + /- 53.0 pg/mL ( p C-reactive protein ( CRP ) decreased significantly on the seventh postoperative day , when plasma levels were 3.6 + /- 1.1 in the treated patients versus 8.2 + /- 2.1 mg/dL in the controls ( p plasma IL-1 and TNF-alpha were found during entire study . CONCLUSIONS Pravastatin induced a precocious modulation of IL-6 expression and a later reduction of plasma CRP levels . Pravastatin;s effects on the expression of these pivotal inflammatory mediators strongly support its well-timed use in CPB",
"OBJECTIVE The preventative effect of statins on postoperative atrial fibrillation has been hypothesized . However , all studies to date have examined patients who did not receive statins before their further allocation to treatment or no treatment . Because guidelines recommend the routine use of statins in patients with coronary artery disease , we set out to examine the effect of intensive statin pretreatment versus continuation of usual statin dose on atrial fibrillation after cardiac surgery . METHODS Patients receiving routine statin treatment and undergoing coronary artery bypass surgery or aortic valve replacement with no history of atrial fibrillation or antiarrhythmic medication were r and omized to receive atorvastatin 80 mg or atorvastatin 10 mg for 7 days before surgery in a single-blind fashion . The primary end point was the development of postoperative atrial fibrillation during hospital stay . RESULTS A total of 104 consecutive patients were included . Postoperative atrial fibrillation occurred in 33 patients ( 32.4 % ) . No significant differences were found in demographics , medical history , or intraoperative variables between treatment groups , with the exception of higher rate of β-blocker use in the atorvastatin 10 mg group ( 75 % vs 53 % , P = .002 ) and previous myocardial infa rct ion ( 62 % vs 42 % , P = .049 ) . The incidence of postoperative atrial fibrillation was lower in the atorvastatin 80 mg group when compared with the atorvastatin 10 mg group , but this difference did not reach statistical significance ( 29 % vs 36 % , P = .43 ) . CONCLUSIONS High-dose atorvastatin for 7 days before cardiac surgery conferred a nonsignificant reduction in postoperative atrial fibrillation when compared with a low-dose regimen . A larger study would be necessary to confirm the beneficial effect of high-dose statins in this setting",
"BACKGROUND C-reactive protein ( CRP ) lowering is associated with a reduction in recurrent and permanent atrial fibrillation . This study sought to determine whether CRP lowering also results in a reduction of paroxysmal atrial fibrillation ( PAF ) during daily life . METHODS AND RESULTS We enrolled 80 patients with proven PAF , CRP between 0.8 and 13 mg/L , and at least 1 episode of PAF on ambulatory electrocardiographic monitoring . Forty patients were r and omized to placebo ( placebo group ) and 40 to atorvastatin ( treatment group ) . Plasma CRP levels and ambulatory monitoring were repeated after 4 to 6 months of therapy . The 2 groups were comparable with respect to baseline characteristics , number of episodes of PAF , and baseline plasma CRP levels . The treatment group had lower median CRP levels at study end and experienced a significant reduction in the number of episodes of PAF compared with the placebo group . Paroxysmal atrial fibrillation was completely resolved in 26 ( 65 % ) of 40 patients in the treatment group versus 4 ( 10 % ) of 40 in the placebo group . The treatment group exhibited a highly significant reduction in PAF ( P atorvastatin was an independent predictor of PAF resolution . CONCLUSIONS C-reactive protein lowering with atorvastatin appears to be effective in eliminating PAF during daily life in a significant proportion of patients",
"AIMS To evaluate the effect of atorvastatin in achieving stable sinus rhythm ( SR ) 30 days after electrical cardioversion ( CV ) in patients with persistent atrial fibrillation ( AF ) . METHODS AND RESULTS The study included 234 patients . The patients were r and omized to treatment with atorvastatin 80 mg daily ( n = 118 ) or placebo ( n = 116 ) in a prospect i ve , double-blinded fashion . Treatment was initiated 14 days before CV and was continued 30 days after CV . The two groups were well-balanced with respect to baseline characteristics . Mean age was 65 + /- 10 years , 76 % of the patients were male and 4 % had ischaemic heart disease . Study medication was well-tolerated in all patients but one . Before primary endpoint 12 patients were excluded . In the atorvastatin group 99 patients ( 89 % ) converted to SR at electrical CV compared with 95 ( 86 % ) in the placebo group ( P = 0.42 ) . An intention-to-treat analysis with the available data , by r and omization group , showed that 57 ( 51 % ) in the atorvastatin group and 47 ( 42 % ) in the placebo group were in SR 30 days after CV ( OR 1.44 , 95%CI 0.85 - 2.44 , P = 0.18 ) . CONCLUSION Atorvastatin was not statistically superior to placebo with regards to maintaining SR 30 days after CV in patients with persistent AF",
"BACKGROUND Atrial fibrillation ( AF ) after coronary artery bypass graft ( CABG ) surgery is still the most common arrhythmic complication . This study evaluated whether pretreatment with atorvastatin protects against AF after off-pump CABG . METHODS One hundred twenty-four patients without a history of AF or previous statin use , who were scheduled to undergo elective off-pump CABG , were enrolled . Patients were r and omized to control group ( n = 62 ) or to atorvastatin group ( n = 62 ) who were administered atorvastatin 20 mg/d for 3 days before the surgery . Primary outcome was the incidence of postoperative AF . Secondary outcomes were major adverse cardiac and cerebrovascular events , persistent AF at 1 month , and identification of the markers to predict inhospital postoperative AF . RESULTS The incidence of AF was significantly lower in the atorvastatin group than in the control group ( 13 % vs 27 % , P = .04 ) . The incidence of major adverse cardiac and cerebrovascular events and persistent AF at 1 month was similar in comparisons between the groups . Postoperative peak N-terminal pro-brain natriuretic peptide levels were significantly higher in the patients with AF ( P = .03 ) . Multivariate analysis identified pretreatment with atorvastatin as an independent factor associated with a significant reduction in postoperative AF ( odds ratio 0.34 , P = .04 ) . Higher postoperative peak N-terminus pro-B-type natriuretic peptide levels were associated with the development of postoperative AF ( odds ratio 1.02 per 100 pg/mL , P = .03 ) . CONCLUSIONS Pretreatment with atorvastatin significantly reduced the occurrence of postoperative AF after off-pump CABG",
"BACKGROUND Observational analyses and short-term r and omized trials have suggested that statins reduce occurrence or recurrence of atrial fibrillation ( AF ) . We tested the hypothesis that long-term treatment with high-dose atorvastatin reduces occurrence of AF in patients with prior stroke or transient ischemic attack . METHODS We examined development of new AF in the SPARCL trial that compared atorvastatin 80 mg daily with placebo in 4,731 patients with prior stroke or transient ischemic attack . Patients who had chronic or paroxysmal AF or were taking medications for treatment or prophylaxis of AF at the time of enrollment were excluded . Atrial fibrillation was identified from electrocardiograms su bmi tted to a blinded central electrocardiographic laboratory and from investigators ' adverse event reports . RESULTS Patients were followed up for a median of 4.8 years , corresponding to > 20,000 patient-years of observation with a median of 5 electrocardiograms per patient . The primary efficacy measure , the time from r and omization to first occurrence of new AF , did not differ between treatment groups . By intention to treat , there were 139 cases of new AF in the atorvastatin group and 122 cases in the placebo group , corresponding to incidence rates of 1.32 and 1.14 cases per 100 patient-years observation ( hazard ratio 1.15 , 95 % CI 0.90 - 1.46 , P = .26 ) . On-treatment analysis yielded similar findings , with incidence rates of 1.26 and 1.01 cases per 100 patient-years observation in the atorvastatin and placebo groups , respectively ( hazard ratio 1.25 , 95 % CI 0.94 - 1.67 , P = .12 ) . CONCLUSION High-dose atorvastatin does not prevent development of AF in patients with prior stroke or transient ischemic attack",
"AIM Cardiopulmonary bypass is associated with a complex systemic inflammatory response and the extent of their increase has been correlated with the development of postoperative complications . Recent studies suggest that treatment with statins is associated with a significant and marked decrease in inflammation-associated variables such as cytokines . Therefore , we investigated the effects of preoperative simvastatin treatment on systemic inflammatory response and perioperative morbidity after cardiopulmonary bypass . METHODS A prospect i ve , r and omized study , was design ed . Forty-four subjects undergoing elective coronary artery bypass grafting who fulfilled the inclusion criteria were r and omized to treatment with simvastatin ( 20 mg/day , group A , N. 22 ) or control ( group B , N. 22 ) before surgery . Plasma levels of interleukins ( IL-6 , IL-8 , TNF-alpha ) , and systemic inflammatory response score ( SIRS ) were measured during the surgical intervention and over the following 48 postoperative hours . Cytokine levels were measured by enzyme-linked assays from plasma sample s obtained at specific time points pre- and post-operation . RESULTS In both groups the serum levels of the proinflammatory cytokines ( IL-6 , IL-8 , TNF-alpha ) , and leukocytes , and the SIRS score increased significantly over the baseline , though no significant differences were observed between the two groups . The preoperative and postoperative course did not differ between both groups . CONCLUSIONS In patients undergoing coronary artery bypass grafting with cardiopulmonary bypass , the administration of simvastatin doses not produce any changes in the inflammatory response as measured by the levels of IL-6 , IL-8 , TNF-alpha and SIRS score , nor does it reduce the complications after cardiac surgery",
"To test the hypothesis that a statin could reduce the recurrence rate of atrial fibrillation after electrical cardioversion ( EC ) , we performed an open , controlled multicenter study . Patients ( n = 114 ) who had atrial fibrillation > 48 hours and who were scheduled for EC were r and omized to receive 40 mg of pravastatin once daily for 3 weeks before and 6 weeks after EC or no drug in addition to st and ard therapy . Pravastatin did not reduce the recurrence rate of atrial fibrillation after EC",
"AIMS Increasing evidence supports a role for inflammation in promoting atrial fibrillation ( AF ) and statins have anti-inflammatory effects that may be relevant for the prevention of AF . However , studies of statin therapy and incident AF have yielded mixed results and not focused on individuals with an underlying pro-inflammatory response . We studied whether high-sensitivity C-reactive protein is associated with incident AF and whether treatment with rosuvastatin is associated with a lower incidence of AF compared with placebo . METHODS AND RESULTS We r and omized men and women with LDL cholesterol receive either rosuvastatin 20 mg daily or placebo . Atrial fibrillation was determined from treatment-blind adverse event reports . Among 17 120 participants without prior history of arrhythmia , each increasing tertile of baseline high-sensitivity C-reactive protein was associated with a 36 % increase in the risk of developing AF ( 95 % CI : 1.16 - 1.60 ; P-trend to rosuvastatin when compared with placebo was associated with a 27 % reduction in the relative risk of developing AF during the trial period ; specifically , AF was reported among 138 participants in the placebo group and 100 in the rosuvastatin group ( incidence rate 0.78 vs. 0.56/100 person-years , HR : 0.73 , 95 % CI : 0.56 - 0.94 , P = 0.01 ) . The exclusion of participants who developed a major cardiovascular event prior to the report of AF yielded similar results . CONCLUSION Within the JUPITER trial cohort of individuals selected for underlying inflammation , increasing levels of high-sensitivity C-reactive protein were associated with an increased risk of incident AF and r and om allocation to rosuvastatin significantly reduced that risk",
"To study the effect of atorvastatin on recurrence of atrial fibrillation ( AF ) after electrical cardioversion ( EC ) , 48 patients with AF lasting 48 hours who were scheduled for EC were r and omized to the atorvastatin ( group I ) and control ( group II ) groups . Six patients in group I ( 25 % ) and 2 patients in group II ( 8.3 % ) had spontaneous conversion before EC ( p > 0.05 ) . The end point was the recurrence of AF during 3 months of follow-up . Eighteen patients in group I ( 12.5 % ) and 11 patients in group II ( 45.8 % ) had recurrence ( p = 0.01 , log-rank test ) . With the Cox proportional model , the predictors of recurrence included a body mass index of 25 to 30 kg/m2 ( relative risk [ RR ] 0.07 , 95 % confidence interval [ CI ] 0.008 to 0.59 ) , body mass index > or = 30 kg/m2 ( RR 0.24 , 95 % CI 0.08 to 0.72 ) , AF duration of > or = 3 months ( RR 0.28 , 95 % CI 0.09 to 0.83 ) , diabetes mellitus ( RR 0.34 , 95 % CI 0.12 to 0.98 ) , and left atrial diameter of > or = 45 mm ( RR 0.23 , 95 % CI 0.07 to 0.74 ) . Atorvastatin was associated with a significantly reduced risk of developing AF ( unadjusted RR 0.23 , 95 % CI 0.064 to 0.82 , p = 0.024 ) . This association remained significant after adjustment for these predictors ( adjusted RR 0.19 , 95 % CI 0.052 to 0.72 , p = 0.01 ) . High-sensitivity C-reactive protein levels at baseline were not different between the 2 groups ( p = 0.92 ) . Although the high-sensitivity C-reactive protein levels decreased significantly 48 hours after EC compared with the baseline levels in group I ( 2.82 + /- 1.46 vs 2.56 + /- 1.3 mg/dl , p = 0.02 ) , no significant change occurred in group II ( 2.87 + /- 0.8 vs 2.84 + /- 0.8 mg/dl , p = 0.09 ) . In conclusion , atorvastatin decreased the recurrence rate of AF after EC",
"Objectives : Systemic inflammatory response occurs frequently after coronary artery bypass surgery , and it is strongly correlated with the risk of postoperative morbidity and mortality . Recent studies demonstrate that treatment with statin is associated with a significant and marked decrease in inflammation-associated variables such as the C-reactive protein , cytokines , and adhesion molecules . Therefore , we investigated the effects of preoperative atorvastatin treatment on systemic inflammatory response and perioperative morbidity after cardiopulmonary bypass . Design : Double-blinded , placebo-controlled , r and omized study . Setting : University hospital . Patients : Forty patients were r and omized to treatment with atorvastatin ( 20 mg/day , group A , n = 20 ) or placebo ( group B , n = 20 ) 3 wks before surgery . Interventions : Three-week treatment by atorvastatin 20 mg/day . Measurement and Main Results : Postoperative serum levels of both interleukin-6 and interleukin-8 increased significantly over baseline , but the peak levels observed 4 hrs postoperatively were significantly lower in the atorvastatin group . In the same fashion , CD11b expression on neutrophils was significantly lower in the statin group at 4 and 24 hrs postoperatively . Finally , neutrophil-endothelial adhesion was significantly reduced in the statin patients compared with controls . The operation time , blood loss , need for inotropic support , intubation time , and length of intensive care unit or hospital stay did not differ significantly between the two groups . The systemic inflammatory response syndrome score on postoperative days 1 and 2 was comparable in both groups . Conclusions : Pretreatment with atorvastatin significantly reduces cytokine release and neutrophil adhesion to the venous endothelium in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass"
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BACKGROUND Several studies suggest that weight loss reduces C-reactive protein ( CRP ) level ; however , the consistency and magnitude of this effect has not been well characterized . Our objective was to test the hypothesis that weight loss is directly related to a decline in CRP level . DATA SOURCES We search ed the Cochrane Controlled Trials Register and MEDLINE data bases and conducted h and search es and review s of bibliographies to identify relevant weight loss intervention studies . STUDY SELECTION We included all weight loss intervention studies that had at least 1 arm that was a surgical , lifestyle , dietary , and /or exercise intervention . Abstract s were independently selected by 2 review ers . DATA EXTRACTION Two review ers independently abstract ed data on the characteristics of each study population , weight loss intervention , and change in weight and CRP level from each arm of all included studies . DATA SYNTHESIS We analyzed the mean change in CRP level ( milligrams per liter ) and the mean weight change ( kilograms ) , comparing the preintervention and postintervention values from each arm of 33 included studies using graphical displays of these data and weighted regression analyses to quantify the association . RESULTS Weight loss was associated with a decline in CRP level . Across all studies ( lifestyle and surgical interventions ) , we found that for each 1 kg of weight loss , the mean change in CRP level was -0.13 mg/L ( weighted Pearson correlation , r = 0.85 ) . The weighted correlation for weight and change in CRP level in the lifestyle interventions alone was 0.30 ( slope , 0.06 ) . The association appeared roughly linear . CONCLUSION Our results suggest that weight loss may be an effective nonpharmacologic strategy for lowering CRP level
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"OBJECTIVE : Cardiovascular disease is strongly associated with obesity and there is evidence that weight loss has positive effects on cardiovascular disease risk . The aims of this study were to compare meal replacements ( MR ) with a conventional low-fat diet as weight loss strategies and to examine the effect of weight loss on flow-mediated dilatation ( FMD ) and other markers of endothelial function in overweight Australians with raised triglycerides ( TG ) ( > 2 mmol/l ) . RESEARCH METHODS : Subjects matched for age , gender , fasting plasma TG and body mass index were r and omized to two low- fat high- carbohydrate weight loss strategies ( both one using MR and the other a structured eating plan , control ( C ) . Subjects followed both diets for 3 months . In total , 55 subjects completed the study . FMD , pulse wave velocity and blood pressure ( BP ) were measured at baseline and at 3 months , as were fasting blood sample s for lipids , glucose , insulin , C reactive protein ( CRP ) and endothelium-derived factors . RESULTS : Mean weight loss was 6.3±3.7 kg ( 6.0±4.2 vs 6.63±3.35 kg , MR vs C ) with no difference between diet groups . TG , insulin , CRP , plasminogen activator inhibitor 1 ( PAI-1 ) and soluble intracellular adhesion molecule-1 ( sICAM1 ) fell after weight loss , but FMD did not change . Systolic BP fell by 8 mmHg and pulse wave velocity improved . DISCUSSION : In subjects with elevated TG , weight loss result ed in significant improvements in cardiovascular risk markers , particularly endothelium-derived factors ( PAI-1 and sICAM1 ) . However , FMD did not improve with weight loss",
"CONTEXT To enhance the effectiveness of diet in lowering cholesterol , recommendations of the Adult Treatment Panel III of the National Cholesterol Education Program emphasize diets low in saturated fat together with plant sterols and viscous fibers , and the American Heart Association supports the use of soy protein and nuts . OBJECTIVE To determine whether a diet containing all of these recommended food components leads to cholesterol reduction comparable with that of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors ( statins ) . DESIGN R and omized controlled trial conducted between October and December 2002 . SETTING AND PARTICIPANTS Forty-six healthy , hyperlipidemic adults ( 25 men and 21 postmenopausal women ) with a mean ( SE ) age of 59 ( 1 ) years and body mass index of 27.6 ( 0.5 ) , recruited from a Canadian hospital-affiliated nutrition research center and the community . INTERVENTIONS Participants were r and omly assigned to undergo 1 of 3 interventions on an outpatient basis for 1 month : a diet very low in saturated fat , based on milled whole-wheat cereals and low-fat dairy foods ( n = 16 ; control ) ; the same diet plus lovastatin , 20 mg/d ( n = 14 ) ; or a diet high in plant sterols ( 1.0 g/1000 kcal ) , soy protein ( 21.4 g/1000 kcal ) , viscous fibers ( 9.8 g/1000 kcal ) , and almonds ( 14 g/1000 kcal ) ( n = 16 ; dietary portfolio ) . MAIN OUTCOME MEASURES Lipid and C-reactive protein levels , obtained from fasting blood sample s ; blood pressure ; and body weight ; measured at weeks 0 , 2 , and 4 and compared among the 3 treatment groups . RESULTS The control , statin , and dietary portfolio groups had mean ( SE ) decreases in low-density lipoprotein cholesterol of 8.0 % ( 2.1 % ) ( P = .002 ) , 30.9 % ( 3.6 % ) ( P reductions in C-reactive protein were 10.0 % ( 8.6 % ) ( P = .27 ) , 33.3 % ( 8.3 % ) ( P = .002 ) , and 28.2 % ( 10.8 % ) ( P = .02 ) . The significant reductions in the statin and dietary portfolio groups were all significantly different from changes in the control group . There were no significant differences in efficacy between the statin and dietary portfolio treatments . CONCLUSION In this study , diversifying cholesterol-lowering components in the same dietary portfolio increased the effectiveness of diet as a treatment of hypercholesterolemia",
"Background —C-reactive protein ( CRP ) has been proposed as an independent risk factor for cardiovascular disease and has been positively associated with body weight and body fatness . We examined the hypothesis that weight loss would reduce plasma CRP levels in obese postmenopausal women . Methods and Results —In a sample of 61 obese ( body mass index , 35.6±5.0 kg/m2 ) , postmenopausal women ( age , 56.4±5.2 years ) , we found that plasma CRP levels were positively associated with dual x-ray absorptiometry – measured total body fatness ( r = 0.36 , P plasma CRP and triglyceride levels ( r = 0.33 , P glucose disposal measured by the hyperinsulinemic-euglycemic clamp technique ( r = −0.29 , P Twenty-five of the 61 women tested at baseline completed a weight loss protocol . The average weight loss was 14.5±6.2 kg ( −15.6 % , P P were reduced by −36.4 % and −23.7 % , respectively ( P were significantly reduced by weight loss : average −32.3 % , from 3.06 ( + 0.69 , −1.29 ) to 1.63 ( + 0.70 , −0.75 ) & mgr;g/mL ( P differences ) . Changes in body weight and in total body fat mass were both positively associated with plasma CRP level reductions . Conclusions —Adiposity was a significant predictor of plasma CRP in postmenopausal women on a cross-sectional basis . Moreover , caloric restriction – induced weight loss decreased plasma CRP levels . Weight loss may represent an important intervention to reduce CRP levels , which may mediate part of its cardioprotective effects in obese postmenopausal women",
"CONTEXT There are few data directly comparing the effects of physical activity and body weight on cardiovascular biomarkers . OBJECTIVE To examine the association of physical activity and body mass index ( BMI , defined as weight in kilograms divided by the square of height in meters ) alone and in combination with cardiovascular biomarkers . DESIGN , SETTING , AND PARTICIPANTS Cross-sectional analysis of 27,158 apparently healthy US women ( mean age , 54.7 years ) at the time of enrollment ( 1992 - 1995 ) in the Women 's Health Study , a r and omized , double-blind , placebo-controlled trial of low-dose aspirin and vitamin E in the primary prevention of cardiovascular disease and cancer . MAIN OUTCOME MEASURES The association of physical activity and BMI with high-sensitivity C-reactive protein ( CRP ) , fibrinogen , soluble intracellular adhesion molecule 1 ( ICAM-1 ) , homocysteine , low- and high-density lipoprotein ( LDL and HDL ) cholesterol , total cholesterol , apolipoprotein A-1 and B100 , lipoprotein(a ) , and creatinine . RESULTS Lower levels of physical activity and higher levels of BMI were independently associated ( P for trend adverse levels of nearly all lipid and inflammatory biomarkers . High BMI showed stronger associations with these biomarkers than physical inactivity . For example , using the reference group of physically active , normal weight women ( energy expenditure > or = 1000 kcal/week ; BMI , 18.5 - 24.9 ) and adjusting for age , race , smoking , blood pressure , diabetes , menopausal status , and hormone use , the odds ratios ( 95 % confidence intervals [ CIs ] ) for having CRP > 3 mg/L were : for inactive , normal weight women 1.26 ( 1.15 - 1.37 ) ; active , overweight 2.68 ( 2.41 - 2.98 ) ; inactive , overweight 3.11 ( 2.84 - 3.41 ) ; active , obese 8.25 ( 7.15 - 9.51 ) ; and inactive , obese 9.86 ( 8.84 - 10.99 ) . In similar analyses , the odds ratios ( 95 % CIs ) for having HDL cholesterol apolipoprotein B100 > 120 mg/dL they were 1.21 ( 1.11 - 1.33 ) ; 1.86 ( 1.66 - 2.08 ) ; 2.06 ( 1.88 - 2.67 ) ; 2.35 ( 2.04 - 2.70 ) ; and 2.33 ( 2.09 - 2.59 ) . Fibrinogen , ICAM-1 , apolipoprotein A1 , total cholesterol , and LDL cholesterol showed similar associations . By contrast , homocysteine , lipoprotein ( a ) , and creatinine showed weak or nonsignificant associations . CONCLUSIONS High BMI was more strongly related to adverse cardiovascular biomarker levels than physical inactivity . However , within BMI categories , physical activity was generally associated with more favorable cardiovascular biomarker levels than inactivity",
"BACKGROUND When substituted for carbohydrate in an energy-reduced diet , dietary protein enhances fat loss in women . It is unknown whether the effect is due to increased protein or reduced carbohydrate . OBJECTIVE We compared the effects of 2 isocaloric diets that differed in protein and fat content on weight loss , lipids , appetite regulation , and energy expenditure after test meals . DESIGN This was a parallel , r and omized study in which subjects received either a low-fat , high-protein ( LF-HP ) diet ( 29 + /- 1 % fat , 34 + /- 0.8 % protein ) or a high-fat , st and ard-protein ( HF-SP ) diet ( 45 + /- 0.6 % fat , 18 + /- 0.3 % protein ) during 12 wk of energy restriction ( 6 + /- 0.1 MJ/d ) and 4 wk of energy balance ( 7.4 + /- 0.3 MJ/d ) . Fifty-seven overweight and obese [ mean body mass index ( in kg/m(2 ) ) : 33.8 + /- 0.9 ] volunteers with insulin concentrations > 12 mU/L completed the study . RESULTS Weight loss ( LF-HP group , 9.7 + /- 1.1 kg ; HF-SP group , 10.2 + /- 1.4 kg ; P = 0.78 ) and fat loss were not significantly different between diet groups even though the subjects desired less to eat after the LF-HP meal ( P = 0.02 ) . The decrease in resting energy expenditure was not significantly different between diet groups ( LF-HP , -342 + /- 185 kJ/d ; HF-SP , -349 + /- 220 kJ/d ) . The decrease in the thermic effect of feeding with weight loss was smaller in the LF-HP group than in the HF-SP group ( -0.3 + /- 1.0 % compared with -3.6 + /- 0.7 % ; P = 0.014 ) . Glucose and insulin responses to test meals improved after weight loss ( P Bone turnover , inflammation , and calcium excretion did not change significantly . CONCLUSION The magnitude of weight loss and the improvements in insulin resistance and cardiovascular disease risk factors did not differ significantly between the 2 diets , and neither diet had any detrimental effects on bone turnover or renal function",
"BACKGROUND Persistent , low- grade inflammation is an independent predictor of several chronic diseases and all-cause mortality . OBJECTIVE The intention of this study was to determine the independent and combined effects of diet-induced weight loss and exercise on markers of chronic inflammation . DESIGN Three hundred sixteen community-dwelling , older ( > or = 60 y ) , overweight or obese [ body mass index ( in kg/m2 ) > or = 28 ] , sedentary men and women with radiographic evidence of knee osteoarthritis were r and omly assigned to four 18-mo treatments : healthy lifestyle control , diet-induced weight loss , exercise , and diet plus exercise . The exercise intervention consisted of combined weight training and walking for 1 h 3 times/wk . The weight-loss intervention consisted of a weekly session with a registered dietitian to provide education and support for lowering energy intake . RESULTS The diet-induced weight-loss intervention result ed in significantly greater reductions in concentrations of C-reactive protein ( P = 0.01 ) , interleukin 6 ( P = 0.009 ) , and soluble tumor necrosis factor alpha receptor 1 ( P = 0.007 ) than did no weight-loss treatment . Changes in soluble tumor necrosis factor alpha receptor 1 but not in C-reactive protein or interleukin 6 correlated with changes in body weight . Exercise training did not have a significant effect on these inflammatory biomarkers , and there was no significant interaction between weight loss and exercise training . CONCLUSIONS These findings provide evidence from a r and omized controlled trial that a dietary intervention design ed to elicit weight loss reduces overall inflammation in older , obese persons . Additional studies are needed to assess the effects of different modes and intensities of exercise on inflammation",
"The aim of this study was to investigate the potential role of adipose cytokines in the obesity-associated insulin resistance . To that end , we compared : 1 ) serum concentrations of interleukin 6 ( IL-6 ) , tumor necrosis factor alpha ( TNFalpha ) , and leptin in eight healthy lean control females and in and roid obese female without ( n = 14 ) and with ( n = 7 ) type 2 diabetes ; and 2 ) the levels of these cytokines both in serum and in sc adipose tissue in the 14 obese nondiabetic women before and after 3 weeks of a very low-calorie diet ( VLCD ) . As compared with lean controls , obese nondiabetic and diabetic patients were more insulin resistant and presented increased values for leptin , IL-6 , TNFalpha , and C-reactive protein . In the whole group , IL-6 values were more closely related to the parameters evaluating insulin resistance than leptin or TNFalpha values . VLCD result ed in weight loss and decreased body fat mass ( approximately 3 kg ) . Insulin sensitivity was improved with no significant change in both serum and adipose tissue TNFalpha levels . In contrast , VLCD induced significant decreases in IL-6 and leptin levels in both adipose tissue and serum . These results suggest that , as for leptin , circulating IL-6 concentrations reflect , at least in part , adipose tissue production . The reduced production and serum concentrations after weight loss could play a role in the improved sensitivity to insulin observed in these patients",
"This study examined the independent and combined effects of diet and exercise on adipocytokine and inflammatory cytokines in postmenopausal women with type 2 diabetes . Using a r and omized , controlled design , 33 women ( age , 50 - 70 years ) were assigned to diet alone ( D ) , exercise alone ( EX ) , or diet + exercise ( D + E ) for 14 weeks . Before and after the interventions , blood sample s for adipocytokines and inflammatory markers were drawn , a meal test was performed , and abdominal fat distribution was measured by magnetic resonance imaging ( MRI ) . Body weight decreased approximately 4.5 + /- 0.6 kg ( P D + E interventions , whereas only small changes in body weight were found with the exercise-alone intervention . Plasma C-reactive protein levels were decreased by approximately 15 % with all 3 interventions , whereas leptin levels were reduced with the D and D + E intervention ( D : pre = 48.7 + /- 6.0 , post = 38.9 + /- 5.0 ng/mL ; D + E : pre = 38.5 + /- 6.0 , post = 22.9 + /- 5.0 ng/mL ; P leptin levels to decrease in the EX group ( P = .06 ) . Plasma resistin levels were not altered by the 3 interventions from pre- to posttreatment ( D : pre = 6.9 + /- 0.6 , post = 6.2 + /- 0.4 ng/mL ; D + E : pre = 5.6 + /- 0.6 , post = 5.7 + /- 0.4 ng/mL ; E : pre = 6.2 + /- 0.6 , post = 5.9 + /- 0.6 ng/mL , P > .05 ) , and no differences in adiponectin and tumor necrosis factor alpha ( TNF- alpha ) levels were found . Visceral adipose tissue and tumor necrosis factor alpha were the only predictors of calculated insulin resistance ( P adipocytokines and inflammatory cytokines in older women with type 2 diabetes , suggesting that dramatic weight loss or clinical interventions are needed",
"Several prospect i ve studies have demonstrated a direct association between C-reactive protein ( CRP ) levels and the risks of developing cardiovascular disease . Few studies , however , have explored the interrelations between CRP levels and other risk factors for cardiovascular disease . We evaluated the relation of CRP with several cardiovascular risk factors in a cross-sectional survey of 1,172 apparently healthy men . There were significant positive associations between CRP levels and age , number of cigarettes smoked per day , body mass index , systolic and diastolic blood pressure , total cholesterol , triglycerides , lipoprotein(a ) , apolipoprotein B , tissue-type plasminogen activator antigen , D-dimers , total homocysteine , and fibrinogen ( all p values lipoprotein(a ) , and total homocysteine were independent correlates of CRP levels . Finally , in an analysis controlled either for all the independent correlates or for several usual risk factors , we observed progressive increases in levels of CRP with increasing prevalence of risk factors ( p for trend large cohort of apparently healthy men , CRP levels were associated with several cardiovascular risk factors . These data are compatible with the hypothesis that CRP levels may be a marker for pre clinical cardiovascular disease",
"There are two key methods in which fat intake may be manipulated ; the ' substitution model ' and the ' reduction model ' . However insufficient information is known about the mechanisms of dietary fat reduction in individuals who have successfully reduced their fat intake , to be clear as to which strategy offers the greatest chance of success . Our objective was to ascertain the most effective dietary intervention for improving cardiovascular risk profile . Eighty female volunteers ( high fat consumers ) were recruited . Each subject was r and omly allocated into one of the following groups . Substitution of high-fat foods was made with reduced-fat products , by the reduction of high-fat foods , by a combination of substitution and reduction strategies , or no advice was given . Each intervention lasted 3 months . Anthropometric measures and fasting blood sample s were taken at baseline and follow-up . The substitution intervention result ed in weight loss ( mean -1.4 ( 95 % CI -2.4 , -0.2 ) kg ) and reduced percentage body fat ( mean -1.3 ( 95 % CI -2.0 , -0.5)% ) . There was no significant weight change with the other interventions . Fasting triacylglycerols ( -0.2 ( SEM 0.07 ) mm ; P=0.04 ) , cholesterol and C-reactive protein ( CRP ) levels ( 0.8 ( SEM 0.2 ) mg/l ; P=0.04 ) fell with the substitution intervention , but not with the other interventions . Insulin-like growth factor-1 increased with both substitution and reduction ( P=0.02 ) . There was no significant change in fasting insulin or glucose with any intervention . The substitution model of dietary intervention is effective even over a relatively short interval of time in reducing fasting total cholesterol , triacylglycerols and CRP . Although the group size for the present study was small and involved females only , it has significant implication s for population intervention strategies",
"Background : Human adipose tissue expresses and releases proinflammatory cytokines and these measures of chronic inflammation have recently been associated with obesity . Hypothesis : To test whether the proinflammatory state is reversible in subjects undergoing weight loss by surgical measures .Subjects and Methods : Twenty morbidly obese women participated in this prospect i ve study . Subjects were examined for fat mass , high-sensitive C-reactive protein ( hs-CRP ) , interleukin 6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF-α ) before and 1 y after Swedish adjustable gastric b and ing . Results : Anthropometric measures displayed a significant reduction of the body mass index ( BMI ) from 41.6±5.4 to 30.8±6.1 kg/m2 and the fat mass from 53.9±10.3 to 29.8±12.1 kg ( mean±s.d . ) . Hs-CRP levels decreased significantly from 1.33±1.21 mg/dl in pre-gastric b and ing subjects to 0.40±0.61 mg/dl in post-gastric b and ing subjects , respectively . IL-6 and TNF-α levels did not differ significantly between pre- and post-gastric b and ing subjects . Conclusions : We speculate that in these patients the marked reduction in C-reactive protein might be beneficial in reducing their cardiovascular risk and is not solely mediated by IL-6 and TNF-α",
"BACKGROUND Limited evidence suggests that a higher ratio of protein to carbohydrate during weight loss has metabolic advantages . OBJECTIVE The objective was to evaluate the effects of a diet with a high ratio of protein to carbohydrate during weight loss on body composition , cardiovascular disease risk , nutritional status , and markers of bone turnover and renal function in overweight women . DESIGN The subjects were r and omly assigned to 1 of 2 isocaloric 5600-kJ dietary interventions for 12 wk according to a parallel design : a high-protein ( HP ) or a high-carbohydrate ( HC ) diet . RESULTS One hundred women with a mean ( + /-SD ) body mass index ( in kg/m(2 ) ) of 32 + /- 6 and age of 49 + /- 9 y completed the study . Weight loss was 7.3 + /- 0.3 kg with both diets . Subjects with high serum triacylglycerol ( > 1.5 mmol/L ) lost more fat mass with the HP than with the HC diet ( x + /- SEM : 6.4 + /- 0.7 and 3.4 + /- 0.7 kg , respectively ; P = 0.035 ) and had a greater decrease in triacylglycerol concentrations with the HP ( -0.59 + /- 0.19 mmol/L ) than with the HC ( -0.03 + /- 0.04 mmol/L ) diet ( P = 0.023 for diet x triacylglycerol interaction ) . Triacylglycerol concentrations decreased more with the HP ( 0.30 + /- 0.10 mmol/L ) than with the HC ( 0.10 + /- 0.06 mmol/L ) diet ( P = 0.007 ) . Fasting LDL-cholesterol , HDL-cholesterol , glucose , insulin , free fatty acid , and C-reactive protein concentrations decreased with weight loss . Serum vitamin B-12 increased 9 % with the HP diet and decreased 13 % with the HC diet ( P Folate and vitamin B-6 increased with both diets ; homocysteine did not change significantly . Bone turnover markers increased 8 - 12 % and calcium excretion decreased by 0.8 mmol/d ( P Creatinine clearance decreased from 82 + /- 3.3 to 75 + /- 3.0 mL/min ( P = 0.002 ) . CONCLUSION An energy-restricted , high-protein , low-fat diet provides nutritional and metabolic benefits that are equal to and sometimes greater than those observed with a high-carbohydrate diet",
"CONTEXT Weight loss elicits physiological adaptations relating to energy intake and expenditure that antagonize ongoing weight loss . OBJECTIVE To test whether dietary composition affects the physiological adaptations to weight loss , as assessed by resting energy expenditure . DESIGN , STUDY , AND PARTICIPANTS : A r and omized parallel- design study of 39 overweight or obese young adults aged 18 to 40 years who received an energy-restricted diet , either low-glycemic load or low-fat . Participants were studied in the General Clinical Research Centers of the Brigham and Women 's Hospital and the Children 's Hospital , Boston , Mass , before and after 10 % weight loss . The study was conducted from January 4 , 2001 , to May 6 , 2003 . MAIN OUTCOME MEASURES Resting energy expenditure measured in the fasting state by indirect calorimetry , body composition by dual-energy x-ray absorptiometry , cardiovascular disease risk factors , and self-reported hunger . RESULTS Resting energy expenditure decreased less with the low-glycemic load diet than with the low-fat diet , expressed in absolute terms ( mean [ SE ] , 96 [ 24 ] vs 176 [ 27 ] kcal/d ; P = .04 ) or as a proportion ( 5.9 % [ 1.5 % ] vs 10.6 % [ 1.7 % ] ; P = .05 ) . Participants receiving the low-glycemic load diet reported less hunger than those receiving the low-fat diet ( P = .04 ) . Insulin resistance ( P = .01 ) , serum triglycerides ( P = .01 ) , C-reactive protein ( P = .03 ) , and blood pressure ( P = .07 for both systolic and diastolic ) improved more with the low-glycemic load diet . Changes in body composition ( fat and lean mass ) in both groups were very similar ( P = .85 and P = .45 , respectively ) . CONCLUSIONS Changes in dietary composition within prevailing norms can affect physiological adaptations that defend body weight . Reduction in glycemic load may aid in the prevention or treatment of obesity , cardiovascular disease , and diabetes mellitus",
"The authors evaluated the cross-sectional and prospect i ve associations between the serum concentration of C-reactive protein and measures of obesity and fat distribution , hormone replacement therapy ( HRT ) use , and serum sex hormones in postmenopausal women from the Healthy Women Study ( Allegheny County , Pennsylvania , 1998 ) . The authors tested the hypothesis that C-reactive protein levels would be higher among HRT users and among women with greater body mass index , waist circumference , or visceral fat . There were 207 women in the study who were > or = 8 years postmenopausal ( 101 HRT users and 106 HRT nonusers ) . The median levels of C-reactive protein were 3.01 mg/liter in HRT users compared with 1.74 mg/liter in nonusers ( p = 0.002 ) . C-reactive protein levels were strongly positively correlated with measures of body size , fatness , fat distribution , and weight gain among HRT users and nonusers . C-reactive protein was also positively correlated with serum estrone levels ( r(s ) = 0.38 ) among HRT nonusers . The highest level of C-reactive protein was found among HRT users in the highest quartile of visceral fat ( 4.29 mg/liter ) compared with women not on HRT and in the lowest quartile of visceral fat ( 0.96 mg/liter ) . The use of HRT and measures of overall body fatness are important correlates of C-reactive protein among postmenopausal women",
"Background —Plasma C-reactive protein ( CRP ) concentrations are increased in obese and /or hyperinsulinemic individuals . The goal of this study was to determine if the relation between insulin resistance and CRP was independent of obesity . Methods and Results —Plasma CRP concentrations were measured before and after 3 months of calorie restriction in 38 healthy , obese women . Steady-state plasma glucose ( SSPG ) concentration during a 180-minute infusion of octreotide , glucose , and insulin was used to stratify participants into insulin-resistant ( IR , n=20 ) or insulin-sensitive ( n=18 ) groups , similar in terms of mean age ( 46±2 versus 44±2 years ) , body mass index ( 32.0±0.4 versus 31.4±0.3 kg/m2 ) , and waist circumference ( 96±2 versus 95±2 cm ) . Mean CRP ( 0.39±0.08 versus 0.12±0.03 mg/dL , P = 0.003 ) concentrations were higher in the IR group , as were day-long plasma glucose and insulin responses ( P CRP and day-long plasma integrated insulin response ( r = 0.47 , P = 0.001 ) but not between CRP and body mass index ( r = 0.14 ) or waist circumference ( r = 0.10 ) . Weight loss was similar in the two groups ( 8.7±0.9 versus 8.4±0.8 kg ) but was associated with significant ( P in SSPG and CRP concentrations in the IR group only . Regression analysis showed that SSPG and day-long plasma insulin response were the only significant predictors of CRP concentration . Conclusions —CRP concentrations are elevated predominantly in obese individuals who are also insulin resistant and fall in parallel with weight loss – associated improvements in insulin resistance . The relation between CRP concentrations and insulin resistance is independent of obesity",
"BACKGROUND Chronic hyperglycemia has been hypothesized to contribute to coronary heart disease ( CHD ) , but the extent to which hemoglobin A(1c ) ( HbA(1c ) ) level , a marker of long-term glycemic control , is independently related to CHD risk is uncertain . METHODS We conducted a prospect i ve case-cohort study of 1321 adults without diabetes and a cohort study of 1626 adults with diabetes from the Atherosclerosis Risk in Communities Study . Using proportional hazards models , we assessed the relation between HbA(1c ) level and incident CHD during 8 to 10 years of follow-up . RESULTS In adults with diabetes , the relative risk ( RR ) of CHD was 2.37 ( 95 % confidence interval [ CI ] , 1.50 - 3.72 ) for the highest quintile of HbA(1c ) level compared with the lowest after adjustment for CHD risk factors . In persons without diabetes , the adjusted RR of CHD in the highest quintile of HbA(1c ) level was 1.41 ( 95 % CI , 0.90 - 2.30 ) ; however , there was evidence of a nonlinear relationship in this group . In nondiabetic adults , HbA(1c ) level was not related to CHD risk below a level of 4.6 % but was significantly related to risk above that level ( P risk of CHD increased throughout the range of HbA(1c ) levels . In the adjusted model , the RR of CHD for a 1-percentage point increase in HbA(1c ) level was 2.36 ( 95 % CI , 1.43 - 3.90 ) in persons without diabetes but with an HbA(1c ) level greater than 4.6 % . In diabetic adults , the RR was 1.14 ( 95 % CI , 1.07 - 1.21 ) per 1-percentage point increase in HbA(1c ) across the full range of HbA(1c ) values . CONCLUSION Elevated HbA(1c ) level is an independent risk factor for CHD in persons with and without diabetes",
"Reductions in low-density lipoprotein-cholesterol ( LDL-C ) result from diets containing almonds , or diets that are either low in saturated fat or high in viscous fibers , soy proteins , or plant sterols . We have therefore combined all of these interventions in a single diet ( portfolio diet ) to determine whether cholesterol reductions could be achieved of similar magnitude to those reported in recent statin trials which reduced cardiovascular events . Twenty-five hyperlipidemic subjects consumed either a portfolio diet ( n=13 ) , very low in saturated fat and high in plant sterols ( 1.2 g/1,000 kcal ) , soy protein ( 16.2 g/1,000 kcal ) , viscous fibers ( 8.3 g/1,000 kcal ) , and almonds ( 16.6 g/1,000 kcal ) , or a low-saturated fat diet ( n=12 ) based on whole-wheat cereals and low-fat dairy foods . Fasting blood , blood pressure , and body weight were obtained at weeks 0 , 2 , and 4 of each phase . LDL-C was reduced by 12.1 % + /- 2.4 % ( P ratio of LDL-C to high-density lipoprotein-cholesterol ( HDL-C ) significantly ( 30.0 % + /- 3.5 % ; P reductions in LDL-C and the LDL : HDL-C ratio were both significantly lower on the portfolio diet than on the control diet ( P Mean weight loss was similar on test and control diets ( 1.0 kg and 0.9 kg , respectively ) . No difference was seen in blood pressure , HDL-C , serum triglycerides , lipoprotein(a ) [ Lp(a ) ] , or homocysteine concentrations between diets . Combining a number of foods and food components in a single dietary portfolio may lower LDL-C similarly to statins and so increase the potential effectiveness of dietary therapy",
"Aims /hypothesisThis study compared the long-term weight loss and health outcomes at 1-year follow-up , after a 12-week intensive intervention consisting of two low-fat , weight-loss diets , which differed in protein content . Methods We r and omly assigned 66 obese patients ( BMI : 27–40 kg/m2 ) with Type 2 diabetes to either a low-protein ( 15 % protein , 55 % carbohydrate ) or high-protein diet ( 30 % protein , 40 % carbohydrate ) for 8 weeks of energy restriction ( ~6.7 MJ/day ) and 4 weeks of energy balance . Subjects were asked to maintain the same dietary pattern for a further 12 months of follow-up . Results The study was completed by 38 of the subjects , with equal dropouts in each group . At Week 64 , weight reductions against baseline were −2.2±1.1 kg ( low protein ) and −3.7±1.0 kg ( high protein ) , p diet effect . Fat mass was not different from baseline in either group . At Week 12 , both diets reduced systolic and diastolic blood pressure by 6 and 3 mm Hg respectively , but blood pressure increased more with weight regain during follow-up in the low-protein group ( p≤0.04 ) . At Week 64 , both diets significantly increased HDL cholesterol and lowered C-reactive protein concentrations . There was no difference in the urinary urea : creatinine ratio at baseline between the two groups , but this ratio increased at Week 12 ( in the high-protein group only , p high-protein weight-reduction diet may in the long term have a more favourable cardiovascular risk profile than a low-protein diet with similar weight reduction in people with Type 2 diabetes",
"BACKGROUND Cross-sectional studies suggest that regular exercise has anti-inflammatory effects , leading to lower levels of several proatherogenic inflammatory markers . However , this has yet to be confirmed by r and omized prospect i ve trials . We performed a r and omized controlled trial to assess whether exercise training decreases levels of 5 inflammatory markers linked to future cardiovascular risk : white blood cell count , fibrinogen , C-reactive protein , soluble intercellular adhesion molecule 1 , and soluble CD40 lig and . METHODS One hundred fifty-two healthy female smokers were r and omized to either 12 weeks of exercise training or health education as part of a smoking cessation program . Smoking was held steady for the first 6 weeks , and thereafter , smoking cessation was actively attempted . One hundred four participants completed 6 weeks , and 88 completed 12 weeks . Fitness and circulating inflammatory marker levels were measured at baseline , 6 weeks , and 12 weeks . To avoid potential confounding from changes in smoking exposure during the second 6 weeks of the trial , the primary end point was change in inflammatory marker levels from baseline to 6 weeks . Change in inflammatory markers from baseline to 12 weeks was a secondary end point . RESULTS At baseline , greater physical fitness was associated with lower white blood cell , fibrinogen , and C-reactive protein levels , but these associations were not statistically significant after adjusting for body mass index ( P > .1 for all ) . Fitness improved significantly in the exercise group at both 6 and 12 weeks . However , there were no differences in levels of any inflammatory marker between the exercise and control groups at either 6 weeks ( primary end point ) or 12 weeks ( secondary end point ) ( P > .05 for all comparisons ) . CONCLUSION In female smokers , baseline associations between fitness and inflammatory markers were largely attributable to differences in body fat ; regular exercise did not reduce levels of any of the inflammatory markers studied despite a significant improvement in fitness at both 6 and 12 weeks",
"OBJECTIVE To determine the efficacy of a weight-loss diet using packaged portion-controlled entrees compared with a self-selected diet based on the U.S. Department of Agriculture Food Guide Pyramid ( FGP ) ( United States Department of Agriculture , Center for Nutrition Policy and Promotion , Washington , DC ; 1996 ) . RESEARCH METHODS AND PROCEDURES Sixty healthy women ( BMI 26 to 40 kg/m(2 ) ; 24 to 60 years old ) were r and omized into two intervention groups for an 8-week parallel arm study . The portion-controlled group consumed two frozen entrees daily , plus additional food servings from the FGP . The self-selected diet group consumed a recommended number of servings from the FGP . Diets were design ed to be the same in composition ( 55 % carbohydrate , 25 % protein , 20 % fat ) and energy level ( 1365 kcal ) . Each group met weekly to monitor compliance and take measures . Outcomes included weight , body composition by DXA , hip and waist circumference , blood pressure , fasting blood lipids , glucose , insulin , and C-reactive protein . Significant differences were assessed using repeated measures ANOVA . RESULTS The portion-controlled group ( n = 26 ) experienced greater decreases in weight ( 5.6 + /- 2.2 kg or 6.5 % vs. 3.6 + /- 2.5 kg or 4.2 % ) , fat mass ( 3.6 + /- 1.8 vs. 2.3 + /- 1.4 kg ) , total cholesterol ( 24.4 + /- 21.5 mg/dL or 12.4 % vs. 13.0 + /- 13.9 mg/dL or 6.7 % ) , and fasting insulin ( -1.8 + /- 3.7 vs.+0.3 + /- 3.8 micro U/mL ) than the self-selected diet group ( n = 27 ) ( p portion-controlled entrees result ed in greater losses of weight and fat , thereby reducing cardiovascular disease risk . Accurate portion control is an important factor in weight loss success , and use of packaged entrees is an effective method of achieving this",
"OBJECTIVES To identify a stable biochemical marker of disease severity in patients with intermittent claudication and to use these findings to assess the effect of therapeutic exercise training . DESIGN Case-control study : prospect i ve r and omised-controlled trial of exercise training . MATERIAL S AND METHODS Plasma fibrinogen , serum amyloid A protein ( SAA ) , C-reactive protein ( CRP ) and urinary albumin-creatinine ratio ( ACR ) were measured in 67 claudicants and 15 controls . Twenty-two patients were r and omised to supervised exercise training and 17 r and omised to observation . Subjects were review ed at 3 , 6 and 12 months . RESULTS The median ( interquartile range ) baseline fibrinogen was 3.7 g/l ( 3.3 - 4.25 ) in claudicants and 3.5 g/l ( 2.9 - 3.95 ) in controls ( p = 0.045 ) ; CRP was 4.7 mg/l ( 2.2 - 9.0 ) and 2.1 mg/l ( 1.0 - 2.8 ) , respectively ( p SAA was 72 mg/l ( 35 - 132 ) and 30 mg/l ( 20 - 89 ) ( p = 0.0009 ) . Claudicants showed an increased urinary ACR following treadmill exercise ( Wilcoxon , p Exercise training reduced SAA at 6 months , CRP at 3 months and progressively attenuated the post-exercise increase in ACR . No similar changes were found in controls . CONCLUSIONS Repetitive low- grade inflammatory events in claudicants lead to elevation of serum acute-phase proteins . Exercise training is associated with symptomatic improvement and reduction inflammatory markers . The concern that exercise has adverse systemic effects therefore seems to be unjustified",
"The purpose of this study was to determine whether a hypocaloric diet with and without exercise training is effective in reducing plasma C-reactive protein , IL-6 , TNFalpha , and their soluble receptors ( sIL-6R , sTNFR1 , and sTNFR2 ) , and whether changes in these inflammatory markers are related to changes in regional lipolysis in obese ( body mass index , 32.78 + /- 4.73 ) postmenopausal women ( diet alone , n = 17 ; diet plus exercise , n = 17 ) . All inflammatory markers were measured by an ELISA method . In vitro lipolysis was evaluated by measuring glycerol release using a one-step enzymatic fluorometric technique . Six months of diet and diet plus exercise decreased total and abdominal fat to a similar degree . Diet plus exercise , but not diet alone , decreased plasma levels of C-reactive protein , IL-6 , sIL-6R , and sTNFR1 and increased basal and postreceptor stimulated lipolysis in both abdominal and gluteal regions . Changes in abdominal stimulated lipolysis correlated significantly with changes in plasma IL-6 ( r = -0.39 ) and TNFR1 ( r = -047 ) . Thus , diet plus exercise training , but not diet alone , is effective in reducing chronic inflammation in obese postmenopausal women . In addition , modification of chronic inflammation is associated with changes in local adipose tissue metabolism in response to diet and exercise",
"This study examines the association between physical activity and C-reactive protein levels , indicating that high levels of strenuous aerobic activity are associated with lower C-reactive protein levels among men",
"Background Increased arterial stiffness has been found in patients with chronic high- grade inflammatory diseases . Whether mitigation of low- grade systemic inflammation , through a low-cholesterol/low-saturated fat diet , may have a role in improving arterial stiffness is still untested . Design We investigated whether variations in blood lipids and plasma C-reactive protein induced by low-cholesterol/low-saturated fat diet are associated with variations in large-artery stiffness in hypercholesterolemia . Methods Thirty-five patients with primary hypercholesterolemia and 15 normal control subjects were recruited for the study . Hypercholesterolaemic patients followed an 8-week low-cholesterol/low-saturated fat diet ( 30 % total fat , 5 % saturated fat , cholesterol . Anthropometric characteristics , blood lipids , plasma C-reactive protein and arterial stiffness were measured at baseline and after the diet . Results Arterial stiffness and C-reactive protein levels were higher in hypercholesterolaemic patients than in controls . Significant reductions in body weight ( 2 kg , 3 % ) , plasma total cholesterol ( 13.4mg/dl , 5.3 % ) , low-density lipoprotein cholesterol ( 11.2 mg/dl , 6.4 % ) , C-reactive protein ( 0.7 mg/l , 39 % ) and arterial stiffness ( from 8.9 ± 2.0 to 8.1 ± 1.9 m/s , 11 % ) were achieved among hypercholesterolaemic patients after the 8-week diet ( P reduction in arterial stiffness after short-term diet to be associated with reduction of plasma C-reactive protein levels ( r = 0.59 , β = 0.38 , P<0.05 for both )",
"The purpose of this study was to determine the effect of exercise training on the levels of C-reactive protein ( CRP ) and adiponectin , and to assess whether exercise-induced changes in insulin resistance could be explained in part by changes in these inflammation markers . Study participants included 51 middle-aged ( 45.3+/-8.3 years ; mean+/-SD ) , overweight ( 33.7+/-4.8 BMI ) , insulin-resistant , nondiabetic individuals . Subjects had their insulin sensitivity , body fat , CRP , and adiponectin levels measured , and their predicted maximal fitness calculated before and after 16 weeks of moderate , intense , or no exercise training . Modest improvements in fitness , body composition , and insulin sensitivity were observed , but these changes were not associated with decreased CRP or increased adiponectin levels , even when subjects were stratified by their change in fitness or obesity . Regression analysis demonstrated that the change in percentage of body fat was significantly related to changes in insulin sensitivity , whereas changes in VO2 MAX , CRP , and adiponectin were not . Participation in moderate to intense exercise was not associated with improved measures of chronic inflammation markers , as measured by CRP and adiponectin . Moreover , improvements in insulin sensitivity result ing from exercise or modest weight loss did not appear to be related to changes in these markers",
"CONTEXT Obesity is an independent risk factor for cardiovascular disease , which may be mediated by increased secretion of proinflammatory cytokines by adipose tissue . OBJECTIVE To determine the effect of a program of changes in lifestyle design ed to obtain a sustained reduction of body weight on markers of systemic vascular inflammation and insulin resistance . DESIGN AND SETTING R and omized single-blind trial conducted from February 1999 to February 2002 at a university hospital in Italy . PATIENTS One hundred twenty premenopausal obese women ( body mass index > or = 30 ) aged 20 to 46 years without diabetes , hypertension , or hyperlipidemia . INTERVENTIONS The 60 women r and omly assigned to the intervention group received detailed advice about how to achieve a reduction of weight of 10 % or more through a low-energy Mediterranean-style diet and increased physical activity . The control group ( n = 60 ) was given general information about healthy food choices and exercise . MAIN OUTCOME MEASURES Lipid and glucose intake ; blood pressure ; homeostatic model assessment of insulin sensitivity ; and circulating levels of interleukin 6 ( IL-6 ) , interleukin 18 ( IL-18 ) , C-reactive protein ( CRP ) , and adiponectin . RESULTS After 2 years , women in the intervention group consumed more foods rich in complex carbohydrates ( 9 % corrected difference ; P energy ( -310 kcal/d ; P saturated fat ( -3.5 % ; P = .007 ) , and cholesterol intake ( -92 mg/d ; P Body mass index decreased more in the intervention group than in controls ( -4.2 ; P serum concentrations of IL-6 ( -1.1 pg/mL ; P = .009 ) , IL-18 ( -57 pg/mL ; P = .02 ) , and CRP ( -1.6 mg/L ; P = .008 ) , while adiponectin levels increased significantly ( 2.2 microg/mL ; P = .01 ) . In multivariate analyses , changes in free fatty acids ( P = .008 ) , IL-6 ( P = .02 ) , and adiponectin ( P = .007 ) levels were independently associated with changes in insulin sensitivity . CONCLUSION In this study , a multidisciplinary program aim ed to reduce body weight in obese women through lifestyle changes was associated with a reduction in markers of vascular inflammation and insulin resistance",
"Higher levels of physical activity are associated with lower risk of cardiovascular disease . There is growing evidence that the development of the atherosclerotic plaque is associated with inflammation . In this study , the authors investigated the cross-sectional association between physical activity and markers of inflammation in a healthy elderly population . Data obtained in 1989 - 1990 and 1992 - 1993 from the Cardiovascular Health Study , a cohort of 5,888 men and women aged > /=65 years , were analyzed . Concentrations of the inflammation markers-C-reactive protein , fibrinogen , Factor VIII activity , white blood cells , and albumin-were compared cross-sectionally by quartile of self-reported physical activity . Compared with persons in the lowest quartile , those in the highest quartile of physical activity had 19 % , 6 % , 4 % , and 3 % lower concentrations of C-reactive protein , white blood cells , fibrinogen , and Factor VIII activity , respectively , after adjustment for gender , the presence of cardiovascular disease , age , race , smoking , body mass index , diabetes , and hypertension . Multivariate regression models suggested that the association of higher levels of physical activity with lower levels of inflammation markers may be mediated by body mass index and glucose . There was no association between physical activity and albumin . Higher levels of physical activity were associated with lower concentrations of four out of five inflammation markers in this elderly cohort . These data suggest that increased exercise is associated with reduced inflammation . Prospect i ve studies will be required for verification of these findings",
"Elevated levels of serum amyloid A ( SAA ) and C-reactive protein ( CRP ) have been associated with increased cardiovascular risk . Although levels of CRP decrease with weight loss , it is not known whether SAA decreases with weight loss or whether dietary macronutrient composition affects levels of either SAA or CRP . SAA and CRP levels were measured retrospectively on baseline and 3-month plasma sample s from 41 obese ( mean body mass index 33.63 + /- 1.86 kg/m2 ) women completing a r and omized trial comparing a low-fat diet ( n = 19 ) and a very low-carbohydrate diet ( n = 22 ) . For the 41 participants , there were significant decreases from baseline to 3 months in both LogSAA ( P = 0.049 ) and LogCRP ( P = 0.035 ) . The very low-carbohydrate dieters had a significantly greater decrease in LogSAA ( P = 0.04 ) , but their weight loss also was significantly greater ( -7.6 + /- 3.2 vs. -4.3 + /- 3.5 kg , P inflammatory markers correlated significantly with weight loss ( r = 0.44 , P = 0.004 vs. LogSAA and r = 0.35 , P = 0.03 vs. LogCRP ) . Also , change in LogSAA correlated with change in insulin resistance ( r = 0.35 , P = 0.03 ) . Thus , in otherwise healthy , obese women , weight loss was associated with significant decreases in both SAA and CRP . These effects were proportional to the amount of weight lost but independent of dietary macronutrient composition",
"Context Few data address whether exercise slows progression of atherosclerosis . Contribution In this 6-year trial , middle-aged Finnish men were r and omly assigned to progressive aerobic exercise or usual activity . Progressive exercise targeted 45- to 60-minute sessions 5 times weekly of activities such as walking , jogging , or cycling . Exercisers improved their ventilatory aerobic threshold and decreased their resting heart rate . However , intimamedia thickness of the carotid artery measured by ultrasonography did not differ between groups , except in a subgroup of men not taking statins . Implication s Aerobic exercise did not slow progression of atherosclerosis in middle-aged men , except for those not taking statins . The Editors Observational studies suggest that physical inactivity and low cardiorespiratory fitness predict atherosclerotic cardiovascular disease ( CVD ) ( 1 - 6 ) and that an increase in habitual physical activity ( 7 ) and cardiorespiratory fitness ( 8) are associated with decreased mortality . These findings are the basis for a general public health message recommending a minimum of 30 minutes of regular moderate exercise per day ( 9 ) . While exercise training at a weekly energy expenditure of 1500 kcal or more attenuates the progression of angiographically established coronary atherosclerosis ( 10 ) , there are no data from r and omized , controlled trials on the antiatherosclerotic effects of regular physical exercise in a general population . Moreover , studies using CVD mortality as an end point would require enormous sample sizes , and ethical issues limit the use of intracoronary arteriography in asymptomatic persons . Ultrasonographically assessed intimamedia thickness of the carotid arteries allows noninvasive investigation of pre clinical stages of atherosclerosis in unselected human population s ( 11 ) . Intimamedia thickness has been used as a surrogate end point for clinical coronary events ( 12 ) and in clinical trials ( 13 ) . We previously reported an inverse association of cardiorespiratory fitness to carotid artery intimamedia thickness ( 14 ) and its progression rate ( 15 ) . Clinical trials have revealed several plausible antiatherogenic mechanisms of exercise , such as favorable changes in plasma lipid levels , blood pressure , body adiposity , plasma glucose levels , insulin levels , and hemostatic factors ( 9 ) . However , these effects only partially explain the inverse association between physical activity and CVD . Inflammation plays a major role in the pathogenesis of atherosclerosis ( 16 ) . High-sensitivity C-reactive protein ( CRP ) levels are a marker of inflammation , and even slightly elevated serum levels of CRP predict clinical manifestations of atherosclerotic CVD ( 17 ) . Short-term uncontrolled studies suggest that physical activity has a beneficial impact on the inflammatory reaction ( 18 ) . In the DNASCO ( DNA Polymorphism and Carotid Atherosclerosis ) Study , a 6-year r and omized , controlled trial in a population -based sample of middle-aged men , we investigated the effect of regular long-term physical exercise on chronic low- grade inflammation and the progression of atherosclerosis , as assessed by noninvasive repeated measurements of carotid artery intimamedia thickness . Methods Study Design The primary end point was progression of the mean intimamedia thickness of the carotid artery in a 6-year r and omized , controlled trial of an exercise intervention . The Research Ethics Committee of the Kuopio University Hospital approved the protocol . Figure 1 shows the flow of patients through the study during recruitment , intervention allocation , and follow-up to data analysis . Participants were a r and om sample obtained from the population registry . Men were sent a letter inviting them to participate , and all participants provided signed informed consent . Forty-eight men did not respond to the invitation , and another 40 men did not present to the laboratory for the baseline examinations ; no data are available on the characteristics of these 88 men . Figure 1 . Flow of participants through the study . In 1994 to 1995 , 140 men were r and omly assigned to the exercise group ( n= 70 ) or the control group ( n= 70 ) by selecting a sealed , opaque envelope that contained the group assignment . The envelopes appeared identical , and an equal number was reserved for both study groups . Exclusion criteria were diseases or physical conditions restricting participation in regular exercise and malignant diseases or mental states restricting cooperation . During the 6-year intervention , 20 men ( 9 in the exercise group and 11 in the control group ) dropped out because of death ( 2 in the exercise group and 4 in the control group ) , severe diseases ( 4 in the control group ) , relocation ( 1 in the exercise group ) , or loss of motivation ( 6 in the exercise group and 3 in the control group ) . For statistical analyses , multiple imputation methods were applied to replace missing end-point values . The first dropouts , all due to death , did not take place until the third year . Table 1 shows the number of patients with common chronic diseases as well as the number of patients who received drug treatment during the intervention . Table 1 . Patients with Chronic Diseases and Those Who Received Drug Treatment during the Intervention Primary End Point Carotid artery atherosclerosis was measured ultrasonographically as the mean intimamedia thickness . The same certified sonographer performed all biannual scannings during the 6 years , and we report results from 6 study visits ( at baseline and at years 2 through 6 ) . An ultrasound device with a high-resolution 10-MHz transducer was used , following a st and ardized and pretested protocol , and the scannings were recorded on super VHS videotape . The calibration of the ultrasound unit was routinely checked . Another certified sonographer measured intimamedia thickness of the far wall of the right carotid artery . Both sonographers were blinded to the r and omization status of the study participants . The measurement of intimamedia thickness extended to the longest wall region where the lumenintimal and mediaadventitial boundaries could be clearly identified by an automated edge-detection program on the basis of active contour ( 19 ) . The mean intimamedia thickness of the traced region was used for the statistical analysis . Cardiorespiratory Performance , Exercise Electrocardiography , and Blood Pressure To allow assessment of changes in cardiorespiratory fitness and to monitor exercise habits more objective ly , all participants annually performed a bicycle ergospirometry test . The patients ' electrocardiograms were continuously monitored and recorded every minute during the test and up to 7 minutes after exercise . An exercise physiologist visually defined ventilatory aerobic threshold as the first nonlinear increase of ventilation in the ergospirometry test . A trained nurse measured blood pressure annually . After the men had been lying on an examination bed for 45 minutes , blood pressure was measured by a r and om-zero mercury sphygmomanometer , according to the MONICA ( MONItoring CArdiovascular disease ) protocol ( 20 ) . Exercise Intervention The men in the exercise group were prescribed walking , jogging , cross-country skiing , swimming , and cycling as the main methods of aerobic exercise . The program was progressive : During the first 3 months , the men were advised to exercise 3 times per week for 30 to 45 minutes per session . Thereafter , they were asked to exercise 5 times per week for 45 to 60 minutes per session . Exercise intensity was determined individually , and modified when necessary , to correspond to ventilatory threshold level , that is , 40 % to 60 % of maximal oxygen uptake . The men in the exercise group were given heart rate monitors to help them adhere to the prescribed training heart rate . The participants performed the program on their own and were asked to report each exercise session in a diary , which was checked in a face-to-face meeting with an exercise physiologist at 6-month intervals . In accordance with the regulations of the Ethics Committee , men in the control group were allowed to choose whether to engage in physical exercise , but no efforts were made to change their habitual activity . Accordingly , the participants in the control group were not asked to report their exercise habits in a diary . Biochemical Analyses Blood sampling and serum assays for fasting cholesterol and its subfractions have been described elsewhere ( 21 ) . Serum high-sensitivity CRP levels were measured by a commercial immunoassay ( IMMULITE 2000 High-Sensitivity CRP , Diagnostic Products Corp. , Los Angeles , California ) using the IMMULITE 2000 Analyzer ( Diagnostic Products Corp. ) . Other Methods Participants were asked about smoking habits and were classified as smokers or nonsmokers on the basis of current smoking status . Dietary energy and fat intake were assessed annually with 4-day food records ( 3 weekdays and Sunday ) . Portion sizes were estimated by using a picture booklet or household measurement units . Records were analyzed by using MicroNutrica software ( The Social Insurance Institution , Turku , Finl and ) , based on nutrient files from Finnish food analyses ( 22 ) . Statistical Analysis An estimate of the sample size ( 2n= 114 ) was based on assumptions about the reduction ( 25 % ) in the rate of progression of intimamedia thickness between the exercise and control groups , the duration of the trial ( 6 years ) , the number of equally spaced end-point measurements ( 7 ) , variability due to participants and measurement error ( 0.4 mm ) , and dropout rate ( 25 % ) . The significance level was 5 % , with a power of 90 % ( 23 ) . Statistical analyses were based primarily on an intention-to-treat approach with 140 participants . For secondary analyses , patients treated with cholesterol synthesis inhibitors , which are known to have a powerful antiatherosclerotic effect ( 24 ) , were excluded ( 6 in the exercise group and 9 in the control group ) ( Figure 1 ) . Multiple imputation methods available in"
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In recent years , questions have been raised regarding the cardiovascular safety of testosterone replacement therapy ( TRT ) . The objective of this study was to systematic ally review the available evidence on TRT safety in men , specifically with respect to the risk of stroke . We identified publications from MEDLINE , EMBASE , and the Cochrane Central Register of Controlled Trials up to May 2017 . Articles eligible for review included observational studies evaluating TRT and the risk of stroke among men aged 18 or older . R and omized controlled trials ( RCTs ) comparing testosterone to placebo in men were also eligible , provided stroke was identified as an adverse event . Among seven cohort studies of hypogonadal men , one study reported that TRT was associated with a significant decrease in the risk of ischemic stroke ( hazard ratio ( HR ) 0.64 ; 95 % confidence interval ( CI ) 0.52 - 0.80 ) . Another reported a similar decrease in risk ( HR 0.64 ; 95 % CI 0.43 - 0.96 ) among treated men who achieved normalized levels of testosterone . Limitations in study design , including immortal time bias and residual confounding , may have influenced both of these results . The remaining observational studies did not report measures of association to estimate the independent risk of stroke associated with TRT . Among eight RCTs , a low frequency of stroke events ( TRT and the risk of stroke in men remains unclear , and further large and method ologically robust studies are needed to establish this relationship
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"Testosterone ( T ) therapy in older men with low serum T levels increases lean body mass and decreases fat mass . These changes might improve physical performance and strength ; however , it has not been established whether T therapy improves functional outcome in older men . Moreover , concerns exist about the impact of T therapy on the prostate in older men . The administration of finasteride ( F ) , which partially blocks the conversion of T to the more potent and rogen , dihydrotestosterone , attenuates the impact of T replacement on prostate size and prostate-specific antigen . We hypothesized that T replacement in older , hypogonadal men would improve physical function and that the addition of F to this regimen would continue to provide the T-induced improvements in physical performance , strength , and body composition . Seventy men with low serum T ( , were r and omly assigned to receive one of three regimens for 36 months : 1 ) T enanthate , 200 mg i m every 2 wk , with placebo pills daily ( T-only ) ; 2 ) T enanthate , 200 mg every 2 wk , with 5 mg F daily ( T + F ) ; or 3 ) placebo injections and pills ( placebo ) . We obtained serial measurements of timed physical performance , grip strength , lower extremity strength , body composition ( by dual-energy x-ray absorptiometry ) , fasting cholesterol profiles , and hormones . Fifty men completed the 36-month protocol . After 36 months , T therapy significantly improved performance in a timed functional test when compared with baseline and placebo [ 4.3 + /- 1.6 % ( mean + /- sem , T-only ) and 3.8 + /- 1.0 % ( T + F ) vs. -5.6 + /- 1.9 % for placebo ( P h and grip strength compared with baseline and placebo ( P lean body mass [ 3.77 + /- 0.55 kg ( T-only ) and 3.64 + /- 0.56 kg ( T + F ) vs. -0.21 + /- 0.55 kg for placebo ( P decreased fat mass , and significantly decreased total cholesterol , low-density lipoprotein , and leptin , without affecting high-density lipoprotein , adiponectin , or fasting insulin levels . These results demonstrate that T therapy in older men with low serum T improves physical performance and strength over 36 months , when administered alone or when combined with F , and suggest that high serum levels of dihydrotestosterone are not essential for these beneficial effects of T in men",
"IMPORTANCE Rates of testosterone therapy are increasing and the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown . A recent r and omized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety . OBJECTIVES To assess the association between testosterone therapy and all-cause mortality , myocardial infa rct ion ( MI ) , or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease . DESIGN , SETTING , AND PATIENTS A retrospective national cohort study of men with low testosterone levels ( coronary angiography in the Veterans Affairs ( VA ) system between 2005 and 2011 . MAIN OUTCOMES AND MEASURES Primary outcome was a composite of all-cause mortality , MI , and ischemic stroke . RESULTS Of the 8709 men with a total testosterone level lower than 300 ng/dL , 1223 patients started testosterone therapy after a median of 531 days following coronary angiography . Of the 1710 outcome events , 748 men died , 443 had MIs , and 519 had strokes . Of 7486 patients not receiving testosterone therapy , 681 died , 420 had MIs , and 486 had strokes . Among 1223 patients receiving testosterone therapy , 67 died , 23 had MIs , and 33 had strokes . At 3 years after coronary angiography , the Kaplan-Meier estimated cumulative percentages with events were 19.9%in the no testosterone therapy group vs 25.7%in the testosterone therapy group , with an absolute risk difference of 5.8%(95%CI , -1.4%to 13.1 % ) [corrected].The Kaplan-Meier estimated cumulative percentages with events among the no testosterone therapy group vs testosterone therapy group at 1 year after coronary angiography were 10.1 % vs 11.3 % ; at 2 years , 15.4 % vs 18.5 % ; and at 3 years , 19.9 % vs 25.7 [corrected].There was no significant difference in the effect size of testosterone therapy among those with and without coronary artery disease ( test for interaction , P = .41 ) . CONCLUSIONS AND RELEVANCE Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level , the use of testosterone therapy was associated with increased risk of adverse outcomes . These findings may inform the discussion about the potential risks of testosterone therapy",
"And rogen replacement therapy ( ART ) efficacy on late-onset hypogonadism ( LOH ) has been widely investigated in Western countries ; however , it remains controversial whether ART can improve health and prolong active lifestyles . We prospect ively assessed long-term ART effects on the physical and mental statuses of aging men with LOH in Japan . The primary endpoint was health-related quality of life assessed by question naires . Secondary endpoints included glycemic control , lipid parameters , blood pressure , waist circumference , body composition , muscular strength , International Prostate Symptom Scores ( IPSS ) , International Index of Erectile Function-5 ( IIEF-5 ) scores , and serum prostate-specific antigen levels . Of the 1637 eligible volunteers , 334 patients > 40 years with LOH were r and omly assigned to either the ART ( n = 169 ) or control groups ( n = 165 ) . Fifty-two weeks after the initial treatment , ART significantly affected the role physical subdomain of the short form-36 health survey ( SF-36 ) scale ( P = 0.0318 ) . ART was also associated with significant decreases in waist circumstance ( P = 0.002 ) and serum triglyceride ( TG ) ( P = 0.013 ) and with significant increases in whole-body and leg muscle mass volumes ( P = 0.071 and 0.0108 , respectively ) , serum hemoglobin ( P IPSS voiding subscore ( P = 0.0418 ) , and the second question on IIEF-5 ( P = 0.0049 ) . There was no significant difference between the groups in terms of severe adverse events . In conclusion , in patients with LOH , long-term ART exerted beneficial effects on Role Physical subdomain of the SF-36 scale , serum TG , waist circumstance , muscle mass volume , voiding subscore of IPSS , and the second question of IIEF-5 . We hope our study will contribute to the future development of this area",
"AIMS Chronic heart failure is associated with maladaptive and prolonged neurohormonal and pro-inflammatory cytokine activation causing a metabolic shift favouring catabolism , vasodilator incapacity , and loss of skeletal muscle bulk and function . In men , and rogens are important determinants of anabolic function and physical strength and also possess anti-inflammatory and vasodilatory properties . METHODS AND RESULTS We conducted a r and omized , double-blind , placebo-controlled parallel trial of testosterone replacement therapy ( 5 mg And roderm ) at physiological doses in 76 men ( mean+/-SD , age 64+/-9.9 ) with heart failure ( ejection fraction 32.5+/-11 % ) over a maximum follow-up period of 12 months . The primary endpoint was functional capacity as assessed by the incremental shuttle walk test ( ISWT ) . At baseline , 18 ( 24 % ) had serum testosterone below the normal range and bioavailable testosterone correlated with distance walked on the initial ISWT ( r=0.3 , P=0.01 ) . Exercise capacity significantly improved with testosterone therapy compared with placebo over the full study period ( mean change + 25+/-15 m ) corresponding to a 15+/-11 % improvement from baseline ( P=0.006 ANOVA ) . Symptoms improved by at least one functional class on testosterone in 13 ( 35 % ) vs. 3 ( 8 % ) on placebo ( P=0.01 ) . No significant changes were found in h and grip strength , skeletal muscle bulk by cross-sectional computed tomography , or in tumour necrosis factor levels . Testosterone therapy was safe with no excess of adverse events although the patch preparation was not well tolerated by the study patients . CONCLUSION Testosterone replacement therapy improves functional capacity and symptoms in men with moderately severe heart failure",
"To determine the effects of daily oral doses of enclomiphene citrate compared with topical testosterone gel treatment on serum total testosterone ( TT ) , luteinising hormone ( LH ) , follicle‐stimulating hormone ( FSH ) , and sperm counts in men with secondary hypogonadism",
"OBJECTIVE Previous studies of sex hormone concentrations in depression yielded inconsistent results . However , the activation of the hypothalamic-pituitary-adrenal system seen in depression may negatively affect gonadal function at every level of regulation . The objective of this study was to explore whether major depressive episodes are indeed associated with an alteration of gonadal function . METHODS Testosterone , pulsatile LH secretion , FSH , and cortisol were assessed using frequent sampling during a 24-hour period in 15 male in patients with major depression of moderate to high severity and in 22 healthy comparison subjects ( age range 22 - 85 years ) . RESULTS An analysis of covariance model showed that after adjustment for age only , daytime testosterone ( p nighttime testosterone ( p 24-hour mean testosterone secretion ( p LH pulse frequency in the depressed patients ( p Gonadal function may be disturbed in men with a depressive episode of moderate to high severity",
"AIMS The aim of this study was to assess cardiovascular ( CV ) safety of testosterone replacement therapy ( TRT ) in a large , diverse cohort of European men with hypogonadism ( HG ) . METHODS The Registry of Hypogonadism in Men ( RHYME ) was design ed as a multi-national , longitudinal disease registry of men diagnosed with hypogonadism ( HG ) at 25 clinical sites in six European countries . Data collection included a complete medical history , physical examination , blood sampling and patient question naires at multiple study visits over 2 - 3 years . Independent adjudication was performed on all mortalities and CV outcomes . RESULTS Of 999 patients enrolled with clinical ly diagnosed HG , 750 ( 75 % ) initiated some form of TRT . Registry participants , including both treated and untreated patients , contributed 23 900 person-months ( 99.6 % of the targeted ) follow-up time . A total of 55 reported CV events occurred in 41 patients . Overall , five patients died of CV-related causes ( 3 on TRT , 2 untreated ) and none of the deaths were adjudicated as treatment-related . The overall CV incidence rate was 1522 per 100 000 person-years . CV event rates for men receiving TRT were not statistically different from untreated men ( P=.70 ) . Regardless of treatment assignment , CV event rates were higher in older men and in those with increased CV risk factors or a prior history of CV events . CONCLUSIONS Age and prior CV history , not TRT use , were predictors of new-onset CV events in this multi-national , prospect i ve hypogonadism registry",
"As men age , serum testosterone concentrations decrease , the percentage of body mass that is fat increases , the percentage of lean body mass decreases , and muscle strength decreases . Because these changes are similar to those that occur in hypogonadal men , we hypothesized that increasing the serum testosterone concentration of men over 65 yr of age to that in young men would decrease their fat mass , increase their lean mass , and increase their muscle strength . We r and omized 108 men over 65 yr of age to wear either a testosterone patch or a placebo patch in a double blind study for 36 months . We measured body composition by dual energy x-ray absorptiometry and muscle strength by dynamometer before and during treatment . Ninety-six men completed the entire 36-month protocol . Fat mass decreased ( -3.0+/-0.5 kg ) in the testosterone-treated men during the 36 months of treatment , which was significantly different ( P = 0.001 ) from the decrease ( -0.7+/-0.5 kg ) in the placebo-treated men . Lean mass increased ( 1.9+/-0.3 kg ) in the testosterone-treated men , which was significantly different ( P decrease in fat mass in the testosterone-treated men was principally in the arms ( -0.7+/-0.1 kg ; P lean mass was principally in the trunk ( 1.9+/-0.3 kg ; P strength of knee extension and flexion at 60 degrees and 180 degrees angular velocity during treatment , however , was not significantly different between the two groups . We conclude that increasing the serum testosterone concentrations of normal men over 65 yr of age to the midnormal range for young men decreased fat mass , principally in the arms and legs , and increased lean mass , principally in the trunk , but did not increase the strength of knee extension and flexion , as measured by dynamometer",
"Transdermal testosterone ( T ) delivery represents an effective alternative to injectable and rogens . We studied 163 hypogonadal men who applied 5 , 7.5 , or 10 g And roGel ( T gel ) 1 % CIII per day for up to 42 months . Efficacy data were presented in 123 subjects considered evaluable . Continuous And roGel treatment normalized mean serum T and free T levels . Mean serum 5alpha-dihydrotestosterone concentrations and 5alpha-dihydrotestosterone/T ratio slightly increased , mean serum estradiol/T ratio doubled , and mean serum FSH and LH levels were suppressed by T replacement . Sexual function and mood parameters improved rapidly and were maintained throughout T treatment . Lean body mass increased ( P = 0.0001 ) and fat mass decreased ( P = 0.0001 ) , and these changes were maintained with treatment but were not accompanied by significant increases in muscle strength . Increases in serum bone markers suggestive of increased bone formation were followed by gradual and progressive increases in bone mineral density more in the spine ( P = 0.0001 ) than the hip ( P = 0.0004 ) . Mild local skin irritation occurred in 12 subjects , result ing in discontinuation in only one subject . Except for the anticipated increase in hematocrit and hemoglobin , there were no clinical ly significant changes in blood counts or biochemistry . In three subjects with elevated serum prostate-specific antigen , prostate biopsies showed cancer . We conclude that continued application of And roGel result ed in beneficial effects similar to those with injectables and other transdermal preparations . This study was neither placebo controlled nor powered to determine the effects of T treatment on prostate cancer risk . Thus , monitoring for prostatic disease and assessment for erythrocytosis are strongly advised to reduce the risk of adverse events with T treatment of hypogonadal men",
"IMPORTANCE Testosterone use in older men is increasing , but its long-term effects on progression of atherosclerosis are unknown . OBJECTIVE To determine the effect of testosterone administration on sub clinical atherosclerosis progression in older men with low or low-normal testosterone levels . DESIGN , SETTING , AND PARTICIPANTS Testosterone 's Effects on Atherosclerosis Progression in Aging Men ( TEAAM ) was a placebo-controlled , double-blind , parallel-group r and omized trial involving 308 men 60 years or older with low or low-normal testosterone levels ( 100 - 400 ng/dL ; free testosterone Recruitment took place between September 2004 and February 2009 ; the last participant completed the study in May 2012 . INTERVENTIONS One hundred fifty-six participants were r and omized to receive 7.5 g of 1 % testosterone and 152 were r and omized to receive placebo gel packets daily for 3 years . The dose was adjusted to achieve testosterone levels between 500 and 900 ng/dL. MAIN OUTCOMES AND MEASURES Co primary outcomes included common carotid artery intima-media thickness and coronary artery calcium ; secondary outcomes included sexual function and health-related quality of life . RESULTS Baseline characteristics were similar between groups : patients were a mean age of 67.6 years ; 42 % had hypertension ; 15 % , diabetes ; 15 % , cardiovascular disease ; and 27 % , obesity . The rate of change in intima-media thickness was 0.010 mm/year in the placebo group and 0.012 mm/year in the testosterone group ( mean difference adjusted for age and trial site , 0.0002 mm/year ; 95 % CI , -0.003 to 0.003 , P = .89 ) . The rate of change in the coronary artery calcium score was 41.4 Agatston units/year in the placebo group and 31.4 Agatston units/year in the testosterone group ( adjusted mean difference , -10.8 Agatston units/year ; 95 % CI , -45.7 to 24.2 ; P = .54 ) . Changes in intima-media thickness or calcium scores were not associated with change in testosterone levels among individuals assigned to receive testosterone . Sexual desire , erectile function , overall sexual function scores , partner intimacy , and health-related quality of life did not differ significantly between groups . Hematocrit and prostate-specific antigen levels increased more in testosterone group . CONCLUSIONS AND RELEVANCE Among older men with low or low-normal testosterone levels , testosterone administration for 3 years vs placebo did not result in a significant difference in the rates of change in either common carotid artery intima-media thickness or coronary artery calcium nor did it improve overall sexual function or health-related quality of life . Because this trial was only powered to evaluate atherosclerosis progression , these findings should not be interpreted as establishing cardiovascular safety of testosterone use in older men . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00287586"
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Necrotizing enterocolitis ( NEC ) is a major cause of mortality ( 25 % ) and morbidity including recurrent sepsis , dependence on parenteral nutrition , need for surgery , and survival with short bowel syndrome in preterm very low birth weight infants . Mortality ( 45 - 100 % ) and morbidity including the risk of long-term neurodevelopmental impairment are higher in extremely preterm infants needing surgery for NEC . Systematic review s of r and omized controlled trials ( RCT ) indicate that probiotics significantly reduce the risk of NEC ( RR 0.39 ; 95 % CI 0.29 - 0.52 ; p and all-cause mortality ( RR 0.52 ; 95 % CI 0.40 - 0.69 ; p 25 RCT ( ∼5,000 neonates ) and reports on routine use ( ∼3,000 neonates ) indicates that significant adverse effects of probiotics are rare . Despite the robust evidence , there is still reluctance in incorporating routine probiotic prophylaxis in clinical practice . If the goal is to have zero tolerance for NEC , then probiotic prophylaxis must be adopted as soon as possible . Current gaps in knowledge can be addressed by continued research while providing routine probiotic supplementation . We believe that the concept of evidence -based practice of medicine has been stretched too far in this case . Trial sequential analysis has already shown that the evidence for probiotic supplementation was conclusive after 10 trials . Results of the ongoing trials are unlikely to change the conclusions of the systematic review s significantly . Currently we are at trial number 25 ; how many more trials do we need ? What will it take to change clinical practice
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"UNLABELLED The aim of the study is to compare the role of killed ( KP ) Lactobacillus acidophilus with living ( LP ) in reducing incidence of sepsis ( NS ) and necrotizing enterocolitis ( NEC ) in neonates . R and omized double blind placebo study , included 150 neonates admitted to NICU at day 1 , sixty received oral ( LP ) and 60 received ( KP ) and 30 received placebo . One gram of stools was collected on admission , at day 7 , at end of the study , as well as on suspected NEC or NS and was sent for culture . RESULTS LP and KP were preventive factors for NEC with absolute risk reduction ( AAR ) 16 , 15 % , respectively and 18 % for NS compared to placebo . Incidence of NEC and NS did not differ significantly between neonates supplemented with LP and those with KP . Preterm neonates supplemented with KP showed significantly lower incidence of NEC compared to placebo , while incidence of NS showed no significant difference between both groups . There is significant reduction in NS and NEC among neonates with positive Lactobacillus colonization of gut compared to those none colonized at day 7 ( 27.9 vs. 85.9 % , 0 vs. 7.8 % ) and at day 14 ( 48.7 vs. 91.7 % for NS and 0 vs. 20.8 % for NEC ) . Overall comparison between the three groups showed statistical significant reduction in the incidence of NEC . Present conclusions are that early gut colonization with beneficial bacteria lowers the incidence of NEC and NS . KP retained similar benefits to live bacteria",
"BACKGROUND Probiotics are used for the prevention of necrotizing enterocolitis ( NEC ) because of their positive effects on intestinal motor function , modulation of inflammatory response , and mucosal barrier function . OBJECTIVE The objective was to assess whether the combined use of Lactobacillus casei and Bifidobacterium breve may prevent the occurrence of NEC stage ≥ 2 by the criteria of Bell in very-low-birth-weight preterm infants . DESIGN A double-blind , r and omized , controlled clinical trial was conducted in 231 preterm infants weighing from 750 to 1499 g at birth . The intervention group was composed of 119 infants who received human milk with probiotic supplementation ( B. breve and L. casei ) and a control group of 112 infants who received human milk containing no probiotics . The primary outcome was the occurrence of NEC stage ≥ 2 as defined by Bell 's modified criteria . RESULTS Four confirmed cases of NEC stage ≥ 2 by Bell 's criteria occurred only in the control group . CONCLUSIONS Oral supplementation of B. breve and L. casei reduced the occurrence of NEC ( Bell 's stage ≥ 2 ) . It was considered that an improvement in intestinal motility might have contributed to this result . This trial was registered at www.is rct in.org as number 67165178 ( International St and ard R and omized Controlled Trial )",
"Diastolic dysfunction is usually identified by the combination of characteristic mitral and pulmonary vein flow patterns . However , obtaining a complete set of echocardiographic parameters can be technically difficult and data may conflict . We hypothesized that as a st and -alone variable , ( ventricular ) diastolic dominant pulmonary vein flow would predict heart failure ( HF ) hospitalizations and cardiovascular death . St and ard transthoracic echocardiograms were obtained in 906 subjects from the Heart and Soul Study , a prospect i ve study of the effects of depression on coronary heart disease . Pulmonary vein flow pattern was determined using the dominant velocity-time integral . Cardiac events were determined by 2 independent adjudicators , and Cox proportional hazards models were used . Systolic dominant pulmonary vein flow was present in 89 % of subjects , and diastolic dominant , in the remaining 11 % . During an average 4.1 years of follow-up , subjects with diastolic dominant pulmonary vein flow had a 25 % rate of HF hospitalization and 9 % rate of cardiovascular death . After multivariate adjustment including left ventricular ejection fraction , diastolic pulmonary vein flow was associated with a 3-fold risk of HF hospitalization ( p = 0.001 ) and a 2-fold risk of HF hospitalization or death ( p = 0.004 ) . In conclusion , diastolic dominant pulmonary vein flow pattern was a st and -alone predictor of adverse cardiac events , and its presence was associated with significantly higher rates of HF hospitalizations and cardiovascular death",
"ABSTRACT The gastrointestinal microbiota of preterm infants in a neonatal intensive care unit differs from that of term infants . In particular , the colonization of preterm infants by bifidobacteria is delayed . A double-blind , placebo-controlled , r and omized clinical study was performed on 69 preterm infants to investigate the role of Bifidobacterium lactis Bb12 supplementation in modifying the gut microbiota . Both culture-dependent and culture-independent approaches were used to study the gut microbiota . Bifidobacterial numbers , determined by fluorescence in situ hybridization , were significantly higher in the probiotic than in the placebo group ( log10 values per g of fecal wet weight : probiotic , 8.18 + 0.54 [ st and ard error of the mean ] ; placebo , 4.82 + 0.51 ; P bifidobacterial numbers was also obtained with the culture-dependent method . The infants supplemented with Bb12 also had lower viable counts of Enterobacteriaceae ( log10 values of CFU per g of fecal wet weight : probiotic , 7.80 + 0.34 ; placebo , 9.03 + 0.35 ; P = 0.015 ) and Clostridium spp . ( probiotic , 4.89 + 0.30 ; placebo , 5.99 + 0.32 ; P = 0.014 ) than the infants in the placebo group . Supplementation of B. lactis Bb12 did not reduce the colonization by antibiotic-resistant organisms in the study population . However , the probiotic supplementation increased the cell counts of bifidobacteria and reduced the cell counts of enterobacteria and clostridia",
"Objective : To evaluate the efficacy of probiotics in the prevention of gastrointestinal colonization by C and ida species , of late-onset sepsis and neurological outcome in preterm newborns . Study Design : A prospect i ve study was conducted in 249 preterms who were subdivided into three groups : one group ( n=83 ) was supplemented with Lactobacillus ( L. ) reuteri , one group with L. rhamnosus ( n=83 ) and the other with no supplementation ( n=83 ) . The fungal colonization in the gastrointestinal tract , the late onset of sepsis and clinical parameters were recorded . A neurological structured assessment was further performed at 1 year of age . Result : C and ida stool colonization was significantly higher ( P L. reuteri group presented a significantly higher reduction in gastrointestinal symptoms than did the L. rhamnosus and control groups . Infants treated with probiotics showed a statistically significant lower incidence of abnormal neurological outcome than did the control group . Conclusion : The use of both probiotics seems to be effective in the prevention of gastrointestinal colonization by C and ida , in the protection from late-onset sepis and in reducing abnormal neurological outcomes in preterms",
"BACKGROUND AND OBJECTIVE : It has been suggested that probiotics may decrease infant mortality and nosocomial infections because of their ability to suppress colonization and translocation of bacterial pathogens in the gastrointestinal tract . We design ed a large double-blinded placebo-controlled trial using Lactobacillus reuteri to test this hypothesis in preterm infants . METHODS : Eligible infants were r and omly assigned during the first 48 hours of life to either daily probiotic administration or placebo . Infants in the intervention group were administered enterally 5 drops of a probiotic preparation containing 108 colony-forming units of L reuteri DSM 17938 until death or discharge from the NICU . RESULTS : A total of 750 infants ≤2000 g were enrolled . The frequency of the primary outcome , death , or nosocomial infection , was similar in the probiotic and placebo groups ( relative risk 0.87 ; 95 % confidence interval : 0.63–1.19 ; P = .376 ) . There was a trend toward a lower rate of nosocomial pneumonia in the probiotic group ( 2.4 % vs 5.0 % ; P = .06 ) and a nonsignificant 40 % decrease in necrotizing enterocolitis ( 2.4 % vs 4.0 % ; P = .23 ) . Episodes of feeding intolerance and duration of hospitalization were lower in infants ≤ 1500 g ( 9.6 % vs 16.8 % [ P = .04 ] ; 32.5 days vs 37 days [ P = .03 ] ) . CONCLUSIONS : Although L reuteri did not appear to decrease the rate of the composite outcome , the trends suggest a protective role consistent with what has been observed in the literature . Feeding intolerance and duration of hospitalization were decreased in premature infants ≤1500",
"Abstract Background Late onset sepsis is a frequent complication of prematurity associated with increased mortality and morbidity . The commensal bacteria of the gastrointestinal tract play a key role in the development of healthy immune responses . Healthy term infants acquire these commensal organisms rapidly after birth . However , colonisation in preterm infants is adversely affected by delivery mode , antibiotic treatment and the intensive care environment . Altered microbiota composition may lead to increased colonisation with pathogenic bacteria , poor immune development and susceptibility to sepsis in the preterm infant . Probiotics are live microorganisms , which when administered in adequate amounts confer health benefits on the host . Amongst numerous bacteriocidal and nutritional roles , they may also favourably modulate host immune responses in local and remote tissues . Meta-analyses of probiotic supplementation in preterm infants report a reduction in mortality and necrotising enterocolitis . Studies with sepsis as an outcome have reported mixed results to date .Allergic diseases are increasing in incidence in \" westernised \" countries . There is evidence that probiotics may reduce the incidence of these diseases by altering the intestinal microbiota to influence immune function . Methods / Design This is a multi-centre , r and omised , double blinded , placebo controlled trial investigating supplementing preterm infants born at , with a probiotic combination ( Bifidobacterium infantis , Streptococcus thermophilus and Bifidobacterium lactis ) . A total of 1,100 subjects are being recruited in Australia and New Zeal and . Infants commence the allocated intervention from soon after the start of feeds until discharge home or term corrected age . The primary outcome is the incidence of at least one episode of definite ( blood culture positive ) late onset sepsis before 40 weeks corrected age or discharge home . Secondary outcomes include : Necrotising enterocolitis , mortality , antibiotic usage , time to establish full enteral feeds , duration of hospital stay , growth measurements at 6 and 12 months ' corrected age and evidence of atopic conditions at 12 months ' corrected age . Discussion Results from previous studies on the use of probiotics to prevent diseases in preterm infants are promising . However , a large clinical trial is required to address outst and ing issues regarding safety and efficacy in this vulnerable population . This study will address these important issues . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : ACTRN012607000144415 The product \" ABC Dophilus Probiotic Powder for Infants ® \" , Solgar , USA has its 3 probiotics strains registered with the Deutsche Sammlung von Mikroorganismen und Zellkulturen ( DSMZ - German Collection of Microorganisms and Cell Cultures ) as BB-12 15954 , B-02 96579 , Th-4 15957",
"Background : Nosocomial infections endanger preterm infants . Objective : The aim of the present controlled r and omized trial was to investigate whether Bifidobacterium lactis reduces the incidence of nosocomial infections in infants with very low birth weight ( VLBW ; Patients and Methods : In a r and omized controlled trial , 183 VLBW infants were stratified according to gestational age ( 23–26 and 27–29 weeks ) and early antibiotic therapy ( days 1–3 , yes or no ) and r and omly assigned to have their milk feedings supplemented with B. lactis ( 6 × 2.0 × 109 CFU/kg/day , 12 billion CFU/kg/day ) or placebo for the first 6 weeks of life . Primary outcome was the ‘ incidence density ’ of nosocomial infections defined as periods of elevated C-reactive protein ( > 10 mg/l ) from day 7 after initiation of milk feedings until the 42nd day of life ( number of nosocomial infections/total number of patient days ) . The main secondary outcome was necrotizing enterocolitis ( NEC ; ≧stage 2 ) . Results : There were 93 infants in the B. lactis group and 90 in the placebo group . There was no significant difference between the two groups with regard to the incidence density of nosocomial infections ( 0.021 vs. 0.016 ; p = 0.9 , χ2 test ) . There were 2 cases of NEC in the B. lactis group and 4 in the placebo group . None of the blood cultures grew B. lactis . Conclusion : In the present setting , B. lactis at a dosage of 6 × 2.0 × 109 CFU/kg/day ( 12 billion CFU/kg/day ) did not reduce the incidence density of nosocomial infections in VLBW infants . No adverse effect of B. lactis was observed",
"Background A r and omised , double-blind clinical trial was undertaken in order to assess the effectiveness of probiotics in the prevention of necrotising enterocolitis ( NEC ) in newborns weighing Methods We studied a group of 150 patients who were r and omised in two groups after parental consent was obtained , to receive either a daily feeding supplementation with a multispecies probiotic ( Lactobacillus acidophilus , Lactobacillus rhamnosus , Lactobacillus casei , Lactobacillus plantarum , Bifidobacteruim infantis , Streptococcus thermophillus ) 1 g per day plus their regular feedings or to receive their regular feedings with nothing added ( control group ) , over the period of January 2007 through June 2010 . Clinicians in care of the infants were blinded to the group assignment . Results The primary outcome was the development of NEC . Both groups were comparable , with no differences during hospitalisation , including the type of nutrition received . Blood cultures obtained from cases that developed sepsis did not reveal lactobacillus or Bifidobacteria growth . No differences were detected in terms of NEC risk reduction ( RR : 0.54 , 95 % CI 0.21 to 1.39 ) although we did observe a clear trend in the reduction of NEC frequency in the studied cases : 6 ( 8 % ) versus 12 ( 16 % ) in the control group . When the combined risk of NEC or death was calculated as a post hoc analysis , we found a significantly lower risk ( RR : 0.39 , 95 % CI 0.17 to 0.87 ) for the study group . Conclusions Probiotics may offer potential benefits for premature infants and are a promising strategy in the reduction of the risk of NEC in preterm newborns",
"BACKGROUND Saccharomyces boulardii ( SB ) is a yeast that acts both as a probiotic and as a polyamine producer . Probiotics prevent the overgrowth of pathogens in the gut while polyamines enhance intestinal maturation . The aim of this r and omized study was to investigate the ability of SB to modify the gut microbial ecology and its function . METHODS A total of 87 healthy babies with gestational age 28 - 32 weeks were studied . They were r and omly assigned to receive a preterm formula to which SB or maltodextrins was added for 30 days . Evaluations were made on the following : SB tolerance and weight gain , faecal flora analysis , intestinal D-xylose absorption and faecal lipid excretion . RESULTS SB was well tolerated by the infants . There was no difference in weight gain between the two groups . Median log of colony forming units per gram of faeces for Escherichia coli and enterococci was significantly lower in the SB group [ E. coli : 2.67 ( 0.045 ) vs. 2.75 ( 0.058 ) , P number of bifidobacteria and staphylococci in the stools was significantly higher in the SB group [ bifidobacteria : 2.65 ( 0.083 ) vs. 2.27 ( 0.075 ) , P D-Xylose and lipid absorption was not improved by SB [ median blood D-xylose : 1.5 ( 0.4 ) mmol/l vs. 1.35 ( 0.3 ) mmol/l , P>0.1 ; median stool steatocrit : 64 % ( 3.05 % ) vs. 65 % ( 2.72 % ) P>0.5 ] . CONCLUSIONS An SB-supplemented formula is well tolerated by preterm infants , it has a beneficial effect on stool flora bringing it closer to that of breast fed babies but it does not improve D-xylose or lipid gut absorption",
"BACKGROUND Preterm infants have increased intestinal permeability which can render them susceptible to infections from enterobacteriae . OBJECTIVES The primary objective was to investigate whether probiotic administration to preterm infants decreases intestinal permeability . Secondary outcomes studied were : somatic growth , tolerance , rates of sepsis and necrotizing enterocolitis . METHODS In a prospect i ve r and omized case-control study 41 stable preterm infants of 27 to 36 weeks gestation and 34 matched comparison infants consecutively admitted to the neonatal unit were studied . The study group received a preterm formula supplemented with Bifidobacter lactis ( 2 x 10(7 ) cfu/g of dry milk ) while the control group received the same formula but without supplementation . Intestinal permeability was measured within two days of birth and then seven and thirty days later using the sugar absorption test . Additionally anthropometric parameters were recorded throughout the study as well as acceptance and tolerance of the formula . RESULTS All infants tolerated the study formula well . Median counts of stool bifidobacteria and lactulose/mannitol ratios at baseline were comparable . After 7 days of supplementation median bifidobacteria counts were significantly higher in the study group than in the control group ( p=0.0356 ) and they remained higher to the end of the study ( p at day 30=0.075 ) . The L/M ratio in the study group was significantly lower at day 30 of the study as compared to the control group ( p=0.003 ) . Head growth was significantly higher in the study group ( p=0.001 ) . CONCLUSIONS The administration of a bifidobacter supplemented infant formula decreases intestinal permeability of preterm infants and leads to increased head growth",
"Studies were carried out on premature infants in the neonatal intensive care unit to determine the effect of feeding of lactobacilli on colonization of the gastrointestinal tract by antibiotic-resistant gram-negative enteric organisms . Thirty premature infants were matched by birth weight and gestational age , r and omized and fed double blind either lactobacilli-containing formula or non-lactobacilli-containing formula within 72 hours of delivery . The two study groups were screened weekly by culture for stool lactobacilli , for gram-negative bacteria and for antibiotic resistance of these bacteria . Lactobacilli were cultured from the stools of 13 of 15 patients receiving lactobacilli and from 3 of 15 patients not receiving lactobacilli ( P Gram-negative enteric organisms were isolated during 40 of the 86 weeks ( 47 % ) of hospitalization for patients receiving lactobacilli and during 28 of 57 weeks ( 49 % ) for patients not receiving lactobacilli . There was no significant difference between the study groups in the number of resistant organisms or in the proportion of resistant organisms per gram-negative enteric isolates ( 4 of 40 vs. 0 of 28 ) . These results suggest that facultative gram-negative enteric bacterial colonization , with either total or aminoglycoside-resistant strains , is not decreased by oral feedings of Lactobacillus acidophilus in premature infants",
"Background : It has been suggested that probiotics can reduce the overgrowth of pathogens in the bowels of preterm infants and contribute to the reduction of the incidence of nosocomial infections in neonatal intensive care units ( NICUs ) . The purpose of this study was to evaluate the effectiveness of Lactobacillus GG supplementation in reducing the incidence of urinary tract infections ( UTIs ) , bacterial sepsis and necrotizing enterocolitis ( NEC ) in preterm infants . Methods : A double-blind study was conducted in 12 Italian NICUs . Newborn infants with a gestational age were r and omized to receive st and ard milk feed supplemented with Lactobacillus GG ( Dicoflor ® , Dicofarm , Rome , Italy ) in a dose of 6 × 109 colony-forming units ( cfu ) once a day until discharge , starting with the first feed or placebo . Results : Five hundred eighty-five patients were studied . The probiotics group ( n = 295 ) and the placebo group ( n = 290 ) exhibited similar clinical characteristics . The duration of Lactobacillus GG and placebo supplementation was 47.3 ± 26.0 and 48.2 ± 24.3 days , respectively . Although UTIs ( 3.4 vs. 5.8 % ) and NEC ( 1.4 vs. 2.7 % ) were found less frequently in the probiotic group compared to the control group , these differences were not significant . Bacterial sepsis was more frequent in the probiotics group ( 4.4 % , n = 11 ) than in the placebo group ( 3.8 % , n = 9 ) , but the difference was not significant . Conclusion : Seven days of Lactobacillus GG supplementation starting with the first feed is not effective in reducing the incidence of UTIs , NEC and sepsis in preterm infants . Further studies are required to confirm our results in lower birthweight population",
"Objective : The objective of this trial was to test whether probiotic-supplemented feeding to extremely low-birth-weight ( ELBW ) infants will improve growth as determined by decreasing the percentage of infants with weight below the 10th percentile at 34 weeks postmenstrual age ( PMA ) . Other important outcome measures , such as improving feeding tolerance determined by tolerating larger volume of feeding per day and reducing antimicrobial treatment days during the first 28 days from the initiation of feeding supplementation were also evaluated . Study Design : We conducted a multicenter r and omized controlled double-blinded clinical study . The probiotics-supplementation ( PS ) group received Lactobacillus rhamnosus GG and Bifidobacterium infantis added to the first enteral feeding and continued once daily with feedings thereafter until discharge or until 34 weeks ( PMA ) . The control ( C ) group received unsupplemented feedings . Infant weight and feeding volumes were recorded daily during the first 28 days of study period . Weights were also recorded at 34 weeks PMA . Result : A total of 101 infants were enrolled ( PS 50 versus C 51 ) . There was no difference between the two groups in the percentage of infants with weight below the 10th percentile at 34 weeks PMA ( PS group 58 % versus C group 60 % , ( P value 0.83 ) ) or in the average volume of feeding during 28 days after study entry ( PS group 59 ml kg−1 versus C group 71 ml kg−1 , ( P value 0.11 ) ) . Calculated growth velocity was higher in the PS group compared with the C group ( 14.9 versus 12.6 g per day , ( P value 0.05 ) ) . Incidences of necrotizing enterocolitis ( NEC ) , as well as mortality were similar between the two groups . Conclusion : Although probiotic-supplemented feedings improve growth velocity in ELBW infants , there was no improvement in the percentage of infants with growth delay at 34 weeks PMA . There were no probiotic-related adverse events reported",
"OBJECTIVE To evaluate the growth and neurodevelopment outcomes of very low-birth-weight ( VLBW ) preterm infants supplemented with oral probiotics for the prevention of necrotizing enterocolitis ( NEC ) . STUDY DESIGN This prospect i ve follow-up study was conducted in a cohort of VLBW preterm infants enrolled in a r and omized controlled clinical trial to evaluate the efficacy of oral probiotics for the prevention of NEC . Growth outcomes included weight , length , and head circumference . Cognitive and neuromotor development were assessed by using the Bayley Scales of Infant Development II . Sensory and neurological performance was evaluated by st and ard techniques . The primary outcome was neurodevelopmental impairment at 18 to 22 months ' corrected age . RESULTS A total of 221 infants completed the trial protocol . Of the 208 infants eligible for follow-up , 174 infants ( 86 in the probiotics group and 88 in the control group ) were evaluated . There was no significant difference in growth and neurodevelopmental outcomes between the two groups . CONCLUSION Oral probiotic administered to VLBW infants to reduce the incidence and severity of NEC started with the first feed did not affect growth , neuromotor , neurosensory , and cognitive outcomes at 18 to 22 months ' corrected age",
"BACKGROUND Colonization by C and ida species is the most important predictor of the development of invasive fungal disease in preterm neonates , and the enteric reservoir is a major site of colonization . We evaluated the effectiveness of an orally supplemented probiotic ( Lactobacillus casei subspecies rhamnosus ; Dicoflor [ Dicofarm spa ] ; 6 x 10(9 ) cfu/day ) in the prevention of gastrointestinal colonization by C and ida species in preterm , very low birth weight ( i.e. , METHODS Over a 12-month period , a prospect i ve , r and omized , blind , clinical trial that involved 80 preterm neonates with a very low birth weight was conducted in a large tertiary neonatal intensive care unit . During the first 3 days of life , the neonates were r and omly assigned to receive either an oral probiotic added to human ( maternal or pooled donors ' ) milk ( group A ) or human milk alone ( group B ) for 6 weeks or until discharge from the NICU , if the neonate was discharged before 6 weeks . On a weekly basis , specimens obtained from various sites ( i.e. , oropharyngeal , stool , gastric aspirate , and rectal specimens ) were collected from all patients for surveillance culture , to assess the occurrence and intensity of fungal colonization in the gastrointestinal tract . RESULTS The incidence of fungal enteric colonization ( with colonization defined as at least 1 positive culture result for specimens obtained from at least 1 site ) was significantly lower in group A than in group B ( 23.1 % vs. 48.8 % ; relative risk , 0.315 [ 95 % confidence interval , 0.120 - 0.826 ] ; P = .01 ) . The numbers of fungal isolates obtained from each neonate ( P = .005 ) and from each colonized patient ( P = .005 ) were also lower in group A than in group B. L. casei subspecies rhamnosus was more effective in the subgroup of neonates with a birth weight of 1001 - 1500 g. There were no changes in the relative proportions of the different C and ida strains . No adverse effects potentially associated with the probiotic were recorded . CONCLUSIONS Orally administered L. casei subspecies rhamnosus significantly reduces the incidence and the intensity of enteric colonization by C and ida species among very low birth weight neonates",
"Background / Objective : The identification of probiotic species involved in gut homeostasis and their potential therapeutic benefits have led to an interest in their use for preventing necrotizing enterocolitis ( NEC ) . Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials . Lactobacillus sporogenes has not been used in the prevention of NEC in very low-birth weight infants yet . The objective of this study was to evaluate the efficacy of orally administered L sporogenes in reducing the incidence and severity of NEC in very low-birth weight ( VLBW ) infants . Subjects/ Methods : A prospect i ve , blinded , r and omized controlled trial was conducted in preterm infants with a gestational age of The infants in the study group were given L. sporogenes with a dose of 350 000 000 c.f.u . added to breast milk or formula , once a day , starting with the first feed until discharged . The infants in the control group were fed without L. sporogenes supplementation . The primary outcome measurement was death or NEC ( Bell 's stage ⩾2 ) . Results : A total of 221 infants were studied : 110 in the study group and 111 in the control group . There was no significant difference in the incidence of death or NEC between the groups . Feeding intolerance was significantly lower in the probiotics group than in the control group ( 44.5 % ( n : 49 ) vs 63.1 % ( n : 70 ) , respectively ; P=0.006 ) . Conclusions : L. sporogenes supplementation at the dose of 350 000 000 c.f.u/day is not effective in reducing the incidence of death or NEC in VLBW infants , however , it could improve the feeding tolerance ",
"OBJECTIVE To evaluate growth and neurodevelopmental outcomes in preterm very low birth weight ( PVLBW ) infants treated with oral probiotics for the prevention of necrotizing enterocolitis ( NEC ) . STUDY DESIGN A prospect i ve follow-up study was performed in a cohort of PVLBW infants enrolled in a single center with a masked r and omized control trial to evaluate the efficacy of oral probiotics in preventing NEC . Growth measures included weight , length , and head circumference . Neurologic and sensory performance was evaluated with st and ard techniques . Psychometric parameters were measured used the Bayley Scales of Infant Development II ( BSID-II ) . The studies were performed at 3 years corrected age . The primary outcome was death or neurodevelopmental impairment . RESULTS Of the 367 subjects enrolled in trial , 301 ( 89.9 % ) were evaluated ( 153 in the probiotics group and 148 in the control group ) . There were no significant differences in growth or in any of the neurodevelopmental and sensory outcomes between the 2 groups . CONCLUSIONS Oral probiotics given to PVLBW infants at 1 week after birth to reduce the incidence of NEC did not affect growth and neurodevelopmental and sensory outcomes at 3 years corrected age",
"OBJECTIVES To determine the mortality and morbidity for infants weighing 401 to 1500 g ( very low birth weight [ VLBW ] ) at birth by gestational age , birth weight , and gender . STUDY DESIGN Perinatal data were collected prospect ively on an inborn cohort from January 1995 through December 1996 by 14 participating centers of the National Institute of Child Health and Human Development Neonatal Research Network and were compared with the corresponding data from previous reports . Sociodemographic factors , perinatal events , and the neonatal course to 120 days of life , discharge , or death were evaluated . RESULTS Eighty four percent of 4438 infants weighing 501 to 1500 g at birth survived until discharge to home or to a long-term care facility ( compared with 80 % in 1991 and 74 % in 1988 ) . Survival to discharge was 54 % for infants 501 to 750 g at birth , 86 % for those 751 to 1000 g , 94 % for those 1001 to 1250 g , and 97 % for those 1251 to 1500 g . The incidence of chronic lung disease ( CLD ; defined as receiving supplemental oxygen at 36 weeks ' postmenstrual age ; 23 % ) , proven necrotizing enterocolitis ( NEC ; 7 % ) , and severe intracranial hemorrhage ( ICH ; grade III or IV ; 11 % ) remained unchanged between 1991 and 1996 . Furthermore , 97 % of all VLBW infants and 99 % of infants weighing weights less than the 10th percentile at 36 weeks ' postmenstrual age . Mortality for 195 infants weighing 401 to 500 g was 89 % , with nearly all survivors developing CLD . Mortality in infants weighing 501 to 600 g was 71 % ; among survivors , 62 % had CLD , 35 % had severe ICH , and 15 % had proven NEC . CONCLUSIONS Survival for infants between 501 and 1500 g at birth continued to improve , particularly for infants weighing survival was not associated with an increase in major morbidities , because the incidence of CLD , proven NEC , and severe ICH did not change . However , poor postnatal growth remains a major concern , occurring in 99 % of infants weighing Mortality and major morbidity ( CLD , severe ICH , and NEC ) remain high for the smallest infants , particularly those weighing < 600 g at birth",
"BACKGROUND Although recent reports suggest that supplementation with probiotics may enhance intestinal function in premature infants , the mechanisms are unclear , and questions remain regarding the safety and efficacy of probiotics in extremely low-birth-weight infants . OBJECTIVE The objective was to evaluate the efficacy of probiotics on the digestive tolerance to enteral feeding in preterm infants born with a very low or extremely low birth weight . DESIGN In a bicentric , double-blind , r and omized controlled clinical trial that was stratified for center and birth weight , 45 infants received enteral probiotics ( Bifidobacterium longum BB536 and Lactobacillus rhamnosus GG ; BB536-LGG ) and 49 received placebo . The primary endpoint was the percentage of infants receiving > 50 % of their nutritional needs via enteral feeding on the 14th day of life . A triangular test was used to perform sequential analysis . RESULTS The trial was discontinued after the fourth sequential analysis concluded a lack of effect . The primary endpoint was not significantly different between the probiotic ( 57.8 % ) and placebo ( 57.1 % ) groups ( P = 0.95 ) . However , in infants who weighed > 1000 g , probiotic supplementation was associated with a shortening in the time to reach full enteral feeding ( P = 0.04 ) . Other than colonization by the probiotic strains , no alteration in the composition of intestinal microbiota or changes in the fecal excretion of calprotectin was observed . No colonization by probiotic strains was detected in infants who weighed gastrointestinal tolerance to enteral feeding in very-low-birth-weight infants but may improve gastrointestinal tolerance in infants weighing > 1000 g. This trial was registered at clinical trials.gov as NCT 00290576",
"There have been over twenty prospect i ve , r and omized trials of the use of probiotics to prevent necrotizing enterocolitis ( NEC ) in premature babies . A Cochrane meta- analysis of 16 of the studies ( 1 ) including 2842 preterm infants , reported that ‘ enteral probiotics supplementation significantly reduced the incidence of severe NEC ( stage II or more ) ( typical RR , 0.35 ; 95 % CI , 0.24–0.52 ) and mortality ( typical RR , 0.40 ; 95 % CI , 0.27–0.60 ) with no evidence of harm . They concluded , ‘ Enteral supplementation of probiotics prevents severe NEC and all-cause mortality in preterm infants ’ . In a sensitivity analysis , including only the 4 highest quality studies , the results and conclusions were unchanged . For neonates born at , the number needed to treat in order to prevent one NEC or one death is twenty . The risks of probiotics are minimal . A more recently published systematic review included several additional r and omized controlled trials , mostly published in the Chinese literature , and analysed a total of 20 publications and over 3800 preterm infants ; it came to similar conclusions as the Cochrane meta- analysis ( 2 ) . Probiotics are used in many European units but only rarely in North-America . In spite of the evidence , this safe and effective treatment for one of the most serious complications of prematurity has never been studied in the United States and perhaps never will . Probiotics will probably never be approved by the U.S. Food and Drug Administration ( FDA ) . Instead , they will remain in regulatory purgatory , neither approved nor unapproved , an evidence -based treatment that can not become the st and ard of care , a safe and effective treatment that is not on hospital formularies in the United States . Probiotics fall into a peculiar lacuna of the regulatory system . Most innovative treatments are either drugs or devices , and the regulatory pathways for evaluating and approving them are fairly well defined by federal law . The FDA has jurisdiction over both drugs and devices . Probiotics are neither drugs nor devices , and they are made by companies that generally market health products to the general public . In contrast , in Canada , probiotics are under the jurisdiction of the Natural Health Products Directorate ( NHPD ) which has rigorous requirements for quality control and detailed labelling . But the NHPD does not evaluate overtly medical cl aims made about a product . It has little experience dealing with either a product that could actually decrease major complications or save lives in a particularly fragile population where mortality is rather common . Probiotics are quite inexpensive to manufacture . People can even make them at home . They are in most yogurts . For pennies , some parents buy them for their preterm infants in health food stores . Some mothers have started adding probiotics to their breast milk . In these cases , the medical team can either be unaware a preterm infant is in fact receiving probiotics or tacitly not interfere with these parental initiatives . Given the low cost of probiotics and Articles in the series A Different View are edited by William Meadow ( [email protected] ) . We encourage you to offer your own different view either in response to A Different View you do not fully agree with , or on an unrelated topic . Send your article to Dr. Meadow ( [email protected] )",
"AIM To investigate the colonisation withBifidobacterium breve of the bowels of very low birthweight ( VLBW ) infants . METHODS The adverse effects of B breve were examined in 66 VLBW infants ( preliminary study ) . A prospect i ve r and omised clinical study of 91 VLBW infants was also completed and these infants were followed up for three years . Precise viable bacterial counts of serial stool specimens were examined for the first eight weeks after birth in 10 infants . The colonisation rates of administered bacteria were examined using immunohistochemical staining of stool specimens with a B breve specific monoclonal antibody . RESULTS In the preliminary study there were no side effects attributable to the bacteria . Immunohistochemical staining of stool specimens showed that the colonisation rates of the administered bacteria were 73 % at 2 weeks of age , but only 12 % in the control group . Early administration of B brevesignificantly decreased aspirated air volume from the stomach and improved weight gain . CONCLUSIONS B breve can colonise the immature bowel very effectively and is associated with fewer abnormal abdominal signs and better weight gain in VLBW infants , probably as a result of stabilisation of their intestinal flora and accelerated feeding schedules"
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This systematic review analysed the literature comparing marginal adaptation of mineral trioxide aggregate ( MTA ) with other filling material s in root-end cavities . The PubMed , Ovid , Web of Science , SCOPUS , and Cochrane library data bases were search ed using appropriate keywords related to root-end filling material s and adaptation . Of 38 articles assessed , 20 met the inclusion criteria . No in vivo study was identified . In 10 studies , MTA gave the best marginal adaptation results , but no significant differences were found between MTA and any of the tested filling material s in seven studies . There was great variability in the study design s including analysed surface , unit of gap measurement and magnification amount during analysis . On the basis of available evidence , MTA presented good marginal adaptation to dentine walls . This review identified the need for the development of st and ardised methods to evaluate the adaptation property of root-end filling material s in ex vivo studies as well as in clinical studies evaluating outcome
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"Introduction The importance of perfect apical seal in endodontics , more specifically in periradicular surgery , is the motivation/reason for development of root-end filling material s with favorable physical , chemical and biological characteristics . The aim of this in vitro study was to evaluate the marginal adaptation of root-end filling material s using scanning electron microscopy . Material s and Methods Twenty five human maxillary anterior teeth were prepared using a K-File # 50 to 1 mm short of the apical foramen and filled with gutta-percha and Sealapex using the lateral compaction technique . The apical 3 mm of the roots were sectioned perpendicularly to the long axis of the teeth . A 3-mm-deep root-end cavity was prepared using ultrasonic tips powered by an Enac ultrasonic unit . The teeth were r and omly assigned to five groups according to the material s tested including IRM , amalgam , ProRoot MTA , Super-EBA and Epiphany/Resilon . Root-end cavities were filled with the material s prepared according to the manufacturers ’ instructions . The root apices were carefully prepared for sputter coating and later evaluation using Scanning Electron Microscope ( SEM ) . The images of root-end fillings were divided into four quadrants and distributed into five categories according to the level of marginal adaptation between the root-end material and the root canal walls . The Fisher exact test with Bonferroni correction was used for statistical analysis . The level of significance was set at P = 0.005 . Results SEM images showed the presence of gaps in the root-end filling material s. No significant difference was observed between the tested material s ( P > 0.005 ) . Conclusion ProRoot MTA , IRM , amalgam , Super-EBA and Epiphany/Resilon showed similar marginal adaptation as root-end filling material",
"Context : Where nonsurgical endodontic intervention is not possible , or it will not solve the problem , surgical endodontic treatment must be considered . A major cause of surgical endodontic failures is an inadequate apical seal , so the use of the suitable substance as root-end filling material that prevents egress of potential contaminants into periapical tissue is very critical . Aims : The aim of the present ex-vivo study was to compare and evaluate the three root-end filling material s of mineral trioxide aggregate ( MTA ) family ( white MTA [ WMTA ] , grey MTA [ GMTA ] and Portl and cement [ PC ] ) for their marginal adaptation at the root-end dentinal wall using scanning electron microscopy ( SEM ) . Material s and Methods : Sixty human single-rooted teeth were decoronated , instrumented , and obturated with Gutta-percha . After the root-end resection and apical cavity preparation , the teeth were r and omly divided into three-experimental groups ( each containing 20 teeth ) and each group was filled with their respective experimental material s. After longitudinal sectioning of root , SEM examination was done to determine the overall gap between retro grade material s and cavity walls in terms of length and width of the gap ( maximum ) at the interface . Descriptive statistical analysis was performed to calculate the means with corresponding st and ard errors , median and ranges along with an analysis of variance and Tukey 's test . Results : The least overall gap was observed in GMTA followed by PC and WMTA . While after statistically analyzing the various data obtained from different groups , there was no significant difference among these three groups in terms of marginal adaptation . Conclusion : GMTA showed the best overall adaptation to root dentinal wall compared to PC and WMTA . Being biocompatible and cheaper , the PC may be an alternative but not a substitute for MTA",
"INTRODUCTION Recent meta-analyses of the outcome of apical surgery using modern techniques including microsurgical principles and high-power magnification have yielded higher rates of healing . However , the information is mainly based on 1- to 2-year follow-up data . The present prospect i ve study was design ed to re-examine a large sample of teeth treated with apical surgery after 5 years . METHODS Patients were recalled 5 years after apical surgery , and treated teeth were classified as healed or not healed based on clinical and radiographic examination . ( The latter was performed independently by 3 observers ) . Two different methods of root-end preparation and filling ( primary study parameters ) were to be compared ( mineral trioxide aggregate [ MTA ] vs adhesive resin composite [ COMP ] ) without r and omization . RESULTS A total of 271 patients and teeth from a 1-year follow-up sample of 339 could be re-examined after 5 years ( dropout rate = 20.1 % ) . The overall rate of healed cases was 84.5 % with a significant difference ( P = .0003 ) when comparing MTA ( 92.5 % ) and COMP ( 76.6 % ) . The evaluation of secondary study parameters yielded no significant difference for healing outcome when comparing subcategories ( ie , sex , age , type of tooth treated , post/screw , type of surgery ) . CONCLUSIONS The results from this prospect i ve nonr and omized clinical study with a 5-year follow-up of 271 teeth indicate that MTA exhibited a higher healing rate than COMP in the longitudinal prognosis of root-end sealing",
"The aim of this study was to evaluate the sealing ability and marginal adaptation of calcium silicate-based cements ( CSCs ) in root-end cavities prepared by ultrasonic and laser tips . A total of 72 extracted human maxillary incisor teeth were r and omly divided as 60 teeth in experimental groups and 6 teeth each for positive and negative control groups . Specimens in experimental groups were obturated , their root-end resections were performed and r and omly divided into six groups ( n = 10 ) as follows : G1 : Ultrasonic retrotip + MTA , G2 : Ultrasonic retrotip + Calcium Enriched Mixture ( CEM ) , G3 : Ultrasonic retrotip + Biodentine , G4 : Er : YAG laser tip + MTA , G5 : Er : YAG laser tip + CEM , G6 : Er : YAG laser tip + Biodentine . The sealing ability was measured by fluid transport method . Six specimens from each experimental group were r and omly selected to analyze marginal adaptation and prepared for scanning electron microscopy ( SEM ) analysis . Micrographs were scored and also analyzed using Image J software . Data were analyzed with ; two-way ANOVA , Bonferroni , Kruskall-Wallis , Mann-Whitney-U , Siegel & Castellan , and Spearman correlation coefficient tests . No significant difference was found between material s regarding the sealing ability and marginal adaptation ( p > 0.05 ) . Significantly greater fluid movement and poor marginal adaptation were seen for material s placed in cavities prepared by laser tips ( p ultrasonic-retrotips for preparing root-end cavities which are going to be filled with one of these CSCs",
"Introduction : This prospect i ve r and omized controlled study evaluated the clinical and radiographic outcome of endodontic microsurgery when using iRoot BP Plus Root Repair Material ( BP‐RRM ; Innovative BioCeramix Inc , Vancouver , BC , Canada ) or mineral trioxide aggregate ( MTA ) as the retro grade filling material and analyzed the relationship between some potential prognostic factors and the outcome of the surgery . Methods : By using strict inclusion and exclusion criteria , 240 teeth were successfully enrolled and r and omly and equally allocated to either the MTA or BP‐RRM treatment group . A st and ardized surgical procedure was performed by a single operator . The patients were followed up at 1 week , 3 months , 6 months , and 12 months ; follow‐up included clinical and radiographic examination . Clinical and radiographic evaluations acquired at the 12‐month follow‐up were taken as the primary outcome . For the identification of prognostic factors , the dichotomous outcome ( success vs failure ) was taken as the dependent variable . Results : A total of 158 teeth were analyzed at the 12‐month follow‐up , including 87 teeth in the MTA group and 71 teeth in the BP‐RRM group . The success rate in the MTA and BP‐RRM groups was 93.1 % ( 81/87 teeth ) and 94.4 % ( 67/71 teeth ) , respectively ( P > .05 ) . Three significant outcome predictors were identified : quality of root filling ( P tooth type ( P and size of the lesion ( P that BP‐RRM is comparable with MTA in clinical outcome when used as root‐end filling material s in endodontic microsurgery",
"Apicoectomy failure is generally related to inappropriate marginal sealing of the retrocavity , which allows percolation of microorganisms and their products from root canal system to periapex . This study evaluated tubular penetration of canal sealers and marginal permeability after retrocavity irradiation with Er;Cr : YSGG laser and retrofilling with MTA or cyanoacrylate . Twenty-two single-rooted teeth were decoronated and endodontically treated , their apical 3 mm were resected and the root ends were retroprepared with a low-speed bur . Twenty roots were r and omly assigned to 4 groups ( n=5 ) : GI and GII -- retrofilling with MTA and cyanoacrylate , respectively ; GIII and GIV -- retrocavity irradiation with Er;Cr : YSGG laser ( 2.78 microm , 4 W , 20 Hz , 70.8 J/cm(2 ) ) and retrofilling with MTA and cyanoacrylate , respectively . The remaining 2 roots served as positive and negative controls . The analysis of rhodamine B dye infiltration ( p=0.05 ) demonstrated that laser irradiation and MTA retrofilling presented significantly higher permeability rates ( p cyanoacrylate showed significantly lower permeability , either when laser was used or not on retrocavity . SEM analysis depicted more cyanoacrylate penetration through dentinal tubules when compared to MTA , suggesting a more efficient marginal sealing . Based on these results , it may be concluded that cyanoacrylate provided a less permeable retrofilling regardless of the retropreparation method , suggesting a more favorable condition to the establishment of the periapical healing",
"This in vitro study used rhodamine B fluorescent dye and a confocal microscope to evaluate the sealing ability of amalgam , super EBA , and a mineral trioxide aggregate when used as root end filling material s. Thirty single-canal teeth were cleaned , shaped , and obturated with gutta-percha and root canal sealer . After application of nail polish to the external surface , the apical 3 mm of each root was resected and 3-mm deep root end preparations were made . The roots were r and omly divided into three groups and the root end preparations filled with the experimental material s. All roots were then exposed to an aqueous solution of rhodamine B fluorescent dye for 24 h , longitudinally sectioned , and the extent of dye penetration measured using a confocal microscope . Statistical analysis showed that the mineral trioxide aggregate leaked significantly less than amalgam and super EBA",
"Objective The aim of this study was to evaluate the marginal adaptation of Biodentine in comparison with Mineral Trioxide Aggregate ( MTA ) and Intermediate Restorative Material ( IRM ) , as a root end filling material , using Scanning Electron Microscopy ( SEM ) . Material s and Methods : Thirty permanent maxillary central incisors were chemo-mechanically prepared and obturated . Three millimetres of the root end were resected and 3 mm retro cavity preparation was done using ultrasonic retrotips . The sample s were r and omly divided into three groups ( n=10 ) and were restored with root end filling material s : Group I – MTA , Group II – Biodentine , Group III – IRM . The root ends were sectioned transversely at 1 mm and 2 mm levels and evaluated for marginal adaptation using SEM . The gap between dentin and retro filling material was measured at four quadrants . The mean gap at 1 mm level and 2 mm level from the resected root tip and combined mean were calculated . The data were statistically analyzed , using one-way ANOVA and Tukey ’s HSD post hoc test for intergroup analysis and paired t-test for intragroup analysis . Results : The overall results showed no statistically significant difference between MTA and IRM but both were superior when compared to Biodentine . At 1 mm level there was no statistically significant difference among any of the tested material s. At 2 mm level MTA was superior to both IRM and Biodentine . Conclusion : In overall comparison , MTA and IRM were significantly superior when compared to Biodentine in terms of marginal adaptation , when used as retro grade filling material",
"INTRODUCTION The purpose of the present study was to evaluate the clinical outcomes of endodontic microsurgery when super ethoxy-benzoic acid ( Super EBA ; Harry J. Bosworth , Skokie , IL ) and mineral trioxide aggregate ( MTA ) were used as root-end filling material s in a prospect i ve r and omized controlled study . METHODS Of the 388 teeth eligible for endodontic microsurgery , 128 teeth were excluded from the study , and 260 teeth were r and omly assigned to either the Super EBA group or the MTA group with equal numbers using the \" minimization method . \" Endodontic microsurgical procedures were performed according to the Yonsei protocol reported in a previous study and were carried out by a single operator . The patients were followed up at 3 , 6 , and 12 months . The primary outcome measure was the change in the apical bone density at 12 months , and the secondary outcome measures were the presence of clinical symptoms or abnormal findings at 12 months . RESULTS A total of 192 teeth were examined at the 12-month follow-up ; 102 teeth were in the Super EBA group , and 90 were in the MTA group . The overall success rate was 94.3 % , with a success rate of 95.6 % ( 86/90 teeth ) for MTA and 93.1 % ( 95/102 teeth ) for Super EBA . The statistical analysis of the success rate results did not show any significant difference between the groups ( P = .472 ) . CONCLUSIONS In this prospect i ve r and omized controlled study , there was no significant difference in the clinical outcomes of endodontic microsurgery when Super EBA and MTA were used as root-end filling material",
"Objective : This study compared the marginal adaptation of mineral trioxide aggregate ( MTA ) and MTA-like material s as root-end fillings after incubation in phosphate buffer saline ( PBS ) , a synthetic tissue fluid , for either 1 week or 2 months . Material s and Methods : In this experimental study , seventy-two extracted human single-rooted teeth were prepared and obturated with gutta-percha and AH26 sealer . The apical 3 mm of the roots were resected . Root-end cavities were prepared with an ultrasonic retrotip . The specimens were r and omly divided into three groups ( n=24 ) and filled with either ProRoot MTA , OrthoMTA , or RetroMTA . Half of the specimens in each group were stored in PBS for 1 week the other half for 2 months . Epoxy resin replicas from the resected root-end surfaces and longitudinally sectioned roots were fabricated . The gaps at the material /dentin interface were measured using a scanning electron microscope ( SEM ) . Transversal , longitudinal , and overall gap sizes were measured . The data were analyzed using Kruskal-Wallis and Mann-Whitney tests . The significance level was set at p marginal adaptation of ProRoot MTA , RetroMTA , and OrthoMTA in both transverse and longitudinal sections after incubation for either 1 week or 2 months ( p > 0.05 ) . In addition , the test groups were not significantly different regarding the overall mean gap values ( p > 0.05 ) . Conclusion : Under the conditions of this study , there was no difference between the marginal adaptation of ProRoot MTA , OrthoMTA , and RetroMTA as root-end filling material s after exposure to PBS for either 1 week or 2 months",
"Objectives : The aim of this study was to evaluate marginal adaptation of mineral trioxide aggregate ( MTA ) , calcium enriched mixture ( CEM ) cement , Biodentine and BioAggregate in presence of normal saline and human blood . Material s and Methods : In this in-vitro experimental study , 80 extracted single-rooted human teeth were instrumented and filled with gutta-percha . After resecting the root-end , apical cavity preparation was done and the teeth were r and omly divided into 4 groups (N=20)(a total of 8 subgroups ) . Root-end filling material s were placed in 3 mm root-end cavities prepared ultrasonically . Half the specimens in each group were exposed to normal saline and the other half to fresh whole human blood . After 4 days , epoxy resin replicas of the apical portion of sample s were fabricated and scanning electron microscopy ( SEM ) analysis was performed to find gaps in the adaptation of the root-end filling material s at their interface with dentin . The Kruskal-Wallis and Mann-Whitney tests were used for statistical analysis of data with P marginal adaptation of the 8 tested groups ( P>0.05 ) . Conclusion : Based on the results , blood contamination does not affect the marginal adaptation of MTA , CEM cement , Biodentine or BioAggregate",
"AIM To compare the surface topography of root apices following ultrasonic root-end preparation , and again after root-end fillings su bmi tted to three different finishing techniques . METHODOLOGY Eighty-one root-end cavities prepared ultrasonically in human canines , were divided at r and om into three test groups of 27 each . The cavities were filled with Super-EBA , IRM , or ProRoot-MTA and finished by ball burnishing . Eighteen roots from each group received a final finish with either a 30-fluted tungsten carbide finishing bur , or a Zekrya carbide 28 mm bur after storage in water at 37 degrees C for 24 h. The root-end surface topographies were reproduced by means of polyvinylsiloxane impressions and epoxy resin replicas . Scanning electron micrography ( SEM ) images of each replica were taken prior to and after root-end filling . An image analysis system was used to compare the alteration of the marginal chipping areas and to calculate the gaps located in the dentine/root-end filling interface . RESULTS When a bur was used to finish the set material s , a significant ( P marginal chipping was eliminated . The finishing technique did not significantly ( P > 0.05 ) affect the incidence of gaps in groups root-end filled with MTA or IRM . Super-EBA and IRM retrofillings finished with a ball burnisher or a Zekrya bur displayed a significantly ( P calculated gap area than roots filled with MTA . CONCLUSION Under this in vitro study , the marginal adaptation of MTA was good with or without finishing procedures . Applying a finishing bur over the condensed and set IRM and Super-EBA created better marginal adaptation",
"AIM To assess the success rate of the root-end filling material , Mineral Trioxide Aggregate ( MTA ) . METHODOLOGY Referred adult patients were recruited using strict entry criteria and r and omly allocated to receive MTA or IRM . A st and ardized surgical technique was employed : the root end was resected perpendicularly and a root-end cavity was prepared ultrasonically and filled . A radiograph taken immediately after surgery was compared with those taken at 12 and 24 months . Customised film holders and the paralleling technique were used ; radiographs were assessed by two trained observers using agreed criteria . The results from 122 patients ( 58 in IRM group , 64 in MTA group ) after 12 months and 108 patients ( 47 in IRM group , 61 in MTA group ) for the 24-month review period were analysed using the chi2 test . RESULTS The highest number of teeth with complete healing at both times was observed when MTA was used . When the numbers of teeth with complete and incomplete ( scar ) healing , and those with uncertain and unsatisfactory healing were combined , the success rate for MTA was higher ( 84 % after 12 months , 92 % after 24 months ) compared with IRM ( 76 % after 12 months , 87 % after 24 months ) . However , statistical analysis showed no significant difference in success between material s ( P > 0.05 ) at both 12 and 24 months . CONCLUSIONS In this study , the use of MTA as a root-end filling material result ed in a high success rate that was not significantly better than that obtained using IRM",
"The purpose of this study was to compare the sealing ability of high-copper amalgam , glass ionomer cement , and silver glass ionomer cement as retrofilling material s when used with and without varnish . Seventy extracted human single-rooted anterior teeth were instrumented and the root canals obturated with laterally condensed gutta-percha and sealer . The apical 3 mm of each root was resected and a 2 mm-deep apical Class I preparation cut . The roots were then r and omly allocated to six groups of 10 teeth and retrofilled with one of the experiment material s. Group I comprised high-copper amalgam ; group 2 , high-copper amalgam with cavity varnish ; group 3 , glass ionomer cement without varnish ; group 4 , glass ionomer cement with varnish ; group 5 , silver glass ionomer cement without varnish ; and group 6 , silver glass ionomer cement with varnish . Two groups of five roots each were used as positive and negative controls . The root surfaces were coated with nail polish and specimens immersed in 2 % methylene blue solution for 14 days . After vertical sectioning , dye penetration was examined under a stereomicroscope . The results of the study were analysed statistically . The sealing ability of the conventional glass ionomer cement with varnish was significantly better while dye penetration was higher in silver glass ionomer cement without varnish group than the other groups ( P < 0.01 )",
"OBJECTIVE The dentinal walls of root-end cavities were examined for the presence of cracks and debris in correlation with the area of the root surfaces that remained after the resection . STUDY DESIGN One hundred extracted single-rooted teeth were endodontically treated , mounted in acrylic resin blocks , and the apical 2 mm of the root-apex was resected . According to the resected root surface area the teeth were divided into 2 groups having large ( > 2 mm(2 ) ) or small ( retro grade cavity preparation 4 devices were used : slow-speed h and piece , diamond coated stainless steel ultrasonic tip , smooth stainless steel ultrasonic tips , and sonic diamond-coated tips . Teeth were examined under a videomicroscope for the presence of fractures , dentin chips , and gutta-percha remnants on cavity walls . Preparation time was also recorded . RESULTS Preparation with smooth stainless steel ultrasonic tips produced few intradentin cracks . Dentin debris was more frequently seen in rotary preparations whereas gutta-percha remnants were seen mainly at ultrasonically prepared teeth . CONCLUSIONS Sonic and ultrasonic devices produced cleaner , well-centered , and more conservative root-end cavities than the rotary instrumentation . Cracks do not correlate directly with the surface area of the root-end surfaces but rather with the type of retrotip used to prepare the root-end cavity",
"AIM The aim of this investigation was to assess the marginal adaptation of Super-EBA ( EBA ) and Pro Root MTA ( MTA ) root-end fillings and the occurrence of microcracks in resected root-ends of extracted teeth before and after occlusal loading for a five-year equivalent period in a computer-controlled masticator . METHODOLOGY Twenty-four molar teeth were root-filled using lateral condensation and their root-ends resected . Root-end cavities were prepared and either EBA or MTA root-end fillings were placed . All surgical procedures were completed in vitro under an operating microscope . Replicas taken of the root-end fillings and resected root-ends were examined using an SEM before and after they were subjected to in vitro chewing cycles in a computer-controlled chewing simulator for the equivalent of 5 years . Marginal adaptation and integrity of the two root-end filling material s were evaluated and the presence of microcracks recorded . RESULTS Before loading , a continuous margin was observed with 99.4 + /- 2.4 % of EBA and 99.2 + /- 1.6 % of MTA root-end fillings . After loading , the percentage of continuous margin decreased to 93.1 + /- 6.6 % and 98.9 + /- 3.2 % for EBA and MTA , respectively . After occlusal loading , 39.5 % of the EBA root-end fillings were overfilled , whilst 52.6 % of the MTA root-end fillings were underfilled . In total , 12.5 % of the resected root-end surfaces showed microcracking before loading and 25 % after occlusal loading . CONCLUSIONS Both EBA and MTA displayed excellent marginal adaptation before masticatory loading . After loading , the amount of continuous margin for both root-end filling material s decreased slightly but was still high",
"INTRODUCTION The purpose of the present study was to evaluate the long-term clinical outcome of endodontic microsurgery when mineral trioxide aggregate ( MTA ) and super ethoxybenzoic acid ( Super EBA ; Harry J. Bosworth , Skokie , IL ) were used as root-end filling material s. Additionally , this study aim ed to compare the clinical outcome of endodontic microsurgery at the 1-year follow-up with that at the 4-year follow-up . METHODS Two hundred sixty teeth were r and omly assigned to either the MTA or Super EBA group in equal numbers using the minimization method . Endodontic microsurgery was performed according to the Yonsei protocol . The previous study of 192 teeth examined at the 1-year follow-up revealed a success rate of 95.6 % for MTA and 93.1 % for Super EBA . Patients were recalled 4 years after surgery , and treated teeth were classified as successes or failures with Molven 's criteria . The Pearson chi-square test and the McNemar test were conducted to analyze and compare the success rates . RESULTS A total of 182 teeth were examined at the 4-year follow-up . The success rate was 91.6 % for MTA and 89.9 % for Super EBA . Statistical analysis of the success rate did not show any significant difference between the 2 material s ( P = .8 ) . The overall success rate at the 4-year follow-up was 89.5 % , which was slightly lower compared with 94.3 % at the 1-year follow-up . However , there was no significant difference between the follow-up periods ( P = .063 ) . CONCLUSIONS This study identified no significant difference in the 4-year success rates of MTA and Super EBA as root-end filling material s in endodontic microsurgery . Additionally , compared with short-term outcomes , long-term follow-up outcomes were not significantly different",
"OBJECTIVE Recurrent periapical disease poses a substantial challenge to the dental practitioner . However , the use of novel methods and material s in periapical surgery has increased the success rates of treatment . The objective of this study was to assess the effects of mineral trioxide aggregate ( MTA ) retrofilling and apical sealing with Nd : YAG laser ( at 10 Hz , 150 mJ , 1.5 W , in 60 sec pulses ) as adjuncts to apicoectomy . METHODS Perpendicular root end resection was performed with diamond-coated burs on 40 canine teeth previously subjected to endodontic treatment . Teeth were r and omly allocated into four groups : group A , apicoectomy alone ; group B , apicoectomy+Nd : YAG laser ; group C , apicoectomy+MTA retrofilling ; group D , apicoectomy+MTA retrofilling+Nd : YAG laser . Specimens were embedded in epoxy resin and sliced lengthwise and crosswise . RESULTS Scanning electron microscopy ( SEM ) analysis showed more homogeneous and canaliculi-free apical surfaces in groups B and D ( p Marginal gaps between the dentin surface and filling material were observed in decreasing order of gap size in groups B , A , D , and C ( p phosphorus ( p lower calcium ( p content in the Nd : YAG-irradiated groups . CONCLUSIONS In this study , Nd : YAG laser irradiation had a positive effect on dentin surface sealing , despite an untoward dimensional effect when associated with MTA retrofilling",
"This study compared the push-out bond strength of mineral trioxide aggregate ( MTA ) and a new endodontic cement ( NEC ) as root-end filling material s in root-end cavities prepared by ultrasonic technique ( US ) or Er , Cr : YSGG laser ( L ) . Eighty single-rooted extracted human teeth were endodontically treated , apicectomised and r and omly divided into four following groups ( n = 20 ) : US/MTA , US/NEC , L/MTA and L/NEC . In US/MTA and US/NEC groups , root-end cavities were prepared with ultrasonic retrotip and filled with MTA and NEC , respectively . In L/MTA and L/NEC groups , root-end cavities were prepared using Er , Cr : YSGG laser and filled with MTA and NEC , respectively . Each root was cut apically to create a 2 mm-thick root slice for measurement of bond strength using a universal testing machine . Then , all slices were examined to determine the mode of bond failure . Data were analysed using two-way anova . Root-end filling material s showed significantly higher bond strength in root-end cavities prepared using ultrasonic technique ( US/MTA and US/NEC ) ( P bond strengths of MTA and NEC did not differ significantly . The failure modes were mainly adhesive for MTA , but cohesive for NEC . In conclusion , bond strengths of MTA and NEC to root-end cavities were comparable and higher in ultrasonically prepared cavities",
"INTRODUCTION The aim of this study was to evaluate the effect of smear layer removal on the push-out bond strength between radicular dentin and three calcium silicate cements ( CSC ) in comparison with gutta percha and sealer . METHODS Eighty human anterior extracted teeth were decoronated , cleaned and shaped to size 50/0.05 apically and r and omly divided into 2 major groups : ( A ) smear layer preserved , and ( B ) smear layer removed using irrigation with 17 % EDTA . Roots within each major group were further divided into 4 subgroups according to the obturation material used : ( 1 ) ProRoot MTA , ( 2 ) Biodentine , ( 3 ) Harvard MTA , ( 4 ) Gutta percha and AH-plus sealer . Obturated roots were stored in synthetic tissue fluid for 7 days to allow maximum setting of the root filling material s. Three 2-mm-thick slices were obtained from each root at different section levels ( coronal , middle , apical ) . The canal diameters and slice thickness were measured , and the adhesion surface area for each slice was calculated . Push-out bond strength test was carried out using a universal testing machine . The bond failure mode was assessed under an optical microscope at 40 × . RESULTS The mean push-out bond strength in groups 1A , 2A and 3A were 7.54 ( ±1.11 ) , 7.64 ( ±1.08 ) and 8.79 (±1.55)MPa respectively , while those for groups 1B , 2B and 3B were 6.58 ( ±1.13 ) , 6.47 ( ±1.08 ) , 7.71 (±1.81)MPa , respectively . In the gutta percha and sealer groups the push-out bond strength means were : 1.98 ( ±0.48 ) and 2.09 (±0.51)MPa in the preserved and removed smear layer groups respectively . The push-out strength values were significantly reduced when the smear layer was removed in the CSC groups ( P<0.05 ) while no significant difference was detected in the gutta percha and sealer groups . CONCLUSIONS Based on the conditions of this ex vivo study , it can be concluded that smear layer removal is detrimental to the bond strength between calcium silicate cements and dentin"
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BACKGROUND Patients with prosthetic heart valves are at increased risk for valve thrombosis and arterial thromboembolism . Oral anticoagulation alone , or the addition of antiplatelet drugs , has been used to minimise this risk . An important issue is the effectiveness and safety of the latter strategy . OBJECTIVES This is an up date of our previous review ; the goal was to create a valid synthesis of all available , method ologically sound data to further assess the safety and efficacy of combined oral anticoagulant and antiplatelet therapy versus oral anticoagulant monotherapy in patients with prosthetic heart valves . SEARCH METHODS We up date d the previous search es from 2003 and 2010 on 16 January 2013 and search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) on The Cochrane Library ( 2012 , Issue 12 ) , MEDLINE ( OVID , 1946 to January Week 1 2013 ) , and EMBASE ( OVID , 1980 to 2013 Week 02 ) . We have also looked at reference lists of individual reports , review articles , meta-analyses , and consensus statements . We included reports published in any language or in abstract form . SELECTION CRITERIA All reports of r and omised controlled trials comparing st and ard-dose oral anticoagulation to st and ard-dose oral anticoagulation and antiplatelet therapy in patients with one or more prosthetic heart valves . DATA COLLECTION AND ANALYSIS Two review authors independently performed the search strategy , assessed trials for inclusion and study quality , and extracted data . We collected adverse effects information from the trials . MAIN RESULTS One new study has been identified and included in this up date . In total , 13 studies involving 4122 participants were included in this review up date . Years of publication ranged from 1971 to 2011 . Compared with anticoagulation alone , the addition of an antiplatelet agent reduced the risk of thromboembolic events ( odds ratio ( OR ) 0.43 , 95 % confidence interval ( CI ) 0.32 to 0.59 ; P total mortality ( OR 0.57 , 95 % CI 0.42 to 0.78 ; P = 0.0004 ) . Aspirin and dipyridamole reduced these events similarly . The risk of major bleeding was increased when antiplatelet agents were added to oral anticoagulants ( OR 1.58 , 95 % CI 1.14 to 2.18 ; P = 0.006).For major bleeding , there was no evidence of heterogeneity between aspirin and dipyridamole and in the comparison of trials performed before and after 1990 , around the time when anticoagulation st and ardisation with the international normalised ratio was being implemented . A lower daily dose of aspirin ( major bleeding risk than higher doses . AUTHORS ' CONCLUSIONS Adding antiplatelet therapy , either dipyridamole or low-dose aspirin , to oral anticoagulation decreases the risk of systemic embolism or death among patients with prosthetic heart valves . The risk of major bleeding is increased with antiplatelet therapy . These results apply to patients with mechanical prosthetic valves or those with biological valves and indicators of high risk such as atrial fibrillation or prior thromboembolic events . The effectiveness and safety of low-dose aspirin ( 100 mg daily ) appears to be similar to higher-dose aspirin and dipyridamole . In general , the quality of the included trials tended to be low , possibly reflecting the era when the majority of the trials were conducted ( 1970s and 1980s when trial methodology was less advanced )
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"Abstract Either dipyridamole , a vasodilator known to reduce platelate adhesiveness and aggregation , or a placebo was given in a daily dose of 400 mg as a r and om , blind trial to 70 patients who had undergone prosthetic cardiac-valve replacement . Patients in both groups were given anticoagulation with warfarin sodium . Of 36 patients in the placebo group followed for 557 months systemic arterial embolism occurred in 17 per cent . Twenty-seven patients in the dipyridamole group followed for 393 months gave no clinical evidence of arterial embolism . Dipyridamole was discontinued shortly after surgery in seven patients , and these were followed for 110 months . In two of them cerebral emboli developed six months after treatment was discontinued . It is tentatively concluded that the addition of dipyridamole to a program of anticoagulation reduces the frequency of postoperative arterial emboli originating on prosthetic cardiac valves in patients who can tolerate the drug",
"Authors studied the effect of coumarin , and its combination with low-dose ( 125 mg/day ) acetylsalicylic acid in the prevention of thromboembolic complication during a 10-year period ( average 4.7 years ) in a r and omized trial of 296 patients aged 18 - 60 year with tilting disc type prosthetic heart valve ( 159 mitral and 137 aortic ) in sinus rhythm . In the group treated with coumarin ( 152 patients , 743.4 patient-years ) 4 cases ( 2 of them fatal ) of valve thrombosis , 12 cases of peripheral embolism and 9 cases ( 3 intracranial , 3 among them fatal ) of major bleeding were observed ; in the group treated with coumarin plus acetylsalicylic acid ( 144 patients , 638.7 patient-years ) 2 cases ( 1 of them fatal ) of valve thrombosis , 4 cases of peripheral embolism and 14 cases ( 3 of them fatal ) of major bleeding were observed . In the case of valve thromboses the difference between the two groups was non-significant but still clinical ly remarkable ; peripheral embolism occurred in significantly higher number ( p bleeding complications between the two groups . The results suggest that the combination of coumarin plus low-dose acetylsalicylic acid is more effective in the prevention of thromboembolic complications in patients with mitral and aortic prosthetic heart valve than coumarin alone ; the danger of bleeding complications seems to be acceptable with adequate control",
"Despite the use of oral anticoagulation in patients with prosthetic heart valves , persistent thromboembolism over time warrants a search for improved methods of prevention . Thus , patients receiving 1 or more mechanical prosthetic heart valves were r and omized to therapy with warfarin plus dipyridamole ( 400 mg/day ) or warfarin plus aspirin ( 500 mg/day ) on the basis of location and type of valve and surgeon , and followed up with a concurrent , nonr and omized control group taking warfarin alone . In 534 patients followed up 1,319 patient-years , excessive bleeding ( necessitating blood transfusion or hospitalization ) was noted in the warfarin plus aspirin group ( 23 of 170 [ 14 % ] , or 6.0/100 patient-years ) compared with warfarin plus dipyridamole ( 7 of 181 [ 4 % ] , or 1.6/100 patient-years , p less than 0.001 ) , or warfarin alone ( 9 of 183 [ 5 % ] , or 1.8/100 patient-years , p less than 0.001 ) . A trend was evident toward a reduction in thromboembolism in the warfarin plus dipyridamole group ( 2 of 181 [ 1 % ] , or 0.5/100 patient-years ) as compared with warfarin plus aspirin ( 7 of 170 [ 4 % ] , or 1.8/100 patient-years ) , or warfarin alone ( 6 of 183 [ 4 % ] , or 1.2/100 patient-years ) . Adequacy of anticoagulation ( based on 12,720 prothrombin time determinations ) was similar in all 3 groups with 65 % of prothrombin times in the therapeutic range ( 1.5 less than or equal to prothrombin time/control less than or equal to 2.5 ) , 30 % too low , and 5 % too high . Warfarin plus aspirin therapy result ed in excessive bleeding and is contraindicated . Longer follow-up study is needed to determine whether further separation of the incidence of thromboembolism can be detected",
"BACKGROUND Mechanical heart valve replacement requires lifelong anticoagulant treatment . Aspirin has proved useful in further reducing thromboembolic events when added to oral anticoagulants . However , increased ( gastrointestinal ) bleeding was observed at the doses previously tested for this combination in heart valve prostheses . METHODS We performed a prospect i ve r and omized trial to compare the combination of low-intensity oral anticoagulants ( international normalized ratio 2.5 to 3.5 ) plus aspirin ( 100 mg/day ) ( arm A ) versus high-intensity oral anticoagulants alone ( arm B ) ( international normalized ratio 3.5 to 4.5 ) . Arm A included 258 patients and arm B 245 patients . The two groups were comparable for all baseline characteristics . RESULTS The outcomes of the study were embolism , valve thrombosis , and major hemorrhage . The median follow-up was 23 months . The two treatments offered similar antithrombotic protection . The incidence of embolic episodes was 1.32 per 100 patient-years ( 95 % confidence interval 0.53 to 2.7 ) for arm A and 1.48 per 100 patient-years ( 95 % confidence interval 0.59 to 3.03 ) for arm B. Major hemorrhage occurred in 1.13 per 100 patient-years ( 95 % confidence interval 0.41 to 2.45 ) for arm A and 2.33 per 100 patient-years ( 95 % confidence interval 1.17 to 4.14 ) for arm B. Gastrointestinal bleeding was not increased by this combined reduced dose of aspirin and coumarin",
"OBJECTIVE Antiplatelet agents are used for prevention of thromboembolism in surgical patients and in patients with chronic atrial fibrillation . Up to date , however , results of r and omized studies comparing antiplatelet agents and oral anticoagulation have not been reported . The aim of this study was to compare the efficacy and safety of triflusal ( an antiplatelet agent ) versus acenocoumarol for primary prevention of thromboembolism in the early postoperative period after implantation of a bioprosthesis . METHODS In this prospect i ve , multicentric , r and omized , open pilot trial , patients were assigned to treatment with triflusal ( 600mg/d ) or acenocoumarol ( target INR 2.0 - 3.0 ) . Study medication was started 24 - 48h after valve replacement with a bioprosthesis , and continued for 3 months . Four follow-up visits were scheduled : baseline , and at 1 , 3 and 6 months thereafter . The primary end-point was a composite of the rate of thromboembolism , severe hemorrhage and valve-related mortality . RESULTS A total of 193 patients were included ( 97 received triflusal and 96 acenocoumarol ) , with a mean age of 72.5 years . Half were men . Aortic valve replacement was performed in 181 patients ( 93.8 % ) , mitral valve replacement in 10 patients ( 5.2 % ) and double valve replacement in 2 ( 1.0 % ) . Hospital mortality was 11 ( 5.7 % ) . Primary outcome was recorded in 9 patients with triflusal ( 9.4 % ) and in 10 patients with acenocoumarol ( 11 % ) . There were nine episodes ( 4.7 % ) of thromboembolism , six in the triflusal group and three in the acenocoumarol group , and three episodes of permanent neurological deficits , one in the triflusal group and two in the acenocoumarol group . Severe hemorrhage : nine episodes , six in the acenocoumarol group and three in the triflusal group . None of the observed differences in efficacy were statistically significant . Regarding safety , three patients in triflusal group reported at least one hemorrhage , compared to 10 in acenocoumarol group ( P=0.048 ) . CONCLUSIONS There were no significant differences in efficacy between both groups , however , triflusal showed a significantly lower incidence of bleeding episodes",
"BACKGROUND Despite the use of warfarin , major systemic embolism remains an important complication in patients with heart-valve replacement . Although the addition of antiplatelet agents has the potential to reduce this complication , their efficacy and safety when given in combination with warfarin are uncertain . METHODS In a r and omized , double-blind , placebo-controlled trial , we assessed the efficacy and safety of adding aspirin ( 100 mg per day ) to warfarin treatment ( target international normalized ratio , 3.0 to 4.5 ) in 370 patients with mechanical heart valves or with tissue valves plus atrial fibrillation or a history of thromboembolism . RESULTS A total of 186 patients were r and omly assigned to aspirin and 184 to placebo , and they were followed for up to 4 years ( average , 2.5 ) . Major systemic embolism or death from vascular causes occurred in 6 aspirin-treated patients ( 1.9 percent per year ) and 24 placebo-treated patients ( 8.5 percent per year ) ( risk reduction with aspirin , 77 percent ; 95 percent confidence interval , 44 to 91 percent ; P Major systemic embolism , nonfatal intracranial hemorrhage , or death from hemorrhage or vascular causes occurred in 12 patients assigned to aspirin ( 3.9 percent per year ) and 28 patients assigned to placebo ( 9.9 percent per year ) ( risk reduction , 61 per cent ; 95 percent confidence interval , 24 to 80 percent ; P = 0.005 ) ; major systemic embolism or death from any cause occurred in 13 patients ( 4.2 percent ) and 33 patients ( 11.7 percent ) , respectively ( risk reduction , 65 percent ; 95 percent confidence interval , 33 to 82 percent ; P death from all causes occurred in 9 patients ( 2.8 percent ) and 22 patients ( 7.4 percent ) , respectively ( risk reduction , 63 percent ; 95 percent confidence interval , 19 to 83 percent ; P = 0.01 ) . Bleeding occurred in 71 patients in the aspirin group ( 35.0 percent ) , as compared with 49 patients in the placebo group ( 22.0 percent ) ( increase in risk , 55 percent ; 95 percent confidence interval , 8 to 124 percent ; P = 0.02 ) ; major bleeding occurred in 24 and 19 patients , respectively ( increase in risk , 27 percent ; 95 percent confidence interval , -30 to 132 percent ; P = 0.43 ) . CONCLUSIONS In patients with mechanical heart valves and high-risk patients with prosthetic tissue valves , the addition of aspirin to warfarin therapy reduced mortality , particularly mortality from vascular causes , together with major systemic embolism . Although there was some increase in bleeding , the risk of the combined treatment was more than offset by the considerable benefit",
"Patients who had undergone prosthetic valve replacement were treated with warfarin ( anticoagulant ) alone or in combination of ticlopidine ( 200 mg/day ) or aspirin ( 81 mg/day ) ( anti-platelet agents ) . The study of blood coagulation factors and platelet aggregation were carried out with these cases . 1 ) The patients ( n = 24 ) receiving warfarin for 21 days after prosthetic valve replacement revealed marked increases in PIVKA-II and vitamin K1-epoxide . The protein C activity was significantly lower than that before the operation . High levels of more than 5 ng/ml of TAT were found before operation and after warfarin administration for 21 days . 2 ) Warfarin did not affect platelet aggregation , whereas ticlopidine inhibited ADP-induced platelet aggregation and aspirin inhibited both collagen-induced and arachidonic acid-induced aggregation . In conclusion , combined use of anticoagulants and antiplatelet agents after prosthetic valve replacement will suppress not only the blood coagulation but also the platelet aggregation systems",
"OBJECTIVES The aim of the study was to test the value of low dose aspirin associated with st and ard oral anticoagulants ( OAC ) after mechanical mitral valve replacement ( MMRV ) to reduce str and s , thrombi and thromboembolic events . BACKGROUND Str and s and thrombi are thought to increase the risk of embolic events after MMVR , particularly in the immediate postoperative period . METHODS Two hundred twenty-nine patients were prospect ively recruited : 109 patients ( group A+ ) were r and omly assigned to aspirin ( 200 mg per day ) with OAC and 120 patients ( group A- ) to OAC alone ( international normalized ratio 2.5 to 3.5 ) . All patients were subjected to multiplane transesophageal echocardiography at nine days and five months and were followed up for one year . RESULTS At nine days and five months , there was a high and comparable incidence of str and s in the two groups ( group A+ : 44 % , 58 % ; group A- : 49 % , 63 % ) . However , the incidence of nonobstructive periprosthetic valve thrombi was significantly lower in group A+ at 9 days : 5 % versus 13 % , p = 0.03 . Total thromboembolic events were reduced in group A+ ( 9 % vs. 25 % , p = 0.004 ) although there was an increased incidence of gastrointestinal hemorrhage ( 7 % vs. 0 % ) . Overall mortality was 9 % in group A+ and 4 % in group A- . Valve-related events were similar in both groups . Early thrombi , but not str and s , were associated with higher morbidity , especially thromboembolic events ( 30 % vs. 13 % , p = 0.003 ) . CONCLUSIONS One year after MMVR , the association of aspirin with OAC reduced thrombi and thromboembolic events , but not morbidity , due to an increase in hemorrhagic complications",
"A quantitative systematic review , or meta- analysis , uses statistical methods to combine the results of multiple studies . Meta-analyses have been done for systematic review s of therapeutic trials , diagnostic test evaluations , and epidemiologic studies . Although the statistical methods involved may at first appear to be mathematically complex , their purpose is simple : They are trying to answer four basic questions . Are the results of the different studies similar ? To the extent that they are similar , what is the best overall estimate ? How precise and robust is this estimate ? Finally , can dissimilarities be explained ? This article provides some guidance in underst and ing the key technical aspects of the quantitative approach to these questions . We have avoided using equations and statistical notations ; interested readers will find implementations of the described methods in the listed references . We focus here on the quantitative synthesis of reports of r and omized , controlled , therapeutic trials because far more meta-analyses on therapeutic studies than on other types of studies have been published . For practical reasons , we present a stepwise description of the tasks that are performed when statistical methods are used to combine data . These tasks are 1 ) deciding whether to combine data and defining what to combine , 2 ) evaluating the statistical heterogeneity of the data , 3 ) estimating a common effect , 4 ) exploring and explaining heterogeneity , 5 ) assessing the potential for bias , and 6 ) presenting the results . Deciding Whether To Combine Data and Defining What To Combine By the time one performs a quantitative synthesis , certain decisions should already have been made about the formulation of the question and the selection of included studies . These topics were discussed in two previous articles in this series [ 1 , 2 ] . Statistical tests can not compensate for lack of common sense , clinical acumen , and biological plausibility in the design of the protocol of a meta- analysis . Thus , a reader of a systematic review should always address these issues before evaluating the statistical methods that have been used and the results that have been generated . Combining poor- quality data , overly biased data , or data that do not make sense can easily produce unreliable results . The data to be combined in a meta- analysis are usually either binary or continuous . Binary data involve a yes/no categorization ( for example , death or survival ) . Continuous data take a range of values ( for example , change in diastolic blood pressure after antihypertensive treatment , measured in mm Hg ) . When one is comparing groups of patients , binary data can be summarized by using several measures of treatment effect that were discussed earlier in this series [ 3 ] . These measures include the risk ratio ; the odds ratio ; the risk difference ; and , when study duration is important , the incidence rate . Another useful clinical measure , the number needed to treat ( NNT ) , is derived from the inverse of the risk difference [ 3 ] . Treatment effect measures , such as the risk ratio and the odds ratio , provide an estimate of the relative efficacy of an intervention , whereas the risk difference describes the intervention 's absolute benefit . The various measures of treatment effect offer complementary information , and all should be examined [ 4 ] . Continuous data can be summarized by the raw mean difference between the treatment and control groups when the treatment effect is measured on the same scale ( for example , diastolic blood pressure in mm Hg ) , by the st and ardized mean difference when different scales are used to measure the same treatment effect ( for example , different pain scales being combined ) , or by the correlation coefficients between two continuous variables [ 5 ] . The st and ardized mean difference , also called the effect size , is obtained by dividing the difference between the mean in the treatment group and the mean in the control group by the SD in the control group . Evaluating the Statistical Heterogeneity of the Data This step is intended to answer the question , Are the results of the different studies similar ( homogeneous ) ? It is important to answer this question before combining any data . To do this , one must calculate the magnitude of the statistical diversity ( heterogeneity ) of the treatment effect that exists among the different sets of data . Statistical diversity can be thought of as attributable to one or both of two causes . First , study results can differ because of r and om sampling error . Even if the true effect is the same in each study , the results of different studies would be expected to vary r and omly around the true common fixed effect . This diversity is called the within- study variance . Second , each study may have been drawn from a different population , depending on the particular patients chosen and the interventions and conditions unique to the study . Therefore , even if each study enrolled a large patient sample , the treatment effect would be expected to differ . These differences , called r and om effects , describe the between- study variation with regard to an overall mean of the effects of all of the studies that could be undertaken . The test most commonly used to assess the statistical significance of between- study heterogeneity is based on the chi-square distribution [ 6 ] . It provides a measure of the sum of the squared differences between the results observed and the results expected in each study , under the assumption that each study estimates the same common treatment effect . A large total deviation indicates that a single common treatment effect is unlikely . Any pooled estimate calculated must account for the between- study heterogeneity . In practice , this test has low sensitivity for detecting heterogeneity , and it has been suggested that a liberal significance level , such as 0.1 , should be used [ 6 ] . Estimating a Common Effect The questions that this step tries to answers are , 1 ) To the extent that data are similar , what is their best common point estimate of a therapeutic effect , and 2 ) how precise is this estimate ? The mathematical process involved in this step generally involves combining ( pooling ) the results of different studies into an overall estimate . Compared with the results of individual studies , pooled results can increase statistical power and lead to more precise estimates of treatment effect . Each study is given a weight according to the precision of its results . The rationale is that studies with narrow CIs should be weighted more heavily than studies with greater uncertainty . The precision is generally expressed by the inverse of the variance of the estimate of each study . The variance has two components : the variance of the individual study and the variance between different studies . When the between- study variance is found to be or assumed to be zero , each study is simply weighted by the inverse of its own variance , which is a function of the study size and the number of events in the study . This approach characterizes a fixed-effects model , as exemplified by the Mantel-Haenszel method [ 7 , 8 ] or the Peto method [ 9 ] for dichotomous data . The Peto method has been particularly popular in the past . It has the advantage of simple calculation ; however , although it is appropriate in most cases , it may introduce large biases if the data are unbalanced [ 10 , 11 ] . On the other h and , r and om-effects models also add the between- study variance to the within- study variance of each individual study when the pooled mean of the r and om effects is calculated . The r and om-effects model most commonly used for dichotomous data is the DerSimonian and Laird estimate of the between- study variance [ 12 ] . Fixed- and r and om-effects models for continuous data have also been described [ 13 ] . Pooled results are generally reported as a point estimate and CI , typically a 95 % CI . Other quantitative techniques for combining data , such as the Confidence Profile Method [ 14 ] , use Bayesian methods to calculate posterior probability distributions for effects of interest . Bayesian statistics are based on the principle that each observation or set of observations should be viewed in conjunction with a prior probability describing the prior knowledge about the phenomenon of interest [ 15 ] . The new observations alter this prior probability to generate a posterior probability . Traditional meta- analysis assumes that nothing is known about the magnitude of the treatment effect before r and omized trials are performed . In Bayesian terms , the prior probability distribution is noninformative . Bayesian approaches may also allow the incorporation of indirect evidence in generating prior distributions [ 14 ] and may be particularly helpful in situations in which few data from r and omized studies exist [ 16 ] . Bayesian analyses may also be used to account for the uncertainty introduced by estimating the between- study variance in the r and om-effects model , leading to more appropriate estimates and predictions of treatment efficacy [ 17 ] . Exploring and Explaining Heterogeneity The next important issue is whether the common estimate obtained in the previous step is robust . Sensitivity analyses determine whether the common estimate is influenced by changes in the assumptions and in the protocol for combining the data . A comparison of the results of fixed- and r and om-effects models is one such sensitivity analysis [ 18 ] . Generally , the r and om-effects model produces wider CIs than does the fixed-effects model , and the level of statistical significance may therefore be different depending on the model used . The pooled point estimate per se is less likely to be affected , although exceptions are possible [ 19 ] . Other sensitivity analyses may include the examination of the residuals and the chi-square components [ 13 ] and assessment of the effect of deleting each study in turn . Statistically significant results that depend on a single study may require further exploration . Cumulative Meta- Analysis",
"OBJECTIVES The clinical effect of combined warfarin and antiplatelet therapy on the incidence of stroke and postoperative complications after mitral ( plus aortic ) valve replacement was studied and compared with that observed with warfarin therapy alone . BACKGROUND It has been reported that combined warfarin and antiplatelet therapy may be effective but may be associated with an increased hemorrhagic risk . Therefore , definite benefits of the treatment in patients with an implanted prosthetic valve have not been clearly documented . METHODS Between January 1980 and December 1992 , 195 patients with a St. Jude Medical valve at the mitral ( plus aortic ) position were assigned to receive treatment with either warfarin alone ( 125 patients ) or warfarin plus antiplatelet agents ( 70 patients ) , such as dipyridamole ( 150 or 300 mg daily , 14 patients ) or ticlopidine ( 200 or 400 mg daily , 56 patients ) . A minimal dose of aspirin ( 10 to 40 mg ) was added ( 29 patients ) if the maximal platelet aggregation rate by collagen was not reduced . The target thrombotest level was 10 % to 20 % . RESULTS The two treatment groups were similar with regard to gender and age distribution . The number of patients with atrial fibrillation , left atrial thrombus , history of previous stroke , simultaneous aortic valve operation and previously performed valve procedures were comparable in the two groups . Actuarial survival rate at 10 years was 98.3 + /- 1.7 % ( mean + /- SD ) in the warfarin plus antiplatelet group and 90.3 + /- 3.2 % in the warfarin group ( p actuarial stroke-free rate at 10 years was 95.3 + /- 3.4 % and 84.3 + /- 3.8 % , respectively ( p actuarial complication-free rate at 10 years was 89.4 + /- 4.3 % and 67.9 + /- 4.8 % , respectively ( p hemorrhagic complications were seen in the warfarin plus antiplatelet group . CONCLUSIONS The results strongly indicate the effectiveness and safety of combined warfarin plus antiplatelet treatment after St. Jude Medical valve replacement for mitral ( plus aortic ) valve disease",
"Prevention of arterial thromboembolism with acetylsalicylic acid ( ASA ) was studied in 148 patients with single Starr-Edwards aortic ball-valve prostheses . These patients are suitable for such a study because they have a high incidence of arterial emboli derived mainly from thrombi formed on the valves . They were given either 1 Gm . of ASA daily or placebo in combination with anticoagulants , and were observed for 2 years . Only two emboli occurred in patients receiving ASA , none of them severe . In the placebo group 12 thromboembolic episodes were diagnosed in 10 patients , and three with cerebral emboli died ; in one a subdural hematoma unrelated to the embolus was found . In addition , one fatal and the one nonfatal intracranial bleeding occurred in each group , whereas gastrointestinal complications were seen more frequently in patients taking ASA . It is concluded that ASA combined with anticoagulants offered a significantly better protection against arterial thromboembolism than did anticoagulant therapy alone",
"SUMMARY The long-term thromboembolic risk ( TER ) was estimated in a series of 1096 prosthesis carriers review ed by the same group between 1963 and 1980 , and in which the following points were particularly studied : the 376 first subjects operated upon with a mean follow-up of 6 + 3 years , involving all types of prostheses , but more particularly Starr-Edwards 1260 and 6120 valves . selected groups of patients : 60 aortic B jork valves , 50 aortic xenografts , 18 late thromboses of surgical or anatomic valves",
"BACKGROUND Mechanical reperfusion with stenting for ST-elevation myocardial infa rct ion ( STEMI ) is supported by dual antiplatelet treatment with aspirin and clopidogrel . Prasugrel , a potent and rapid-acting thienopyridine , is a potential alternative to clopidogrel . We aim ed to assess prasugrel versus clopidogrel in patients undergoing percutaneous coronary intervention ( PCI ) for STEMI . METHODS We undertook a double-blind , r and omised controlled trial in 707 sites in 30 countries . 3534 participants presenting with STEMI were r and omly assigned by interactive voice response system either prasugrel ( 60 mg loading , 10 mg maintenance [ n=1769 ] ) or clopidogrel ( 300 mg loading , 75 mg maintenance [ n=1765 ] ) and were unaware of the allocation . The primary endpoint was cardiovascular death , non-fatal myocardial infa rct ion , or non-fatal stroke . Efficacy analyses were by intention to treat . Follow-up was to 15 months , with secondary analyses at 30 days . This trial is registered with Clinical Trials.gov , number NCT00097591 . FINDINGS At 30 days , 115 ( 6.5 % ) individuals assigned prasugrel had met the primary endpoint compared with 166 ( 9.5 % ) allocated clopidogrel ( hazard ratio 0.68 [ 95 % CI 0.54 - 0.87 ] ; p=0.0017 ) . This effect continued to 15 months ( 174 [ 10.0 % ] vs 216 [ 12.4 % ] ; 0.79 [ 0.65 - 0.97 ] ; p=0.0221 ) . The key secondary endpoint of cardiovascular death , myocardial infa rct ion , or urgent target vessel revascularisation was also significantly reduced with prasugrel at 30 days ( 0.75 [ 0.59 - 0.96 ] ; p=0.0205 ) and 15 months ( 0.79 [ 0.65 - 0.97 ] ; p=0.0250 ) , as was stent thrombosis . Treatments did not differ with respect to thrombolysis in myocardial infa rct ion ( TIMI ) major bleeding unrelated to coronary-artery bypass graft ( CABG ) surgery at 30 days ( p=0.3359 ) and 15 months ( p=0.6451 ) . TIMI life-threatening bleeding and TIMI major or minor bleeding were also similar with the two treatments , and only TIMI major bleeding after CABG surgery was significantly increased with prasugrel ( p=0.0033 ) . INTERPRETATION In patients with STEMI undergoing PCI , prasugrel is more effective than clopidogrel for prevention of ischaemic events , without an apparent excess in bleeding",
"BACKGROUND Ticagrelor is an oral , reversible , direct-acting inhibitor of the adenosine diphosphate receptor P2Y12 that has a more rapid onset and more pronounced platelet inhibition than clopidogrel . METHODS In this multicenter , double-blind , r and omized trial , we compared ticagrelor ( 180-mg loading dose , 90 mg twice daily thereafter ) and clopidogrel ( 300-to-600-mg loading dose , 75 mg daily thereafter ) for the prevention of cardiovascular events in 18,624 patients admitted to the hospital with an acute coronary syndrome , with or without ST-segment elevation . RESULTS At 12 months , the primary end point -- a composite of death from vascular causes , myocardial infa rct ion , or stroke -- had occurred in 9.8 % of patients receiving ticagrelor as compared with 11.7 % of those receiving clopidogrel ( hazard ratio , 0.84 ; 95 % confidence interval [ CI ] , 0.77 to 0.92 ; P other composite end points , as well as myocardial infa rct ion alone ( 5.8 % in the ticagrelor group vs. 6.9 % in the clopidogrel group , P=0.005 ) and death from vascular causes ( 4.0 % vs. 5.1 % , P=0.001 ) but not stroke alone ( 1.5 % vs. 1.3 % , P=0.22 ) . The rate of death from any cause was also reduced with ticagrelor ( 4.5 % , vs. 5.9 % with clopidogrel ; P rates of major bleeding was found between the ticagrelor and clopidogrel groups ( 11.6 % and 11.2 % , respectively ; P=0.43 ) , but ticagrelor was associated with a higher rate of major bleeding not related to coronary-artery bypass grafting ( 4.5 % vs. 3.8 % , P=0.03 ) , including more instances of fatal intracranial bleeding and fewer of fatal bleeding of other types . CONCLUSIONS In patients who have an acute coronary syndrome with or without ST-segment elevation , treatment with ticagrelor as compared with clopidogrel significantly reduced the rate of death from vascular causes , myocardial infa rct ion , or stroke without an increase in the rate of overall major bleeding but with an increase in the rate of non-procedure-related bleeding . ( Clinical Trials.gov number , NCT00391872 .",
"Dipyridamole is a vasodilator known to reduce platelet adhesiveness and aggregation . Either dipyridamole or a placebo was given in a daily dose of 400 mg as a r and om , blind trial to 100 patients who had undergone prosthetic cardiac valve replacement . Patients in both groups were anticoagulated with warfarin sodium . Fifty patients of the placebo group followed for 695 months had 18 % incidence of systemic arterial embolism . Forty-two patients in the dipyridamole group were followed for 553 months . One patient exhibited clinical evidence of arterial embolism . Dipyridamole was discontinued shortly after surgery in eight patients followed for 119 months . Two of these patients developed cerebral emboli six months after discontinuation of treatment . It is tentatively concluded that the addition of dipyridamole to a program of anticoagulation reduces the incidence of postoperative arterial emboli originating on prosthetic cardiac valves in those patients who can tolerate the drug",
"After cardiac valve replacement patients were blindly r and omized into two groups , both receiving aspirin ( 330 mg ) and dipyridamole ( 75 mg ) twice daily and the oral anticoagulant acenocoumarol ( Sintrom ) . An international normalized ratio of 2.0 to 2.99 was assigned to group A and 3.0 to 4.5 to group B ; both groups were subsequently analyzed for thromboembolic and hemorrhagic complications . Final evaluation included 51 and 48 patients , respectively . The follow-up was 626 months for group A ( 12.3 months/patient ) and 486 months for group B ( 10.1 months/patient ) . The frequency of thromboembolism was equal in both groups : one transient ischemic attack in group A ( a rate of 1.92/100 patient-years ) and two transient ischemic attacks in group B ( a rate of 4.94/100 patient-years ) . There was , however , a statistical difference in bleeding complications between the two groups ( p less than 0.02 ) . Two patients bled in group A , a rate of 3.9 % ( 3.8/100 patient-years ) , which represents an incidence of one episode each 25.6 years of treatment ; 10 patients bled in group B , a rate of 20.8 % ( 24.7/100 patient-years ) representing an incidence of one episode each 4 years of treatment . We conclude that an international normalized ratio of 2 to 3 is safer than a ratio of 3 to 4.5 and confers good protection from thromboembolism when oral anticoagulant therapy is used conjointly with platelet function-inhibiting drugs in patients with mechanical substitute heart valves",
"INTRODUCTION This study was design ed to evaluate safety and efficacy of combined low dose aspirin and warfarin therapy following mechanical heart valve replacement . METHODS A total of 1496 patients ( 686 males , mean age 35±8.5 years ) undergoing mechanical heart valvular replacement were r and omly divided into study ( warfarin plus 75 - 100 mg aspirin ) or control ( warfarin only ) group . International normalized ratio ( INR ) and prothrombin time was maintained at 1.8 - 2.5 and 1.5 - 2.0 times of the normal value , respectively . Thromboembolic events and major bleedings were registered during follow up . RESULTS Patients were followed up for 24±9 months . The average dose of warfarin in the study and control group was 2.92±0.87 mg and 2.89±0.79 mg , respectively ( p>0.05 ) . The overall thromboembolic events in study group were lower than in control group ( 2.1 % vs. 3.6 % , p=0.044 ) . No statistically significant differences were found in hemorrhage events ( 3.5 % vs. 3.7 % , p>0.05 ) or mortality ( 0.3 % vs 0.4 % , p>0.05 ) between the two groups . CONCLUSIONS Following mechanical valve replacement , combined low dose aspirin and warfarin therapy was associated with a greater reduction in thromboembolism events than warfarin therapy alone . This combined treatment was not associated with an increase in the rate of major bleeding or mortality ",
"The objective of this study was to evaluate the safety and efficacy of low-intensity warfarin treatment plus aspirin during the first 6 months after surgery in patients undergoing heart valve substitution with mechanical prostheses . Vitamin K antagonists ( VKA ) are able to reduce but not eliminate thrombosis and systemic embolism in patients with mechanical heart valves . The intensity of treatment and additional use of aspirin in these patients is still controversial . Consecutive patients undergoing aortic or mitral valve replacement ( or a combination of the two ) with mechanical prostheses were invited to participate in the study . After stratifying for site of prosthesis , patients were r and omized to receive low intensity VKA treatment ( target INR 2.5 ) plus aspirin ( 100 mg/day ) for the first six months ( Group A ) or st and ard-intensity ( INR target 3.7 ) VKA treatment ( Group B ) . Mean follow-up was 1.5 years . Principal outcome events were systemic embolism , major bleeding , and vascular death . A total of 94 patients in Group A and 104 in Group B were r and omized and followed up for 144 and 163 patient years , respectively . There were 5 ( 5 % ) events in Group A ( 4 major bleeding events and 1 vascular death ) and 4 ( 4 % ) in group B ( 2 major bleeding events and 2 ischemic stroke ) . All the events except 1 occurred within the first 6 months after surgery . Cumulative incidence of primary outcome events was 5.8 % ( 95 % CI 0.9 to 10.7 ) in Group A and 4.3 % ( 95 % CI 0,2 to 8.4 ) in Group B ( p=0.6 ) . Low-intensity treatment plus aspirin during the first six months after surgery appears to be as effective and safe as moderate-high-intensity anticoagulation"
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41171e0a-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The Internet could provide a means of delivering secondary prevention programmes to people with coronary heart disease ( CHD ) . OBJECTIVES To determine the effectiveness of Internet-based interventions targeting lifestyle changes and medicines management for the secondary prevention of CHD . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) , MEDLINE , EMBASE , in December 2014 . We also search ed six other data bases in October 2014 , and three trials registers in January 2015 together with reference checking and h and search ing to identify additional studies . SELECTION CRITERIA R and omised controlled trials ( RCTs ) evaluating Internet-delivered secondary prevention interventions aim ed at people with CHD . DATA COLLECTION AND ANALYSIS Two review authors independently assessed risk of bias and extracted data according to the Cochrane H and book for Systematic Review s of Interventions . We assessed evidence quality using the GRADE approach and presented this in a ' Summary of findings ' table . MAIN RESULTS Eighteen trials met our inclusion criteria . Eleven studies are complete ( 1392 participants ) , and seven are ongoing . Of the completed studies , seven interventions are broad , targeting the lifestyle management of CHD , and four focused on physical activity promotion . The comparison group in trials was usual care ( n = 6 ) , minimal intervention ( n = 3 ) , or traditional cardiac rehabilitation ( n = 2).We found no effects of Internet-based interventions for all-cause mortality ( odds ratio ( OR ) 0.27 , 95 % confidence interval ( CI ) 0.04 to 1.63 ; participants = 895 ; studies = 6 ; low- quality evidence ) . There was only one case of cardiovascular mortality in a control group ( participants = 895 ; studies = 6 ) . No incidences of non-fatal re-infa rct ion were reported across any of the studies . We found no effects for revascularisation ( OR 0.69 , 95 % CI 0.37 to 1.27 ; participants = 895 ; studies = 6 ; low- quality evidence ) .We found no effects for total cholesterol ( mean difference ( MD ) 0.00 , 95 % CI -0.27 to 0.28 ; participants = 439 ; studies = 4 ; low- quality evidence ) , high-density lipoprotein ( HDL ) cholesterol ( MD 0.01 , 95 % CI -0.06 to 0.07 ; participants = 437 ; studies = 4 ; low- quality evidence ) , or triglycerides ( MD 0.01 , 95 % CI -0.17 to 0.19 ; participants = 439 ; studies = 4 ; low- quality evidence ) . We did not pool the data for low-density lipoprotein ( LDL ) cholesterol due to considerable heterogeneity . Two out of six trials measuring LDL cholesterol detected favourable intervention effects , and four trials reported no effects . Seven studies measured systolic and diastolic blood pressure ; we did not pool the data due to substantial heterogeneity . For systolic blood pressure , two studies showed a reduction with the intervention , but the remaining studies showed no effect . For diastolic blood pressure , two studies showed a reduction with the intervention , one study showed an increase with the intervention , and the remaining four studies showed no effect . Five trials measured health-related quality of life ( HRQOL ) . We could draw no conclusions from one study due to incomplete reporting ; one trial reported no effect ; two studies reported a short- and medium-term effect respectively ; and one study reported both short- and medium-term effects . Five trials assessed dietary outcomes : two reported favourable effects , and three reported no effects . Eight studies assessed physical activity : five of these trials reported no physical activity effects , and three reported effectiveness . Trials are yet to measure the impact of these interventions on compliance with medication . Two studies measured healthcare utilisation : one reported no effects , and the other reported increased usage of healthcare services compared to a control group in the intervention group at nine months ' follow-up . Two trials collected cost data : both reported that Internet-delivered interventions are likely to be cost-effective . In terms of the risk of bias , the majority of studies reported appropriate r and omisation and appropriate concealment of r and omisation processes . A lack of blinding result ed in a risk of performance bias in seven studies , and a risk of detection bias in five trials . Two trials were at risk of attrition bias , and five were at risk for reporting bias . AUTHORS ' CONCLUSIONS In general , evidence was of low quality due to lack of blinding , loss to follow-up , and uncertainty around the effect size . Few studies measured clinical events , and of those that did , a very small number of events were reported , and therefore no firm conclusions can be made . Similarly , there was no clear evidence of effect for cardiovascular risk factors , although again the number of studies reporting these was small . There was some evidence for beneficial effects on HRQOL , dietary outcomes , and physical activity , although firm conclusions can not yet be made . The effects on healthcare utilisation and cost-effectiveness are also inconclusive , and trials are yet to measure the impact of Internet interventions on compliance with medication . The comparison groups differed across trials , and there were insufficient studies with usable data for subgroup analyses . We intend to study the intensity of comparison groups in future up date s of this review when more evidence is available . The completion of the ongoing trials will add to the evidence base
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[
"Background — Secondary prevention by risk factor modification improves patient outcomes , yet it is often not achieved in clinical practice . Reasons for failure stem from challenges of prioritizing risk factor reduction and engaging patients in changing their behaviors . We hypothesize that a novel telemedicine intervention with tailored patient education could improve cardiovascular risk factors . Methods — To evaluate this intervention , we propose enrolling 450 patients with a recent myocardial infa rct ion and hypertension into a 3-arm r and omized , controlled trial . The first arm ( n=150 ) will receive home blood pressure ( BP ) monitors plus a nurse-delivered , telephone-based tailored patient education intervention and will be enrolled into HealthVault , a Microsoft electronic health record platform . The second arm ( n=150 ) will also receive BP monitors plus a tailored patient education intervention and be enrolled in HeartVault . However , the patient education intervention will be delivered by a Web-based program and will cover topics identical to those in the nurse-delivered intervention . Both arms will be compared with a control group receiving st and ard care ( n=150 ) . All participants will have an in-person assessment at baseline and at completion of the study , including st and ardized measurements of BP , LDL cholesterol , and glycosylated hemoglobin ( in diabetic subjects ) . The study design will allow assessment of a telephone-based , nurse-administered disease management program versus st and ard care . The main outcome of interest is the reduction in systolic BP in each intervention group compared with the control group at 12 months . Secondary outcomes assessed will include reductions in LDL cholesterol , body weight , and glycosylated hemoglobin , as well as adherence to evidence -based therapies and improvement in health behaviors . Conclusion — If successful in optimizing BP control , managing other coronary heart disease risk factors , and demonstrating a lower cost , the Web-based disease management tool has the potential to enhance coronary artery disease management , quality of care , and ultimately , patient outcomes . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00901277",
"Of 22 r and omized trials of rehabilitation with exercise after myocardial infa rct ion ( MI ) , one trial had results that achieved conventional statistical significance . To determine whether or not these studies , in the aggregate , show a significant benefit of rehabilitation after myocardial infa rct ion , we performed an overview of all r and omized trials , involving 4,554 patients ; we evaluated total and cardiovascular mortality , sudden death , and fatal and nonfatal reinfa rct ion . For each endpoint , we calculated an odds ratio ( OR ) and 95 % confidence interval ( 95 % CI ) for the trials combined . After an average of 3 years of follow-up , the ORs were significantly lower in the rehabilitation than in the comparison group : specifically , total mortality ( OR = 0.80 [ 0.66 , 0.96 ] ) , cardiovascular mortality ( OR = 0.78 [ 0.63 , 0.96 ] ) , and fatal reinfa rct ion ( OR = 0.75 [ 0.59 , 0.95 ] ) . The OR for sudden death was significantly lower in the rehabilitation than in the comparison group at 1 year ( OR = 0.63 [ 0.41 , 0.97 ] ) . The data were compatible with a benefit at 2 ( OR = 0.76 [ 0.54 , 1.06 ] ) and 3 years ( OR = 0.92 [ 0.69 , 1.23 ] ) , but these findings were not statistically significant . For nonfatal reinfa rct ion , there were no significant differences between the two groups after 1 ( OR = 1.09 [ 0.76 , 1.57 ] ) , 2 ( OR = 1.10 [ 0.82 , 1.47 ] ) , or 3 years ( OR = 1.09 [ 0.88 , 1.34 ] ) of follow-up . The observed 20 % reduction in overall mortality reflects a decreased risk of cardiovascular mortality and fatal reinfa rct ion throughout at least 3 years and a reduction in sudden death during the 1st year after infa rct ion and possibly for 2 - 3 years . With respect to the independent effects of the physical exercise component of cardiac rehabilitation , the relatively small number of \" exercise only \" trials , combined with the possibility that they may have had a formal or informal nonexercise component precludes the possibility of reaching any definitive conclusion . To do so would require a r and omized trial of sufficient size to distinguish between no effect and the most plausible effect based on the results of this overview",
"Abstract Objective : To evaluate the use of a computerised support system for decision making for implementing evidence based clinical guidelines for the management of asthma and angina in adults in primary care . Design : A before and after pragmatic cluster r and omised controlled trial utilising a two by two incomplete block design . Setting : 60 general practice s in north east Engl and . Participants : General practitioners and practice nurses in the study practice s and their patients aged 18 or over with angina or asthma . Main outcome measures : Adherence to the guidelines , based on review of case notes and patient reported generic and condition specific outcome measures . Results : The computerised decision support system had no significant effect on consultation rates , process of care measures ( including prescribing ) , or any patient reported outcomes for either condition . Levels of use of the software were low . Conclusions : No effect was found of computerised evidence based guidelines on the management of asthma or angina in adults in primary care . This was probably due to low levels of use of the software , despite the system being optimised as far as was technically possible . Even if the technical problems of producing a system that fully supports the management of chronic disease were solved , there remains the challenge of integrating the systems into clinical encounters where busy practitioners manage patients with complex , multiple conditions",
"Aim To determine the effectiveness and cost-effectiveness of a mobile phone intervention to improve exercise capacity and physical activity behaviour in people with ischaemic heart disease ( IHD ) . Methods and results In this single-blind , parallel , two-arm , r and omized controlled trial adults ( n = 171 ) with IHD were r and omized to receive a mobile phone delivered intervention ( HEART ; n = 85 ) plus usual care , or usual care alone ( n = 86 ) . Adult participants aged 18 years or more , with a diagnosis of IHD , were clinical ly stable as out patients , able to perform exercise , able to underst and and write English , and had access to the Internet . The HEART ( Heart Exercise And Remote Technologies ) intervention involved a personalized , automated package of text messages and a secure website with video messages aim ed at increasing exercise behaviour , delivered over 24 weeks . All participants were able to access usual community-based cardiac rehabilitation , which involves encouragement of physical activity and an offer to join a local cardiac support club . All outcomes were assessed at baseline and 24 weeks and included peak oxygen uptake ( PVO2 ; primary outcome ) , self-reported physical activity , health-related quality of life , self-efficacy and motivation ( secondary outcomes ) . Results showed no differences in PVO2 between the two groups ( difference −0.21 ml kg−1 min−1 , 95 % CI : −1.1 , 0.7 ; p = 0.65 ) at 24 weeks . However significant treatment effects were observed for selected secondary outcomes , including leisure time physical activity ( difference 110.2 min/week , 95 % CI : −0.8 , 221.3 ; p = 0.05 ) and walking ( difference 151.4 min/week , 95 % CI : 27.6 , 275.2 ; p = 0.02 ) . There were also significant improvements in self-efficacy to be active ( difference 6.2 % , 95 % CI : 0.2 , 12.2 ; p = 0.04 ) and the general health domain of the SF36 ( difference 2.1 , 95 % CI : 0.1 , 4.1 ; p = 0.03 ) at 24 weeks . The HEART programme was considered likely to be cost-effective for leisure time activity and walking . Conclusions A mobile phone intervention was not effective at increasing exercise capacity over and above usual care . The intervention was effective and probably cost-effective for increasing physical activity and may have the potential to augment existing cardiac rehabilitation services",
"Background : The CardioFit internet-based expert system was design ed to promote physical activity in patients with coronary heart disease ( CHD ) who were not participating in cardiac rehabilitation . Design : This r and omized controlled trial compared CardioFit to usual care to assess its effects on physical activity following hospitalization for acute coronary syndromes . Methods : A total of 223 participants were recruited at the University of Ottawa Heart Institute or London Health Sciences Centre and r and omly assigned to either CardioFit ( n = 115 ) or usual care ( n = 108 ) . The CardioFit group received a personally tailored physical-activity plan upon discharge from the hospital and access to a secure website for activity planning and tracking . They completed five online tutorials over a 6-month period and were in email contact with an exercise specialist . Usual care consisted of physical activity guidance from an attending cardiologist . Physical activity was measured by pedometer and self-reported over a 7-day period , 6 and 12 months after r and omization . Results : The CardioFit internet-based physical activity expert system significantly increased objective ly measured ( p = 0.023 ) and self-reported physical activity ( p = 0.047 ) compared to usual care . Emotional ( p = 0.038 ) and physical ( p = 0.031 ) dimensions of heart disease health-related quality of life were also higher with CardioFit compared to usual care . Conclusions : Patients with CHD using an internet-based activity prescription with online coaching were more physically active at follow up than those receiving usual care . Use of the CardioFit program could extend the reach of rehabilitation and secondary -prevention services",
"OBJECTIVE To assess the impact and cost-effectiveness of two information-based provider reminder interventions design ed to improve self-care management and outcomes of heart failure ( HF ) patients . DATA SOURCES / STUDY SETTING Interview and agency administrative data on 628 home care patients with a primary diagnosis of HF . STUDY DESIGN Patients were treated by nurses r and omly assigned to usual care or one of two intervention groups . The basic intervention was an e-mail to the patient 's nurse highlighting six HF-specific clinical recommendations . The augmented intervention supplemented the initial nurse reminder with additional clinician and patient re sources . DATA COLLECTION Patient interviews were conducted 45 days post admission to measure self-management behaviors , HF-specific outcomes ( Kansas City Cardiomyopathy Question naire-KCCQ ) , health-related quality of life ( EuroQoL ) , and service use . PRINCIPAL FINDINGS Both interventions improved the mean KCCQ summary score ( 15.3 and 12.9 percent , respectively ) relative to usual care ( p EuroQoL score relative to usual care ( p medication knowledge , diet , and weight monitoring . The basic intervention was more cost-effective than the augmented intervention in improving clinical outcomes . CONCLUSIONS This study demonstrates the positive impact of targeting evidence -based computer reminders to home health nurses to improve patient self-care behaviors , knowledge , and clinical outcomes . It also advances the field 's limited underst and ing of the cost-effectiveness of selected strategies for translating research into practice",
"Objective To investigate whether an internet based , nurse led vascular risk factor management programme promoting self management on top of usual care is more effective than usual care alone in reducing vascular risk factors in patients with clinical ly manifest vascular disease . Design Prospect i ve r and omised controlled trial . Setting Multicentre trial in secondary and tertiary healthcare setting . Participants 330 patients with a recent clinical manifestation of atherosclerosis in the coronary , cerebral , or peripheral arteries and with at least two treatable risk factors not at goal . Intervention Personalised website with an overview and actual status of patients ’ risk factors and mail communication via the website with a nurse practitioner for 12 months ; the intervention combined self management support , monitoring of disease control , and drug treatment . Main outcome measures The primary endpoint was the relative change in Framingham heart risk score after 1 year . Secondary endpoints were absolute changes in the levels of risk factors and the differences between groups in the change in proportion of patients reaching treatment goals for each risk factor . Results Participants ’ mean age was 59.9 ( SD 8.4 ) years , and most patients ( n=246 ; 75 % ) were male . After 1 year , the relative change in Framingham heart risk score of the intervention group compared with the usual care group was −14 % ( 95 % confidence interval −25 % to −2 % ) . At baseline , the Framingham heart risk score was higher in the intervention group than in the usual care group ( 16.1 ( SD 10.6 ) v 14.0 ( 10.5 ) ) , so the outcome was adjusted for the separate variables of the Framingham heart risk score and for the baseline Framingham heart risk score . This produced a relative change of −12 % ( −22 % to −3 % ) in Framingham heart risk score for the intervention group compared with the usual care group adjusted for the separate variables of the score and −8 % ( −18 % to 2 % ) adjusted for the baseline score . Of the individual risk factors , a difference between groups was observed in low density lipoprotein cholesterol ( −0.3 , −0.5 to −0.1 , mmol/L ) and smoking ( −7.7 % , −14.9 % to −0.4 % ) . Some other risk factors tended to improve ( body mass index , triglycerides , systolic blood pressure , renal function ) or tended to worsen ( glucose concentration , albuminuria ) . Conclusion An internet based , nurse led treatment programme on top of usual care for vascular risk factors had a small effect on lowering vascular risk and on lowering of some vascular risk factors in patients with vascular disease . Trial registration Clinical trials NCT00785031",
"Background Depression is common in people with coronary heart disease ( CHD ) and associated with worse outcome . This study explored the acceptability and feasibility of procedures for a trial and for an intervention , including its potential costs , to inform a definitive r and omized controlled trial ( RCT ) of a nurse-led personalised care intervention for primary care CHD patients with current chest pain and probable depression . Methods Multi-centre , outcome assessor-blinded , r and omized parallel group study . CHD patients reporting chest pain and scoring 8 or more on the HADS were r and omized to personalized care ( PC ) or treatment as usual ( TAU ) for 6 months and followed for 1 year . Primary outcome was acceptability and feasibility of procedures ; secondary outcomes included mood , chest pain , functional status , well being and psychological process variables . Result 1001 people from 17 General Practice CHD registers in South London consented to be contacted ; out of 126 who were potentially eligible , 81 ( 35 % female , mean age = 65 SD11 years ) were r and omized . PC participants ( n = 41 ) identified wide ranging problems to work on with nurse-case managers . Good acceptability and feasibility was indicated by low attrition ( 9 % ) , high engagement and minimal nurse time used ( mean/SD = 78/19 mins assessment , 125/91 mins telephone follow up ) . Both groups improved on all outcomes . The largest between group difference was in the proportion no longer reporting chest pain ( PC 37 % vs TAU 18 % ; mixed effects model OR 2.21 95 % CI 0.69 , 7.03 ) . Some evidence was seen that self efficacy ( mean scale increase of 2.5 vs 0.9 ) and illness perceptions ( mean scale increase of 7.8 vs 2.5 ) had improved in PC vs TAU participants at 1 year . PC appeared to be more cost effective up to a QALY threshold of approximately £ 3,000 . Conclusions Trial and intervention procedures appeared to be feasible and acceptable . PC allowed patients to work on unaddressed problems and appears cheaper than TAU . Trial Registration Controlled-Trials.com IS RCT",
"Background The purpose of this study was to evaluate the effect of a physical activity telemonitoring program on daily physical activity level , oxygen uptake capacity ( VO2peak ) , and cardiovascular risk profile in coronary artery disease ( CAD ) patients who completed phase II cardiac rehabilitation ( CR ) . Methods Eighty CAD patients who completed phase II CR were r and omly assigned to an additional telemonitoring intervention or st and ard CR . The patients in the intervention group ( n = 40 ) wore a motion sensor continuously for 18 weeks . Each week these patients received a step count goal , with the aim to gradually increase the patients ’ physical activity level . In the control group ( n = 40 ) , the patients wore an unreadable motion sensor for seven days for measurement purpose s only ( at start of follow-up , and after six and 18 weeks ) . At start of follow-up and after 18 weeks blood lipid profile , glycemic control , waist circumference and body mass index was assessed . VO2peak was assessed at start of follow-up , and after six and 18 weeks . Re-hospitalisation rate was followed during this timeframe . Results In the intervention group , VO2peak increased significantly during follow-up ( P = 0.001 ) , in the control group it did not ( P = 0.273 ) . A significant correlation was found between daily aerobic step count and improvement in VO2peak ( P = 0.030 , r = 0.47 ) . Kaplan-Meier curve analysis showed a trend towards fewer re-hospitalisations for patients in the telemonitoring group ( P = 0.09 ) . Conclusions The study showed that , to maintain exercise tolerance and lower re-hospitalisation rate after hospital-based CR in CAD patients , a physical activity telemonitoring program might be an effective intervention",
"Background Angina affects more than 50 million people worldwide . Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population . An Internet-based version could offer a feasible alternative . Objective Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina . Methods We conducted a r and omized controlled trial , recruiting those diagnosed with angina from general practitioners ( GPs ) in primary care to an intervention or control group . Intervention group participants were offered a 6-week Web-based rehabilitation program ( “ ActivateYourHeart ” ) . The program was introduced during a face-to-face appointment and then delivered via the Internet ( no further face-to-face contact ) . The program contained information about the secondary prevention of coronary heart disease ( CHD ) and set each user goals around physical activity , diet , managing emotions , and smoking . Performance against goals was review ed throughout the program and goals were then reset/modified . Participants completed an online exercise diary and communicated with rehabilitation specialists through an email link/synchronized chat room . Participants in the control group continued with GP treatment as usual , which consisted of being placed on a CHD register and attending an annual review . Outcomes were measured at 6-week and 6-month follow-ups during face-to-face assessment s. The primary outcome measure was change in daily steps at 6 weeks , measured using an accelerometer . Secondary outcome measures were energy expenditure ( EE ) , duration of sedentary activity ( DSA ) , duration of moderate activity ( DMA ) , weight , diastolic/systolic blood pressure , and body fat percentage . Self-assessed question naire outcomes included fat/fiber intake , anxiety/depression , self-efficacy , and quality of life ( QOL ) . Results A total of 94 participants were recruited and r and omized to the intervention ( n=48 ) or the usual care ( n=46 ) group ; 84 and 73 participants completed the 6-week and 6-month follow-ups , respectively . The mean number of log-ins to the program was 18.68 ( SD 13.13 , range 1 - 51 ) , an average of 3 log-ins per week per participant . Change in daily steps walked at the 6-week follow-up was + 497 ( SD 2171 ) in the intervention group and –861 ( SD 2534 ) in the control group ( 95 % CI 263 - 2451 , P=.02 ) . Significant intervention effects were observed at the 6-week follow-up in EE ( + 43.94 kcal , 95 % CI 43.93 - 309.98 , P=.01 ) , DSA ( –7.79 minutes , 95 % CI –55.01 to –7.01 , P=.01 ) , DMA ( + 6.31 minutes , 95 % CI 6.01 - 51.20 , P=.01 ) , weight ( –0.56 kg , 95 % CI –1.78 to –0.15 , P=.02 ) , self-efficacy ( 95 % CI 0.30 - 4.79 , P=.03 ) , emotional QOL score ( 95 % CI 0.01 - 0.54 , P=.04 ) , and angina frequency ( 95 % CI 8.57 - 35.05 , P=.002 ) . Significant benefits in angina frequency ( 95 % CI 1.89 - 29.41 , P=.02 ) and social QOL score ( 95 % CI 0.05 - 0.54 , P=.02 ) were also observed at the 6-month follow-up . Conclusions An Internet-based secondary prevention intervention could be offered to those with angina . A larger pragmatic trial is required to provide definitive evidence of effectiveness and cost-effectiveness . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 90110503 ; http://www.controlled-trials.com/IS RCT N90110503/IS RCT N90110503 ( Archived by WebCite at http://www.webcitation.org/6RYVOQFKM )",
"PURPOSE The purpose for this study was to evaluate the association between depression-focused interpersonal counseling ( IPC ) and the use of healthcare services in Finl and after myocardial infa rct ion ( MI ) . DESIGN AND METHODS The measures were done at 6 and 18 months after MI in the r and omized intervention ( n= 51 ) and the control group ( n= 52 ) . FINDINGS There was less use of somatic specialized healthcare services in the intervention group from 6 to 18 months after hospital discharge , and with intervention patients who had no other long-term disease during 6 months . PRACTICE IMPLICATION S Confirmation of possible benefits of IPC for practice calls for more specific studies",
"OBJECTIVE The aim of this study was to evaluate the impact of an integrated patient-specific electronic clinical reminder system on diabetes and coronary artery disease ( CAD ) care and to assess physician attitudes toward this reminder system . DESIGN We enrolled 194 primary care physicians caring for 4549 patients with diabetes and 2199 patients with CAD at 20 ambulatory clinics . Clinics were r and omized so that physicians received either evidence -based electronic reminders within their patients ' electronic medical record or usual care . There were five reminders for diabetes care and four reminders for CAD care . MEASUREMENTS The primary outcome was receipt of recommended care for diabetes and CAD . We created a summary outcome to assess the odds of increased compliance with overall diabetes care ( based on five measures ) and overall CAD care ( based on four measures ) . We surveyed physicians to assess attitudes toward the reminder system . RESULTS Baseline adherence rates to all quality measures were low . While electronic reminders increased the odds of recommended diabetes care ( odds ratio [ OR ] 1.30 , 95 % confidence interval [ CI ] 1.01 - 1.67 ) and CAD ( OR 1.25 , 95 % CI 1.01 - 1.55 ) , the impact of individual reminders was variable . A total of three of nine reminders effectively increased rates of recommended care for diabetes or CAD . The majority of physicians ( 76 % ) thought that reminders improved quality of care . CONCLUSION An integrated electronic reminder system result ed in variable improvement in care for diabetes and CAD . These improvements were often limited and quality gaps persist",
"Background The future risk of heart disease can be predicted with increasing precision . However , more research is needed into how this risk is conveyed and presented . The aim of this study is to compare the effects of presenting cardiovascular risk in different formats on individuals ' intention to change behaviour to reduce risk , underst and ing of risk information and emotional affect . Methods / design A r and omised controlled trial comprising four arms , with a between subjects design will be performed . There will be two intervention groups and two control groups . The first control comprises a pre-intervention question naire and presents risk in a bar graph format . The second control presents risk in a bar graph format without pre-intervention question naire . These two control groups are to account for the potential Hawthorne effect of thinking about cardiovascular risk before viewing actual risk . The two intervention groups comprise presenting risk in either a pictogram or metonym format ( image depicting seriousness of having a myocardial infa rct ion ) . 800 individuals ' aged between 45 and 64 years , who have not been previously diagnosed with heart disease and have access to a computer with internet , will be given a link to a website comprising a risk calculator and electronic question naires . 10-year risk of having a coronary heart disease event will be assessed and presented in one of the three formats . A post-intervention question naire will be completed after viewing the risk format . Main outcome measures are ( i ) intention to change behaviour , ( ii ) underst and ing of risk information , ( iii ) emotional affect and ( iv ) worry about future heart disease . Secondary outcomes are the sub-components of the theory of planned behaviour : attitudes , perceived behavioural control and subjective norms . Discussion Having review ed the literature , we are not aware of any other studies which have used the assessment of actual risk , in a trial to compare different graphical cardiovascular risk presentation formats . This trial will provide data about which graphical cardiovascular risk presentation format is most effective in encouraging behaviour change to reduce cardiovascular risk . Trial registration Current Controlled Trials IS RCT",
"Introduction Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk . In this project , we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice . Consumer Navigation of Electronic Cardiovascular Tools ( CONNECT ) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Isl and er and non-indigenous adults , recruited through primary care , at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care . Methods and analysis R and omised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk . The trial will be augmented by formal economic and process evaluations to assess acceptability , equity and cost-effectiveness of the intervention . The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management . The programme is electronically integrated with the primary care provider 's software and will include interactive smart phone and Internet platforms . The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline -recommended blood pressure ( BP ) and cholesterol targets . Secondary outcomes include change in mean BP and fasting cholesterol levels , proportion meeting BP and cholesterol targets separately , self-efficacy , health literacy , self-reported point prevalence abstinence in smoking , body mass index and waist circumference , self-reported physical activity and self-reported medication adherence . Ethics and dissemination Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council . Results will be disseminated via the usual scientific forums including peer- review ed publications and presentations at international conferences Clinical Trials registration number ACTRN12613000715774",
"Background Using the Internet may prove useful in providing nutrition counselling and social support for patients with chronic diseases . Objective We evaluated the impact of Web-based nutrition counselling and social support on social support measures , anthropometry , blood pressure , and serum cholesterol in patients at increased cardiovascular risk . Methods We conducted a r and omized controlled trial among patients with increased cardiovascular risk in Canadian family practice s. During 8 months , patients in the intervention group and control groups received usual care . Patients in the intervention group also had access to a Web-based nutrition counselling and social support tool ( Heartweb ) . Site use during the study was monitored . We measured social support , body mass index , waist/hip ratio , blood pressure , and cholesterol levels at baseline and at 4 and 8 months to assess the effectiveness of the intervention . Results We r and omized 146 patients into the Web-based intervention ( n=73 ) or the control group ( n=73 ) . Within the Web-based intervention group , Heartweb was used by only 33 % ( 24/73 ) of patients , with users being significantly younger than nonusers ( P=.03 ) . There were no statistically significant differences between the intervention group and the control group in changes in social support , anthropometry , blood pressure , and serum cholesterol levels . Conclusions Uptake of the Web-based intervention was low . This study showed no favourable effects of a Web-based nutrition counselling and social support intervention on social support , anthropometry , blood pressure , and serum cholesterol . Improvements in reach and frequency of site use are needed to increase the effectiveness of Web-based interventions",
"This study evaluated the efficacy of a theory of planned behaviour ( TPB ) based intervention to increase fruit and vegetable consumption . The extent to which fruit and vegetable consumption and change in intake could be explained by the TPB was also examined . Participants were r and omly assigned to two levels of intervention frequency matched for intervention content ( low frequency n=92 , high frequency n=102 ) . Participants received TPB-based email messages design ed to increase fruit and vegetable consumption , messages targeted attitude , subjective norm and perceived behavioural control ( PBC ) . Baseline and post-intervention measures of TPB variables and behaviour were collected . Across the entire study cohort , fruit and vegetable consumption increased by 0.83 servings/day between baseline and follow-up . Intention , attitude , subjective norm and PBC also increased ( p TPB successfully modelled fruit and vegetable consumption at both time points but not behaviour change . The increase of fruit and vegetable consumption is a promising preliminary finding for those primarily interested in increasing fruit and vegetable consumption . However , those interested in theory development may have concerns about the use of this model to explain behaviour change in this context . More high quality experimental tests of the theory are needed to confirm this result",
"Cardiac pain arising from chronic stable angina ( CSA ) is a cardinal symptom of coronary artery disease and has a major negative impact on health-related quality of life ( HRQL ) , including pain , poor general health status , and inability to self-manage . Current secondary prevention approaches lack adequate scope to address CSA as a multidimensional ischemic and persistent pain problem . This trial evaluated the impact of a low-cost six-week angina psychoeducation program , entitled The Chronic Angina Self-Management Program ( CASMP ) , on HRQL , self-efficacy , and re source fulness to self-manage anginal pain . One hundred thirty participants were r and omized to the CASMP or three-month wait-list usual care ; 117 completed the study . Measures were taken at baseline and three months . General HRQL was measured using the Medical Outcomes Study 36-Item Short Form and the disease-specific Seattle Angina Question naire ( SAQ ) . Self-efficacy and re source fulness were measured using the Self-Efficacy Scale and the Self-Control Schedule , respectively . The mean age of participants was 68 years , 80 % were male . Analysis of variance of change scores yielded significant improvements in treatment group physical functioning [ F=11.75(1,114 ) , P general health [ F=10.94(1,114 ) , P=0.001 ] aspects of generic HRQL . Angina frequency [ F=5.57(1,115 ) , P=0.02 ] , angina stability [ F=7.37(1,115 ) , P=0.001 ] , and self-efficacy to manage disease [ F=8.45(1,115 ) , P=0.004 ] were also significantly improved at three months . The CASMP did not impact re source fulness . These data indicate that the CASMP was effective for improving physical functioning , general health , anginal pain symptoms , and self-efficacy to manage pain at three months and provide a basis for long-term evaluation of the program",
"Objective Cardiac rehabilitation ( CR ) is pivotal in preventing recurring events of myocardial infa rct ion ( MI ) . This study aims to investigate the effect of a smartphone-based home service delivery ( Care Assessment Platform ) of CR ( CAP-CR ) on CR use and health outcomes compared with a traditional , centre-based programme ( TCR ) in post-MI patients . Methods In this unblinded r and omised controlled trial , post-MI patients were r and omised to TCR ( n=60 ; 55.7±10.4 years ) and CAP-CR ( n=60 ; 55.5±9.6 years ) for a 6-week CR and 6-month self-maintenance period . CAP-CR , delivered in participants ’ homes , included health and exercise monitoring , motivational and educational material delivery , and weekly mentoring consultations . CAP-CR uptake , adherence and completion rates were compared with TCR using intention-to-treat analyses . Changes in clinical outcomes ( modifiable lifestyle factors , biomedical risk factors and health-related quality of life ) across baseline , 6 weeks and 6 months were compared within , and between , groups using linear mixed model regression . Results CAP-CR had significantly higher uptake ( 80 % vs 62 % ) , adherence ( 94 % vs 68 % ) and completion ( 80 % vs 47 % ) rates than TCR ( p improvements in 6-minute walk test from baseline to 6 weeks ( TCR : 537±86–584±99 m ; CAP-CR : 510±77–570±80 m ) , which was maintained at 6 months . CAP-CR showed slight weight reduction ( 89±20–88±21 kg ) and also demonstrated significant improvements in emotional state ( K10 : median ( IQR ) 14.6 ( 13.4–16.0 ) to 12.6 ( 11.5–13.8 ) ) , and quality of life ( EQ5D-Index : median ( IQR ) 0.84 ( 0.8–0.9 ) to 0.92 ( 0.9–1.0 ) ) at 6 weeks . Conclusions This smartphone-based home care CR programme improved post-MI CR uptake , adherence and completion . The home-based CR programme was as effective in improving physiological and psychological health outcomes as traditional CR . CAP-CR is a viable option towards optimising use of CR services . Trial registration number ANZCTR12609000251224",
"Background Non-communicable diseases ( NCDs ) are the leading causes of death globally and are associated with a limited set of common , modifiable health behaviours : tobacco use , physical inactivity , harmful use of alcohol and unhealthy diet . General practice offers an ideal avenue for addressing such health behaviours on a population -wide basis . This paper describes the protocol of a multiple health behaviour change intervention design ed for implementation in general practice and summarises the baseline characteristics of its participants . Method / Design The 10 Small Steps ( 10SS ) study , a r and omised controlled trial , involved 4,678 adult general practice patients in Queensl and , Australia . Self-reported data were collected to establish the proportion of participants meeting recommended guidelines for ten health behaviours : physical activity , body mass index , alcohol , smoking and six dietary behaviours . Participants were r and omised to four groups : contact at baseline only ( ' single intervention ' and corresponding control group ) and contact at baseline and 3 months ( ' dual intervention ' and corresponding control group ) . At each contact the participants received a computer-tailored feedback and one page information sheet according to their allocation to intervention or control groups . Change in the intervention group compared to the control group was assessed at 3 and 12 months after baseline data collection .Responses were summed to calculate an individual lifestyle score ( the Prudence Score ) , which ranged from 0 to 10 . The baseline response was 56.5 % ( 4678 of 8343 invited participants ) and the study sample was primarily female ( 68.7 % ) with an average age of 47 years . The mean Prudence Score was 5.8 ( 95%CI 5.75 - 5.85 ) . Discussion Baseline data from the 10SS study show that nearly all participants engage in some health behaviours but relatively few adhere simultaneously to a core set of dietary and lifestyle behaviours associated with risk of NCDs . Ample scope exists to improve health behaviour to reduce NCDs in the general practice setting and the 10SS study trial will provide data on the extent to which a minimal computer-tailored intervention can meet this objective . The protocol developed for the 10SS study has potential for translation into routine general practice as it has minimal impact on practice routine whilst contributing to primary prevention objectives .Trial Registration The Australian New Zeal and Clinical Trials Registry",
"OBJECTIVE To determine if patients hospitalized for angioplasty could learn about symptoms , risk factors , and care-seeking behaviors before and after discharge and to assess patient acceptability of the intervention . METHODS Thirty-two women and 32 men were r and omly assigned to groups and completed an intervention pretest . The experimental group viewed the Know & Go ! slide presentation at baseline and 2 and 4 months after discharge . A satisfaction survey was mailed to patients in the experimental group . RESULTS There were no significant differences between groups in clinical or sociodemographic characteristics . The experimental group scored significantly higher on an intervention posttest at study completion ( F = 15.21 ; P highly satisfied with the program and computer technology ( range 0 - 12 , M = 9.57 ± 1.83 ) . CONCLUSION The Know & Go ! intervention was safe , effective , and acceptable to patients in pilot testing . Results support refinement and further testing of the intervention for patients diagnosed with coronary heart disease",
"Objectives : To examine whether a Web-based health and leadership development program— design ed specifically for managers — was associated with changes in self-reported and biometric indicators of cardiovascular disease within the context of a r and omized control trial . Methods : A total of 145 managers from 8 organizations participated in a 6-month Internet-based program or a control condition . They completed pre- and posttest assessment s that included both self-reported attitudes ( on diet , exercise , and mental health ) and biometric measures ( eg , body weight , waist circumference ) . Results : The intervention was associated with improvements in dietary attitudes , dietary self-efficacy , and exercise , and reductions in distress symptoms . Women in the program reduced their waist circumference significantly more than controls . Conclusions : The program showed promise for reducing cardiovascular disease risk factors . Similar results across diverse organizations suggest the program may be useful across industry types",
"Summary In the TeleGuard trial , 1500 patients with established coronary artery disease ( CAD ) were recruited and r and omized to control or intervention groups . Patients in the intervention group were equipped with a 12-lead event recorder and could contact a call centre and transmit an ECG whenever they wished . In a 12-month study , the composite endpoint ( all-cause mortality , myocardial infa rct ion , re-hospitalization or re-vascularization ) was seen in 40 % of the intervention patients and in 38 % of the control patients . In both groups , approximately 40 % were re-hospitalized . In total , 73 patients experienced re-vascularization , 75 showed an infa rct ion and 33 died . Equipping CAD patients with a 12-lead ECG device and providing a telemedicine centre with 24-hour availability did not decrease risk for the composite endpoint ( re-hospitalization , re-vascularization , ( subsequent ) myocardial infa rct ion and /or death ) . It is likely that the clinical pathway used in the telemedicine centre led to an increased hospital admission rate in the intervention group",
"Background It is possible to provide patients with secure access to their medical records using the Internet . Such access may assist patients in the self-management of chronic diseases such as heart failure . Objective To assess how a patient-accessible online medical record affects patient care and clinic operations . The SPPARO ( System Providing Access to Records Online ) software consisted of a web-based electronic medical record , an educational guide , and a messaging system enabling electronic communication between the patient and staff . Methods A r and omized controlled trial was conducted in a specialty practice for patients with heart failure . Surveys assessing doctor-patient communication , adherence , and health status were conducted at baseline , 6 months , and 1 year . Use of the system , message volume , utilization of clinical services , and mortality were monitored . Results One hundred and seven patients were enrolled ( 54 intervention and 53 controls ) . At 12 months , the intervention group was not found to be superior in self-efficacy ( KCCQ self-efficacy score 91 vs. 85 , p=0.08 ) , but was superior in general adherence ( MOS compliance score 85 vs. 78 , p=0.01 ) . A trend was observed for better satisfaction with doctor-patient communication . The intervention group had more emergency department visits ( 20 vs. 8 , p=0.03 ) , but these visits were not temporally related to use of the online medical record . There were no adverse effects from use of the system . Conclusions Providing patients with congestive heart failure access to an online medical record was feasible and improved adherence . An effect on health status could not be demonstrated in this pilot study",
"OBJECTIVE To evaluate the implementation of clinical guidelines for hypertension in general practice by use of a computer-based clinical decision support system ( CDSS ) and a specific implementation strategy . Evaluation of patient outcome . DESIGN R and omised study with health centres as units . The intervention group had the CDSS installed and made ready for use , doctors and assistants were trained and received a user-manual , the doctors were offered telephone repetitions , a seminar in risk intervention and , at the same seminar , further demonstration of the CDSS . The doctors received baseline registration s with information of how they treated their own hypertensive patients , and use of the CDSS was checked repeatedly . SETTING General practice in Sør- and Nord-Trøndelag counties in Norway , 380,000 inhabitants . PARTICIPANTS Seventeen health centres with 24 doctors and 984 patients in the intervention group . Data from 879 patients used in the final analyses . Twelve health centres with 29 doctors and 1255 patients in the control group . Data from 1119 patients used in the final analyses . MAIN OUTCOME MEASURES After an intervention period of 18 months , group differences in level of systolic and diastolic blood pressure , serum cholesterol , body mass index , and risk score for myocardial infa rct ion were calculated , as well as group differences in fractions of smokers . RESULTS Significant group difference in favour of intervention group : diastolic blood pressure 1 mmHg ( 95 % CI -1.89 , -0.17 ) . However , a significant baseline difference in systolic blood pressure in favour of control group of 2.7 mmHg ( 95 % CI 1.0 , 4.5 ) had been reduced to 1.2 mmHg ( 95 % CI -0.6 , 3.0 ) after intervention . CONCLUSION Implementation of clinical guidelines in the treatment of hypertensive patients in general practice by means of a CDSS and several other procedures for implementation did not affect patient outcome in any clinical ly significant way",
"OBJECTIVE This pilot study examined the effect of a home communication intervention ( HCI ) to augment home health care ( HHC ) on functioning and recovery outcomes of elderly patients undergoing coronary artery bypass graft . DESIGN A r and omized , experimental two-group ( N = 50 ) repeated- measures design was used . Both HCI and control subjects received HHC , and the HCI group also received the 12-week HCI delivered by a telehealth device , the Health Buddy ( Health Hero Network ) . The Medical Outcome Study Short Form-36 measured physiologic and psychosocial functioning at baseline , 6 weeks , and 3 months after surgery . Follow-up subject interviews ascertained self-report of postoperative problems and health care use . SAMPLE Subjects had an average age of 75.3 years and included males ( 56 % ) and females ( 44 % ) . RESULTS By using repeated- measures analyses of covariance , covariating for the total number of HHC visits , HCI subjects , compared with the HHC group only , had a significantly higher adjusted mean general health functioning score ( F = 8.41 [ 1 , 36 ] , P physical , role-physical , and mental health functioning , indicating that both groups improved over time . The groups reported similar postoperative problems ; however , the control group had more emergency department visits than the HCI group . CONCLUSIONS Findings demonstrate the potential benefit of using an HCI to further augment outcomes of high-risk patients undergoing coronary artery bypass graft surgery referred to HHC after hospitalization",
"The aim of this study was to assess whether our online closed community heart care support group and information re source could sustain changes in health behaviour after the moderators withdrew their support . Heart patients ( n = 108 ) living in a deprived area of Greater Manchester were recruited from general practitioners ' coronary heart disease registries . The sample for this r and omized controlled trial was divided in half at r and om where half of the participants received password-protected access to our health portal and the other half did not . At 6 months follow-up ( based on the moderated phase ) , there was a significant difference between the experimental group and the controls in terms of self-reported diet ( eating bad foods less often ) . This change in behaviour was not sustained during the 3-month unmoderated phase . During this unmoderated phase of the intervention , the experimental group had significantly more health care visits compared with the controls . There was no significant difference between the two phases for either group in terms of exercise , smoking or social support . This study offers insight into the potential implication s for health changes of moderating arrangements for online health communities",
"For this study a r and omized clinical trial was design ed to test the effects of an early home recovery information intervention on physical functioning , psychological distress , and symptom frequency 1 month following coronary artery bypass graft surgery ( CABG ) . Recovery outcomes were compared between two groups : those receiving an audiotape of information on expected physical sensations and their management ( Cardiac Home Information Program [ CHIP ] ) in addition to the usual care , and those receiving the usual cardiac discharge information protocol . A nonprobability sample of 180 patients ( 84 women and 96 men ; mean age = 62 years ) was equally distributed between the two study groups . When controlling for age , comorbidity , and cardiac functional status , the results showed positive effects on physical functioning in women and psychological distress , vigor and fatigue in men . Consistent with other studies , women had worse physical functioning and more symptom frequency than men . These findings indicate that the CHIP intervention is an effective method to prepare CABG patients for home recovery",
"This paper reports the effects of a tailored Web-based delivery system on self-efficacy as it relates to a patients ' response to acute myocardial information ( AMI ) symptoms . The data reported are from MI-HEART , a r and omized trial examining ways in which a clinical information system can favorably influence the appropriateness and rapidity of decision-making in patients suffering from symptoms of acute myocardial infa rct ion . Participants were r and omized into one of three groups : tailored Web-based , non-tailored Web-based and non-tailored paper based . A theoretically based behavioral-cognitive model was used to identify key variables upon which to tailor education material . A key variable in the model is self-efficacy , operationalized with a three-dimensional scaling . Results show trends in improved self-efficacy scores for all groups at 1-month follow up , with sustained significant increases in baseline to 3-month scores only in the tailored Web-based group . One possible explanation could be related to \" hit-count \" , which was significantly higher in the tailored group . This study is a first step in quantifying the contribution of Web-based tailoring over non-tailoring in changing key determinants of patient delay to AMI symptoms",
"Background Nonpharmacological secondary prevention of coronary heart disease is considered a safe and effective measure to substantially reduce mortality . Despite the effectiveness of lifestyle changes , the compliance rate of patients is very low mainly due to psychosocial barriers . Psychotherapeutic approaches that address how persons think about themselves and their behaviors appear to have a significant potential for improving health behavior . Methods / design Against this background , our study aims to examine the feasibility and effects of a Psychodynamic Motivation and Training program ( PMT ) as compared to one session of advice in exercise training ( EX ) and treatment as usual ( TAU ) . For that purpose , 90 patients with stable coronary heart disease and a physically inactive lifestyle will be r and omly assigned to the three groups ( each with n = 30 ) . The primary outcome is the change in the individual anaerobic threshold as determined by spiroergometry from baseline to six month follow-up . Secondary endpoints include change in endothelial function , biomarkers of inflammation and oxidative stress , quality of life , symptoms of fatigue , illness perception and feasibility of the treatment approach . We hypothesize that physical fitness will improve more in PMT than in EX and TAU , with PMT and EX more than TAU , and that the effects will be more pronounced for participants with current mental or psychosocial distress . Discussion The results of the study will help to determine the effectiveness of a psychodynamic lifestyle change approach and to identify measures for design ing specifically tailored interventions to improve compliance with cardiovascular prevention . Trial registration Clinical Trials.gov Identifier :",
"The effectiveness of lifestyle interventions within secondary prevention of coronary heart disease ( CHD ) remains unclear . This systematic review aim ed to determine their effectiveness and included r and omized controlled trials of lifestyle interventions , in primary care or community setting s , with a minimum follow-up of three months , published since 1990 . 21 trials with 10,799 patients were included ; the interventions were multifactorial ( 10 ) , educational ( 4 ) , psychological ( 3 ) , dietary ( 1 ) , organisational ( 2 ) , and exercise ( 1 ) . The overall results for modifiable risk factors suggested improvements in dietary and exercise outcomes but no overall effect on smoking outcomes . In trials that examined mortality and morbidity , significant benefits were reported for total mortality ( in 4 of 6 trials ; overall risk ratio ( RR ) 0.75 ( 95 % confidence intervals ( CI ) 0.65 , 0.87 ) ) , cardiovascular mortality ( 3 of 8 trials ; overall RR 0.63 ( 95 % CI 0.47 , 0.84 ) ) , and nonfatal cardiac events ( 5 of 9 trials ; overall RR 0.68 ( 95 % CI 0.55 , 0.84 ) ) . The heterogeneity between trials and generally poor quality of trials make any concrete conclusions difficult . However , the beneficial effects observed in this review are encouraging and should stimulate further research",
"Background Efficacious strategies for the primary prevention of coronary heart disease ( CHD ) are underused , and , when used , have low adherence . Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice . Methods We conducted a r and omized trial of a CHD prevention intervention ( including a computerized decision aid and automated tailored adherence messages ) at one university general internal medicine practice . After obtaining informed consent and collecting baseline data , we r and omized patients ( men and women age 40 - 79 with no prior history of cardiovascular disease ) to either the intervention or usual care . We then saw them for two additional study visits over 3 months . For intervention participants , we administered the decision aid at the primary study visit ( 1 week after baseline visit ) and then mailed 3 tailored adherence reminders at 2 , 4 , and 6 weeks . We assessed our outcomes ( including the predicted likelihood of angina , myocardial infa rct ion , and CHD death over 10 years ( CHD risk ) and self-reported adherence ) between groups at 3 month follow-up . Data collection occurred from June 2007 through December 2009 . All study procedures were IRB approved . Results We r and omized 160 eligible patients ( 81 intervention ; 79 control ) and followed 96 % to study conclusion . Mean predicted CHD risk at baseline was 11.3 % . The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points ( 95 % CI 8 % to 42 % ) , with the biggest effect for aspirin . It also changed predicted CHD risk by -1.1 % ( 95 % CI -0.16 % to -2 % ) , with a larger effect in a pre-specified subgroup of high risk patients . Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk . Clinical trials registration number Clinical Trials.gov :",
"Background Cardiac rehabilitation ( CR ) is a secondary prevention program that offers education and support to assist patients with coronary heart disease ( CHD ) make lifestyle changes . Despite the benefits of CR , attendance at centre-based sessions remains low . Mobile technology ( mHealth ) has potential to reach more patients by delivering CR directly to mobile phones , thus providing an alternative to centre-based CR . The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours ( for example , physically active , fruit and vegetable intake , not smoking , low alcohol consumption ) over and above usual CR services in New Zeal and adults diagnosed with CHD . Methods / design A two-arm , parallel , r and omised controlled trial will be conducted at two Auckl and hospitals in New Zeal and . One hundred twenty participants will be r and omised to receive a 24-week evidence - and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone ( control ) . The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months , measured using a composite health behaviour score . Secondary outcomes include overall cardiovascular disease risk , body composition , illness perceptions , self-efficacy , hospital anxiety/depression and medication adherence . Discussion This study is one of the first to examine an mHealth-delivered comprehensive CR program . Strengths of the trial include quality research design and in-depth description of the intervention to aid replication . If effective , the trial has potential to augment st and ard CR practice s and to be used as a model for other disease prevention or self-management programs . Trial registryAustralian New Zeal and Clinical Trials Registry :",
"BACKGROUND Dyslipidemia remains underdiagnosed and undertreated in patients with coronary artery disease . The Computer-based Clinical Decision Support System provides an opportunity t close these gaps . OBJECTIVES To study the impact of computerized intervention on secondary prevention of CAD . METHODS The CDSS was programmed to automatically detect patients with CAD and to evaluate the availability of an up date d lipoprotein profile and treatment with lipid-lowering drugs . The program produced automatic computer-generated monitoring and treatment recommendations . Adjusted primary clinics were r and omly assigned to intervention ( n=56 ) or st and ard care arms ( n=56 ) . Reminders were mailed to the primary medical teams in the intervention arm every 4 months updating them with current lipid levels and recommendations for further treatment . Compliance and lipid levels were monitored . The study group comprised all patients with CAD who were alive at least 3 months after hospitalization . RESULTS Follow-up was available for 7448 patients ( median 19.8 months , range 6 - 36 months ) . Overall , 51.7 % of patients were adequately screened , and 55.7 % of patients were compliant with treatment to lower lipid level . In patients with initial low density lipoprotein > 120 mg/dl , a significant decrease in LDL levels was observed in both arms , but was more pronounced in the intervention arm : 121.9 + /- 34.2 vs. 124.3 + /- 34.6 mg/dl ( P cardiac rehospitalizations was documented in patients who were adequately treated with lipid-lowering drugs , 37 % vs. 40.9 % ( P CAD patients often do not adhere to clinical guidelines , presenting a major obstacle to implementing effective secondary prevention . Our automatic computerized reminders system substantially facilitates adherence to guidelines and supports wide-range implementation",
"Background Cardiac rehabilitation programs aim to improve health status and to decrease the risk of further cardiac events . Persons undergoing rehabilitation often have difficulties transferring the learned health behaviors into their daily routine after returning home and maybe to work . This includes physical activity as well as fruit and vegetable consumption . Computer-based tailored interventions have been shown to be effective in increasing physical activity as well as fruit and vegetable consumption . The aim of this study is , to support people in transferring these two learned behavior changes and their antecedents into their daily life after cardiac rehabilitation . Methods The study will have a r and omized controlled design and will be conducted among German and Dutch people who participated in cardiac rehabilitation . The study will consist of one intervention group which will be compared to a waiting list control group . During the eight week duration of the intervention , participants will be invited to participate in the online after-care program once per week . The intervention encourages participants to define individual health behavior goals as well as action , and coping plans to reach these self-determined goals . The effectiveness of the program will be compared between the intervention condition and the control group in terms of behavior change , antecedents of behavior change ( e.g. , self-efficacy ) , ability to return to work and increased well-being . Further , subgroup-differences will be assessed including differences between the two countries , socioeconomic inequalities and across age groups . Discussion The present study will make a contribution to underst and ing how such an online-based tailored interventions enables study participants to adopt and maintain a healthy lifestyle . Implication s can include how such an online program could enrich cardiac rehabilitation aftercare further . Trial registration NTR 3706 ,",
"Background Coronary heart disease ( CHD ) and depression are leading causes of disease burden globally and the two often co-exist . Depression is common after Myocardial Infa rct ion ( MI ) and it has been estimated that 15 - 35 % of patients experience depressive symptoms . Co-morbid depression can impair health related quality of life ( HRQOL ) , decrease medication adherence and appropriate utilisation of health services , lead to increased morbidity and suicide risk , and is associated with poorer CHD risk factor profiles and reduced survival . We aim to determine the feasibility of conducting a r and omised , multi-centre trial design ed to compare a tele-health program ( MoodCare ) for depression and CHD secondary prevention , with Usual Care ( UC ) . Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome ( ACS ) are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensl and . Consenting participants are then contacted at two weeks post-discharge for baseline assessment . One hundred eligible participants are to be r and omised to an intervention or a usual medical care control group ( 50 per group ) . The intervention consists of up to 10 × 30 - 40 minute structured telephone sessions , delivered by registered psychologists , commencing within two weeks of baseline screening . The intervention focuses on depression management , lifestyle factors ( physical activity , healthy eating , smoking cessation , alcohol intake ) , medication adherence and managing co-morbidities . Data collection occurs at baseline ( Time 1 ) , 6 months ( post-intervention ) ( Time 2 ) , 12 months ( Time 3 ) and 24 months follow-up for longer term effects ( Time 4 ) . We are comparing depression ( Cardiac Depression Scale [ CDS ] ) and HRQOL ( Short Form-12 [ SF-12 ] ) scores between treatment and UC groups , assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects . A cost-effectiveness analysis of the costs and outcomes for patients in the intervention and control groups is being conducted from the perspective of health care costs to the government . Discussion This manuscript presents the protocol for a r and omised , multi-centre trial to evaluate the feasibility of a tele-based depression management and CHD secondary prevention program for ACS patients . The results of this trial will provide valuable new information about potential psychological and wellbeing benefits , cost-effectiveness and acceptability of an innovative tele-based depression management and secondary prevention program for CHD patients experiencing depression . Trial Registration NumberAustralia and New Zeal and Clinical Trials Register ( ANZCTR ) :",
"Background : Nurse-led interventions have proven beneficial to reduce estimated cardiovascular risk . Aim : The purpose of this study was to evaluate the effect of systematic , nurse-led individual lifestyle counseling sessions on the reduction of 10-year cardiovascular risk scores in patients with coronary artery disease ( CAD ) . Methods : This was a r and omized clinical trial of CAD patients treated at a tertiary referral hospital . The intervention group received nurse-led guidance by means of five face-to-face sessions and telephone contact over the course of one year , starting three months after hospital discharge . Exercise and dietary goals were set for each patient and monitored at each session . The control group received st and ard medical advice . Patients were stratified by Framingham risk score and compared at the end of the follow-up period . Results : The final sample comprised 74 patients , 38 in the intervention group and 36 in the control group . Mean age was 58±9 years ; 74 % of patients were male . A 1.7 point ( −13.6 % ) reduction in risk score was recorded in the intervention group , vs a 1.2 point increase in risk score ( + 11 % ) in the control group ( p=0.011 ) . Significant between-group differences were detected for weight ( intervention , 78±14 kg at baseline vs 77±14 kg at study end ; control , 78±15 kg vs 79±15 kg ; p=0.04 ) , systolic blood pressure ( intervention , 136±22 mm Hg vs 124±15 mm Hg ; control , 126±15 mm Hg vs 129±16 mm Hg ; p=0.005 ) , and diastolic blood pressure ( intervention , 82±10 mm Hg vs 77±09 mm Hg ; control , 79±09 mm Hg vs 80±10 mm Hg ; p=0.02 ) . Conclusion : Structured and systematic nurse-led lifestyle counseling effectively reduced cardiovascular risk score",
"OBJECTIVE : Suboptimal treatment of hyperlipidemia in patients with coronary artery disease ( CAD ) is well documented . We report the impact of a computer-assisted physician-directed intervention to improve secondary prevention of hyperlipidemia . DESIGN AND SETTING : Two hundred thirty-five patients under the care of 14 primary care physicians in an academically affiliated practice with an electronic health record were enrolled in this proof-of-concept physician-blinded r and omized , controlled trial . Each patient with CAD or risk equivalent above National Cholesterol Education Program-recommended low-density lipoprotein ( LDL ) treatment goal for greater than 6 months was r and omized , stratified by physician and baseline LDL . Physicians received a single e-mail per intervention patient . E-mails were visit independent , provided decision support , and facilitated “ one-click ” order writing . MEASUREMENTS : The primary outcomes were changes in hyperlipidemia prescriptions , time to prescription change , and changes in LDL levels . The time spent using the system was assessed among intervention patients . RESULTS : A greater proportion of intervention patients had prescription changes at 1 month ( 15.3 % vs 2 % , P=.001 ) and 1 year ( 24.6 % vs 17.1 % , P=.14 ) . The median interval to first medication adjustment occurred earlier among intervention patients ( 0 vs 7.1 months , P=.005 ) . Among patients with baseline LDLs > 130 mg/dL , the first postintervention LDLs were substantially lower in the intervention group ( 119.0 vs 138.0 mg/dL , P=.04 ) . Physician processing time was under 60 seconds per e-mail . CONCLUSION : A visit-independent disease management tool result ed in significant improvement in secondary prevention of hyperlipidemia at 1-month postintervention and showed a trend toward improvement at 1 year",
"Background : In this study , we tested the efficacy of a low-intensity lifestyle intervention aim ed at reducing the risk of cardiovascular disease among mid-life individuals . Methods : We conducted a r and omized controlled trial in which participants were r and omly assigned either to receive a health report card with counselling ( from a Telehealth nurse ) on smoking , exercise , nutrition and stress or to receive usual care . The patients were divided into 2 groups on the basis of risk : the primary prevention group , with a Framingham risk score of 10 % or higher ( intervention , n = 157 ; control , n = 158 ) , and the secondary prevention group , who had a diagnosis of coronary artery disease ( intervention , n = 153 ; control , n = 143 ) . The primary outcome was a change in the Framingham global risk score between baseline and 1-year follow-up . Data were analyzed separately for the 2 prevention groups using an intention-to-treat analysis controlling for covariates . Results : Within the primary prevention group , there were statistically significant changes for the treatment group relative to the controls , from baseline to year 1 , in Framingham score ( intervention , –3.10 [ 95 % confidence interval ( CI ) –3.98 to –2.22 ] ; control , –1.30 [ 95 % CI –2.18 to –0.42 ] ; p 0.01 ) and scores for total cholesterol ( intervention , –0.41 [ 95 % CI –0.59 to –0.23 ] ; control , –0.14 [ 95 % CI –0.32 to 0.04 ] ; p ( intervention , –7.49 [ 95 % CI –9.97 to –5.01 ] ; control , –3.58 [ 95 % CI –6.08 to –1.08 ] ; p level ( intervention , 0.30 [ 95 % CI 0.13 to 0.47 ] ; control , –0.05 [ 95 % CI –0.22 to 0.12 ] ; p confidence ( intervention , 0.20 [ 95 % CI 0.09 to 0.31 ] ; control , 0.04 [ 95 % CI –0.07 to 0.15 ] ; p intervention addressing multiple risk factors for primary prevention at 1 year using Framingham risk score report cards and telephone counselling . ( Requirement for clinical trial registration waived [ enrolment completed before requirement became applicable ] .",
"OBJECTIVE Older adults with poor functioning preoperatively are at risk for delayed recovery and more impaired outcomes after coronary artery bypass surgery ( CABS ) . The study objective was to determine whether a 6-week early recovery telehealth intervention , design ed to improve self-efficacy and management related to symptoms after CABS , was effective in improving outcomes ( physical activity , physiologic , and psychologic functioning ) for older adults ( aged > 65 years ) with higher disease burden . METHODS A descriptive , repeated- measures experimental design was used . Follow-up data were collected at 3 and 6 weeks and 3 months after CABS . Subjects were drawn from a larger r and omized clinical trial . Parent study subjects who had high disease burden preoperatively ( physical component score of 6 ) were included ( N = 55 ) , with 23 subjects in the early recovery intervention group and 31 subjects in the usual care group ( n = 31 ) . Subjects ranged in age from 65 to 85 years ( M = 71.6 + 5.1 years ) . RESULTS There was a significant main effect by group ( F[1,209 ] = 4.66 , P intervention group had a least square means of 27.9 kcal/kg/d of energy expenditure compared with the usual care group of 26.6 kcal/kg/d per the RT3 accelerometer ( Stayhealthy , Inc , Monrovia , CA ) . Both groups had significantly improved physical ( F[2,171 ] = 3.26 , P role-physical ( F[2,171 ] = 6.64 , P functioning over time . CONCLUSION The subgroup of subjects undergoing CABS with high disease burden were responsive to an early recovery telehealth intervention . Improving patients ' physical activity and functioning can reduce morbidity and mortality associated with poor functioning after cardiac events",
"BACKGROUND Translating guidelines into clinical practice has proved to be quite difficult , even when the guidelines are well accepted and noncontroversial . Both computerized reminders and academic detailing have been effective in changing physician prescribing behavior . In this study , we sought to use these methods , mediated by clinical pharmacists , to improve adherence to the secondary prevention guidelines in hospitalized patients with myocardial infa rct ion . METHODS A r and omized , prospect i ve study was performed in which computerized alerts identifying hospitalized patients with elevated troponin I levels were routed to clinical pharmacists . The pharmacists then conducted academic detailing for physicians caring for patients with acute myocardial infa rct ion who were r and omized to the intervention group . Patients in the control group received st and ard care . The main outcome measure was the proportion of patients discharged on a regimen of aspirin , beta-blockers , angiotensin-converting enzyme inhibitors , and statins . RESULTS The intervention had a significant impact on the proportion of patients discharged on a regimen of angiotensin-converting enzyme inhibitors ( 328/365 [ 89.9 % ] vs 409/488 [ 83.8 % ] , intervention vs control , respectively , P = .02 ) , and statins ( 344/365 [ 94.2 % ] vs 436/488 [ 89.3 % ] , P = .02 ) . There was no statistical impact on beta-blocker ( 350/365 [ 95.9 % ] vs 448/488 [ 91.8 % ] , P = .10 ) or aspirin use ( 352/365 [ 96.4 % ] vs 471/488 [ 96.5 % ] , P = .87 ) . When all 4 classes were considered together , 305 ( 83.6 % ) of 365 patients vs 343 ( 70.3 % ) of 488 patients were discharged on a regimen of all secondary prevention medications to which they did not have a contraindication ( P computerized alert with pharmacist-mediated academic detailing is an effective means to increase adherence to secondary prevention guidelines for coronary heart disease",
"A unique feature of the International Verapamil SR/Tr and olapril Study ( INVEST ) is the Internet‐based , electronic data capture system developed at the University of Florida for this trial . This system allows for direct collection of patient enrollment data , r and omization , study drug prescribing , and real‐time monitoring of patient data online . In this trial , immediate transmission of patient‐specific data occurs using online data collection forms . Investigators only need a personal computer with access to the Internet ; no complicated hardware , software systems , or paper storage files are necessary . INVEST is the first large r and omized clinical trial to use electronic prescribing systems in the research setting . Electronic prescribing eliminates errors associated with illegible h and writing , inappropriate dosing , and inappropriate medication choice . Because the INVEST protocol allows flexibility of medication choice and dosage range within r and omly assigned treatment strategies based on patient tolerance and blood pressure response , physician investigators may use individual practice patterns and preferences . The electronic system provides guidance to physicians relative to the addition of medication or dosage adjustments within the protocol . Electronic tracking and reporting mechanisms have enabled investigators in this complex megatrial to enroll , r and omize , and manage patients in real time with great accuracy",
"We compared two models of assistance ( telecardiology versus usual care ) for patients discharged after acute coronary syndrome ( ACS ) , in the assessment of angina . Two hundred patients were r and omized into two groups at discharge for ACS : Group A to telecardiology and Group B to usual care . Early hospital readmission ( in the first month ) occurred in 16 patients ( seven in Group A and nine in Group B ) . Six of Group A were readmitted for a cardiac cause ( non-cardiac in one ) . Angina was the only cardiac cause . Five of the Group B patients were readmitted for a cardiac cause ( non-cardiac in four ) . The results of the present study emphasize that patients with ACS suffer from a definite rate of cardiac symptoms within the first month ( 63 % ) . Angina occurs more frequently within the first two weeks ( 68 % of cases ) . Telecardiology slightly reduces hospital readmissions ( telecardiology 44 % versus usual care 56 % ) , but better identifies true angina",
"BACKGROUND Cardiovascular risk reduction in ambulatory patients who survive myocardial infa rct ion ( MI ) is effective but underused . We sought to evaluate a provider-directed , Internet-delivered intervention to improve cardiovascular management for post-MI out patients . METHODS The Department of Veterans Affairs ( VA ) MI-Plus study was a cluster-r and omized trial involving 168 community-based primary care clinics and 847 providers in 26 states , the Virgin Isl and s , and Puerto Rico , from January 1 , 2002 , through December 31 , 2008 , with the clinic as the r and omization unit . We collected administrative data for 15,847 post-MI patients and medical record data for 10,452 of these . A multicomponent , Internet-delivered intervention included quarterly educational modules , practice guidelines , monthly literature summaries , and automated e-mail reminders delivered to providers for 27 months . Main outcome measures included percentage of patients who achieved each of 7 clinical indicators , a composite score of the 7 clinical indicators , and mean low-density lipoprotein cholesterol and hemoglobin A(1c ) levels . RESULTS Clinics had a median of 3 providers ( interquartile range , 2 - 6 ) , with a median of 50.0 % of providers ( 33.3%-66.7 % ) participating in the study . Patients in intervention clinics had greater improvements ( from 70.0 % to 85.5 % ) in the percentages prescribed β-blockers than patients in control clinics ( 71.9 % to 84.0 % ; adjusted improvement gain for intervention vs control , 2.6 % ; 95 % CI , 0.1%-4.1 % ) . We found nonsignificant differences in improvements favoring patients in intervention clinics for 5 of 6 remaining clinical indicators and levels of low-density lipoprotein cholesterol and hemoglobin A(1c ) . CONCLUSION A longitudinal , Internet-delivered intervention improved only 1 of 7 clinical indicators of cardiovascular management in ambulatory post-MI patients",
"OBJECTIVE To evaluate the feasibility of a web-based coaching programme for vascular risk factor treatment , to describe the patterns of use and to measure changes in risk factors . METHODS Patients with a clinical manifestation of arterial disease and Internet access were asked to participate in the nurse-led Internet-based risk factor management programme . At the first clinic visit , a personalized action plan was made for the treatment of risk factors . Patients were instructed on communication with a specialized nurse through Internet and encouraged to enter self-measured risk factor levels at their personalized website . The nurse practitioner replied on working days and gave feedback , support , and recommendations on lifestyle and medical treatment . After 6 months , risk factors were re-measured . RESULTS Fifty patients participated , 70 % were overweight , 64 % had hypertension , 42 % hyperlipidemia , and 24 % smoked at baseline . During 6 months , the log-in average at the individual website was 35 times per patient ( 1.3 log-ins/week ) ; while the nurse practitioner logged-in at the overall website 23 times/week . The website was hardly used by five patients . Most e-mail messages were sent by patients for hypertension ( 211 times ) and obesity ( 203 times ) , whereas the nurse practitioner sent nearly twice as many e-mail messages for hypertension ( 400 times ) and obesity ( 455 times ) . The level of most risk factors decreased and the fraction of achieved treatment goals increased ( blood pressure from 36 to 58 % , LDL-cholesterol from 58 to 64 % , glucose from 64 to 82 % ) . CONCLUSIONS A web-based vascular risk factor intervention programme is feasible ; it is frequently used by patients and suitable to decrease the level of several risk factors . It has the promise of being an efficacious intervention for risk factor sanitation in patients with symptomatic vascular disease . PRACTICE IMPLICATION S An Internet-based individualised risk management programme could make patients aware of their self-management capability and may contribute to risk factor reduction",
"We compared the effects of evidence -based disease management guidelines delivered to patients with heart failure and diabetes using three different modalities : in-person visits alone ( Control ) , in-person visits and a telephone intervention ( Telephone ) , and in-person visits and telemonitoring ( Telemonitoring ) . Patients were r and omized to the three groups . There were 112 patients in the Control group , 93 in the Telephone group and 98 in the Telemonitoring group . During the first 60 days , 10 % of the Control group were rehospitalized , 17 % of the Telephone group and 16 % of the Telemonitoring group . Having heart failure and receiving more in-person visits were significantly related to readmission and time to readmission . However , after adjusting for diagnosis and visits , the differences between the three groups were non-significant . There was a trend for increased risk of readmission for the Telephone group compared to Control alone ( P = 0.07 , risk ratio 2.2 , 95 % CI : 0.9 to 5.2 ) and for readmission sooner ( P = 0.02 , risk ratio 2.3 , 95 % CI : 1.2 to 4.6 ) . Patient rehospitalization and emergency department visit rates were lower than the national average , making it difficult to detect a difference between groups . Previous rehospitalization was a consistent predictor of those who were rehospitalized , suggesting that it may be a useful indicator for identifying patients likely to need additional attention",
"Background : Cardiac rehabilitation ( CR ) programmes have increased their availability and exp and ed their eligibility criteria . This study sought to identify current predictors and reasons influencing myocardial infa rct ion patients ’ pre-discharge intentions to attend CR . Methods : Patients in this longitudinal , prospect i ve , five site study completed question naires that surveyed their intentions to attend , attendance and main reasons for non-attendance at CR . Results : 84 % of the 1172 patients indicated that they intended to attend CR . Multivariate analyses revealed that age , employment and earlier history of myocardial infa rct ion were significant predictors of intention to attend CR , yet contributed to only a small proportion of the variance . The main reasons given for not intending to attend CR were lack of interest and perception that the programme would not be beneficial . Other obstacles included work , transport or time . A total of 708 ( 60 % ) patients responded at 12 months , and of these , 44 % who did not intend to attend CR had attended . Conclusion : Patient sociodemographic and clinical profile , although significant , are not major predictors of intention to attend CR . Lack of interest and misconceptions regarding CR are cited as key barriers . Some of these seem to have been addressed post discharge as a good proportion of patients who had not intended to attend CR did change their minds and attended . Motivation of patients to participate in CR , including the identification of barriers and the provision of comprehensive information about the purpose and varied formats of CR programmes , could be used to help further address barriers to attendance",
"Less than 25 % of eligible patients attend cardiac rehabilitation programs ( CRP ) , with geographical proximity being a predominant barrier . Therefore , we undertook a pilot study to assess the feasibility and safety of using the Internet as a medium for delivery of an interactive \" virtual \" CRP ( vCRP ) to patients at a distance . Fifteen patients on the waiting list for a local hospital-based CRP were r and omized to either an Internet-based vCRP or observational control . The vCRP consisted of on-line intake forms , one-on-one chat sessions with a nurse , dietitian , and exercise specialist , downloadable exercise heart rate monitoring , education and data monitoring of blood pressure , weight , and glucose . Participants were assessed for exercise capacity , risk factors , and lifestyle behaviors at baseline and at 12 weeks . Those in the vCRP logged onto the Internet-based CRP an average of 4.2 times per week . There were no adverse events in the vCRP participants . The vCRP group significantly improved their HDL-C , triglycerides , total cholesterol : HDL-C ratio , exercise capacity as assessed in metabolic equivalents , weekly physical activity , and exercise specific self-efficacy ( p vCRP group were similar to historical controls in a st and ard CRP . Feedback from exit interviews of the vCRP participants was unanimously positive . This Internet-based CRP result ed in clinical ly significant improvements in risk factors and exercise capacity similar to that of a st and ard CRP . The high user acceptance indicated that this program may have the potential to effectively manage patients who do not have access to traditional hospital-based CRP",
"AIMS To describe the rationale and design of the Which Heart failure Intervention is most Cost-effective & consumer friendly in reducing Hospital care ( WHICH ? ) trial . METHODS WHICH ? is a pragmatic , multicentre , r and omized controlled trial that seeks to determine if multidisciplinary management of chronic heart failure ( CHF ) patients post-acute hospitalization delivered in a patient 's own home is superior to care delivered via a specialist CHF outpatient clinic . The composite primary endpoint is all-cause , unplanned recurrent hospitalization or death during 12 - 18 months of follow-up . Of 688 eligible patients , 280 patients ( 73 % male and 66 % principal diagnosis of CHF ) with a mean age of 71 ± 14 years have been r and omized to home- ( n = 143 ) or clinic-based ( n = 137 ) post-discharge management . This will provide 80 % power ( two-sided alpha of 0.05 ) to detect a 15 % absolute difference in both the primary end-point and rate of all-cause hospital stay . Preliminary data suggest that the two groups are well matched in nearly all baseline socio-economic and clinical parameters . The majority of patients have significant co-morbidity , including hypertension ( 63 % ) , coronary artery disease ( 55 % ) , and atrial fibrillation ( 53 % ) with an accordingly high Charlson Index of Comorbidity Score ( 6.1 ± 2.4 ) . PERSPECTIVE Despite its relatively small size , the WHICH ? trial is well placed to examine the relative impact of two of the most commonly applied forms of face-to-face management design ed to reduce recurrent hospitalization and prolong survival in CHF patients",
"OBJECTIVE The purpose of this study is to determine the impact of a home communication intervention ( HCI ) for ischemic heart failure Coronary Artery Bypass Graft ( CABG ) patients > /= 65 years of age on self-efficacy , coronary artery disease risk factor modification and functioning posthospitalization . DESIGN A r and omized clinical trial with repeated measures was used . SAMPLE A sub sample of ischemic heart failure CABG surgery patients ( n = 35 ) was drawn from the parent study of 180 CABG patients . RESULTS HCI participants ( n = 18 ) had significantly higher adjusted mean self-efficacy scores [ F(1 , 29 ) = 6.40 , P adjusted mean levels of functioning ( physical , general health , mental , and vitality functioning ) compared with the routine care group ( n = 17 ) , using repeated measures analysis of covariance with baseline scores as covariates . There were also significant effects of time on bodily pain and role emotional functioning . Significantly higher exercise adherence ( t = 3.09 , P reported stress ( t = 3.77 , P HCI intervention with more tailored strategies for vulnerable subgroups of CABG patients",
"BACKGROUND Preventive electronic (e)-counselling has been shown to reduce cardiovascular risk factors . However , heterogeneity in outcomes is commonly reported due to differences in e- protocol s. We incorporated key features of an established behavioural therapy , motivational interviewing , to help st and ardize e-counselling in order to reduce blood pressure in patients with hypertension . METHODS Subjects ( n = 387 , mean age = 56 years , 59 % female , 72 % taking ≥ 1 antihypertensive drug ) were diagnosed with stage 1 or 2 hypertension . Subjects were r and omized to a 4-month protocol of e-counselling ( beta version of the \" Blood Pressure Action Plan \" , Heart and Stroke Foundation of Canada ) vs waitlist control ( general e-information on heart-healthy living ) . Outcomes were systolic , diastolic , and pulse pressures , and total lipoprotein cholesterol after treatment . RESULTS Intention to treat analysis did not find a significant group difference in outcomes due to contamination across the 2 arms of this trial . However , per protocol analysis indicated that subjects receiving ≥ 8 e-counselling messages ( a priori therapeutic dose ) vs 0 e-counselling messages ( control ) demonstrated greater reduction in systolic blood pressure ( mean , -8.9 mm Hg ; 95 % confidence interval [ CI ] , -11.5 to -6.4 vs -5.0 mm Hg ; 95 % CI , -6.7 to -3.3 , P = 0.03 ) , pulse pressure ( -6.1 mm Hg ; 95 % CI , -8.1 to -4.1 vs -3.1 mm Hg ; 95 % CI , -4.3 to -1.8 , P = 0.02 ) and total cholesterol ( -0.24 mmol/L ; 95 % CI , -0.43 to -0.06 vs 0.05 mmol/L ; 95 % CI , -0.06 to 0.16 , P = 0.03 ) , but not diastolic blood pressure . CONCLUSIONS These findings support the merit of evaluating whether e-counselling can improve blood pressure control and reduce cardiovascular risk over the long-term",
"OBJECTIVE To test the effectiveness of two interventions design ed to improve the adoption of evidence -based practice s by home health nurses caring for heart failure ( HF ) patients . DATA SOURCES / STUDY SETTING Information on nurse practice s was abstract ed from the clinical records of patients admitted between June 2000 and November 2001 to the care of 354 study nurses at a large , urban , nonprofit home care agency . STUDY DESIGN The study employed a r and omized design with nurses assigned to usual care or one of two intervention groups upon identification of an eligible patient . The basic intervention was a one-time e-mail reminder highlighting six HF-specific clinical recommendations . The augmented intervention consisted of the initial e-mail reminder supplemented by provider prompts , patient education material , and clinical nurse specialist outreach . DATA COLLECTION At each home health visit provided by a study nurse to an eligible HF patient during the 45-day follow-up period , a structured chart abstract ion tool was used to collect information on whether the nurse provided the care practice s highlighted in the e-mail reminder . PRINCIPAL FINDINGS Both the basic and the augmented interventions greatly increased the practice of evidence -based care , according to patient records , in the areas of patient assessment and instructions about HF disease management . While not all results were statistically significant at conventional levels , intervention effects were positive in virtually all cases and effect magnitudes frequently were large . CONCLUSIONS The results of this r and omized trial strongly support the efficacy of just-in-time evidence -based reminders as a means of changing clinical practice among home health nurses who are geographically dispersed and spend much of their time in the field",
"We evaluated whether telehealth counseling augments lifestyle change and risk factor decrease in subjects at high risk for primary or secondary cardiovascular events compared to a recommended guideline for brief preventive counseling . Subjects at high risk or with coronary heart disease ( 35 to 74 years of age , n = 680 ) were r and omized to active control ( risk factor feedback , brief advice , h and outs ) or telehealth lifestyle counseling ( active control plus 6 weekly 1-hour teleconferenced sessions to groups of 4 to 8 subjects ) . Primary outcome was question naire assessment of adherence to daily exercise/physical activity and diet ( daily vegetable and fruit intake and restriction of fat and salt ) after treatment and at 6-month follow-up . Secondary outcomes were systolic and diastolic blood pressures , ratio of total to high-density lipoprotein cholesterol , and 10-year absolute risk for coronary disease . After treatment and at 6-month follow-up , adherence increased for telehealth versus control in exercise ( 29.3 % and 18.4 % vs 2.5 % and 9.3 % , respectively , odds ratio 1.60 , 95 % confidence interval 1.2 to 2.1 ) and diet ( 37.1 % and 38.1 % vs 16.7 % and 33.3 % , respectively , odds ratio 1.41 , 95 % confidence interval 1.1 to 1.9 ) . Telehealth versus control had greater 6-month decreases in blood pressure ( mean ± SE , systolic -4.8 ± 0.8 vs -2.8 ± 0.9 mm Hg , p = 0.04 ; diastolic -2.7 ± 0.5 vs -1.5 ± 0.6 mm Hg , p = 0.04 ) . Decreases in cholesterol ratio and 10-year absolute risk were significant for the 2 groups . In conclusion , telehealth counseling augments therapeutic lifestyle change in subjects at high risk for cardiovascular events compared to a recommended guideline for brief preventive counseling",
"Background —The purpose of this study was to compare long-term outcomes of coronary stenting in all lesions ( elective stenting ) or only in lesions with inadequate morphological and functional results after balloon angioplasty ( guided PTCA ) . Methods and Results —Treatment of multivessel disease , with any lesion length and vessel size , was allowed provided that all lesions were suitable for stent implantation . Patients were r and omized to elective stent implantation ( n=370 ) or guided PTCA ( n=365 ) . An optimal PTCA result ( residual diameter stenosis ≤35 % , coronary flow reserve measured with a Doppler guidewire > 2.0 , absence of threatening dissections ) was achieved in 166 lesions ( 43 % ) . The remaining 218 lesions underwent stent implantation ( provisional stenting ) . Final residual diameter stenosis was lower in the elective and provisional stent groups ( 9.3 % and 10.2 % ) than in the optimal PTCA group ( 24.8 % , P the probability of ≥1 major adverse cardiac event at 12 months was 17.8 % in the elective stenting group and 18.9 % in the guided PTCA group ( 20.1 % for optimal PTCA and 18.0 % for the provisional stenting subgroup , P = NS ) . The incidence of repeat target lesion revascularization at 1 year was 14.9 % in the elective stent group and 15.6 % in the guided PTCA group ( 17.6 % for optimal PTCA and 14.1 % for the provisional stenting subgroup , P = NS ) . Conclusions —When balloon angioplasty is guided by online quantitative angiography and Doppler-derived coronary flow reserve , with provisional stenting reserved for suboptimal results , early and late clinical outcomes are comparable to those achieved by elective stenting of all patients ",
"An Internet-based store- and -retrieval telemedicine system to communicate between patients and their healthcare provider was tested . The system requires no specialized equipment , is Web-based , and allows frequent surveillance of the health status of the patients with heart failure ( HF ) . Thirty six patients were recruited to evaluate a Web-based telemedicine system for reducing care encounters . Eighteen patients were r and omized to the telemedicine arm ( group T ) , and 18 were given usual clinical care ( group C ) in our HF center . Patients in group T reported three times weekly via a secure Internet site for telemedicine intervention . We studied patients with HF with New York Heart Association ( NYHA ) class 2 to 4 with hospitalization within past 6 months . Mean age was 56.1 + /- 12.6 years ( 66.7 % male ; 66.7 % Caucasian , 27.8 % African American , and 5.6 % Hispanic ) . Mean ejection fraction ( EF ) was 23.9 % + /- 17.6 % in group T and 26.6 % + /- 16.4 % in group C. Over an 8-month period , unscheduled ( group T-3 ; group C-5 ) , and scheduled clinic visits ( group T-11 , group C-7 ) were similar ( p = NS ) ; one group T patient was transplanted , one group C patient died . Total hospital days were lower with group T ( 44 days ) compared to group C ( 133 days ) , p telemedicine system was able to closely monitor patients with HF . Surveillance through Internet-based telemedicine result ed in less hospitalization compared to control patients . This system may be helpful in reducing the cost of HF patient care",
"R and omized clinical trials of cardiac rehabilitation following myocardial infa rct ion have typically demonstrated a lower mortality in treated patients , but with a statistically significant reduction in only one trial . To overcome the problem of not being able to detect small but clinical ly important benefits in mortality in r and omized clinical trials of exercise and risk factor rehabilitation after myocardial infa rct ion with small numbers of patients , we carried out a meta- analysis on the combined results of ten r and omized clinical trials that included 4347 patients ( control , 2145 patients ; rehabilitation , 2202 patients ) . The pooled odds ratios of 0.76 ( 95 % confidence intervals , 0.63 to 0.92 ) for all-cause death and of 0.75 ( 95 % confidence intervals , 0.62 to 0.93 ) for cardiovascular death were significantly lower in the rehabilitation group than in the control group , with no significant difference for nonfatal recurrent myocardial infa rct ion . These results suggest that , for appropriately selected patients , comprehensive cardiac rehabilitation has a beneficial effect on mortality but not on nonfatal recurrent myocardial infa rct ion",
"Background An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits , including decreased mortality . Internet- and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation . One component related to the efficacy of these interventions is tailoring of the content to the individual . Objective Our trial assessed the effect of a longitudinally tailored Internet- and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay . We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version . Methods The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone . The participants were r and omized in monthly clusters to a tailored or nontailored ( control ) intervention group . All participants had access to a website with information regarding cardiac rehabilitation , an online discussion forum , and an online activity calendar . Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages . The main outcome was self-reported level of physical activity , which was obtained using an online international physical activity question naire at baseline , at discharge , and at 1 month and 3 months after discharge from the cardiac rehabilitation program . Results Included in the study were 69 participants . One month after discharge , the tailored intervention group ( n=10 ) had a higher median level of overall physical activity ( median 2737.5 , IQR 4200.2 ) than the control group ( n=14 , median 1650.0 , IQR 2443.5 ) , but the difference was not significant ( Kolmogorov-Smirnov Z=0.823 , P=.38 , r=.17 ) . At 3 months after discharge , the tailored intervention group ( n=7 ) had a significantly higher median level of overall physical activity ( median 5613.0 , IQR 2828.0 ) than the control group ( n=12 , median 1356.0 , IQR 2937.0 ; Kolmogorov-Smirnov Z=1.397 , P=.02 , r=.33 ) . The median adherence was 45.0 ( 95 % CI 0.0 - 169.8 ) days for the tailored group and 111.0 ( 95 % CI 45.1 - 176.9 ) days for the control group ; however , the difference was not significant ( P=.39 ) . There were no statistically significant differences between the 2 groups in stage of change , self-efficacy , social support , perceived tailoring , anxiety , or depression . Conclusions Because of the small sample size and the high attrition rate at the follow-up visits , we can not make conclusions regarding the efficacy of our approach , but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention . Trial Registration Clinical Trials.gov : NCT01223170 ; http:// clinical trials.gov/show/NCT01223170 ( Archived by WebCite at http://www.webcitation.org/6Nch4ldcL )",
"To evaluate the usefulness of telephonically-monitored home exercise in patients within two weeks postcoronary bypass surgery , we r and omly enrolled 46 male patients in a 12-week home program of either short walks or bicycle ergometry . Home exercise was done five times weekly and monitored both before and immediately after three times weekly . New arrhythmias or conduction disturbances were detected in 18 of 23 ( 78 percent ) of the bicycle group and in 20 of 23 ( 87 percent ) of the short walk patients . New symptoms developed in three patients , two from the short walk group and one from the bicycle group . Two bikers and one walker developed elevated blood pressure ; all were referred to physicians and were successfully managed . Electrocardiographic abnormalities led directly to diagnostic and therapeutic intervention in nine of the 46 patients -four bikers and five walkers . There were no complications such as ventricular tachycardia or ventricular fibrillation . Technically clear telephone rhythm strips were obtained from patients calling both locally and long distance",
"OBJECTIVE Pharmacologic treatment for secondary prevention of coronary heart disease ( CHD ) is critical to prevent adverse clinical outcomes . In a r and omized controlled trial , we compared antiplatelet and statin adherence among patients with CHD who received : ( 1 ) text messages ( TM ) for medication reminders and education , ( 2 ) educational TM only , or ( 3 ) No TM . METHODS A mobile health intervention delivered customized TM for 30 days . We assessed and analyzed medication adherence with electronic monitoring devices [ Medication Event Monitoring System ( MEMS ) ] by one-way ANOVA and Welch tests , two-way TM response rates by t-tests , and self-reported adherence ( Morisky Medication Adherence Scale ) by Repeated Measures ANOVA . RESULTS Among 90 patients ( 76 % male , mean age 59.2 years ) , MEMS revealed patients who received TM for antiplatelets had a higher percentage of correct doses taken ( p=0.02 ) , percentage number of doses taken ( p=0.01 ) , and percentage of prescribed doses taken on schedule ( p=0.01 ) . TM response rates were higher for antiplatelets than statins ( p=0.005 ) . Self-reported adherence revealed no significant differences among groups . CONCLUSION TM increased adherence to antiplatelet therapy demonstrated by MEMS and TM responses . PRACTICE IMPLICATION S Feasibility and high satisfaction were established . Mobile health interventions show promise in promoting medication adherence",
"BACKGROUND Secondary prevention is not adequately implemented after myocardial infa rct ion ( MI ) . We assessed the effect on quality of care and prognosis of a long-term , relatively intensive rehabilitation strategy after MI . METHODS We conducted a multicenter , r and omized controlled trial in patients following st and ard post-MI cardiac rehabilitation , comparing a long-term , reinforced , multifactorial educational and behavioral intervention with usual care . A total of 3241 patients with recent MI were r and omized to a 3-year multifactorial continued educational and behavioral program ( intervention group ; n = 1620 ) or usual care ( control group ; n = 1621 ) . The combination of cardiovascular ( CV ) mortality , nonfatal MI , nonfatal stroke , and hospitalization for angina pectoris , heart failure , or urgent revascularization procedure was the primary end point . Other end points were major CV events , major cardiac and cerebrovascular events , lifestyle habits , and drug prescriptions . RESULTS End point events occurred in 556 patients ( 17.2 % ) . Compared with usual care , the intensive intervention did not decrease the primary end point significantly ( 16.1 % vs 18.2 % ; hazard ratio [ HR ] , 0.88 ; 95 % confidence interval [ CI ] , 0.74 - 1.04 ) . However , the intensive intervention decreased several secondary end points : CV mortality plus nonfatal MI and stroke ( 3.2 % vs 4.8 % ; HR , 0.67 ; 95 % CI , 0.47 - 0.95 ) , cardiac death plus nonfatal myocardial infa rct ion ( 2.5 % vs 4.0 % ; HR , 0.64 ; 95 % CI , 0.43 - 0.94 ) , and nonfatal MI ( 1.4 % vs 2.7 % ; HR , 0.52 ; 95 % CI , 0.31 - 0.86 ) . A marked improvement in lifestyle habits ( ie , exercise , diet , psychosocial stress , less deterioration of body weight control ) and in prescription of drugs for secondary prevention was seen in the intervention group . CONCLUSION The GOSPEL Study is the first trial to our knowledge to demonstrate that a multifactorial , continued reinforced intervention up to 3 years after rehabilitation following MI is effective in decreasing the risk of several important CV outcomes , particularly nonfatal MI , although the overall effect is small . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00421876",
"PURPOSE Despite demonstrated benefits of cardiac rehabilitation and risk factor reduction , only 11 % to 38 % of eligible patients with cardiovascular disease ( CVD ) participate in cardiac rehabilitation programs . Women and older adults are particularly less likely to participate in cardiac rehabilitation . In an effort to broaden access to cardiac rehabilitation , the authors developed an alternative Internet-based program that allows nurse case managers to provide risk factor management training , risk factor education , and monitoring services to patients with CVD . METHODS The evaluation consisted of a r and omized , clinical trial involving 104 patients with CVD , 53 of whom used the program as a special intervention ( SI ) for 6 months and 51 of whom received usual care ( UC ) . RESULTS The results indicate that fewer cardiovascular events occurred among the SI subjects ( 15.7 % ) than among the UC subjects ( 4.1 % ) ( P = .053 ) , result ing in a gross cost savings of $ 1418 US dollars per patient . With a projected program cost of $ 453 USD per patient , the return on investment is estimated at 213 % . More weight loss occurred in the SI group ( -3.68 pounds ) than in the UC group ( + .47 pounds ) ( P = .003 ) . The differences between the two groups in terms of blood pressure , lipid levels , depression scores , minutes of exercise , and dietary habits were not statistically significant . CONCLUSION An Internet-based case management system could be used as a cost-effective intervention for patients with CVD , either independently or in conjunction with traditional cardiac rehabilitation",
"BACKGROUND Effective therapies exist for reducing mortality in persons with coronary heart disease ( CHD ) , but they remain underused . OBJECTIVE To report the design and baseline results of a quality improvement project design ed to increase the use of hydroxymethyl glutaryl coenzyme A ( HMG-CoA ) reductase inhibitors , beta-adrenergic blocking agents , and angiotensin-converting enzyme ( ACE ) inhibitors in patients with CHD in a network-model managed care setting . METHODS Patients with CHD were identified by search ing a cl aims data base . Use of therapies was assessed by linkage with a pharmacy benefits data base . A survey was mailed to primary care physicians to collect information related to attitudes and behavioral intentions regarding aggressive management of CHD . An intervention , consisting of a guideline summary , performance feedback , and medical chart reminders , was evaluated in a r and omized , practice -based trial . RESULTS Among 1189 patients with CHD , the median prevalence of receipt of HMG-CoA reductase inhibitors , beta-adrenergic blocking agents , and ACE inhibitors across practice s at baseline ( the first 3 months of 1999 ) was 50.0 % , 35.0 % , and 18.8 % , respectively . Reported barriers included a perception that aggressive management of CHD is thought to be unimportant by support staff yet to require significant staff time . Aggressive management of CHD was perceived to incur non-reimbursable costs , to be unimportant in their patient population , to require a great deal of patient education and self-management , and to be limited because many patients do not adhere to therapy . CONCLUSIONS Opportunities exist for enhancing the quality of care provided to patients with CHD . Our experience to date supports the logistical feasibility of implementing network-level quality enhancement efforts in managed care networks",
"Summary Patients with established coronary artery disease ( CAD ) were recruited in 11 hospitals and r and omized to an intervention ( telemedicine system ; n = 752 ) or a control group ( usual medical care ; n = 748 ) . On the day before discharge , patients in the intervention group were equipped with a 12-lead event recorder and trained to use the device . Whenever they had symptoms , they could contact the call centre , transmit an ECG ( without redialling ) and consult a physician . During a 12-month study , 171 patients ( 23 % ) in the intervention group contacted the call centre , a total of 269 times . The main reasons for calling were chest pain and radiating pain . Pathological changes were seen in 24 % of the transmitted ECGs . Only 23 % of the calls were made in the first hour after onset of symptoms and a further 12 % in the subsequent hour , suggesting that patients should be encouraged to use ECG transmission at an earlier stage . At follow-up , 157 patients ( 21 % ) had had at least one recurrent cardiac event ( myocardial infa rct ion , cardiac hospital stay , re-vascularization ) . The proportion was significantly higher in telemedicine users ( 35 % ) than in non-users ( 17 % ) , P telemedicine system was helpful ( users = 93 % , non-users = 89 % ; P = 0.095 )",
"The decision to admit a patient to a coronary care unit for acute coronary syndrome ( ACS ) has serious medical and financial consequences . In this study , we aim ed to develop a computer program to predict the existence of ACS in patients with chest pain at home ; it is intended that patients will be able to access the program via the website to test its validity . This study proceeded in two phases . In the first phase , a computer-based decision protocol was developed using recursive-partitioning analysis to predict ACS in 250 patients with chest pain on the basis of their historical data . In the second phase , this protocol was tested in 115 patients for diagnosis of ACS prospect ively . Thirty-two of the patients answered the algorithm questions on the website . All of the patients who visited the website of this study were advised to go to the emergency department . Although the algorithm showed the presence of ACS in 82 of 115 patients , 60 of 115 patients were diagnosed as having ACS in the emergency department ( n = 55 ) or at follow-up . The agreement between the diagnosis of the algorithm and the true diagnosis was moderate and statistically significant ( Kappa coefficient 0.61 , P sensitivity of the algorithm was 100 % , although its specificity was 60 % . The accuracy of the algorithm in diagnosing ACS was 81 % . The algorithm diagnoses patients with ACS at a high ratio and decreases the number of patients being unnecessarily admitted to the emergency with non-ACS",
"Background Approximately half of American adults do not meet recommended physical activity guidelines . Face-to-face lifestyle interventions improve health outcomes but are unlikely to yield population -level improvements because they can be difficult to disseminate , expensive to maintain , and inconvenient for the recipient . In contrast , Internet-based behavior change interventions can be disseminated widely at a lower cost . However , the impact of some Internet-mediated programs is limited by high attrition rates . Online communities that allow participants to communicate with each other by posting and reading messages may decrease participant attrition . Objective Our objective was to measure the impact of adding online community features to an Internet-mediated walking program on participant attrition and average daily step counts . Methods This r and omized controlled trial included sedentary , ambulatory adults who used email regularly and had at least 1 of the following : overweight ( body mass index [ BMI ] ≥ 25 ) , type 2 diabetes , or coronary artery disease . All participants ( n = 324 ) wore enhanced pedometers throughout the 16-week intervention and uploaded step-count data to the study server . Participants could log in to the study website to view graphs of their walking progress , individually-tailored motivational messages , and weekly calculated goals . Participants were r and omized to 1 of 2 versions of a Web-based walking program . Those r and omized to the “ online community ” arm could post and read messages with other participants while those r and omized to the “ no online community \" arm could not read or post messages . The main outcome measures were participant attrition and average daily step counts over 16 weeks . Multiple regression analyses assessed the effect of the online community access controlling for age , sex , disease status , BMI , and baseline step counts . Results Both arms significantly increased their average daily steps between baseline and the end of the intervention period , but there were no significant differences in increase in step counts between arms using either intention-to-treat or completers analysis . In the intention-to-treat analysis , the average step count increase across both arms was 1888 ± 2400 steps . The percentage of completers was 13 % higher in the online community arm than the no online community arm ( online community arm , 79 % , no online community arm , 66 % , P = .02 ) . In addition , online community arm participants remained engaged in the program longer than no online community arm participants ( hazard ratio = 0.47 , 95 % CI = 0.25 - 0.90 , P = .02 ) . Participants with lower baseline social support posted more messages to the online community ( P more posts ( P online community features to an Internet-mediated walking program did not increase average daily step counts but did reduce participant attrition . Participants with low baseline social support used the online community features more than those with high baseline social support . Thus , online communities may be a promising approach to reducing attrition from online health behavior change interventions , particularly in population s with low social support . Trial Registration NCT00729040 ; http:// clinical trials.gov/ct2/show/NCT00729040 ( Archived by WebCite at http://www.webcitation.org/5v1VH3n0A",
"OBJECTIVE Advances in web-based animation technologies provide new opportunities to develop graphic health communications for dissemination throughout communities . We developed imagery and text contents of brief , computer-based programmes about heart disease risk , with both imagery and text contents guided by the common-sense model ( CSM ) of self-regulation . The imagery depicts a three-dimensional , beating heart tailored to user-specific information . DESIGN A 2 × 2 × 4 factorial design was used to manipulate concrete imagery ( imagery vs. no imagery ) and conceptual information ( text vs. no text ) about heart disease risk in prevention-oriented programmes and assess changes in representations and behavioural motivations from baseline to 2 days , 2 weeks , and 4 weeks post-intervention . METHODS Sedentary young adults ( N= 80 ) were r and omized to view one of four programmes : imagery plus text , imagery only , text only , or control . Participants completed measures of risk representations , worry , and physical activity and healthy diet intentions and behaviours at baseline , 2 days post-intervention ( except behaviours ) , and 2 weeks ( intentions and behaviours only ) and 4 weeks later . RESULTS The imagery contents increased representational beliefs and mental imagery relating to heart disease , worry , and intentions at post-intervention . Increases in sense of coherence ( underst and ing of heart disease ) and worry were sustained after 1 month . The imagery contents also increased healthy diet efforts after 2 weeks . The text contents increased beliefs about causal factors , mental images of clogged arteries , and worry at post-intervention , and increased physical activity 2 weeks later and sense of coherence 1 month later . CONCLUSION The CSM-based programmes induced short-term changes in risk representations and behaviour motivation . The combination of CSM-based text and imagery appears to be most effective in instilling risk representations that motivate protective behaviour",
"Patients with chronic conditions are heavy users of the health care system . There are opportunities for significant savings and improvements to patient care if patients can be maintained in their homes . A r and omized control trial tested the impact of 3 months of telehome monitoring on hospital readmission , quality of life , and functional status in patients with heart failure or angina . The intervention consisted of video conferencing and phone line transmission of weight , blood pressure , and electrocardiograms . Telehome monitoring significantly reduced the number of hospital readmissions and days spent in the hospital for patients with angina and improved quality of life and functional status in patients with heart failure or angina . Patients found the technology easy to use and expressed high levels of satisfaction . Telehealth technologies are a viable means of providing home monitoring to patients with heart disease at high risk of hospital readmission to improve their self-care abilities",
"AIM To evaluate the effects of interpersonal counselling on health-related quality of life after myocardial infa rct ion . BACKGROUND Depression is a risk factor for poor health-related quality of life after myocardial infa rct ion . Interpersonal counselling seems to reduce depressive symptoms and distress after myocardial infa rct ion . METHODS Myocardial infa rct ion patients ( n=103 ) were r and omised into an intervention group ( n=51 ) with 1 - 6 ( mean 4·6 ) interpersonal counselling-sessions focusing on managing depressive symptoms and a control group ( n=52 ) . Health-related quality of life after myocardial infa rct ion was measured with EuroQol-5D ( EQ-5D ) in hospital , at six and 18 months after discharge . RESULTS No differences in the changes of health-related quality of life were found between the groups during follow-up . However , health-related quality of life improved significantly in the intervention group . In the group of patients under 60 years , the effect of interpersonal counselling was significant in the intervention group compared with the control group . CONCLUSIONS Interpersonal counselling does not seem to improve health-related quality of life better than st and ard care after myocardial infa rct ion in general , but it does seem to be beneficial with younger myocardial infa rct ion patients . RELEVANCE TO CLINICAL PRACTICE There is a need to study the effects of interpersonal counselling further with younger myocardial infa rct ion patients and to develop the intervention further , before using it systematic ally as part of nursing practice",
"PURPOSE We wanted to determine the impact of automated family history assessment and tailored messages for coronary heart disease , stroke , diabetes , colorectal , breast , and ovarian cancer on preventive behaviors compared with a st and ard preventive message . METHODS The study was a cluster-r and omized clinical trial that included 41 primary care practice s , the majority in the Midwest , using Family Healthware , a self-administered , Web-based tool that assesses familial risk for the diseases and provides personalized risk-tailored messages . Patients in the control group received an age- and sex-specific health message related to lifestyle and screening . Smoking cessation , fruit and vegetable intake , physical activity , aspirin use , blood pressure , and cholesterol and blood glucose screening were assessed at baseline and 6 months after the intervention . RESULTS Of 4,248 participants , 3,344 ( 78 % ) completed the study . Participants were white ( 91 % ) , female ( 70 % ) , and insured ( 97 % ) , and had a mean age of 50.6 years ( range 35–65 years ) . Intervention participants were more likely to increase daily fruit and vegetable consumption from 5 or fewer servings a day to 5 or more servings a day ( OR = 1.29 ; 95 % confidence interval [ CI ] , 1.05–1.58 ) and to increase physical activity ( OR = 1.47 ; 95 % CI , 1.08–1.98 ) to 5 to 6 times a week for 30 minutes or more a week . The absolute differences in proportion were 3 % and 4 % , respectively . Intervention participants were less likely to move from not having cholesterol screening in the last 5 years to having their cholesterol measured within 5 years ( OR = 0.34 ; 95 % CI , 0.17–0.67 ) , with an absolute difference of 15 % . CONCLUSIONS Messages tailored to an individual ’s familial risk for 6 common diseases modestly increased self-reported physical activity and fruit and vegetable intake but reduced the likelihood of receiving cholesterol screening",
"OBJECTIVE Given the multimodal medical and interventional treatment options in coronary artery disease ( CAD ) , the current value of intensified lifestyle modification remains unclear . No r and omized studies have so far assessed the impact of lifestyle modification on coronary artery calcium ( CAC ) . We examined the long-term effects of a one-year comprehensive lifestyle modification on risk factors and CAC by means of a r and omized clinical trial . METHODS 96 participants ( age range 35 - 75 years , 22 women ) of the SAFE-LIFE r and omized trial in patients with established CAD completed 3-year follow-up . The active treatment was a one-year lifestyle modification and stress reduction intervention ( LG ) , while the control group received written advice only ( AG ) . CAC ( derived from electron beam tomography ) , blood lipids , heart rate , blood pressure , anginal symptoms and quality -of-life were assessed on entry and at 3-year follow-up . RESULTS Lifestyle modification had no impact on change of CAC after three years ( median progression factor [ 25th,75th percentile ] 1.46 [ 1.16,2.19 ] in LG and 1.41 [ 1.20,1.79 ] in AG ; p=0.68 ) , but led to reductions of blood pressure , heart rate and to dose-reductions in anti-ischemic medications as compared to AG . Multiple regression analysis indicated that in the pooled study population increase of CAC was related to psychosocial factors and heart rate . CONCLUSION In the presence of modern treatments , complementary prescription of comprehensive lifestyle modification has no impact on CAC progression but sustainable benefit for blood pressure , heart rate and the need of anti-ischemic medication is demonstrated . A possible influence of stress reduction measures on CAC progression should be further evaluated",
"OBJECTIVE This study compared differences in nurse and patient communication profiles between two telehealth modes : telephone and videophone , and evaluated longitudinal changes in communication , nurse perceptions , and patient satisfaction . METHODS Subjects were enrolled in a r and omized controlled clinical trial evaluating a 90-day home-based intervention for heart failure . Telephone ( n=14 ) and videophone ( n=14 ) interactions were audio taped and analyzed using the Roter Interaction Analysis System . RESULTS Nurses were more likely to use open-ended questions , back-channel responses , friendly jokes , and checks for underst and ing on the telephone compared to videophone . Compliments given and partnership were more common on the videophone . Patients were more likely to give lifestyle information and approval comments on the telephone , and used more closed-ended questions on the videophone . Nurses perceptions of the interactions were not different between the telephone and videophone , nor did their perceptions change significantly over the course of the intervention . There were no significant differences in patient satisfaction between the telephone and videophone . CONCLUSIONS The results of this study did not support use of a videophone over the telephone . PRACTICE IMPLICATION S It is critical to match technologies to patient needs and use the least complex technology possible . When considering use a videophone , health care providers should critically examine the trade-offs between additional complexities with the added value of the visual interaction",
"Objective To determine whether a computer-assisted reminder would alter prescribing habits for the treatment of hypertension in accordance with current clinical guidelines in a general internal medicine clinic . Design A r and omized trial . Setting The General Internal Medicine Clinic of the Veterans Affairs Puget Sound Health Care System , Seattle Division . Patients / Participants Clinic providers were r and omized to a control group ( n=35 ) or intervention group ( n=36 ) . We targeted the providers of patients being treated for hypertension with calcium channel blockers , a class of drug not recommended for initial therapy . InterventionAn automated computer query identified eligible patients and their providers . A guideline reminder was placed in the charts of patients of intervention providers ; the charts of patients of control providers received no reminder . Measurements and main results During the 5-month study period , 346 patients were seen by the 36 primary care providers ( staff physicians , nurse practitioners , residents , and fellows ) in the intervention group , and 373 patients were seen by the 35 providers in the control group . Intervention providers changed 39 patients ( 11.3 % ) to other medications during the study period , compared with 1 patient ( angina in 23.1 % , indications other than those for hypertension in 9.5 % , intolerable adverse effects with first-line therapy in 13.9 % , and inadequte control with first-line therapy in 13.9 % . Of those patients without provider-indicated contraindications , 23.6 % were switched from calcium channel blockers to first-line agents during the intervention period . Conclusions The use of a computerized , clinic-based intervention increased compliance with guidelines in the treatment of primary hypertension in general , and decreased the use of calcium channel blockers for the treatment of hypertension in particular",
"Many primary care physicians have not learned about key advances in caring for patients after acute myocardial infa rct ion , including the use of -blockers ( 1 ) and angiotensin-converting enzyme inhibitors ( 2 ) . Although professional organizations have disseminated guidelines for the care of acute myocardial infa rct ion ( 3 , 4 ) , important therapies continue to be underused ( 5 ) . Physicians read guidelines to stay up-to- date ( 6 ) , but reading without additional interaction is relatively ineffective for learning ( 7 ) and has little effect on practice ( 8) . Physicians therefore need better methods for learning from guidelines . Self- assessment tests are often used to enhance self- study of printed material s ( 9 , 10 ) , but physicians can now choose from a growing number of World Wide Web sites that offer on-line self- study ( 11 ) . Since the 1960s , computer-assisted instruction has been explored as a method for medical education ( 12 - 15 ) . In theory , computer-assisted instruction can enhance self- study by tailoring presentations to learners ' individual needs and by including interactive simulations ( 16 ) . Two previous studies comparing computer-assisted instruction systems with carefully constructed self- study controls found mixed results ( 17 , 18 ) . In both of these studies , the systems were developed for and tested among medical students before the advent of the Web . Therefore , physicians have little direct evidence to inform their choices among currently available self- study methods . We conducted a r and omized trial to compare the educational outcomes produced by a Web-based tutorial on myocardial infa rct ion guidelines with those produced by self- assessment based and study from print versions of the same guidelines . We hypothesized that print-based self- study would result in substantial learning but Web-based self- study would produce incrementally greater knowledge gains , retention , learning efficiency , and satisfaction . We conducted this trial among residents rather than community physicians because residents frequently use self- study material s and because we anticipated that they would be more feasible to recruit . Methods Design of Self- Study Alternatives Guidelines and Learning Objectives The American College of Cardiology ( ACC ) , the American Heart Association ( AHA ) , and the American College of PhysiciansAmerican Society of Internal Medicine ( ACPASIM ) allowed us to use their guidelines for this trial . We wrote 20 cognitive learning objectives ( 19 ) , covering knowledge from one or both guidelines that would be important for physicians who provide primary care to patients after myocardial infa rct ion . One of the authors , an expert in evidence -based cardiology , edited the objectives for content validity and importance . The final set of learning objectives is shown in the Appendix Table . Knowledge Tests We wrote multiple-choice questions that had one correct response demonstrating the knowledge in a single learning objective . Thirty attending physicians and fellows in internal medicine , family medicine , and cardiology critiqued the clarity and difficulty of prospect i ve questions by using an electronic mail quiz system that tracked each question 's average score ( 20 ) . These data were used to assemble a 20- question pretest and a different 20- question post-test . The tests included one question per learning objective and were approximately equivalent in overall difficulty . Expected scores on the final pretest and post-test differed by less than 6 % . For each question on the final test forms , participants could place a check mark next to the statement , I would like to review available evidence or recommendations on this topic . We referred to this feature as the review flag . For both of the self- study alternatives in this trial , learners initially completed the pretest on paper . Web-Based Self- Study Material s We constructed a Web-based learning system called SAGE ( Self- Study Acceleration with Graphic Evidence ) . Participants who used SAGE copied their pretest answers into the system and were then taken to the main tutorial page , which presents an overview of the user 's pretest results for each learning objective . By clicking on hyperlinks , users could view a sequence of learning re sources for each objective . The first re source for each objective was the relevant pretest answer . From there , users could click on hyperlinks to view the relevant guideline passages ( highlighted segments of text in an on-line version of the complete guideline document ) . When guidelines referred to l and mark clinical trials , users could click on a link to open a graphic evidence browser ( Figure 1 ) . Complete instructions for using SAGE were provided in the system . The program was intended to combine two strategies of computer-assisted instruction : a tutorial strategy , which focuses the learner on deficits in previous knowledge , and a simulation strategy , which reinforces knowledge through interaction with graphic models of r and omized trial evidence . We wrote software for SAGE in Server-side JavaScript , using the Netscape Enterprise Server ( Mountain View , California ) running on a Sun Ultrasparc2 workstation ( Mountain View , California ) . For animated statistical graphics , we wrote a Java applet . Figure 1 . The SAGE ( Self- Study Acceleration with Graphic Evidence ) r and omized trial viewer . Printed Self- Study Material s Printed material s for the control group included the same self- assessment test and guidelines as the Web-based material s. The printed material s included 1 ) a booklet showing the correct answer for each pretest question and the learning objective each question was intended to evaluate and 2 ) complete reprints of the ACPASIM and ACC/AHA guidelines . Learners were instructed to compare their pretest answers with the correct answers and look up the evidence or guideline recommendations for each learning objective that they may not have met by using the outline structure of the ACPASIM guidelines and the index of the ACC/AHA guidelines . Material s in the control group were intended to provide learning through self- assessment and study from the actual guideline documents as distributed by the specialty societies . The control material s contained the same pretest answers and guideline content as SAGE but lacked the hypermedia navigation features and the detailed , interactive , graphic presentations of l and mark trial evidence . Of note , however , the guideline material s for both self- study groups contained all of the information that learners would need to meet each learning objective , including narrative descriptions of the key trial results that were available graphically in SAGE . Study Sample We recruited residency programs in family and internal medicine at four universities . Approval for research involving humans was obtained from each university 's institutional review board . A total of 5 family medicine and 7 internal medicine programs agreed to participate . We recorded the name , sex , and training year of every resident across all 12 programs in a confidential recruitment data base . Letters were placed in residents ' mailboxes inviting them to attend a 1.25-hour learning session in which they would be r and omly assigned to study from computer or printed material s on the care of myocardial infa rct ion . An honorarium of $ 30 was offered for completing the trial . The trial was also announced at resident conferences . All residents who attended a session and gave consent became eligible participants . Self- Study Sessions Participants used the self- study material s in a single session that began with the pretest and ended with an immediate post-test . After completing the pretest , participants kept carbon copies of their answers , returned their originals , and received their r and omly generated study group assignment . Those assigned to the control group were given the printed material s , and those assigned to SAGE went to an adjacent computer classroom , where they logged on and entered their pretest answers . Participants in both groups were asked to study until they felt that they had met the learning objectives , at which point the self- study material s were removed and they immediately took the post-test on paper . Each session was proctored to ensure that all learning was attributable to self- study from the assigned material without use of extraneous material s or discussion with colleagues . No irregularities occurred . Participants could not attend more than one session and were not allowed to keep the printed self- study material s or to access SAGE after completing their session . Study Group Assignment Individual participants were r and omly assigned to study groups by a computer program that generated blocked r and omization stratified by the participants ' sex and residency year . As each resident arrived at a session , he or she was registered on a laptop computer that contained coded records from the recruitment data base . As the first participants finished the pretest , a r and omization program run on the laptop generated a balanced pool of assignments for each sexresidency year category ( using a block size of 2 [ 21 ] ) . For each registered participant , the program chose an assignment at r and om from the appropriate pool . As participants turned in their pretests , they and the investigators looked up their assignments on the laptop screen . Study group assignment was therefore simultaneously revealed to the participants and to the investigators . Outcome Measures Knowledge scores from multiple-choice tests were calculated by assigning 1 point per correct answer ; unanswered items were considered incorrect . This created scores that could range from 0 to 20 points . The primary outcome of the trial was knowledge on the immediate post-test . The time spent study ing was measured by using a time-stamp machine for participants in the control group and the server log for participants in the SAGE group . Learning efficiency was calculated as the point gain from pretest to immediate post-test divided by the",
"Aim of the study was to assess efficacy of educational technology -- School for patients with stable angina -- in conditions of practical health care . We r and omized 100 patients with ischemic heart disease ( IHD ) and stable FC I-III angina into 2 groups one of which went through learning in a School for patients with IHD ( 6 90 min sessions 2 times a week ) . Patients of both main and control groups were followed up for 12 months . During the whole term of the investigation in both groups observation and treatment of patients was conducted by physicians of city polyclinic in accordance with generally accepted method of care of patients with diagnosis \" IHD , stable angina pectoris \" . Results of the investigation evidence that study ing in the School for patients with stable angina significantly elevates level of medical information adopted by patients , ensures positive dynamics of the whole row of clinical and psychological parameters as well as integral parameters of quality of life of patients with IHD",
"CONTEXT Depressive symptoms commonly follow coronary artery bypass graft ( CABG ) surgery and are associated with less positive clinical outcomes . OBJECTIVE To test the effectiveness of telephone-delivered collaborative care for post-CABG depression vs usual physician care . DESIGN , SETTING , AND PARTICIPANTS Single-blind effectiveness trial at 7 university-based and community hospitals in or near Pittsburgh , Pennsylvania . Participants were 302 post-CABG patients with depression ( 150 , intervention ; 152 , usual care ) and a comparison group of 151 r and omly sample d post-CABG patients without depression recruited between March 2004 and September 2007 and observed as out patients until June 2008 . INTERVENTION Eight months of telephone-delivered collaborative care provided by nurses working with patients ' primary care physicians and supervised by a psychiatrist and primary care physician from this study . MAIN OUTCOME MEASURES Mental health-related quality of life ( HRQL ) measured by the Short Form-36 Mental Component Summary ( SF-36 MCS ) at 8-month follow-up ; secondary outcome measures included assessment of mood symptoms ( Hamilton Rating Scale for Depression [ HRS-D ] ) , physical HRQL ( SF-36 PCS ) , and functional status ( Duke Activity Status Index [ DASI ] ) ; and hospital readmissions . RESULTS The intervention patients reported greater improvements in mental HRQL ( all P 0.5 - 6.0 ) , physical functioning ( DASI : Delta , 4.6 points ; 95 % CI , 1.9 - 7.3 ) , and mood symptoms ( HRS-D : Delta , 3.1 points ; 95 % CI , 1.3 - 4.9 ) ; and were more likely to report a 50 % or greater decline in HRS-D score from baseline ( 50.0 % vs 29.6 % ; number needed to treat , 4.9 [ 95 % CI , 3.2 - 10.4 ] ) than usual care patients ( P . Men with depression were particularly likely to benefit from the intervention ( SF-36 MCS : Delta , 5.7 points ; 95 % CI , 2.2 - 9.2 ; P = .001 ) . However , the mean HRQL and physical functioning of intervention patients did not reach that of the nondepressed comparison group . CONCLUSION Compared with usual care , telephone-delivered collaborative care for treatment of post-CABG depression result ed in improved HRQL , physical functioning , and mood symptoms at 8-month follow-up . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00091962",
"OBJECTIVE The study objective was to examine the effect of a symptom management ( SM ) telehealth intervention on physical activity and functioning and to describe the health care use of older adult patients ( aged > 65 years ) after coronary artery bypass surgery ( CABS ) by group ( SM intervention group and usual care group ) . METHODS A r and omized clinical trial design was used . The study was conducted in 4 Midwestern tertiary hospitals . The 6-week SM telehealth intervention was delivered by the Health Buddy ( Health Hero Network , Palo Alto , CA ) . Measures included Modified 7-Day Activity Interview , RT3 accelerometer ( Stayhealthy , Inc , Monrovia , CA ) , physical activity and exercise diary , Medical Outcomes Study Short-Form 36 , and subjects ' self-report and provider records of health care use . Follow-up times were 3 and 6 weeks and 3 and 6 months after CABS . RESULTS Subjects ( N = 232 ) had a mean age of 71.2 ( + 4.7 ) years . There were no significant interactions using repeated- measures analyses of covariance . There was a significant group effect for average kilocalories/kilogram/day of estimated energy expenditure as measured by the RT3 accelerometer , with the usual care group having a higher estimated energy expenditure . Both groups had significant improvements over time for role-physical , vitality , and mental functioning . Both groups had similar health care use . CONCLUSION Subjects were able to return to preoperative levels of functioning between 3 and 6 months after CABS and to increase their physical activity over reported preoperative levels of activity . Further study of those patients undergoing CABS who could derive the most benefit from the SM intervention is warranted",
"Translating evidence into clinical practice in the management of acute coronary syndromes ( ACS ) is challenging . Few ACS quality improvement interventions have been rigorously evaluated to determine their impact on patient care and clinical outcomes . We design ed a pragmatic , 2-arm , cluster-r and omized trial involving 34 clusters ( Brazilian public hospitals ) . Clusters were r and omized to receive a multifaceted quality improvement intervention ( experimental group ) or routine practice ( control group ) . The 6-month educational intervention included reminders , care algorithms , a case manager , and distribution of educational material s to health care providers . The primary end point was a composite of evidence -based post-ACS therapies within 24 hours of admission , with the secondary measure of major cardiovascular clinical events ( death , nonfatal myocardial infa rct ion , nonfatal cardiac arrest , and nonfatal stroke ) . Prescription of evidence -based therapies at hospital discharge were also evaluated as part of the secondary outcomes . All analyses were performed by the intention-to-treat principle and took the cluster design into account using individual-level regression modeling ( generalized estimating equations ) . If proven effective , this multifaceted intervention would have wide use as a means of promoting optimal use of evidence -based interventions for the management of ACS",
"PURPOSE : Efficient ways are needed to implement the secondary prevention ( SP ) of coronary heart disease . Because few studies have investigated Web-based SP programs , our aim was to determine the usefulness of a new Web-based telemonitoring system , connecting patients provided with self-measurement devices and care managers via mobile phone text messages , as a tool for SP . METHODS : A single-blind , r and omized controlled , clinical trial of 203 acute coronary syndrome ( ACS ) survivors , was conducted at a hospital in Madrid , Spain . All patients received lifestyle counseling and usual-care treatment . Patients in the telemonitoring group ( TMG ) sent , through mobile phones , weight , heart rate , and blood pressure ( BP ) weekly , and capillary plasma lipid profile and glucose monthly . A cardiologist accessed these data through a Web interface and sent recommendations via short message service . Main outcome measures were BP , body mass index ( BMI ) , smoking status , low-density lipoprotein-cholesterol ( LDL-c ) , and glycated hemoglobin A1c ( HbA1c ) . RESULTS : At 12-month followup , TMG patients were more likely ( RR = 1.4 ; 95 % CI = 1.1−1.7 ) to experience improvement in cardiovascular risk factors profile than control patients ( 69.6 % vs 50.5 % , P = .010 ) . More TMG patients achieved treatment goals for BP ( 62.1 % vs 42.9 % , P = .012 ) and HbA1c ( 86.4 % vs 54.2 % , P = .018 ) , with no differences in smoking cessation or LDL-c . Body mass index was significantly lower in TMG ( −0.77 kg/m2 vs + 0.29 kg/m2 , P = .005 ) . CONCLUSIONS : A telemonitoring program , via mobile phone messages , appears to be useful for improving the risk profile in ACS survivors and can be an effective tool for secondary prevention , especially for overweight patients",
"Background . Experts have called for the inclusion of values clarification ( VC ) exercises in decision aids ( DAs ) as a means of improving their effectiveness , but little research has examined the effects of such exercises . Objective . To determine whether adding a VC exercise to a DA on heart disease prevention improves decision-making outcomes . Design . R and omized trial . Setting . UNC Decision Support Laboratory . Patients . Adults ages 40 to 80 with no history of cardiovascular disease . Intervention . A Web-based heart disease prevention DA with or without a VC exercise . Measurements . Pre- and postintervention decisional conflict and intent to reduce coronary heart disease ( CHD ) risk and postintervention self-efficacy and perceived values concordance . Results . The authors enrolled 137 participants ( 62 in DA ; 75 in DA + VC with moderate decisional conflict ( DA 2.4 ; DA + VC 2.5 ) and no baseline differences among groups . After the interventions , they found no clinical ly or statistically significant differences between groups in decisional conflict ( DA 1.8 ; DA + VC 1.9 ; absolute difference VC — DA 0.1 , 95 % confidence interval [ CI ] : —0.1 to 0.3 ) , intent to reduce CHD risk ( DA 98 % ; DA + VC 100 % ; absolute difference VC — DA : 2 % , 95 % CI : —0.02 % to 5 % ) , perceived values concordance ( DA 95 % ; DA + VC 92 % ; absolute difference VC — DA —3 % , 95 % CI : —11 % to + 5 % ) , or self-efficacy for risk reduction ( DA 97 % ; DA + VC 92 % ; absolute difference VC — DA —5 % , 95 % CI : —13 % to + 3 % ) . However , DA + VC tended to change some decisions about risk reduction strategies . Limitations . Use of a hypothetical scenario ; ceiling effects for some outcomes . Conclusions . Adding a VC intervention to a DA did not further improve decision-making outcomes in a population of highly educated and motivated adults responding to scenario-based questions . Work is needed to determine the effects of VC on more diverse population s and more distal outcomes",
"The White Paper Choosing health acknowledges that there is no lack of information in the system about healthy lifestyles , but the manner of communication of risk and the level of support for lifestyle change need improvement . Action also has to be taken to address inequalities in health and to focus on securing better access to healthier choices for people in disadvantaged groups or areas . Accordingly , this r and omized controlled trial examined whether access to a purpose -built health portal for heart disease could enable patients to manage better their heart conditions . We recruited 108 men and women aged 50—74 from coronary heart disease registries from a deprived area of Greater Manchester . Every participant received a new computer and one-year broadb and subscription ; however , only the experimental group received access to the Hearts of Salford health portal . Our results indicate that the experimental group changed their diet significantly . Specifically , they reported eating ` bad foods ' ( such as chips , sweets , crisps , fried foods , ready meals and cakes/biscuits ) significantly less often compared to the controls"
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BACKGROUND Clinical trials have shown that calcium supplementation in children can increase bone mineral density ( BMD ) although this effect may not be maintained . There has been no quantitative systematic review of this intervention . OBJECTIVES . To determine the effectiveness of calcium supplementation for improving BMD in children . . To determine if any effect varies by sex , pubertal stage , ethnicity or level of physical activity , and if any effect persists after supplementation is ceased . SEARCH STRATEGY We search ed CENTRAL , ( Cochrane Central Register of Controlled Trials ) ( Issue 3 , 2005 ) , MEDLINE ( 1966 to 1 April 2005 ) , EMBASE ( 1980 to 1 April 2005 ) , CINAHL ( 1982 to 1 April 2005 ) , AMED ( 1985 to 1 April 2005 ) , MANTIS ( 1880 to 1 April 2005 ) ISI Web of Science ( 1945 to 1 April 2005 ) , Food Science and Technology Abstract s ( 1969 to 1 April 2005 ) and Human Nutrition ( 1982 to 1 April 2005 ) . Conference abstract books ( Osteoporosis International , Journal of Bone and Mineral Research ) were h and - search ed . SELECTION CRITERIA R and omised controlled trials of calcium supplementation ( including by food sources ) compared with placebo , with a treatment period of at least 3 months in children without co-existent medical conditions affecting bone metabolism . Outcomes had to include areal or volumetric BMD , bone mineral content ( BMC ) , or in the case of studies using quantitative ultrasound , broadb and ultrasound attenuation and ultrasonic speed of sound , measured after at least 6 months of follow-up . DATA COLLECTION AND ANALYSIS Two authors independently assessed trial quality and extracted data including adverse events . We contacted study authors for additional information . MAIN RESULTS The 19 trials included 2859 participants , of which 1367 were r and omised to supplementation and 1426 to placebo . There was no heterogeneity in the results of the main effects analyses to suggest that the studies were not comparable . There was no effect of calcium supplementation on femoral neck or lumbar spine BMD . There was a small effect on total body BMC ( st and ardised mean difference ( SMD ) + 0.14 , 95 % CI+0.01 , + 0.27 ) and upper limb BMD ( SMD + 0.14 , 95%CI + 0.04 , + 0.24 ) . Only the effect in the upper limb persisted after supplementation ceased ( SMD+0.14 , 95%CI+0.01 , + 0.28 ) . This effect is approximately equivalent to a 1.7 % greater increase in supplemented groups , which at best would reduce absolute fracture risk in children by 0.1 - 0.2%per annum . There was no evidence of effect modification by baseline calcium intake , sex , ethnicity , physical activity or pubertal stage . Adverse events were reported infrequently and were minor . AUTHORS ' CONCLUSIONS While there is a small effect of calcium supplementation in the upper limb , the increase in BMD which results is unlikely to result in a clinical ly significant decrease in fracture risk . The results do not support the use of calcium supplementation in healthy children as a public health intervention . These results can not be extrapolated to children with medical conditions affecting bone metabolism
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"Objective . To examine how cumulative teenage sports histories and time-averaged teenage calcium intake are related to total body bone mineral gain between ages 12 and 18 years and to proximal femur bone mineral density ( BMD ) at age 18 years . Design . Longitudinal . Setting . University Hospital and local suburban community in Central Pennsylvania . Study Participants . Eighty-one white females in the ongoing Penn State Young Women 's Health Study . Outcome Measures . Total body and proximal femur ( hip ) bone measurements by dual energy radiograph absorptiometry ; nutrient intakes , including calcium , from 33 days of prospect i ve food records collected at regular intervals between ages 12 and 18 years ; and self-reported sports – exercise scores between ages 12 and 18 years . Results . Cumulative sports – exercise scores between ages 12 and 18 years were associated with hip BMD at age 18 years ( r = .42 ) but were not related to total body bone mineral gain . Time-averaged daily calcium intake , which ranged from 500 to 1500 mg/day in this cohort was not associated with hip BMD at age 18 years , or with total body bone mineral gain at age 12 through 18 years . Conclusions . The amount of physical activity that distinguishes a primarily sedentary teenager from one who engages in some form of exercise on a nearly daily basis is related to a significant increase in peak hip BMD",
"We have previously demonstrated a negative impact on peak bone mass in girls with precocious puberty treated with GnRH agonist ( GnRHa ) . Several studies have shown that a high calcium intake positively influences bone mass in prepubertal girls and leads to a higher peak bone mass . The aim of this study was to evaluate the effect of calcium supplementation in girls with precocious puberty during GnRHa treatment . Forty girls affected by true central precocious puberty and treated with the GnRHa triptorelin were studied for 2 yr . After diagnosis , the patients were r and omly assigned to three groups : group A , treated only with GnRHa ; group B , treated for 12 months solely with GnRHa and then supplemented with calcium gluconolactate/carbonate ( 1 g calcium/day in two doses ) for 12 months ; and group C , treated from the beginning with combined GnRHa and calcium . Bone mineral density ( BMD ) at the lumbar spine was measured by dual energy x-ray absorptiometry at the beginning of the study and after 12 and 24 months and was expressed as the calculated true volumetric density ( BMDv ) in milligrams per cm3 . Group A showed a decrease in absolute BMDv levels , in SD score for chronological age ( CA ) , and even more in SD score for bone age ( BA ) . Group B showed the same behavior during the first year , but this trend was reversed in the second year , when calcium supplementation was added to GnRHa treatment . Group C showed an increase in absolute BMDv levels and in SD score for CA and BA . BMDv variations ( expressed as absolute values , SD score for CA , and SD score for BA ) became statistically significant at 24 months between groups C and A ( P = 0.036 , P = 0.032 , and P = 0.025 , respectively ) . The behavior of the lumbar spine BMDv in the three groups is consistent with a positive effect of calcium supplementation during GnRHa treatment . In calcium-supplemented patients , the normal process of bone mass accretion at puberty is preserved despite GnRHa treatment . Therefore , the reduction in BMD during GnRHa treatment in girls with precocious puberty is at least completely reversible and preventable if calcium supplementation is associated from the beginning",
"Carbonated beverages have been reported to increase fracture risk in children but the mechanism is unclear . The aim of this population -based case-control study was to investigate the association between soft drink and milk consumption , physical activity , bone mass , and upper limb fractures in children aged 9–16 years . A total of 206 fracture cases and 206 r and omly selected individually matched controls were studied . There were 47 h and fractures ; 128 wrist and forearm fractures , and 31 upper arm fractures . An interviewer-administered question naire was utilized to retrospectively assess last-year physical activity ( including television , computer , and video watching ) and to recall the average weekly consumption of milk , colas , and total carbonated drinks . Bone mass at the spine , hip , and total body was assessed by dual-energy X-ray absorptiometry ( DXA ) and metacarpal morphometry . For total fractures , none of the above drink types was significantly different between cases and controls . For wrist and forearm fractures , there was a positive association between cola drink consumption and fracture risk ( OR 1.39/unit , 95 % CI : 1.01 , 1.91 ) . Cola consumption was significantly correlated with television , computer , and video watching ( r = 0.20 , P = 0.001 ) but not bone mineral density or milk drinks . After adjustment for television , computer , and video watching and bone mineral density , the association between cola drinks and fracture risk became nonsignificant ( OR 1.31/unit , 95 % CI : 0.94 , 1.83 ) . No association with other fracture sites was observed . In conclusion , cola , but not total carbonated beverage consumption , is associated with increased wrist and forearm fracture risk in children . However , this association is not independent of other factors and appears to be mediated by television watching and bone mineral density but not by decreased milk intake ",
"Over the past 20 years , orally administered biphosphonates have been used extensively in the management of a number of common skeletal disorders of different etiology . Recently , in clinical practice , in a number of cases in whom oral therapy is insufficient or contraindicated , intravenous administration of pamidronate presents an alternative therapeutic option . In order to investigate the clinical and radiological effects of cyclic intravenous pamidronate administration in children with osteogenesis imperfecta , a prospect i ve open study of pamidronate treatment was undertaken in a cohort of eight bed-bounded ( 3.6 - 13.8 years ) patients with severe osteoporosis and vertebral deformities . Pamidronate was administered at a dose of 0.5 mg/kg/ day for three days . Tri-monthly cyclic intravenous infusions were performed over-one year . Bone density , verebral corpus heights , estimated volumetric bone density and biochemical measurements were analyzed . Side effects of the therapy were determined via question naire . Significant reductions in the number of bone fractures and pain were observed in all patients . Ambulation scores were significantly altered and seven of eight patients became independent . Serum alkaline phosphatase levels decreased significantly . Lumbar X-ray and densitometry showed a striking improvement by the end of the treatment period . Even spaced dense lines corresponding to infusion periods were observed on roentgenograms of the radio-ulnar region . Pubertal progression and growth velocity were not affected inversely during therapy . Although we did not observe any severe side effect , one patient 's blood urea nitrogen level was altered slightly . In conclusion , one year cyclical pamidronate treatment seems to be effective and safe in improving bone mineralization and in reducing fracture incidence in severe osteoporosis",
"BACKGROUND There is no agreement on how much calcium young girls need for optimal bone mineralization . OBJECTIVE We evaluated whether the effect of calcium supplementation on whole-body bone mineral accretion depends on habitual calcium intake . DESIGN This was a r and omized , double-blind , placebo-controlled , 1-y calcium intervention study of girls aged 12 - 14 y selected from a larger group according to habitual calcium intake : subgroup A ( n = 60 ) habitually consumed 1000 - 1307 mg/d ( 40th-60th percentile ) , and subgroup B ( n = 53 ) habitually consumed mg/d ( girls from each subgroup were r and omly assigned to receive either 500 mg Ca/d or placebo . Whole-body bone mineral content ( BMC ) , bone area ( BA ) , bone mineral density ( BMD ) , and BMC adjusted for BA , height , and weight ( size-adjusted BMC ) were measured at baseline and after 1 y. RESULTS There was no significant effect modification of baseline habitual calcium intake on the relation between calcium supplementation and height , weight , BMC , size-adjusted BMC , BA , BMD , or alkaline phosphatase . Calcium supplementation had an effect on BMD ( 0.8 % ; P = 0.049 ) and tended to show signs of an effect on size-adjusted BMC ( 0.5 % ; P = 0.08 ) . CONCLUSION A modest effect of calcium supplementation on BMD was shown . However , the effect was independent of habitual calcium intake",
"BACKGROUND Osteoporosis may be prevented or delayed by maximizing peak bone mass through diet modification and physical activity during adolescence . OBJECTIVE We studied whether increases in calcium intake and physical activity effectively increase the bone mineral status of adolescent girls aged 16 - 18 y. DESIGN We conducted a 15.5-mo study of calcium supplementation ( 1000 mg Ca/d as carbonate ) in 144 adolescent girls aged 17.3 + /- 0.3 y ( + /- SD ) . The subjects were r and omly allocated to an exercise ( three 45-min exercise-to-music classes/wk during term time ) or nonexercise group . Dual-energy X-ray absorptiometry of the whole body , spine , forearm , and hip was performed before and after intervention . RESULTS The mean ( + /- SD ) percentage of subjects compliant with supplement taking was 70 + /- 27 % and with exercise class attendance was 36 + /- 25 % . Baseline calcium intake was 938 + /- 411 mg/d . Calcium supplementation significantly increased size-adjusted bone mineral content . The effect was stronger in subjects with good compliance ( percentage difference + /- SE ) : whole body , 0.8 + /- 0.3 % ( P Attendance at > 50 % of the exercise sessions was significant at the total hip ( 1.4 + /- 0.7 % ; P trochanter ( 2.6 + /- 1.2 % ; P Calcium supplementation and exercise enhanced bone mineral status in adolescent girls . Whether this is a lasting benefit , leading to the optimization of peak bone mass and a reduction in fracture risk , needs to be determined",
"BACKGROUND Rural Gambian children have poor growth , delayed puberty , a low bone mineral content , and a low calcium intake . OBJECTIVE We investigated the effect of a calcium supplement on bone mineral accretion in rural Gambian children . DESIGN A r and omized , double-blind , placebo-controlled study was conducted in 160 children ( 80 boys , 80 girls ) aged 8.3 - 11.9 y. Bone mineral content ( BMC ) , bone mineral density ( BMD ) , and BMC adjusted for bone width , body weight , and height ( size-adjusted BMC ) were measured at the midshaft and distal radius . Each child received either 1000 mg Ca/d ( as calcium carbonate ) or a placebo 5 d/wk for 12 mo . Supplementation increased calcium intake from 342 to 1056 mg/d ( 8.6 to 26.4 mmol/d ) . RESULTS Calcium supplementation result ed in a higher BMC , BMD , and size-adjusted BMC ( & xmacr ; difference + /- SE ) : midshaft radius- BMC ( 3.0 + /- 1.4 % ; P = 0.034 ) , BMD ( 4.5 + /- 0.9 % ; P size-adjusted BMC ( 4.6 + /- 0.9 % ; P distal radius- BMC ( 8 . 4 + /- 3.2 % ; P = 0.009 ) , BMD ( 7.0 + /- 2.7 % ; P = 0.011 ) , and size-adjusted BMC ( 5.5 + /- 2.7 % ; P = 0.042 ) . Supplementation had no significant effect on height , weight , or bone width at the midshaft radius or distal radius . At the end of the study , the calcium group had a significantly lower mean plasma osteocalcin concentration than the placebo group after adjustment for baseline concentration , sex , and pubertal status ( -21.9 + /- 6.5 % ; P = 0.001 ) . CONCLUSIONS Increased calcium intake result ed in increased bone mineral status , possibly in association with a decreased bone remodeling space . Further studies are needed to determine whether an increased calcium intake has long-term benefits in Gambian children",
"A r and omized , double-blind , controlled calcium supplementation trial was conducted for 18 mo to determine its effects on bone acquisition and height increment in 162 7-y-old Chinese children ( 87 boys and 75 girls ) with habitually low calcium intakes ( 280 mg/d ) . Distal one-third radial bone mineral content ( BMC ) , area bone density ( BMC /bone width ) , and height were evaluated every 6 mo . Baseline dietary intakes , serum 25-hydroxycholecalciferol , and physical activity were determined . The study group received 300 mg Ca/d as calcium carbonate ; control subjects received placebo tablets . After 18 mo the study group had significantly greater gains in BMC ( 16.5 % vs 13.97 % ; P = 0.02 ) and BMC /bone width ( 9.45 % vs 6.31 % ; P = 0.0008 ) than the control subjects . The findings confirm a positive effect of calcium intake on bone acquisition but no effect on height increment . Whether a higher bone mass attained at age 8 - 9 y would be maintained and beneficial to future peak bone mass requires longitudinal investigation . Further study is warranted to determine calcium requirements for Chinese children",
"BACKGROUND Bone loss is a critical concern for space travelers , and a dietary countermeasure would be of great benefit . Dietary protein and potassium-associated bicarbonate precursors may have opposing effects on the acid-base balance in the body and therefore on bone loss . OBJECTIVE In 2 studies , we examined the ability of dietary protein and potassium to predict markers of bone metabolism . DESIGN In the first study , 8 pairs of male identical twins were assigned to 1 of 2 groups : bed rest ( sedentary , or SED , group ) or bed rest with supine treadmill exercise in a lower-body negative pressure chamber ( EX group ) . In a second study , groups of 4 subjects lived in a closed chamber for 60 or 91 d , and dietary data were collected for two or three 5-d sessions . Urinary calcium , N-telopeptide , and pyridinium cross-links were measured before bed rest ; on bed rest days 5 - 6 , 12 - 13 , 19 - 20 , and 26 - 27 ; and daily during the chamber studies . Data were analyzed by Pearson 's correlation ( P ratio of animal protein intake to potassium intake was significantly correlated with N-telopeptide in the SED group during bed rest weeks 3 and 4 ( r = 0.77 and 0.80 ) and during the 91-d chamber study ( r = 0.75 ) . The ratio of animal protein intake to potassium intake was positively correlated with pyridinium cross-links before bed rest in the EX group ( r = 0.83 ) , in the EX group during bed rest week 1 ( r = 0.84 ) , and in the SED group during bed rest week 2 ( r = 0.72 ) but not during either chamber study . In both studies , these relations were not significant with the ratio of vegetable protein intake to potassium intake . CONCLUSIONS The ratio of animal protein intake to potassium intake may affect bone in ambulatory and bed-rest subjects . Changing this ratio may help to prevent bone loss on Earth and during space flight",
"BACKGROUND High calcium intakes during adolescence may increase bone acquisition . The magnitude of the effect of dietary calcium supplementation and the timing of its administration to achieve significant effects on bone health are still incompletely defined . OBJECTIVE The objective of this study was to assess the effect of calcium supplementation on bone mass accretion in postmenarcheal adolescent girls with low calcium intakes . DESIGN A double-blind , placebo-controlled calcium supplementation study was implemented . One hundred girls with a mean ( + /- SD ) age of 14 + /- 0.5 y with habitual calcium intakes The treatment group received a daily supplement containing 1000 mg elemental calcium . Bone mineral density ( BMD ) and bone mineral content ( BMC ) of the total body , lumbar spine , and femoral neck were determined at inclusion , 6 mo , and 12 mo . Also measured were serum concentrations of biochemical markers of bone turnover ( osteocalcin and deoxypyridinoline ) , parathyroid hormone , and vitamin D. RESULTS The calcium-supplemented group had greater accretion of total-body BMD and lumbar spine BMD but not BMC than did the control group . Calcium supplementation appeared selectively beneficial for girls who were 2 y postmenarcheal . Calcium supplementation significantly decreased bone turnover and decreased serum parathyroid hormone concentrations . CONCLUSION Calcium supplementation of postmenarcheal girls with low calcium intakes enhances bone mineral acquisition , especially in girls > 2 y past the onset of menarche",
"BACKGROUND Our r and omized , placebo-controlled supplementation study of 160 rural Gambian children aged 8.3 - 11.9 y showed that an increase in calcium intake of 714 mg/d for 12 mo result ed in a 5 % increase in forearm bone mineral acquisition and a 22 % decrease in plasma osteocalcin concentration , a bone formation marker , but had no effect on height or bone dimensions . OBJECTIVE We investigated whether these results were sustained after supplement withdrawal . DESIGN All participants were followed up 12 ( FU1 ) and 24 ( FU2 ) mo after supplementation ended . Bone mineral content ( BMC ) , bone mineral density ( BMD ) , and BMC adjusted for bone width , body weight , and height ( size-adjusted BMC ) were measured at the midshaft and distal radius . Plasma osteocalcin concentration was measured at FU1 . RESULTS At follow-up , the calcium group had greater bone mineral status than did the placebo group at the midshaft radius ( mean difference + /- SE ) , FU1 : BMC ( 4.7 + /- 1.6 % ; P = 0.004 ) , BMD ( 5.1 + /- 1.1 % ; P size-adjusted BMC ( 5.0 + /- 1.1 % ; P BMC ( 3.8 + /- 1.6 % ; P = 0.02 ) , BMD ( 2.7 + /- 1.3 % ; P = 0.04 ) , size-adjusted BMC ( 2.5 + /- 1.3 % ; P = 0.06 ) . Similar differentials were observed at the distal radius but were not significant . No significant differences in plasma osteocalcin concentrations ( FU1 : -0.5 + /- 6.5 % ; P = 0.9 ) were observed between groups . CONCLUSION Although some of the effects of calcium supplementation were still evident at follow-up , further studies are required to determine whether short-term increases in calcium intake have lasting benefits for Gambian children",
"BACKGROUND Short-term studies established that calcium influences bone accretion during growth . Whether long-term supplementation influences bone accretion in young adults is not known . OBJECTIVE This study evaluated the long-term effects of calcium supplementation on bone accretion among females from childhood to young adulthood . DESIGN A 4-y r and omized clinical trial recruited 354 females in pubertal stage 2 and optionally was extended for an additional 3 y. The mean dietary calcium intake of the participants over 7 y was approximately 830 mg/d ; calcium-supplemented persons received an additional approximately 670 mg/d . Primary outcome variables were distal and proximal radius bone mineral density ( BMD ) , total-body BMD ( TBBMD ) , and metacarpal cortical indexes . RESULTS Multivariate analyses of the primary outcomes indicated that calcium-supplementation effects vary over time . Follow-up univariate analyses indicated that all primary outcomes were significantly larger in the supplemented group than in the placebo group at the year 4 endpoint . However , at the year 7 endpoint , this effect vanished for TBBMD and distal radius BMD . Longitudinal models for TBBMD and proximal radius BMD , according to the time since menarche , showed a highly significant effect of supplementation during the pubertal growth spurt and a diminishing effect thereafter . Post hoc stratifications by compliance-adjusted total calcium intake and by final stature or metacarpal total cross-sectional area showed that calcium effects depend on compliance and body frame . CONCLUSIONS Calcium supplementation significantly influenced bone accretion in young females during the pubertal growth spurt . By young adulthood , significant effects remained at metacarpals and at the forearm of tall persons , which indicated that the calcium requirement for growth is associated with skeletal size . These results may be important for both primary prevention of osteoporosis and prevention of bone fragility fractures during growth",
"This study evaluated the long-term efficacy of supplemental calcium and dairy products on bone mineral areal density of the hip and spine and on the bone geometry and volumetric bone mineral density of the forearm in young females during late adolescence . The study was conducted among participants of a r and omized double-blinded , placebo-controlled clinical trial with calcium supplements and among participants of an observational study with higher consumption of dairy products . Hip and spine measurements by dual-energy X-ray absorptiometry were done every 6 mo ( dairy group every 12 mo ) during last 3 y of the follow-up while peripheral quantitative computerized tomography of the forearm was done at the last visit . The results of the study show a positive influence of calcium supplementation and dairy products on bone mineral density of the hip and the forearm . Dairy products were also associated with a higher bone mineral density of the spine while calcium supplementation did not have an effect . Calcium exerts its action on bone accretion during growth primarily by influencing volumetric bone mineral density while milk may have an additional impact on bone growth and periosteal bone expansion",
"Achievement of maximal calcium retention during adolescence may influence the magnitude of peak bone mass and subsequently lower the risk of osteoporosis . Calcium retention is generally considered to reach a plateau at a certain calcium intake . To test this hypothesis , calcium balance was measured in 35 females with a mean ( + /-SD ) age of 12.7 + /- 1.2 y ( range : 12 - 15 y ) who consumed from 841 + /- 153 to 2173 + /- 149 mg Ca/d . Subjects ate a basal diet that included a fortified beverage containing different amounts of calcium citrate malate . Twenty-one subjects were studied at two dietary calcium intakes with use of a crossover design . Results from a previous study in 14 subjects who were studied at only one calcium intake were included in the data analysis . Calcium retention was modeled as a nonlinear function of calcium intake that included a parameter representing mean maximal retention . Mean maximal calcium retention was 473 mg/d ( 95 % CI : 245 , 701 mg Ca/d ) . At higher postmenarcheal ages , maximal calcium retention was lower but the intake required to achieve this was not affected . Calcium intake explained 79 % and 6 % , respectively , of the variation in fecal and urinary calcium excretion . Intake of 1200 mg Ca/d , the recommended dietary allowance for calcium published in 1989 , result ed in a mean calcium retention that was 57 % of the maximal value ( 95 % CI : 25 % , 89 % ) . Intake of 1300 mg Ca/d was the smallest intake that allowed some adolescent females to achieve 100 % of maximal calcium retention ( 95 % CI : 26 % , 100 % ) . These data support the idea that calcium retention plateaus at a certain calcium intake although it continues to increase at intakes > 2 g/d",
"BACKGROUND Calcium supplementation during childhood and adolescence increases bone-mass accrual . Whether or not this benefit persists after discontinuation of supplementation is not known . We previously showed a favourable effect of milk-extracted calcium phosphate incorporated in various foods on accumulation of bone mineral mass in 8-year-old girls . We now report the results of a follow-up study undertaken more than 3 years after the end of calcium supplementation . METHODS Anthropometric and bone variables were measured in 116 of the 144 girls whose data had been studied at the end of the supplementation period . The mean time elapsed between the end of the intervention period and this follow-up measurement was 3.5 years . Areal bone mineral density was measured by dual-energy X-ray absorptiometry at the same six skeletal sites as those studied during the intervention phase . FINDINGS We were able to remeasure 62 and 54 girls of the calcium-supplemented and placebo groups , respectively . The increase from baseline in the overall mean bone mineral density of the six skeletal sites was still highly significant ( calcium-supplemented group 179 mg/cm(2 ) [ SE 8 ] vs placebo group 151 mg/cm(2 ) [ 7 ] , p=0.012 ) . A significant difference in favour of the supplemented group was also seen with respect to mean bone mineral content ( p=0.031 ) and mean bone area ( p=0.04 ) . Difference in pubertal maturation did not seem to account for the recorded differences . INTERPRETATION Our results suggest that this form of milk-extracted calcium phosphate taken during the prepubertal period can modify the trajectory of bone mass growth and cause a long-st and ing increase in bone mass accrual , which lasts beyond the end of supplementation",
"The trial is conducted to evaluate the effects of calcium on bone mineral accretion in adolescents . 161 healthy adolescents aged of 9 to 20 year-old are recruited and are r and omly divided into experimental groups in which 300 mg Ca is supplemented per day for each participant and control group . The dietary calcium , physical activity , SMR , distal one-third radial bone mineral content ( BMC ) , bone width ( BW ) , height , weight and serum total ALP are measured at both the beginning and the end of the trial . It is found that the average calcium intake from dietary sources is 500 mg/d in both groups . Increasing daily calcium intake via calcium supplementation in adolescents results in a moderate increases of BMC , and there is a significant increase of BMC in the females during the late adolescence . No significant differences in anthropometry are observed between the two groups at the end of the study while the increase of serum ALP level in the females in experiment group is significantly lower than that in the control group during the late adolescence . It is concluded that during the pubertal years when the BMC accretion is evident , there are no significant differences in bone mass accrual between the two groups . While in the females , calcium supplementation may help enhance the bone mineral accrual during late adolescence when the BMC accretion is remarkably reduced",
"To evaluate the correlation between dietary calcium intake and mineralization of the immature skeleton 55 children and adolescents aged 5 - 14 years ( mean , 9.5 years ) with a positive radioallergosorbent test ( RAST ) for serum antibodies to cow 's milk protein were evaluated . Bone mineral density ( BMD ) in the lumbar spine and proximal femurs were measured by dual energy X-ray absorptiometry . BMD at each site for each subject was converted to an age-adjusted Z score based on our own series of 95 normal pediatric controls . Calcium intake was determined using a detailed food frequency question naire administered by a nutritionist during a 30 - 40-min interview . Dietary adjustments to the condition varied and result ed in a wide range of calcium intakes . Calcium supplements were taken by 22 % of the subjects and were included in the determination of daily calcium intake . The group of 55 subjects was divided into quartiles based on calcium intake ( mean + /- S.E mg calcium/day ) : Group 1 , 409 + /- 21 , Group 2 , 663 + /- 16 , Group 3 , 950 + /- 32 , Group 4 , 1437 + /- 124 . Bone density Z scores in the proximal femur serially increased across the calcium intake groups ( mean + /- S.E. ) : Group 1 , -0.16 + /- 0.31 ; Group 2 , 0.05 + /- 0.33 ; Group 3 , 0.44 + /- 0.24 ; Group 4 , 0.79 + /- 0.41 ( P = 0.03 ) . A similar pattern was found with lumbar spine BMD Z scores : Group 1 , -0.16 + /- 0.27 ; Group 2 , 0.10 + /- 0.21 ; Group 3 , 0.18 + /- 0.20 ; Group 4 , 0.30 + /- 0.25 ( P = 0.05 ) . These data add further to the evidence that dietary calcium intake is important for optimal mineralization of the growing skeleton",
"This 2-year prospect i ve study examined associations among bone mineral acquisition and physical , maturational , and lifestyle variables during the pubertal transition in healthy girls . Forty-five girls , initially 10.5+/-0.6 years , participated . Body composition and bone mineral content ( BMC ) at the spine and total body ( TB ) were assessed at baseline and annually thereafter using dual-energy X-ray absorptiometry ( DXA ) . Nutrient intakes were assessed using 3-day diet records and a calcium food frequency question naire ( FFQ ) , physical activity by question naire , sexual maturation using Tanner 's stages of breast and pubic hair maturation , growth by height and weight , and eating attitudes using the children 's Eating Attitudes Test ( Children 's EAT ) . Mean children 's EAT subscale scores ( dieting , oral control [ OC ] , and bulimia ) were stable over time . Median split of OC subscale scores was used to form high and low OC groups . Groups had similar body composition , dietary intake , activity , and Tanner stage at baseline and 2 years . Using height , weight , and Tanner breast stage as covariates , girls with low OC scores had greater TB BMC at baseline ( 1452+/-221 g vs. 1387+/-197 g ; p = 0.030 ) and 2 years ( 2003+/-323 g vs. 1909+/-299 g ; p = 0.049 ) and greater lumbar spine ( LS ) BMC at 2 years ( 45.2+/-8.8 g vs. 41.2+/-9.6 g ; p = 0.042 ) . In multiple regression analysis , OC score predicted baseline , 2 years , and 2-year change in TB and spinal BMC , contributing 0.9 - 7.6 % to explained variance . Calcium intake predicted baseline , 2 years , and 2-year change in TB BMC , explaining 1.6 - 5.3 % of variance . We conclude that both OC and habitual calcium intake may influence bone mineral acquisition",
"BACKGROUND Women may lose bone during lactation because of calcium lost in breast milk . We studied whether calcium supplementation prevents bone loss during lactation or augments bone gain after weaning . METHODS We conducted two r and omized , placebo-controlled trials of calcium supplementation ( 1 g per day ) in postpartum women . In one trial ( the study of lactation ) , 97 lactating and 99 nonlactating women were enrolled a mean ( + /-SD ) of 16+/-2 days post partum . In the second trial ( the study of weaning ) , 95 lactating women who weaned their infants in the 2 months after enrollment and 92 nonlactating women were enrolled 5.6+/-0.8 months post partum . The bone density of the total body , lumbar spine , and forearm was measured at enrollment and after three and six months . RESULTS The bone density of the lumbar spine decreased by 4.2 percent in the lactating women receiving calcium and by 4.9 percent in those receiving placebo and increased by 2.2 and 0.4 percent , respectively , in the nonlactating women ( P bone density of the lumbar spine increased by 5.9 percent in the lactating women receiving calcium and by 4.4 percent in those receiving placebo ; it increased by 2.5 and 1.6 percent , respectively , in the nonlactating women ( P bone density in the forearm , and there was no effect of calcium supplementation on the calcium concentration in breast milk . CONCLUSIONS Calcium supplementation does not prevent bone loss during lactation and only slightly enhances the gain in bone density after weaning",
"HYPOTHESIS If calcium and phosphorus are administered to very low birth weight infants in amounts larger than those currently used in st and ard parenteral nutrition solutions , apparent retention of calcium and phosphorus ( intake minus urinary excretion ) will increase and bone mineralization will improve . DESIGN R and omized , controlled , double-blind trial . SETTING Neonatal intensive care unit . PATIENTS Twenty-four very low birth weight infants ( parenteral nutrition exclusively for approximately 3 weeks beginning 3 days after birth . INTERVENTIONS Infants received parenteral nutrition solutions , either the st and ard mixture containing 1.25 mmol calcium and 1.5 mmol phosphorus per deciliter ( group ST AND : n = 12 , birth weight 921 + /- 171 gm , gestational age 27 + /- 2 weeks ( mean + /- SD ) ) or 1.7 mmol calcium and 2.0 mmol phosphorus per deciliter ( group HIGH : n = 12 , 857 + /- 180 gm , 27 + /- 2 weeks ) . MAIN OUTCOME MEASURES Intake , urinary excretion , and apparent retention of calcium , phosphorus , and magnesium every 3 days during parenteral nutrition therapy . Serum indexes of mineral status twice during therapy . Bone mineral content of the distal segment of the left radius at 1 , 4 , 8 , and 26 weeks . RESULTS Apparent calcium retention ( 1.2 + /- 0.2 vs 1.6 + /- 0.2 mmol.kg-1.d-1 ) and phosphorus retention ( 1.4 + /- 0.2 vs 1.8 + /- 0.4 mmol.kg-1.d-1 ) differed significantly ( p Serum calcium , magnesium , parathyroid hormone , 25-hydroxyvitamin D , and osteocalcin concentrations were similar in both groups . Serum phosphorus concentration was significantly higher in group HIGH than in group ST AND ( p = 0.025 ) . The absolute bone mineral content and the rate of increase in bone mineral content between 1 and 4 , 1 and 8 , and 1 and 26 weeks were significantly greater in group HIGH than in group ST AND . CONCLUSIONS Increased parenteral intakes of calcium and phosphorus result ed in greater retention of these minerals during parenteral nutrition therapy and in greater bone mineral content after therapy",
"BACKGROUND Bone loss occurs during the first 6 months after renal transplantation ( RT ) , and corticosteroid therapy plays an important role . Although calcium plus vitamin D administration prevents corticosteroid-induced osteoporosis , its use in RT recipients is limited by the risk of hypercalcemia . METHODS This double-blind , r and omized , and controlled prospect i ve intervention trial examined the effect of intermittent calcitriol ( 0.5 microg/48 h ) during the first 3 months after RT , plus oral calcium supplementation ( 0.5 g/day ) during 1 year with calcium supplementation alone . The primary outcome measure was the change in bone mineral density ( BMD ) at 3 and 12 months after RT ; we also explored whether the effect of calcitriol on BMD was different among vitamin D receptor ( VDR ) genotypes ( BsmI ) . Forty-five recipients were r and omized to calcitriol therapy ( CT ) and 41 were r and omized to placebo ( PL ) . RESULTS Both groups had a similar degree of pre-existing hyperparathyroidism ( 197 + /- 229 vs. 191 + /- 183 pg/mL ) , but a more pronounced decrease of parathyroid hormone ( PTH ) levels after RT was observed in CT patients ( at 3 months : 61.4 + /- 42.2 vs. 85.7 + /- 53.1 pg/mL , P= 0.02 ; at 12 months : 67.3 + /- 33.7 vs. 82.6 + /- 37 pg/mL ; P= 0.08 ) . CT patients preserved their BMD at the total hip significantly better than those on PL ( 3 months : 0.04 + /- 3.3 vs. -1.93 + /- 3.2 % , P= 0.01 ; 12 months : 0.32 + /- 4.8 vs. -2.17 + /- 4.4 % , P= 0.03 ) ; significant differences were noted at the intertrochanter , trochanter , and Ward 's triangle . Differences did not reach significance at the femoral neck . Two CT patients ( 4.4 % ) and 4 PL patients ( 9.8 % ) developed a hypercalcemic episode during the first 3 months after RT . The effect of CT on BMD at 3 months was more prominent in recipients with the at-risk allele of the VDR gene ( P= 0.03 ) . CONCLUSION Therapy with low-dose calcium supplements during 1 year , plus intermittent calcitriol for 3 months after RT , is safe , decreases PTH levels more rapidly , and prevents bone loss at the proximal femur ; a more pronounced effect is seen in recipients with at least one at-risk allele of the VDR genotype",
"One of the main focuses of lifestyle modification for the prevention of osteoporosis and osteoporotic fractures in Japan is improvement in dietary calcium intake . However , virtually no r and omized controlled trial to assess the preventive effects of administration of calcium on the risk of fractures has been conducted in Japan . In this study , we review ed all the scientific papers currently available from medical literature data bases to propose evidence -based recommendations on the preventive procedures for osteoporosis . The result of the present systematic review gives the evidence showing that calcium supplementation or optimal dietary calcium intake increases bone density in childhood and adolescence and reduces the risk of fracture due to osteoporosis in the elderly people regardless of the gender . The evidence also supports the current health policy guiding the elderly to increase their dietary calcium intake in daily life",
"OBJECTIVE Childhood weight-bearing physical activity is recognized as an important determinant of peak bone mass , and physical activity intervention may represent a feasible strategy for primary prevention of osteoporosis . Previous school-based exercise interventions have all been of high-impact , circuit-based , jumping intervention ( 10 minutes , 3 times a week ) over 2 school years and compared changes in bone mineral content ( BMC ) over 20 months ( 2 school years ) in 9.9 + /- 0.6-year-old intervention girls ( N = 32 ) and controls ( 10.3 + /- 0.4 years , N = 43 ) . METHODS We measured BMC for the total body , lumbar spine , proximal femur ( and femoral neck and trochanteric subregions ) , and lean and fat mass by dual-energy radiograph absorptiometry ( Hologic QDR 4500 ) , and height , sitting height , leg length , and weight at baseline and 20 months . We assessed Tanner stage , general physical activity , and calcium intake by question naire . RESULTS Girls were Tanner breast stage 1 to 3 at baseline . There were no significant differences in baseline or 20-month change in body size or composition , average physical activity , or calcium intake between groups . There were substantially greater gains in lumbar spine ( 41.7 % vs 38.0 % ) and femoral neck ( 24.8 % vs 20.2 % ) BMC in intervention than in control girls ( P high-impact exercise per week implemented over 2 consecutive years within the elementary school curriculum elicited a substantial bone mineral accrual advantage in pubertal girls",
"BACKGROUND The achievement of a peak bone mass is an important factor in the prevention of osteoporotic fractures . In normal children , the amount of calcium intake could affect bone mineral increment . AIM To assess the effect of a daily 500 mg calcium supplement on bone mineral density , in a group of healthy Chilean girls . PATIENTS AND METHODS Fifty healthy girls were studied and 25 were r and omly assigned to receive a 500 mg calcium supplement during 10 months . Bone mineral density of the distal and ultradistal region of the forearm was measured in all girls by single X ray absorptiometry ( Osteometer DTX-100 ) at the beginning and end of the study . Bone mineral density was expressed as Z values . RESULTS Significant increments in bone mineral density at the distal radioulnar region were obtained in the supplemented girls . No significant changes in bone density were observed in control girls . CONCLUSIONS A daily 500 mg calcium supplement for 10 months increased bone mineral density in healthy girls",
"OBJECTIVE To develop and test a model based on B and ura 's social cognitive theory to predict healthy lifestyle behaviors for the prevention of osteoporosis . METHODS Participants were 354 girls , ages 8 - 11 years , recruited from area Girl Scout troops . Baseline data from a r and omized trial of behavioral interventions are presented . Measures of social support , knowledge , self-efficacy , dietary calcium intake , and weight-bearing physical activity ( WBPA ) were obtained via interviews and self-administered question naires . RESULTS A structural equation model was tested and fit the data well . Family social support , perceived self-efficacy for eating a calcium-rich diet , and knowledge of WBPA significantly predicted calcium intake . Friend and family support for exercise predicted WBPA . Self-efficacy partially mediated the relationship between family support and calcium intake , as confirmed by Holmbeck 's post-hoc probing strategy ( 2002 ) . CONCLUSIONS Suggestions are made for primary prevention interventions such as parent and peer involvement , health education , and problem-solving training",
"OBJECTIVES This study examined whether higher intakes of milk and other calcium-rich foods during adult years can reduce the risk of osteoporotic fractures . METHODS This was a 12-year prospect i ve study among 77761 women , aged 34 through 59 years in 1980 , who had never used calcium supplements . Dietary intake was assessed with a food-frequency question naire in 1980 , 1984 , and 1986 . Fractures of the proximal femur ( n = 133 ) and distal radius ( n = 1046 ) from low or moderate trauma were self-reported on biennial question naires . RESULTS We found no evidence that higher intakes of milk or calcium from food sources reduce fracture incidence . Women who drank two or more glasses of milk per day had relative risks of 1.45 for hip fracture ( 95 % confidence interval [ CI ] = 0.87 , 2.43 ) and 1.05 for forearm fracture ( 95 % CI = 0.88 , 1.25 ) when compared with women consuming one glass or less per week . Likewise , higher intakes of total dietary calcium or calcium from dairy foods were not associated with decreased risk of hip or forearm fracture . CONCLUSIONS These data do not support the hypothesis that higher consumption of milk or other food sources of calcium by adult women protects against hip or forearm fractures",
"Abstract : The maximum amount of bone a person can obtain during the first two decades of life is an important determinant of bone mass in later life , and an increase in peak bone mass has been associated with decreased risk for osteoporotic fractures . It is known that growth of bone and thus development of peak bone mass are strongly controlled by genetic factors , but information on the role of environmental factors , such as exercise and nutrition , ( e.g. , exercise ) on growing bone is limited . We tested a hypothesis that in growing girls the benefit of mechanical loading on bone mineral mass and bone strength is better before rather than after the menarche . Sixty-four girls ( 25 premenarcheal , 39 postmenarcheal ) carried out a supervised 9-month step-aerobic program ( two sessions per week ) , each session complemented with additional jumps . Sixty-two girls ( 33 premenarcheal , 29 postmenarcheal ) served as controls . Bone mineral content ( BMC ) at the lumbar spine and proximal femur was measured by dual-energy X-ray absorptiometry ( DXA ) . In addition , the cortical density ( CoD , mg/cm3 ) and cortical cross-sectional area ( CoA , mm2 ) and the density-weighted polar section modulus ( BSI , mm3 ) of the tibial midshaft were determined by peripheral quantitative tomography ( pQCT ) . In the premenarcheal girls , BMC increased statistically significantly more in the trainees than controls at the lumbar spine ( p= 0.012 ) ( 8.6 % vs 5.3 % ) and femoral neck ( p= 0.014 ) ( 9.3 % vs 5.3 % ) . In the tibial midshaft , the intergroup differences ( CoD , CoA and BSI ) were not significant . The postmenarcheal girls showed no significant post-training intergroup differences in any of the bone parameters ( BMC increased in the lumbar spine 6.0 % vs 4.9 % ; femoral neck 3.4 % vs 3.2 % ; and trochanter 2.6 % vs 3.5 % ) . Although a large proportion of bone mineral increase in the growing girls of this study was attributable to growth itself , this 9-month exercise intervention showed that a clear and large additional bone gain could be obtained in exercising premenarcheal girls , but not in exercising postmenarcheal girls . In other words , exercise seemed more beneficial for additional bone mineral acquisition before menarche ( i.e. , during the growth spurt ) rather than after it",
"Childhood and adolescence is the period of most rapid skeletal growth in an individual 's lifetime . A greater peak bone mass achieved in the first 2 - 3 decades of life , may protect against the risk of osteoporotic fracture in later life . The aim of this r and omized , controlled study was to assess in pre-pubertal boys and girls ( aged 8 - 10 years ) the effect of 18 months of a calcium enriched , cocoa flavoured product on bone density , bone growth and bone size in New Zeal and children . One hundred and fifty four pre-pubertal boys and girls ( aged 8 - 10 years ) were r and omized to receive a high calcium dairy drink or a control drink reconstituted with water for 18 months . They were assessed at baseline and then every 6 months for the first 18 months , while they were having the supplement ; they were then followed up 12 months after supplementation had finished . Bone mineral density and bone mineral content were assessed at the total body , hip and spine . Indicators of bone size ( vertebral width and height ) were also measured at the spine . Anthropometric data was collected , medical history question naires were administered ( including the Tanner or pubertal stage question naire ) , dietary calcium intake was assessed with a calcium food frequency question naire and calcium supplement compliance was determined . There was no significant difference between the 2 groups for bone mineral density or bone mineral content at any time point . There was no difference in vertebral height or width at any stage of the study , indicating no additional influence on bone size at the lumbar vertebrae . There were no significant differences between height , weight , lean mass or fat mass at any time point . Both groups had higher habitual calcium intakes than recommended for this age group going into the study and throughout the study . In this 2(1/2 ) year study ( 18 months supplementation , 1 year follow-up ) we did not observe a difference in bone mineral density in pre-pubertal children . This was probably due to their high habitual dietary calcium intake whereby minimal addition of calcium to the diet reached the threshold level where no further benefit was seen . There were no significant differences between the two groups in body composition . Growth and the mean height and weight remained between the 50th and 75th percentile for their age . We have shown calcium supplementation in children with high habitual dietary calcium intake appears not to have additional effects on bone mass . Calcium supplementation needs to be targeted in those children with low habitual dietary calcium intake ",
"Physical activity during childhood is advocated as one strategy for enhancing peak bone mass ( bone mineral content [ BMC ] ) as a means to reduce osteoporosis-related fractures . Thus , we investigated the effects of high-intensity jumping on hip and lumbar spine bone mass in children . Eighty-nine prepubescent children between the ages of 5.9 and 9.8 years were r and omized into a jumping ( n = 25 boys and n = 20 girls ) or control group ( n = 26 boys and n = 18 girls ) . Both groups participated in the 7-month exercise intervention during the school day three times per week . The jumping group performed 100 , two-footed jumps off 61-cm boxes each session , while the control group performed nonimpact stretching exercises . BMC ( g ) , bone area ( BA ; cm2 ) , and bone mineral density ( BMD ; g/cm2 ) of the left proximal femoral neck and lumbar spine ( L1-L4 ) were assessed by dual-energy X-ray absorptiometry ( DXA ; Hologic QDR/4500-A ) . Peak ground reaction forces were calculated across 100 , two-footed jumps from a 61-cm box . In addition , anthropometric characteristics ( height , weight , and body fat ) , physical activity , and dietary calcium intake were assessed . At baseline there were no differences between groups for anthropometric characteristics , dietary calcium intake , or bone variables . After 7 months , jumpers and controls had similar increases in height , weight , and body fat . Using repeated measures analysis of covariance ( ANCOVA ; covariates , initial age and bone values , and changes in height and weight ) for BMC , the primary outcome variable , jumpers had significantly greater 7-month changes at the femoral neck and lumbar spine than controls ( 4.5 % and 3.1 % , respectively ) . In repeated measures ANCOVA of secondary outcomes ( BMD and BA ) , BMD at the lumbar spine was significantly greater in jumpers than in controls ( 2.0 % ) and approached statistical significance at the femoral neck ( 1.4 % ; p = 0.085 ) . For BA , jumpers had significantly greater increases at the femoral neck area than controls ( 2.9 % ) but were not different at the spine . Our data indicate that jumping at ground reaction forces of eight times body weight is a safe , effective , and simple method of improving bone mass at the hip and spine in children . This program could be easily incorporated into physical education classes",
"High calcium intake during childhood has been suggested to increase bone mass accrual , potentially result ing in a greater peak bone mass . Whether the effects of calcium supplementation on bone mass accrual vary from one skeletal region to another , and to what extent the level of spontaneous calcium intake may affect the magnitude of the response has , however , not yet been clearly established . In a double-blind , placebo-controlled study , 149 healthy prepubertal girls aged 7.9+/-0.1 yr ( mean+/-SEM ) were either allocated two food products containing 850 mg of calcium ( Ca-suppl . ) or not ( placebo ) on a daily basis for 1 yr . Areal bone mineral density ( BMD ) , bone mineral content ( BMC ) , and bone size were determined at six sites by dual-energy x-ray absorptiometry . The difference in BMD gain between calcium-supplemented ( Ca-suppl . ) and placebo was greater at radial ( metaphysis and diaphysis ) and femoral ( neck , trochanter , and diaphyses ) sites ( 7 - 12 mg/cm2 per yr ) than in the lumbar spine ( 2 mg/cm2 per yr ) . The difference in BMD gains between Ca-suppl . and placebo was greatest in girls with a spontaneous calcium intake below the median of 880 mg/d . The increase in mean BMD of the 6 sites in the low-calcium consumers was accompanied by increased gains in mean BMC , bone size , and statural height . These results suggest a possible positive effect of calcium supplementation on skeletal growth at that age . In conclusion , calcium-enriched foods significantly increased bone mass accrual in prepubertal girls , with a preferential effect in the appendicular skeleton , and greater benefit at lower spontaneous calcium intake",
"Two related studies were conducted to assess the associations between markers of skeletal modeling and remodeling in healthy children . Members of monozygotic twin pairs , aged 6 - 14 , enrolled in a clinical trial of calcium supplementation , were studied at the end of the period of supplementation and for 3 years thereafter . Supplemented children had significantly higher rates of gain in bone mineral density ( BMD ) ( + 3 % on average ) during the period of supplementation accompanied by significantly lower concentrations of serum osteocalcin ( OC , -15 % ) . During postsupplement follow-up , both differences in BMD and OC disappeared . Black females , age matched to the baseline ages of the white children , had significantly lower serum concentrations of both OC and tartrate-resistant acid phosphatase ( TRAP ) at all ages and higher BMDs . When stratified on serum TRAP concentrations , regardless of race , children with lower concentrations had significantly higher BMDs , and no racial differences were apparent . In regression models accounting for 70 - 80 % of the variability in BMD in children , body size and TRAP , but not race , remained significantly associated with BMD . The skeletal advantages seen with calcium supplementation and black race appear to be associated with reduced rates of skeletal turnover . Given that markers of turnover during growth reflect both skeletal modeling and remodeling , and there is no apparent advantage to reduced skeletal modeling , it seems probable that reduced remodeling is the factor that accounts for the increases in bone mass",
"OBJECTIVE To determine whether pubertal girls assigned to calcium-rich diets or their usual calcium intakes differ significantly in weight gain . DESIGN This is a pilot study conducted on data from an experimental research project . SUBJECTS/ SETTING The sample included 59 girls , 9 years of age , from Omaha metropolitan communities . INTERVENTION Participants were r and omly assigned to a calcium-rich diet supplying at least 1,500 mg of calcium per day or their usual diet . MAIN OUTCOME MEASURE The outcome measure was change in weight during 2 years of study . STATISTICAL ANALYSES Data were analyzed using descriptive statistics , Mann-Whitney U , t tests of paired and independent sample s , and analysis of covariance . RESULTS The girls in the calcium-rich diet group had a mean ( + /-st and ard deviation ) calcium intake of 1,656+/-191 mg/day , whereas the girls on their usual diets averaged 961+/-268 mg/day . Although the participants in the treatment group consumed nearly twice as much dietary calcium -- primarily from dairy foods -- they did not have greater increases in body weight , body mass index , or fat or lean mass than the control group . These findings held when the data were grouped by tertile of calcium intake . Compared with girls on their usual diets , the girls who consumed the calcium-rich diet also significantly increased their intake of essential nutrients . CONCLUSION We conclude that calcium-rich diets do not cause excessive weight gain in pubertal girls but do contribute positively to overall nutrition . These findings provide support for programs to promote calcium-rich diets , which are critical for attaining peak bone mass",
"PURPOSE : To test the effects of an osteoporosis prevention program given to high school students DESIGN : R and omized , multisite field study . SAMPLE : The final sample for analysis was composed of 693 teens from 18 schools . FINDINGS : The average knowledge difference score of the OPTIONS group was 8.4 percentage points higher than that of the control group . Some of the analysis suggested that girls gained more from the intervention than did boys . Students from all types of schools , responded equivalently to the intervention . Health beliefs about barriers to preventive action were not influenced by the intervention . DISCUSSION : This intervention increased students ' knowledge about how to build healthy bones ; however , the real challenge lies in building on that knowledge gain to influence behaviors . The modest gain in knowledge also suggests that educational interventions of this type should be tested with younger children , who might be more receptive",
"BACKGROUND Steroid-related bone loss is a recognized complication after renal transplantation . In a prospect i ve , r and omized , multicenter study we compared the influence of a steroid-free immunosuppressive regimen with a regimen with limited steroid exposure on the changes in bone mass after renal transplantation . METHODS A total of 364 recipients of a renal transplant were r and omized to receive either daclizumab ( 1 mg/kg on days 0 and 10 after transplantation ; steroid-free group n=186 ) or prednisone ( 0.3 mg/kg per day tapered to 0 mg at week 16 after transplantation ; steroids group n=178 ) . All patients received tacrolimus , mycophenolate mofetil , and , during the first 3 days , 100 mg prednisolone intravenously . Changes in bone mineral density ( BMD ) were evaluated in 135 and 126 patients in the steroid-free and steroids group , respectively . RESULTS The mean ( + /- SD ) BMD of the lumbar spine decreased slightly in both groups during the first 3 months after transplantation ( steroid-free -1.3 + /- 4.0 % [ P steroids -2.3 + /-4.2 % [ P lumbar BMD recovered in both groups ( P lumbar BMD at 12 months after transplantation comparable with the baseline value . No difference between the groups was found at 3 months ( steroid-free versus steroids + 1.0 % ; 95 % confidence interval -0.0%-+2.0 % , P=0.060 ) and at 12 months after transplantation ( steroid-free versus steroids + 0.9 % ; 95 % confidence interval -0.8%-+2.6 % , NS ) . CONCLUSION The use of a moderate dose of steroids during 4 months after transplantation has no important influence on bone mass during the first year after renal transplantation . On average , both regimens prevented accelerated bone loss",
"Abstract : Lifestyle factors , such as diet , are believed to be involved in modifying bone health , although the results remain controversial , particularly in children and adolescents . The objective of the study was to identify associations between dietary factors and whole body bone measurements in 10-year-old children . The study was a cross-sectional analysis of a r and om sample of 105 healthy Danish children , aged 10 years ( 9.97 ± 0.09 ) . Whole body bone mineral content ( BMC ) and bone area ( BA ) were determined by dual-energy X-ray absorptiometry . The influence of diet ( 7 day food records ) on BMC and BA were examined in bi- and multivariate analyses . The mean intakes of calcium , protein , phosphorus and sodium were 1226 mg , 78 g , 1523 mg and 3.3 g , respectively . In bivariate analyses , BMC and BA were strongly positively correlated with height ( p . BMC was adjusted for size by including BA , height and weight in the multiple linear regression , and BA was adjusted for size by including height and weight in the multiple linear regression . In multivariate analyses , size-adjusted BMC was positively associated with calcium intake ( p = 0.02 ) . Size-adjusted BA was positively associated with dietary protein ( p = 0.003 ) , and negatively associated with intakes of sodium ( p = 0.048 ) and phosphorus ( p = 0.01 ) . In conclusion , calcium intake was positively associated with bone mineralization . There was a positive association between protein and BA , while for phosphorus and sodium the association was negative . The findings suggest that in addition to calcium , the intake of other nutrients influences bone development in prepubertal children",
"In order to study the effect of calcium supplementation on bone resorption , a r and omized controlled crossover study was carried out on eight healthy 18 - 19 year old female volunteers using either AAACa heated oyster shell with vacuum-heated seaweed or milk . Regimen A consisted of an oral dose of 200 mg calcium in the form of AAACa . B 200 ml milk after breakfast and supper and at bedtime , and C control with no calcium supplement . Early morning fasting blood and urine sampling was carried out after 7 days of calcium supplementation . Serum calcium was higher in groups A and B than in C , and serum intact parathyroid hormone ( PTH ) was significantly lower in group A than in groups B and C , according to a paired t-test . Urinary excretion of crosslinked collagen degradation product , pyridinoline and deoxypyridinoline showed a similar decrease in groups A and B but not in C. The more effective suppression of PTH by AAACa than by milk may be due to its higher bioavailability and the absence of phosphate stimulating PTH secretion",
"UNLABELLED Bone metabolism follows a seasonal pattern with high bone turnover and bone loss during the winter . In a r and omized , open-label 2-year sequential follow-up study of 55 healthy adults , we found that supplementation with oral vitamin D3 and calcium during winter abolished seasonal changes in calciotropic hormones and markers of bone turnover and led to an increase in BMD . Supplementation with oral vitamin D3 and calcium during the winter months seems to counteract the effects of seasonal changes in vitamin D and thus may be beneficial as a primary prevention strategy for age-related bone loss . INTRODUCTION Bone metabolism follows a seasonal pattern characterized by high bone turnover and bone loss during winter . We investigated whether wintertime supplementation with oral vitamin D3 and calcium had beneficial effects on the circannual changes in bone turnover and bone mass . MATERIAL S AND METHODS This prospect i ve study comprised an initial observation period of 12 months ( \" year 1 \" ) , followed by an intervention during parts of year 2 . Fifty-five healthy subjects living in southwestern Germany ( latitude , 49.5 degrees N ) were r and omized into two groups : 30 subjects were assigned to the treatment group and received oral cholecalciferol ( 500 IU/day ) and calcium ( 500 mg/day ) during the winter months of year 2 ( October-April ) , while 25 subjects assigned to the control group obtained no supplements . Primary endpoints were changes in calciotropic hormones [ serum 25(OH)D , 1,25(OH)2D , and parathyroid hormone ] , markers of bone formation ( serum bone-specific alkaline phosphatase ) and of bone resorption ( urinary pyridinoline and deoxypyridinoline ) , and changes in lumbar spine and femoral neck BMD . RESULTS Forty-three subjects completed the study . During year 1 , calciotropic hormones , markers of bone turnover , and BMD varied by season in both groups . During the winter months of year 1 , bone turnover was significantly accelerated , and lumbar spine and femoral BMD declined by 0.3 - 0.9 % . In year 2 , seasonal changes in calciotropic hormones and markers of bone turnover were either reversed or abolished in the intervention group while unchanged in the control cohort . In the subjects receiving oral vitamin D3 and calcium , lumbar and femoral BMD increased significantly ( lumbar spine : + 0.8 % , p = 0.04 versus year 1 ; femoral neck : + 0.1 % , p = 0.05 versus year 1 ) , whereas controls continued to lose bone ( intervention group versus control group : lumbar spine , p = 0.03 ; femoral neck , p = 0.05 ) . CONCLUSIONS Supplementation with oral vitamin D3 and calcium during winter prevents seasonal changes in bone turnover and bone loss in healthy adults . It seems conceivable that annually recurring cycles of low vitamin D and mild secondary hyperparathyroidism during the winter months contributes , at least in part and over many years , to age-related bone loss . Supplementation with low-dose oral vitamin D3 and calcium during winter may be an efficient and inexpensive strategy for the primary prevention of bone loss in northern latitudes",
"Low dietary calcium intake has been demonstrated to be a risk factor for hip and vertebral fractures in studies conducted among Hong Kong Chinese . Few studies have demonstrated the effect of milk supplementation in bone accretion in Chinese children . The aim was to examine the effects of milk powder supplementation in enhancing bone accretion in Chinese children . Three hundred and forty-four children , aged 9–10 years old , were r and omized to receive milk powder equivalent to 1300 mg and 650 mg calcium , and to a control group , respectively . Bone mineral density ( BMD ) at the proximal femur , lumbar spine and total body were measured at 6 months , 12 months and 18 months . The treatment effects were modeled using linear mixed effect models and compared using linear contrast F-tests , by intention-to-treat . Subjects r and omized to milk powder equivalent to 1300 mg calcium had significantly higher increase in BMD at both the total hip ( 7.4±0.4 % in treatment group versus 6.3±0.4 % in the control ) and the spine ( 8.4±0.5 % in the treatment group versus 7.0±0.5 % in the control group ) . Subjects r and omized to milk powder equivalent to 650 mg calcium had smaller increases in BMD at the total hip and spine , although the increase in BMD at the total body was significantly higher ( 3.1±0.3 % in treatment group versus 2.4±0.2 % in controls ) . It is concluded that supplementing the diet of Chinese children with milk powder was effective in enhancing bone accretion ",
"Although increased physical activity early in life is recommended for optimizing bone health , no controlled trials on the effect of activity on bone mass accretion during periods of rapid growth have been reported . The purpose of this study was to determine whether infants r and omized to a 1 year gross motor activity program had a greater bone mass accretion than infants r and omized to a fine motor activity program . The gross motor program included activities that focused on loading the skeleton and were performed for 15 - 20 minutes/day , 5 days/week by study personnel . Infants ( n = 72 ) were enrolled at 6 months of age , and total body bone mineral content ( BMC ) , 3-day diet records , and activity levels were obtained at 6 , 9 , 12 , 15 , and 18 months . BMC was associated with weight , length , and bone area at all ages and correlated with earlier calcium intakes . Calcium intake appeared to modify the effect of gross motor activity on bone mass accretion ; infants in both groups had similar bone accretion at moderately high calcium intakes , but at low calcium intakes infants in the gross motor program had less bone accretion than infants in the fine motor program . Compliant infants in the gross motor group had lower BMC at 18 months compared with noncompliant infants . These results indicate that BMC in infants is related to calcium intake , and we speculate that participation in a gross motor program during rapid bone growth may lead to reduced bone accretion in the presence of a moderate to moderately low calcium intake",
"Abstract : Symptomatic fractures are a significant problem in terms of both morbidity and financial cost . Marked variation in both total and site-specific fracture incidence has been documented internationally but there is limited within-country data . This prospect i ve population -based study documented the incidence of all symptomatic fractures occurring from July 1 , 1997 to June 30 , 1999 in adults ≥50 years of age resident in Southern Tasmania ( total population ≥50 years : 64 688 ) . Fractures were ascertained by review ing reports from all the radiology providers within the area . There were 701 fractures in men and 1309 fractures in women . The corresponding fracture incidence in men and women was 1248 and 1916 per 100 000 person-years , respectively . Residual lifetime fracture risk in a person aged 50 years was 27 % for men and 44 % for women with fractures other than hip fractures constituting the majority of symptomatic fracture events . These fracture risk estimates remained remarkably constant with increasing age . In comparison to Geelong , there were significantly lower hip fracture rates ( males : RR 0.59 , 95 % CI 0.45–0.76 ; females : RR 0.61 , 95 % CI 0.53–0.71 ) but significantly higher distal forearm fractures ( males : RR 1.87 , 95 % CI 1.10–3.78 ; females : RR 1.31 , 95 % CI 1.11–1.55 ) and total fractures in men ( RR 1.31 , 95 % CI 1.17–1.46 ) but not women ( RR 1.05 , 95 % CI 0.98–1.13 ) . In contrast , Southern Tasmania had lower age-st and ardized rates of all fractures compared with Dubbo ( RR 0.28–0.79 ) . In conclusion , this study provides compelling evidence that fracture incidence varies between different geographic sites within the same country , which has important implication s for health planning . In addition , the combination of high residual fracture risk and short life expectancy in elderly subjects suggests fracture prevention will be most cost-effective in later life",
"High calcium intake combined with physical activity during childhood have been shown to improve bone mass accrual and bone mineral density . Our aim was to study the combined effect of calcium and exercise on bone gain in children . Two milk-powder products containing either 800 mg of calcium phosphate ( calcium ) or not ( placebo ) were r and omly allocated to 113 healthy premenarchal girls on a daily basis for 1 year . The group was composed of 63 exercise ( 7.2 + /- 4 hours of exercise/week ) and 50 sedentary ( 1.2 + /- 0.8 hours of exercise/week ) children . The final experiment had 4 groups : exercise/calcium ( n = 12 ) , exercise/placebo ( n = 42 ) , sedentary/calcium ( n = 10 ) , and sedentary/placebo ( n = 21 ) . Bone mineral density ( BMD ) at 6 skeletal sites and body composition were determined by DXA . Bone age was calculated and the daily spontaneous calcium intake was assessed by a frequency question naire . All the tests were performed at baseline and 1 year by the same observer . BMD gains were significantly greater in the exercise/calcium group than in other groups at the total body ( increase of 6.3 % , p calcium supplementation increases the effect of physical exercise on bone mineral acquisition in the period preceding puberty , and that calcium supplementation without physical activity does not improve the BMD acquisition during this period . Physical exercise that stimulates bone accretion needs a high calcium intake to be completely effective",
"The effect of calcium supplementation on bone mineral density ( BMD ) was evaluated in female twin pairs aged 10–17 years with a mean age of 14 years . Forty-two twin pairs ( 22 monozygotic , 20 dizygotic ; ( including one monozygotic pair from a set of triplets ) completed at least 6 months of the intervention : 37 pairs to 12 months and 28 pairs to 18 months . BMD was measured by dual-energy X-ray absorptiometry ( DXA ) . In a double-blind manner , one twin in each pair was r and omly assigned to receive daily a 1000 mg effervescent calcium tablet ( S and ocal 1000 ) , and the other a placebo tablet similar in taste and appearance to the calcium supplement but containing no calcium . Compliance ( at least 80 % tablets consumed ) , as measured by tablet count , was 85 % in the placebo group and 83 % in the calcium group over the 18 months of the study , on average increasing dietary calcium to over 1600 mg/day . There was no within-pair difference in the change in height or weight . When the effect of calcium supplementation on BMD was compared with placebo at approximately 6 , 12 and 18 months , it was found that there was a 0.015±0.007 g/ cm2 greater increase in BMD ( 1.62±0.84 % ) at the spine in those on calcium after 18 months . At the end of the first 6 months there was a significant within-pair difference of 1.53±0.56 % at the spine and 1.27±0.50 % at the hip . However , there were no significant differences in the changes in BMD after the initial effect over the first 6 months . Therefore , we found an increase in BMD at the spine with calcium supplementation in females with a mean age of 14 years . The greatest effect was seen in the first 6 months ; thereafter the difference was maintained , but there was no accelerated increase in BMD associated with calcium supplementation . The continuance of the intervention until the attainment of peak bone mass and follow-up after cessation of calcium supplementation will be important in clarifying the optimal timing for increased dietary calcium and the sustained , long-term effects of this intervention",
"We conducted a double-blind , placebo-controlled , r and omized trial to determine whether 1 year of supplemental calcium intake would augment hip [ greater trochanter , GT , femoral neck ( FN ) , total hip ( TH ) ] , spine ( LS ) , and femoral mid-shaft ( Fmr ) BMD in female distance runners . Twenty-three women ( age : 23.7 + /- 4.7 yrs , height : 165.6 + /- 6.3 cm , weight : 55.7 + /- 6.1 kg ) were r and omly assigned to receive either 1000 mg/d of supplemental calcium ( N = 13 ) or placebo tablets ( N = 10 ) for 1 year . BMD was determined by DXA ( Hologic 1000-W ) and tablet compliance by self-report logs . Compliance averaged 79 % and 71 % for supplement and placebo groups , respectively . Calcium supplementation did not affect hip or spine BMD , but did prevent loss at the femoral mid-shaft ( GT : -0.5 % vs. 0.2 % , FN : 0.9 % vs. 1.1 % , TH : -0.3 % vs. 0.2 % , LS : 0.3 % vs. 1.2 % , Fmr : 0.1 % vs. -1.8 % , for calcium vs. placebo , respectively ) . We conclude that the addition of 800 mg/d of supplemental calcium to the diet of young adult female distance runners with habitual calcium intakes of approximately 1000 mg/d , prevents cortical but not trabecular bone loss",
"Successful renal transplantation corrects many of the metabolic abnormalities associated with the development of renal osteodystrophy , but despite a well-functioning graft osteopenia , growth failure , spontaneous fractures , and avascular necrosis remain prevalent in adult and pediatric kidney recipients . A paucity of information exists regarding the effects of different therapies to prevent and treat bone loss in the renal transplant recipients . We constructed a design to study the effect of different modalities of treatment on bone mass in our renal transplant children . Among 93 patients who underwent renal transplantation at the age of 17 yr or less and were subjected to dual-energy X-ray absorptiometry ( DEXA ) , we blindly r and omized 60 patients who had osteopenia or osteoporosis ( T-score = -1 by DEXA ) in a prospect i ve study . Their mean age at time of transplantation was 13.4 + /- 4.3 yr . The mean duration after transplantation was 48 + /- 34 months . The patients were classified r and omly into four groups . Each group consisted of 15 patients : group 1 was the control group , group 2 received oral alfacalcidol 0.25 microg daily , group 3 received oral alendronate 5 mg daily , and group 4 received 200 IU/day nasal spray calcitonin . Parameters of bone turnover , calcium metabolism , and DEXA were measured before and after 12 months of treatment duration . The characteristics of all groups were comparable at the beginning of the study . At the lumber spine , bone mass density decreased from -2.4 to -2.8 in group 1 , increased from -2.3 to -0.5 in group 2 , from -2.3 to -1.9 in group 3 , and from -2.3 to -1.0 in group 4 . The four groups had similar patient profiles , serum creatinine , intact parathyroid hormone , osteocalcin , and deoxypyridinoline . This study confirmed the value of alfacalcidol and antiresorptive agents in the treatment of osteopenia and osteoporosis in young renal transplant recipients . These therapies were safe , tolerable , simple to administer and potentially applicable to other renal transplant patients",
"One hundred and twelve Caucasian girls , 11.9±0.5 years of age at entry , were r and omized into a 24-month , double-masked , placebo-controlled trial to determine the effect of calcium supplementation on bone mineral content , bone area and bone density . Supplementation was 500 mg calcium as calcium citrate malate ( CCM ) per day . Controls received placebo pills , and compliance of both groups averaged 72 % . Bone mineral content , bone mineral area and bone mineral density of the lumbar spine and total body were measured by dual energy X-ray absorptiometry ( DXA ) . Calcium intake from dietary sources averaged 983 mg/day for the entire study group . The supplemented group received , on average , an additional 360 mg calcium/day from CCM . At baseline and after 24 months , the two groups did not differ with respect to anthropometric measurements , urinary reproductive hormone levels or any measurement of pubertal progression . The supplemented group had greater increases of total body bone measures : content 39.9 % versus 35.7 % ( p=0.01 ) , area 24.2 % versus 22.5 % ( p=0.15 ) and density 12.2 % versus 10.1 % ( p=0.005 ) . Region-of-interest analyses showed that the supplemented group had greater gains compared with the control group for bone mineral density , content and area . In particular , in the lumbar spine and pelvis , the gains made by the supplemented group were 12%–24 % greater than the increases made by the control group . Bone acquisition rates in the two study groups were further compared by subdividing the groups into those with below- or above-median values for Tanner score and dietary calcium intake . In subjects with below-median Tanner scores , bone acquisition was not affected by calcium supplementation or dietary calicum level . However , the calcium supplemented subjects with above-median Tanner had higher bone acqusition rates than the placebo group with above-median Tanner scores . Relative to the placebo group , the supplemented group had increased yearly gains of bone content , area and density which represented about 1.5 % of adult female values . Such increases , if held to adult skeletal maturity , could provide protection against future risk of osteoporotic fractures",
"There is limited information relating Ca intake to bone and height acquisition among Oriental children who consume little or even no milk . The present controlled study investigated the acquisition of bone mass and height of Chinese children with an initial Ca intake of approximately 567 mg/d who were supplemented to about 800 mg/d . Eighty-four 7-year-old Hong Kong Chinese children underwent an 18-month r and omized , double-blind , controlled Ca-supplementation trial . The children were r and omized to receive either 300 mg elemental Ca or a placebo tablet daily . Bone mass of the distal one-third radius was measured by single-photon absorptiometry , lumbar spine and femoral neck were determined using dual-energy X-ray absorptiometry . Measurements were repeated 6-monthly . Baseline serum 25-hydroxycholecalciferol concentration and physical activity were also assessed . Baseline Ca intakes of the study group and controls were respectively 571 ( SD 326 ) and 563 ( SD 337 ) mg/d . There were no significant differences in baseline serum 25-hydroxycholecalciferol concentration ( P = 0.71 ) and physical activity ( P = 0.36 ) between the study and control groups . After 18 months the study group had significantly greater increases in lumbar-spinal bone mineral content ( 20.9 v. 16.34 % ; P = 0.035 ) , lumbar-spinal area ( 11.16 v. 8.71 % ; P = 0.049 ) , and a moderately greater increment in areal bone mineral density of the radius ( 7.74 v. 6.00 % ; P = 0.081 ) when compared with the controls . The results confirm a positive effect of Ca on bone mass of the spine and radius but no effects on femoral-neck and height increase . A longer trial is warranted to confirm a positive Ca effect during childhood that may modify future peak bone mass",
"Our recent 18‐month calcium supplementation trial demonstrated a significant increase in radial bone mineral mass in 7‐year‐old children with calcium intake ∼ 300 mg/day ( Am J Clin Nutr 1994 ; 60 : 744‐50 ) . The persistence of higher bone mass after cessation of calcium supplementation is unknown . This is a follow‐up study to investigate the lasting effect of calcium supplementation on bone acquisition . Subjects were 159 Chinese children aged 8.7 years . Distal one‐third radial bone mineral content ( BMC ) and bone width ( BW ) were measured by single‐photon absorptiometry . After 12 months , the significant difference in mean ± SD percentage radial BMC disappeared between the study and control groups ( 7.34 ± 6.77 % vs 8.67 ± 6.46 % . p > 0.05 ) . Dietary calcium intakes were similar between the groups . During the supplementation phase , the study group had 17.9 % greater BMC gain than that of controls . In the follow‐up phase , however , the study group had 16.1 % less BMC gain than that of controls . It appears that an increased acquisition rate during the supplementation phase was almost balanced by a reduced acquisition rate during follow‐up phase . Moreover , throughout the entire 30‐month period , the overall BMC acquisition rates of the study and control groups were 25 % and 23.8 % , respectively . Hence , the overall acquisition rate of the study group was only 5 % higher than that of controls . Therefore , the effect of calcium supplementation on bone mineral gain appears to reflect a transient reduction in bone turnover rate . Longer‐term calcium trials are necessary to confirm whether a sustainable higher calcium intake throughout childhood will enhance peak bone mass",
"BACKGROUND Non-r and omised studies have suggested beneficial effects of bisphosphonates in osteogenesis imperfecta . We assessed the effects of oral olpadronate in children with this disorder in a r and omised double-blind placebo-controlled trial . METHODS 34 children recruited from the Dutch national centre for osteogenesis imperfecta were r and omly assigned olpadronate ( 10 mg/m2 daily ; n=16 ) or placebo ( n=18 ) for 2 years . All children also received calcium and vitamin D supplements . Primary endpoints were incident fractures of long bones and changes in bone mineral content ( BMC ) , bone mineral density ( BMD ) , and functional outcome . Anthropometry , vertebral height , and urinary markers of bone resorption were also studied . Analyses were by intention to treat . FINDINGS Fracture follow-up was complete for all the children , including two who withdrew from the study ( one from each group ) . Olpadronate treatment was associated with a 31 % reduction in relative risk of fracture of long bones ( hazard ratio 0.69 [ 95 % CI 0.52 - 0.91 ] , p=0.01 ) . The olpadronate group showed significantly greater increases than the placebo group in spinal BMC ( difference between groups 2.24 g/year [ 0.20 - 4.29 ] , p=0.03 ) and spinal BMD ( difference between groups 0.054 g/cm2 per year [ 0.012 - 0.096 ] , p=0.01 ) . There were no detectable effects on functional outcome , anthropometrics , or vertebral height and no differences between the groups in changes in urinary markers of bone resorption . INTERPRETATION Oral treatment with olpadronate at a daily dose of 10 mg/m2 results in a reduction of fracture risk of long bones in children with osteogenesis imperfecta . However , the issue of whether bisphosphonates will alter the natural course of osteogenesis imperfecta remains unresolved , and further studies are needed",
"The purpose of this study was to evaluate the contributions of exercise , fitness , body composition , and calcium intake during adolescence to peak bone mineral density and bone structural measurements in young women . University Hospital and 75 healthy , white females in the longitudinal Penn State Young Women 's Health Study were included . Body composition , total body , and hip bone mineral density ( BMD ) were measured by dual-energy X-ray absorptiometry ( DXA ) , exercise scores by sports-exercise question naire during ages 12 - 18 years , and estimated aerobic capacity by bike ergometry . Section modulus values ( a measurement of bending strength ) cross-sectional area ( CSA ) , subperiosteal width , and cortical thickness were calculated from DXA scan data for the femoral neck and femoral shaft . Calcium intakes were calculated from 39 days of prospect i ve food records collected at 13 timepoints between ages 12 and 20 years ; supplemental calcium intakes were included . Section moduli at the femoral neck and shaft were correlated significantly with lean body mass , sports-exercise scores ( R(2 ) = 0.07 - 0.19 , p aerobic capacity ( R(2 ) = 0.06 - 0.57 , p Sports-exercise scores correlated with BMD at the femoral neck and shaft . Average total daily calcium intake at age 12 - 20 years ranged from 486 to 1958 mg/day and was not significantly associated with total or regional peak BMD or bone structure measures at 20 years of age . It was shown that achievable levels of exercise and fitness have a favorable effect on BMD and section modulus of the femoral neck and femoral shaft in young adult women , whereas daily calcium intake of > 500 mg in female adolescents appears to have little , if any effect",
"Bone mineral density and fracture rates in children with osteogenesis imperfecta improve with intravenous bisphosphonates . The efficacy of oral bisphosphonates has not been established . This report is an analysis of an open-label , prospect i ve , r and omized clinical trial of oral compared to intravenous bisphosphonate medications in children with osteogenesis imperfecta . Children were stratified according to bone age , pubertal stage , and type of osteogenesis imperfecta and then r and omized to receive intravenous pamidronate , 3 mg/kg over 3 days every 4 months , or oral alendronate 1 mg/kg , from a minimum of 10 mg to a maximum of 20 mg daily . The primary efficacy outcome was change in bone mineral density . Secondary outcomes included change in biomarkers of bone turnover , fracture incidence , and growth rate . Ten children were r and omized ( 6 oral and 4 intravenous ) . Two other children were assigned to intravenous treatment due to chronic abdominal pain . In each group , three patients had type III/IV osteogenesis imperfecta , while three had type I. All 12 children completed 8 months of therapy ; nine completed 12 months . Bone mineral density increased in both oral and intravenous groups equally and beyond that expected with normal growth . All children had a decrease in biochemical markers of bone turnover . Linear growth showed a moderate increase above that for age . There was a non-significant decrease in fracture incidence in both groups",
"OBJECTIVE The effect of varying mineral intakes on total body bone mass accretion during the first year of life in healthy full-term infants is unknown . The purpose of this study was to determine whether total body bone mass accretion during the first year of life was influenced by the calcium and phosphorus intake of an infant and whether early differences in bone accretion persist through 1 year of age . DESIGN This prospect i ve , r and omized trial was conducted in two phases . In phase I , 67 infants were r and omized within the first 2 weeks of life into either a low ( 439 mg of calcium per liter and 240 mg of phosphorus per liter ) or moderate ( 510 mg of calcium per liter and 390 mg of phosphorus per liter ) mineral-containing formula feeding group . An additional group of 34 human milk-fed ( low mineral ) infants also was enrolled . Phase II involved an additional r and omization of all infants at 6 months of age into moderate-mineral formula ( see above ) , high-mineral formula ( 1350 mg of calcium per liter and 900 mg of phosphorus per liter ) , or cow milk ( 1230 mg of calcium per liter and 960 mg of phosphorus per liter ) feeding group . Anthropometric measurements , nutrient intake , and total body bone mineral content ( BMC ) by dual-energy x-ray absorptiometry were measured at 1 , 3 , 6 , 9 , and 12 months . RESULTS During the first 6 months , the moderate-mineral group had a greater increase in weight ( 3.42 + /- 0.62 kg ) compared with the human milk group ( 2.93 + /- 0.56 kg ) ; the low-mineral group ( 3.19 + /- 0.62 kg ) was intermediate . Bone mass accretion differed in a similar direction , with the moderate-mineral feeding group having a greater increase than the human milk group and the low-mineral group being intermediate of the two . Including weight , length , and bone area as covariates , both the low-mineral formula- and human milk-fed groups had similar BMC , which was lower than that of the moderate-mineral group at 3 and 6 months of age . Adjusted mean BMC values for the moderate-mineral formula-fed group compared with the low-mineral formula- and human milk-fed groups were 127.8 + /- 1.5 ( SEM ) g vs 119 . 2 + /- 1.5 and 122.1 + /- 1.4 g , respectively , at 3 months of age and 168.7 + /- 2.5 g vs 157.6 + /- 2.5 and 158.7 + /- 2.4 g , respectively , at 6 months of age . The BMC at 6 months of age among the formula-fed infants was correlated with both average dietary phosphorus intake ( r = .592 ) and average daily calcium intake ( r = .620 ) during the first 6 months . The relationships between BMC and these minerals remained significant even after controlling for caloric intake . It was not possible to determine the independent effects of dietary calcium and phosphorus on BMC because of the strong correlation of these minerals with each other . Despite significant differences in both calcium and phosphorus intakes during the second 6 months of life , there were no differences in growth parameters or bone mass accretion . Means for BMC , adjusted for body weight , length , and bone area , were not significantly different among feeding groups at either 9 or 12 months of age . Adjusted means were 199 + /- 2 ( SEM ) and 237 + /- 3 g at 9 and 12 months of age for infants receiving moderate-mineral formula ; 198 + /- 2 and 236 + /- 3 g at 9 and 12 months of age for infants receiving the high-mineral formulas and 202 + /- 5 and 233 + /- 5 g at 9 and 12 months of age for infants receiving cow milk . The gain in bone mass during the second 6 months differed by the first 6-month feeding group ; mean changes in BMC between 6 and 12 months , adjusted for changes in weight , length , and bone area , were greater in human milk-fed infants than in either the low- or moderate-mineral-containing formula groups : 81 + /- 16 g in human milk-fed infants and 73 + /- 15 and 71 + /- 15 g in the low- and moderate-mineral formula groups , respectively . Infants fed whole cow milk during the second 6 months were excluded from this analysis because of the small number of infants completing the study . By 12 months of age",
"A 2-year milk intervention trial was carried out with 757 girls , aged 10 years , from nine primary schools in Beijing ( April 1999 - March 2001 ) . Schools were r and omised into three groups : group 1 , 238 girls consumed a carton of 330 ml milk fortified with Ca on school days over the study period ; group 2 , 260 girls received the same quantity of milk additionally fortified with 5 or 8 microg cholecalciferol ; group 3 , 259 control girls . Anthropometric and bone mineralisation measurements , as well as dietary , health and physical-activity data , were collected at baseline and after 12 and 24 months of the trial . Over the 2-year period the consumption of this milk , with or without added cholecalciferol , led to significant increases in the changes in height ( > or = 0.6 % ) , sitting height ( > or = 0.8 % ) , body weight ( > or 2.9 % ) , and ( size-adjusted ) total-body bone mineral content ( > or = 1.2 % ) and bone mineral density ( > or = 3.2 % ) . Those subjects receiving additional cholecalciferol compared with those receiving the milk without added 25-hydoxycholecalciferol had significantly greater increases in the change in ( size-adjusted ) total-body bone mineral content ( 2.4 v. 1.2 % ) and bone mineral density ( 5.5 v. 3.2 % ) . The milk fortified with cholecalciferol significantly improved vitamin D status at the end of the trial compared with the milk alone or control groups . It is concluded that an increase in milk consumption , e.g. by means of school milk programmes , would improve bone growth during adolescence , particularly when Ca intake and vitamin D status are low",
"Combining exercise with calcium supplementation may produce additive or multiplicative effects at loaded sites ; thus , we conducted a single blind , prospect i ve , r and omized controlled study in pre- and early-pubertal girls to test the following hypotheses . ( 1 ) At the loaded sites , exercise and calcium will produce greater benefits than exercise or calcium alone . ( 2 ) At non-loaded sites , exercise will have no benefit , whereas calcium with or without exercise will increase bone mass over that in exercise alone or no intervention . Sixty-six girls aged 8.8 + /- 0.1 years were r and omly assigned to one of four study groups : moderate-impact exercise with or without calcium or low-impact exercise with or without calcium . All participants exercised for 20 minutes , three times a week and received Ca-fortified ( 434 + /- 19 mg/day ) or non-fortified foods for 8.5 months . Analysis of covariance ( ANCOVA ) was used to determine interaction and main effects for exercise and calcium on bone mass after adjusting for baseline bone mineral content and growth in limb lengths . An exercise-calcium interaction was detected at the femur ( 7.1 % , p exercise-calcium interaction detected at the tibia-fibula ; however , there was a main effect of exercise : bone mineral content increased 3 % more in the exercise than non-exercise groups ( p Bone mineral content increased 2 - 4 % more in the calcium-supplemented groups than the non-supplemented groups at the humerus ( 12.0 % vs. 9.8 % , respectively , p bone mass at loaded sites may be achieved when short bouts of moderate exercise are combined with increased dietary calcium , the former conferring region-specific effects and the latter producing generalized effects",
"The goal of health education is to provide information to affect attitudes , beliefs , and intentions for behavior change . However , little is known about the effects of changes in knowledge on behaviors for osteoporosis prevention . Our objective is to develop and test theoretical models of the effects of knowledge , attitude , and self-efficacy on exercise and calcium intake among young women before and after an intervention program . First , we hypothesized that knowledge would positively predict attitude , self-efficacy , calcium intake , and exercise . Second , attitude would positively predict self-efficacy , calcium intake , and exercise . Third , self-efficacy would positively predict calcium intake and exercise . Fourth , attitude and self-efficacy would mediate the effect of knowledge on calcium intake and exercise . At the beginning and end of the study , participants in the control group and intervention group completed the osteoporosis knowledge test , the osteoporosis health belief scale , the osteoporosis self-efficacy scale , a self-report for food records , and exercise . The causal model was examined as a result of our study . After the intervention program , calcium intake and exercise were predicted by knowledge when mediated by attitudes and self-efficacy . The final model accounted for 30 % and 45 % of the variance in calcium intake and exercise , respectively . We conclude that interventions to enhance young women 's knowledge and self-efficacy may result in increased calcium intake and exercise",
"OBJECTIVE To evaluate the effect of calcium supplementation on bone acquisition in adolescent white girls . DESIGN A r and omized , double-blind , placebo-controlled trial of the effect of 18 months of calcium supplementation on bone density and bone mass . SUBJECTS Ninety-four girls with a mean age of 11.9 + 0.5 years at study entry . SETTING University hospital in a small town . INTERVENTIONS Calcium supplementation , 500 mg/d calcium as calcium citrate malate ; controls received placebo pills . MAIN OUTCOME MEASURES Bone mineral density and bone mineral content of the lumbar spine and total body were measured by dual-energy x-ray absorptiometry and calcium excretion from 24-hour urine specimens . RESULTS Calcium intake from dietary sources averaged 960 mg/d for the entire study group . The supplemented group received , on average , an additional 354 mg/d of calcium . The supplemented group compared with the placebo group had greater increases of lumbar spine bone density ( 18.7 % vs 15.8 % ; P = .03 ) , lumbar spine bone mineral content ( 39.4 % vs 34.7 % ; P = .06 ) , total body bone mineral density ( 9.6 % vs 8.3 % ; P = .05 ) , and 24-hour urinary calcium excretion ( 90.4 vs 72.9 mg/d ; P = .02 ) , respectively . CONCLUSIONS Increasing daily calcium intake from 80 % of the recommended daily allowance to 110 % via supplementation with calcium citrate malate result ed in significant increases in total body and spinal bone density in adolescent girls . The increase of 24 g of bone gain per year among the supplemented group translates to an additional 1.3 % skeletal mass per year during adolescent growth , which may provide protection against future osteoporotic fracture",
"BACKGROUND Calcium supplementation during childhood and adolescence is considered an early means of preventing osteoporosis in adults . Prepuberty is an opportune time for detecting the benefits of calcium in girls . OBJECTIVE The objective was to assess whether calcium supplementation increases bone mass gain in prepubertal boys in a skeletal site-specific manner . METHODS In a 12-month double-blind , placebo-controlled trial with 1-yr follow-up , 235 healthy prepubertal boys aged 7.4 + /- 0.4 yr ( mean + /- sd ) were r and omized to receive two food products providing 850 mg/d calcium ( calcium supplement group , n = 116 ) or an isocaloric placebo ( n = 119 ) . Areal bone mineral density ( aBMD ) was determined by dual-energy x-ray absorptiometry at radius ( two sites ) , hip ( two sites ) , femoral diaphysis ( FDia ) , and L2-L4 vertebrae . RESULTS At 12 months , aBMD gain was greater at the FDia and at the mean of the five appendicular skeletal sites in the calcium supplement group in both intention-to-treat analysis [ 76 + /- 32 vs. 64 + /- 33 mg/cm(2).yr ; difference , 12.0 ( 95 % confidence interval , CI , 3.6 - 20.3 ) , P = 0.006 ; and 33 + /- 16 vs. 28 + /- 16 mg/cm(2).yr ; difference , 5.1 ( 95 % CI , 0.9 - 9.2 ) ; P = 0.018 , respectively ] and active treatment analysis [ 81 + /- 32 vs. 64 + /- 31 mg/cm(2).yr ; difference , 17.2 ( 95 % CI , 7.9 - 26.5 ) ; n = 174 , P no beneficial effect of calcium on lumbar spine . The calcium effect was still detectable by ANOVA repeated measures analysis at the FDia ( P = 0.004 ) and at the mean of the five appendicular skeletal sites ( P = 0.002 ) 1 yr after the end of intervention ( active treatment analysis ) . There was no change in bone size . CONCLUSION In prepubertal boys , calcium-enriched foods increased aBMD at several appendicular skeleton sites , but not at the lumbar spine , and this without any bone size change . This effect was maintained 1 yr after treatment discontinuation",
"A cross-sectional study of a r and om sample of 649 girls , aged 12 - 14 years ( mean + /- SD : 12.9 + /- 0.6 years ) , in the Beijing area examined the relationship between diet and bone mineral status . Food and nutrient intakes over the past year were estimated by means of a semiquantitative food frequency question naire . Bone mineral content ( BMC ) and bone width ( BW ) at the distal one-third and one-tenth radius and ulna were measured by single-photon absorptiometry . Results showed Beijing pubertal girls had a low mean milk consumption ( fresh and powdered milk , vitamin D-fortified milk , and yogurt ) at 50 g/day ( 95 % confidence interval [ CI ] 44 - 55 g/day whereas one-third consumed no milk at all . Mean calcium intake was 356 + /- 97 mg/day of which only 21 % was provided by milk and milk products . Milk intake varied by region ( rural , suburban , and urban : 9 , 36 , and 83 g/day , respectively , p Bone mineral density ( BMD ) at the distal one-third and one-tenth radius and one-tenth ulna was positively associated with milk consumption ( p weight , bone age , Tanner stage , and School Physical Activity Score ( SPAS ) , showed that milk intake was the only dietary factor included in the models for BMC at the four bone sites measured . The model explained 54%-65 % of the variation in BMC , and milk alone accounted for up to 3.2 % of the variation . Milk was the only food group with significant partial correlation with BMC . SPAS , weight , bone age , and Tanner stage each accounted for a smaller variation in BMC ( bone mass of Beijing pubertal girls and was a better nutritional determinant of BMC than intake of any milk nutrient alone . Promotion of milk consumption should be considered for achieving optimal bone mass in this population group",
"BACKGROUND This paper describes decisions about the experimental design for the Youth , Osteoporosis , and Underst and ing Total Health Project ( YOUTH ) , a trial design ed to test the efficacy of a health plan-based lifestyle intervention for increasing bone mineral density among adolescent women 14 to 16 years of age . METHODS This r and omized controlled trial recruited adolescent women who were at higher risk for developing osteoporosis ( body mass index 16 - 23 ) from a large HMO in the Pacific Northwest . The intervention focused on improving diet ( high calcium foods , fruits , and vegetables ) and increasing physical activity ( high impact and spinal motion ) . The intervention included both group and individual activities . The primary endpoint in the study was total bone mineral density as measured by dual-energy X-ray absorptiometry ( DEXA ) . RESULTS Baseline data were collected on the trial cohort of 228 adolescent women and their families . This paper discusses how research ers met the following challenges in design ing and implementing the trial : determining appropriate dietary and exercise targets to affect bone mineral density in adolescents ; choosing suitable assessment s ; and developing an intervention well suited for implementation in a non-school ( health plan ) setting . We also discuss the rationale for the specific study population chosen ( females , younger adolescents ) . CONCLUSIONS The YOUTH project is one of very few preventive research interventions with adolescents conducted in a health plan setting . Many of the recruitment and intervention strategies used in this trial may be appropriate for adoption in other health plan-based prevention studies",
"This study examined the effects of increasing milk on bone and body composition responses to resistance training in adolescents . Twenty-eight boys ( 13 to 17 years of age ) were r and omly assigned to consume , in addition to their habitual diet , 3 servings/day of 1 % fluid milk ( n=14 ) or juice not fortified with calcium ( n=14 ) while engaged in a 12-week resistance-training program . For all subjects combined , there were significant ( P changes in height ( + 0.5 % ) , sigmaseven skin folds ( -7.7 % ) , body mass ( + 2.6 % ) , lean body mass ( + 5.1 % ) , fat mass ( -9.3 % ) , whole-body bone mineral content ( + 3.6 % ) , bone mineral density ( + 1.8 % ) , and maximal strength in the squat ( + 43 % ) and bench press ( + 23 % ) . Compared with juice , the milk group had a significantly greater increase in bone mineral density ( 0.014 vs 0.028 g/cm(2 ) ) . Increasing intake of milk in physically active adolescent boys may enhance bone health",
"The age and developmental stage at which calcium supplementation produces the greatest bone effects remain controversial . We tested the hypothesis that calcium supplementation may improve bone accrual in premenarcheal females . Fifty-one pairs of premenarcheal female twins ( 27 monozygotic and 24 dizygotic ; mean + /- sd age , 10.3 + /- 1.5 yr ) participated in a r and omized , single-blind , placebo-controlled trial with one twin of each pair receiving a 1200-mg calcium carbonate ( Caltrate ) supplement . Areal bone mineral density ( aBMD ) was measured at baseline and 6 , 12 , 18 and 24 months . There were no within-pair differences in height , weight , or calcium intake at baseline . Calcium supplementation was associated ( P aBMD compared with placebo , adjusted for age , height , and weight at the following time points from baseline : total hip , 6 months ( 1.9 % ) , 12 months ( 1.6 % ) , and 18 months ( 2.4 % ) ; lumbar spine , 12 months ( 1.0 % ) ; femoral neck , 6 months ( 1.9 % ) . Adjusted total body bone mineral content was higher in the calcium group at 6 months ( 2.0 % ) , 12 months ( 2.5 % ) , 18 months ( 4.6 % ) , and 24 months ( 3.7 % ) , respectively ( all P Calcium supplementation was effective in increasing aBMD at regional sites over the first 12 - 18 months , but these gains were not maintained to 24 months",
"A meta- analysis of adult exercise studies and an infant activity trial show a possible interaction between physical activity and calcium intake on bone . This r and omized trial of activity and calcium supplementation was conducted in 239 children aged 3 - 5 years ( 178 completed ) . Children were r and omized to participate in either gross motor or fine motor activities for 30 minutes/day , 5 days per week for 12 months . Within each group , children received either calcium ( 1000 mg/day ) or placebo . Total body and regional bone mineral content by DXA and 20 % distal tibia measurements by peripheral quantitative computed tomography ( pQCT ) were obtained at 0 and 12 months . Three-day diet records and 48-h accelerometer readings were obtained at 0 , 6 , and 12 months . Higher activity levels were observed in gross motor versus fine motor activity groups , and calcium intake was greater in calcium versus placebo ( 1354 + /- 301 vs. 940 + /- 258 mg/day , p total body bone mineral content or leg bone mineral content by DXA . However , the difference in leg bone mineral content gain between gross motor and fine motor was more pronounced in children receiving calcium versus placebo ( interaction , p = 0.05 ) . Children in the gross motor group had greater tibia periosteal and endosteal circumferences by pQCT compared with children in the fine motor group at study completion ( p activity groups in both cortical thickness and cortical area : among children receiving placebo , thickness and area were smaller with gross motor activity compared with fine motor activity , but among children receiving calcium , thickness and area were larger with gross motor activity . These findings indicate that calcium intake modifies the bone response to activity in young children",
"BACKGROUND Maximal bone acquisition in adolescent girls through dietary and lifestyle practice s is advocated to prevent or minimize the development of osteoporosis and its associated complications in later life . Longitudinal investigations of bone acquisition in children and adolescents have utilized areal bone mineral density ( BMD , mg/cm(2 ) ) as a measure of bone mass and strength . Peripheral quantitative computed tomography ( pQCT ) , which provides a three-dimensional display of data , separate analyses of bone compartments , and bone mass in terms of volumetric BMD ( vBMD , mg/cm(3 ) ) , has recently been introduced for clinical use . OBJECTIVE To assess the impact of a 12-month daily calcium supplement on total and trabecular bone acquisition as measured by pQCT in preadolescent girls . DESIGN Early adolescent Caucasian girls ( aged 12 years , Tanner Stage 2 ) were enrolled in a r and omized trial of daily calcium supplement ( TX , 800 mg calcium carbonate and 400 IU vitamin D ) or placebo ( C ) . Body weight , height , and distal tibia measurements by pQCT were obtained at enrollment , 6 and 12 months . Pubertal status and physical activity records were assessed at baseline and 12 months . Three-day food intake records were completed every three months . RESULTS Seventy-one girls completed the 12-month trial ( TX=35 , C=36 ) . No differences were found for age , weight , height , body mass index , pubertal maturation , or reported physical activity at enrollment or during the study . Average intakes during the study were 1524 mg calcium and 496 IU vitamin D ( TX ) versus 865 mg calcium and 160 IU vitamin D ( C ) per day . Baseline total bone values were similar , however , trabecular values were greater in TX girls despite r and omization . Percent changes were calculated to adjust for baseline differences . Because of the small cortical thickness at the 10 % site ( mean values cortical mass and density were not analyzed . The percent changes for trabecular bone mineral content ( BMC , mg ) and vBMD were significantly greater in TX girls ( + 4.1 % BMC and + 1.0 % vBMD TX versus -1.6 % BMC and -2.0 % vBMD C , p Trabecular bone area ( BA , cm(2 ) ) and total bone change , however , did not differ between groups . CONCLUSIONS Daily calcium and vitamin D supplementation promotes greater trabecular BMC and vBMD acquisition in preadolescent girls . The single site selected for pQCT evaluation in this study did not allow evaluation of the cortical bone compartment . Future studies that utilize the pQCT technique need to incorporate multiple measurement sites to better assess total , cortical , and trabecular bone",
"The effect of calcium carbonate supplementation on bone growth and mineral accretion was studied in 143 boys aged 16 - 18 yr , r and omized to 1000 mg Ca/d or a matching placebo for 13 months . Anthropometry and dual-energy x-ray absorptiometry of the whole body , lumbar spine , hip , and forearm were performed before , during , and after the intervention . The intervention result ed in greater bone mineral content ( BMC ) of the whole body ( + 1.3 % , P = 0.02 ) , lumbar spine ( + 2.5 % , P = 0.004 ) , and hip ( total + 2.3 % , P = 0.01 ; neck + 2.4 % , P = 0.02 ; intertrochanter + 2.7 % , P = 0.01 ) . This was associated with greater height ( + 0.4 % , P = 0.0004 , equivalent to 7 mm ) , lean mass ( + 1.3 % , P = 0.02 ) , and lumbar spine bone area ( + 1.5 % , P = 0.003 ) . The increases in BMC diminished after size adjustment , suggesting that the intervention effect was mediated through an effect on growth . The BMC response at the intertrochanter was greater in subjects with high physical activity ( + 4.4 % , P = 0.05 ) . There were no other significant interactions with physical activity , plasma testosterone , calcium intake , or tablet compliance . We conclude that calcium carbonate supplementation of adolescent boys increased skeletal growth , result ing in greater stature and bone mineral acquisition . Follow-up studies will determine whether this reflects a change in the tempo of growth or an effect on skeletal size that persists into adulthood",
"Twelve months of a consistent average daily intake of calcium to at least the 1200-mg Recommended Dietary Allowance ( RDA ) was achieved by 22 adolescent girls . At the end of the year the calcium-enriched group showed no significant differences in body composition , bone mass , or bone density from peers consuming an average of 728 mg of calcium",
"The aim of our longitudinal study was to evaluate bone mass in girls affected by central precocious puberty ( CPP ) that have reached final height , treated with GnRH agonist triptorelin ( GnRHa ) , with or without calcium supplementation . We studied 48 Caucasian females affected by CPP ( age at diagnosis , 7.19 + /- 0.96 yr ) , r and omly assigned to two groups : group A ( n = 21 ) treated with GnRHa and group B ( n = 27 ) treated with GnRHa plus calcium gluconolactate and carbonate ( 1 g calcium/day in two doses ) for at least 2 yr . Auxological parameters ( st and ing height , weight , body mass index ) and bone mineral density ( BMD ) at the lumbar spine [ L2-L4 , anteroposterior (AP)-BMD ; lateral BMD ; volumetric (v)BMD ) ] by dual-energy x-ray absorptiometry were evaluated at the beginning [ chronological age ( CA ) , 7.29 + /- 0.91 yr ; bone age ( BA ) , 8.80 + /- 1.24 yr ] and end of treatment ( CA , 11.27 + /- 0.97 yr ; BA , 12.35 + /- 0.43 yr ) and at final height ( CA , 16.17 + /- 1.9 yr ; BA , 16.93 + /- 0.98 yr , in each case > 15 yr ) . Total bone mineral content , total BMD , and fat percentage were evaluated at the end of the study period using dual-energy x-ray absorptiometry . Final height was significantly higher than predicted height at diagnosis ( 159.9 + /- 6.3 cm vs. 152.9 + /- 9.6 cm ; P Body mass index and fat percentage were not statistically different from control values . Densitometric values at final evaluation in groups A and B together were lower than in controls , but the differences were not statistically significant . The vBMD was significantly higher in group B than in group A at the end of treatment period ( 0.213 + /- 0.022 g/cm(3 ) vs. 0.192 + /- 0.021 g/cm(3 ) ; P change ( Delta% ) between the start and end of treatment period in AP-BMD and vBMD was significantly higher in group B than in group A ( Delta% AP-BMD : 20.36 % + /- 1.10 % vs. 16.16 % + /- 1.90 % , P vBMD : 19.08 % + /- 3.52 % vs. 9.26 % + /- 5.15 % ; P AP-BMD : 61.23 % + /- 1.61 % vs. 56.97 % + /- 1.45 % , P vBMD : 36.69 % + /- 5.01 % vs. 28.01 % + /- 5.76 % , P all our females with CPP treated with GnRHa , bone densitometric parameters were in the normal range for age and sex . However , bone mass achievement seemed to be better preserved in the group of patients supplemented with calcium",
"Abstract Objectives : To investigate the effect of milk supplementation on total body bone mineral acquisition in adolescent girls . Design : 18 month , open r and omised intervention trial . Subjects : 82 white girls aged 12.2 ( SD 0.3 ) years , recruited from four secondary schools in Sheffield . Intervention : 568 ml ( one pint ) of whole or reduced fat milk per day for 18 months . Main outcome measures : Total body bone mineral content and bone mineral density measured by dual energy x ray absorptiometry . Outcome measures to evaluate mechanism included biochemical markers of bone turnover ( osteocalcin , bone alkaline phosphatase , deoxypyridinoline , N-telopeptide of type I collagen ) , and hormones important to skeletal growth ( parathyroid hormone , oestradiol , insulin-like growth factor I ) . Results : 80 subjects completed the trial . Daily milk intake at baseline averaged 150 ml in both groups . The intervention group consumed , on average , an additional 300 ml a day throughout the trial . Compared with the control group , the intervention group had greater increases of bone mineral density ( 9.6 % v 8.5 % , P=0.017 ; repeated measures analysis of variance ) and bone mineral content ( 27.0 % v 24.1 % , P=0.009 ) . No significant differences in increments in height , weight , lean body mass , and fat mass were observed between the groups . Bone turnover was not affected by milk supplementation . Serum concentrations of insulin-like growth factor I increased in the milk group compared with the control group ( 35 % v 25 % , P=0.02 ) . Conclusion : Increased milk consumption significantly enhances bone mineral acquisition in adolescent girls and could favourably modify attainment of peak bone mass . Key messages Osteoporosis is a major public health problem ; 40 % of women will sustain an osteoporotic fracture Maximising peak bone mass at skeletal maturity may be one of the most important protective measures against fracture in later life Adolescence is a critical time for bone mineral acquisition An increase in milk consumption among adolescent girls result ed in significant gains in bone mineral over an 18 month period This simple intervention indicates that increased milk consumption may be associated with higher peak bone",
"OBJECTIVE To study the effect of calcium supplementation with dairy products on the bone and body composition of pubertal girls . DESIGN R and omized control study with 12-month follow-up . SETTING General community . SUBJECTS Forty-eight white girls whose mean age was 11 years and sexual development at Tanner stage 2 . INTERVENTION One group 's diet was supplemented with dairy products to the recommended dietary allowance of 1200 mg calcium daily . The other group ate their usual diet . MAIN OUTCOME MEASURES Bone mineral content and density were measured at the radius , femoral neck , lumbar spine , and total body bone mineral by single-photon and dual-energy x-ray absorptiometry at the start of the study and after 3 , 6 , 9 , and 12 months . Body composition ( lean body mass and body fat ) was measured by dual-energy x-ray absorptiometry at the same intervals . Serum calcium , phosphate , 25-hydroxyvitamin D , 1,25-dihydroxyvitamin D , alkaline phosphatase , magnesium , and albumin concentrations were determined at the start and end of the study . The urinary calcium/creatinine ratio and hydroxyproline concentration were also determined . RESULTS The dairy group had higher intakes of calcium , phosphate , vitamin D , and protein than control subjects . The dairy group had significantly greater increases during the 1-year study in bone mineral density at the lumbar spine bones ( 22.8 % + /- 6.9 % vs 12.9 % + /- 8.3 % ) and in total body bone mineral ( 14.2 % + /- 7.0 % vs 7.6 % + /- 6.0 % ) than control subjects . Dietary calcium , phosphate , vitamin D , and protein intakes were associated with the lumbar bone density and total body bone calcium . There were no differences in serum or urinary biochemical values between the two groups at the start or end of the study . CONCLUSIONS Young girls whose dietary calcium intake was provided primarily by dairy products at or above the recommended dietary allowances had an increased rate of bone mineralization . Increased intake of dairy foods did not increase overall total or saturated fat intake and was not associated with excessive weight gain or increased body fat",
"Summary Background Bone mineral density ( BMD ) is largely genetically determined and this influence is most powerful in the period of rapid skeletal development in childhood and late adolescence but environmental factors such as exercise and dietary calcium intake may influence up to 20 % . Aims of the study The aims of the study were to examine healthy late adolescent females for the effects and benefits of a high calcium intake from dairy product foods on bone mineral density , body composition , lipids and biochemistry . The secondary aim is determine whether a high intake of dairy product foods in the diet is acceptable for this age group long term . Methods Ninety-one teenage girls who participated in a two-year r and omised controlled study on the effect of dairy food supplementation on dietary patterns , body composition and bone density in post-pubertal teenage girls were approached one year after the cessation of the study to determine the effects of the cessation of dairy supplements on bone mineral density , dietary habits , biochemical markers , body composition and blood lipids . Bone mineral density and bone mineral content were assessed at the hip , spine and total body . Anthropometric data were collected , and exercise , Tanner , dietary assessment , preference and compliance question naires were administered . Lipid profiles , hydroxyproline excretion and urinary calcium and sodium excretion measurements were performed . Results There were no significant differences between the 2 groups for height , weight , lean and fat mass . The supplemented group had significantly higher calcium , phosphorus and protein intake during the supplementation period ( p exercise level , preference or acceptability of dairy products or in the lipids and bone markers between baseline the end of supplementation and 1 year follow-up . There was a significant increase in trochanter ( 4.6 % ) , lumbar spine ( 1.5 % ) and femoral neck ( 4.8 % ) BMD ( p in bone mineral content at the trochanter ( p lumbar spine ; however the latter was not statistically significant , in the high calcium group at the end of supplementation . There was no difference in vertebral height or width at any stage of the study , indicating no influence on bone size . Conclusions In this 3 year study ( 2 years of supplementation , 1 year follow-up ) , teenage girls , aged 15–18 years , were able to significantly increase their BMD at the trochanter , femoral neck and lumbar spine when supplemented with dairy product foods to a mean calcium intake of 1160 mg/d . There was also an effect seen on the BMC particularly at the trochanter and to a lesser extent at the lumbar spine . The dietary calcium intake achieved did not adversely affect body weight , fat and lean mass or blood lipid profiles . Twelve months after the supplementation finished the girls had returned to their baseline diet , indicating self- selection of a high dairy product diet may be hard to achieve",
"Both late menarcheal age and low calcium intake ( Ca intake ) during growth are risk factors for osteoporosis , probably by impairing peak bone mass . We investigated whether lasting gain in areal bone mineral density ( aBMD ) in response to increased Ca intake varies according to menarcheal age and , conversely , whether Ca intake could influence menarcheal age . In an initial study , 144 prepubertal girls were r and omized in a double-blind controlled trial to receive either a Ca supplement ( Ca-suppl . ) of 850 mg/d or placebo from age 7.9 - 8.9 yr . Mean aBMD gain determined by dual energy x-ray absorptiometry at six sites ( radius metaphysis , radius diaphysis , femoral neck , trochanter , femoral diaphysis , and L2-L4 ) was significantly ( P = 0.004 ) greater in the Ca-suppl . than in the placebo group ( 27 vs. 21 mg/cm(2 ) ) . In 122 girls followed up , menarcheal age was recorded , and aBMD was determined at 16.4 yr of age . Menarcheal age was lower in the Ca-suppl . than in the placebo group ( P = 0.048 ) . Menarcheal age and Ca intake were negatively correlated ( r = -0.35 ; P aBMD gains from age 7.9 - 16.4 yr and menarcheal age at all skeletal sites ( range : r = -0.41 to r = -0.22 ; P Ca-suppl . on the mean aBMD gain from baseline remained significantly greater in girls below , but not in those above , the median of menarcheal age ( 13.0 yr ) . Early menarcheal age ( 12.1 + /- 0.5 yr ) : placebo , 286 + /- 36 mg/cm(2 ) ; Ca-suppl . , 317 + /- 46 ( P = 0.009 ) ; late menarcheal age ( 13.9 + /- 0.5 yr ) : placebo , 284 + /- 58 ; Ca-suppl . , 276 + /- 50 ( P > 0.05 ) . The level of Ca intake during prepuberty may influence the timing of menarche , which , in turn , could influence long-term bone mass gain in response to Ca supplementation . Thus , both determinants of early menarcheal age and high Ca intake may positively interact on bone mineral mass accrual",
"Calcium intake is one of the most important predictors of the amount of bone mass gained during growth . Therefore , this study was design ed to estimate the dietary calcium intake of Costa Rican urban and rural adolescents ages 13 - 18 years old . Calcium dietary intake was determined using prospect i ve 3-d diet records . Two-thirds ( or 66.7 % ) or less of the Adequate Intake ( AI ) was used as the criterion for inadequate calcium intake as suggested by several authors . Reported mean daily calcium intake was 573 mg + /- 290 . On average 82 % of the adolescents did not meet two-thirds of the Al for calcium . A higher percentage of rural than urban youngsters reported inadequate calcium intake ( 92 % and 75 % respectively , p = 0.000 ) . Likewise a higher percentage of girls ( 91 % ) than boys ( 77 % ) reported marginal calcium intake . This study shows evidence that nutritional interventions and educational strategies are urgent for increasing calcium consumption among adolescents in order to reduce the future burden of osteoporosis in old age",
"BACKGROUND Increased dietary intake of calcium during childhood , usually as calcium in milk , is associated with increased bone mass in adulthood ; the increase in mass is important in modifying the later risk of fracture . Whether the increase is due to the calcium content of milk , however , is not certain . METHODS We conducted a three-year , double-blind , placebo-controlled trial of the effect of calcium supplementation ( 1000 mg of calcium citrate malate per day ) on bone mineral density in 70 pairs of identical twins ( mean [ + /- SD ] age , 10 + /- 2 years ; range , 6 to 14 ) . In each pair , one twin served as a control for the other ; 45 pairs completed the study . Bone mineral density was measured by photon absorptiometry at two sites in the radius ( at base line , six months , and one , two , and three years ) and at three sites in the hip and in the spine ( at base line and three years ) . RESULTS The mean daily calcium intake of the twins given placebo was 908 mg , and that of the twins given calcium supplements was 1612 mg ( 894 mg from the diet and 718 mg from the supplement ) . Among the 22 twin pairs who were prepubertal throughout the study , the twins given supplements had significantly greater increases in bone mineral density at both radial sites ( mean difference in the increase in bone mineral density : midshaft radius , 5.1 percent [ 95 percent confidence interval , 1.5 to 8.7 percent ] ; distal radius , 3.8 percent [ 95 percent confidence interval , 1.4 to 6.2 percent ] ) and in the lumbar spine ( increase , 2.8 percent [ 95 percent confidence interval , 1.1 to 4.5 percent ] ) after three years ; the differences in the increases at two of three femoral sites approached significance ( Ward 's triangle in the femoral neck , 2.9 percent ; greater trochanter , 3.5 percent ) . Among the 23 pairs who went through puberty or were postpubertal , the twins given supplements received no benefit . CONCLUSIONS In prepubertal children whose average dietary intake of calcium approximated the recommended dietary allowance , calcium supplementation increased the rate of increase in bone mineral density . If the gain persists , peak bone density should be increased and the risk of fracture reduced",
"* The up date s are underlined for quick reference . INTRODUCTION A critical need exists for efficient , measurable systems of disease management that reconcile conflicts between socioeconomic responsibility and patient welfare . Clinical guidelines have become an important component of these systems because they address elements of care that are effective and that reduce the variability in our approach to patient management . The American Association of Clinical Endo-crinologists ( AACE ) 2001 Medical Guidelines for Clinical Practice for the Prevention and Management of Postmenopausal Osteoporosis address the prevention , diagnosis , and management of postmenopausal osteoporo-sis , a disorder that is recognized as a major public health problem because of its physical and socioeconomic consequences . They are intended to simplify medical decision making and to help physicians and their patients make good decisions about skeletal health and postmenopausal osteoporosis . The specific goals of these guidelines are to reduce the incidence of fractures related to osteoporosis and to achieve the highest quality of life for individual patients by using the most effective and efficient methods of diagnosis and management . In the preparation of this 2001 edition , reports in the peer- review ed literature dealing with prevention , diagnosis , and treatment of postmenopausal osteoporosis , which were published and indexed between 1996 ( the publication date of the previous edition of these guidelines ) and January 2001 , were identified by computer search , review ed , and grade d for clinical relevance and scientific merit . Although cost-effectiveness was carefully considered , variabilities in actual costs could not be accurately determined . Therefore , cost-effectiveness modeling was not undertaken . Whenever possible , recommendations were based on r and omized , prospect i ve , double-blind studies of well-defined patient population s. Studies that used the most relevant clinical endpoint , fracturing , were considered \" level 1 \" evidence . When level 1 evidence was not available , recommendations were based on cross-sectional studies , investigations that tested smaller or nonr and omized patient population s , or studies that tested secondary or surrogate clinical endpoints for fracture , such as bone mineral density ( BMD ) or bone turnover markers , in treated population s ( level 2 evidence ) . When stronger evidence was not available , review s , editorials , and expert opinions were used ( level 3 evidence ) . We recognize that the process of developing clinical guidelines necessarily results in a narrowing and codifica-tion of clinical choices , which can be inappropriate in some clinical situations . Because the application of objective information to the specific needs of patients is the ultimate responsibility of the practicing physician , clinical practice guidelines are not intended to be rigid or restrictive , nor",
"Purpose . This study evaluated whether a combined behavioral and dietary intervention would affect young women 's calcium intake and bone mineral content ( BMC ) . Design . The design was a two by three mixed design with one between-subjects factor ( treatment vs. control ) and one within-subjects factor ( time — baseline , 3-month , and 6-month ) . Setting . The study was conducted in a university setting in Memphis , Tennessee . Participants . A total of 80 premenopausal women ( ages 18 to 30 ) with low baseline calcium intake ( were included in the analyses . There were 40 women in the treatment group and 40 women in the control group . Measures . Hertzler and Frary 's rapid assessment question naire was employed to evaluate calcium intake , and dual-energy x-ray absorptiometry ( DEXA ) was employed to assess BMC . Results . Repeated measures analysis of variance ( RM ANOVA ) was employed to analyze results . Results indicated that women in the treatment group made greater increases in total calcium intake and supplemental calcium than women in the control group and that all women made significant increases in dietary calcium intake . Additionally , analyses of BMC revealed that women in the treatment group did not experience significant changes in total BMC , and women in the control group experienced significant losses in total BMC . Conclusions . In the current study , women were losing BMC , and the women who made the largest increases in calcium intake were able to retard this bone loss . There is increasing evidence that dietary calcium intake in young people is extremely low , and the results of the current study highlight the need for much more intensive evaluations investigating the factors that are positively associated with premenopausal bone mineral change"
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Aim Exercise is one of the most important components in frailty prevention and treatment . Therefore , we systematic ally review ed the effect of resistance training ( RT ) alone or combined with multimodal exercise intervention on muscle hypertrophy , maximal strength , power output , functional performance , and falls incidence in physically frail elderly . Methods MEDLINE , Cochrane CENTRAL , PEDro , and SPORTD iscus data bases were search ed from 2005 to 2017 . Studies must have mentioned the effects of RT ( i.e. , included or not in multimodal training ) on at least one of the following parameters : muscle mass , muscle strength , muscle power , functional capacity , and risk of falls in frail elderly . Results The initial search identified 371 studies and 16 were used for qualitative analysis for describing the effect of strength training performed alone or in a multimodal exercise intervention . We observed that RT alone or in a multimodal training may induce increases of 6.6–37 % in maximal strength ; 3.4–7.5 % in muscle mass , 8.2 % in muscle power , 4.7–58.1 % in functional capacity and risk of falls , although some studies did not show enhancements . Conclusion Frequency of 1–6 sessions per week , training volume of 1–3 sets of 6–15 repetitions and intensity of 30–70%1-RM promoted significant enhancements on muscle strength , muscle power , and functional outcomes . Therefore , in agreement with previous studies , we suggest that supervised and controlled RT represents an effective intervention in frailty treatment
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"The aims of this r and omised controlled trial were to determine if a high-intensity functional exercise program improves balance , gait ability , and lower-limb strength in older persons dependent in activities of daily living and if an intake of protein-enriched energy supplement immediately after the exercises increases the effects of the training . One hundred and ninety-one older persons dependent in activities of daily living , living in residential care facilities , and with a Mini-Mental State Examination ( MMSE ) score of ? 10 participated . They were r and omised to a high-intensity functional exercise program or a control activity , which included 29 sessions over 3 months , as well as to protein-enriched energy supplement or placebo . Berg Balance Scale , self-paced and maximum gait speed , and one-repetition maximum in lower-limb strength were followed-up at three and six months and analysed by 2 x 2 factorial ANCOVA , using the intention-to-treat principle . At three months , the exercise group had improved significantly in self-paced gait speed compared with the control group ( mean difference 0.04 m/s , p = 0.02 ) . At six months , there were significant improvements favouring the exercise group for Berg Balance Scale ( 1.9 points , p = 0.05 ) , self-paced gait speed ( 0.05 m/s , p = 0.009 ) , and lower-limb strength ( 10.8 kg , p = 0.03 ) . No interaction effects were seen between the exercise and nutrition interventions . In conclusion , a high-intensity functional exercise program has positive long-term effects in balance , gait ability , and lower-limb strength for older persons dependent in activities of daily living . An intake of protein-enriched energy supplement immediately after the exercises does not appear to increase the effects of the training",
"Background and aim Physical frailty has been regarded as a precursor state to disability and dependence on others for daily activities . Frail individuals are considered to be the group of patients that presents the most complex and challenging problems to health care professionals . The purpose of this study was to evaluate whether a 12-week functional circuit training program ( FCT ) could reduce self-reported fear of falling and improve health status in a group of physically frail community-dwelling older individuals . Methods Fifty-one individuals ( 31 F , 20 M ) , mean age ( SD ) 84 ( 2.9 ) years old , were considered frail and tested at week 0 and r and omly assigned into two groups ( intervention group , FCT = 26 ; control group , CG = 25 ) . FCT underwent a structured 12-week FCT program , which focused on a combination of functional balance and lower-body strength-based exercises . CG met once a week for health education meetings . Measures of self-reported fear of falling ( Activities-specific Balance Confidence scale ) and health status ( SF-12 ) were assessed at week 0 , 12 and 36 . All longitudinal analyses for continuous variables that were measured at the three time points ( week 0 , 12 and 36 ) were performed using linear mixed modeling . Results FCT participants had greater improvements than those in the CG in fear of falling and self-reported physical function , physical composite score and mental composite score ; these improvements were maintained in the week 36 follow-up , with significant group-by-time interactions by the end of the study . Conclusions These data indicate that a FCT program is effective in improving self-reported measures of fear of falling and health status in a group of physically frail individuals",
"Background Older adults have the highest rates of disability , functional dependence and use of healthcare re sources . Training interventions for older individuals are of special interest where regular physical activity ( PA ) has many health benefits . The main purpose of this study was to assess the immediate and long-term effects of a 6-month multimodal training intervention ( MTI ) on functional fitness in old adults . Methods For this study , 117 participants , 71 to 90 years old , were r and omized in immediate intervention group and a control group ( delayed intervention group ) . The intervention consisted of daily endurance and twice-a-week strength training . The method was based on a r and omized-controlled cross-over design . Short Physical Performance Battery ( SPPB ) , 8 foot up- and -go test , strength performance , six min walking test ( 6 MW ) , physical activity , BMI and quality of life were obtained at baseline , after a 6-month intervention- and control phase , again after 6-month crossover- and delayed intervention phase , and after anadditional 6-month follow-up . Results After 6 months of MTI , the intervention group improved in physical performance compared with the control group via Short Physical Performance Battery ( SPPB ) score ( mean diff = 0.6 , 95 % CI : 0.1 , 1.0 ) and 8-foot up- and -go test ( mean diff = −1.0 s , 95 % CI : -1.5 , -0.6 ) , and in endurance performance via 6-minute walking test ( 6 MW ) ( mean diff = 44.2 meters , 95 % CI : 17.1 , 71.2 ) . In strength performance via knee extension the intervention group improved while control group declined ( mean diff = 55.0 Newton , 95 % CI : 28.4 , 81.7 ) , and also in PA ( mean diff = 125.9 cpm , 95 % CI : 96.0 , 155.8 ) . Long-term effects of MTI on the particpants was assesed by estimating the mean difference in the variables measured between time-point 1 and 4 : SPPB ( 1.1 points , 95 % CI : 0.8 , 1.4 ) ; 8-foot up- and -go ( −0.9 s , 95 % CI : -1.2 , -0.6 ) ; 6 MW ( 18.7 m , 95 % CI : 6.5 , 31.0 ) ; knee extension ( 4.2 Newton , 95 % CI : -10.0 , 18.3 ) ; h and grip ( 6.7 Newton , 95 % CI : -4.4 , 17.8 ) ; PA ( −4.0 cpm , 95 % CI : -33.9 , 26.0 ) ; BMI ( −0.6 kg/m2 , 95 % CI : -0.9 , -0.3 ) and Icel and ic quality of life ( 0.3 points , 95 % CI : -0.7 , 1.4 ) . Conclusions Our results suggest that regular MTI can improve and prevent decline in functional fitness in older individuals , influence their lifestyle and positively affect their ability to stay independent , thus reducing the need for institutional care . Trial registration This study was approved by the National Bioethics Committee in Icel and , VSNb20080300114/03 -",
"Background and aims : The most common cause of accidental injury and death in people over age 65 results from impacts associated with falling . Balance impaired older adults have poorer balance control than healthy young adults or healthy older adults . Lack of sufficient lower extremity strength and inability to rapidly produce muscle force may contribute to diminished balance control in the elderly . This study evaluated the effect of a 10-week high intensity strength- training program targeting key lower extremity muscles for the purpose of improving postural control in frail older adults . Methods : Thirteen experimental and fourteen control subjects , all balance impaired older adults were evaluated in response to unexpected platform perturbations that simulated slips . Results : Following strength training the experimental group was significantly stronger than the control group . Mean ankle moments improved in the experimental group following strength training during forward sway ( Right : p=0.067 , Left : p=0.009 ) and backward sway ( Right : p=0.031 , Left : p=0.058 ) . For the backward sway condition the ankle rate of torque production increased significantly in the experimental group ( Right : p=0.016 , Left : p=0.031 ) . Conclusions : Enhancement of lower extremity strength contributed to improvements in balance stability demonstrated by greater ankle force production , in response to balance threats",
"Background Although resistance exercise interventions have been shown to be beneficial in prefrail or frail older adults it remains unclear whether there are residual effects when the training is followed by a period of detraining . The aim of this study was to establish the sustainability of a muscle power or muscle strength training effect in prefrail older adults following training and detraining . Methods 69 prefrail community-dwelling older adults , aged 65–94 years were r and omly assigned into three groups : muscle strength training ( ST ) , muscle power training ( PT ) or controls . The exercise interventions were performed for 60 minutes , twice a week over 12 weeks . Physical function ( Short Physical Performance Battery = SPPB ) , muscle power ( sit-to-st and transfer = STS ) , self-reported function ( SF-LLFDI ) and appendicular lean mass ( aLM ) were measured at baseline and at 12 , 24 and 36 weeks after the start of the intervention . Results For the SPPB , significant intervention effects were found at 12 weeks in both exercise groups ( ST : p = 0.0047 ; PT : p = 0.0043 ) . There were no statistically significant effects at 24 and 36 weeks . In the ST group , the SPPB declined continuously after stop of exercising whereas the PT group and controls remained unchanged . No effects were found for muscle power , SF-LLFDI and aLM . Conclusions The results showed that both intervention types are equally effective at 12 weeks but did not result in statistically significant residual effects when the training is followed by a period of detraining . The unchanged SPPB score at 24 and 36 weeks in the PT group indicates that muscle power training might be more beneficial than muscle strength training . However , more research is needed on the residual effects of both interventions . Taken the drop-out rates ( PT : 33 % , ST : 21 % ) into account , muscle power training should also be used more carefully in prefrail older adults . Trial registration This trial has been registered with clinical trials.gov ( NCT00783159",
"This r and omized controlled trial examined the effects of multicomponent training on muscle power output , muscle mass , and muscle tissue attenuation ; the risk of falls ; and functional outcomes in frail nonagenarians . Twenty-four elderly ( 91.9 ± 4.1 years old ) were r and omized into intervention or control group . The intervention group performed a twice-weekly , 12-week multicomponent exercise program composed of muscle power training ( 8–10 repetitions , 40–60 % of the one-repetition maximum ) combined with balance and gait retraining . Strength and power tests were performed on the upper and lower limbs . Gait velocity was assessed using the 5-m habitual gait and the time-up- and -go ( TUG ) tests with and without dual-task performance . Balance was assessed using the FICSIT-4 tests . The ability to rise from a chair test was assessed , and data on the incidence and risk of falls were assessed using question naires . Functional status was assessed before measurements with the Barthel Index . Midthigh lower extremity muscle mass and muscle fat infiltration were assessed using computed tomography . The intervention group showed significantly improved TUG with single and dual tasks , rise from a chair and balance performance ( P and a reduced incidence of falls . In addition , the intervention group showed enhanced muscle power and strength ( P the total and high-density muscle cross-sectional area in the intervention group . The control group significantly reduced strength and functional outcomes . Routine multicomponent exercise intervention should be prescribed to nonagenarians because overall physical outcomes are improved in this population",
"This systematic review examines the effectiveness of current exercise interventions for the management of frailty . Eight electronic data bases were search ed for r and omized controlled trials that identified their participants as “ frail ” either in the title , abstract , and /or text and included exercise as an independent component of the intervention . Three of the 47 included studies utilized a vali date d definition of frailty to categorize participants . Emerging evidence suggests that exercise has a positive impact on some physical determinants and on all functional ability outcomes reported in this systematic review . Exercise programs that optimize the health of frail older adults seem to be different from those recommended for healthy older adults . There was a paucity of evidence to characterize the most beneficial exercise program for this population . However , multicomponent training interventions , of long duration ( ≥5 months ) , performed three times per week , for 30–45 minutes per session , generally had superior outcomes than other exercise programs . In conclusion , structured exercise training seems to have a positive impact on frail older adults and may be used for the management of frailty",
"Objective To investigate the combined and separate effects of exercise and milk fat globule membrane ( MFGM ) supplementation on frailty , physical function , physical activity level , and hematological parameters in community-dwelling elderly Japanese women . Methods A total of 131 frail , elderly women over 75 years were r and omly assigned to one of four groups : exercise and MFGM supplementation ( Ex+MFGM ) , exercise and placebo ( Ex+Plac ) , MFGM supplementation , or the placebo group . The exercise group attended a 60-minute training program twice a week for three months , and the MFGM group ingested 1 g of the MFGM supplement in pill form , daily for 3 months . The primary outcome measure was change in frailty status based on Fried ’s frailty phenotype . Secondary outcome measures included body composition , physical function and hematological parameters , and interview survey components assessing lifestyle factors . Participants were followed for 4 months post-intervention . Results Significant group × time interactions were observed for usual walking speed ( P = 0.005 ) , timed up & go ( P insulin-like growth factor-binding protein 3 / insulin-like growth factor 1 ratio ( P = 0.013 ) . The frailty components revealed that weight loss , exhaustion , low physical activity , and slow walking speed were reversed , but low muscle strength did not significantly changed . Frailty reversal rate was significantly higher in the Ex+MFGM ( 57.6 % ) than in the MFGM ( 28.1 % ) or placebo ( 30.3 % ) groups at post-intervention ( χ2 = 8.827 , P = 0.032 ) , and at the follow-up was also significantly greater in the Ex+MFGM ( 45.5 % ) and Ex+Plac ( 39.4 % ) groups compared with the placebo ( 15.2 % ) group ( χ2 = 8.607 , P = 0.035 ) . The exercise+MFGM group had the highest odds ratio ( OR ) for frailty reversal at post-intervention and follow-up ( OR = 3.12 , 95 % confidence interval ( CI ) = 1.13–8.60 ; and OR = 4.67 , 95 % CI = 1.45–15.08 , respectively ) . Conclusion This study suggests that interventions including exercise and nutrition can improve frailty status . Statistically significant additive effects of MFGM with exercise could not be confirmed in this population , and further investigation in larger sample s is necessary . Trial Registration The Japan Medical Association Clinical Trial Registry",
"Background Falling can lead to severe health issues in the elderly and importantly contributes to morbidity , death , immobility , hospitalization , and early entry to long-term care facilities . The aim of this study was to devise a recurrent fall prevention program for elderly women in rural areas . Material / Methods This study adopted an assessor-blinded , r and omized , controlled trial methodology . Subjects were enrolled in a 12-week recurrent fall prevention program , which comprised strength training , balance training , and patient education . Muscle strength and endurance of the ankles and the lower extremities , static balance , dynamic balance , depression , compliance with preventive behavior related to falls , fear of falling , and fall self-efficacy at baseline and immediately after the program were assessed . Sixty-two subjects ( mean age 69.2±4.3 years old ) completed the program – 31 subjects in the experimental group and 31 subjects in the control group . Results When the results of the program in the 2 groups were compared , significant differences were found in ankle heel rise test , lower extremity heel rise test , dynamic balance , depression , compliance with fall preventative behavior , fear of falling , and fall self-efficacy ( p improves muscle strength and endurance , balance , and psychological aspects in elderly women with a fall history",
"OBJECTIVES To evaluate the effectiveness of exercise and amino acid supplementation in enhancing muscle mass and strength in community-dwelling elderly sarcopenic women . DESIGN R and omized controlled trial . SETTING Urban community in Tokyo , Japan . PARTICIPANTS One hundred fifty-five women aged 75 and older were defined as sarcopenic and r and omly assigned to one of four groups : exercise and amino acid supplementation ( exercise + AAS ; n = 38 ) , exercise ( n = 39 ) , amino acid supplementation ( AAS ; n = 39 ) , or health education ( HE ; n = 39 ) . INTERVENTION The exercise group attended a 60-minute comprehensive training program twice a week , and the AAS group ingested 3 g of a leucine-rich essential amino acid mixture twice a day for 3 months . MEASUREMENTS Body composition was determined using bioelectrical impedance analysis . Data from interviews and functional fitness parameters such as muscle strength and walking ability were collected at baseline and after the 3-month intervention . RESULTS A significant group × time interaction was seen in leg muscle mass ( P = .007 ) , usual walking speed ( P = .007 ) , and knee extension strength ( P = .017 ) . The within-group analysis showed that walking speed significantly increased in all three intervention groups , leg muscle mass in the exercise + AAS and exercise groups , and knee extension strength only in the exercise + AAS group ( 9.3 % increase , P = .01 ) . The odds ratio for leg muscle mass and knee extension strength improvement was more than four times as great in the exercise + AAS group ( odds ratio = 4.89 , 95 % confidence interval = 1.89 - 11.27 ) as in the HE group . CONCLUSION The data suggest that exercise and AAS together may be effective in enhancing not only muscle strength , but also combined variables of muscle mass and walking speed and of muscle mass and strength in sarcopenic women",
"OBJECTIVES To assess the effects of an 8-week exercise training program with a special focus on light- to moderate-intensity resistance exercises ( 30 - 70 % of one repetition maximum , 1RM ) and a subsequent 4-week training cessation period ( detraining ) on muscle strength and functional capacity in participants aged 90 and older . DESIGN R and omized controlled trial performed during March to September 2009 . SETTING Geriatric nursing home . PARTICIPANTS Forty nonagenarians ( 90 - 97 ) were r and omly assigned to an intervention or control group ( 16 women and 4 men per group ) . INTERVENTION Eight-week muscle strength exercise intervention focused on lower limb strength exercises of light to moderate intensity . MEASUREMENTS PRIMARY OUTCOME 1RM leg press . SECONDARY OUTCOMES h and grip strength , 8-m walk test , 4-step stairs test , Timed Up and Go test , and number of falls . RESULTS A significant group by time interaction effect ( P=.02 ) was observed only for the 1RM leg press . In the intervention group , 1RM leg press increased significantly with training by 10.6 kg [ 95 % confidence interval (CI)=4.1 - 17.1 kg ; P=.01 ] . Except for the mean group number of falls , which were 1.2 falls fewer per participant in the intervention group ( 95 % CI=0.0 - 3.0 ; P=.03 ) , no significant training effect on the secondary outcome measures was found . CONCLUSION Exercise training , even of short duration and light to moderate intensity , can increase muscle strength while decreasing fall risk in nonagenarians",
"The purpose of this study was to evaluate whether a 12-wk functional circuit-training program ( FCT ) could alter markers of physical frailty in a group of frail community-dwelling adults . Fifty-one individuals ( 31 women , 20 men ) , mean age ( ± SD ) 84 ( ± 2.9 ) yr , met frailty criteria and were r and omly assigned into groups ( FCT = 26 , control group [ CG ] = 25 ) . FCT underwent a 12-wk exercise program . CG met once a week for health education meetings . Measures of physical frailty , function , strength , balance , and gait speed were assessed at Weeks 0 , 12 , and 36 . Physical-frailty measures in FCT showed significant ( p .05 ) improvements relative to those in CG ( Barthel Index at Weeks 0 and 36 : 73.41 ( ± 2.35 ) and 77.0 ( ± 2.38 ) for the FCT and 70.79 ( ± 2.53 ) and 66.73 ( ± 2.73 ) for the CG . These data indicate that an FCT program is effective in improving measures of function and reducing physical frailty among frail older adults"
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Background Cardiac rehabilitation is offered to individuals after cardiac events to aid recovery and reduce the likelihood of further cardiac illness . However , patient participation remains suboptimal and the provision of high quality care to an exp and ing population of patients with chronic heart conditions is becoming increasingly difficult . A systematic review and meta- analysis was conducted to determine the effect of telephone support interventions compared with st and ard post-discharge care on coronary artery disease patient outcomes . Methods The Cochrane Library , MEDLINE , EMBASE , and CINAHL were search ed and r and omized controlled trials that directly compared telephone interventions with st and ard post-discharge care in adults following a myocardial infa rct ion or a revascularization procedure were included . Study selection , data extraction and quality assessment were completed independently by two review ers . Where appropriate , outcome data were combined and analyzed using a r and om effects model . For each dichotomous outcome , odds ratios ( OR ) and 95 % confidence intervals ( CI ) were derived for each outcome . For continuous outcomes , weighted mean differences ( WMD ) and st and ardized mean differences ( SMD ) and 95 % CI were calculated . Results 26 studies met the inclusion criteria . No difference was observed in mortality between the telephone group and the group receiving st and ard care OR 1.12 ( 0.71 , 1.77 ) . The intervention was significantly associated with fewer hospitalizations than the comparison group OR 0.62 ( 0.40 , 0.97 ) . Significantly more participants in the telephone group stopped smoking OR 1.32 ( 1.07 , 1.62 ) ; had lower systolic blood pressure WMD −0.22 ( −0.40 , −0.04 ) ; lower depression scores SMD −0.10 ( −0.21 , −0.00 ) ; and lower anxiety scores SMD −0.14 ( −0.24 , −0.04 ) . However , no significant difference was observed for low-density lipoprotein levels WMD −0.10 ( −0.23 , 0.03 ) . Conclusions Compared to st and ard post-discharge care , regular telephone support interventions may help reduce feelings of anxiety and depression as well as , improve systolic blood pressure control and the likelihood of smoking cessation
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"A r and omized trial of a pharmacist-delivered intervention ( PI ) versus usual care ( UC ) was conducted ; 689 subjects with known coronary heart disease were recruited from cardiac catheterization laboratories . Participants in the PI condition received 5 pharmacist-delivered telephone counseling calls post-hospital discharge . At one year , 65 % in the PI condition and 60 % in the UC condition achieved an LDL-C level mean statin adherence was 0.88 in the PI , and 0.90 in the UC ( P = .51 ) . The highest percentage of those who reached the LDL-C goal were participants who used statins as opposed to those who did not use statins ( 67 % versus 58 % , P = .05 ) . However , only 53 % and 56 % of the patients in the UC and PI conditions , respectively , were using statins . We conclude that a pharmacist-delivered intervention aim ed only at improving patient adherence is unlikely to positively affect outcomes . Efforts must be oriented towards influencing physicians to increase statin prescription rates",
"Objective : To determine if the improved risk factor profile at 1 year attributed to the Choice of Health Options In prevention of Cardiovascular Events ( CHOICE ) program was maintained at 4 years . Design : Single-blind r and omized controlled trial with post-hoc 47 ± 6 months follow-up ( 76 % complete ) . Setting : Australian tertiary referral hospital . Patients : Two hundred and eight acute coronary syndrome survivors . Interventions : Acute coronary syndrome survivors not accessing cardiac rehabilitation ( CR ) were r and omized to control ( n = 72 ) or CHOICE ( n = 72 ) comprising the tailored risk factor reduction packaged as a clinic visit and 3 months phone support . A contemporary CR reference group were also recruited ( n = 64 ) . Blinded risk assessment occurred at baseline , 1 and 4 years . Main outcome measures : Total cholesterol , systolic blood pressure , smoking status , physical activity . Results : One year improvements in all the modifiable risk factors achieved in CHOICE were maintained at 4 years . CHOICE and control were well-matched at baseline . At 4 years , there was a trend towards lower total cholesterol in CHOICE compared with controls ( mean 4.0 ± 0.1 vs. 4.2 ± 0.1 mmol/l , P = 0.05 ) , significantly better systolic blood pressure ( mean 132.2 ± 2.1 vs. 136.8 ± 2.0 mmHg , P = 0.01 ) , physical activity scores ( 1200 ± 209 vs. 968 ± 196 metabolic equivalent min/week , P = 0.02 ) and proportion with three or more risk factors above national targets ( 20 vs. 42 % , P = 0.02 ) . Participants in CHOICE were at higher baseline risk than CR but at 4 years they had similar risk factor profiles . Conclusion : Participants in CHOICE maintained favorable changes in coronary risk profile at 4 years compared with control , indicating that CHOICE is an effective long-term intervention among those not accessing facility-based CR",
"Abstract BACKGROUND : Poor mood adjustment to chronic medical illness is often accompanied by decrements in function . OBJECTIVE : To evaluate the effectiveness of a telephone-based intervention for psychologic distress and functional impairment in cardiac illness . DESIGN : R and omized , controlled trial . METHODS : We recruited survivors of acute coronary syndromes using the Hospital and Anxiety Depression Scale ( HADS ) with scores indicative of mood disturbances at 1-month postdischarge . Recruited patients were r and omized to experimental or control status . Intervention patients received 6 30-minute telephone counseling sessions to identify and address illness-related fears and concerns . Control patients received usual care . Patients ’ responses to the HADS and the Workplace Social Adjustment Scale ( WSAS ) were collected at baseline , 2 , 3 , and 6 months using interactive voice recognition technology . At baseline , the PRIME-MD was used to establish diagnosis of depression . We used mixed effects regression to study changes in outcomes . RESULTS : We enrolled 100 patients . Mean age was 60 ; 67 % of the patients were male . Findings confirmed that the intervention group had a 27 % improvement in depression symptoms ( P=.05 ) , 27 % in anxiety ( P=.02 ) , and a 38 % improvement in home limitations ( P=.04 ) compared with controls . Symptom improvement tracked those for WSAS measures of home function ( P=.04 ) but not workplace function . CONCLUSIONS : The intervention had a moderate effect on patient ’s emotional and functional outcomes that were observed during a critical period in patients ’ lives . Patient convenience , ease of delivery , and the effectiveness of the intervention suggest that the counseling can help patients adjust to chronic illness",
"OBJECTIVE The purpose of this study was to determine the effectiveness of an information and support telephone intervention for reducing anxiety in patients who have undergone coronary artery bypass graft surgery and their partners . DESIGN The study is a r and omized controlled trial . Intervention began at discharge ; 6 telephone calls were made to patients and partners over 7 weeks . Primary outcome was Beck Anxiety Inventory measured at baseline in hospital , at home on day 3 , week 4 , and week 8 . SAMPLE The subjects were 131 patients who have undergone elective coronary artery bypass graft surgery and their partners . RESULTS Patients ' anxiety was moderate to severe the day before discharge . It was significantly lower in the treatment group than in the control group at day 2 at home . Partners always had lower anxiety than patients . A more sustained decrease in anxiety in the partner treatment group was found at both day 2 and week 4 . CONCLUSION Intervention effect is in the early period after discharge-- the time most affected by reduced lengths of stay",
"Background Home-based cardiac rehabilitation ( CR ) has been demonstrated to be as effective as institution-based CR in post-coronary artery bypass graft surgery ( CABG ) patients in terms of short-term physical and psychosocial outcomes . The sustainability of these effects is less well studied . The aim of this study was to examine the sustainability of observed changes in physical , quality of life ( HRQL ) , and social support ( SS ) outcomes in patients 12 months after discharge from a r and omized controlled trial ( RCT ) of 6 months of monitored home-based versus supervised hospital-based CR . Design Two-hundred and twenty-two ( n = 222 ) patients were followed-up 12 months after discharge from a RCT of 6 months of monitored ‘ Home ' versus supervised ‘ Hospital ' CR after CABG . Methods At discharge from the 6-month RCT , participants who consented to the 12-month follow-up study , were given individualized guidelines for ongoing exercise , and were not contacted for 1 year . The primary outcome was peak oxygen uptake ( VO2 ) . Secondary outcomes were : HRQL , SS and habitual physical activity . Results One hundred and ninety-eight patients ( 89.2 % ) , 102 ‘ Hospital ' and 96 ‘ Home ' , returned for follow-up 12-months after discharge from CR . Both groups had similar medical and socio-demographic characteristics . Peak VO2 declined in ‘ Hospital ' but was sustained in ‘ Home ' patients 12 months after discharge from CR ( P=0.002 ) . Physical HRQL was higher in the ‘ Home ' group at the 12-month follow-up ( P Mental HRQL showed general , minor deterioration over time in both groups ( P=0.019 ) . Twelve months after discharge from CR , physical and mental HRQL remained higher than at entry to CR in both groups . ‘ Home ' patients had higher habitual physical activity scores compared to ‘ Hospital ' patients . Conclusions This follow-up study suggests that low-risk patients whose CR is initiated in the home environment may be more likely to sustain positive physical and psychosocial changes over time than patients whose program is initially institution-based",
"The purpose of this trial was to determine the effectiveness of advanced practice nursing support on cardiac surgery patients ’ during the first 5 weeks following hospital discharge . Patients ( N = 200 ) were r and omly allocated to two groups : ( a ) an intervention group who received telephone calls from an advanced practice nurse ( APN ) familiar with their clinical condition and care needs , twice during the first week following discharge then weekly thereafter for 4 weeks , and ( b ) a usual care group . Measures of health-related quality of life ( HRQL ) , symptom distress , satisfaction with recovery care , and unexpected health care contacts were obtained at 5 weeks following discharge . There were no significant group differences in HRQL , unexpected contacts with the health care system , or symptom distress . The provision of APN support via telephone followup after cardiac surgery is feasible . However , further r and omized trials of single and multicomponent APN interventions are needed to prove effectiveness",
"Background Providing information is an important part of st and ard care and treatment for acute myocardial infa rct ion in patients . Evidence exists indicating that acute myocardial infa rct ion patients experience an information gap in the period immediately after discharge from the hospital . The aim of this study was to assess the short-term effects of a nurse-led telephone follow-up intervention to provide information and support to patients with acute myocardial infa rct ion after their discharge from hospital . Design and method A prospect i ve r and omized , controlled trial with a 6-month follow-up was conducted . A total of 288 patients were allocated to either an intervention group ( n = 156 ) or a control group ( n = 132 ) . The latter received routine post-discharge care . The primary endpoint measured at 3 and 6 months after discharge was the health-related quality of life using the 36-item Short Form Health Survey . Secondary endpoints included smoking and exercise habits . Results In both groups , health-related quality of life improved significantly over time on most subscales . A statistically significant difference in favour of the intervention group was found on the 36-item Short Form Health Survey Physical Health Component Summary Scale ( P=0.034 ) after 6 months . No difference was found between the groups on the Mental Health Component Summary Scale . We found a significant difference with respect to frequency of physical activity in favour of the intervention group after 6 months ( P=0.004 ) . More participants in the intervention group than the control group had ceased smoking at the 6-month follow-up ( P=0.055 ) . Conclusion A nurse-led systematic telephone follow-up intervention significantly improved the physical dimension of health-related quality of life in patients in the intervention group compared with usual care patients . Participation in this intervention also seemed to promote health behaviour change in patients after acute myocardial infa rct ion",
"OBJECTIVE The purpose of this study was to test the effect of a post-discharge telephone counseling intervention on women 's psychosocial adjustment following a cardiac event . DESIGN The study was a prospect i ve , r and omized , controlled trial . PATIENTS Women ( n = 196 ) were recruited from 4 hospitals in Sydney , Australia , who were hospitalized for coronary artery disease : myocardial infa rct ion , coronary artery bypass grafts , coronary angioplasty , or stable angina . Women were r and omized to usual care ( n = 103 ) or telephone counseling ( n = 93 ) and were 67 years of age ( range 34 - 92 ) . The majority had not completed high school ( 92 % ) and were not employed ( 84 % ) . OUTCOMES Psychosocial adjustment was measured by the Psychosocial Adjustment to Illness Scale and the Hospital Anxiety and Depression Scale the day before hospital discharge and 12 weeks postdischarge . INTERVENTION Individualized information and support , was design ed to promote self-managed recovery and psychosocial adjustment , and began with an evaluation during admission and was followed up by telephone counseling at 1 , 2 , 3 , and 6 weeks after discharge . RESULTS The intervention had no effect on psychosocial adjustment ( F[1,182 ] = 0.06 , P = .8 ) , anxiety ( F[1,182 ] = 0.15 , P = .69 ) or depression ( F[1,182 ] = 0.11 , P = .74 ) at 12 weeks after discharge . Women made significant improvements during the 12 weeks on mean scores for psychosocial adjustment ( F[1,182 ] = 58.37 , P = .00 ) , anxiety ( F [ 1,182 ] = 74.58 , P = .00 ) and depression ( F[1,182 ] = 14.11 , P = .00 ) . The predictors of poor psychosocial outcomes for women included being less than 55 years of age , being unemployed or retired , having poor psychosocial adjustment to illness at baseline , having readmission , or experiencing a stressful , personal event during follow-up . CONCLUSIONS Women at risk for poor outcomes following hospitalization for a cardiac event can be identified ( ie , women less than 55 years of age , unemployed or retired , poorly adjusted to their cardiac illness , or readmitted to hospital within 12 weeks of a previous cardiac admission ) , but an effective intervention to enhance psychosocial outcomes remains to be established",
"BACKGROUND Disease management programs in which drugs are prescribed by dietitians or nurses have been shown to improve the coronary risk factor profile in patients with coronary heart disease . However , those disease management programs in which drugs are not prescribed by allied health professionals have not improved coronary risk factor status . The objective of the Coaching patients On Achieving Cardiovascular Health ( COACH ) study was to determine whether dietitians or nurses who did not prescribe medications could coach patients with coronary heart disease to work with their physicians to achieve the target levels for their total cholesterol ( TC ) and other risk factors . METHODS Multicenter r and omized controlled trial in which 792 patients from 6 university teaching hospitals underwent a stratified r and omization by cardiac diagnosis within each hospital : 398 were assigned to usual care plus The COACH Program and 394 to usual care alone . Patients in The COACH Program group received regular personal coaching via telephone and mailings to achieve the target levels for their particular coronary risk factors . There was one coach per hospital . The primary outcome was the change in TC ( DeltaTC ) from baseline ( in hospital ) to 6 months after r and omization . Secondary outcomes included measurement of a wide range of physical , nutritional , and psychological factors . The analysis was performed by intention to treat . RESULTS The COACH Program achieved a significantly greater DeltaTC than usual care alone : the mean DeltaTC was 21 mg/dL ( 0.54 mmol/L ) ( 95 % confidence interval [ CI ] , 16 - 25 mg/dL [ 0.42 - 0.65 mmol/L ] ) in The COACH Program vs 7 mg/dL ( 0.18 mmol/L ) ( 95 % CI , 3 - 11 mg/dL [ 0.07 - 0.29 mmol/L ] ) in the usual care group ( P reduction in TC from baseline to 6 months after r and omization was 14 mg/dL ( 0.36 mmol/L ) ( 95 % CI , 8 - 20 mg/dL [ 0.20 - 0.52 mmol/L ] ) greater in The COACH Program group than in the usual care group . Coaching produced substantial improvements in most of the other coronary risk factors and in patient quality of life . CONCLUSIONS Coaching , delivered as The COACH Program , is a highly effective strategy in reducing TC and many other coronary risk factors in patients with coronary heart disease . Coaching has potential effectiveness in the whole area of chronic disease management",
"Objective To compare the long-term effectiveness of hospital versus telephone-monitored home-based exercise training during cardiac rehabilitation ( CR ) on exercise capacity and habitual physical activity . Design Six-year follow-up of patients who participated in a r and omised controlled trial of hospital versus monitored home-based exercise training during CR after coronary artery bypass graft surgery . Setting Outpatient CR centre in Central -South Ontario , Canada . Participants 196 Patients who participated in the original r and omised controlled trial and who attended an evaluation 1 year after CR . Interventions 6 months of home or hospital-based exercise training during CR . Main outcome measures Peak oxygen uptake ( peak Vo2 ) , Physical Activity Scale in the Elderly ( PASE ) to assess habitual activity , semi-structured interviews to assess vital status , demographic and descriptive information . Results Of the 196 eligible patients , 144 ( 75.5 % ; 74 Hospital , 70 Home ) were available for participation . Patients were predominantly male ( n=120 ; 83.3 % ) aged 70±9.5 years . Clinical and sociodemographic outcomes were similar in both groups . While exercise performance declined over time , there were significant between-group differences in peak Vo2 ( 1506±418 ml/min vs 1393±341 ml/min ; p=0.017 ) and PASE scores ( 166.7±90.2 vs 139.7±66.5 ; p=0.001 ) at 6-year follow-up in favour of the home group . Conclusions Home and hospital-based exercise training maintained exercise capacity above pre-CR levels 6 years after CR . Exercise training initiated in the home environment in low-risk patients undergoing coronary artery bypass graft surgery conferred greater long-term benefit on Vo2 and persistent physical activity compared with traditional hospital-based CR ",
"Background Telephone counseling in chronic disease self-management is increasing , but has not been tested in studies that control for quality of medical care . Objective To test the effectiveness of a six-session outpatient telephone-based counseling intervention to improve secondary prevention ( behaviors , medication ) in patients with acute coronary syndrome ( ACS ) following discharge from hospital , and impact on physical functioning and quality of life at 8 months post-discharge . Design Patient-level r and omized trial of hospital quality improvement ( QI-only ) versus quality improvement plus brief telephone coaching in three months post-hospitalization ( QI-plus ) . Data : medical record , state vital records , patient surveys ( baseline , three and eight months post-hospitalization ) . Analysis : pooled-time series generalized estimating equations to analyze repeated measures ; intention-to-treat analysis . Participants Seven hundred and nineteen patients admitted to one of five hospitals in two contiguous mid-Michigan communities enrolled ; 525 completed baseline surveys . Measurements We measured secondary prevention behaviors , physical functioning , and quality of life . Results QI-plus patients showed higher self-reported physical activity ( OR = 1.53 ; p = .01 ) during the first three months , with decline after active intervention was withdrawn . Smoking cessation and medication use were not different at 3 or 8 months ; functional status and quality of life were not different at 8 months . Conclusions Telephone coaching post-hospitalization for ACS was modestly effective in accomplishing short-term , but not long-term life-style behavior change . Previous positive results shown in primary care did not transfer to free-st and ing telephone counseling as an adjunct to care following hospitalization",
"Community studies have demonstrated suboptimal achievement of lipid targets in the management of patients with coronary heart disease ( CHD ) . An effective strategy is required for the application of evidence -based prevention therapy for CHD . The objective of this study was to test coaching as a technique to assist patients in achieving the target cholesterol level of coronary intervention ) to receive either the coaching intervention ( n = 121 ) or usual medical care ( n = 124 ) . The primary outcome measure was fasting serum total cholesterol ( TC ) , serum triglyceride ( TG ) , high-density lipoprotein cholesterol ( HDL-C ) , and calculated low-density lipoprotein cholesterol ( LDL-C ) level , measured at 6 months post-r and omization . At 6 months , the serum TC and LDL-C levels were significantly lower in the coaching intervention group ( n = 107 ) than the usual care group ( n = 112 ) : mean TC ( 95%CI ) 5.00 ( 4.82 - 5.17 ) mmol/L versus 5.54 ( 5.36 - 5.72 ) mmol/L ( P LDL-C ( 95%CI ) 3.11 ( 2.94 - 3.29 ) mmol/L versus 3.57 ( 3.39 - 3.75 ) mmol/L ( P Coaching had no impact on TG or on HDL-C levels . Multivariate analysis showed that being coached ( P coaching intervention is best explained by both adherence to drug therapy and to dietary advice given . Coaching may be an appropriate method to reduce the treatment gap in applying evidence -based medicine to the \" real world .",
"The purpose of this study was to investigate the impact of a supportive-educative telephone program on the levels of knowledge and anxiety of patients undergoing coronary artery bypass graft surgery during the first 6 weeks after hospital discharge . With a posttest-only control group design , the first 74 patients scheduled , between September 1986 and February 1987 , for coronary artery bypass graft surgery in a large , western Canadian teaching hospital were r and omly assigned to either an experimental or a control group . The effect of the intervention , which was implemented by a cardiac rehabilitation nurse specialist , was assessed by a knowledge test and a state anxiety inventory . Data were collected without knowledge of the participants ' group assignment . As hypothesized , data analysis with independent t tests revealed a statistically significant ( p less than 0.05 ) difference between the knowledge level of the experimental and the control group in the areas of coronary artery disease , diet , medications , physical activity restrictions , exercise , and rest . A statistically significant difference between the state anxiety level of the experimental and the control group was also evident , as was a statistically significant inverse relationship between participants ' knowledge and anxiety levels . From these findings , several implication s and recommendations for nursing practice and research have been generated",
"PURPOSE Cardiac rehabilitation ( CR ) is beneficial for those who attend , but alternative models for nonattenders need investigation . We tested the effectiveness of modular prevention on risk factors in survivors of acute coronary syndrome ( ACS ) not accessing CR . METHODS We r and omly allocated ACS survivors not accessing CR to a control group ( n = 72 ) receiving conventional care or modular group ( n = 72 ) who participated in risk factor modules on the basis of patient-centered care and collaborative goal setting to systematic ally lower risk factors . We also recruited a consecutive reference group of ACS survivors participating in CR ( n = 64 ) . Blinded measurements of risk factors and global risk were completed at baseline and 3 months . RESULTS Although well matched for risk factor level and prevalence at baseline , by 3 months , the modular group had significantly reduced risk factor level in comparison with controls for most risk factors including total cholesterol ( 158 ± 3.9 vs 186 ± 3.9 mg/dL , P .001 ) , systolic blood pressure ( 133.5 ± 2.0 vs 144.4 ± 2.4 mm Hg , P .01 ) , body mass index ( 28.9 ± 0.7 vs 31.0 ± 0.7 kg/m2 , P = .02 ) , and physical activity ( 1,187 ± 164 vs 636 ± 115 metabolic equivalents [METS]/kg/min , P smoked than in the control group ( 6 % vs 23 % , P with Pravastatin in Ischemic Disease ( LIPID ) score ( 40 % vs 59 % , P = .02 ) . Although the modular group had higher risk factors at baseline , they achieved similar mean levels as the CR group at 3 months . CONCLUSIONS Patient-centered modular prevention significantly improves coronary risk profile in comparison with conventional care and provides an effective alternative for the large numbers of ACS survivors not accessing CR ",
"BACKGROUND We aim ed to determine whether the frequency of General Practitioner and Cardiologist consultations impacted on improvements in risk factors in Choice of Health Options in Reducing Cardiovascular Events ( CHOICE ) r and omised controlled trial . METHODS Retrospective subgroup analysis of single-blind r and omised controlled trial . We included acute coronary syndrome survivors not accessing cardiac rehabilitation in the CHOICE trial whose General Practitioner or Cardiologist returned a visit frequency survey . The CHOICE group participated in tailored risk factor reduction packaged as clinic visit plus 3 months telephone support . Controls participated in physician-directed usual medical care . We compared total cholesterol , systolic blood pressure , smoking status , physical activity , number of modifiable risk factors and medications with frequency of medical consultations at baseline and 12 months . RESULTS Most control and CHOICE patients saw their General Practitioner≥5 times ( 85 % vs 90 % ) and Cardiologist at least once ( 65 % vs 57 % ) . CHOICE patients had a significantly better modifiable risk profile ( factor levels and multiples ) and more patients were on evidence -based medications at 12 months compared to controls . In CHOICE , the significant reduction in total cholesterol was unrelated to medical visits but lower systolic blood pressure was significant in patients who saw their General Practitioner≥5 compared with ≤4 times . In controls , frequency of medical visits was not associated with any changes in risk profile . CONCLUSIONS Acute coronary syndrome survivors receiving frequent medical follow-up without packaged secondary prevention had no improvement in multiple risk factors over 12 months . CHOICE patients who saw their doctors frequently were more likely to have significantly reduced systolic blood pressure and be on evidence -based medications",
"AIMS An earlier combined proactive and reactive telephone follow-up intervention for acute myocardial infa rct ion patients after discharge from hospital showed positive effects after six months . The aim of the present study was to assess whether the intervention has long-term effects up to 18 months after discharge . DESIGN A prospect i ve r and omised controlled trial with 18 months follow-up . METHOD The trial was conducted with 288 patients allocated to a telephone follow-up intervention group ( n = 156 ) or control group ( n = 132 ) . The primary endpoint was health-related quality of life using the SF-36 . Secondary endpoints included smoking and exercise habits , return to work and rehospitalisation due to chest pain . RESULTS There were significant improvements over time on most dimensions of health-related quality of life in both the intervention and control group to US norm population levels on most SF-36 dimensions and summary scores . The intervention group showed no overall significant improvement beyond six months in the physical or mental summary scores , but there was a significant effect for those aged 70 or above . Although there was a promising effect for rehospitalisation due to chest pain , no significant differences were found between the groups on the secondary endpoints after six months . CONCLUSION This study demonstrated that despite positive short-term effects at six months , the telephone follow-up intervention had no long-term effects on health-related quality of life or secondary endpoints . However , the potential for improvement beyond six months was less than anticipated reflecting a reduced morbidity among acute myocardial infa rct ion patients . RELEVANCE TO CLINICAL PRACTICE Telephone follow-up after discharge from hospital is an easy implementable follow-up intervention enabling individualised provision of information and support in a time often experienced as stressful by patients . Our study indicates that six months is an adequate support period . Despite positive results six months after discharge no significant added long-term effects of telephone follow-up , compared to usual care were found in this study",
"A health education and counselling programme was offered to myocardial infa rct ion patients during and after hospitalization . A r and omized pre-test-post-test control group design was used to evaluate the effects of the experimental intervention . During hospitalization the intervention consisted of two individual counselling sessions and two group health education sessions focusing on medication , healthy habits , anxiety and depression . On completion of these sessions , weekly telephone calls were made to patients for a period of six weeks after discharge from hospital . The intervention was offered to 30 myocardial infa rct ion patients and their partners ( the experimental group ) in addition to st and ard medical care . Thirty control patients received st and ard medical care only . Two months after myocardial infa rct ion , patients in the experimental condition reported a significantly greater increase in physical activity , and a significantly greater decrease in unhealthy eating habits . No effects were found regarding smoking cessation , anxiety and depression . Twelve months after discharge from hospital patients in the experimental condition reported a significantly greater decrease in unhealthy eating habits . No effects were found regarding smoking cessation , physical activity , anxiety and depression . In addition , two months after myocardial infa rct ion , it was found that patients whose partners participated in the health education sessions showed a significantly greater decrease in smoking and unhealthy eating habits and a significantly greater increase in physical activity than patients with no partner participating . Twelve months after discharge the only significant result favouring the patients whose partner participated in the health education sessions concerned smoking cessation",
"The effects of a nurse-managed secondary prevention program for patients after acute cardiac events were examined . Special interest was given to gender-specific results . The design was a prospect i ve , r and omized , controlled trial involving 343 patients following 3 weeks of inpatient cardiac rehabilitation , r and omly assigned to either of two study groups . Patients in the treatment group were contacted monthly by phone over 1 year . The main goals of the intervention were the reduction of behavioural coronary risk factors and enhancing quality of life . The program was conducted by specially trained nurses . The control group received written information only . Primary outcome was the Framingham risk score . Follow-up examination after 12 months was completed by 297 patients . Patients in the intervention group showed lower Framingham risk scores as compared to controls . Separate analyses by sex revealed that this was mostly due to the men in the sample . Women , on the other h and , showed a significant rise of clinical ly relevant anxiety/depressiveness in the control but not in the intervention group ; in males there were no differences between study conditions . In conclusion , telephone counselling by specially trained nurses seems a cost-effective way to achieve a lasting reduction in cardiac risk factors and to maintain the effects of cardiac rehabilitation . Effekte eines von Pflegepersonal durchgefuehrten Nachsorgeprogramms fuer Koronarpatienten wurden untersucht . Besondere Aufmerksamkeit galt moeglichen Gendereffekten . Es h and elt sich um eine prospektive , r and omisierte , kontrollierte Studie . 343 Patienten wurden nach stationaerer kardiologischer Rehabilitation auf eine von zwei Studiengruppen r and omisiert . Patienten in der Interventions gruppe wurden über ein Jahr ca . einmal i m Monat telephonisch kontaktiert . Hauptziele der Intervention waren die effektive und nachhaltige Reduktion verhaltensgebundener Risikofaktoren sowie die Verbesserung der Lebensqualitaet . Das Programm wurde von speziell dafuer fortgebildetem Pflegepersonal durchgefuehrt . Die Kontrollgruppe erhielt nur schriftliches Informations material . Primaerer Endpunkt war das globale koronare Risiko ( Framingham Score ) . Von 297 Patienten wurden komplette Date n bei der Abschlussuntersuchung nach 12 Monaten erhalten . Patienten in der Interventions gruppe zeigten niedrigere Framingham-Scores als Kontrollpatienten . Getrennte Analysen nach Geschlecht ergaben , dass dieser Effekt hauptsaechlich auf die Maenner zurueckzufuehren ist ; bei den Frauen zeigten sich keine Unterschiede zwischen den Studiengruppen . Auf der and eren Seite zeigte sich bei den Frauen in der Kontrollgruppe eine deutliche Zunahme an Angst bzw . Depressivitaet ; ein entsprechender Effekt f and sich bei den Maennern nicht . Telefonische Nachsorge durch speziell fortgebildetes Pflegepersonal scheint ein kostenguenstiger Weg zu sein , koronare Risikofaktoren zu reduzieren und die Effekte von kardiologischer Rehabilitation aufrechtzuerhalten . Se evaluaron los result ados de un programa secundario de prevención dirigido por el personal de enfermería para pacientes que han sufrido un trastorno cardiovascular agudo . Se dio una especial importancia a los result ados específicos para cada sexo . Se trata de un estudio prospect ivo , aleatorizado , comparativo , en el que participaron 343 pacientes tras 3 semanas de haber recibido rehabilitación cardiovascular , a quienes se dividieron en dos grupos , de manera aleatoria . Los pacientes del grupo que recibió tratamiento fueron contactados por teléfono una vez al mes durante 1 año . Los principales objetivos de la intervención fueron reducir los factores de riesgo de las cardiopatías arterioscleróticas relacionados con el actuar de los pacientes , y mejorar la calidad de vida de éstos . La realización del programa estuvo a cargo de un grupo de enfermeras y enfermeros especialmente entrenados para ello . El grupo de referencia recibió información sólo por escrito . Los result ados iniciales se obtuvieron aplic and o la escala de riesgo de Framingham . En las valoraciones de seguimiento , realizadas tras 12 meses , participaron 292 pacientes . Los valores en la escala de riesgo de Framingham fueron más bajos en los pacientes del grupo que recibió la intervención que en el grupo de referencia . Los análisis según el sexo revelaron que el aporte mayor a este result ado provino de los varones de la muestra . Por su parte , las mujeres del grupo de referencia presentaron un aumento importante de la ansiedad/depresión relacionada con el proceso de enfermedad , lo cual no se apreció en el grupo que recibió tratamiento . Entre los varones no se apreciaron diferencias relacionadas con las condiciones del estudio . En conclusión , el apoyo emocional por vía telefónica brindado por el personal de enfermería especialmente entrenado para ello parece ser una manera rentable de disminuir de forma perdurable los factores de riesgo para las cardiopatías arterioscleróticas , así como de perpetuar los result ados de la rehabilitación cardiovascular . Cette étude examine les effets d'un programme de prévention secondaire sous surveillance du personnel infirmier pour les patients ayant souffert d'incidents cardiaques aigus . Une attention toute particulière a été donnée aux résultats selon le sexe . L'essai était de type prospect if , r and omisé et contrôlé , avec la participation de 343 patients après 3 semaines de rééducation cardiaque dans des conditions d'hospitalisation , affectés de manière aléatoire à l'un ou l'autre des deux groupes d'étude . Les patients appartenant au groupe de traitement ont été contactés tous les mois par téléphone sur une période de 1 an . Les principaux objectifs de l'intervention étaient la réduction des facteurs comportementaux de risque coronaire et l'amélioration de la qualité de vie . Le programme était administré par des infirmiers spécialement formés . Le groupe témoin recevait simplement des informations écrites . Le principal résultat était le score de risque de Framingham . 297 patients ont subi des examens de suivi après 12 mois . Les patients appartenant au groupe d'intervention ont affiché des scores de risque de Framingham inférieurs à ceux du groupe témoin . Les analyses séparées par sexe révèlent que la différence porte principalement sur les hommes . Les femmes , par contre , affichent une augmentation significative des tendances dépressives/à l'anxiété , cliniquement pertinente dans le groupe témoin , contrairement au groupe d'intervention ; chez les hommes , on ne note aucune différence entre les conditions d'étude . En conclusion , le conseil téléphonique administré par des infirmiers spécialement formés semble constituer un mode économique et efficace pour parvenir à une réduction durable des facteurs de risques cardiaques et préserver les effets de la rééducation cardiaque",
"Objective : The objective of this study was to evaluate the effectiveness of a telephone-based intervention on psychological distress among patients with cardiac illness . Methods : We recruited hospitalized patients surviving an acute coronary syndrome with scores on the Hospital and Anxiety Depression Scale ( HADS ) indicating mild to severe depression and /or anxiety at 1 month postdischarge . Recruited patients were r and omized into either an intervention or control group . Intervention patients received up to six 30-minute telephone-counseling sessions focused on identifying cardiac-related fears . Control patients received usual care . For both groups , we collected patients ’ responses to the HADS and to the Global Improvement ( CGI-I ) subscale of the Clinical Global Impressions ( CGI ) Scale at baseline and at 2 , 3 , and 6 months postbaseline using Interactive Voice Recognition ( IVR ) technologies . We used mixed-effects analysis to estimate patients ’ changes in CGI-I measures over the three time points of data collection postbaseline . Results : We enrolled 100 patients , and complete CGI-I measures were collected for 79 study patients . The mean age was 60 years ( st and ard deviation = 10 ) , and 67 % of the patients were male . A mixed-effects analysis confirmed that patients in the intervention group had significantly greater improvements in self-rated health ( SRH ) between baseline and month 3 than the control group ( p = .01 ) . Between month 3 and month 6 , no significant differences in SRH improvements were observed between the control and intervention groups . Conclusions : Study patients reported greater SRH improvement result ing from the telephone-based intervention compared with control subjects . Future research should include additional outcome measures to determine the effect of changes in SRH on patients with comorbid physical and emotional disorders . ACS = acute coronary syndrome ; ADL = activities of daily living ; CAD = coronary artery disease ; CGI = Clinical Global Impressions Scale ; CGI-I = Global Improvement subscale of the Clinical Global Impressions ( CGI ) Scale ; ENRICHD = Enhancing Recovery in Heart Disease Patients trial ; HADS = Hospital and Anxiety Depression Scale ; HTS = Healthcare Technology Systems ; ICD-9 = International Classification of Diseases , Ninth Edition ; IRB = Institutional Review Boards ; IVR = interactive voice recognition ; MI = myocardial infa rct ion ; SADHART = the Sertraline Antidepressant Heart Attack R and omized Trial ; SRH = self-rated health ",
"OBJECTIVE A pilot study was conducted to determine the feasibility and potential efficacy of an interactive voice response ( IVR ) follow-up system for smokers recently hospitalized with coronary heart disease ( CHD ) . METHODS Ninety-nine smokers hospitalized with CHD completed a baseline question naire , were provided with bedside counseling , and offered nicotine replacement therapy . They were r and omly assigned to a usual care ( UC ) or an IVR group . The IVR group received automated telephone follow-up calls 3 , 14 and 30 days after discharge inquiring about their smoking status and confidence in remaining smoke-free . When deemed necessary , they were offered additional counseling . Smoking status was determined 52 weeks after hospital discharge . RESULTS The 52-week point prevalence abstinence rate in the IVR group was 46.0 % compared to 34.7 % in the UC group ( OR=1.60 , 95 % CI : 0.71 - 3.60 ; P=.25 ) . After adjustment for education , age , reason for hospitalization , length of hospitalization , and quit attempts in the past year , the odds of quitting in the IVR group compared to the UC group were 2.34 ( 95 % CI : 0.92 - 5.92 ; P=.07 ) . CONCLUSIONS IVR is a promising technology for following CHD patients attempting to quit smoking following discharge from hospital , however , a larger trial is required to confirm its efficacy . PRACTICE IMPLICATION S IVR may enhance the timely provision of follow-up counseling for smoking cessation in patients with CHD",
"Objective : To determine the effect of a new CHOICE ( Choice of Health Options In prevention of Cardiovascular Events ) programme on cardiovascular risk factors in acute coronary syndrome ( ACS ) survivors . Design : Single-blind r and omised controlled trial . Setting : Tertiary referral hospital in Sydney Australia . Patients : 144 ACS survivors who were not accessing st and ard cardiac rehabilitation . Data were also collected on a further 64 ACS survivors attending st and ard cardiac rehabilitation . Intervention : The CHOICE group ( n = 72 ) participated in a brief , patient-centred , modular programme comprising a clinic visit plus telephone support , encompassing m and atory cholesterol lowering and tailored preferential risk modification . The control group ( n = 72 ) participated in continuing conventional care but no central ly coordinated secondary prevention . Main outcome measures : Values for total cholesterol , systolic blood pressure , smoking status and physical activity . Results : CHOICE and control groups were well matched at baseline . At 12 months , the CHOICE group ( n = 67 ) had significantly better risk factor levels than controls ( n = 69 ) for total cholesterol ( TC ) ( mean ( SEM ) 4.0 ( 0.1 ) vs 4.7 ( 0.1 ) mmol/l , p systolic blood pressure ( 131.6 ( 1.8 ) vs 143.9 ( 2.3 ) mm Hg , p body mass index ( 28.9 ( 0.7 ) vs 31.2 ( 0.7 ) kg/m2 , p = 0.025 ) and physical activity ( 1369.1 ( 167.2 ) vs 715.1 ( 103.5 ) METS/kg/min , p = 0.001 ) as well as a better knowledge of risk factor targets . Also at 1 year , fewer CHOICE participants ( 21 % ) had three or more risk factors above widely recommended levels then controls ( 72 % ) ( p CHOICE programme significantly improved the modifiable risk profiles and risk factor knowledge of ACS survivors over 12 months . CHOICE is an effective alternative for dealing with the widespread underuse of existing secondary prevention programmes . Trial registration number : IS RCT"
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41171f04-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES This study systematic ally review the literature to assess the effectiveness of antibacterial monomers incorporated into dental adhesive systems against major oral bacteria ; as well as the research advances and the future prospect s of this technology . METHODS The following seven data bases were screened : MedLine ( PubMed ) , Lilacs , Ibecs , Web of Science , Scopus , Scielo , and The Cochrane Library . Furthermore , the online system Questel Orbit ( Paris , France ) was accessed to obtain patent data . The inclusion criteria were articles and patents that investigated the antimicrobial activity of antibacterial monomers in dental adhesive systems . Only documents written in English , Spanish or Portuguese were included . RESULTS After screening , 33 studies and eight patents fulfilled all the criteria and were included . Antibacterial agents , such as QA , MDPB , DMAHM and DMADDM were found in patents , which cl aim ed their incorporation into adhesive compositions , dental cements , composite resins . MDPB was the only antimicrobial monomer incorporated into a commercially available adhesive system , Clearfil Protect Bond ™ ( Kuraray Co. Ltd. , Japan ) . All studies reported the inclusion of antimicrobial monomers in adhesive systems to be an effective dental treatment strategy . SIGNIFICANCE There are potential areas to be explored with antibacterial monomers for dentistry , and their use could have important implication s for future more conservative dental treatments . Although there is evidence of antibacterial activity from in vitro studies , clinical studies must be conducted to confirm the effectiveness of these material s in the prevention of dental pathologies
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"This study evaluated the cariostatic effect of antibacterial self-etching adhesive systems , by means of an in vitro bacterial caries model . Seventy-five prepared bovine slabs were r and omly divided into groups ( n=15 ) : ( 1 ) unbonded composite , no carious challenge ( UNB-NC ) ; ( 2 ) unbonded composite , carious challenge ( UNB-C ) ; ( 3 ) Clearfil SE Bond , no antibacterial agent ( CSE ) ; ( 4 ) Protect Bond , containing MDPB and fluoride ( PB ) ; and ( 5 ) Reactmer Bond , fluoride-releasing ( RB ) . All preparations were restored with Filtek Z-250 . Groups (2)-(5 ) were su bmi tted to a medium containing Streptococcus mutans ( ATCC-- 25175 ) for 5 days , and Group ( 1 ) was kept in a noninoculated medium . Insoluble polysaccharides present in tooth biofilms were quantified , Knoop hardness ( KHN ) was measured on the enamel adjacent to restorations , and st and ard 35-mm polarized light photomicrographs were taken as illustrations . Polysaccharide and Knoop hardness results were analyzed with the use of ANOVA , with a split-split-plot statistical design for KHN . Except for Group ( 1 ) , all groups showed similar caries formation . Biofilm over PB restorations showed the smallest amounts of polysaccharides ( 14.37 microg/mg ) , and CSE showed the highest amounts ( 20.87 microg/mg ) . All self-etching systems tested were unable to inhibit secondary caries in a bacterial model simulating a high caries challenge , even though there was reduced glucan synthesis provided by the adhesive system containing MDPB and fluoride",
"There is no consensus about an association between microleakage and secondary caries , especially considering the presence of fluoride ( F ) at the tooth/restoration interface . Thus , a r and omized , double-blind , crossover study was carried out to evaluate in situ the effect of microleakage on caries around enamel-dentine restorations in the presence of F from dental material s or dentifrice , either alone or in combination . In 4 phases of 14 days each , 14 volunteers wore palatal devices containing dental slabs restored with composite resin ( CR ) or resin-modified glass ionomer cement ( GI ) . Restorations were made without leakage ( L– ) , following the recommended adhesive procedures , or with leakage ( L+ ) , in the absence of adhesive procedures . Plaque-like biofilm ( PLB ) was left to accumulate on the restored slabs , which were exposed extraorally to a 20 % sucrose solution 10 × /day . The volunteers used a non-F ( NF ) or an F ( FD ) dentifrice 3 × /day , depending on the experimental phase . No differences were found between L+ or L– restorations ( p > 0.05 ) . Higher demineralization in both enamel and dentine around CR restorations was observed under NF ( p ) . F concentration was higher in the fluid of PLB exposed to FD or formed onto GI restoration ( p increased F levels in the PLB , thereby decreasing caries progression",
"INTRODUCTION The aims of this study were to evaluate the effect of an antibacterial monomer-containing self-etching adhesive in reducing enamel demineralization around orthodontic brackets in vivo and to compare it with the conventional adhesive system quantitatively . METHODS Fourteen orthodontic patients were r and omly divided into 2 equal groups ; they received brackets fitted to all their teeth , bonded with either Clearfil Protect Bond ( Kuraray Medical , Okayama , Japan ) ( experimental group ) or Transbond XT ( 3 M Unitek , Monrovia , Calif ) ( control group ) . Block r and omization to obtain equal numbers in each group was used . After 30 days , all first premolars were extracted with orthodontic indications and longitudinally sectioned . Demineralization was assessed by cross-sectional microhardness . Determinations were made at the bracket edge cementing limits and at occlusal and cervical points 100 and 200 μm away from the edge . In all of these positions , 6 indentations were made at depths of 10 to 90 μm from the enamel surface . Analysis of variance ( ANOVA ) and the Tukey post-hoc test were used . The statistical significance level was set at P adhesive type , position , depth , and their interactions ( P monomer-containing adhesive was significantly more efficient than the conventional adhesive system , reducing enamel demineralization in almost all evaluations ( P antibacterial monomer-containing adhesive for bonding orthodontic brackets successfully inhibited caries in vivo . This cariostatic effect was localized at the area around the brackets and was significant after 30 days",
"PURPOSE To compare the antibacterial activity of an adhesive system containing an antibacterial monomer MDPB , Clearfil Protect Bond with three different cavity disinfectants , chlorhexidine gluconate-based Consepsis , benzalkonium chloride-based Tubulicid Red and 3 % hydrogen peroxide . METHODS Material s were tested using agar well technique and a tooth cavity model . The test material s were filled in the agar wells of plates inoculated with Streptococcus mutans . After 48 hours of incubation , the zones of inhibitions were measured in millimeters . For the tooth cavity model test , cylindrical cavities were prepared in the flat occlusal dentin of human extracted molars . The teeth were left in a broth culture of Streptococcus mutans at 37 degrees C for 72 hours allowing bacteria to invade . Teeth were then r and omly assigned into five groups of five teeth ( 10 cavity preparations ) each . In the first four groups test material s were applied into the cavities following the manufacturer 's instructions and the cavities in the fifth group were left untreated for control . The teeth were kept in saline for 72 hours . St and ard amounts of dentin chips were obtained from the cavity walls and the number of bacteria recovered was counted . RESULTS The results were analyzed by ANOVA , Dunnett C and Bonferroni tests . For the agar well technique , Clearfil Protect Bond primer exhibited greater inhibition zones than all three cavity disinfectants ( P Clearfil Protect Bond system result ed in significantly less bacterial recovery than all disinfectants ( P antibacterial activities of Consepsis and Tubulicid Red ( P > 0.05 ) . They were superior to hydrogen peroxide in the cavity test method ( P < 0.05 )",
"OBJECTIVES The presence of cariogenic biofilm could result in surface degradation of composite and ionomeric restorative material s. Thus , this study evaluated in situ the alterations in the surface microhardness of these material s under biofilm accumulation and cariogenic challenge . METHODS In a split-mouth , double-blind , cross-over study , 10 volunteers wore palatal intra-oral devices containing bovine enamel slabs restored with composite resin ( CR - Z250 ) or resin-modified glass ionomer ( RMGI - Vitremer ) . Two phases of 14 days were carried out , one for each restorative material . In one side of the device , biofilm was allowed to accumulate under a plastic mesh , whereas in the opposing side , regular brushing was carried out 3 times/day with a dentifrice containing 1100 μg F/g as NaF. A 20 % sucrose solution was applied extra-orally 10 × /day on each restored dental slab . Knoop microhardness was used to calculate the percentage of surface hardness loss ( % SHL ) . RESULTS All material s showed a decrease in surface hardness after the in situ period . The restorative material s presented the following average for % SHL : RMGI without biofilm accumulation=8.9 and with biofilm accumulation=25.6 , CR without biofilm accumulation=14.7 and with biofilm accumulation=17.0 . CONCLUSION Biofilm accumulation and the presence of cariogenic challenge promoted faster degradation of ionomeric material s , but this was not observed for composite resin . CLINICAL SIGNIFICANCE The oral environment affects the surface hardness of aesthetic restorative material s. Biofilm accumulation and cariogenic challenge promote surface degradation for ionomeric material s , but not for composite resin",
"PURPOSE To evaluate in situ the anticariogenic effect of fluoride and MDPB containing adhesive systems at the restoration interface , by microhardness tests . METHODS 120 fragments containing preparations for resin composite restorations performed at the cemento-enamel junction were r and omly distributed among the adhesive systems to be tested . The adhesive systems were applied in accordance with the manufacturers ' instructions : Optibond FL , Adper Single Bond 2 , Prime & Bond 2.1 , Optibond Solo Plus , Adper Prompt , Clearfil Protect Bond and restored with the nanoparticulate resin composite Z350 . Twenty volunteers used a palatal appliance containing fragments restored with each adhesive system for 21 days , and applied 20 % sucrose on them eight times a day to simulate a high cariogenic challenge . Microhardness tests were performed at different depths ( 20 microm , 40 microm and 60 microm from the occlusal margin of the restoration ) and at different distances ( 100 microm , 200 microm and 300 microm from the adhesive interface ) . RESULTS ANOVA showed that for enamel , there was significant difference between the adhesive systems ( P=0.0106 ) ; the interaction adhesive system*distance was a significant ( P=0.0006 ) , and the one-step self-etching adhesive system containing fluoride ( Adper Prompt ) presented a higher anticariogenic effect . However , for dentin , the adhesive system used did not interfere in decreasing the severity of caries formation"
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Background : Human factors play an important role in health-care outcomes of heart failure ( HF ) patients . A systematic review and meta- analysis of clinical trial studies on HF hospitalization may yield positive proofs of the beneficial effect of specific care management strategies . Purpose : To investigate how the 8 guiding principles of choice , rest , environment , activity , trust , interpersonal relationships , outlook , and nutrition reduce HF readmissions . Basic Procedures : Appropriate keywords were identified related to the ( 1 ) independent variable of hospitalization and treatment , ( 2 ) the moderating variable of care management principles , ( 3 ) the dependent variable of readmission , and ( 4 ) the disease of HF to conduct search es in 9 data bases . Data bases search ed included CINAHL , Cochrane Central Register of Controlled Trials , Cochrane Data base of Systematic Review s , ERIC , MEDLINE , PubMed , PsycInfo , Science Direct , and Web of Science . Only prospect i ve studies associated with HF hospitalization and readmissions , published in English , Chinese , Spanish , and German journals between January 1 , 1990 , and August 31 , 2015 , were included in the systematic review . In the meta- analysis , data were collected from studies that measured HF readmission for individual patients . Main Findings : The results indicate that an intervention involving any human factor principles may nearly double an individual ’s probability of not being readmitted . Participants in interventions that incorporated single or combined principles were 1.4 to 6.8 times less likely to be readmitted . Principal Conclusions : Interventions with human factor principles reduce readmissions among HF patients . Overall , this review may help reconfigure the design , implementation , and evaluation of clinical practice for reducing HF readmissions in the future
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"BACKGROUND Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure , but data to support this practice are lacking . Using a technology-based heart failure monitoring system , we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline -driven heart failure care . METHODS This was a r and omized , controlled trial . Patients hospitalized with New York Heart Association class III or IV heart failure , with a left ventricular ejection fraction receive heart failure program care or heart failure program care plus the AlereNet system ( Alere Medical , Reno , Nev ) and followed-up for 6 months . The primary end point was 6-month hospital readmission rate . Secondary end points included mortality , heart failure hospitalization readmission rate , emergency room visitation rate , and quality of life . RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were r and omized : 138 received the AlereNet system and 142 received st and ard care . Mean age was 59 + /- 15 years and 68 % were male . The population had very advanced heart failure , New York Heart Association class III ( 75 % ) or IV ( 25 % ) , as evidence d by serum norepinepherine levels , 6-minute walk distance and outcomes . No differences in hospitalization rates were observed . There was a 56.2 % reduction in mortality ( P patients with advanced heart failure . Despite no difference in the primary end point of rehospitalization rates , mortality was significantly reduced for patients r and omized to the AlereNet system without an increase in utilization , despite specialized and aggressive heart failure care in both groups",
"BACKGROUND Hospital admissions for heart failure are common and readmission rates are high . Many admissions and readmissions may be avoidable , so that alternative strategies are needed to improve long-term management . METHODS We conducted a r and omized trial of the effect of a guideline -based intervention on rates of readmission within 90 days of hospital discharge and costs of care for patients who were hospitalized due to decompensated heart failure . The intervention consisted of comprehensive education of the patient and family , a prescribed diet and intensive application of guidelines ' recommendations on pharmacological therapy . The intervention started before discharge and continued thereafter with follow-up visits for up to 3 months . Two hundred and nine guideline -managed patients were compared to 209 concurrent normally-discharged patients . RESULTS Patients in the study group were more prescribed beta-blockers , ACE-inhibitors , angiotensin receptor blockers , and spironolactone . Sixteen patients ( 8 % ) in the intervention group and 31 ( 15 % ) among controls were readmitted for DRG 127 , within 3 months of discharge ( Fisher 's exact test , p 6-month mortality rate was similar between groups ( 9 and 11.5 % respectively ) . Quality of life significantly improved from 5.6 + /- 1.0 to 6.1 + /- 1.9 ( Mann-Whitney U-test , p overall costs of care were lower for guideline -managed patients ( 110 vs 150 Euro per patient per month ) , due to the lower readmission rates . CONCLUSIONS Our study showed that a guideline -based management program for patients with heart failure at discharge improves quality of life and reduces readmission for DRG 127 and total bed days , allowing relevant cost savings",
"Abstract Background : Disease management programmes ( DMPs ) improve quality of care for patients with heart failure ( HF ) . However , only a limited number of trials have studied the efficacy of such programmes for patients with heart failure with preserved ejection fraction ( HFPEF ) . Objective : To estimate the impact of a structured , nurse-led patient education programme and care plan in general practice on outcome parameters and events in patients with HFPEF . Methods : Single blinded r and omized clinical trial with an intervention over six months and a follow-up during 12 additional months . In the control group , the patients ( n = 41 ) were managed according to Russian national guidelines . Patients in the intervention group ( n = 44 ) received education on individual lifestyle changes and modifications of cardiovascular disease ( CVD ) risk factors , home-based exercise training and weekly nurse consultations in addition to usual care . Results : Six months after their inclusion , patients in the intervention group significantly improved body mass index , waist circumference , six-min walk test distance , total cholesterol , low-density lipoprotein , left ventricular end-diastolic volume index , quality of life and level of anxiety . After 18 months , there were 11 deaths ( 25 % ) or hospitalizations in the intervention group and 12 ( 29 % ) in the control group ( P = 0.134 ) . Cardiovascular mortality and readmission rate were not reduced significantly after six months of follow-up : the hazard ratio was 0.47 ( 95 % CI : 0.17–1.28 ; P = 0.197 ) . After 18 months , this was 0.85 ( 0.42–1.73 ; P = 0.658 ) . Conclusion : This primary care based DMP for patients with HFPEF improved the patients ’ emotional status and quality of life , positively influenced body weight , functional capacity and lipid profile , and attenuated heart remodelling",
"Aim Multidisciplinary disease management programmes ( MDPs ) for heart failure have been shown to be effective in Western countries . However , it is not known whether they improve outcomes in a high population density country with a national health insurance programme . Methods In total , 349 patients hospitalized because of heart failure were r and omized into control and MDP groups . All-cause death and re-hospitalization related to heart failure were analyzed . The median follow-up period was approximately 2 years . Results Mean patient age was 60 years ; 31 % were women ; and 50 % of patients had coronary artery disease . MDP was associated with fewer all-cause deaths [ hazard ratio ( HR ) = 0.49 , 95 % confidence interval ( CI ) = 0.27–0.91 , P = 0.02 ] and heart failure-related re-hospitalizations ( HR = 0.44 , 95 % CI = 0.25–0.77 , P = 0.004 ) . MDP was still associated with better outcomes for all-cause death ( HR = 0.53 , 95 % CI = 0.29–0.98 , P = 0.04 ) and heart failure-related re-hospitalization ( HR = 0.46 , 95 % CI = 0.26–0.81 , P = 0.007 ) , after adjusting for age , diuretics , diabetes mellitus , chronic kidney disease , hypertension , sodium , and albumin . However , MDPs ’ effect on all-cause mortality and heart failure-related re-hospitalization was significantly attenuated after adjusting for angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers or & bgr;-blockers . A stratified analysis showed that MDP combined with guideline -based medication had synergistic effects . Conclusions MDP is effective in lowering all-cause mortality and re-hospitalization rates related to heart failure under a national health insurance programme . MDP synergistically improves the effectiveness of guidelines -based medications for heart failure",
"BACKGROUND Patients with heart failure ( HF ) experience depressive symptoms that contribute to poorer outcomes . We tested the effects of a brief cognitive therapy intervention on depressive symptoms , negative thinking , health-related quality of life , and cardiac event-free survival . METHODS AND RESULTS Hospitalized patients with depressive symptoms ( n = 41 , 66 ± 11 years , 45 % female , 81 % New York Heart Association Class III/IV ) were r and omly assigned to control group or a brief , nurse-delivered cognitive therapy intervention , delivered during hospitalization and followed by a 1-week booster phone call . Depressive symptoms , negative thinking , and health-related quality of life were measured at 1 week and 3 months . Cardiac event-free survival was assessed at 3 months . Mixed models repeated measures analysis of variance , Kaplan-Meier , and Cox regression were used for data analysis . There were significant improvements in depressive symptoms and health-related quality of life in both groups but no interactions between group and time . The control group had shorter 3-month cardiac event-free survival ( 40 % versus 80 % , P CONCLUSION Nurses can deliver a brief intervention to hospitalized patients with heart failure that may improve short-term , event-free survival . Future research is needed to verify these results with a larger sample size",
"OBJECTIVES The purpose of this study was to assess the rate of death and hospitalization for heart failure ( HF ) 1 and 3 years after a r and omized trial of telephone intervention aim ed to improve education and compliance in stable patients with HF ended . BACKGROUND The long-term effects of HF programs are not well known . METHODS In all , 1,518 patients with HF were r and omized into the DIAL ( R and omized Trial of Phone Intervention in Chronic Heart Failure ) . After completion of the trial , patients were followed up to 3 years to assess major outcomes . Compliance with diet , weight control , and treatment was evaluated . The effect of the intervention on mortality and HF hospitalizations was assessed using relative risk ( RR ) , relative risk reduction , and Cox proportional hazards model for adjusting by potential confounders . RESULTS The rate of death or hospitalization for HF was lower in the intervention group ( 37.2 % vs. 42.6 % , RR : 0.81 , 95 % confidence interval [ CI ] : 0.69 to 0.96 ; p = 0.013 ) 1 and 3 years ( 55.7 % vs. 57.5 % , RR : 0.88 , 95 % CI : 0.77 to 1.00 ; p = 0.05 ) after the intervention ended . This benefit was mainly caused by a reduction in admission for HF ( 28.5 % vs. 35.1 % after 3 years , RR : 0.72 , 95 % CI : 0.60 to 0.87 ; p = 0.0004 ) . Patients who showed improvement in 1 or more of 3 key compliance indicators ( diet , weight control , and medication ) had lower risks of events . CONCLUSIONS The benefit observed during the intervention period persisted and was sustained 1 and 3 years after the intervention ended . This effect may be explained by the impact of the educational intervention on patients ' behavior and habits",
"AIMS To test the effect of education and support by a nurse on self-care and re source utilization in patients with heart failure . METHODS A total of 179 patients ( mean age 73 , 58 % male , NYHA III-IV ) hospitalized with heart failure were evaluated prospect ively . Patients were r and omized to the study intervention or to ' care as usual ' . The supportive educative intervention consisted of intensive , systematic and planned education by a study nurse about the consequences of heart failure in daily life , using a st and ard nursing care plan developed by the research ers for older patients with heart failure . Education and support took place during the hospital stay and at a home visit within a week of discharge . Data were collected on self-care abilities , self-care behaviour , readmissions , visits to the emergency heart centre and use of other health care re sources . RESULTS Education and support from a nurse in a hospital setting and at home significantly increases self-care behaviour in patients with heart failure . Patients from both the intervention and the control group increased their self-care behaviour within 1 month of discharge , but the increase in the intervention group was significantly more after 1 month . Although self-care behaviour in both groups decreased during the following 8 months , the increase from baseline remained statistically significant in the intervention group , but not in the control group . No significant effects on re source utilization were found . CONCLUSIONS Intensive , systematic , tailored and planned education and support by a nurse results in an increase in patients ' self-care behaviour . No significant effects were found on use of health care re sources . Additional organisational changes , such as longer follow-up and the availability of a heart failure specialist would probably enhance the effects of education and support",
"INTRODUCTION AND OBJECTIVES Multidisciplinary strategies for the management of heart failure ( HF ) improve outcomes . We aim ed to evaluate the effectiveness of noninvasive home telemonitoring in ambulatory patients with HF already included in a structured multidisciplinary HF program . METHODS Prospect i ve intervention study with before/after comparison design of an interactive telemedicine platform in HF patients , r and omized 1:1 into two groups : A ) Motiva System with educational videos , motivational messages , and question naires , and B ) Motiva System + self monitoring of blood pressure , heart rate , and weight . Hospitalizations were compared over 12 months prior to and post study inclusion . Quality of life was evaluated using the generic EuroQoL visual analogue scale and the specific question naire Minnesota Living With Heart Failure Question naire . RESULTS There were 92 patients included ( 71 % male ; 66.3 ± 11.5 years ; 71 % ischemic aetiology ) . During real-time telemonitoring over 11.8 months ( interquartile range 8.6 - 12 ) , 14,730 question naires were administered with 89 % median response rate . Hospitalizations for HF decreased by 67.8 % ( P = .010 ) and for other cardiac causes by 57.6 % ( P = .028 ) . The number of days in hospital for HF decreased by 73.3 % ( P = .036 ) , without statistically significant differences between groups , and for other cardiac causes by 82.9 % ( P = .008 ) . The perception of quality of life improved significantly both for the generic scale ( P HF patients who used an interactive telehealth system with motivational support tools at home spent less time in hospital and felt their quality of life had significantly improved . No significant differences were observed between groups",
"Background .The high cost of caring for patients with congestive heart failure ( CHF ) results primarily from frequent hospital readmissions for exacerbations . Home nurse visits after discharge can reduce readmissions , but the intervention costs are high . Objectives .To compare the effectiveness of three hospital discharge care models for reducing CHF-related readmission charges : 1 ) home telecare delivered via a 2-way video-conference device with an integrated electronic stethoscope ; 2 ) nurse telephone calls ; and 3 ) usual outpatient care . Research Design . One-year r and omized trial . Subjects . English-speaking patients 40 years of age and older with a primary hospital admission diagnosis of CHF . Measures .Our primary outcome was CHF-related readmission charges during a 6-month period after r and omization . Secondary outcomes included all-cause readmissions , emergency department ( ED ) visits , and associated charges . Results .Thirty-seven subjects were r and omized : 13 to home telecare , 12 each telephone care and 12 to usual care . Mean CHF-related readmission charges were 86 % lower in the telecare group ( $ 5850 , SD $ 21,094 ) and 84 % lower in the telephone group ( $ 7320 , SD $ 24,440 ) than in the usual care group ( $ 44,479 , SD $ 121,214 ) . However , the between-group difference was not statistically significant . Both intervention groups had significantly fewer CHF-related ED visits ( P = 0.0342 ) and charges ( P = 0.0487 ) than the usual care group . Trends favoring both interventions were noted for all other utilization outcomes . Conclusions .Substantial reductions in hospital readmissions , emergency visits , and cost of care for patients with CHF might be achieved by widespread deployment of distance technologies to provide posthospitalization monitoring . Home telecare may not offer incremental benefit beyond telephone follow-up and is more expensive",
"OBJECTIVE The aim was to investigate if family members of patients with chronic heart failure ( CHF ) increased knowledge about CHF through a group-based multi-professional educational programme and whether there was an effect on patients ' health care utilization . METHODS Family members ( n=128 ) were r and omly assigned to intervention-group ( IG ) who received CHF education programme or control-group ( CG ) who received information according to hospital routines . Programme effects were evaluated with CHF knowledge question naire , patient readmissions and number of days hospitalised during 18 months . RESULTS Knowledge about CHF increased in both groups , significantly higher in IG at second assessment ( IG 16±1.9 vs. CG 14.9±2.1 , p=0.006 ) , and knowledge maintained at third assessment . In IG 17 patients were re-admitted at least once and 28 patients in CG due to CHF ( p=0.085 ) . There were no differences in frequency of readmissions or number of days hospitalised . CONCLUSION A group-based multi-professional education programme increased family members ' knowledge about CHF . Despite this , effect on patient 's health care utilization could not be seen during follow-up period . PRACTICAL IMPLICATION S We suggest that CHF education programmes for family members should be provided at clinics , with information preferably repeated 2 - 3 times during a period of six months to maintain knowledge level",
"OBJECTIVES The goal of this study was to make a head-to-head comparison of 2 common forms of multidisciplinary chronic heart failure ( CHF ) management . BACKGROUND Although direct patient contact appears to be best in delivering CHF management overall , the precise form to optimize health outcomes is less clear . METHODS This prospect i ve , multicenter r and omized controlled trial with blinded endpoint adjudication comprised 280 hospitalized CHF patients ( 73 % male , age 71 ± 14 years , and 73 % with left ventricular ejection fraction ≤45 % ) r and omized to home-based intervention ( HBI ) or specialized CHF clinic-based intervention ( CBI ) . The primary endpoint was all-cause , unplanned hospitalization or death during 12- to 18-month follow-up . Secondary endpoints included type/ duration of hospitalization and healthcare costs . RESULTS The primary endpoint occurred in 102 of 143 ( 71 % ) HBI versus 104 of 137 ( 76 % ) CBI patients ( adjusted hazard ratio [ HR ] : 0.97 [ 95 % confidence interval ( CI ) : 0.73 to 1.30 ] , p = 0.861 ) : 96 ( 67.1 % ) HBI versus 95 ( 69.3 % ) CBI patients had an unplanned hospitalization ( p = 0.887 ) , and 31 ( 21.7 % ) versus 38 ( 27.7 % ) died ( p = 0.252 ) . The median duration of each unplanned hospitalization was significantly less in the HBI group ( 4.0 [ interquartile range ( IQR ) : 2.0 to 7.0 ] days vs. 6.0 [ IQR : 3.5 to 13 ] days ; p = 0.004 ) . Overall , 75 % of all hospitalization was attributable to 64 ( 22.9 % ) patients , of whom 43 ( 67 % ) were CBI patients ( adjusted odds ratio : 2.55 [ 95 % CI : 1.37 to 4.73 ] , p = 0.003 ) . HBI was associated with significantly fewer days of all-cause hospitalization ( -35 % ; p = 0.003 ) and from cardiovascular causes ( -37 % ; p = 0.025 ) but not for CHF ( -24 % ; p = 0.218 ) . Consequently , healthcare costs ( $ AU3.93 vs. $ AU5.53 million ) were significantly less for the HBI group ( median : $ AU34 [ IQR : 13 to 81 ] per day vs. $ AU52 [ 17 to 140 ] per day ; p = 0.030 ) . CONCLUSIONS HBI was not superior to CBI in reducing all-cause death or hospitalization . However , HBI was associated with significantly lower healthcare costs , attributable to fewer days of hospitalization . ( Which Heart failure Intervention is most Cost-effective & consumer friendly in reducing Hospital care [ WHICH ? ] ; ACTRN12607000069459 )",
"OBJECTIVES Medicare penalizes hospitals with 30-day readmissions above their expected rates . Hospitals have responded by implementing transitional care interventions ; however , there is limited evidence to inform the development of a successful intervention . STUDY DESIGN Parallel-group , stratified , r and omized controlled trial . METHODS A total of 512 patients hospitalized at 2 community hospitals , with congestive heart failure ( CHF ) or chronic obstructive pulmonary disease ( COPD ) , were r and omly assigned to the intervention ( n = 253 ) or usual care ( n = 259 ) . The intervention encompassed a 90-day hospital-based transitional care program . The primary end points were 30- and 90-day all-cause readmissions . Secondary measures included all-cause emergency department ( ED ) visits and mortality . RESULTS On average , study participants were 67 years of age , 57 % female , and 70 % insured by Medicare . There was no statistical difference between treatment groups on 30-day readmission incidence rates ( difference , 0.040 ; 95 % CI , -0.047 to 0.127 ; P = .36 ) , or 90-day readmission incidence rates ( difference of 0.035 ; 95 % CI -0.122 to 0.192 ; P = .66 ) . Groups also did not differ in ED visit incidence rates at 30 or 90 days . The mortality rate among patients with CHF showed no difference between groups ( risk ratio = 0.90 ; 95 % CI , 0.40 - 2.05 ) . However , for COPD , mortality at 90 days was lower in the intervention group than in the usual care group ( risk ratio = 0.28 ; 95 % CI , 0.10 - 0.83 ) . CONCLUSIONS St and -alone community hospitals may be unable to prevent readmissions despite the use of comprehensive , evidence -based intervention components that are within their control . Better collaboration between hospitals and community-based providers is needed to ensure continuity of care for discharged patients . TRIAL REGISTRATION Clinical Trials.gov , Identifier : NCT01855022",
"Background —Although disease management programs for patients hospitalized with heart failure ( HF ) are effective , they are , however , often re source intensive , limiting their uptake . Peer support programs have led to improved outcomes among patients with other chronic conditions and may result in similar improvements for patients with HF . Methods and Results —In this r and omized controlled trial , Reciprocal Peer Support ( RPS ) arm patients participated in a HF nurse practitioner – led goal setting group session , received brief training in peer communication skills , and were paired with another participant in their cohort with whom they were encouraged to talk weekly using a telephone platform . Participants were also encouraged to attend 3 nurse practitioner – facilitated peer support group sessions . Patients in the nurse care management arm attended a nurse practitioner – led session to address their HF care questions and receive HF educational material s and information on how to access care management services . The median age of the patients was 69 years ; 51 % were female and 26 % were racial/ethnic minorities . Only 55 % of RPS patients participated in peer calls or group sessions . In intention-to-treat analyses , the RPS and nurse care management groups did not differ in time-to-first all-cause rehospitalization or death or in mean numbers of rehospitalizations or deaths . There were no differences in improvements in 6-month measures of HF-specific quality of life or social support . Conclusions —Among patients recently hospitalized for HF , more than half of RPS participants had no or minimal engagement with the RPS program , and the program did not improve outcomes compared with usual HF nurse care management . Clinical Trial Registration —URL : http://www . clinical trials.gov . Unique identifier : NCT00508508",
"Background : Previous investigators have demonstrated that patient adherence to optimal weight monitoring result ed in fewer heart failure (HF)–related rehospitalizations . Objective : The aim of this study was to determine whether a weight management ( WM ) intervention can improve patients ’ WM ability and cardiac function and reduce HF-related rehospitalizations . Methods : Heart failure patients were r and omly assigned to an intervention group ( n = 32 ) or a control group ( n = 34 ) . The intervention group received the WM intervention , including education about regular daily weight monitoring and coping skills when detecting sudden weight gain , with a WM booklet and scheduled telephone visits . Patients ’ WM ability was measured by the Weight Management Question naire ( WMQ ) . We compared scores on the WMQ , New York Heart Association ( NYHA ) classification , and HF-related rehospitalizations between the 2 groups at enrollment and at 6 months . We also analyzed the association of adherence to weight monitoring and rehospitalization in the intervention group during the 6-month follow-up . Results : There were no significant differences in weight monitoring adherence , WM ability , and NYHA classification between the 2 groups at baseline . At 6 months , scores on all 4 subscales of the WMQ significantly increased within the intervention group , and the WM- practice subscale significantly improved within the control group . Adherence to weight monitoring was significantly improved in the intervention group compared with the control group ( 81.25 % vs 11.76 % ; P ( P = .03 ) . Rehospitalizations related to HF were also fewer in the intervention group ( 0.28 ± 0.63 vs 0.79 ± 1.18 ; P = .03 ) during the follow-up duration . In the intervention group , those who weighed themselves regularly reported less HF-related rehospitalizations than did those who did not ( 0.23 ± 0.43 vs 0.50 ± 1.23 ; P = .62 ) . Conclusion : This study demonstrates that the WM intervention had a positive impact on patients ’ adherence to weight monitoring , WM ability , and NYHA classification and reduced HF-related rehospitalization ",
"UNLABELLED The objective of the study was to evaluate whether improvements obtained during an intervention programme were maintained after the programme was stopped . 153 patients discharged with a diagnosis of heart failure ( HF ) were r and omized to either usual care or an intervention programme , which included patient education , consultation with the cardiologist and monitoring in the Heart Failure Unit . After an average period of 16+/-8 months , the intervention programme was stopped . One year later , all the patients were re-examined to assess HF readmissions , all-cause mortality , quality of life , and prescribed medical treatment . During the 16+/-8-month treatment period , patients in the intervention group had a lower rate of HF readmissions ( 17 % vs. 51 % , p all-cause mortality ( 13 % vs. 27 % , p=0.03 ) , improvement in quality of life ( 1.5+/-0.8 vs. 1.9+/-1 , p=0.03 ) and optimisation of medical treatment was achieved . One year after stopping the intervention , there was no difference in HF readmissions ( 28 % vs. 25 % , p=0.72 ) , all-cause mortality ( 14 % vs. 17 % , p=0.64 ) and quality of life ( 1.7+/-0.9 vs. 1.8+/-1 , p=0.24 ) between the groups . Survival and the probability of not being readmitted due to HF were similar in both groups . There was also a reduction in the use of beta-blockers and spironolactone in the intervention group . CONCLUSIONS The positive effects of an intervention programme are clearly reduced when it is stopped , due to less strict control of the patients and a decrease in the use of drugs with proven efficacy in HF",
"PURPOSE This work addresses the unanswered question of whether multidisciplinary care ( MDC ) of heart failure ( HF ) can reduce readmissions when optimal medical care is applied in both intervention and control groups . METHODS In a r and omized , controlled study , 98 patients ( mean age , 70.8 + /- 10.5 years ) admitted to hospital with left ventricular failure ( New York Heart Association Class IV ) were assigned to routine care ( RC , n = 47 ) or MDC ( n = 51 ) . All patients received the same components of inpatient , optimal medical care of HF : specialist-led inpatient care ; titration to maximum tolerated dose of angiotensin-converting enzyme inhibitor before discharge ; attainment of predetermined discharge criteria ( weight stable , off all intravenous therapy , and no change in oral regimen for 2 days ) . Only those in the MDC group received inpatient and outpatient education and close telephone and clinic follow-up . The primary study endpoint was rehospitalization or death for a HF-related issue at 3 months . MAIN FINDINGS At 3 months , four people had events in the MDC group ( 7.8 % rate over 3 months ) compared with 12 people ( 25.5 % rate over 3 months ) in the RC group ( P = 0.04 ) . CONCLUSION These data demonstrate for the first time the intrinsic benefit of MDC in the setting of protocol -driven , optimal medical management of HF . Moreover , the event rate of 7.8 % at 3 months , as the lowest reported rate for such a high-risk group , underlines the value of this approach to the management of heart failure",
"BACKGROUND Managing patients with heart failure ( HF ) is labor intensive , and follow-up is often inadequate to detect day-to-day changes that ultimately lead to decompensation . We tested the effect of an Internet-based telemedicine ( T ) system that provides frequent surveillance and increased communicate between HF patients and their provider on frequency of hospitalization in a cohort of patients with advanced HF . METHODS AND RESULTS HF patients in NYHA Class II-IV were r and omized to usual care ( UC , n = 24 ) or T ( T plus UC , n = 24 ) and followed for 1 year . Office visits , emergency department visits , hospitalizations , telephone calls , and number of Internet communications were measured over the 1-year period . Left ventricular ejection fraction ( EF ) was assessed by echocardiography in both groups . For T , mean age was 53.2 + /- 2.0 years ( 72 % male , 61 % Caucasian , 39 % African American ) . For UC , mean age was 54.1 + /- 2.6 years ( 76 % male , 72 % Caucasian , 14 % African American , and 14 % Hispanic ) . HF etiologies and EF were similar in both groups . During the 12-month period , UC had 74 total phone calls to the practice , whereas T had 88 telephone calls plus 1887 telemedicine data messages ( 6.5 messages/patient/month ) . ER visits were lower in the T group ( T 5 , UC 12 ; P Hospital admissions ( T 24 , C 40 ; P = .025 ) and total hospital days ( T 84 , UC 226 days ; P Unscheduled clinic visits ( T 13 , UC 13 ; P = NS ) and scheduled clinic visits ( T 78 , UC 94 ; P = NS ) were similar in both groups . CONCLUSIONS Frequent monitoring and patient management using a telemedicine system may help to reduce hospitalizations , hospital days , and emergency department visits",
"BACKGROUND Nursing approaches to manage patients with heart failure ( HF ) showed benefits in reducing the morbidity and mortality . However , combining intra-hospital education with telephone contact after hospital discharge has been little explored . OBJECTIVE To compare two nursing intervention groups among patients hospitalized due to decompensated HF : the intervention group ( IG ) received educational nursing intervention during hospitalization followed by telephone monitoring after discharge and the control group ( CG ) received in-hospital intervention only . Outcomes were levels of HF and self-care knowledge , the frequency of visits to the emergency room , rehospitalizations and deaths in a three-month period . METHODS R and omized clinical trial . We studied adult HF patients with left ventricle ejection fraction ( LVEF ) HF awareness was evaluated through a st and ardized question naire that also included questions regarding self-care knowledge , which was answered during the hospitalization period and three months later . For patients in the IG group contacts were made using phone calls and final interviews were conducted in both groups at end of the study . RESULTS Forty-eight patients were assigned to the IG and 63 to the CG . Mean age ( 63 ± 13 years ) and L ( around 29 % ) were similar in the two groups . Scores for HF and self-care knowledge were similar at baseline . Three months later , both groups showed significantly improved HF awareness and self-care knowledge scores ( P An in-hospital educational nursing intervention benefitted all HF patients in underst and ing their disease , regardless of telephone contact after discharge",
"OBJECTIVE The purpose of this study was to test the efficacy of a heart failure ( HF ) training program on patients ' ability to recognize and respond to changes in HF symptoms . The primary aim was to compare event-free survival at 90 days . METHODS A total of 99 HF patients r and omized to the HF symptom training intervention or usual care completed instruments about self-care ( Self-Care of HF Index ) and at baseline and 3 months . Demographic , clinical , and comorbidity data were collected by interview and chart review . Time to first event ( death or a HF-related hospitalization ) was tracked by electronic records and patient interview . RESULTS The sample was predominately male ( 67.7 % ) , elderly ( 67.7 yrs ± 12.1 ) and Caucasian ( 88.9 % ) . The intervention group reported more events but the difference was not significantly different ( χ(2 ) = 1.18 , p = 0.26 ) . There was no difference in survival time between groups ( χ(2 ) = 1.53 , p = 0.216 ) . In paired t-tests , the intervention group had significantly improved self-care maintenance , management and confidence scores ( all p improved self-care maintenance and management ( both p were higher in the intervention group compared with usual care ( 18.0 vs. 12.9 points ) . CONCLUSIONS HF symptom awareness training appeared to have an early but not sustained benefit result ing in no difference in 90-day event-free survival . However , larger improvement in self-care maintenance and confidence scores in the intervention group compared to usual care is promising . Embedding meaningful symptom monitoring strategies in self-care maintenance interventions requires further investigation",
"Context People with chronic conditions may need tailored , practical help for managing their conditions . Contribution This 12-month trial of assistance with managing systolic- dysfunction heart failure r and omly assigned 406 ethnically diverse adults from Harlem , New York , to usual care or nurse management . Nurses counseled nurse management patients about sodium intake , fluid buildup , medication adherence , and self-management of symptoms ; served as a bridge between patients and physicians ; and regularly called patients to discuss problems . Compared with usual care patients , nurse management patients had fewer hospitalizations and better functioning . Implication s Nurse management can improve some outcomes in ethnically diverse patients with systolic-dysfunction heart failure in ambulatory practice s. The Editors Heart failure disproportionately affects black and elderly people and is a leading cause of hospitalization among people 65 years of age or older ( 1 , 2 ) . Although effective therapies can improve functioning and survival in patients with systolic dysfunction , many patients may not be receiving the full benefit of existing knowledge ( 35 ) . Patients play a critical role in managing a chronic condition , such as heart failure . Patients may not realize that specific symptoms are related to heart failure or that adhering to medications and diet can reduce symptoms and life-threatening episodes ( 6 ) . Evidence -based guidelines for systolic dysfunction recommend that physicians not only offer patients effective therapies but also teach them the importance of adherence and self-monitoring ( 3 , 4 ) . Clinicians have fallen short in prescribing angiotensin-converting enzyme inhibitors and -blockers for patients with systolic dysfunction ( 5 , 7 , 8) . When prescribed , the doses have often been lower than those proven to convey greater benefits ( 3 , 9 ) . Clinicians have also documented counseling only a fraction of patients with heart failure about self-management ( 10 , 11 ) . System-related factors may also influence patients ' ability to obtain quality care ( 12 , 13 ) . Systematic review s of clinical behavior change have suggested that interventions targeted to specific problems are more likely to be successful ( 14 , 15 ) . On the basis of shortfalls identified in patient self-management and clinical care in Harlem , New York , a predominately nonwhite area , we tailored a nurse management intervention to address documented problems and evaluated its effectiveness in a r and omized , controlled trial . Our trial among primarily minority patients addresses important gaps in the literature . We targeted problems documented among patients with heart failure in Harlem , enrolled patients from ambulatory care practice s , r and omly assigned patients to either nurse management or usual care , and evaluated the patients ' subsequent health-related outcomes . We hypothesized that patients in the focused nurse management program would have fewer hospitalizations and report better functioning than patients in usual care . Methods Development of the Intervention During interviews with patients with heart failure at Mount Sinai Hospital , New York , New York , patients reported inadequate underst and ing of heart failure and their role in managing it ( 6 ) . Less than half of patients followed a very-low-salt diet , and only about one quarter weighed themselves daily . Regarding clinical management , medical records noted prescriptions for an angiotensin-converting enzyme inhibitor or hydralazinedinitrate combination in 82 % of 322 consecutive black patients with documented systolic dysfunction who were scheduled for visits at the general medicine clinic at Harlem Hospital from February 1995 through February 1997 . The prescribed doses , however , equaled or exceeded those found to be efficacious in clinical trials in only 26 % of these patients ( 3 ) . In design ing a nurse management intervention to address these problems , we built on a Stanford University program that evaluated primarily privately insured patients at Kaiser Permanente in northern California ( 16 , 17 ) . We adapted their question naire on the frequency of foods eaten to incorporate those that are common among African-American and Hispanic people in Harlem . Setting s and Recruitment All 4 hospitals in Harlem , the area 's major providers , collaborated in the trial : 1 large private academic medical center ( 1171 beds ) , 2 medium-sized municipal hospitals ( 286 beds and 363 beds ) , and 1 smaller private community hospital ( 200 beds ) . In 2000 , these hospitals had 521 , 267 , 218 , and 168 discharges for the heart failure diagnosis-related group ( code 127 ) , respectively . All are not-for-profit institutions . The trial had the following inclusion criteria : adults 18 years of age or older ; systolic dysfunction documented on a cardiac test ( echocardiography , radionuclide ventriculography , myocardial stress sestamibi or thallium stress testing , or left-heart catheterization ) ; English- language or Spanish- language speakers ; community-dwelling at enrollment ; and current patient in a general medicine , geriatrics , or cardiology clinic or office at a participating site . Exclusion criteria were medical conditions that prevented interaction with the nurse , including blindness , deafness , or cognitive impairment ; medical conditions requiring individualized management that might differ from st and ard protocol , namely pregnancy , renal dialysis , or terminal illness ; or procedures that corrected systolic dysfunction , such as heart transplantation . Of the 216 clinicians ( 209 physicians and 7 physicians ' assistants or nurse practitioners ) in participating practice s , 1 clinician declined permission to recruit his patients . The institutional review boards for each site approved the study . We identified patients with International Classification of Diseases , Ninth Revision , Clinical Modification ( ICD-9-CM ) , and diagnosis-related group codes on outpatient or inpatient billings for heart failure , March 1999 through February 2001 , who had at least 1 clinician visit to a participating practice and impaired systolic dysfunction . We defined impaired systolic dysfunction as a left ventricular ejection fraction less than 0.40 or moderately or severely reduced systolic dysfunction on echocardiography , radionuclide ventriculography , myocardial stress sestamibi or thallium stress testing , or left-heart catheterization . We obtained clinicians ' permission to recruit specific patients and sent each approved patient a letter from the site 's physician coordinator . Bilingual recruiters telephoned eligible patients or approached them at scheduled clinician appointments . The recruiter confirmed each patient 's eligibility , obtained written informed consent to participate in the study , conducted the baseline survey , and telephoned the project manager for the treatment group assignment . The recruiter conveyed the assignment to the patient and , for each nurse management patient , scheduled the in-person appointment with a nurse . We provided telephone service for 3 patients who did not have it so we could telephone patients in both treatment groups every 3 months for data on end points and so nurse management patients could participate in the intervention . R and omization and Treatment Groups The project 's statistician used a computer-generated , r and om-number sequence without blocking or stratification to central ly determine r and omization assignments and concealed treatment group assignments in sealed , opaque envelopes . Usual care patients received federal consumer guidelines for managing systolic dysfunction but no other intervention ( 18 ) . In the nurse management intervention , 1 of 3 trained registered nurses met once with each patient ( Table 1 ) . In counseling the patient , the nurse stressed the relationship among sodium intake ; fluid buildup ; and symptoms , such as shortness of breath . Nurses mailed patients the reports from the food-frequency question naire after each administration . The nurse also served as a bridge between the patient and the clinician ( Table 1 ) . A local clinical advisory committee implemented national evidence -based guidelines , and a committee of key clinicians from participating sites approved the protocol ( 3 , 4 ) . Nurses contacted patients ' clinicians to discuss specific medications and arranged any prescription changes and examinations ordered ( Table 1 ) . An internist monitored the nurses ' work , initially in weekly and then in biweekly meetings , and a cardiologist provided oversight and substituted for the internist at regular meetings , as necessary . Table 1 . Components of Nurse Management * One nurse who was bilingual in English and Spanish delivered the intervention primarily at the 2 municipal hospitals , a second bilingual nurse delivered the intervention primarily at the small community hospital , and the second and a third English- language speaking nurse delivered the intervention primarily at the academic center . All 3 nurses covered each other , especially for the follow-up telephone calls . Outcomes and Measurement To measure hospitalizations , we used billing data from the 4 participating hospitals . At quarterly telephone surveys , interviewers who were blinded to treatment assignment asked patients about hospitalizations at nonparticipating hospitals ; however , we present the analysis of billing data because they measure hospitalizations independent of possibly socially acceptable responses or survey nonresponse of the patients . For functional status , we used the generic Short Form-12 ( SF-12 ) physical component score and the condition-specific Minnesota Living with Heart Failure ( MLHF ) Question naire , with both scales administered at the quarterly interviews . We measured deaths recorded in the National Death Index plus deaths reported by patients ' families for patients with no subsequent billings . Since both nurse management and usual care involved only services delivered in routine practice , the study did not monitor adverse effects . As required by the",
"Background . The growing number of patients with congestive heart failure has increased both the pressure on hospital re sources and the need for community management of the condition . Improving hospital-to-home transition for this population is a logical step in responding to current practice guidelines ’ recommendations for coordination and education . Positive outcomes have been reported from trials evaluating multiple interventions , enhanced hospital discharge , and follow-up through the addition of a case management role . The question remains if similar gains could be achieved working with usual hospital and community nurses . Methods . A 12-week , prospect i ve , r and omized controlled trial was conducted of the effect of transitional care on health-related quality of life ( disease-specific and generic measures ) , rates of readmission , and emergency room use . The nurse-led intervention focused on the transition from hospital-to-home and supportive care for self-management 2 weeks after hospital discharge . Results . At 6 weeks after hospital discharge , the overall Minnesota Living with Heart Failure Question naire ( MLHFQ ) score was better among the Transitional Care patients ( 27.2 ± 19.1 SD ) than among the Usual Care patients ( 37.5 ± 20.3 SD;P = 0.002 ) . Similar results were found at 12 weeks postdischarge for the overall MLHFQ and at 6- and 12-weeks postdischarge for the MLHFQ ’s Physical Dimension and Emotional Dimension subscales . Differences in generic quality life , as assessed by the SF-36 Physical component , Mental Component , and General Health subscales , were not significantly different between the Transition and Usual Care groups . At 12 weeks postdischarge , 31 % of the Usual Care patients had been readmitted compared with 23 % of the Transitional Care patients ( P = 0.26 ) , and 46 % of the Usual Care group visited the emergency department compared with 29 % in the Transitional Care group ( & khgr;2 = 4.86 , df 1 , P = 0.03 ) . Conclusions . There were significant improvements in health-related quality of life ( HRQL ) associated with Transitional Care and less use of emergency rooms",
"BACKGROUND Outcomes related to chronic heart failure ( HF ) remain relatively poor , despite advances in pharmacological therapy and medical and nursing care . Experts agree that outpatient care may be among the factors that affect HF outcomes . We hypothesized that the method by which outpatient care is delivered may affect outcomes in this patient population . METHODS A prospect i ve , r and omized design was used to compare HF outcomes from 216 patients r and omized to 1 of 2 home health care delivery methods for 3 months after discharge . Care was delivered by the home nurse visit ( HNV ) or the nurse telemanagement ( NTM ) method . In the latter , patients used transtelephonic home monitoring devices to measure their weight , blood pressure , heart rate , and oxygen saturation . These data were transmitted daily to a secure Internet site . An advanced- practice nurse worked collaboratively with a cardiologist and subsequently treated patients via the telephone . Both delivery methods used the same HF-specific clinical guidelines to direct care . Outcomes include HF readmissions and length of stay , anxiety , depression , self-efficacy , and quality of life . Data were primarily tested using a 2-group analysis of variance ( ANOVA ) . We used a repeated- measures ANOVA to conduct preintervention-postintervention analyses . RESULTS After 3 months , patients in the NTM group ( n = 108 ; mean + /- SD age , 62.9 + /- 13.2 years ; 83 % African American ; 64 % female ) had fewer HF readmissions ( 13 vs 24 ; P lengths of stay ( 49.5 vs 105.0 days ; P HNV group ( n = 108 ; mean + /- SD age , 63.2 + /- 12.6 years ; 89 % African American ; 62 % female ) . Hospitalization charges at 3 months were less in the NTM group compared with the HNV group ( $ 65 023 vs $ 177 365 ; P cumulative readmission charges in the NTM group were also less ( $ 223 638 vs $ 500 343 [ P Quality of life was significantly improved for both groups when we compared postintervention and preintervention scores . CONCLUSION The adaptation of state-of-the-art computerized technology to closely monitor patients with HF with advanced- practice nurse care under the guidance of a cardiologist significantly improves HF management while reducing the cost of care",
"BACKGROUND We sought to determine if outcomes with exercise training in heart failure ( HF ) vary according to ventricular pacing type . METHODS AND RESULTS Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ( HF-ACTION ) r and omized 2,331 out patients with HF and left ventricular ejection fraction ≤35 % to usual care plus exercise training or usual care alone . We examined the relationship between outcomes and r and omized treatment according to ventricular pacing status with the use of Cox proportional hazards modeling . In HF-ACTION 1,118 patients ( 48 % ) had an implanted cardiac rhythm device : 683 with right ventricular ( RV ) and 435 with biventricular ( BiV ) pacemakers . Patients with pacing devices were older , more frequently white , and had lower peak VO2 ( P all ) . Peak VO2 improved similarly with training in groups with and without pacing devices . The primary composite end point-all-cause death or hospitalization-was reduced only in patients r and omized to exercise training without a device ( hazard ratio [ HR ] 0.79 , 95 % confidence interval [ CI ] 0.67 - 0.93 [ P = .004 ] ; RV lead : HR 1.04 , 95 % CI 0.84 - 1.28 [ P = .74 ] ; BiV pacing : HR 1.05 , 95 % CI 0.82 - 1.34 [ P = .72 ] ; interaction P = .058 ) . CONCLUSIONS Exercise training may improve exercise capacity in patients with implanted cardiac devices . However , the apparent beneficial effects of exercise on hospitalization or death may be attenuated in patients with implanted cardiac devices and requires further study",
"BACKGROUND We examined the effect of a home-based intervention ( HBI ) on readmission and death among \" high-risk \" patients with congestive heart failure discharged home from acute hospital care . METHODS Hospitalized patients with congestive heart failure and impaired systolic function , intolerance to exercise , and a history of 1 or more hospital admissions for acute heart failure were r and omized to either usual care ( n=48 ) or HBI at 1 week after discharge ( n=49 ) . Home-based intervention comprised a single home visit ( by a nurse and pharmacist ) to optimize medication management , identify early clinical deterioration , and intensify medical follow-up and caregiver vigilance as appropriate . The primary end point of the study was frequency of unplanned readmissions plus out-of-hospital deaths within 6 months of discharge . Secondary end points included duration of hospital stay and overall mortality . RESULTS During follow-up , patients in the HBI group had fewer unplanned readmissions ( 36 vs 63 ; P=.03 ) and fewer out-of-hospital deaths ( 1 vs 5 ; P=.11 ) : 0.8+/-0.9 vs 1.4+/-1.8 ( mean + /- SD ) events per patient assigned to HBI and usual care , respectively ( P=.03 ) . Patients in the HBI group also had fewer days of hospitalization ( 261 vs 452 ; P=.05 ) and fewer total deaths ( 6 vs 12 ; P=.11 ) . Patients assigned to usual care were more likely to experience 3 or more readmissions for acute heart failure ( P=.02 ) . Predictors of unplanned readmission were ( 1 ) 14 days or more of unplanned readmission during the 6 months before study entry ( odds ratio [ OR ] , 5.2 ; 95 % confidence interval [ CI ] , 1.8 - 16.2 ) , ( 2 ) previous admission for acute myocardial ischemia ( OR , 3.3 ; 95 % CI , 1.2 - 9.1 ) , and ( 3 ) an albumin plasma concentration of 38 g/L or less ( OR , 2.4 ; 95 % CI , 1.2 - 6.0 ) . Home-based intervention was also associated with a trend toward reduced risk of unplanned readmission ( OR , 0.4 ; 95 % CI , 0.2 - 1.1 ) . CONCLUSION Among a cohort of high-risk patients with congestive heart failure , HBI was associated with reduced frequency of unplanned readmissions plus out-of-hospital deaths within 6 months of discharge from the hospital",
"Background : This study evaluated the effectiveness of using trained volunteer staff in reducing 30-day readmissions of congestive heart failure ( CHF ) patients . Methods : From June 2010 to December 2010 , 137 patients ( mean age 73 years ) hospitalized for CHF were r and omly assigned to either : an interventional arm ( arm A ) receiving dietary and pharmacologic education by a trained volunteer , follow-up telephone calls within 48 hours , and a month of weekly calls ; ora control arm ( arm B ) receiving st and ard care . Primary outcomes were 30-day readmission rates for CHF and worsening New York Heart Association ( NYHA ) functional classification ; composite and all-cause mortality were secondary outcomes . Results : Arm A patients had decreased 30-day readmissions ( 7 % vs 19 % ; P ! .05 ) with a relative risk reduction ( RRR ) of 63 % and an absolute risk reduction ( ARR ) of 12 % . The composite outcome of 30-day readmission , worsening NYHA functional class , and death was decreased in the arm A ( 24 % vs 49%;P ! .05 ; RRR 51 % , ARR 25 % ) . St and ard-care treatment and hypertension , age $ 65 years and hypertension , and cigarette smoking were predictors of increased risk for readmissions , worsening NYHA functional class , and all-cause mortality , respectively , in the multivariable analysis . Conclusions : Utilizing trained volunteer staff to improve patient education and engagement might be an efficient and low-cost intervention to reduce CHF readmissions",
"OBJECTIVE The objective of the study was to evaluate the effectiveness of a single home-based educational intervention for patients admitted with heart failure . METHODS There were 106 patients : 42 in the intervention group and 64 in the control group . Patients were r and omly assigned to receive an intervention by nursing staff 1 week after discharge . Primary end points were readmissions , emergency department visits , deaths , costs , and quality of life . RESULTS During the 24-month follow-up , there were fewer mean emergency department visits in the intervention group than in the control group ( .68 vs 2.00 ; P = .000 ) , fewer unplanned readmissions ( .68 vs 1.71 ; P = .000 ) , and lower costs ( € 671.56 = $ 974.63 = GBP598.42 per person vs € 2,154.24 = $ 3,126.01 = GBP1,919.64 ; P = .001 ) . There was a trend toward fewer out-of-hospital deaths ( 14 [ 46.6 % ] vs 31 [ 55.3 % ] ; P = .45 ) and improvement in quality of life . CONCLUSION Patients with heart failure who receive a home-based educational intervention experience fewer emergency department visits and unplanned readmissions with lower healthcare costs ",
"BACKGROUND Heart failure is a common and important cause of morbidity and mortality . Disease management offers promise in reducing the need for hospitalization and improving quality of life for heart failure patients , but experimental data on the efficacy of such programs are limited . METHODS AND RESULTS A total of 151 patients hospitalized with heart failure were r and omized to usual care or scheduled telephone calls by specially trained nurses promoting self-management and guideline -based therapy as prescribed by primary physicians . Nurses also screened patients for heart failure exacerbations , which they managed with supplemental diuretics or by contacting the primary physician for instructions . Outcomes included time to hospital encounter , mortality , number and cost of hospitalizations , functional status , and satisfaction with care . Intervention patients had a longer time to encounter ( hazard ratio [ HR ] = 0.67 ; 95 % confidence interval [ CI ] 0.47 - 0.96 ; P = .029 ) , hospital readmission ( HR = 0.67 ; CI 0.46 - 0.99 ; P = .045 ) , and heart failure-specific readmission ( HR = 0.62 ; CI 0.38 - 1.03 ; P = .063 ) . The number of admissions , hospital days , and hospital costs were significantly lower during the first 6 months after intervention but not at 1 year . The intervention had little effect on functional status , mortality , and satisfaction with care . CONCLUSION A nurse-administered , telephone-based disease management program delayed subsequent health care encounters , but had minimal impact on other outcomes",
"Despite efforts to improve the discharge planning process and subsequent outcomes , existing mechanisms fail to accurately identify elders ' needs for follow-up care . Studies report rehospitalization rates ranging from 12 to 50 % . The two aims of this study were to ( 1 ) examine the difference in outcomes for elders hospitalized with heart failure and caregivers who participated in a professional-patient partnership model of discharge planning compared to those who received the usual discharge planning and ( 2 ) examine differences in costs associated with hospital readmission and use of the emergency room following hospital discharge . A before- and -after nonequivalent control group design was used for this study . Data were collected from the control and the intervention cohorts before discharge and at 2 weeks and 2 months postdischarge . One hundred and fifty-eight patient-caregiver dyads completed both the predischarge and 2-weeks postdischarge interviews ; 140 also completed a 2-month follow up . The average age of elders was 73.7 years ; the average age of the caregivers was 58.5 years . The findings indicated that elders in the intervention cohort felt more prepared to manage care , reported more continuity of information about care management and services , felt they were in better health , and when readmitted spent fewer days in the hospital than the control cohort . Caregivers in the intervention cohort also reported receiving more information about care management and having a more positive reaction to caregiving 2 weeks postdischarge than the control cohort",
"Objective : To evaluate the effects of a nurse based outpatient management programme for elderly patients discharged with heart failure from a university hospital . Design : Patients with heart failure ( New York Heart Association class II – IV ) and left ventricular systolic dysfunction aged 60 years or more were r and omly assigned to follow up within the management programme or to conventional follow up , usually in primary care . Of the 208 participants , 58 % were men , mean age was 75 years , and mean ejection fraction 34 % . All patients were scheduled for three observational study visits at six month intervals . The primary end point was quality of life ( QoL ) and secondary end points were hospitalisation and mortality . Results : More patients achieved target doses of angiotensin converting enzyme ( ACE ) inhibitors in the intervention group than in the control group ( 82 % v 69 % , 88 % v 69 % , and 88 % v 74 % of recommended target doses at 6 , 12 , and 18 months of follow up , respectively , p low QoL had a poor prognosis . After a mean 1122 days of follow up , 82 % of all patients had been readmitted . There were on average 4.7 readmissions per patient and 66 % were due to non-cardiac diagnoses . There were no differences in QoL or health care consumption between the two study groups during follow up . Conclusion : A nurse based management programme is more effective than follow up in primary care in optimising medication for elderly patients with heart failure . However , such a programme does not seem to have a favourable influence on QoL or readmission rate during long term follow up",
"AIMS To determine the effect of an integrated heart failure management programme , involving patient and family , primary and secondary care , on quality of life and death or hospital readmissions in patients with chronic heart failure . METHODS AND RESULTS This trial was a cluster r and omized , controlled trial of integrated primary / secondary care compared with usual care for patients with heart failure . The intervention involved clinical review at a hospital-based heart failure clinic early after discharge , individual and group education sessions , a personal diary to record medication and body weight , information booklets and regular clinical follow-up alternating between the general practitioner and heart failure clinic . Follow-up was for 12 months . One hundred and ninety-seven patients admitted to Auckl and Hospital with an episode of heart failure were enrolled in the study . There was no significant difference between the intervention and control groups for the combined end-point of death or hospital readmission . The physical dimension of quality of life showed a greater improvement in the intervention group from baseline to 12 months compared with the control group ( -11.1 vs -5.8 respectively , 2 P=0.015 ) . The main effect of the intervention was attributable to the prevention of multiple admissions ( 56 intervention group vs 95 control group , 2 P=0.015 ) and associated reduction in bed days . CONCLUSIONS This integrated management programme for patients with chronic heart failure improved quality of life and reduced total hospital admissions and total bed days",
"INTRODUCTION AND OBJECTIVES Home-based interventions after hospital discharge in patients with heart failure ( HF ) have been shown to decrease readmission and mortality rates . The primary aim of this study was to determine the effect of a home-based educational intervention carried out by nursing staff on the readmission rate , emergency department visits , and healthcare costs . PATIENTS AND METHOD Patients hospitalized with systolic HF were r and omly assigned to receive either usual care or a single home-based educational intervention 1 week after discharge . RESULTS Between July 2001 and November 2002 , 70 patients entered the study : 34 in the intervention group and 36 in the control group . During the 6-month follow-up , there were fewer unplanned readmissions in the intervention group than in the control group ( 0.09 vs 0.94 ; P emergency department visits ( 0.21 vs 1.33 ; P out-of-hospital deaths ( 2 vs 11 ; P Costs were also significantly lower in the intervention group ( difference , ; 1190.9 ; P patient-perceived health status , as indicated by scores on a quality -of-life question naire , increased significantly in the intervention group . CONCLUSIONS In a cohort of patients with systolic HF who received a home-based educational intervention there were significant reductions in the unplanned readmission rate , mortality , and healthcare costs , and better quality of life . Some limitations of the study warrant validation of the result ats in further studies",
"Background —Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure , the benefit attributable to patient education alone is not known . We hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure . Methods and Results —We conducted a r and omized , controlled trial of 223 systolic heart failure patients and compared the effects of a 1-hour , one-on-one teaching session with a nurse educator to the st and ard discharge process . Subjects were contacted by telephone at 30 , 90 , and 180 days to collect information about clinical events , symptoms , and self-care practice s. The primary end point of the study was the total number of days hospitalized or dead in the 180-day follow-up period . Subjects r and omized to receive the teaching session ( n=107 ) had fewer days hospitalized or dead in the follow-up period ( 0 and 10 days , median and 75th percentiles ) than did controls ( n=116 , 4 and 19 days ; P=0.009 ) . Patients receiving the education intervention had a lower risk of rehospitalization or death ( relative risk , 0.65 ; 95 % confidence interval , 0.45 to 0.93 ; P=0.018 ) . Costs of care , including the cost of the intervention , were lower in patients receiving the education intervention than in control subjects by $ 2823 per patient ( P=0.035 ) . Conclusions —The addition of a 1-hour , nurse educator – delivered teaching session at the time of hospital discharge result ed in improved clinical outcomes , increased self-care measure adherence , and reduced cost of care in patients with systolic heart failure",
"OBJECTIVE To evaluate the effectiveness of a Transcendental Meditation ( TM ) stress reduction program for African Americans with congestive heart failure ( CHF ) . DESIGN R and omized , controlled study PARTICIPANTS AND INTERVENTION We recruited 23 African American patients > or = 55 years of age who were recently hospitalized with New York Heart Association class II or III CHF and with an ejection fraction of TM or health education ( HE ) group . MAIN OUTCOME MEASURES Primary outcome measure was six-minute walk test ; secondary outcomes were generic and disease-specific health-related quality of life , quality of well being , perceived stress , Center for Epidemiologic Studies Depression Scale ( CES-D ) , rehospitalizations , brain natriuretic peptide , and cortisol . Changes in outcomes from baseline to three and six months after treatment were analyzed by using repeated measures analysis of variance , covarying for baseline score . RESULTS For the primary outcome of functional capacity , the TM group significantly improved on the six-minute walk test from baseline to six months after treatment compared to the HE group ( P = .034 ) . On the secondary outcome measures , the TM group showed improvements in SF-36 subscales and total score on the Minnesota Living with Heart Failure scale . On the CES-D , the TM group showed significant decrease from baseline to six months compared to the HE group ( P = .03 ) . Also , the TM group had fewer rehospitalizations during the six months of followup . CONCLUSIONS Results indicate that TM can be effective in improving the quality of life and functional capacity of African American CHF patients . Further validation of outcomes is planned via a large , multicenter trial with long-term follow-up",
"INTRODUCTION AND OBJECTIVES The objective of this study was to determine whether a home-based intervention can reduce mortality and hospital readmissions and improve quality of life in patients with heart failure . METHODS A r and omized clinical trial was carried out between January 2004 and October 2006 . In total , 283 patients admitted to hospital with a diagnosis of heart failure were r and omly allocated to a home-based intervention ( intervention group ) or usual care ( control group ) . The primary end-point was the combination of all-cause mortality and hospital readmission for worsening heart failure at 1-year follow-up . RESULTS The primary end-point was observed in 41.7 % of patients in the intervention group and in 54.3 % in the control group . The hazard ratio was 0.70 ( 95 % confidence interval [ CI ] 0.55 - 0.99 ) . Taking significant clinical variables into account slightly reduced the hazard ratio to 0.62 ( 95 % CI 0.50 - 0.87 ) . At the end of the study , the quality of life of patients in the intervention group was better than in the control group ( 18.57 vs. 31.11 ; P intervention for patients with heart failure reduced the aggregate of mortality and hospital readmissions and improved quality of life",
"INTRODUCTION AND OBJECTIVES To determine the effectiveness of a primarily educational intervention in heart failure ( HF ) patients implemented in a home care unit . METHODS This r and omized controlled clinical trial involved 279 HF patients who were discharged from a tertiary-care hospital between February 2001 and June 2002 . Patients with dementia , terminal non-cardiac disease , or chronic obstructive pulmonary disease were excluded . Data collected included the cause of cardiac decompensation . A primarily educational intervention was implemented in the patient 's home for up to 15 days after hospital discharge . Treatment was adjusted during the first week if necessary . The primary outcome measure was the 1-year cumulative incidence of readmission or death . Secondary measures were the incidence of readmission , mortality , and emergency department admission . Telephone interviews were carried out 3 , 6 and 12 months after discharge , and clinical records were up date d when necessary . Emergency department admission in the first 6 months was monitored . RESULTS At 1-year follow-up , 62 of the 137 patients ( 45.3 % ) in the intervention group had been readmitted or died , compared with 75 of the 142 ( 52.8 % ) in the control group , ( relative risk=0.86 , P=.232 ) . Among patients who suffered decompensation because failure to adhere to treatment , 16 of the 45 ( 35.6 % ) in the intervention group were readmitted or died , compared with 34 of the 56 ( 60.7 % ) control group patients ( relative risk=0.59 , P=.016 ) . CONCLUSIONS This intervention is feasible but , when applied indiscriminately to every discharged heart failure patient , the best that can be expected is only a modest reduction in readmission and death rates , which , in this study in particular , did not achieve statistical significance",
"BACKGROUND Despite the availability of proven therapies , outcomes in patients with heart failure ( HF ) remain poor . In this 2-stage , multicenter trial , we evaluated the effect of a disease management program on clinical and economic outcomes in patients with HF . METHODS AND RESULTS In Stage 1 , a pharmacist or nurse assessed each patient and made recommendations to the physician to add or adjust angiotensin-converting enzyme ( ACE ) inhibitors and other HF medications . Before discharge ( Stage 2 ) , patients were r and omized to a patient support program ( PSP ) ( education about HF , self-monitoring , adherence aids , newsletters , telephone hotline , and follow-up at 2 weeks , then monthly for 6 months after discharge ) or usual care . In Stage 1 ( 766 patients ) ACE inhibitor use increased from 58 % on admission to 83 % at discharge ( P dose ( in enalapril equivalents ) increased from 11.3 + /- 8.8 mg to 14.5 + /- 8.8 mg ( P Stage 2 ( 276 patients ) there was no difference in ACE inhibitor adherence , but a reduction in cardiovascular-related emergency room visits ( 49 versus 20 , P = .030 ) , hospitalization days ( 812 versus 341 , P = .003 ) , and cost of care ( 2,531 Canadian dollars less per patient ) in favor of the PSP . CONCLUSION Simple interventions can improve ACE inhibitor use and patient outcomes",
"BACKGROUND Hospital admissions among patients with congestive heart failure ( CHF ) are a major contributor to health-care costs . Previous investigations suggest that the therapeutic efficacy of pharmacotherapy in CHF may be improved by strategies incorporating home visits to identify and address factors precipitating deterioration and result ant readmission . METHODS Chronic CHF patients discharged home after acute hospital admission were r and omly assigned usual care ( n=100 ) or a multidisciplinary , home-based intervention ( n=100 ) , consisting of a home visit by a cardiac nurse 7 - 14 days after discharge . The primary endpoint of the study was frequency of unplanned readmission plus out-of-hospital death within 6 months . FINDINGS During 6 months ' follow-up there were 129 primary endpoint events in the usual-care group and 77 in the intervention group ( p=0.02 ) . More intervention-group than usual-care patients remained event-free ( 38 vs 51 ; p=0.04 ) . Overall , there were fewer unplanned readmissions ( 68 vs 118 ; p=0.03 ) and associated days in hospital ( 460 vs 1173 ; p=0.02 ) among intervention-group patients . Hospital-based costs were Australian $ 490,300 for the intervention group and A$ 922,600 for the usual-care group ( p=0.16 ) ; the mean cost of the intervention was A$ 350 per patient , and other community-based costs were similar for both groups . INTERPRETATION A home-based intervention has the potential to decrease the rate of unplanned readmissions and associated health-care costs , prolong event-free and total survival , and improve quality of life among patients with chronic CHF",
"HF is a leading health care concern , often under-recognized and under-treated in older women . Management of this complex condition frequently requires a multidisciplinary approach and a clinical pathway can be used to deliver coordinated care . This report is based on the intervention/treatment arm ( n = 45 ) of a r and omized controlled trial in older women who participated in a multidisciplinary clinic . We describe the development of a clinical pathway for HF and the variance reporting including factors affecting adherence with the pathway . Variances are patient or staff actions that did not meet the expected outcomes . Of the 45 intervention arm female patients , 5 were able to fully complete the program , meaning that all of the intended 12 visits were completed successfully . Thirteen women missed more than three clinic visits , and the rest attended most visits . Variance tracking identified that visits were interrupted most often by patient-related health issues , such as fatigue and pain , which may not be surprising given the expected multiple co-morbidities in this population . Transportation problems were identified as a barrier to attendance . Our study demonstrates that a clinical pathway can be implemented in an older , female population with HF . This report identifies some of the challenges and provides future recommendations for prospect i ve pathway development",
"AIMS This paper is a report on the effectiveness of a self-management programme based on the self-efficacy construct , in older people with heart failure . BACKGROUND Heart failure is a major health problem worldwide , with high mortality and morbidity , making it a leading cause of hospitalization . Heart failure is associated with a complex set of symptoms that arise from problems in fluid and sodium retention . Hence , managing salt and fluid intake is important and can be enhanced by improving patients ' self-efficacy in changing their behaviour . DESIGN R and omized controlled trial . METHODS Heart failure patients attending cardiac clinics in northern Taiwan from October 2006-May 2007 were r and omly assigned to two groups : control ( n = 46 ) and intervention ( n = 47 ) . The intervention group received a 12-week self-management programme that emphasized self-monitoring of salt/fluid intake and heart failure-related symptoms . Data were collected at baseline as well as 4 and 12 weeks later . Data analysis to test the hypotheses used repeated- measures anova models . RESULTS Participants who received the intervention programme had significantly better self-efficacy for salt and fluid control , self-management behaviour and their heart failure-related symptoms were significantly lower than participants in the control group . However , the two groups did not differ significantly in health service use . CONCLUSION The self-management programme improved self-efficacy for salt and fluid control , self-management behaviours , and decreased heart failure-related symptoms in older Taiwanese out patients with heart failure . Nursing interventions to improve health-related outcomes for patients with heart failure should emphasize self-efficacy in the self-management of their disease",
"BACKGROUND The aim of this study was to determine the effects of a home-based exercise program on clinical outcomes . Exercise training improves exercise capacity in patients with heart failure ( HF ) but the long-term effects on clinical outcomes remain unknown . METHODS We r and omized 173 patients with systolic HF to control ( n = 87 ) or home-based exercise ( n = 86 ) . The primary end point was a composite of all-cause hospitalizations , emergency department admissions , urgent transplantation , and death at 12 months . Functional performance ( as assessed by cardiopulmonary exercise testing and the 6-minute walk test ) , quality of life , and psychological states were measured at baseline , 3 months , and 6 months . RESULTS There was no significant difference between experimental and control groups in the combined clinical end point at 12 months and in functional status , quality of life , or psychological states over 6 months . Patients in the exercise group had a lower incidence of multiple ( 2 or more ) hospitalizations compared with the control group : 12.8 % versus 26.6 % , respectively ( P = .018 ) . CONCLUSIONS A home-based walking program that incorporated aerobic and resistance exercise did not result in improved clinical outcomes at 1-year follow-up in this cohort of patients with systolic HF . However , the exercise program result ed in reduced rehospitalization rates",
"Exercise is an important behavior for long-term weight control in overweight and obese patients . However , little evidence exists confirming such findings in patients with advanced heart failure ( HF ) . Using a prospect i ve , experimental design , the effects of 24 weeks of a low-level , home-based walking program on weight loss were studied in overweight and obese ( body mass index > or = 27 kg/m(2 ) ) patients with advanced HF who were r and omized to exercise ( n = 48 ) and control ( n = 51 ) groups . Weight changes between the 2 groups at baseline and 6 months were compared using repeated- measures analysis of variance . Patients were on average aged 53.3 + /- 10.1 years and predominantly male ( 75 % ) , Caucasian ( 57 % ) , and married ( 55 % ) . Most patients were in New York Heart Association class III or IV ( 67 % ) , with a mean ejection fraction of 25 % . Patients in the exercise group showed significant weight reduction from baseline to 6 months compared with those in the control group ( -6.37 + /- 11.7 vs -0.33 + /- 9.3 kg , p = 0.002 ) . No significant differences were noted between the 2 groups in 6-minute walk distance or depression , although the changes were in the anticipated direction . Modest weight losses of > 5 % were associated with cardiopulmonary exercise test-documented workload levels at 6 months ( r = 0.331 , p = 0.006 ) , as well as decreased depression ( r = -0.315 , p = 0.01 ) and hostility ( r = -0.355 , p = 0.005 ) . The number of hospital admissions was significantly smaller for patients in the exercise group compared with those in the control group ( 0.63 + /- 0.94 vs 1.07 + /- 0.95 , p low-level , home-based walking program on weight loss in overweight and obese patients with advanced HF",
"OBJECTIVE The purpose of this study was to determine the effect of a tailored message intervention on heart failure readmission rates , quality of life , and health beliefs in persons with heart failure ( HF ) . DESIGN This r and omized control trial provided a tailored message intervention during hospitalization and 1 week and 1 month after discharge . Theoretic framework The organizing framework was the Health Belief Model . SUBJECTS Seventy persons with a primary diagnosis of chronic HF were included in the study . RESULTS HF readmission rates and quality of life did not significantly differ between the treatment and control groups . Health beliefs , except for benefits of medications , significantly changed from baseline in the treatment group in directions posited by the Health Belief Model . CONCLUSIONS A tailored message intervention changed the beliefs of the person with HF in regard to the benefits and barriers of taking medications , following a sodium-restricted diet , and self-monitoring for signs of fluid overload . Future research is needed to explore the effect of health belief changes on actual self-care behaviors",
"BACKGROUND A growing body of evidence suggests that the fluid accumulation plays a key role in the pathophysiology of heart failure ( HF ) and that the inflammatory and neurohormonal activation contribute strongly to the progression of this disorder . METHODS AND RESULTS The study evaluated the long-term effects of 2 different sodium diets on cytokines neurohormones , body hydration and clinical outcome in compensated HF out patients ( New York Heart Association Class II ) . A total of 173 patients ( 105 males , mean age 72.5+/-7 ) recently hospitalized for worsening advanced HF and discharged in normal hydration and in clinical compensation were r and omized in 2 groups ( double blind ) . In Group 1 , 86 patients received a moderate restriction in sodium ( 120mmol to 2.8g/day ) plus oral furosemide ( 125 to 250 mg bid ) ; in Group 2 , 87 patients : received a low-sodium diet ( 80mmol to 1.8g/day ) plus oral furosemide ( 125 to 250 mg bid ) . Both groups were followed for 12 months and the treatment was associated with a drink intake of 1000mL daily . Neurohormonal ( brain natriuretic peptide , aldosterone , plasma rennin activity ) and cytokines values ( tumor necrosis factor-alpha , interleukin-6 ) were significantly reduced with a significant increase of the anti-inflammatory cytokine interleukin-10 at 12 months in normal , P activation of neurohormones and cytokines and worsening the body hydration , whereas moderate sodium restriction maintained dry weigh and improved outcome in the long term . CONCLUSIONS Our results appear to suggest a surprising efficacy of a new strategy to improve the chronic diuretic response by increasing Na intake and limiting fluid intake . This counterintuitive approach underlines the need for a better underst and ing of factors that regulate sodium and water h and ling in chronic congestive HF . A larger sample of patients and further studies are required to evaluate whether this is due to the high dose of diuretic used or the low-sodium diet",
"We evaluated a structured pharmaceutical care program for elderly patients ( > 65 yrs ) with congestive heart failure ( CHF ) based on objective measures of disease control , quality of life , and use of health care facilities in a r and omized , controlled , longitudinal , prospect i ve clinical trial . The 42 patients in group A received education from a pharmacist on the disease and its treatment , and lifestyle changes that could help control symptoms . Patients also were encouraged to monitor their symptoms and comply with prescribed drug therapy . If necessary , dosage regimens were simplified in liaison with hospital physicians . The 41 control patients ( group B ) received st and ard care . The following outcome measures were assessed in all patients at baseline ( before the start of the trial ) and at 3 , 6 , 9 , and 12 months : 2-minute walk test , blood pressure , body weight , pulse , forced vital capacity , quality of life [ disease-specific ( Minnesota Living with Heart Failure question naire ) and generic ( SF-36 ) ] , knowledge of symptoms and drugs , compliance with therapy , and use of health care facilities ( hospital admissions , visits to emergency room , emergency calls ) . Patients in group A showed improved compliance with drug therapy , which in turn improved their exercise capacity compared with those in group B ; education on management of symptoms , lifestyle changes , and dietary recommendations were also of benefit . Group A patients significantly improved knowledge of their drug therapy over the 12-month study and had fewer hospital admissions compared with group B patients . They also had improved outcomes compared with group B , despite the small sample s. An extension of this trial to other sites with pooling of results would provide additional evidence of the value of this structured program in elderly patients with CHF",
"BACKGROUND The multidisciplinary approach to managing heart failure has been shown to improve outcomes . The role of a clinical pharmacist in treating heart failure has not been evaluated . METHODS One hundred eighty-one patients with heart failure and left ventricular dysfunction ( ejection fraction were r and omized to an intervention or a control group . Patients in the intervention group received clinical pharmacist evaluation , which included medication evaluation , therapeutic recommendations to the attending physician , patient education , and follow-up telemonitoring . The control group received usual care . The primary end point was combined all-cause mortality and heart failure clinical events . All clinical events were adjudicated by a blinded end point committee . RESULTS Baseline characteristics were similar except for slightly higher age in the intervention group . Median follow-up was 6 months . All-cause mortality and heart failure events were significantly lower in the intervention group compared with the control group ( 4 vs 16 ; P= .005 ) . In addition , patients in the intervention group received higher angiotensin-converting enzyme inhibitor doses as reflected by the median fraction of target reached ( 25th and 75th percentiles ) , 1.0 ( 0.5 and 1 ) and 0.5 ( 0.1875 and 1 ) in the intervention and control groups , respectively ( P use of other vasodilators in angiotensin-converting enzyme inhibitor-intolerant patients was higher in the intervention group ( 75 % vs 26 % ; P= .02 ) . CONCLUSIONS Outcomes in heart failure can be improved with a clinical pharmacist as a member of the multidisciplinary heart failure team . This observation may be due to higher doses of angiotensin-converting enzyme inhibitors and /or closer follow-up",
"Objective To study the effects of a management programme on hospitalisation and health care costs one year after admission for heart failure . Design Prospect i ve , r and omised trial . Setting University hospital with a primary catchment area of 250 000 inhabitants . Patients 190 patients ( aged 65–84 years , 52.3 % men ) hospitalised because of heart failure . Intervention Two types of patient management were compared . The intervention group received education on heart failure and self management , with follow up at an easy access , nurse directed outpatient clinic for one year after discharge . The control group was managed according to routine clinical practice . Main outcome measures Time to readmission , days in hospital , and health care costs during one year . Results The one year survival rate was 71.8 % ( n = 79 ) in the control group and 70.0 % ( n = 56 ) in the intervention group ( NS ) . The mean time to readmission was longer in the intervention group than in the control group ( 141 ( 87 ) v106 ( 101 ) ; p number of days in hospital tended to be fewer ( 4.2 ( 7.8 ) v 8.2 ( 14.3 ) ; p = 0.07 ) . There was a trend towards a mean annual reduction in health care costs per patient of US$ 1300 ( US$ 1 = SEK 7.76 ) in the intervention group compared with costs in the controls ( US$ 3594 v 2294 ; p = 0.07 ) . Conclusions A management programme for patients with heart failure discharged after hospitalisation reduces health care costs and the need for readmission ",
"BACKGROUND Patients with chronic heart failure characteristically have multiple hospital admissions for symptom control , deleteriously affecting their quality of life and imposing a burden on national healthcare costs . We assessed the effect of a novel transtelephonic monitoring and follow-up program on the admission rate and length of hospital stay as well as changes in their subjectively rated quality of life of patients with chronic heart failure . METHODS This prospect i ve 1-year study was conducted on compliant subscribers to ' SHL ' , a telecardiological service with > 60,000 subscribers , who were admitted > or = 2 times during the previous year for recurrent pulmonary edema or deterioration in heart failure . Their heart rate , blood pressure and body weight measurements were now automatically transmitted daily to ' SHL\"s data bank and added to stored and up date d medical records . A question naire survey acquired information on their quality of life . RESULTS The study cohort included 118 patients , mean age 75 years ( range 49 - 89 years ) , 65 % males , a II-IV class functional capacity and a 25 % ( range 10 - 39 % ) mean ejection fraction . There was a 66 % reduction in the total hospitalization days ( from 1623 in the year preceding study entry to 558 during the study period , p quality of life . CONCLUSIONS Data are provided to demonstrate that a transtelephonic system allowing primary care at the patient 's home can significantly reduce hospitalization rate and length of stay and significantly enhance the quality of life of patients with chronic heart failure",
"Studies have shown that patients with compensated heart failure ( HF ) receiving high diuretic doses associated with normal sodium diet and fluid intake restrictions demonstrated significant reductions in readmissions and mortality compared with those who received low-sodium diets , and over a 6-month observation period , a reduction in neurohormonal activation was also observed . The aim of this study was to evaluate the effects of different sodium diets associated with different diuretic doses and different levels of fluid intake on hospital readmissions and neurohormonal changes after 6-month follow-up in patients with compensated HF . Four hundred ten consecutive patients with compensated HF ( New York Heart Association class II to IV ) aged 53 to 86 years , with ejection fractions , were r and omized into 8 groups : group A ( n = 52 ) : 1,000 ml/day of fluid intake , 120 mmol/day , and 250 mg furosemide twice daily ; group B ( n = 51 ) : 1,000 ml/day of fluid intake , 120 mmol/day , and 125 mg furosemide twice daily ; group C ( n = 51 ) : 1,000 ml/day fluid intake , 80 mmol/day , and 250 mg furosemide twice daily ; group D ( n = 51 ) : 1,000 ml/day fluid intake , 80 mmol/day , and 125 mg furosemide twice daily ; group E ( n = 52 ) : 2,000 ml/day fluid intake , 120 mmol/day , and 250 mg furosemide twice daily ; group F ( n = 50 ) : 2,000 ml/day fluid intake , 120 mmol/day , and 125 mg furosemide twice daily ; group G ( n = 52 ) : 2,000 ml/day fluid intake , 80 mmol/day , and 250 mg furosemide twice daily ; and group H ( n = 51 ) : 2,000 ml/day fluid intake , 80 mmol/day , and 125 mg furosemide twice daily . All patients received the treatments > or=30 days after discharge and for 180 days afterward . Signs of HF , body weight , blood pressure , heart rate , laboratory parameters , electrocardiograms , echocardiograms , brain natriuretic peptide , aldosterone , and plasma renin activity were examined at baseline and 180 days later . Group A showed the best results , with a significant reduction ( p readmissions , brain natriuretic peptide , aldosterone , and plasma renin activity compared with the other groups during follow-up ( p normal-sodium diet with high diuretic doses and fluid intake restriction , compared with different combinations of sodium diets with more modest fluid intake restrictions and conventional diuretic doses , leads to reductions in readmissions , neurohormonal activation , and renal dysfunction",
"BACKGROUND Patients with heart failure must monitor for and recognize escalating symptoms to take action to relieve symptoms and decrease hospitalizations . However , symptom monitoring is not commonly performed . One way to promote patients ' engagement in symptom monitoring is by providing a symptom diary . PURPOSE The aim of this study was to test the effect of a comprehensive daily symptom diary intervention on event-free survival and health-related quality of life ( HRQOL ) . METHODS Patients were r and omized into either intervention ( n = 23 ) or usual-care groups ( n = 21 ) . The intervention group received a symptom diary with self-care education and counseling at baseline with 5 follow-up calls for 3 months . All patients were interviewed to obtain survival data at 1 month and 3 months . HRQOL was measured at baseline , 1 month , and 3 months . Kaplan-Meier curves with the log-rank test were used to compare group differences in time to first event . Linear mixed models were conducted to examine the relationship between groups and changes in HRQOL over 3 months . RESULTS The intervention group had longer event-free survival than the usual-care group ( P = .03 ) . There were no differences in changes in HRQOL scores between the groups over 3 months . CONCLUSIONS Positive effects of the intervention on survival were found . However , there was no significant difference in changes in HRQOL",
"BACKGROUND Currently , fluid restriction recommendations in heart failure ( HF ) are based on expert opinion . After implementing a 1,000-mL/d fluid restriction for 60 days after discharge , outcomes were examined . METHODS AND RESULTS In a r and omized controlled design , hyponatremic patients ( serum sodium ≤137 mg/dL ) received usual care ( UC ; n = 26 ) or 1,000 mL/d fluid restriction ( n = 20 ) at discharge . Quality of life ( QoL ) , thirst , difficulty following fluid recommendations , adherence to fluid restriction , HF emergency care , HF rehospitalization , and all-cause death were examined . Mean age was 62.8 ± 12.8 years ; 46 % were white . There were no differences by group in baseline demographics , comorbidities , and QoL , except that more UC patients had New York Heart Association ( NYHA ) functional class III/IV status ( P = .019 ) . Median [ interquartile range ] QoL scores were better in the 1,000 mL/d group for symptom burden ( 83.3 [ 68.8 - 91.7 ] vs 50 [ 29.2 - 79.2 ] ; P = .018 ) , total symptoms ( 77.1 [ 58.1 - 91.7 ] vs 54.2 [ 30.2 - 73.9 ] ; P = .022 ) , overall QoL summary ( 72.6 [ 52.2 - 86.3 ] vs 51.0 [ 37.7 - 68.5 ] ; P = .038 ) , and clinical QoL summary ( 75.5 [ 57.8 - 92.9 ] vs 59.1 [ 35.7 - 77.3 ] ; P = .039 ) . There were no group differences in thirst , difficulty adhering to fluid recommendations , adherence to fluid restriction , or health care consumption . CONCLUSIONS The 1,000 mL/d fluid restriction led to improved QoL at 60 days after discharge . Future research in a larger more heterogeneous sample is needed",
"Background : Heart failure ( HF ) has clinical ly significant psychological and physical consequences for older persons , and hospitalization for HF is frequent and costly to the Medicare program . As HF is the most common primary Medicare home care diagnosis , there is a critical need to develop home care services that improve heath-related outcomes for this population . The primary aim of this pilot study was to develop , implement , and test the initial feasibility and potential efficacy of the Home-Care Education , Assessment , Remote-Monitoring , and Therapeutic Activities ( HEART ) trial , a nurse-directed multicomponent home care intervention . Observed outcomes were quality of life ( QOL ) , depressive symptoms , and 90-day hospitalization . Methods : Twenty-four patients with a primary diagnosis of HF were assigned to the intervention ( n = 12 ) or control group ( n = 12 ) according to geographical location in a large multibranch Medicare-certified home health agency . Intervention group patients received 8 structured nurse education visits using evidence -based protocol s design ed in previous trials to teach HF self-management and to prevent/reduce depression , as well as a telemonitoring system . Control group patients received usual care and telemonitoring . Quality of life was assessed using the Minnesota Living With Heart Failure question naire . Depressive symptoms were assed using the Patient Health Question naire 9 at baseline and 90-day study end point . Results : Study protocol s and instrumentation were found to be feasible and effective . Examination of enrollment data led to a reevaluation of eligibility criteria . Patients participating in the HEART intervention demonstrated significantly improved QOL ( F = 8.99 , P = .007 ) and significantly reduced depressive symptoms ( F = 35.10 , P = .001 ) in comparison to control group patients at the study end point . There was a trend toward lower hospital readmission rates in the intervention group ( 16 % vs 25 % ) , but this was not statistically significant . Conclusion : This pilot study suggests that a full-scale trial of the HEART intervention is feasible",
"OBJECTIVE To assess the efficacy of a multifactorial educational intervention carried out by a pharmacist in patients with heart failure ( HF ) . METHOD A r and omized , prospect i ve , open clinical trial in patients admitted for HF . The patients assigned to the intervention group received information about the disease , drug therapy , diet education , and active telephone follow-up . Visits were completed at 2 , 6 , and 12 months . Hospital re-admissions , days of hospital stay , treatment compliance , satisfaction with the care received , and quality of life ( EuroQol ) were evaluated ; a financial study was conducted in order to assess the possible impact of the program . The intervention was performed by the pharmacy department in coordination with the cardiology unit . RESULTS 134 patients were included , with a mean age of 75 years and a low educational level . The patients of the intervention group had a higher level of treatment compliance than the patients in the control group . At 12 months of follow-up , 32.9 % fewer patients in the intervention group were admitted again vs. the control group . The mean days of hospital stay per patient in the control group were 9.6 ( SD=18.5 ) vs. 5.9 ( SD=14.1 ) in the intervention group . No differences were recorded in quality of life , but the intervention group had a higher score in the satisfaction scale at two months [ 9.0 ( SD=1.3 ) versus 8.2 ( SD=1.8 ) p=0.026 ] . Upon adjusting a Cox survival model with the ejection fraction , the patients in the intervention group had a lower risk of re-admission ( Hazard ratio 0.56 ; 95 % CI : 0.32 - 0.97 ) . The financial analysis evidence d savings in hospital costs of euro 578 per patient that were favorable to the intervention group . CONCLUSIONS Postdischarge pharmaceutical care allows for reducing the number of new admissions in patients with heart failure , the total days of hospital stay , and improves treatment compliance without increasing the costs of care",
"Objective : To determine the feasibility and potential impact of a non-pharmacologic multidisciplinary intervention for reducing hospital readmissions in elderly patients with congestive heart failure . Design : Prospect i ve , r and omized clinical trial , with 2:1 assignment to the study intervention or usual care . Setting : 550-bed secondary and tertiary care university teaching hospital . Patients and participants : 98 patients ≥70 years of age ( mean 79±6 years ) admitted with documented congestive heart failure . Interventions : Comprehensive multidisciplinary treatment strategy consisting of intensive teaching by a geriatric cardiac nurse , a detailed review of medications by a geriatric cardiologist with specific recommendations design ed to improve medication compliance and reduce side effects , early consultation with social services to facilitate discharge planning , dietary teaching by a hospital dietician , and close follow-up after discharge by home care and the study team . Measurements and main results : All patients were followed for 90 days after initial hospital discharge . The primary study endpoints were rehospitalization within the 90-day interval and the cumulative number of days hospitalized during follow-up . The 90-day readmission rate was 33.3 % ( 21.7%–44.9 % ) for the patients receiving the study intervention ( n=63 ) compared with 45.7 % ( 29.2–62.2 % ) for the control patients ( n=35 ) . The mean number of days hospitalized was 4.3±1.1 ( 2.1–6.5 ) for the treated patients vs. 5.7±2.0 ( 1.8–9.6 ) for the usual-care patients . In a prospect ively defined subgroup of patients at intermediate risk for readmission ( n=61 ) , readmissions were reduced by 42.2 % ( from 47.6 % to 27.5 % ; p=0.10 ) , and the average number of hospital days during follow-up decreased from 6.7±32 days to 3.2±1.2 days ( p = NS ) . Conclusions : These pilot data suggest that a comprehensive , multidisciplinary approach to reducing repetitive hospitalizations in elderly patients with congestive heart failure may lead to a reduction in readmissions and hospital days , particularly in patients at moderate risk for early rehospitalization . Further evaluation of this treatment strategy , including an assessment of the cost-effectiveness , is warranted",
"Background : The Self-management and Care of Heart Failure through Group Clinics Trial evaluated the effects of multidisciplinary group clinic appointments on self-care skills and rehospitalizations in high-risk heart failure ( HF ) patients . Objective : The purpose of this article is to ( 1 ) describe key Self-management and Care of Heart Failure through Group Clinics Trial group clinic interactive learning strategies , ( 2 ) describe re sources and material s used in the group clinic appointment , and ( 3 ) present results supporting this patient-centered group intervention . Methods : This clinical trial included 198 HF patients ( r and omized to either group clinical appointments or to st and ard care ) . Data were collected from 72 group clinic appointments via patients ’ ( 1 ) group clinic session evaluations , ( 2 ) HF self-care behaviors skills , ( 3 ) HF-related discouragement and quality of life scores , and ( 4 ) HF-related reshopitalizations during the 12-month follow-up . Also , the costs of delivery of the group clinical appointments were tabulated . Results : Overall , patients rated group appointments as 4.8 of 5 on the “ helpfulness ” in managing HF score . The statistical model showed a 33 % decrease in the rate of rehospitalizations ( incidence rate ratio , 0.67 ) associated with the intervention over the 12-month follow-up period when compared with control patients ( & khgr;21 = 3.9 , P = .04 ) . The total cost for implementing 5 group appointments was $ 243.58 per patient . Conclusion : The intervention was associated with improvements in HF self-care knowledge and home care behavior skills and managing their for HF care . In turn , better self-care was associated with reductions in HF-related hospitalizations",
"Purpose : Many health systems have implemented interventions to reduce the rate of heart failure readmissions . Pharmacists have the training and expertise to provide effective medication-related education . However , few studies have examined the impact of discharge education provided by pharmacy students and residents on patients hospitalized with heart failure exacerbations . Methods : This was a nonr and omized intervention study evaluating the impact of a pharmacy student and resident-led discharge counseling program on heart failure readmissions . The primary end point was the 30-day heart failure readmission rate . Secondary end points included self-reported patient underst and ing of medications , number of medication errors documented , and estimated associated cost avoidance . Results : A total of 86 and 94 patients were enrolled into the intervention and control groups , respectively . No statistically significant difference in readmission rates was detected between the intervention and the control groups . Thirty-four medication errors and discrepancies were documented , or 1 for every 2.5 patients counseled , result ing in an estimated cost avoidance of $ 4241 for the institution . Eighty-nine percent of patients who received discharge counseling agreed they had a better underst and ing of their medications after speaking with a pharmacy resident or student . Conclusions : There was no statistically significant difference in readmission rates ; however , several medication errors were prevented , and a large percentage of patients expressed an improved underst and ing of their medications",
"AIMS Mild cognitive impairment ( MCI ) is prevalent in heart failure , and can contribute to poor self-care and higher hospital readmissions . Strategies to improve self-care in patients with MCI have not been studied . This r and omized controlled trial aim ed to test the effect of a targeted intervention on self-care , heart failure knowledge , and 30-day readmissions . METHODS AND RESULTS The study included 125 patients hospitalized for exacerbation of heart failure who screened positive for MCI . The treatment group received a targeted self-care teaching intervention using principles of cognitive training . Self-care , heart failure knowledge , depression , and social support were assessed at baseline and 30 days post-discharge . Mean heart failure knowledge scores improved significantly in the intervention group , but decreased in the control group ( P in heart failure knowledge than patients in the control group ( P = 0.027 ) . Black race was significantly associated with lower heart failure knowledge scores ( P = 0.030 ) . Mean change scores for self-care showed greater improvement in the intervention group when compared with the control group ; however , this was not statistically significant . There was no difference in readmission rates between the groups . CONCLUSION It is feasible to conduct a r and omized controlled trial in patients with MCI . Patients in the treatment group had greater heart failure knowledge at 30 days post-discharge ; however , this did not impact readmission rates . Further research is needed to describe how MCI affects self-care and knowledge , and how race and other factors may influence outcomes in this population",
"OBJECTIVE To explore the effects on the st and ardized management of patients with coronary atherosclerotic heart disease complicated with chronic heart failure . METHODS A total of 823 patients discharged from our department were r and omly enrolled . Among 734 patients with follow-up consents , they were divided into management and control groups ( n = 440 , 294 ) . The management group received st and ardized out-of-hospital management , regular health education and follow-ups of telephone and outpatient visits . RESULTS Compared with the control group , the management group had lower rates of all-cause mortality , cardiac death and readmission due to cardiovascular events ( CVE ) declining by 26.5 % , 32.2 % and 57.0 % respectively . Over a 4-year period , the annular survival rate of management group was 92 % , 85 % , 83 % and 82 % while that of control group 95 % , 89 % , 82 % and 75 % respectively . Patient compliance of digoxin and diuretics in the control group was inferior to that in the management group . CONCLUSION Through st and ardized out-of-hospital management , the patients with coronary atherosclerotic heart disease plus chronic heart failure may achieve significant benefits through reducing the rates of all-cause mortality , cardiac death and readmission due to CVE and improving survival rate",
"Abstract Objectives . To evaluate whether a new home intervention system ( HIS , OPTILOGG ® ) consisting of a specialised software , a tablet computer ( tablet ) wirelessly connected to a weight scale may improve self-care behaviour , health-related quality of life ( HRQoL ) , knowledge about heart failure ( HF ) and reduce hospital days due to HF . Design . 82 patients ( 32 % females ) with mean age : 75 ± 8 years hospitalised with HF were r and omised at discharge to an intervention group ( IG ) equipped with the HIS or to a control group ( CG ) receiving st and ard HF information only . The tablet contained information about HF and lifestyle advice according to current guidelines . It also showed present dose of diuretic , changes in patient-measured weight and HRQoL over time . Results . After 3 months the IG displayed a dramatic improvement in self-care with p : 17 , 25 ] ) . The disease-specific HRQoL was measured by Kansas City Cardiomyopathy Question naire . The IG had significantly higher score ( median IG : 65.1 [ IQR : 38.5 , 83.3 ] vs. CG : 52.1 [ IQR : 41.1 , 64.1 ] p 0.05 ) and an improved physical limitation ( median IG : 54.2 [ IQR : 37.7 , 83.3 ] vs. CG : 45.8 [ IQR : 25.0 , 54.2 ] p ) There was no difference in knowledge . IG showed fewer HF-related days in the hospital , with 1.3 HF-related hospital days/patient versus 3.5 in CG ( risk ratio : 0.38 ; 95 % confidence interval : 0.31–0.46 ; p . HF patients with a HIS tablet computer and scale improved in self-care and HRQoL. Days in hospital due to HF were reduced . A medical device that is easy to use can be a valuable tool for improving self-care and outcome in patients with HF ",
"Peer support has been used effectively in a variety of patient population s , but its effectiveness in improving outcomes in persons with chronic heart failure has not been explored . We trained 9 persons with heart failure to mentor other heart failure patients and tested the effectiveness of this approach in a r and omized controlled clinical trial . A low proportion ( 37 % ) of the eligible population of hospitalized patients agreed to participate . At the end of the 3-month trial , there was significantly higher heart failure self-care in the intervention group ( P perceived support reciprocity in the intervention group ( F = 5.94 , P = .004 ) . No significant group differences in heart failure readmissions , length of stay , or cost were evident at 90-days , although the heart failure readmission rate was 96 % higher in the intervention group when compared to that in the control group . The reasons for low overall enrollment and high readmission rates in the intervention group require further study . Including additional self-care education by a professional , rather than leaving all the education to the mentor , could strengthen the peer support intervention trialed in this study . Small group meetings may be less intrusive and more desirable for this patient population",
"Community care for heart failure patients is difficult due to multiple comorbidities , polypharmacy , and advanced age of patients . Studies show that hospital admissions and emergency room visits decrease with increased nursing interventions in home and community setting s. The purpose of this study 1 was to assess the effectiveness of regular telephone interventions by nursing students on outcomes of heart failure patients in the home . Senior students were paired with community nursing staff and assigned 2 heart failure patients to follow up by telephone calls for 12 to 14 weeks . Patients who received telephone interventions had fewer hospital readmissions ( 13 % ) than the comparison group ( 35 % ) . Patients in the telephone intervention group also had fewer overt heart failure symptoms as measured by the Minnesota Living With Heart Failure Question naire",
"OBJECTIVES To examine the effectiveness of a transitional care intervention delivered by advanced practice nurses ( APNs ) to elders hospitalized with heart failure . DESIGN R and omized , controlled trial with follow-up through 52 weeks postindex hospital discharge . SETTING Six Philadelphia academic and community hospitals . PARTICIPANTS Two hundred thirty-nine eligible patients were aged 65 and older and hospitalized with heart failure . INTERVENTION A 3-month APN-directed discharge planning and home follow-up protocol . MEASUREMENTS Time to first rehospitalization or death , number of rehospitalizations , quality of life , functional status , costs , and satisfaction with care . RESULTS Mean age of patients ( control n=121 ; intervention n=118 ) enrolled was 76 ; 43 % were male , and 36 % were African American . Time to first readmission or death was longer in intervention patients ( log rank chi(2)=5.0 , P=.026 ; Cox regression incidence density ratio=1.65 , 95 % confidence interval=1.13 - 2.40 ) . At 52 weeks , intervention group patients had fewer readmissions ( 104 vs 162 , P=.047 ) and lower mean total costs ( $ 7,636 vs $ 12,481 , P=.002 ) . For intervention patients , only short-term improvements were demonstrated in overall quality of life ( 12 weeks , P physical dimension of quality of life ( 2 weeks , P patient satisfaction ( assessed at 2 and 6 weeks , P comprehensive transitional care intervention for elders hospitalized with heart failure increased the length of time between hospital discharge and readmission or death , reduced total number of rehospitalizations , and decreased healthcare costs , thus demonstrating great promise for improving clinical and economic outcomes",
"BACKGROUND Congestive heart failure is the most common indication for admission to the hospital among older adults . Behavioral factors , such as poor compliance with treatment , frequently contribute to exacerbations of heart failure , a fact suggesting that many admissions could be prevented . METHODS We conducted a prospect i ve , r and omized trial of the effect of a nurse-directed , multidisciplinary intervention on rates of readmission within 90 days of hospital discharge , quality of life , and costs of care for high-risk patients 70 years of age or older who were hospitalized with congestive heart failure . The intervention consisted of comprehensive education of the patient and family , a prescribed diet , social-service consultation and planning for an early discharge , a review of medications , and intensive follow-up . RESULTS Survival for 90 days without readmission , the primary outcome measure , was achieved in 91 of the 142 patients in the treatment group , as compared with 75 of the 140 patients in the control group , who received conventional care ( P = 0.09 ) . There were 94 readmissions in the control group and 53 in the treatment group ( risk ratio , 0.56 ; P = 0.02 ) . The number of readmissions for heart failure was reduced by 56.2 percent in the treatment group ( 54 vs. 24 , P = 0.04 ) , whereas the number of readmissions for other causes was reduced by 28.5 percent ( 40 vs. 29 , P not significant ) . In the control group , 23 patients ( 16.4 percent ) had more than one readmission , as compared with 9 patients ( 6.3 percent ) in the treatment group ( risk ratio , 0.39 ; P = 0.01 ) . In a subgroup of 126 patients , quality -of-life scores at 90 days improved more from base line for patients in the treatment group ( P = 0.001 ) . Because of the reduction in hospital admissions , the overall cost of care was $ 460 less per patient in the treatment group . CONCLUSIONS A nurse-directed , multidisciplinary intervention can improve quality of life and reduce hospital use and medical costs for elderly patients with congestive heart failure",
"BACKGROUND Heart failure ( HF ) disease management programs are widely implemented , but data about their effect on outcome have been inconsistent . METHODS The Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure ( COACH ) was a multicenter , r and omized , controlled trial in which 1023 patients were enrolled after hospitalization because of HF . Patients were assigned to 1 of 3 groups : a control group ( follow-up by a cardiologist ) and 2 intervention groups with additional basic or intensive support by a nurse specializing in management of patients with HF . Patients were studied for 18 months . Primary end points were time to death or rehospitalization because of HF and the number of days lost to death or hospitalization . RESULTS Mean patient age was 71 years ; 38 % were women ; and 50 % of patients had mild HF and 50 % had moderate to severe HF . During the study , 411 patients ( 40 % ) were readmitted because of HF or died from any cause : 42 % in the control group , and 41 % and 38 % in the basic and intensive support groups , respectively ( hazard ratio , 0.96 and 0.93 , respectively ; P = .73 and P = .52 , respectively ) . The number of days lost to death or hospitalization was 39 960 in the control group , 33 731 days for the basic intervention group ( P = .81 ) , and 34 268 for the intensive support group ( P = .49 ) . All-cause mortality occurred in 29 % of patients in the control group , and there was a trend toward lower mortality in the intervention groups combined ( hazard ratio , 0.85 ; 95 % confidence interval , 0.66 - 1.08 ; P = .18 ) . There were slightly more hospitalizations in the 2 intervention groups ( basic intervention group , P = .89 ; and intensive support group , P = .60 ) . CONCLUSIONS Neither moderate nor intensive disease management by a nurse specializing in management of patients with HF reduced the combined end points of death and hospitalization because of HF compared with st and ard follow-up . There was a nonsignificant , potentially relevant reduction in mortality , accompanied by a slight increase in the number of short hospitalizations in both intervention groups . Clinical Trial Registry http://trialregister.nl Identifier : NCT 98675639",
"Eighty-two patients aged > or = 70 years with heart failure were r and omized to a gentle , seated exercise program or to usual care . Six-minute walk distance and quality of life did not change between groups , but daily activity as measured by accelerometry increased in the exercise group relative to the control group",
"In this r and omized controlled trial we tested the efficacy of an intervention program ( CARE : Creating Avenues for Relative Empowerment ) for improving outcomes of hospitalized older adults and their family caregivers ( FCGs ) . FCG-patient dyads ( n = 407 ) were r and omized into two groups . The CARE group received a two-session empowerment-educational program 1 - 2 days post-admission and 1 - 3 days pre-discharge . The attention control group received a generic information program during the same timeframe . Follow-up was at 2 weeks and 2 months post-discharge . There were no statistically significant differences in patient or FCG outcomes . However , inconsistent evidence of role outcome differences suggests that CARE may benefit certain FCG subgroups instead of being a one-size-fits-all intervention strategy . Closer examination of CARE 's mechanisms and effects is needed",
"OBJECTIVE To investigate the business case of postdischarge care transition ( PDCT ) among Medicare beneficiaries by conducting a cost-benefit analysis . DESIGN R and omized controlled trial . SETTING A general hospital in upstate New York State . PARTICIPANTS Elderly Medicare beneficiaries being treated from October 2008 through December 2009 were r and omly selected to receive services as part of a comprehensive PDCT program ( intervention--173 patients ) or regular discharge process ( control--160 patients ) and followed for 12 months . INTERVENTION The intervention comprised five activities : development of a patient-centered health record , a structured discharge preparation checklist of critical activities , delivery of patient self-activation and management sessions , follow-up appointments , and coordination of data flow . MEASUREMENTS Cost-benefit ratio of the PDCT program ; self-management skills and abilities . RESULTS The 1-year readmission analysis revealed that control participants were more likely to be readmitted than intervention participants ( 58.2 % vs 48.2 % ; P = .08 ) ; with most of that difference observed in the 91 to 365 days after discharge . Findings from the cost-benefit analysis revealed a cost-benefit ratio of 1.09 , which indicates that , for every $ 1 spent on the program , a saving of $ 1.09 was realized . In addition , participating in a care transition program significantly enhanced self-management skills and abilities . CONCLUSION Postdischarge care transition programs have a dual benefit of enhancing elderly adults ' self-management skills and abilities and producing cost savings . This study builds a case for the inclusion of PDCT programs as a reimbursable service in benefit packages",
"BACKGROUND It is still a matter of debate whether exercise training ( ET ) is a beneficial treatment in chronic heart failure ( CHF ) . METHODS AND RESULTS To determine whether long-term moderate ET improves functional capacity and quality of life in patients with CHF and whether these effects translate into a favorable outcome , 110 patients with stable CHF were initially recruited , and 99 ( 59+/-14 years of age ; 88 men and 11 women ) were r and omized into 2 groups . One group ( group T , n=50 ) underwent ET at 60 % of peak & f1;O2 , initially 3 times a week for 8 weeks , then twice a week for 1 year . Another group ( group NT , n=49 ) did not exercise . At baseline and at months 2 and 14 , all patients underwent a cardiopulmonary exercise test , while 74 patients ( 37 in group T and 37 in group NT ) with ischemic heart disease underwent myocardial scintigraphy . Quality of life was assessed by question naire . Ninety-four patients completed the protocol ( 48 in group T and 46 in group NT ) . Changes were observed only in patients in group T. Both peak & f1;O2 and thallium activity score improved at 2 months ( 18 % and 24 % , respectively ; P Quality of life also improved and paralleled peak VO2 . Exercise training was associated both with lower mortality ( n=9 versus n=20 for those with training versus those without ; relative risk (RR)=0.37 ; 95 % CI , 0.17 to 0.84 ; P=0.01 ) and hospital readmission for heart failure ( 5 versus 14 ; RR=0.29 ; 95 % CI , 0.11 to 0.88 ; P=0.02 ) . Independent predictors of events were ventilatory threshold at baseline ( beta-coefficient=0.378 ) and posttraining thallium activity score ( beta-coefficient -0.165 ) . CONCLUSIONS Long-term moderate ET determines a sustained improvement in functional capacity and quality of life in patients with CHF . This benefit seems to translate into a favorable outcome",
"BACKGROUND Multidisciplinary heart failure programs including patient education and self-management strategies such as daily recording of body weight and use of a patient diary decrease hospital readmissions and improve quality of life . However , the degree of uptake of individual components of these programs and their contribution to patient benefit are uncertain . METHODS Patients with heart failure admitted to Auckl and Hospital were r and omised into the management or usual care groups of the Auckl and heart failure management study ( AHFMS ) . Patients in the management group were given a heart failure diary for the recording of daily weights , attended a heart failure clinic and were encouraged to attend three education sessions . Patients in the usual care group received routine clinical care , mainly from general practitioners . Patients were followed to 12 months . This study investigated the uptake of self-management by assessing diary use and self-weighing behaviour in the group receiving the heart failure intervention , and compared the level of knowledge of heart failure self-management of the management group to the control group after 12 months . RESULTS Of the 197 patients in the AHFMS , 100 patients were included in the management group and received a diary and education about heart failure self-management including monitoring weight daily . Of these patients , 76 patients used the diary . These patients were on more medication ; were more likely to attend the education sessions , heart failure clinic , and primary care , and had a lower mortality rate over the course of the study . Variables independently associated with use of the diary included less severe symptoms ( OR 15 , 95 % confidence intervals 1.7 , 144 ) , frequent attendance at the heart failure clinic ( OR 15 , 95 % CI 3 , 78 ) and attendance at an education session ( OR 8 , 95 % CI 1.5 , 42 ) . Of the 76 patients who used the diary , 51 weighed themselves regularly . More of these patients owned scales at home ; they were also more likely to attend the education sessions , and experienced fewer hospital admissions than those patients who did not weigh themselves regularly . Variables independently associated with regular self-weighing included the presence of scales at home ( OR 6.3 , 95 % CI 1.7 , 14.1 ) , left ventricular ejection fraction > 30 % ( OR 4.3 , 95 % CI 1.1 , 17.5 ) , and attendance at the education session(s ) ( OR 6.3 , 95 % CI 1.7 , 14.1 ) . Patients in the management group exhibited higher levels of knowledge at 12 months of follow-up and were more likely to monitor their condition using daily weighing , compared to the control group . CONCLUSIONS At 12 months of follow-up , implementation of self-management strategies including daily weight monitoring and level of education on self-management was significantly higher in the management group than the control group . For the patients in the management group , not using the diary or inability to perform daily weighing were associated with less frequent attendance at the heart failure clinic and education sessions and poorer health outcomes . In this study , attendance at the education sessions was associated with the adoption of self-management , underlining the importance of education in multidisciplinary heart failure programmes . Self-weighing could be increased by provision of scales to all patients . The subset of patients who did not adopt self-management strategies in this study were at high risk of death or readmission",
"This study sought to determine the effect of an advanced- practice -nurse (APN)-led telephone intervention on hospital readmissions , quality of life , and self-care behaviors ( SCBs ) of patients with heart failure ( HF ) . Twenty participants were r and omly assigned to either an experimental group that received the APN-led telephone intervention ( ALTI ) or a control group that received usual care in this pretest-posttest experimental study . The results of this study support the idea that an ALTI positively impacts outcomes of patient with HF , particularly by improving SCBs and decreasing hospital readmissions . An ALTI warrants consideration to improve outcomes of patients with HF",
"AIMS Disease management programs can reduce hospitalizations in high-risk heart failure ( HF ) patients , but generalizability to the population hospitalized for HF remains to be proven . We aim ed to assess the effectiveness of a discharge and outpatient management program in a non-selected cohort of patients hospitalized for HF . METHODS AND RESULTS Patients admitted with decompensated HF were r and omized to receive usual care ( n=174 ) or an intervention ( n=164 ) consisting of a comprehensive hospital discharge planning and close follow-up at a HF clinic . After a median of 509 days , there were fewer events ( readmission or death ) in the intervention as compared with the control group ( 156 vs. 250 ) , which represents 47 % ( 95%CI : 29 - 65 ; P time to first event , time to first all-cause and HF readmission , and time to death were increased in the intervention group ( P All-cause and HF readmission rates per observation year were significantly lower , quality of life improved and overall cost of care was reduced in the intervention group . CONCLUSIONS This comprehensive hospital discharge and outpatient management program prolonged time to first event , reduced hospital readmissions , improved survival and quality of life of patients hospitalized for HF , while reducing cost of management",
"Background Heart failure is a common and costly condition , particularly in the elderly . A range of models of interventions have shown the capacity to decrease hospitalizations and improve health-related outcomes . Potentially , cardiac rehabilitation models can also improve outcomes . Aim To assess the impact of a nurse-coordinated multidisciplinary , cardiac rehabilitation program to decrease hospitalizations , increase functional capacity , and meet the needs of patients with heart failure . Method In a r and omized control trial , a total of 105 patients were recruited to the study . Patients in the intervention group received an individualized , multidisciplinary 12-week cardiac rehabilitation program , including an individualized exercise component tailored to functional ability and social circumstances . The control group received an information session provided by the cardiac rehabilitation coordinator and then follow-up care by either their cardiologist or general practitioner . This trial was stopped prematurely after the release of state-based guidelines and funding for heart failure programs . Results During the study period , patients in the intervention group were less likely to have been admitted to hospital for any cause ( 44 vs. 69 % , P = 0.01 ) or after a major acute coronary event ( 24 vs. 55 % , P = 0.001 ) . Participants in the intervention group were more likely to be alive at 12 months , ( 93 vs. 79 % ; P = 0.03 ) ( odds ratio = 3.85 ; 95 % confidence interval = 1.0314.42 ; P = 0.0042 ) . Quality of life scores improved at 3 months compared with baseline ( intervention t = 4.37 , P [ 0.0001 ; control t= 3.52 , P [ 0.01 ) . Improvement was also seen in 6-min walk times at 3 months compared with baseline in the intervention group ( t = 3.40 ; P = 0.01 ) . Conclusion This study shows that a multidisciplinary heart failure cardiac rehabilitation program , including an individualized exercise component , coordinated by a specialist heart failure nurse can substantially reduce both all-cause and cardiovascular readmission rates , improve functional status at 3 months and exercise tolerance",
"BACKGROUND Chronic heart failure ( CHF ) remains a common cause of disability , death and hospital admission . Several investigations support the usefulness of programs of disease management for improving clinical outcomes . However , the effect of home-based telemanagement programs on the rate of hospital readmission is still unclear and the cost-effectiveness ratio of such programs is unknown . The aim of the study was to determine whether a home-based telemanagement ( HBT ) programme in CHF patients decreased hospital readmissions and hospital costs in comparison with the usual care ( UC ) follow-up programme over a one-year period . METHODS AND RESULTS Four hundred-sixty CHF patients ( pts ) , aged 57+/-10 years were r and omised to two management strategies : 230 pts to HBT programme and 230 pts to UC programme . The HBT pts received a portable device , transferring , by telephone , a one-lead trace to a receiving station where a nurse was available for interactive teleconsultation . The UC pts were referred to their primary care physicians and cardiologists . The primary objective of the study was one-year hospital readmission for cardiovascular reasons . During one-year follow-up 55 pts ( 24 % ) in HBT group and 83 pts ( 36 % ) in UC group had at least one readmission ( RR=0.56 ; 95 % CI : 0.38 - 0.82 ; p=0.01 ) . After adjusting for clinical and demographic characteristics , the HBT group had a significantly lower risk of readmission compared with the UC group ( HR=0.50 , 95 % CI : 0.34 - 0.73 ; p=0.01 ) . The intervention was associated with a 36 % decrease in the total number of hospital readmissions ( HBT group : 91 readmissions ; UC group : 142 readmissions ) and a 31 % decrease in the total number of episodes of hemodynamic instability ( 101 in HBT group vs 147 in UC group ) . The rate of hearth failure-related readmission was 19 % ( 43 pts ) in HBT group and 32 % ( 73 pts ) in UC group ( RR=0.49 , 95 % [ CI ] : 0.31 - 0.76 ; p=0.0001 ) . No significant difference was found on cardiovascular mortality between groups . Mean cost for hospital readmission was significantly lower in HBT group ( euro 843+/-1733 ) than in UC group ( euro 1298+/-2322 ) , ( -35 % , p hospital readmissions and costs in CHF patients",
"OBJECTIVES We compared the longer-term impact of the two most commonly applied forms of post-discharge management design ed to minimize recurrent hospitalization and prolong survival in typically older patients with chronic heart failure ( CHF ) . METHODS We followed a multi-center r and omized controlled trial cohort of Australian patients hospitalized with CHF and initially allocated to home-based or specialized CHF clinic-based intervention for 1368 ± 216 days . Blinded endpoints included event-free survival from all-cause emergency hospitalization or death , all-cause mortality and rate of all-cause hospitalization and stay . RESULTS 280 patients ( 73 % male , aged 71 ± 14 years and 73 % left ventricular systolic dysfunction ) were initially r and omized to home-based ( n=143 ) or clinic-based ( n=137 ) intervention . During extended follow-up ( complete for 274 patients ) , 1139 all-cause hospitalizations ( 7477 days of hospital stay ) and 121 ( 43.2 % ) deaths occurred . There was no difference in the primary endpoint ; 20 ( 14.0 % ) home-based versus 13 ( 7.4 % ) clinic-based patients remained event-free ( adjusted HR 0.89 , 95 % CI 0.70 to 1.15 ; p=0.378 ) . Significantly fewer home-based ( 51/143 , 35.7 % ) than clinic-based intervention ( 71/137 , 51.8 % ) patients died ( adjusted HR 0.62 , 95 % CI 0.42 to 0.90 : p=0.012 ) . Home-based versus clinic-based intervention patients accumulated 592 and 547 all-cause hospitalizations ( p=0.087 ) associated with 3067 ( median 4.0 , IQR 2.0 to 6.8 ) versus 4410 ( 6.0 , IQR 3.0 to 12.0 ) days of hospital stay ( p clinic-based intervention , home-based intervention was not associated with prolonged event-free survival . Home-based intervention was , however , associated with significantly fewer all-cause deaths and significantly fewer days of hospital stay in the longer-term . TRIAL REGISTRATION Australian New Zeal and Clinical Trials Registry number 12607000069459 ( http://www.anzctr.org.au/Trial/ Registration /Trial Review .aspx?id=81803 )",
"BACKGROUND The Support , Education , and Research in Chronic Heart Failure ( SEARCH ) study was design ed to assess the impact of a mindfulness-based psychoeducational intervention on clinical outcomes , depression , and quality of life in patients with chronic heart failure ( CHF ) . Although research has shown that psychosocial factors including depression are important risk factors for adverse events in patients with CHF , no large clinical trials have investigated the efficacy of psychosocial interventions to reduce these factors in this population . METHODS This was a prospect i ve cohort study of 208 adults with left ventricular ejection fraction geographically assigned to treatment or control groups with follow-up at 3 , 6 , and 12 months . Treatment groups met weekly for 8 consecutive weeks for training in mindfulness meditation , coping skills , and support group discussion . RESULTS Subjects had a mean age of 61 years , left ventricular ejection fraction 26 % , and median New York Heart Association class II . The majority were treated with angiotensin-converting enzyme inhibitors ( 80 % ) and beta-blockers ( 86 % ) . At baseline , patients in the treatment group had more severe CHF with higher New York Heart Association class ( P = .0209 ) and more severe psychological distress ( Center of Epidemiology - Depression , Profile of Mood States ; P anxiety ( Profile of Mood States , P = .003 ) , depression ( Center of Epidemiology - Depression , P = .05 ) , improved symptoms ( Kansas City Cardiomyopathy Question naire symptom scale , P = .033 ) and clinical scores ( Kansas City Cardiomyopathy Question naire clinical score , P = .024 ) over time . There were no treatment effects on death/rehospitalization at 1 year . CONCLUSIONS An 8-week mindfulness-based psychoeducational intervention reduced anxiety and depression ; this effect was attenuated at 1 year . Importantly , the intervention led to significantly better symptoms of CHF at 12 months compared to control subjects . Our results suggest that interventions of this type might have a role in optimal therapy for CHF",
"Background — Patients with heart failure ( HF ) who live in rural areas have less access to cardiac services than patients in urban areas . We conducted a r and omized , clinical trial to determine the impact of an educational intervention on the composite end point of HF rehospitalization and cardiac death in this population . Methods and Results — Patients ( n=602 ; age , 66±13 years ; 41 % female ; 51 % with systolic HF ) were r and omized to 1 of 3 groups : control ( usual care ) , Fluid Watchers LITE , or Fluid Watchers PLUS . Both intervention groups included a face-to-face education session delivered by a nurse focusing on self-care . The LITE group received 2 follow-up phone calls , whereas the PLUS group received biweekly calls ( mean , 5.3±3.6 ; range , 1–19 ) until the nurse judged the patient to be adequately trained . Over 2 years of follow-up , 35 % of patients ( n=211 ) experienced cardiac death or hospitalization for HF , with no difference among the 3 groups in the proportion who experienced the combined clinical outcome ( P=0.06 ) . Although patients in the LITE group had reduced cardiac mortality compared with patients in the control group over the 2 years of follow-up ( 7.5 % and 17.7 % , respectively ; P=0.003 ) , there was no significant difference in cardiac mortality between patients in the PLUS group and the control group . Conclusions — A face-to-face education intervention did not significantly decrease the combined end point of cardiac death or hospitalization for HF . Increasing the number of contacts between the patient and nurse did not significantly improve outcome . Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT00415545"
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Abstract Sarcopenia is a potentially modifiable risk factor for falls and fractures in older adults , but the strength of the association between sarcopenia , falls , and fractures is unclear . This study aims to systematic ally assess the literature and perform a meta‐ analysis of the association between sarcopenia with falls and fractures among older adults . A literature search was performed using MEDLINE , EMBASE , Cochrane , and CINAHL from inception to May 2018 . Inclusion criteria were the following : published in English , mean/median age ≥ 65 years , sarcopenia diagnosis ( based on definitions used by the original studies ' authors ) , falls and /or fractures outcomes , and any study population . Pooled analyses were conducted of the associations of sarcopenia with falls and fractures , expressed in odds ratios ( OR ) and 95 % confidence intervals ( CIs ) . Subgroup analyses were performed by study design , population , sex , sarcopenia definition , continent , and study quality . Heterogeneity was assessed using the I 2 statistics . The search identified 2771 studies . Thirty‐six studies ( 52 838 individuals , 48.8 % females , and mean age of the study population s ranging from 65.0 to 86.7 years ) were included in the systematic review . Four studies reported on both falls and fractures . Ten out of 22 studies reported a significantly higher risk of falls in sarcopenic compared with non‐sarcopenic individuals ; 11 out of 19 studies showed a significant positive association with fractures . Thirty‐three studies ( 45 926 individuals ) were included in the meta‐ analysis . Sarcopenic individuals had a significant higher risk of falls ( cross‐sectional studies : OR 1.60 ; 95 % CI 1.37–1.86 , P 37 % ) and fractures ( cross‐sectional studies : OR 1.84 ; 95 % CI 1.30–2.62 , P = 0.001 , I 2 = 91 % ; prospect i ve studies : OR 1.71 ; 95 % CI 1.44–2.03 , P = 0.011 , I 2 = 0 % ) compared with non‐sarcopenic individuals . This was independent of study design , population , sex , sarcopenia definition , continent , and study quality . The positive association between sarcopenia with falls and fractures in older adults strengthens the need to invest in sarcopenia prevention and interventions to evaluate its effect on falls and fractures
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[
"Muscle mass decreases with age , leading to \" sarcopenia , \" or low relative muscle mass , in elderly people . Sarcopenia is believed to be associated with metabolic , physiologic , and functional impairments and disability . Methods of estimating the prevalence of sarcopenia and its associated risks in elderly population s are lacking . Data from a population -based survey of 883 elderly Hispanic and non-Hispanic white men and women living in New Mexico ( the New Mexico Elder Health Survey , 1993 - 1995 ) were analyzed to develop a method for estimating the prevalence of sarcopenia . An anthropometric equation for predicting appendicular skeletal muscle mass was developed from a r and om sub sample ( n = 199 ) of participants and was extended to the total sample . Sarcopenia was defined as appendicular skeletal muscle mass (kg)/height2 ( m2 ) being less than two st and ard deviations below the mean of a young reference group . Prevalences increased from 13 - 24 % in persons under 70 years of age to > 50 % in persons over 80 years of age , and were slightly greater in Hispanics than in non-Hispanic whites . Sarcopenia was significantly associated with self-reported physical disability in both men and women , independent of ethnicity , age , morbidity , obesity , income , and health behaviors . This study provides some of the first estimates of the extent of the public health problem posed by sarcopenia",
"Background Patients with hip fracture frequently have sarcopenia and are at great risk of loss of mobility . We have investigated if sarcopenia predicts change in mobility after hip fracture . Methods This is a prospect i ve , multicenter observational study with one-year follow-up . Patients with hip fracture who were community-living and capable of walking before the fracture were included at three hospitals in Norway ( 2011–2013 ) . The primary outcome of the study was change in mobility , measured by the New Mobility Score ( NMS ) . Sarcopenia was determined postoperatively by anthropometry , grip strength , and NMS . Results We included 282 participants and sarcopenia status was determined in 201 , of whom 38 % ( 77/201 ) had sarcopenia , 66 % ( 128/194 ) had low muscle mass , 52 % ( 116/222 ) had low grip strength and 8 % ( 20/244 ) had low pre-fracture mobility ( NMS change in mobility ( effect 0.2 points ; 95 % CI –0.5 to 0.9 , P = 0.6 ) , but it was associated with having lower mobility at one-year ( NMS 5.8 ( SD 2.3 ) vs. 6.8 ( SD 2.2 ) , P = 0.003 ) , becoming a resident of a nursing home ( odds ratio 3.2 , 95 % CI 0.9 to 12.4 , P = 0.048 ) , and the combined endpoint of becoming a resident of a skilled nursing home or death ( odds ratio 3.6 , 95 % CI 1.2 to 12.2 , P = 0.02 ) . Conclusions Sarcopenia did not predict change in mobility in the year after hip fracture",
"Sarcopenia , a complex multifactorial condition , is characterized by loss of muscle mass and function , which increases progressively with age . The existence of different definitions has contributed to the large variation in the prevalence estimates of sarcopenia . We aim ed to estimate the prevalence of sarcopenia in the general population using the European Working Group on Sarcopenia in Older People ( EWGSOP ) proposed definition and compared baseline demographic and clinical characteristics between the nonsarcopenia , presarcopenia , and sarcopenia individuals , with particular emphasis on the overlap with osteoporosis and fracture risk . We studied 5911 subjects at a mean age of 69.2 years ( 55.8 % female ) with data on sarcopenia participating in the Rotterdam Study , a prospect i ve population -based cohort study in Rotterdam , the Netherl and s. Presarcopenia was defined as having only low muscle mass , whereas sarcopenia was defined based on the presence of low muscle mass , plus either low muscle strength or low physical performance . The prevalence of presarcopenia and sarcopenia was 5.9 % and 4.4 % , respectively . Individuals with sarcopenia were older , more often males , smokers , with less optimal dietary intake , and more often disabled with lower physical activity . Although the prevalence of fractures was higher in individuals with low lean mass ( presarcopenic [ 16.6 % ] and sarcopenic [ 23.5 % ] ) compared with the no sarcopenic group ( 15.5 % ) , the differences were not present after correcting for age and sex . There were no statistical differences in the prevalence of chronic diseases , with the exception of a higher prevalence of COPD in presarcopenic ( 29.1 % ) and sarcopenic ( 26.9 % ) individuals compared with nonsarcopenic ( 13.4 % ) individuals . Osteoporotic individuals with ( odds ratio [ OR ] = 2.59 , 95 % confidence interval [ CI ] 1.41 - 4.45 ) and without sarcopenia ( OR = 2.75 , 95 % CI 2.01 - 3.75 ) had similar elevated risk of nonvertebral fractures . The presence of sarcopenia appears to be independent of chronic diseases with the exception of COPD and more related to lifestyle factors and disabilities . Sarcopenic individuals in the general population are at no greater risk of fracture than what is determined by their low bone mineral density . © 2018 American Society for Bone and Mineral Research",
"AIM The purpose of the present study was to investigate whether sarcopenia was associated with future falls in the general Japanese older population . METHODS This study was a 2-year prospect i ve observational study . Participants were recruited from individuals who had an annual town-sponsored medical check-up and had not received nursing care . The inclusion criteria for participants in our study were : ( i ) agreement to participate ; ( ii ) living independently ; and ( iii ) the ability to walk to where the survey was carried out and to provide self-reported data . A total of 223 residents ( 82 men , 141 women ) participated in the baseline assessment in the study . Demographic information , previous fall history , locomotive syndrome , body function and structural measurements and pain at the knee and /or lumber spine were assessed . The Asian Working Group for Sarcopenia algorithm was used to classify the presence of sarcopenia , and assess the history of falling when the participant received their annual medical check-up . RESULTS A total of 162 participants had an annual follow-up assessment , 50 of whom ( 30.8 % ) fell at least once during the 2-year observational period after baseline assessment . Previous falling history , prevalence of locomotive syndrome , sarcopenia and pain were significantly higher in participants who had fallen compared with participants who had not . Multiple logistic regression analysis showed the prevalence of sarcopenia was a significant predictor of falling . CONCLUSION The key finding of the present study suggests that sarcopenia is a risk factor for falling in older adults who are living independently even after adjustment for previous falls and confounding factors . Geriatr Gerontol Int 2017 ; 17 : 2124 - 2130",
"Summary There is no clear consensus on definition , cut-points or st and ardised assessment s of sarcopenia . We found a lower limb strength assessment was at least as effective in predicting balance , mobility and falls in 419 older people as muscle mass-based measures of sarcopenia . Introduction There is currently no consensus on the definition , cut-points or st and ardised assessment s of sarcopenia . This study aim ed to investigate whether several published definitions of sarcopenia differentiate between older people with respect to important functional and health outcomes . Methods Four hundred nineteen community-living older adults ( mean age 81.2 ± 4.5 , 49 % female ) completed assessment s of body composition ( dual-energy X-ray absorptiometry ) , strength , balance , mobility and disability . Falls were recorded prospect ively for a year using monthly calendars . Sarcopenia was defined according to four skeletal mass-based definitions , two strength-based definitions ( h and grip or knee extensor force ) and a consensus algorithm ( low mass and low strength or slow gait speed ) . Obesity was defined according to percentage fat mass or waist circumference . Results The four skeletal mass-based definitions varied considerably with respect to the percentage of participants classified as sarcopenic and their predictive accuracy for functional and health outcomes . The knee extension strength-based definition was equivalent to or better than the mass-based and consensus algorithm definitions ; i.e. weaker participants performed poorly in tests of leaning balance , stepping reaction time , gait speed and mobility . They also had higher physiological fall risk scores and were 43 % more likely to fall at home than their stronger counterparts . Adding obesity to sarcopenia definitions identified participants with greater self-reported disability . Conclusions A simple lower limb strength assessment was at least as effective in predicting balance , functional mobility and falls in older people as more expensive and time-consuming muscle mass-based measures . These findings imply that functional terms such as muscle weakness or motor impairment are preferable to sarcopenia",
"Objective Sarcopenia might be associated with bone fragility in elderly individuals . This study aim ed to investigate the prevalence of sarcopenia and its association with fragility fracture sites in elderly Chinese patients . Methods Patients ( 322 men and 435 women ) aged 65–94 years and with a history of fragility fractures in the ankle , wrist , vertebrae or hip , and healthy men ( n = 1263 ) and women ( n = 1057 ) aged 65–92 years without a history of fractures were enrolled . Whole-body dual energy X-ray absorptiometry was used to analyze skeletal muscle mass index ( SMI ) , fat mass and bone mineral density . Sarcopenia was defined as SMI less than two st and ard deviations below the mean of a young reference group . Results Sarcopenia occurrence varied with fracture location . Sarcopenia was more common in females with vertebral and hip fractures and in men with hip and ankle fractures than in the non-fracture group ) . Sarcopenia was significantly more prevalent in men with wrist , hip and ankle fractures than in women . SMI was correlated with BMD in different fracture groups . Logistic regression analyses revealed that lower SMI was associated with an increased risk of hip fracture both in men and women and ankle fracture in men . Discussion Sarcopenia may be an independent risk factor for hip and ankle fractures in men , and for hip fractures in women",
"Background : The decline in skeletal muscle in old age is a factor in the development of functional limitations . Objective : The objective of this study was to assess if there is a correlation between muscle mass based on bioelectrical impedance analysis ( BIA ) detection and the fall incidence in nursing home residents and to examine the risk factors for falling in nursing home residents . Methods : This prospect i ve cohort study was part of a longitudinal study on nutritional issues in 52 nursing homes in Antwerp ( Belgium ) from October 2007 to April 2008 . Two hundred and seventy-six people aged 65 years and older were included . Each subject was assessed with BIA , the timed get-up- and -go test , the Katz score , the Mini Nutritional Assessment – Short Form and the 36-Item Short Form Health Survey . The primary outcome parameter was fall incidence during the study . Results : The prevalence of sarcopenia varied from 24.3 to 81.5 % depending on which definition was used . No association was found between BIA-derived muscle mass and fall incidence . Logistic regression analysis showed that gait speed ( odds ratio 1.029 ; p = 0.003 ) and mental health ( odds ratio 0.981 ; p = 0.015 ) are significantly associated with fall incidence in nursing homes . A receiver operating characteristic curve showed that none of the BIA-derived muscle parameters are good predictors of the risk of falling . Conclusions : This study shows that there is no association between sarcopenia based on BIA and fall incidence and that BIA-derived muscle mass has no additional value in predicting fall incidents compared to the timed get-up- and -go test",
"Background Lack of appropriate reporting of method ological details has previously been shown to distort risk of bias assessment s in r and omized controlled trials . The same might be true for observational studies . The goal of this study was to compare the Newcastle-Ottawa Scale ( NOS ) assessment for risk of bias between review ers and authors of cohort studies included in a published systematic review on risk factors for severe outcomes in patients infected with influenza . Methods Cohort studies included in the systematic review and published between 2008–2011 were included . The corresponding or first authors completed a survey covering all NOS items . Results were compared with the NOS assessment applied by review ers of the systematic review . Inter-rater reliability was calculated using kappa ( K ) statistics . Results Authors of 65/182 ( 36 % ) studies completed the survey . The overall NOS score was significantly higher ( p . Inter-rater reliability by item ranged from slight ( K = 0.15 , 95 % confidence interval [ CI ] = −0.19 , 0.48 ) to poor ( K = −0.06 , 95 % CI = −0.22 , 0.10 ) . Reliability for the overall score was poor ( K = −0.004 , 95 % CI = −0.11 , 0.11 ) . Conclusions Differences in assessment and low agreement between review ers and authors suggest the need to contact authors for information not published in studies when applying the NOS in systematic review",
"OBJECTIVES To examine whether the inclusion of sarcopenia in prediction models adds any incremental value to fracture risk assessment tool ( FRAX ) . DESIGN , SETTING , AND PARTICIPANTS Data from a prospect i ve cohort of 4000 community-dwelling Chinese men and women aged 65 years and older with adjudicated fracture outcomes were analyzed . MEASUREMENTS At baseline , femoral neck bone mineral density ( BMD ) was assessed , as were the clinical risk factors included in FRAX , along with additional appendicular skeletal muscle mass , grip strength , and gait speed . Sarcopenia was defined according to the Asian Working Group for Sarcopenia algorithm . Incident fractures were documented during the follow-up period from 2001 to 2013 . RESULTS Of 4000 participants , 565 experienced at least 1 type of incident fracture and 132 experienced a hip fracture during a follow-up of 10.2 years . Hazard ratios ( HRs ) for 1-unit increase in FRAX score without BMD in men were 1.12 [ 95 % confidence interval ( CI ) 1.08 - 1.16 ] for all fractures combined and 1.19 ( 95 % CI 1.13 - 1.27 ) for hip fracture , and in women were 1.04 ( 95 % CI 1.03 - 1.06 ) for all fractures combined and 1.08 ( 95 % CI 1.06 - 1.11 ) for hip fracture . Similar to results of the FRAX score without BMD , HRs for 1-unit increase in FRAX score with BMD in men were 1.04 ( 95 % CI 1.03 - 1.06 ) for all fractures combined and 1.19 ( 95 % CI 1.13 - 1.25 ) for hip fracture , and in women were 1.04 ( 95 % CI 1.03 - 1.05 ) for all fractures combined and 1.06 ( 95 % CI 1.05 - 1.08 ) for hip fracture . Sarcopenia was significantly associated with all fractures combined ( Adjusted HR 1.87 ; 95 % CI 1.30 - 2.68 ) and hip fracture ( Adjusted HR 2.67 ; 95 % CI 1.46 - 4.90 ) in men but not in women . The discriminative values for fracture , as measured by the area under the receiver operating characteristic curve , were 0.60 - 0.73 and 0.62 - 0.76 for FRAX without and with BMD , respectively . Adding sarcopenia did not significantly improve the discriminatory capacity over FRAX ( P > .05 ) . Using reclassification techniques , sarcopenia significantly enhanced the integrated discrimination improvement by 0.6 % to 1.2 % and the net reclassification improvement by 7.2 % to 20.8 % in men , but it did not contribute to predictive accuracy in women . CONCLUSIONS Sarcopenia added incremental value to FRAX in predicting incident fracture in older Chinese men",
"OBJECTIVES To determine whether obesity concurrent with sarcopenia ( low muscle mass ) or dynapenia ( low muscle strength ) is associated with increased falls risk in middle-aged and older adults . METHODS 5-year prospect i ve cohort study including 674 community-dwelling volunteers ( mean ± SD age 61.4 ± 7.0 years ; 48 % female ) . Sarcopenia and dynapenia were defined as lowest sex-specific tertiles for dual-energy X-ray (DXA)-assessed appendicular lean mass ( adjusted for height and fat mass ) or lower-limb strength , respectively . Obesity was defined as the highest tertiles of DXA-assessed total or trunk fat mass . Change in falls risk was calculated using the Physiological Profile Assessment ( z-scores : 0 - 1 = mild increased risk ; 1 - 2 = moderate increased risk ; > 2 = marked increased risk ) . RESULTS Multivariable linear regression analyses revealed mild but significantly increased falls risk scores for dynapenic obesity ( change in mean z-score compared to non-dynapenic , non-obese group : 0.33 , 95 % CI 0.06 - 0.59 [ men ] and 0.46 , 95 % CI 0.21 - 0.72 [ women ] ) and dynapenia ( 0.25 , 95 % CI 0.05 - 0.46 [ women only ] ) . CONCLUSIONS Dynapenic obesity , but not sarcopenic obesity , is predictive of increased falls risk score in middle-aged and older adults . In clinical setting s , muscle function assessment s may be useful for predicting falls risk in obese patients",
"Objectives : Purpose To compare the performance of low muscle mass and function with falls risk , incident fracture and mortality over 10 years . Methods 1041 participants ( 50 % women ; mean age 63±7.5 years ) were prospect ively followed for 10 years . Falls risk was measured using the Physiological Profile Assessment , fractures were self-reported and mortality was ascertained from the death registry . Appendicular lean mass ( ALM ) was assessed using dual energy X-ray absorptiometry . Four anthropometric : ( ALM/height2 , ALM/body mass index , ALM/weight × 100 , a residuals method of ALM on height and total body fat ) and four performance-based measures : ( h and grip strength , lower-limb muscle strength , upper and lower-limb muscle quality ) were examined . Participants in the lowest 20 % of the sex-specific distribution for each anthropometric and performance-based measure were classified has having low muscle mass or function . Regression analyses were used to estimate associations between each anthropometric and performance-based measure at baseline and 10-year falls risk , incident fractures and mortality . Results Mean falls risk z-score at 10 years was 0.64 ( SD 1.12 ) , incident fractures and mortality over 10 years were 16 % and 14 % respectively . All baseline performancebased measures were significantly associated with higher falls risk score at 10 years . Low h and grip ( RR 1.55 , 95 % CI : 1.09 , 2.20 ) and ALM/body mass index ( RR 1.54 , 95 % CI : 1.14 , 2.08 ) were the only significant predictors of fracture and mortality respectively . Conclusions Low h and grip strength , a simple and inexpensive test could be considered in clinical setting s for identifying future falls and fractures . ALM/ body mass index could be most suitable in estimating 10-year mortality risk , but requires specialised equipment",
"Summary In this study , we compare the extent to which seven available definitions of sarcopenia and two related definitions predict the rate of falling . Our results suggest that the definitions of Baumgartner and Cruz-Jentoft best predict the rate of falls among sarcopenic versus non-sarcopenic community-dwelling seniors . Introduction The purpose of the study is to compare the extent to which seven available definitions of sarcopenia and two related definitions predict the prospect i ve rate of falling . Methods We studied a cohort of 445 seniors ( mean age 71 years , 45 % men ) living in the community who were followed with a detailed fall assessment for 3 years . For comparing the rate of falls in sarcopenic versus non-sarcopenic individuals , we used multivariate Poisson regression analyses adjusting for gender and treatment ( original intervention tested vitamin D plus calcium against placebo ) . Of the seven available definitions , three were based on low lean mass alone ( Baumgartner , Delmonico 1 and 2 ) and four required both low muscle mass and decreased performance in a functional test ( Fielding , Cruz-Jentoft , Morley , Muscaritoli ) . The two related definitions were based on low lean mass alone ( Studenski 1 ) and low lean mass contributing to weakness ( Studenski 2 ) . Results Among 445 participants , 231 fell , sustaining 514 falls over the 3-year follow-up . The prospect i ve rate of falls in sarcopenic versus non-sarcopenic individuals was best predicted by the Baumgartner definition based on low lean mass alone ( RR = 1.54 ; 95 % CI 1.09–2.18 ) with 11 % prevalence of sarcopenia and the Cruz-Jentoft definition based on low lean mass plus decreased functional performance ( RR = 1.82 ; 95 % CI 1.24–2.69 ) with 7.1 % prevalence of sarcopenia . Consistently , fall rate was non-significantly higher in sarcopenic versus non-sarcopenic individuals based on the definitions of Delmonico 1 , Fielding , and Morley . Conclusion Among the definitions investigated , the Baumgartner definition and the Cruz-Jentoft definition had the highest validity for predicting the rate of falls",
"OBJECTIVES To test the hypothesis that men and women with low bone mineral density ( BMD ) and sarcopenia have a higher risk of fracture than those with only one or neither conditions . DESIGN The Osteoporotic Fractures in Men Study and the Study of Osteoporotic Fractures in women are prospect i ve observational studies with a mean follow up of 9 ( 2000 - 2012 ) and 8 years ( 1997 - 2009 ) , respectively . SETTING U.S. clinical centers . PARTICIPANTS Men ( n = 5,544 ; mean age 73.7 ) and women ( n = 1,114 ; mean age 77.6 ) aged 65 and older , able to walk without assistance , and without bilateral hip replacement . MEASUREMENTS Sarcopenia was defined as low appendicular lean mass plus slowness or weakness and low BMD according to the World Health Organization definition of a T-score less than -1.0 . Participants were classified as having normal BMD and no sarcopenia ( 3,367 men , 308 women ) , sarcopenia only ( 79 men , 48 women ) , low BMD only ( 1,986 men , 626 women ) , and low BMD and sarcopenia ( 112 men , 132 women ) . RESULTS Men with low BMD and sarcopenia ( hazard ratio (HR)=3.79 , 95 % confidence interval (CI)=2.65 - 5.41 ) and men with low BMD only ( HR=1.67 , 95 % CI=1.45 - 1.93 ) but not men with sarcopenia only ( HR=1.14 , 95 % CI=0.62 - 2.09 ) had greater risk of fracture than men with normal BMD and no sarcopenia . Women with low BMD and sarcopenia ( HR=2.27 , 95 % CI=1.37 - 3.76 ) and women with low BMD alone ( HR=2.62 , 95 % CI=1.74 - 3.95 ) , but not women with only sarcopenia , had greater risk of fracture than women with normal BMD and no sarcopenia . CONCLUSION Men with low BMD and sarcopenia are at especially high risk of fracture . Sarcopenia alone did not increase fracture risk in either group"
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